Medication
POPULARITY
19 episodes with avastin
21 episodes with avastin
14 episodes with avastin
2 episodes with avastin
9 episodes with avastin
2 episodes with avastin
4 episodes with avastin
3 episodes with avastin
2 episodes with avastin
Next-generation anti-VEGF agents are designed for durability. But does that actually change the rate at which they're administered? David Miller, MD, joins us to review a pair of ARVO 2025 presentations that examined his clinic's real-world administration patterns for bevacizumab (Avastin, Genentech), faricimab (Vabysmo, Genentech/Roche), and high-dose aflibercept (Eylea HD, Regeneron). What were the differences—and did they really matter? Also, Robert Wang, MD, helped us understand the state of play in the TKI pipeline as he shared data from the phase 2b ODYSSEY study. What are the latest data on CLX-AX (Clearside Biomedcial)? And where does it stack up against the other TKIs in the pipeline? Stick with us to find out.
View the Show Notes Page for This Episode Become a Member to Receive Exclusive Content Sign Up to Receive Peter's Weekly Newsletter Susan Desmond-Hellmann is a physician and scientist whose remarkable career has spanned clinical medicine, oncology, biotech innovation, and global health leadership. In this episode, Susan shares insights from her journey training in internal medicine during the early AIDS crisis, treating HIV-related cancers in Uganda, and developing groundbreaking cancer therapies like Herceptin and Avastin. She reflects on her leadership roles at UCSF and the Bill and Melinda Gates Foundation, offering lessons on guiding large-scale health initiatives, navigating uncertainty, and fostering scientific innovation. The conversation explores the promise of precision medicine, the integration of patient care and policy, and the evolving role of artificial intelligence in transforming diagnostics, drug development, and global access to care. We discuss: Susan's medical training, the start of the AIDS epidemic, and the transformative experiences that shaped her career [3:00]; Susan's experience working on the frontlines of the HIV/AIDS crisis in Uganda [12:30]; Susan's time working in general oncology and her transition to biotech where she helped develop taxol—a top-selling cancer drug [26:30]; Genentech's origins, and its groundbreaking use of recombinant DNA to develop biologic drugs [33:45]; Susan's move to Genentech, and her pivotal role in the development and success of Herceptin as a groundbreaking therapy in targeted oncology [44:00]; The rise of antibody-based cancer therapies: the development of Rituxan and Avastin [52:15]; The step-by-step drug development process and the scientific and strategic challenges involved [1:01:30]; The ethical and economic controversy surrounding Avastin's high cost and limited survival benefit [1:12:30]; Susan's tenure as chancellor at UCSF: leading during a financially strained period, and her strategic approach to fundraising and institutional development [1:14:45]; What Susan learned as CEO of the Bill and Melinda Gates Foundation: strategic processes and decision-making frameworks [1:26:00]; Susan's philosophy of leadership and how she sought to build an empowering, values-driven culture at the Gates Foundation [1:35:15]; The erosion of public trust in science during COVID, the communication failures around controversial treatments like ivermectin, and the need for better public health engagement and transparency [1:39:30]; The role of AI in transforming medicine: from drug development to cancer detection and beyond [1:53:00]; and More. Connect With Peter on Twitter, Instagram, Facebook and YouTube
Episode 10 highlights examples of how patient advocacy groups influenced pharmaceutical decisions at the US Food and Drug Administration (FDA). In a conversation with health policy researcher, author and activist, Sharon Batt PhD, we explore regulatory decisions on Relyvrio (AMX0035), Avastin (bevacizumab), and Addyi (flibanserin) within the context of our latest report “What Needs to Change at the FDA?Protecting and Advancing Public Health.”Pharmanipulation is produced by PharmedOut, a project at Georgetown University Medical Center that advances evidence-based prescribing. Additional Resources Full Report “What Needs to Change at the FDA? Protecting and Advancing Public Health”: https://georgetown.box.com/s/n87us836fpmdhtcvdaqopyobfwx7bymx Webinar on “What Needs to Change at the FDA?”: https://www.youtube.com/watch?v=4g9br3wZW-k&t=11s Article on “How some drug companies manipulate patient advocates” by Judith Garber: https://lowninstitute.org/how-some-drug-companies-manipulate-patient-advocates/
In a conversation with CancerNetwork®, Marwan G. Fakih, MD, spoke about the FDA approval of sotorasib (Lumakras) plus panitumumab (Vectibix), and how it may affect the treatment paradigm for patients with KRAS G12C-mutant metastatic colorectal cancer (CRC). Fakih is a professor in the Department of Medical Oncology & Therapeutics Research, associate director for Clinical Sciences, medical director of the Briskin Center for Clinical Research, division chief of GI Medical Oncology, and co-director of the Gastrointestinal Cancer Program at City of Hope Comprehensive Cancer Center in Duarte, California. According to Fakih, the approval of this combination regimen is a “welcome step” for those with metastatic CRC harboring KRAS G12C mutations. Based on supporting data from the phase 3 CodeBreaK 300 trial (NCT05198934), sotorasib/panitumumab may prolong progression-free survival (PFS) and reduce disease burden in patients while offering improvements in other outcomes vs prior standards of care (SOC) like trifluridine/tipiracil (Lonsurf) and regorafenib (Stivarga). Topline data at the time of the approval showed a median PFS of 5.6 months (95% CI, 4.2-6.3) with sotorasib at 960 mg plus panitumumab vs 2.0 months (95% CI, 1.9-3.9) in the SOC arm, in which patients were assigned to receive trifluridine/tipiracil or regorafenib (HR, 0.48; 95% CI, 0.30-0.78; P = .005). Additionally, the overall response rate was 26% (95% CI, 15%-40%) vs 0% (95% CI, 0%-7%) in each respective arm. Looking ahead, Fakih highlighted the potential next steps for research associated with the sotorasib combination as well as other novel therapeutic strategies in the gastrointestinal cancer space. For example, he described the phase 3 CodeBreaK 301 study (NCT06252649), which will evaluate sotorasib/panitumumab as frontline therapy when administered in combination with folinic acid, fluorouracil, and irinotecan (FOLFIRI) vs FOLFIRI plus bevacizumab (Avastin) in metastatic KRAS G12C-mutant CRC. Other novel agents under development in the space include RAS inhibitors and immunotherapy regimens combining CTLA-4 inhibitors with anti–PD-L1 agents. References 1. FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer. News release. FDA. January 16, 2025. Accessed February 12, 2025. https://shorturl.at/1WviB 2. Kim TW, Price T, Grasselli J, et al. A phase 3 study of first-line sotorasib, panitumumab, and FOLFIRI versus FOLFIRI with or without bevacizumab-awwb for patients with KRAS G12C–mutated metastatic colorectal cancer (CodeBreaK 301). J Clin Oncol. 2025;43(suppl 4):TPS326. doi:10.1200/JCO.2025.43.4_suppl.TPS326
The questions answered in this podcast are listed below.They were compiled by GPs and health professionals around Australia. What are the risks posed by cardiovascular disease when you’re considering menopausal management? What do you consider high risk cardiovascular disease? For example, if a woman has a strong family history of heart disease but a zero-calcium score. Does the use of menopausal hormone therapy reduce the risk of cardiovascular disease and death? Can you diagnose menopause in a woman with amenorrhea, or very irregular periods by doing a progesterone challenge test. Any tips on how to diagnose? Is a persistent high temperature, greater than 39 degrees a vasomotor symptom, because they're suggesting that thermoregulation might be affected? Are you aware of any evidence on cannabidiol oil in treating menopausal symptoms? Can androgen deficiency cause hot flashes, fatigue or their mood? Could you provide more information on where patients can find evidence supporting the use of cognitive behavioural therapy for managing vasomotor symptoms? Additionally, it would be helpful to know if there are online services available that patients can access for this treatment How can you best treat brain fog? Is it reasonable to use different pharmacological agents that target specific symptoms, such as urinary urgency or hot flashes, before considering hormonal treatments? Is this an appropriate approach to managing symptoms? What indicators would there be for treating a woman with Vulvovaginal syndrome of menopause with something like Intrarosa dehydroepiandrosterone (DHEA) instead of Avastin or Estradiol tablets? Would you recommend or suggest starting local oestrogen creams for a patient above 60-years-old for atrophic, vaginitis or dryness? Is there any upper limit? How long can you safely use these vaginal preparations? Can you cut hormone patches when you're weaning someone off menopausal hormone therapy or when the patient just can't obtain the right dose. Is it okay to cut the patches (i.e in half, or thirds)? Why should paroxetine be avoided for the treatment of hot flushes in tamoxifen users and is there anything else we should be avoiding in these patients? Are there any effective treatments for a woman who presents between late 60-70 years old for management of hot flushes that have come back after settling and, should we be using menopause hormone therapy or starting them on non-hormonal therapy? Patient case: I've got a patient classed as BI-RADS D who's currently on menopausal hormone therapy. How should we monitor her? Patient Case: I have a few patients who are starting ashwagandha based on information from social media and blogs. Are there any research studies on its effectiveness? What exactly is ashwagandha, and is it beneficial for managing menopause symptoms? Additionally, are there any potential risks associated with its use? Is there any feedback, data or experiences supporting the efficacy of happy mammoth supplement? Selective serotonin reuptake inhibitors (SSRIs) can sometimes cause sweating as a side effect and is this ever an issue when you're trying to use it for hot flushes? Does Mirtazapine have a role in the management of vasomotor symptoms? Could you please discuss the use of Prometrium per vaginally and the recommended doses when you give it by that route? If you're on a standard or higher dose of something like Estraderm, is there a need to increase the Prometrium dosing on the higher dose? Do you need to give double the dose or give it more often? Can you please clarify the role of Tibolone in menopause, including its relative benefits and risks? I'm having trouble with resistance of some of my patients to start menopause or hormone therapy due to being told by their breast physician, surgeon, and friends that no woman with even a moderately increased risk of breast cancer should ever be on menopause hormone. How would you recommend that we advise these patients? Patient Case: I've got a 40-years-old who's perimenopausal and presents with hot flushes, mood swings, night sweats and brain fog. She has a history of Churg-Strauss syndrome. What is the best option for her treatment? Patient Case: I see lots of perimenopausal patients who have already started menopause hormone therapy and have irregular periods. However, on menopausal hormone therapy they get regular periods and they feel better, do they need contraception advice? Do you need to use contraception if you're on menopausal hormone therapy? Host: Dr Terri Foran | Total Time: 38 mins Expert: Dr Rod Baber, Obstetrician and Gynaecologist Register for our fortnightly FREE WEBCASTSEvery second Tuesday | 7:00pm-9:00pm AEDT Click here to register for the next oneSee omnystudio.com/listener for privacy information.
Join us for an in-depth discussion on the latest developments in wet age-related macular degeneration treatment. We're partnering with the American Society of Retina Specialists (ASRS) to bring you an overview of current treatment options, the impact of the Avastin shortage, and alternative treatments. We will also explore advocacy efforts by ASRS and the American Academy of Ophthalmology to address these issues.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.## Pfizer announces positive results for COVID-19 vaccinePfizer has recently announced positive results from their phase 3 clinical trial for their COVID-19 vaccine. The vaccine showed over 90% effectiveness in preventing COVID-19 in participants. This is a promising development in the fight against the pandemic.## Moderna seeking emergency use authorization for COVID-19 vaccineModerna is seeking emergency use authorization from the FDA for their COVID-19 vaccine. The vaccine has shown promising results in clinical trials and could be available to the public soon. This is another step forward in the race to develop a safe and effective vaccine against COVID-19. ## AstraZeneca facing challenges with COVID-19 vaccine trialAstraZeneca has faced challenges with their COVID-19 vaccine trial, as some participants experienced adverse reactions. The company has paused the trial to investigate these reactions and ensure the safety of the vaccine. This highlights the importance of rigorous testing and monitoring in vaccine development.## Johnson & Johnson pauses COVID-19 vaccine trialJohnson & Johnson has also paused their COVID-19 vaccine trial due to an unexplained illness in a participant. The company is investigating the illness to determine if it is related to the vaccine. This pause emphasizes the need for thorough safety monitoring in clinical trials.## Roche launches rapid antigen test for COVID-19Roche has launched a rapid antigen test for COVID-19 that provides results in just 15 minutes. The test is designed for use in point-of-care settings and can help quickly identify individuals infected with the virus. This could be a valuable tool in controlling the spread of COVID-19.## Novartis acquires Vedere BioNovartis has acquired Vedere Bio, a company focused on developing gene therapies for vision loss. This acquisition expands Novartis' capabilities in gene therapy and strengthens their position in the ophthalmology market. It also demonstrates Novartis' commitment to advancing innovative treatments for patients with vision disorders.## Gilead Sciences receives FDA approval for TrodelvyGilead Sciences has received FDA approval for Trodelvy, a treatment for metastatic triple-negative breast cancer. Trodelvy has shown promising results in clinical trials and provides a new treatment option for patients with this aggressive form of breast cancer. This approval represents an important milestone in the fight against breast cancer.## Vertex Pharmaceuticals acquires Semma TherapeuticsVertex Pharmaceuticals has acquired Semma Therapeutics, a company focused on developing cell-based therapies for diabetes. This acquisition enhances Vertex's pipeline in regenerative medicine and strengthens their commitment to finding a cure for diabetes. It also highlights the growing interest in cell therapy as a treatment approach for chronic diseases.## Eli Lilly announces positive results for Alzheimer's drugEli Lilly has announced positive results from their phase 2 clinical trial for an Alzheimer's drug targeting amyloid plaques in the brain. The drug showed a significant reduction in amyloid levels compared to placebo, indicating potential disease-modifying effects. This is a hopeful development in the search for effective treatments for Alzheimer's disease.## Amgen launches biosimilar of AvastinAmgen has launched a biosimilar of Avastin, a widely used cancer drug that targets blood vessel growth in tumors. The biosimilar, known as Mvasi, offers a more affordable alternative to Avastin while maintaining similar efficacy and safety profiles. This provides patients with greater access to critical cancer treatments at lower costs.## ConclusionIn conclusion, there have been several significant developments in the Pharma and Biotech industry recently. From promising results for COVID-19 vacci
We returned to the Hem/Onc clinic at Arkansas Children's Hospital on Monday morning, fully prepared for Hannah to be admitted so she could finally start her new chemotherapy treatments. But when her bloodwork showed a platelet level of 3,000 (normal is over 150,000), we knew we would not be starting that day. With a platelet count that low, she was at risk for excessive bleeding ... and excessive bleeding is a potential side effect of Avastin, the chemotherapy drug she would be receiving. Her red blood counts were also quite low, so instead of chemo, Hannah spent the day receiving transfusions of platelets and blood.Thank you for joining me for another bonus episode of the While We're Waiting podcast in this year-long series in which I share our family's experiences as our teenage daughter Hannah battled glioblastoma brain cancer from February 2008 through February 2009. My desire is to process through the events of those twelve months with the perspective that 16 years has brought … and point listeners to hope in Jesus along the way.I would love to hear your thoughts on the show. Click here to send me a message!** IMPORTANT** - All views expressed by guests on this podcast are theirs alone, and may not represent the Statement of Faith and Statement of Beliefs of the While We're Waiting ministry. We'd love for you to connect with us here at While We're Waiting! Click HERE to visit our website and learn about our free While We're Waiting Weekends for bereaved parentsClick HERE to learn more about our network of While We're Waiting support groups all across the country. Click HERE to subscribe to our YouTube channelClick HERE to follow our public Facebook pageClick HERE to follow us on Instagram Click HERE to follow us on Twitter Click HERE to make a tax-deductible donation to the While We're Waiting ministryContact Jill by email at: jill@whilewerewaiting.org
In today's episode, supported by Taiho Pharmaceutical, we had the pleasure of speaking with Joleen Hubbard, MD, about practice-changing updates to the colorectal cancer (CRC) treatment paradigm. Dr Hubbard is a medical oncologist at Allina Health Cancer Institute in Minneapolis, Minnesota. In our exclusive interview, Dr Hubbard discussed key efficacy and safety findings from the phase 3 SUNLIGHT trial (NCT04737187) of trifluridine-tipiracil (Lonsurf) plus bevacizumab (Avastin) in patients with refractory metastatic CRC; quality of life outcomes from this trial; and the most practice-changing updates to the National Comprehensive Cancer Network guidelines for CRC.
In 2011, the Food and Drug Administration held a hearing to review a drug previously approved for the treatment of metastatic breast cancer. The hearing was fraught with concerns over the drug's safety competing with cancer patients who felt they were alive because of the drug. Dr. Mikkael Sekeres was on the panel receiving testimony, and weighing what he heard against the long history of the FDA to make sure drugs are safe AND effective. Mikkael Sekeres is a professor of medicine and chief of the division of Hematology at the Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine. He earned a master's and medical degree in clinical epidemiology from the University of Pennsylvania School of Medicine before completing his postgraduate training at Harvard University. He has served as Director of the Leukemia Program and Vice-chair for Clinical Research at the Cleveland Clinic Cancer Center. Sekeres' new book, “Drugs and the FDA,” is set in the context of the FDA's 2011 trial for the drug Avastin. There, he examines the ways the FDA became the sole authority on medicine in the United States and the process of approving drugs.See omnystudio.com/listener for privacy information.
The Bill & Melinda Gates Foundation, with an endowment of over $50 billion, is one of the largest and most influential philanthropic organizations in the world. With a focus on addressing global health, poverty, and education, its initiatives have led to the reduction of malaria mortality by 60% over the past two decades, the near eradication of polio, increased educational opportunities of millions of students, and improved sanitation conditions for millions of people in developing countries. For six years, oncologist Sue Desmond-Hellmann, MD, MPH was the CEO of this organization. Prior to that, she served as Chancellor of the University of California at San Francisco, as well as President of Product Development at Genentech, where she oversaw the development of Herceptin, Avastin, Rituxan, and other blockbuster cancer drugs that are now staples in the arsenal of many medical oncologists.The topics of our discussion in this episode are as varied as Dr. Desmond-Hellman's career. We discuss, among other things, how seeing the work of her pharmacist father encouraged her to pursue a career in medicine, how her early experiences treating HIV patients in Uganda spurred her to tackle global health challenges, how she discovered a passion for product development in the pharmaceutical industry, how she reconciles the ethical quandaries of developing medications that can cause serious adverse effects and that can sometimes cost hundreds of thousands of dollars per dose, what her mission while at the Gates Foundation was, and her perspectives on the role of artificial intelligence and human health and well-being, now that she has joined the board of directors of OpenAI, the company behind ChatGPT.In this episode, you will hear about: 2:50 - How working in her father's pharmacy led Dr. Desmond-Hellmann to a career in medicine4:56 - A brief summary of Dr. Desmond-Hellmann's multifaceted career trajectory15:36 - What the day to day work of pharmaceutical drug development looks like 18:30 - The challenging ethical concerns that surround drug approvals especially as it pertains to safety concerns23:44 - Dr. Desmond-Hellmann's experiences in Uganda that forever transformed her views on poverty 27:55 - The aims of the Gates Foundation 30:47 - How Dr. Desmond-Hellmann views her work both in the non-profit and the for-profit sectors 37:15 - Dr. Desmond-Hellmann's mission when she took on a leading role at The Gates Foundation 38:38 - How Dr. Desmond-Hellmann thinks about shaping the future of AI as she takes a seat on the board of OpenAI45:14 - Dr. Desmond-Hellmann's advice for medical trainees and clinicians on how to navigate the many opportunities available to them along their career pathDr. Sue Desmond-Hellmann can be found on Twitter/X @suedhellmann.Visit our website www.TheDoctorsArt.com where you can find transcripts of all episodes.If you enjoyed this episode, please subscribe, rate, and review our show, available for free on Spotify, Apple Podcasts, or wherever you get your podcasts. If you know of a doctor, patient, or anyone working in health care who would love to explore meaning in medicine with us on the show, feel free to leave a suggestion in the comments or send an email to info@thedoctorsart.com.Copyright The Doctor's Art Podcast 2024
Synopsis: In this episode of Biotech2050, Dr. Ted Love, former CEO of Global Blood Therapeutics and Current Chairman of BIO, shares insights on sickle cell breakthroughs, transitioning from academia to research, navigating a tight funding environment, and protecting an innovative ecosystem to benefit patients. Biography: Dr. Ted Love is the chair of the Board of Directors at the Biotechnology Innovation Organization (BIO), a position he assumed in June 2023. A long-time BIO Board Member, Dr. Love has focused on championing access to care, standing up for science, and improving the narrative around the biopharma industry. Dr. Love previously served as president and chief executive officer of Global Blood Therapeutics (GBT). During his tenure at GBT, Dr. Love led the company from a pre-clinical start-up, through the accelerated approval and launch of Oxbryta®, and into a global commercial company with an advanced pipeline of innovative therapies focused on sickle cell disease. Prior to GBT, Dr. Love was executive vice president, research and development and technical operations, at Onyx Pharmaceuticals, Inc., where he played an instrumental role in the accelerated approval of Kyprolis® for multiple myeloma, and the subsequent purchase of Onyx by Amgen. Previously, Dr. Love served as president, chief executive officer and chairman of Nuvelo, Inc., and as senior vice president, development, at Theravance, Inc. Dr. Love began his biotech career at Genentech in 1992, where he held several senior management positions in clinical science and product development, and ultimately as chairman of Genentech's Product Development Committee. As vice president, product development, Dr. Love oversaw the development strategy and execution leading to approvals of Rituxan®, Herceptin®, Xolair®, TNKase®, Raptiva® and Avastin®. Prior to Genentech, Dr. Love was a member of the Department of Cardiology at the Massachusetts General Hospital. Dr. Love currently serves on the boards of directors of Royalty Pharma and Structure Therapeutics. Dr. Love holds a B.A. in molecular biology from Haverford College and an M.D. from Yale Medical School. He completed a residency in internal medicine and a fellowship in cardiology at the Massachusetts General Hospital.
Dr. Mikkael Sekeres is the author of the book The Drugs and FDA. He served as the chair of the Oncology Drugs Advisory Committee of the FDA, and was on the jury for the controversial trial of the breast cancer drug Avastin. We discuss: - The history of the FDA, - The trial of Avastin which got FDA approval in 2008 and revoked in 2011 - FDA's funding mechanisms - FDA ties to big pharma - What can be improved about the FDA and the criticisms it receives Episode Show Notes: https://livelongerworld.com/p/msekeres TIMESTAMPS: 0:00 Surprising finding about the FDA 2:38 Why did the FDA get established in 1938? 11:48 1962 turning point in the FDA & Thalidomide 19:57 Kennedy's efficacy act on drugs approval 25:40 FDA's accelerated approval; HIV & AIDS 33:23 Avastin breast cancer drug controversy 41:13 Why was Avastin trial contentious? 45:23 Genentech's argument 50:00 Media reaction 53:21 FDA funded by big pharma 56:39 FDA vs. patient activist groups 59:50 Opioid crisis 1:03:30 Does the FDA go against advisory committee? CONNECT WITH AASTHA, LIVE LONGER WORLD: Twitter: https://twitter.com/aasthajs Newsletter: https://livelongerworld.com/ Instagram: https://www.instagram.com/aasthajs/ Airchat: https://www.getairchat.com/aasthajs DR. MIKKAEL SEKERES LINKS: Website: https://www.mikkaelsekeres.com/ Twitter: https://twitter.com/MikkaelSekeres Book: https://www.amazon.com/Drugs-FDA-Safety-Efficacy-Publics/dp/0262047314 If you enjoyed the episode, please share it and leave a rating. Best, Aastha.
After the 2024 Gastrointestinal Cancers Symposium, Jun Gong, MD, and Daneng Li, MD, sat down to discuss the most relevant trial data to have come from the conference. They convened for a live X Space hosted by CancerNetwork®. During the discussion, they covered different trials across the gastrointestinal space, which included those evaluating different disease states from hepatocellular carcinoma (HCC) to colorectal cancer (CRC), and those assessing circulating tumor DNA (ctDNA) dynamics. Gong, a hematologic oncologist focusing on gastrointestinal and genitourinary cancers at Cedars-Sinai Medical Center, and Li, an associate professor in the Department of Medical Oncology and Therapeutics Research at City of Hope, each gave their perspective on the clinical trial data and discussed if they had implemented any of these study treatments into clinical practice. The studies they covered included: 1. Phase 3 NETTER-2 Trial (NCT03972488)1: - Investigated lutetium Lu 177 dotatate (Lutathera) plus octreotide vs octreotide alone for advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). - Lutetium Lu 177 significantly improved progression-free survival (PFS) and overall response rate (ORR) compared with octreotide alone. - The agent may be considered for patients with high-grade GEP-NETs who desire significant tumor shrinkage. 2. Phase 3 EMERALD-1 Trial (NCT03778957)2: - Studied transarterial chemoembolization (TACE) plus durvalumab (Imfinzi) with or without bevacizumab (Avastin) for unresectable HCC. - Durvalumab/bevacizumab plus TACE improved PFS compared with placebo plus TACE. - TACE may be preferred over transarterial radioembolization (TARE) due to faster patient recovery. 3. Phase 3 CheckMate-8HW Trial3: - Evaluated nivolumab (Opdivo) plus ipilimumab (Yervoy) vs chemotherapy for first-line treatment of microsatellite instability-high/mismatch repair deficient metastatic CRC. - Nivolumab/ipilimumab demonstrated superior PFS compared with chemotherapy. - Chemotherapy may no longer be the standard first-line treatment for this patient population. 4. BESPOKE Study (NCT04264702)4: - Assessed the impact of minimal residual disease (MRD) detected by ctDNA on disease recurrence in patients with stage II and III CRC receiving adjuvant chemotherapy. - MRD positivity was associated with worse disease-free survival (DFS). - ctDNA clearance at 12 weeks indicated improved DFS. 5. GALAXY Trial5: - ctDNA is a promising biomarker that can be used to predict recurrence in patients with CRC. - Patients with ctDNA-positive disease had a worse DFS than patients with ctDNA-negative disease. - This suggests that ctDNA may be useful for making treatment decisions, but more research is needed before it can be used in clinical practice. 6. Phase 3 FRESCO-2 Trial (NCT04322539)6: - Fruquintinib (Fruzaqla) improved the quality of life in patients with metastatic CRC when combined with best supportive care and significantly improved quality-adjusted time without symptoms of disease or toxicity compared with placebo and best supportive care. - The study showed positive effects on PFS, response rate, disease control, and duration of response with the fruquintinib combination. - The findings from this trial supported the FDA approval of fruquintinib for metastatic CRC in November 2023.7 References 1. Singh S, Halperin D, Myrehaug S, et al. [177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: primary analysis of the phase 3 randomized NETTER-2 study. J Clin Oncol. 2024(suppl 3):LBA588. doi:10.1200/JCO.2024.42.3_suppl.LBA588 2. Lencioni R, Kudo M, Erinjeri J, et al. EMERALD-1: a phase 3, randomized, placebo-controlled study of transarterial chemoembolization combined with durvalumab with or without bevacizumab in participants with unresectable hepatocellular carcinoma eligible for embolization. J Clin Oncol. 2024;42(suppl 3):LBA432. doi.10.1200/JCO.2024.42.3_suppl.LBA432 3. Andre T, Elez E, Van Cutsem E, et al. Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) as first-line (1L) treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): First results of the CheckMate 8HW study. J Clin Oncol. 2024;42(suppl_3):LBA768. doi.10.1200/JCO.2024.42.3_suppl.LBA768 4. Kasi P, Aushev V, Ensor J, et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): interim analysis of BESPOKE CRC study. J Clin Oncol. 2024;42 (suppl _3):9. doi:10.1200/JCO.2024.42.3_suppl.9 5. Yukami H, Nakamura Y, Mishima S, et al. Circulating tumor DNA (ctDNA) dynamics in patients with colorectal cancer (CRC) with molecular residual disease: Updated analysis from GALAXY study in the CIRCULATE-JAPAN. J Clin Oncol. 2024;42(suppl_3):6. doi:10.1200/JCO.2024.42.3_suppl.6 6. Stintzing S, Tabernero J, Satoh T, et al. Quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) analysis of fruquintinib + best supportive care (BSC) compared with placebo + BSC in metastatic colorectal cancer (mCRC): results from the FRESCO-2 trial. J Clin Oncol. 2024;42(suppl 3):116. doi:10.1200/JCO.2024.42.3_suppl.116 7. FDA approves fruquintinib in refractory metastatic colorectal cancer. FDA. News release. November 8, 2023. Accessed February 7, 2024. https://shorturl.at/isJW2
It's been a busy few weeks here at CURE® and in the oncology space as a whole, as the last two weekends had back-to-back meetings: the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium, and then their Genitourinary Cancers Symposium. Here are some highlights from the conference, but as always, you can find all of our coverage at curetoday.com. Gastrointestinal Cancers Symposium Imfinzi, Avastin, TACE May ‘Set a New Standard of Care' in Liver Cancer For patients with liver cancer whose disease is not eligible to be removed via surgery, adding Imfinzi and Avastin to transarterial chemoembolization — also known as TACE — tended to lengthen the time patients lived before their disease got worse, according to findings from the EMRALD-1 trial. These improvements in progression-free survival over TACE alone could lead to a new standard of care for this patient population, according to the lead study author, Dr. Riccardo Lencioni. More specifically, patients who received Imfinzi and Avastin plus TACE lived for a median of 15 months before death or disease worsening, compared to 8.2 months for patients who received TACE alone. This correlates to a 23% reduction in the risk of disease progression or death, and benefits were seen across different patient subgroups. Notably, the researchers on EMRALD-1 are still monitoring how the addition of the two drugs impacts overall survival. Once those data become more clear, it is possible that the drug manufacturers could submit this regimen to the FDA for approval, thereby officially shaking up the standard of care of TACE, which has remained the main treatment in this setting for about two decades. Cancer in Bloodstream May Predict CRC Outcomes Circulating tumor DNA — also known as ctDNA — was another hot topic at the Gastrointestinal Cancers Symposium. So ctDNA measures little fragments of cancer that are found in the bloodstream after cancer treatment. Now, findings from the BESPOKE trial highlight the fact that ctDNA may offer insight into the recurrence risk in patients with stage 2/3 colorectal cancer who underwent surgery and then chemotherapy. The researchers used ctDNA to help determine minimal residual disease, or MRD, status. Essentially, patients with disease still detected in the blood stream were MRD positive, while those without detectable cancer were MRD negative. Findings showed that those with MRD negativity tended to live longer without experiencing relapse or death compared to patients with MRD positivity. Genitourinary Cancers Symposium Survival Benefits with Keytruda and Padcev in Advanced Urothelial Cancer Back in December, the Food and Drug Administration approved Padcev plus Keytruda for patients with previously treated locally advanced or metastatic bladder cancer. The approval was based on primary findings from the EV-302 trial. Now, updated findings from that trial are showing that the drug duo continues to outperform chemotherapy when it comes to progression-free survival — that's the time patients live before their disease gets worse — as well as overall survival, which is the time patients live before death of any cause. Notably, these survival benefits were seen across patient subgroups, such as those with visceral metastases and lymph node-only disease. According to the lead study author, Dr. Michiel S. Van Der Heijden, this could result in a new standard of care in patients with locally advanced or metastatic urothelial carcinoma. Many Patients Miss Out on Testing to Guide Prostate Cancer Treatment On the prostate cancer front, a study found that many people with metastatic castration-resistant prostate cancer are not undergoing germline or somatic testing. Now this is really important because back in 2020, two PARP inhibitors were approved in this setting. These are targeted drugs approved for patients whose cancers have certain characteristics, which can be determined by these types of tests. Rates of germline and somatic testing have increased since the FDA approvals, but according to the study — which looked at real-world evidence of patients being treated in community cancer and urology centers — about 40% of patients did not undergo standard-of-care testing. Study author, Dr. Neal Shore, said that this indicates the need for improved education on the importance of germline and somatic testing. For more news on cancer updates, research and education, don't forget to subscribe to CURE®'s newsletters here.
El edema macular diabético es una complicación frecuente de la diabetes, en la que el daño a los vasos sanguíneos de la parte posterior del ojo provoca inflamación. Lucentis, Eylea y Avastin son tres fármacos antiangiogénicos que pueden inyectarse en el ojo para tratar estos vasos sanguíneos y reducir la inflamación y recientemente han aparecido fármacos con efectos más duraderos, como Vabysmo y Beovue. En junio de 2023 se actualizó una revisión Cochrane sobre estos medicamentos y se utilizó un metanálisis en red para comparar sus efectos. En este podcast se habla sobre sus hallazgos. Este podcast ha sido traducido por Yasmín García y locutado por Andrea Cervera del Centro Cochrane Iberoamericano.
El edema macular diabético es una complicación frecuente de la diabetes, en la que el daño a los vasos sanguíneos de la parte posterior del ojo provoca inflamación. Lucentis, Eylea y Avastin son tres fármacos antiangiogénicos que pueden inyectarse en el ojo para tratar estos vasos sanguíneos y reducir la inflamación y recientemente han aparecido fármacos con efectos más duraderos, como Vabysmo y Beovue. En junio de 2023 se actualizó una revisión Cochrane sobre estos medicamentos y se utilizó un metanálisis en red para comparar sus efectos. En este podcast se habla sobre sus hallazgos. Este podcast ha sido traducido por Yasmín García y locutado por Andrea Cervera del Centro Cochrane Iberoamericano.
Diabetic macular oedema is a common complication of diabetes, in which damage to the blood vessels at the back of the eye leads to swelling. Lucentis, Eylea and Avastin are three antiangiogenic drugs that can be injected into the eye to treat these blood vessels and reduce the swelling; and drugs with longer lasting effects have recently become available, such as Vabysmo and Beovue. In June 2023, Katie Curran from Queen's University Belfast in the UK and colleagues, updated their Cochrane review of these drugs and used a network meta-analysis to compare their effects. Here's Katie to tell us more.
Diabetic macular oedema is a common complication of diabetes, in which damage to the blood vessels at the back of the eye leads to swelling. Lucentis, Eylea and Avastin are three antiangiogenic drugs that can be injected into the eye to treat these blood vessels and reduce the swelling; and drugs with longer lasting effects have recently become available, such as Vabysmo and Beovue. In June 2023, Katie Curran from Queen's University Belfast in the UK and colleagues, updated their Cochrane review of these drugs and used a network meta-analysis to compare their effects. Here's Katie to tell us more.
Ritu Salani, MD, and Tanios S. Bekaii-Saab, MD, FACP, spoke with CancerNetwork® about key findings presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, and how they may affect clinical practice for gynecologic cancer and gastrointestinal cancer. Salani, the Gynecologic Oncology Fellowship Director at University of California Los Angeles (UCLA) Health and the Gynecologic Oncology editorial board member for the journal ONCOLOGY®, discussed presentations on the treatment of ovarian cancer and other gynecologic malignancies. These included data on dostarlimab-gxly (Jemperli) in advanced or recurrent endometrial cancer in the phase 3 RUBY trial (NCT03981796), mirvetuximab soravtansine-gynx (Elahere) in folate receptor alpha–high platinum-resistant ovarian cancer in the phase 3 MIRASOL trial (NCT04209855), and a bevacizumab (Avastin)-based regimen in newly diagnosed ovarian cancer in the phase 3 DUO-O trial (NCT03737643). Bekaii-Saab, leader of the Gastrointestinal Cancer Program at the Mayo Clinic Comprehensive Cancer Center; medical director of the Cancer Clinical Research Office; vice chair/section chief for Medical Oncology, Department of Internal Medicine, at Mayo Clinic, Phoenix, Arizona; and the Gastrointestinal Cancer chair for the ONCOLOGY® tumor board, detailed findings from presentations in the gastrointestinal cancer space. He discussed data on fam-trastuzumab deruxtecan-nxki (Enhertu) in HER2-positive metastatic colorectal cancer (CRC) in the phase 2 DESTINY-CRC02 study (NCT04744831), sotorasib (Lumakras) in advanced solid tumors with KRAS G12C mutations in the phase 1b/2 CodeBreaK 101 trial (NCT04185883), and bevacizumab plus atezolizumab (Tecentriq) in metastatic CRC in the phase 2 AtezoTRIBE trial (NCT03721653). Don't forget to subscribe to the “Oncology On-The-Go” podcast on Apple Podcasts, Spotify, or anywhere podcasts are available.
Robert Avery, MD, CEO of California Retina Consultants, balances roles as physician and researcher with a lucrative additional career: advising life sciences companies and ophthalmology focused venture capital funds. With colleague and podcast host Firas Rahhal, MD, Dr. Avery talks about how he got into the business side of medicine. He also looks back over 30 years of retina, which includes pioneering the use of anti-VEGF agents for retinal disease.Looking forward, Dr. Avery shares his views on what's on the horizon for drug delivery platforms. And for the drug and device developers in the audience, he discusses how to leverage scientific advisory boards to gain valuable, practical insight.Listen to the podcast today to discover:How Dr. Avery built his clinical research practice in Santa Barbara, California. It's home to University of California Santa Barbara, a Tier 1 research university, but otherwise not a primary center for clinical trials.Tales from the early days of Avastin, including how Dr. Avery helped get the drug approved for off-label use to treat age-related macular degeneration. That it was approved for off-label use before Lucentis received FDA approval helped it become part of the standard of care.How Dr. Avery balances clinical practice with advisory roles and how these dual careers benefit one another.His prediction on emerging drug delivery platforms.What it takes to advise an investment group on drugs and devices as they relate to clinical practice. In other words, will doctors use this?Hit “Play” to Listen.
What happens when the FDA approves a drug that doesn't work? Say it gets accelerated approval from the regulatory body, but further clinical trials demonstrate a lack of efficacy. Normally, the agency requests that the company take their drug off the market, the company does so, and so the wheel turns. But when post-approval clinical trials showed that Genentech's blockbuster breast cancer drug Avastin was killing women, the company broke with more than a century of tradition, and declined to take their drug off the market. We talk with Miami University's Mikkael Sekeres about his experience sitting on the jury for the trial that denied Genentech's right to keep selling Avastin to breast cancer patients, regulatory capture, care for the dying, gamesmanship at the FDA and much, much more. Support the scientific revolution with a monthly donation: https://bit.ly/3lcAasB Or buy Dr. Sekeres' book, Drugs and the FDA: https://amzn.to/3QuIiUk #medicine #fda #cancer Check our short-films channel, @DemystifySci: https://www.youtube.com/c/DemystifyingScience AND our material science investigations of atomics, @MaterialAtomics https://www.youtube.com/@MaterialAtomics Join our mailing list https://bit.ly/3v3kz2S PODCAST INFO: Anastasia completed her PhD studying bioelectricity at Columbia University. When not talking to brilliant people or making movies, she spends her time painting, reading, and guiding backcountry excursions. Michael Shilo also did his PhD at Columbia studying the elastic properties of molecular water. When he's not in the film studio, he's exploring sound in music. They are both freelance professors at various universities. - Blog: http://DemystifySci.com/blog - RSS: https://anchor.fm/s/2be66934/podcast/rss - Donate: https://bit.ly/3wkPqaD - Swag: https://bit.ly/2PXdC2y SOCIAL: - Discord: https://discord.gg/MJzKT8CQub - Facebook: https://www.facebook.com/groups/DemystifySci - Instagram: https://www.instagram.com/DemystifySci/ - Twitter: https://twitter.com/DemystifySci MUSIC: -Shilo Delay: https://g.co/kgs/oty671
Drugs and the FDA: Safety, Efficacy & The Public Trust- Miami Book Fair author Dr. Mikkael Sekeres Mikkael Sikeres, a respected cancer specialist, professor, author and former chair of the FDA's drug advisory committee, explores the Food and Drug Administration's mission, global health crises, patient advocates and politics of the pharmaceutical industry today. While this book primarily tackles the case of the drug Avastin used to treat breast cancer patients, he also covers some inbuilt conflicts of interest between demands for protecting patients and speed of offering potential treatments. Join us to hear if Dr. Sekeres believes the system of checks and balances works or not.
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/new-books-network
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/political-science
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/medicine
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/american-studies
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/public-policy
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/drugs-addiction-and-recovery
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices
In this episode, Ayesha discussed the FDA approval of two new immunotherapies, including Janssen/Johnson & Johnson's bispecific antibody Tecvayli for the treatment of relapsed or refractory multiple myeloma. The drug is the first bispecific T cell antibody to be approved in the US. It is indicated as a fifth line treatment for multiple myeloma patients who have received four or more prior treatments. Find out more about the bispecific antibody and about trials evaluating it in combination with other drugs to potentially move up its treatment line.Ayesha also talked about the FDA approval of AstraZeneca's immunotherapy Imjudo for hepatocellular carcinoma (HCC), which is the most common type of liver cancer. The drug is indicated for use in combination with AstraZeneca's PD-L1 inhibitor Imfinzi in adult patients with unresectable HCC. The new drug combination will be going up against Roche's combo of Tecentriq and Avastin, which recently became the standard of care for HCC. Despite this, the Imjudo and Imfinzi approval offers another promising treatment option for HCC patients and is the first dual immunotherapy treatment regimen for this indication.Read the full articles here:Multiple Myeloma Drug Tecvayli Becomes First FDA-Approved Bispecific T Cell AntibodyAstraZeneca's Immunotherapy Imjudo (tremelimumab) Wins FDA Approval for Liver CancerFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured
On episode 150, we welcome Dr. Mikkael Sekeres to discuss the social and political climate that fostered the necessity to create the FDA, medical charlatans and the history of pseudo-medicine, the necessity of clinical trials for creating safe and effective medications, why anecdotal evidence isn't equivalent to scientific validation, the FDA's decision to remove the breast cancer indication for the drug Avastin and Genentech's decision to fight it, Mikkael's personal experience during that hearing while a member of the jury, the public's distrust of the FDA and where it stems from, Genentech spin-doctoring data to make their case for the safety and efficacy of Avastin, why mostly harmful medications should be removed from circulation if proven so, and how the FDA decides on which drugs to approve and which ones to recommend removing. Dr. Mikkael A. Sekeres is Professor of Medicine and Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, and former Chair of the Oncologic Drugs Advisory Committee of the FDA. He is the author or co-author of over 400 manuscripts and 650 abstracts published in leading journals such as NEJM, Blood, Journal of Clinical Oncology, Nature Genetics, Cancer Cell, Journal of the National Cancer Institute, Journal of Clinical Investigation, PLoS One, and Leukemia. A regular contributor to the Well section of the New York Times, has authored 8 books, including When Blood Breaks Down: Life Lessons from Leukemia and his newest book, available now, is called Drugs and the FDA: Safety, Efficacy, and the Public's Trust. | Mikkael Sekeres | ► Website | https://bit.ly/3UetF8h ► Twitter | https://twitter.com/MikkaelSekeres ► Drugs and the FDA Book | https://amzn.to/3Df18IA Where you can find us: | Seize The Moment Podcast | ► Facebook | https://www.facebook.com/SeizeTheMoment ► Twitter | https://twitter.com/seize_podcast ► Instagram | https://www.instagram.com/seizethemoment ► TikTok | https://www.tiktok.com/@seizethemomentpodcast ► Patreon | https://www.patreon.com/user?u=32208666
In this JCO Precision Oncology Conversations podcast, JCO PO author Dr. Thanh Dellinger of City of Hope National Medical Center shares insights into the research published in her article, “Hyperthermic Intraperitoneal Chemotherapy–Induced Molecular Changes in Humans Validate Preclinical Data in Ovarian Cancer.” Podcast host Dr. Abdul Rafeh Naqash talks with Dr. Dellinger about hyperthermic intraperitoneal chemotherapy (HIPEC) and the various challenges of the treatment of epithelial ovarian cancer (EOC). The study described in this JCO PO article discusses protein expression, RNAseq alterations and signature, and whole-transcriptome sequencing and signatures. Read here https://ascopubs.org/doi/full/10.1200/PO.21.00239 TRANSCRIPT Dr. Abdul Rafeh Naqash: Welcome to ASCO's Precision Oncology Conversations where we bring you the highlights and overview of precision oncology. This podcast is here to provide interactive dialogue focusing on the excellent research published in the JCO Precision Oncology. Our episodes will feature engaging conversations regarding precision oncology with the authors of a clinically relevant and highly significant JCO Precision Oncology article. You can find all our shows including this one at asco.org/podcasts, or wherever you get your podcasts. Hello, I am Dr. Abdul Rafeh Naqash. I'm a medical oncologist and a phase one clinical trialist at the OU Stephenson Cancer Center. You're listening to JCO Precision Oncology Conversations. I have no conflicts of interest related to this podcast. A complete list of disclosures is available at the end of each episode. Today, I will be talking with Dr. Thanh Dellinger from the City of Hope Comprehensive Cancer Center, who's a gynecological oncologist, and we'll be talking about her JCO Precision Oncology article, ‘Hyperthermic Intraperitoneal Chemotherapy-Induced Molecular Changes in Humans Validate Preclinical Data in Ovarian Cancer.' Dr. Dellinger does not have any conflicts of interest. Hi, Dr. Dellinger, welcome to our podcast! Dr. Thanh Dellinger: Hi, Dr. Naqash! It's such a pleasure to be on with you. Dr. Abdul Rafeh Naqash: We recently saw your paper published. It's one of those interesting, clinical translational papers that we felt needed to be highlighted in our Precision Oncology Podcast series. So, we're really excited to have you here today to take a deeper dive into the findings and some of the novel approaches that you used in your recent publication. So, for starters, could you give our listeners a brief idea of what HIPEC is, where it's used, and when it's used in ovarian cancer? Dr. Thanh Dellinger: Right! Thank you very much for this great introduction. So, HIPEC or Hyperthermic Intraperitoneal Chemotherapy has been used in ovarian cancer for quite some time. The most relevant data giving us an indication for ovarian cancer was published by Dr. van Driel in the OVHIPEC-1 randomized trial several years ago in the New England Journal of Medicine, which demonstrated that in stage 3 ovarian cancer patients who undergo an interval tumor debulking with HIPEC, that those patients appear to enjoy both progression-free and overall survival benefit. In fact, the overall survival benefit is nearly 12 months for those patients. So, with this in mind and a number of other data, the HIPEC treatment for those patients that interval debulking has been incorporated into the NCCN guidelines. Nonetheless, there have been some criticisms of HIPEC and it still remains to be seen who those patients are, the ovarian cancer patients who really best benefit from HIPEC, given the morbidity of HIPEC. We now know also that HIPEC is probably equivalent to just cytoreductive surgery alone in terms of morbidity. Dr. Abdul Rafeh Naqash: Thank you for that explanation. And especially for people like myself, who are not surgeons or gynecological oncologists, that was very helpful. So, my next question, and you probably partly answered it, but I'm going to still ask the question is: what is the reason you think that intraperitoneal chemotherapy overall, has not been as widely adopted? Dr. Thanh Dellinger: You touch on a very good point there. As many of the listeners may understand, IP chemotherapy has demonstrated a lot of efficacies in multiple clinical trials over the last decade or two decades even. And part of why, despite its benefit, it has not been taken up in the overall community may really be the difficulty and the complexity of doing IP chemotherapy in the community, especially the side effects are difficult sometimes to take care of. There's increased abdominal pain and there are catheter issues. And so, especially with more recent data, that with the presence of Avastin, IP chemotherapy may not necessarily be as beneficial. Unfortunately, IP chemotherapy hasn't been really taken up in daily oncologic care with ovarian cancer. Nonetheless, we know that there are a lot of theoretical benefits because of the peritoneal metastasis not being as best treated with intravenous chemotherapy as with regional therapy. Dr. Abdul Rafeh Naqash: Thank you! So, now going to the data that you published. I was very intrigued with some of the findings. And from what I understood, your main aim was to understand predictive biomarkers to identify patients or basically identify molecular characteristics for patients' selection for HIPEC. So, could you tell us more about why you initiated this study? And I understand this is one of the, I believe the first study in humans to evaluate some of these interesting biomarkers, both pre- and post-. So, what was the background of doing this trial? And what led to this interesting study? Dr. Thanh Dellinger: Thank you for pointing out this aim. There's a lot of criticism of HIPEC and part of it is that we may not exactly understand the mechanisms of HIPEC, why is it that it works so well in some patients? There's a lot of preclinical data supporting hyperthermia, especially with cisplatin. There's synergy between cisplatin and hyperthermia, and improving the DNA adduct formation. There's increased cytotoxicity seen when the temperature increases up to 43 degrees. And there's also a T-cell activation and immune response that occurs during hyperthermia. So, a lot of this, however, has been done in preclinical studies, in vitro data as well as preclinical mouse models. There hasn't been much or really anything published that, as far as I know, has been done in humans. And so, this particular study looked at both pre-treatments, pre-HIPEC specimens, peritoneal biopsies, as well as immediate post-operative peritoneal biopsies, tumors, and normal samples, and we wanted to look both at the whole transcriptomic sequencing profile, but also at the tumor microenvironment. Dr. Abdul Rafeh Naqash: From a logistic standpoint, from a trial design standpoint, was this a phase 1 study? I know you use the term pilot in the publication. So, were you trying to look at safety also, or was this primarily I would say, a biomarker, pharmacodynamic biomarker-driven study that you were trying to evaluate? Dr. Thanh Dellinger: You're correct. This was essentially a feasibility study. But we additionally looked at safety and feasibility with HIPEC at our institution. And in some respects, we also looked at the feasibility of giving intraperitoneal chemotherapy normothermically early after HIPEC, and so it was also an endpoint to look at safety. Dr. Abdul Rafeh Naqash: Understand! I believe there was some difference in the dose for the cisplatin, I believe, is the chemotherapy that you use. What was the rationale for the difference in the dose for 75 milligrams per meter square that you use in your study? Dr. Thanh Dellinger: The study was initiated at a time before the OVHIPEC-1 trial was published. And so, at that time, the HIPEC dose for cisplatin was still not established. 75 milligrams per meter square for cisplatin was actually used in other trials, and has been noted to be effective in other clinical trials. Dr. Abdul Rafeh Naqash: Thank you! Now going to the patient population for this trial. What type of patients were you enrolling? Was it just epithelial ovarian cancer patients, did these patients need to have peritoneal metastases when you were doing this cytoreductive surgery? What was the patient population that you were targeting in this trial? Dr. Thanh Dellinger: The majority of the patients did have epithelial ovarian cancer. We did enroll a few, actually 5, uterine cancer patients as well, which were not included in this specific publication. But the majority of them were epithelial ovarian cancer patients. Dr. Abdul Rafeh Naqash: Going to the interesting translational analysis. So, you had three subsets of patients based on the biopsy collection. What were your hypotheses, and what drove some of those translational studies to understand the biomarkers? Dr. Thanh Dellinger: The first translational analysis we conducted was the whole transcriptomic sequencing, and specifically, we wanted to look, one, for any potential transcriptomic signatures that may correlate with survival or improved response to HIPEC. The second one was to look at whole exome sequencing. Thirdly, we looked at whole transcriptomic sequencing differences before and after HIPEC treatment. And lastly, we looked at the tumor microenvironment through multiplexing of certain markers associated with T-cell response. Dr. Abdul Rafeh Naqash: From a clinical outcome standpoint - and we'll discuss the biomarkers in more detail - from a clinical standpoint, when I briefly looked over the PFS curves, were the results, as far as expected outcomes, were they similar to what you see with the current standard? Or were there any unusual safety signals? Or would you attribute any of the adverse events that you saw to intraperitoneal chemotherapy specifically? Because I believe some patients did have some chemotherapy pre-surgery, neoadjuvant if I'm correct. So, how would you attribute some of those AEs, and if at all, did you see any interesting safety signals of concern and outcomes as far as PFS is concerned? Dr. Thanh Dellinger: So, one of the major toxicities that we saw in the first half of our trial were actually renal toxicities. In fact, there were actually two patients who could not go on to adjuvant chemotherapy because they suffered chronic renal failure. And because of that, halfway through the trial, we did actually add a nephro protectant called sodium thiosulfate. And this actually dramatically improved those renal toxicities. And for the second half of our study, no patients suffered grade three or grade four renal adverse events. And so, that did change significantly. Dr. Abdul Rafeh Naqash: From a genomic standpoint, it's very interesting that you were able to do all these very cool and interesting translational biomarker studies, including multiplex immunofluorescence. From a genomic standpoint, though, would you say it's fair to say that there was no significant correlation based on the baseline genomics for some of the patients and their outcomes? Is that a fair assessment? Dr. Thanh Dellinger: Yes, that is a very fair assessment. I think that our cohort was really too small to make those kinds of assessments. I don't know whether you saw there recently was a paper published by the OVHIPEC-1 group looking at their cohort of over 200 patients that underwent the interval cytoreductive surgery in HIPEC and they did actually demonstrate benefit in patients who are HIV-positive but BRCA wild-type, but not necessarily in BRCA mutated patients. So, I think that I would point to that study to look for genomic effects with HIPEC patients. Dr. Abdul Rafeh Naqash: Understand. Now, again, going to the biomarkers that your team evaluated, it seems from among good responders especially, you saw an increase in tumor necrosis factor, alpha signaling, NF-kappa B signaling, KRAS signaling, and then you also saw some pathways that were downregulated, especially the G2-M checkpoint, and Myc targets. What would you say the correlation of these is in terms of future drug development in this specific setting? Dr. Thanh Dellinger: I think that we did see some increase in immune pathways in patients who did better in the end. And also, our multiplex results did demonstrate that E1 expression was increased in patients who had better responses after HIPEC. So, our hypothesis is that potentially, there's an activation of T-cell response with HIPEC and that potentially PD-1 inhibitor could be added in the future. This is a hypothesis that certainly would need to have more work, but it's something that is interesting enough to really look at in ways of how to improve HIPEC. Dr. Abdul Rafeh Naqash: Going to your point on the PD-1, I found really intriguing that you were able to see an increase in PD-1 expression on CD8+ T cells but no actual increase in the number of CD8+ T cells suggesting there's some sort of activation of this marker and this may not necessarily be a marker for T-cell exhaustion. So, would you interpret it in a way that in a different setting, perhaps a new adjuvant approach with immunotherapy, would perhaps somehow augment this and then you could see more upregulation? Is there any work being done in that field? How would you put this in the context of your findings? Dr. Thanh Dellinger: You bring up a really great point because to date HIPEC has been demonstrated to have benefit in the interval setting. But there was a more recent study done by, well not recent, a more recently published study by a Korean group that demonstrated no benefit in the adjuvant setting for HIPEC and still some benefit in the interval setting. And the question is, are these really two different types of cohorts who respond differently because of potential differences in immune response and tumor microenvironment? I think that that would be a great way of delving further into this. What are really the differences in tumor microenvironment changes in those two different settings? Dr. Abdul Rafeh Naqash: Definitely! It's very exciting. You've also shown upregulation of, as you mentioned earlier, immune pathways, as well as upregulation of genes related to heat shock proteins. Does that play into future drug development as far as HSP Inhibitors are concerned? Dr. Thanh Dellinger: That is a really great question. Certainly, in preclinical models, heat shock proteins are known to be elevated and they do activate dendritic cells and result in T-cell activation. Now, whether that can be spelled out into actually some future drug therapy definitely remains to be seen. To date, there hasn't been any success in using heat shock types of agents or inhibitors, unfortunately. So, I think while this is of great interest, I'm not entirely sure that this will translate into any drug therapy in the future. Dr. Abdul Rafeh Naqash: And I totally connect with you there as a phase 1 trialist. I completely agree that we see a lot of translational data, more often than not, going into the phase 1 site because many of these targets are not actionable. Now, from a DNA repair standpoint, you did see that there was interference with DNA repair, as far as some of the analyses that you did, but I did not specifically see any markers for DNA damage that were assessed on the biopsies such as Gamma-H2AX, RAD 51, or Phospho-NBS. Was there a reason why that was not looked at? Dr. Thanh Dellinger: I think that we did look at that and there weren't really any significant results. We did put some of the data into the supplementary data. I think that in the end, our cohort was really too small to really make any meaningful data. But I absolutely agree with you looking at HSP and DNA repair is really important. And as I mentioned that most recently published paper does address that. Dr. Abdul Rafeh Naqash: Excellent! Do you think that there could be any confounders in this analysis that could have led to the upregulation of some of these pathways and may not necessarily have been the intraperitoneal chemotherapy? Could you think of some other reasons that this could have been a confounding factor? Or would it primarily be attributed to the intraperitoneal chemotherapy that you guys have looked at in this interesting paper? Dr. Thanh Dellinger: Yeah, it is a rather small cohort. So, I think that more data is required to potentially repeat this in the larger cohort. But what is interesting is that we did have paired analysis. So, we had matched peritoneal samples from the same patients looking before the HIPEC and after the HIPEC, which is very unique and hasn't really been done in the setting before. And while you couldn't necessarily repeat the same exact peritoneal tumor it was very close. And so, in the best setting, I think that we did have a good paired analysis. Dr. Abdul Rafeh Naqash: That was one of the very interesting aspects of this study that I very much appreciated, that you were able to get some of those paired biopsies and do the analyses on samples and look at all these markers. So, this was all excellent work and definitely intrigues the mind into what other ways one could use some of these findings to develop future combination-based approaches, whether it's the neoadjuvant or the adjuvant setting for patients with ovarian cancer. Are there any next steps as part of this project that you are excited about that you can share? Dr. Thanh Dellinger: Right! I'm definitely very excited about trying to build on this and essentially developing a much larger predictive study using hundreds of ovarian cancer HIPEC-treated tumors in collaboration with others. We have definitely developed a great community of HIPEC investigators who are very interested in developing somewhat of a predictive signature for ovarian cancer undergoing HIPEC. So, I'm very excited to hopefully be able to develop this consortium of HIPEC transcriptomic research. And so, I'm looking forward to collaborating with my co-investigators on that. Dr. Abdul Rafeh Naqash: It was definitely exciting to talk to you about your work. Now, I want to ask you about you as an investigator or as a researcher. How did you end up in this field? What was your background while you were pursuing science and medicine? How did you end up in this field and how are you mentoring the next generation? Dr. Thanh Dellinger: When I was a fellow at UCI, my mentor Robert Bristow introduced me to HIPEC and that has really stuck. As a GYN oncologist, it is hard to really do both chemo and be a good surgeon. And in many ways, I have really specialized in surgical oncology more than in medical oncology. And HIPEC is really a very nice blend of the two. It allows you to do clinical trials while still doing surgery and giving some chemotherapy. Really, it was for the introduction of my more recent mentor, Elena Rodriguez, who really introduced me to genomics and applying this to HIPEC samples that this all came about. And so, I think that there are a lot of opportunities for surgical oncologists who do not give chemo and may think that clinical research is not for them, but there are a lot of translational opportunities and clinical trial opportunities for those who don't give chemotherapy, but are surgical oncologists. Dr. Abdul Rafeh Naqash: Thank you so much. We are really excited for all the work that you're doing and will continue to do and hopefully, we'll see more of this evolve as time progresses. Dr. Thanh Dellinger: Thank you so much, Dr. Naqash. It was such a pleasure meeting you and talking to you. Dr. Abdul Rafeh Naqash: Same here. Thank you for listening to JCO Precision Oncology Conversations. To listen to more, visit asco.org/podcasts, or find them on Google Play Spotify and Apple podcasts. To stay up to date, be sure to follow and share JCO Precision Oncology content on Twitter. The Twitter handle is @JCOPO_ASCO. All JCO PO articles and series can be found at ascopubs.org/journals/PO. The purpose of this podcast is to educate and inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement. Guest Bio Dr. Thanh Dellinger, MD, is a gynecologic oncologist and physician-scientist who specializes in ovarian and uterine cancer. She is an expert in hyperthermic (HIPEC) and pressurized aerosolized intraperitoneal chemotherapy (PIPAC), and is the primary investigator of clinical and translational studies focusing on these therapies. She received her medical degree at University of California Irvine, where she also completed a gynecologic oncology fellowship. She is leading the first U.S. clinical trial in PIPAC (pressurized intraperitoneal aerosolized chemotherapy), a novel therapy using pressurized aerosolized chemotherapy for ovarian cancer. Her current research focuses on innovative therapies for ovarian cancer using intraoperative chemotherapy, and novel antibody and nanoparticle therapies.
As always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below.Enjoy!_____________________________________________________________________________________Show notes, articles, and CME form can be found on our website: http://www.the-incubator.org/094/
Recurring guest Mikkael A. Sekeres, MD, Professor of Medicine and Chief of the Division of Hematology, Sylvester Comprehensive Cancer Center, is today's guest of honor to discuss and spotlight his just-published book: Drugs and the FDA: Safety, Efficacy, and the Public's Trust. Dr. Sekeres begins by sharing an anecdote of his experience on the FDA Oncologic Drugs Advisory Committee (ODAC) for Avastin as an inspiration to write the book. Then, he delves into the detailed process of becoming an ODAC member and how conflicts of interest are handled in the screening process, how personal experience bias (rather than data) may influence ODAC members to vote to approve a drug, financial compensation allotted to ODAC members, and how ODAC members balance science with humanity when considering drugs for approval. The conversation ends with a commentary on the good and bad of DTC advertising, the future of clinical trial phasing and designing, and a few other interesting discussion points. Order Drugs and the FDA: Safety, Efficacy, and the Public's Trust. https://www.amazon.com/Drugs-FDA-Safety-Efficacy-Publics/dp/0262047314 Check out Chadi's website for all Healthcare Unfiltered episodes and other content. www.chadinabhan.com/ Watch all Healthcare Unfiltered episodes on Youtube. www.youtube.com/channel/UCjiJPTpIJdIiukcq0UaMFsA
"In part two this ASCO Education Oncology, Etc. podcast, healthcare policy expert, pulmonary physician, epidemiologist, and writer Dr. Peter Bach shares what it was like to face his wife Ruth's cancer and eventual passing − as a husband and as a doctor. The episode also explores delivering difficult news to patients. If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at education@asco.org. Resources: Cancer Topics - Delivering Serious News" The Day I Started Lying to Ruth by Peter Bach, MD After a Cancer Diagnosis, Wishing for a Magic Number - The New York Times TRANSCRIPT Pat Loehrer: Hi, I'm Pat Loehrer, Director of Global Oncology and Health Equity at Indiana University. I'm here with Dave Johnson, a Medical Oncologist at The University of Texas Southwestern in Dallas, Texas. This is the second half of our Oncology, Etc. conversation with health policy and payment expert, pulmonary physician, epidemiologist, and writer, Peter Bach. In part one, we chatted with Dr. Bach about his upbringing, the trajectory of his career from English Literature to Medicine, and from academia to industry. We also explored his seminal work on drug pricing and improving health equity. Today, we're going to continue our conversation with Dr. Bach by asking about something deeply personal: his wife, Ruth, who sadly passed away from cancer at the age of 46. Probably about seven or eight years ago, you wrote a wonderful article in The New York Times, and there was another article you wrote, but the one that I liked reading was called, “The Day I Started Lying to Ruth”, and this is where cancer stabbed you very personally. Can you tell us a little bit about that, and tell us a little bit about your wife, Ruth? Peter Bach: So, it was in New York Magazine, just to give credit where it's due, I'm very grateful to them for running it. I wrote that after she died, and it followed on a series I had in The New York Times called, The Doctor's Wife, which I wrote while she was getting her initial treatment for breast cancer, and then I walked through the steps of adjuvant therapy that she received, in my experience. And then the piece in The New York Magazine talks about her last months basically, and my experiences then. The story goes that she was tragically taken from us and tragically taken from my son when he was very young, and my experience being at her side-- and I think I was a good husband, I was present -- was an alarmingly dissociative experience along every dimension. You know, I'd go to her appointment, I would swipe in with my badge. You know, this was my place, and the doctor who took care of her is and was a dear friend, and so were the other doctors in most cases. And the visits, you know, I had nurses and people in the hall would say "Hi" to me. And then I was going through this absolutely devastating experience, you know, tearing apart the sort of prevailing narrative and experience and structure of my life and our family. And so, for whatever reason, it was this out-of-body experience where I could see stuff very, very clearly. Not only clinical realities, like I knew what was happening, but also the mechanics of healthcare, the interactions, and I felt like I should journal it, if you will. And then when I journaled it, I thought I should publish it, and so I wrote about what it was like to stand there when my friend, Chip Cody, the surgeon said, "This is cancer, I can feel axillary lymph nodes, you've got cancer." And what that morning was like between the-- look, most people have a lump, what's the big deal? We'll go, we'll deal with it. She's young. She had just had a mammogram actually, to that. And then the experience of, you know, and I was in Biostat at MSK. So, I'd sat for a gazillion protocol reviews, I'd read a gazillion informed consent forms, and then there was one in front of her for a randomized trial for adjuvant therapy. I mean, it was Avastin versus placebo versus a longer period of Avastin, if I remember correctly, and ultimately a negative trial I saw at ASCO. But sitting there and actually thinking about like, "What is this like for somebody who doesn't know all of this stuff?" And my wife was way smarter than me, that you guys know me, that is the least surprising fact ever. But it was still dizzying for her. And so, I wrote about that, like, hawt was our conversation like that night after that whole, like, “Do you want to join this trial?" And her peppering me with questions, like, essentially, “What the hell is wrong with you guys? Why don't you know these answers?" And it was sort of like, "Okay, this is why we do randomized trials, this is why we have placebo. This is–” And she's smart, not irate. She was much more relaxed and philosophical through the whole thing up until the day she died, or a few days before, than I ever was. So, I wrote about that. Like, what was that conversation like? What was she being asked to do, and how important was it that she did it? And I remember sitting in the room when that trial was presented, and The Kaplan-Meier overall survival curves, and I was pretty sure I saw the step in that curve. I'm pretty sure I saw her on that graph. And it made me-- obviously, I'm desperately sad that she's gone - but it made me proud that she had contributed to it, even though, you know negative studies are important, too. So, I wrote about those things, and I wrote about prognosis and what it was like to have a conversation when she asked about prognosis, and in an article called ‘Waiting for a Magic Number', where I described her oncologist saying, "Fine, I'll tell you what are your chances of living five years, you tell me what's the cut point. Essentially, above or below, what number are you going to change things in your life? When you tell me that number, I'll tell you whether you're above it or below it." And it was like, "Wow, philosophy from an oncologist, fantastic." Really sunk in with both of us, and that was it. We never asked that question again, he never gave us a number. And I've been greatly rewarded over the years to run into people from here and there who say, "You know, I always hand my patients that article to put that in perspective." And then when she died, I wrote about the sheer horror of what was happening to me. And the title wasn't mine, but it was worked right on point. I found myself in a situation where I didn't want to reveal to her just how bad things were, and it was terribly weak of me. And ultimately, and I describe it in the article, got to a point where I just was ready for it to be over, before it was. And I think it's actually not that hard, to be honest, after you've gone through something like this like I don't really care what people think of me. I went through something really hard. And again, I'm someone with resources, I'm someone with knowledge, I could call her oncologist at two in the morning and he'd answer, that's not something normal people get. And you know, even for me, like this was completely disorienting. And so, that article was very rewarding to write because it allowed me to put it somewhere where I've gotten to revisit it. A couple of years ago, of course, he was young when I published it. He said he had read it; he liked the part about the dog. But I got a lot of notes afterwards from strangers saying that it provided them some comfort that even someone like me went through basically the same experience they went through. And look, this whole, like, "even something like me” seems odd, but I think to the external world, somehow, we're like, "You know, we get those white coats. Stuff is different for us," and of course, it isn't at all. Since that time, and we're all in the same world, so we have the same sets of friends. We probably have many of our overlapping friends who we know have lost spouses. In recent years, I routinely get phone calls from folks like, "I'm going through this, what's the first step?" You know, and it's about everything. "How do I deal with my kid? Should I go dating?" Stuff like that. Dave Johnson: You know, Peter, that article should be required reading for every Oncology fellow. I think it was beautifully written, clearly from the heart. I think your undergraduate degree shows in terms of your writing style, but to write that, I'm sure was emotionally challenging and difficult. In fact, Pat mentioned at the start of our podcast, Trillin's book, About Alice. In a book review that was written in The New York Times, About Alice, Trillin made a comment similar to the one you just made, where people that he didn't even know wrote letters in which they conveyed to him a sense of knowledge of Alice, even though he knew they had never met Alice. And I think your article about your wife conveyed that same sense to anyone who did not meet her. And I think you memorialized her in ways that are really fantastic. But I want to just read something from an article in The New York Times, and this is quoting Trillin. He says, "They may not have known her, but they knew how I felt about her." And he went on to say, "Yes, I got a lot of letters, like the one from a young woman in New York who wrote that she sometimes looked to her boyfriend and thought, "But will he love me like Calvin loves Alice?" I think the same could be written about your relationship with Ruth. And thank you for sharing that. I can't imagine how challenging that must be even all these years later, and I'm glad your son had the opportunity to read that. He should be proud of both his mother and his father. Pat Loehrer: It was a gift to all of us and mankind. You know, again, as I saw that article, there's a photo of you and Ruth on your last vacation. I think it was from Versailles, and I think you were in the Hall of Mirrors. And I think there's a poignant metaphor there about the reflection of your lives and being with her at that time, and we really thank you. We have all experienced this and it's so powerful there. There's this time when you get a result of a test of someone that you know and love and there's this limbo between, they're so naive and life is good, and it really is a time between heaven and hell in which you're the only one there, in which you know that you're going to go in the room now and change their lives forever by sharing this news. And we've been there and we pause, and again, you talked about that - I think being in a car looking at the x-ray. And that's the essence of when you said, the day you started lying to them, which is understandable because you just don't want to shatter that moment there. You know, we pause and reflect on that enormity of the moment there and I thank you deeply for sharing that with us because it's something that we physicians find, and this uniqueness of being a physician, and having someone you care about and knowing something that they don't quite know yet. Thank you for all of that. Peter Bach: The important message is that to patients, it's very isolating. And part of what I think the article did, and this was the message I got at least, was, send a message to other people that you're not alone. That others are going through it, others have gone through it, and I don't know what "it" is in that context, but loss. And there's that wonderful article in The New Yorker called ‘The Aquarium', which is by man who had a sick child-- and I don't remember all the details, but the aquarium metaphor is, I can't remember if he's in the aquarium and the rest of the world's outside or the other way around, but it's that isolation that is particularly frightening. And when I talk with my friends who've gone through it, it's part of it. As I just said, you know, there's a lot of us out there. I don't know if it gives so much reassurance. You know, 40,000 women die a year of breast cancer, so there's a lot of people out there. Dave Johnson: Pat, you had, I think, a final question? Pat Loehrer: Briefly. You know, now I'm asking to be an academic person there, but if you had a young medical student and you were going to try to give them one lesson about communicating bad news to patients, what would that be? Peter Bach: I've obviously been in this situation many times. I'm a Pulmonary Critical Care doc, so I've watched bad news be delivered many, many times. And the first mistake I see people make is trying to fill the silence with words, and I think I made earlier reference to it. One of the key skills doctors need to develop is the ability to listen. And sometimes listening to silence is a version of listening, but it's delivering what you have to say without euphemism, with directness. Not everyone's enamored with it, I am. But then giving time to listen, even just space for people to feel safe, that that communication is part of a relationship, not a sort of text message. You know, in today's metaphor, right, that just arrives and the person moves on. That is really hard for people to do; not experienced doctors, for trainees because it's frightening for a lot of reasons. Over my career, I've certainly rehearsed it many times with people. I made the mistake myself too, of just sort of talking over the thing in the room to avoid, you know, just sort of as you said, the enormity of what you just communicated. Dave Johnson: So, Peter, I think you're right on. I think that's one of the most difficult things to do, is to allow that pause to take place. And so many, even highly experienced physicians attempt to fill that void when it doesn't need to be filled. Been there, done that, been on the receiving end as well as the delivery end of that. It's always challenging. You know, we're out of time, and I'm sad about that because we could go on, I'm sure for quite a long time. Want to end this by asking you, Peter, we talked about a book on the front end, both Pat and I love to read, and we share recommendations all the time. I wonder, is there a book or a podcast, or anything that you think we should read or you think our listeners should know about? And by the way, you can include anything that you wrote if you'd like. Peter Bach: Yeah, it'd be very au courant to pitch my own stuff here, I would never do that. I like to read as well. And so, I just finished Rules of Civility by Amor Towles. Of course, there's a few health events in it, but it's not to do with anything, but, you know, it's a book about New York. I live in New York, so I just enjoyed every single word of it. I'm newly married- Dave Johnson: Congratulations. Peter Bach: -thank you. I feel very lucky. And my wife has noted that I often like to read nonfiction at night. Typically, books about how the world is just going completely to hell. And she's noted that outrage is my happy place, that I sleep extremely well if I read something that's absolutely infuriating. So, the other thing I'll recommend is the book about the Department of Justice has essentially lost its mojo when dealing with corporate crime. If your best soporific is being absolutely furious, it's right up there with a full dose of Ambien. So anyway, those are my two recs. Pat Loehrer: I love it. Yeah, Dave and I both love non-fiction. We love that. So, it's great. Dave Johnson: We've come to an end of another podcast, and we want to thank our listeners for tuning in. We really appreciate your participation. Remember, Oncology, Etc. is an ASCO Educational podcast, where we'll talk about virtually anything and everything. So, if you have an idea for a topic or a guest you'd like for us to interview, please email us at: education@asco.org. Thanks again. You know, speaking of interesting nonfiction, Pat, if ‘pro' and ‘con' are opposite, what's the opposite of progress? Pat Loehrer: Oh, I love that - Congress. Dave Johnson: Yes, Congress. I knew you would get that. Peter Bach: That is a ‘Dad joke' if I ever heard one. Dave Johnson: We don't have good jokes on this show. Pat Loehrer: We're going to have to redo the ending to this because, Dave, you said this was an ASCO Education Podcast. I'm not sure we've taught anybody anything on this one. Dave Johnson: Now, Peter has taught us a lot. Pat Loehrer: That's for sure. Thank you so much, Peter, for a wonderful interview. Dave Johnson: Absolutely perfect. Wonderful. Peter Bach: Thanks for the privilege. It's wonderful seeing you both. Thank you for listening to the ASCO Education podcast. To stay up to date with the latest episodes, please click, "Subscribe." Let us know what you think by leaving a review. For more information, visit the Comprehensive Education Center at: education.asco.org. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy, should not be construed as an ASCO endorsement.
Show notes FDA Approves Stimufend, the US' Sixth Pegfilgrastim Biosimilar https://www.centerforbiosimilars.com/view/fda-approves-stimufend-the-us-sixth-pegfilgrastim-biosimilar FDA Approves Celltrion Biosimilar for Avastin, Vegzelma https://www.centerforbiosimilars.com/view/fda-approves-celltrion-biosimilar-for-avastin-vegzelma Oncology, Ophthalmology Biosimilars Progress in Europe https://www.centerforbiosimilars.com/view/oncology-ophthalmology-biosimilars-progress-in-europe Biosimilars Check-In: Canada Approves Third Etanercept; Prestige Withdraws Trastuzumab Application https://www.centerforbiosimilars.com/view/biosimilars-check-in-canada-approves-third-etanercept-prestige-withdraws-trastuzumab-application Coherus Rep Shares Competition Strategy for Adalimumab, Pegfilgrastim Biosimilars https://www.centerforbiosimilars.com/view/coherus-rep-previews-interchangeable-ranibizumab-adalimumb-launches-on-pro-competitor?seriesVid=5 Policy Harmonization, Clarification Could Aid Biosimilar Uptake Efforts https://www.centerforbiosimilars.com/view/policy-harmonization-clarification-could-aid-biosimilar-uptake-efforts Upcoming WHO Guideline Changes May Reduce Data Requirements for Biosimilar Development https://www.centerforbiosimilars.com/view/upcoming-who-guideline-changes-may-reduce-data-requirements-for-biosimilar-development Dr Ivo Abraham Column: When More May Yield Less—Price Erosion of Biosimilars Following US Market Entry https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-when-more-may-yield-less-price-erosion-of-biosimilars-following-us-market-entry
Expert: Katia Roque Perez, Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru
In part one, of this two-part ASCO Education podcast episode, host Dr. Jeremy Cetnar (Oregon Health & Science University) interviews two very accomplished physicians and researchers, Dr. Lauren Abrey and Dr. Jason Faris. We'll hear about their motivations for pursuing medicine and how they arrived at the different positions they've held in academia and industry. If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at education@asco.org. TRANSCRIPT Dr. Jeremy Cetnar: Hello, and welcome to the ASCO Education podcast episode on career paths and oncology. My name is Jeremy Cetnar. I'm a Medical Oncologist and Associate Professor of Medicine at Oregon Health and Science University in Portland. I'm delighted to introduce today's two guests, whose careers in oncology have crisscrossed academia and industry. Dr. Lauren Abrey and Dr. Jason Faris, I'm excited to chat with you about the inspiration and motivations that drive you, people you've leaned on, how you've made your career decisions, challenges you've faced, and more. So let's start by asking each of you, could you share a little bit about your early life and background, what attracted you to medicine, and who are some of your early mentors and role models? Let's start with you, Dr. Faris. Dr. Jason Faris: Yeah, I'd be happy to. Thank you. So, I grew up in a small town in South Jersey in Greater Philadelphia. My mom was a registered nurse in pediatrics in the maternal infant unit for many years at Cooper Hospital. I was always interested in science and medicine and my mom's dedication to her patients. Her altruism and compassion served as a real inspiration for me, for my eventual decision to go to medical school. But I took a long time to get there. I had a bit of a circuitous route to arrive to my career in medicine though it started off conventionally enough. I was initially geared towards a premedical track in college, majoring in biology, but an exciting summer research project, working on the biochemical mechanisms underlying osmoregulation in a marine crustacean with mentoring from my first true mentor, Dr. Don Lovett, led me to apply to and attend graduate school in molecular biology at Princeton. This was followed by a position at Merck as a molecular biologist in the genetic and cellular toxicology group. I went to veterinary school at the University of Pennsylvania where I met my future wife. And then finally, back to the original plan of attending medical school, but I have to say with a much better sense of why I wanted to attend medical school in the first place, now in my late 20s, which was a bit unconventional at the time. I really did my fair share of exploration of Allied Health careers. That's for sure. I attended Johns Hopkins for medical school, where I quickly discovered a passion for internal medicine. And that was far and away my favorite clerkship and sub-internship. That's the background to how I got to medical school. Dr. Jeremy Cetnar: Dr. Abrey? Dr. Lauren Abrey: Interesting. I love your story. We share... I grew up in a small town, not so far away, but I was in upstate New York. And I think there were two influences that kind of got me to my ultimate passion for brain tumors. And this sounds a little quirky to start with. But I had a pretty serious head injury as a tween. So I guess I was about 12. I had a skull fracture, epidural hematoma. And while I would never have said I woke up at that moment and thought I have to be a doctor, I think I became fascinated about things to do with the brain. In parallel, something that I think tinged a lot of my childhood was a number of family members who had cancer. So both of my grandmothers had breast cancer, while I was well aware of the fact that they were sick and battling this. And two of my aunts also had cancer. And I would say it's an interesting split in my family. So about half of them are survivors and about half ultimately died of their disease. So both of these things really motivated me or focused me on the need to do something important, but also to do something that really motivated me to get out of bed in the morning. I think I was much more to the point. I went straight to college, straight to medical school. I remember calling my parents and telling them I was applying to medical school and having them say, “Wait. You? Really?” So it wasn't necessarily the family expectation that I would do this, but I was very driven and motivated to make some of these choices and then discover my particular interests as I progressed through medical school. So I went to Georgetown for medical school and then have trained at a number of places in the US. I think that's a little bit how I took my first step on this career journey, let's say. Dr. Jeremy Cetnar: So take us through what the decisions were like in your head at the end of fellowship in terms of first jobs. Dr. Faris? Dr. Jason Faris: In terms of my choice to pursue a career in medical oncology, this goes back to medical school during an internal medicine clerkship. I had an assistant chief of service, ACS, at the time, Phil Nivatpumin. He'd go on to become a medical oncologist. He really inspired me with his optimism and bedside manner, including with multiple oncology patients on that clerkship. His enthusiasm for science and medicine, his teaching skills, and an absolutely legendary fund of knowledge. For Phil, he was just an incredible ambassador for both internal medicine and for oncology. After medical school, I went to internship and residency at Mass General Hospital. And in one of my first rotations, I was on the oncology service, which was not so creatively called Team Three. I think they can up the ante there, but oncology services on Team Three. I was caring for many extremely ill patients battling disease progression from their metastatic cancers, or sadly, in many cases complications of their treatments. During that rotation, I was intrigued by clinical trials offering novel treatment options based on cutting edge science, but also struck by the number of patients who just didn't have any clinical trial options. I became aware of the limitations of the conventional treatments that were offered. I was really inspired by the patience and dedication of the nurses and doctors caring for them. And I vividly recall a roughly 50-year-old woman I helped care for with AML, watching as the 7+3 chemotherapy caused lots of side effects for her and being amazed by her strength and grace, her resilience as she faced her illness, her potential mortality, and the intense chemotherapy she was undergoing. And I knew during those moments with that leukemia patient while caring for other patients on that oncology service that this was the field I would pursue. Oncology was really the perfect blend of humanism, problem solving, longitudinal follow-up and rapidly accelerating scientific progress leading to new avenues for clinical trial treatments. Like Lauren, I was motivated and inspired by cancer diagnoses in my own family. My maternal grandmother died of pancreatic cancer during my junior year of college. My dad was diagnosed with colon cancer during my first year of fellowship. So those are all really strong motivators, I would say. And after completing my fellowship at the combined Dana-Farber MGH program, my first position out of fellowship was in the gastrointestinal cancer group at MGH. I actually had been training in genitourinary oncology after my main clinically focused year of fellowship, but I did a chief resident year in the middle of fellowship, and that was the tradition at MGH. And as I was about to return to fellowship for my senior year of fellowship, the head of the GI Group and head of the Cancer Center at the time, Dave Ryan, offered to serve as a clinical research mentor for me in GI cancers. As a senior fellow, I wrote an investigator-initiated trial of cabozantinib for patients with neuroendocrine tumors under his mentorship that went on to demonstrate encouraging results, led to a Phase III study in that cancer population, and I ultimately accepted a position at the MGH Cancer Center in the GI cancer group about 11 years ago. And that was the start of my post-training career. Dr. Jeremy Cetnar: And how about you, Dr. Abrey? Dr. Lauren Abrey: So for people who don't know, I'm actually a neurologist. I finished my training in neurology and then pursued a fellowship in neuro oncology. I would say it was really patients and observations of things that were happening with patients during my residency. I did my residency at the University of Southern California at Los Angeles. I was at the LA County Hospital, which for people who don't know, is one of the largest hospitals in the country. I had the chance to see several patients who had paraneoplastic syndromes, and got the support from different faculty members to write those cases up, and really resulting in my first independent publications. That was what kind of got me bitten by the bug to understand this link between neurology and oncology. I very intentionally went to Memorial Sloan Kettering to have the opportunity to work with Jerry Posner. And I think I no sooner got there than I got totally bitten by the brain tumor bug, which seems a little counterintuitive. But the paraneoplastic work was kind of deep laboratory work. And I realized that I really enjoyed seeing the patients having the partnership with neurosurgeons and digging into what is still a pretty intense unmet medical need. So it was an interesting pivot because I really thought I was going to Sloane to focus on paraneoplasia. I still think I learned so much with that interest that I think we can reflect on when we consider how immunology has finally entered into the treatment landscape today for different tumor types and understanding is there a background in paraneoplastic disorders that could help us. But I have to say it was really the brain tumor work that got me focused and the chance to work with people like Lisa DeAngelis, Phil Gutin, and others that was kind of fundamental to my choices. I stayed there for two years of fellowship and then continued as faculty for about another 15 years at Sloan Kettering. So that's really the start of my academic career and the pivot to industry came much later. Dr. Jeremy Cetnar: So both of you have impressive career CVs, have been trained at very prestigious institutions. So at some point in time, take me through, what was that transition like between, 'Hmm, what I'm doing is enjoyable, but maybe there's something else out there that I want to explore.' And what I mean by that is mostly industry at this point. So that's an important question that I think a lot of junior faculty face, a lot of mid-career faculty, maybe even later-stage faculty. But I think that's a tension point for a lot of people because I think there's a lot of fear. I think there's a lot of anxiety about moving outside of the academic realm. So, tell us a little bit about what was the pull in terms of going to industry and what were some of the thought processes that were going on. Dr. Faris? Dr. Jason Faris: I've experienced two transitions, actually, between academia and industry. I like to do things in pairs, I guess. But the first was, after multiple years at the MGH as a resident fellow and as a clinical investigator at the MGH Cancer Center. As a new attending and clinical investigator, I was attempting to balance my work priorities, providing patients with GI cancers, which is a rewarding but complex and I'd say emotionally intense experience, given the phenomenally aggressive and devastating cancers these patients grapple with such as pancreatic cancer, alongside the other responsibilities of my clinical investigator position. Those other responsibilities included writing grants and papers and protocols, evaluating patients who were interested in open clinical trials, and serving as the principal investigator for multiple studies. I was serving on committees, mentoring and teaching. Patient care was always my top priority as it should and really must be. And I feel incredibly lucky to have had truly amazing colleagues at MGH across several disciplines, from medical oncology, nurse practitioners, practice nurses, radiation oncologists, and surgeons. It was and continues to be a dynamic place full of extremely talented and dedicated clinicians. I think we really all benefited from the coordinated teamwork in both patient care and research in a really tight-knit GI Group. But nonetheless, for me as someone who delighted in spending large amounts of time with my patients in the clinic rooms, and I think my colleagues would agree frequently agonizing over decisions impacting their care, achieving sufficient balance to really focus on writing and overseeing clinical trials was becoming increasingly challenging for me. And it was in that context, after spending roughly a decade and the combination of residency fellowship training and as an attending in the GI cancer group all at MGH that I made a truly difficult decision to move from my beloved outpatient clinical and clinical investigator role to industry to focus more exclusively on clinical research. And after interviewing for several industry-based roles, I accepted a position in the early-phase group at the Novartis Institutes for Biomedical Research or NIBR as we kind of pronounced those words in Cambridge. I absolutely loved my time at NIBR. It's an incredible place with a strong history of and commitment to innovation as well as passionate, talented colleagues, many of whom I've worked with in the past. When I first started at Novartis, I was amazed at the array of experts on the teams I was helping to lead as a clinical program leader. Our teams are the definition of multidisciplinary. They're composed of what we call line function experts in multiple disciplines. This includes preclinical safety experts who design and analyze data from studies that precede the filing of an IND, research scientists, chemists, preclinical, and clinical pharmacologists, statisticians, program managers, drug and regulatory affair colleagues, who focus on the interactions with health authorities, including the FDA, operational colleagues called clinical trial leaders, and many others. In my role as a senior clinical program leader, I also have the opportunity to collaborate frequently with research colleagues on preclinical programs, designing and writing first in human trials, followed by conducting the actual studies and in close collaboration with our academic colleagues, analyzing the clinical and translational results. Dr. Jeremy Cetnar: Dr. Abrey, how about you? Was there a moment or what were the moments that led to you deciding to make this transition? Dr. Lauren Abrey: I guess I have the other sort of story. I got pushed, I would say, in the sense that like many of us, I'm married, and my husband was the one who took a job with Novartis and said, “This would be an adventure. Let's go live in Switzerland.” So similar to Jason, he took a position at NIBR, and I think for many of the same reasons, he really wanted to delve deeply into early mechanism of action and allow himself to dedicate really a chunk of his career to developing key drugs. But moving to Switzerland changes your options suddenly. I think I had spent most of my career at Sloan Kettering doing clinical trials. That was really my comfort zone, my sweet spot. And when we moved over here, I explored briefly, could I set up an academic career here? And very kindly, I was invited by a number of Swiss colleagues to look for opportunities to do that. But I realized what I loved was talking to patients, and that that was going to be difficult with the language barrier. And I equally loved running clinical trials. So I had a great opportunity to join Roche shortly after their merge or full acquisition of Genentech. This allowed me to continue the work I had been doing on Avastin for brain tumors. But I think the other thing that allowed me to do, that was something I was really looking for was to broaden my scope and to no longer be niched as just a brain tumor expert. And if you're in academia and you're a neurologist, obviously, you're going to be fairly constrained in that space. But moving into a role in industry really allows you to look much more broadly and work across multiple tumor types. And I spent the next seven years at Roche running not just the Avastin teams that were developing drugs for a number of indications, but really overseeing the clinical development group based in the European sites. And they had about 14 different drugs in different stages of development as well as partnerships with their early research group that was European based. So it was a fascinating time for me, and I feel kind of like I got thrown into the pond. I knew a lot about clinical trials. I had no idea about so many other aspects of what I needed to consider. And I think Jason started to allude to some of this with the different line function expertise and things I think we take for granted or maybe we simply have blind spots around them when we are sitting in our academic organizations. So it's been a really delightful plunge into the pool. I've continued to swim mostly. Occasionally, a little bit of drowning, but a lot of fun. Dr. Jeremy Cetnar: What would you say are the major differences between an academic career and industry? Dr. Lauren Abrey: I think, as you said, the things that are similar is that the purpose or the mission for both is in many ways the same. We would like to develop better treatments for patients with cancer. And so there's a huge focus on clinical trials. There needs to be a huge focus on patients, and that can get diluted in industry. I think the things that you don't appreciate sometimes when you're sitting on the academic side is just really the overarching business structure and the complexity of some of the very large organizations. So you suddenly are in this huge space with people focused on regulatory approvals focused on pricing, focused on manufacturing, focused on the clinical trial execution, and why you are doing it in different spots. And so I think some of the different factors that you have to consider are things that again, we either take for granted or are super focused when you're in one organization. And I think the tradeoffs and how decisions are made, particularly in large pharma, can be frustrating. I think we are all used to applying for grants or getting the funding we need to do whatever our project or trial is. And then you just start very laser focused on getting to the end. If you're in a large organization and they have a portfolio where they're developing 14, 15, 20 different things, you might suddenly find that the project you think is most important gets de-prioritized against something that the company thinks is more critical to move forward. And that could be because there's better data, but it could also be because there's increasing competition in the space or there's a different pull for a large company. I haven't seen the early development side as much. I've seen the development. I've now seen Medical Affairs for how some of those decisions are made, but I'd be curious to hear what Jason has seen in some of his experiences as well. Dr. Jason Faris: Comparing and contrasting a little bit between the two, because I've run early phase studies on the academic side, I'll talk more about that in a little bit in terms of another academic position that I held. So I've run early-phase studies there. I've run early-phase studies in industry as well. And they share a lot of similarities, certainly following compelling science, the excitement about new therapies that are going to be offered to patients. But I think the execution is a bit different, and I would say, when you're running clinical trials in the academic setting, you're meeting every patient that you're going to put on study or at least one of your colleagues is, if you have sub-eyes on the study, that's a major, major difference, right? You're directly taking care of a patient going on to an experimental therapy, consenting that patient, following them over time, getting the firsthand experience and data from that patient interaction, but not necessarily, unless you're running an investigator-initiated study, not necessarily having access to the data across the whole study. You're hearing about the data across the whole study at certain time points on investigator calls, PI meetings, dose escalation meetings, those kinds of things. But you're not necessarily having access to the real-time emergence of data across the whole study from other people's patients. So you're a bit dependent on the sponsor to provide those glimpses of the data, synthesize that and present overview. So those are some operational differences, I would say, because you're not taking direct care of the patients and having your time split among different commitments in that way I have felt a greater ability to focus on the clinical research that I'm doing in my industry-based role, which I like, of course, but I also miss taking care of patients. I love taking care of patients. So I think it's always a double-edged sword with that if we can use a sword analogy here. But I think they both offer really exciting options to pursue new therapies for patients, which for me, was one of the fundamental reasons that I pursued medical oncology in the first place. It was really this idea that the field is rapidly advancing. I wanted to be a part of that. I saw firsthand what cancer could do to my family or family members, and I took care of patients in the hospital as an intern resident and fellow where I think there's just a tremendous unmet medical need. And so having an opportunity to contribute to the development of new therapies was always a real inspiration for me. Dr. Jeremy Cetnar: With that being said, what led you to go back into academia? Dr. Jason Faris: This is an ongoing saga, I guess. So after several years of professional growth at Novartis, gaining experience with designing and conducting clinical trials on the industry side, I was actually at ASCO and I learned of an open role for the director of the early phase trials program at Dartmouth's Cancer Center. After extensive consideration, which I think you can see as my trademark at this point, I made another difficult decision to interview for the position, which was focused on helping to grow the early phase trials program at an NCI comprehensive designated cancer center that's unique in a way because it's in a rural area. And it had a new director of the Cancer Center, Steve Leach, who's a renowned laboratory scientist with a focus on pancreatic cancer and a surgeon by training. I ultimately decided to accept the early phase director position, moving my family away from Greater Boston, where we had lived for about 15 years, to the upper valley of New Hampshire. And while at Dartmouth, I was part of exciting projects, including writing and overseeing an NCI grant called Catch Up, which was geared towards improving access to early phase clinical trials for rural patients. I opened numerous sponsor-initiated immunotherapy and targeted therapy, early phase trials. Just to say a little bit about Dartmouth's Cancer Center - I think they also benefit from tremendous collaboration, this time across Dartmouth College, the Geisel School of Medicine, the School of Public Health. I think they provide really excellent care to their cancer patients. And I was extremely proud to be part of that culture in the GI Group, which was much smaller than the one at MGH, but also an incredibly dedicated group of multidisciplinary colleagues who work tirelessly to care for their patients. But nonetheless, less than six months into that new position, the COVID pandemic started, and that introduced some significant and new challenges on the clinical trials side in terms of staffing, infrastructure, those kinds of things. In that context, I made a decision to return to NIBR, refocus on clinical research, and hope to harness my background in running clinical trials in both settings, both academic and industry, as well as the resources and pipeline of Novartis to really maximize my impact on drug development. So for me, it was a question of where can I have the maximum impact at this crazy time, difficult time. I saw that my best option was to return to industry to work on studies to try to develop new therapies. Broadly speaking, my role as a senior clinical program leader in the translational and clinical oncology group at NIBR is to design, write, conduct, and analyze innovative clinical trials of early phase therapeutics. Dr. Jeremy Cetnar: Wow, that's fascinating, very, very interesting. A lot of stress. You should definitely be buying lots of presents for your family for moving them all over the place. This concludes part one of our interview with Drs. Abrey and Faris. Thank you so much for sharing your inspiring career stories. And thank you to all our listeners for tuning into this episode of the ASCO Education Cancer Topics podcast. Thank you for listening to the ASCO Education podcast. To stay up to date with the latest episodes, please click subscribe. Let us know what you think by leaving a review. For more information, visit the Comprehensive Education Center at education.asco.org. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Pink Sheet reporters and editors discuss how the hearings for the withdrawal of Avastin's accelerated approval in breast cancer could inform the same process for Makena, Robert Califf's view that public trust in the agency will be rebuilt, and a request to increase the dispensing fees associated with COVID-19 treatments Paxlovid and molnupiravir.
In today's episode, we talk about diabetic retinopathy and cataracts. I dig into what causes this and how to mitigate the effects of such a disease. Enjoy the show! If you want more, sign up for my newsletter at: www.drsamberne.com. SUMMARY KEYWORDS retina, cataracts, eye, vitreous, msm, diabetic retinopathy, blood vessels, health, retinal, inflammation, neuroprotective, lens, body, tiny blood vessels, work, call, suggest, acid xanthine, taurine, eyedrops Hello, everyone, it's Dr. Sam, I'd like to welcome you to my EyeClarity podcast. This is a show that offers cutting-edge information on how to improve your vision and overall wellness through holistic methods. I so appreciate you spending part of your day with me. If you have questions, you can send them to hello@drsamberene.com. Now to the latest EyeClarity episode. 00:02 Hey everybody, its Dr. Sam and I'd like to welcome you to another EyeClarity podcast. I'm going to take a question today but before I do that I want to make an announcement for my upcoming course on improving lens health. So anybody that's concerned that they're developing cataracts they've been diagnosed with cataracts are thinking about cataract surgery. This is a class for you. So this is a two-week extravaganza, and it starts September 11. And it will run for two weeks, you will get a lot of information on how to improve your lens health like one piece of advice I would give to anybody who's suffering cataracts is eliminate sugar from your diet. research studies have shown that if you are having difficulties with managing your glucose levels, if you eat foods that have refined carbohydrates, or sugars, you run a higher risk of developing cataracts. Let's say that you are having difficulties with dietary absorption and you suffer inflammation in your gut. This actually can start to affect your eye health, especially the lens of the eye. So a cataract is basically metabolic waste that starts to accumulate in the a vascular structure we call the lens Why is it a vascular? Because there are no blood vessels that run directly to the lens of the eye. So what this does, this sets up a situation especially as we age that you lose the ability to as we say, Get rid of the trash in the recycling bin and it builds up and this is the oxidative stress that creates a cataract. So I highly recommend this course this for everybody. If you want to prevent cataracts and keep your lenses clear and healthy. You can sign up on my website drsamberne.com on my Instagram bio, on Facebook, a lot of ways to get in touch with me. You can also email me at hello@drsamberne.com. Yeah, and if you have to miss any of the classes, they will be video and audio recorded and you will have access to them. 60 days after the last class you also will receive 10% off on all my products on my webstore so check it out. Alright, today I want to take a question from Kara. And she is writing me from Instagram. Now it's interesting because in this this gal she is suffering diabetic retinopathy and cataracts. So the retinopathy part of it, of course, is in the retina. And diabetes really attacks the retina. She says that she's having bleeds in both eyes, and they've made her way to the vitreous, which is kind of the posterior two-thirds of the iPad sits in front of the retina. And she's been getting injections for the bleeding. Avastin is one and Lucentis is the other. These are common pharmaceutical drugs that are used, especially in wet macular degeneration, but any kind of retinopathy. These are the pharmaceutical drugs that are used that can slow down the degradation of the blood vessels. So she's really feeling compromised, and she's been on the ketogenic diet for a few years. But only recently has she gotten her blood sugar in control. And she's guessing that the damages from previous years have poor poor blood sugar, and mitochondria health. And so she's asking about supplementation.
Our guest this episode is Dr. Beth Karlan, recent recipient of the Lifetime Achievement Award from the International Gynecologic Cancer Society (IGCS), and a surgeon who has three decades of experience treating women with ovarian cancer. You're going to want to find a quiet space to enjoy this interview, because it's our most content-packed episode yet, covering topics that will be useful to anyone with an interest in the current and future state of cancer treatment, and particularly for gynecological cancers.Some of the topics covered:• how precision medicine is moving beyond one size fits all chemotherapy• how to make sure you're getting the best care possible• why it's so important to find care that follows NCCN guidelines• the untapped personal benefits of participating in clinical trials early in the course of treatment• the differences between Phase 1, 2 and 3 clinical trials• what PARP inhibitors are• what germline testing is, and why it should be top of the list for any woman diagnosed with ovarian cancer• the difference between high grade and low grade cancers and how they require different treatment approaches• what's important to know about the checkpoint inhibitor immunotherapy drugs that you see advertised on TV • how Avastin works• information for those considering additional debulking surgery after recurrence• why researchers and doctors are excited about ADCs, or antibody drug conjugates• the importance of getting the right psychosocial support (like Clearity's own Steps Through OC) during treatmentAbout ClearityCancer Connections is produced by Clearity, which provides free support and services to people impacted by ovarian cancer. You can learn more about Clearity and the topics we've discussed today by visiting clearity.org. Or, feel free to email us your questions or comments at podcast@clearity.org. Thanks!
•Barbara's story• I was diagnosed with OM in April 2015. My optometrist found the tumor on a routine eye exam, and then referred me to the retinal specialist. I had a medium sized tumor with plaque treatment (4 days). I had the muscle released to insert the plaque. I didn't have tumor testing because insurance wouldn't pay for it in 2015. I have 20/40 vision in my right eye. I had a cataract removed, a laser surgery and now get regular Avastin shots. I was tested for the inherited BAP1 tumor predisposition syndrome gene due to a family history of cancer and found out last spring that I have the gene. •Dianna's Story• Hi my name is Dianna Beck! I was diagnosed with OM in February 2018 and had enucleation at Stanford. I was 30 at the time of diagnosis and had blurry vision in my left eye for about a month before we found my tumor. It was wrapped around my optic nerve so I would have not had any vision if we had done radiation. My tumor was class 1A but PRAME+, and I found out I have the BAP1 germline mutation. It's been about 3 years since my diagnosis, surgery, and prosthetic eye. I get MRIs every 6 months currently.
Dr. Jeffrey Cleland, Ph.D., Chairman, CEO and President of Ashvattha Therapeutics, a clinical stage biotech company discusses treatments that are in development to address inflammation of the brain caused by COVID. They recently announced positive interim results on its ongoing phase 2 PRANA clinical study, which showed that OP-101, a novel hydroxyl dendrimer therapeutic, has the ability to successfully cross the blood brain barrier and suppress hyperinflammation. The company is also developing a class of novel hydroxyl dendrimer therapeutics that they hope will become the future of targeted therapies and unlock new levels of patient care across oncology, ophthalmology, and inflammatory diseases. #AshvatthaTherapeutics Dr. Cleland has 30 years of industry experience in research and development, including more than a decade at Genentech, Inc. His experience in startups includes major roles in obtaining more than $450 million in capital at stages from Series A through D and exit via IPO including over $300 million in capital raised as CEO. As the founding CEO of Versartis (VSAR), he led one of top biotech IPOs of all time. After Versartis, he led the Series B financing and clinical translation of novel Johns Hopkins University technology as CEO of Graybug Vision (GRAY). He held executive management positions at BaroFold, Novacea and Targesome, and has managed directly all aspects of drug development and late-stage research. While at Genentech, Dr. Cleland served in product development and manufacturing roles. He held important leadership roles in the successful approval of two drugs, Herceptin® and Nutropin Depot®, as well as in early work on Lucentis®, Avastin®, and Kadcyla®. He holds a BS in Chemical Engineering from the University of California, Davis and a PhD in Chemical Engineering from the Massachusetts Institute of Technology. Dr. Cleland has authored more than 100 articles and four books, and holds several issued patents. He serves on the Boards of BIO, Exicure, and Zylem and has advisory roles with small emerging biotechnology companies.
Living with Ovarian Cancer' is a Podcast full of inspiring stories told by Women or their loved ones, who themselves have lived with, or are still living with Ovarian Cancer. Each Woman's story is a gift; unique and is told from the heart in their own words. I am your host, Diane Evans-Wood. In this episode, I am talking to Gemma Lodge who shares her story about her long and winding road of being diagnosed with Ovarian cancer. Her story begins with what was thought to be an isolated Pulmonary Embolism, but she soon developed other symptoms that were attributed to stressful life events at the time. A holiday to Texas saw Gemma taken to hospital as an emergency where she was subsequently diagnosed with Ovarian Cancer. On her immediate return to the UK, she had urgent surgery followed by chemotherapy and Avastin, but this was not effective as a scan showed disease progression. She started a different treatment regime which fortunately is showing a reduction of disease. Gemma tells me how she was at the height of her Law career at the time and had to take sick leave. As a professional with an individual client case load it was essential to be reliable and consistent, but Gemma describes why she wasn't able to continue to work during chemotherapy. We touch on the difficulties surrounding whether to tell an estranged family member about her diagnosis and then the guilt associated with the decision not to. Content warning: we talk about how surgery sadly took away Gemma's ability to have children of her own and how that impacted on her emotionally. Our conversation also broaches hospice and palliative care which is really helping Gemma's quality of life. Gemma's partner has recently proposed to her and so she is now able to focus on planning their wedding. We all wish them both every happiness in their married life together. Thank you so much for listening to ‘Living with Ovarian Cancer'. If you want to get in touch with me or you would like to tell your own story on this Podcast about living with Ovarian Cancer, please email diane.evanswood@gmail.com You can find more information about me on my website by following this link: https://dianeevanswood.wordpress.com My sincere gratitude to Gary and Ruthie Colcombe who continue to carry out all the editing and uploading of each episode of this Podcast. I couldn't have managed without them! You can find their Podcasts here http://celticmythpodshow.comand https://inbedwithadruid.com Intro and outro music is called ‘Waltz for the little mermaid' by Meidi Goh. To read more about Meidi please follow this link http://meidigoh.com Before you go, please don't forget to click ‘subscribe' to this Podcast so that you don't miss future episodes and also if you could leave a rating, I'd be very grateful. Disclaimer: Each story in this Podcast is unique to the woman who is telling it. The content of each episode and the views expressed are not meant to be a substitute for medical advice or intervention. You will hear stories of women who sought alternative therapies, integrated oncology services or even choosing to decline treatment options. However, this is their story, and I am not advocating that you follow the path of any one woman who features in the podcast. If you have a diagnosis of Ovarian Cancer, please make sure that you discuss anything that is going to affect your treatment or wellbeing with your own Medical team. You are unique and so what's right for one woman may not be right for you!
Question 1 from Bruno: “How does caffeine affect the eyes?” Question 2 from Gayle: “Please describe the difference between probiotics and prebiotic fiber?” Question 3 from Bob: “I am currently receiving Avastin injections for my wet macular degeneration. Are there any holistic alternatives.?” Program Note: For Question 3 What is VEGF? This is referred to as: Vascular endothelial growth factor. It is a protein that causes a growth of abnormal blood vessels found in conditions like wet macular degeneration or diabetic retinopathy. Aside from pharmaceutical drugs, natural methods such as increasing lutein, zeaxanthin, astaxanthin, bilberry, the tocotrienol form of Vitamin E, Omega 3 fatty acids, and glutathione may be helpful in neutralizing some of the abnormal blood vessel growth. If you are a smoker or former smoker, do not use beta-carotene as this may lead to a higher risk of lung cancer.
Question 1 from Bruno: “How does caffeine affect the eyes?” Question 2 from Gayle: “Please describe the difference between probiotics and prebiotic fiber?” Question 3 from Bob: “I am currently receiving Avastin injections for my wet macular degeneration. Are there any holistic alternatives.?” Program Note: For Question 3 What is VEGF? This is referred to as: Vascular endothelial growth factor. It is a protein that causes a growth of abnormal blood vessels found in conditions like wet macular degeneration or diabetic retinopathy. Aside from pharmaceutical drugs, natural methods such as increasing lutein, zeaxanthin, astaxanthin, bilberry, the tocotrienol form of Vitamin E, Omega 3 fatty acids, and glutathione may be helpful in neutralizing some of the abnormal blood vessel growth. If you are a smoker or former smoker, do not use beta-carotene as this may lead to a higher risk of lung cancer.
Today Shea and I talk with Cindy about cervical cancer. Cindy's is a story of perseverance, hope, and inspiration. A story of being a young mother of 2 children newly diagnosed with cervical cancer at the age of 42. Cindy discusses her treatments of surgery, chemotherapy, and radiation. She discusses the multiple relapses of her cancer. And the discusses how she came up with a novel therapy that combined Avastin with chemotherapy that worked against her cancer. She has been cancer free for 11 years now. Topic is this episode include: Being a parent with cancer. Finding peace with meditation Exploring clinical trials Therapies of cervical cancer Radical hysterectomy Avastin Spirituality Helping others Cindy talks about finding joy in the midst of difficult treatments through meditation. Towards the end of this episode she describes a mysterious experience during meditation that is the title of this episode. Wait for that....it will give you goosebumps. --- Support this podcast: https://podcasters.spotify.com/pod/show/rick-hyman/support
How has Twitter impacted your pharmacy business? Josh Lurie, Partner & Member of Board of Directors of Symplur joins the podcast to help our pharmacy industry discover the untapped power of Symplur Signals. Quoting an article from June 15, 2016 “Tech Republic” columnist Jason Hiner writes, “From the 1980s until the past several years, when people heard about breaking news via word-of-mouth they typically turned to network news such as Fox or CNN. Today, they turn to Twitter. A recent Pew Research study found that 62% of US adults now get news from social media, up from 49% in 2012.” I am one of these people who will access my Twitter account before any direct news source because it's faster, more sincere, and provides a diverse perspective on the same topic or news story. There's no other organization better positioned to demonstrate the power of Twitter in healthcare than Symplur. With their well-designed “Healthcare Hashtag” Project launching in 2011, Symplur has been researching thousands of hashtags (subject matter) specific to our healthcare industry, scientific research, patient trends, CDC reports, and industry conference interactions, to name a few. Symplur Signals promotes deep understanding of healthcare as seen by patients, doctors and other stakeholders with real-time access to insights from over a billion healthcare social media data points. The richness of data here is mind boggling and if you're not seeing the value yet, be sure to check out Symplur for yourself. Take the specialty pharmacy industry for example. Genentech's Avastin is a cancer medication that interferes with the growth and spread of cancer cells in the body. The anti-cancer drug is used to treat a certain type of brain tumor, and certain types of cancers of the cervix, kidney, lung, colon, and rectum. If specialty pharmacies researched specific hashtag keywords using Twitter such as #CervicalCancerthey could quickly find articles, physicians, insurance providers, and most importantly patients participating in a worldwide conversation about Cervical Cancer. Not only could these patient-care providers reach out to these patients directly through Twitter but strategically could become a digital health industry subject matter expert within that specific subject-topic or hashtag. The Pharmacy Podcast Show will be publishing a series on leveraging the power of healthcare hashtags, which will include a fascinating interview with Symplur executives. Be sure to subscribe to the show and reach out to learn how your Pharmacy business can see a significant benefit using Twitter. See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices
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