Podcasts about Sanofi

It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Lilly becomes the first of the big three insulin makers to settle a class action lawsuit over pricing, the FDA approved Beta Bionics' iLet system, oral meds trialed for T2D seem to work as well as Ozempic injectable, Lego adds a T1D "friend" to their line and a big win for an American Ninja Warrior competitor with T1D. Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines happening now XX In the news is brought to you by VIVI Cap Keeps your insulin at the exact right temperature, even in extreme heat or cold. XX Our top story, Eli Lilly has agreed to pay $13.5 million to end a six-year, class-action lawsuit accusing the company of overpriced its insulin. As part of the settlement, Lilly has agreed to cap out-of-pocket costs for its insulin at $35 per month for four years. That's three months after Lilly said it would cut insulin prices to that level. The lawsuit was filed in 2017, against insulin makers Lilly, Novo Nordisk and Sanofi. Plaintiffs claimed the companies joined in an “arms race” to raise list prices of their meds while the “real” price to pharmacy benefit managers remained constant or in some cases dipped. Price increases of insulins that previously cost $25 per prescription were pushed up to $450, the suit said. The increases, taken in “lockstep,” were “astounding and inexplicable,” according to the class action lawsuit. Novo and Sanofi have yet to settle this case. https://www.fiercepharma.com/pharma/eli-lilly-inks-settlement-long-running-insulin-pricing-lawsuit XX The FDA is changing its draft guidance for industry regarding Antidiabetic Drugs and Biological Products. It's been 15 years since an update. Topics covered in the draft guidance include: Hemoglobin A1c (A1C), a measure of average blood sugar, remaining an acceptable primary efficacy endpoint The FDA now considering a reduction in the risk of hypoglycemia (low blood sugar) to be a clinically relevant outcome measure for diabetes drug clinical trials, when accompanied by either a reduction or maintenance of an acceptable A1C. The use of data collected by continuous glucose monitoring (CGM) systems, which allow for nonstop, passive glucose monitoring, in clinical trials to potentially support hypoglycemia labeling claims. Recent advancements in CGM technology have led the agency to recognize the advantages of data collected from these systems in clinical drug development. The FDA will be accepting comments on the guidance until August 24, 2023. https://www.appliedclinicaltrialsonline.com/view/fda-on-track-to-updates-diabetes-efficacy-endpoints-guidance XX The iLet bionic pancreas from Beta Bionics gets FDA approval for people with type 1 age 6 and up. This is a unique system in that it starts with only the user's weight and requires meal announcements – no carb counting – to automate blood sugar. It will launch with the Dexcom G6 CGM. You'll hear from the company CEO this Tuesday in our next episode where we do a deep dive into the system. https://www.medicaldevice-network.com/news/beta-bionics-fda-insulin-pump/ XX Researchers had observed an increased incidence of type-1 diabetes cases during the COVID-19 pandemic. Now, a new study has confirmed the link and established a temporal association between the development of type-1 diabetes in children and infection with the SARS-CoV-2 virus. The new study published in Jama Network was the first research that used data, which indicated if the type-1 diagnosed children previously had COVID-19 infection. The researchers found the likelihood to develop type-1 diabetes increased by 57% in children who had a confirmed COVID-19 infection, compared to those who did not have the infection. https://www.medicaldaily.com/covid-19-infection-increases-incidence-type-1-diabetes-children-study-469854 XX New oral medication from Pfizer seems to stack up well next to Ozempic for weight loss. New study looked at people with type 2 found danuglipron when given twice a day, lowered blood sugar in patients at all doses and reduced body weight at the highest dose after 16 weeks. The weight loss with danuglipron is of a similar magnitude to that observed in the mid-stage data for Novo Nordisk's semaglutide, known as Ozempic when used for diabetes and Wegovy for obesity. The treatments, including Pfizer's danuglipron, belong to a class of drugs that mimic the gut hormone glucagon-like peptide-1 (GLP-1), which works by suppressing appetite and were initially developed to treat type 2 diabetes. Pfizer is also testing another oral diabetes drug, lotiglipron, which is given once daily and has said it plans to initiate late-stage development of only one of the two candidates. The company believes an oral therapy could appeal to patients who want to avoid injections. https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-diabetes-drug-reduces-weight-similar-novos-ozempic-2023-05-22/ XX Artificial intelligence (AI) algorithms used to screen for and predict type 2 diabetes may be racially biased, which could perpetuate health disparities, according to a study published last week in PLOS Global Public Health. Risk prediction models for type 2 diabetes have shown promise in bolstering early detection and clinical decision-making, but the researchers pointed out that these models can bias the decision-making process if risk is miscalibrated across patient populations. The research team found that the Framingham Offspring Risk Score underestimated type 2 diabetes risk for non-Hispanic Black patients, but overestimated risk for their white counterparts. The ARIC Model and PRT overestimated risk for both groups, but to a greater extent for white patients. Research like this highlights that while data analytics and AI approaches may help find gaps in chronic disease management and care, racial disparities are still a major obstacle to achieving health equity for diabetes patients. A 2021 study of city-level data revealed significant disparities in diabetes mortality rates across the United States. The analysis sourced data from the 30 largest cities in the US and demonstrated that mortality rates were higher for Black individuals than for white individuals. Disparities were also found to be up to four times larger in some cities compared to others, with Washington, DC experiencing the highest rates of diabetes mortality inequities. https://healthitanalytics.com/news/potential-racial-bias-found-in-type-2-diabetes-risk-prediction-models XX 1 in 3 adults with Type 2 diabetes may have undetected cardiovascular disease. Elevated levels However, mildly elevated concentrations of of two protein biomarkers that indicate heart damage may be an early warning sign of changes in the structure and function of the heart, which may increase the risk for future heart failure, coronary heart disease or death. Researchers analyzed health information and blood samples for more than 10,300 adults collected as part of the U.S. National Health and Nutrition Examination Survey from 1999 to 2004. Study participants had reported no history of cardiovascular disease when they enrolled in the study. One-third (33.4%) of adults with Type 2 diabetes had signs of undetected cardiovascular disease, as indicated by elevated levels of the two protein markers, compared to only 16.1% of those without diabetes. https://medicalxpress.com/news/2023-05-adults-diabetes-undetected-cardiovascular-disease.html XX VIVI CAP XX MTV Documentary Films has acquired worldwide rights to Pay or Die, a film about Americans living with diabetes who face a cruel choice: pay the “extortionate” cost of insulin charged by pharmaceutical companies or risk death. Scott Alexander Ruderman and Rachael Dyer directed and produced the documentary, which premiered in March at SXSW. MTV Documentary Films plans a theatrical release later this year, followed by a debut on streaming platform Paramount+. Those personal stories in the film stretch across the country. “From a mother-and-daughter struggling to rebuild their lives after spending their rent money on insulin, to a young adult diagnosed with Type 1 diabetes during the COVID-19 pandemic, to a Minnesota family thrust into the national spotlight when their 26-year-old son dies from rationing his insulin, Pay or Die highlights this devastating struggle to survive while living with diabetes.” https://deadline.com/2023/05/pay-or-die-mtv-documentary-films-acquisition-directors-scott-alexander-ruderman-rachael-dyer-news-1235382566/ XX Katie Bone win the “American Ninja Warrior Women's Championship” — not only claiming the title but a cash prize of $50,000. She donated $5,000 to the Juvenile Diabetes Research Foundation and Pumped NM. Bone has not only appeared on three iterations of the competition series, but is also a nationally-ranked rock climber. While not the youngest competitor anymore, she was the shortest standing at 5 foot, 2 inches. She's been making waves since competing in “American Ninja Warrior Jr.” in 2020. To train for the event during the pandemic, her father built a ninja course in their backyard. During that competition, Bone, who was diagnosed with Type 1 diabetes at 11 years old, competed with both her insulin pump and glucose monitor on her arms. Being on the show also presents Bone with the opportunity to be an ambassador for Type 1 diabetes awareness and representation. Bone says Type 1 diabetes didn't end her life, it just changed it. “I hope I inspire a little kid to wear their pump on their arm,” Bone said. “It makes everything that you do that more amazing.” In February, Bone competed at the USA National Women's Team Climbing trials in Austin, Texas. During her fourth climb, she fell. “Katie heard four pops,” Tammy Bone said. “She tore her ACL and both sides of her meniscus. This was a moment she was preparing for all her life and it got put on pause.” Bone had surgery and has been getting physical therapy in Colorado. The family returned Monday night to New Mexico after being away for three months. Bone still has her eyes on the Olympics, though the road to recovery may take some more time. “I don't need easy, I just need possible,” she said. https://www.abqjournal.com/2602750/17-year-old-new-mexico-ninja-warrior-katie-bone-takes-the-title-in-womens-championship-competition.html XX Today LEGO has revealed the first wave of Friends sets for 2023, bringing in a new cast of characters and an update to the branding with a new logo. A new LEGO Friends television series will also accompany the new sets. LEGO's annual Play Well study revealed that 3 out of 4 children felt there were not enough toys with characters that represent them, so LEGO is aiming to bring more diverse representation to Heartlake City that's inclusive of not just various ethnicities and genders, but also disabilities and neurodivergence. LEGO says the 2023 sets and series will feature characters with limb difference, Downs Syndrome, anxiety, vitiligo, and even pets with disabilities, including a blind dog and a dog with a wheelchair. She has a CGM printed on her arm and even has a printed phone tile showing her blood sugar. Her name is Hannah and she's in 41744 Sports Center https://www.brothers-brick.com/2022/10/27/lego-friends-reveals-5-sets-for-2023-with-diverse-characters-to-better-represent-children-news/ XX XX On the podcast next week.. Beta Bionics CEO Sean Saint. Last week I MedT 780G That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.  

Our Guest: Alex Condoleon, Vice President, Head of the Digital Healthcare - US, General Medicines Business Unit at SanofiWhat you'll get out of this episode: Condoleon's background Overview of Sanofi's digital health focus Why pharmaceutical companies interested in digital health? The Sanofi/Dario Health partnership through the Sanofi lens What's the future of digital health? What's next? Our sponsors for this episode are Sage Growth Partners, FlipMD and Quantum HealthSage Growth Partners accelerates commercial success for healthcare organizations through a singular focus on growth. The company helps its clients thrive amid the complexities of a rapidly changing marketplace with deep domain expertise and an integrated application of research, strategy, and marketing. For more information, please go to www.sage-growth.com & follow Sage Growth Partners on social media - @sagegrowthpartnersFlipMD is an open, competitive marketplace of physicians only offering their consulting services to a wide range of client industries. The ultimate goal of flipMD is to be the best source of physician talent for any industry. The platform is very simple to use, you post a job for free with the specific scope of work and your budget. After the job posting, our physicians respond directly to you with their best offer for the work. Once you accept an offer, you fund the project. Once you receive satisfactory work, you accept and the funds are released to your expert physician consultant. For more information, please go to https://flip-md.com/ & follow FlipMD on social media - @flipmdQuantum Health is an award-winning consumer healthcare navigation company that delivers an unparalleled consumer experience based on empathy and trust, enabling employers to achieve industry-leading satisfaction rates and independently validated claim savings. Launched in 1999, Quantum Health's model is based on years of consumer research and the insights learned from guiding millions of consumers and their providers through their healthcare journey. Follow Quantum health on social media - @Quantum Health

On May 18, the Supreme Court ruled unanimously in favor of Sanofi in its dispute with Amgen over alleged patent infringement. The case involved the application of the statutory enablement requirement of Section 112 of the patent laws to what is referred to as a "genus claim" as it applies in the context of pharmaceutical applications. The two patents in dispute relate to antibody drugs that reduce low-density lipoprotein ("LDL") cholesterol.Specifically at issue was "whether enablement is governed by the statutory requirement that the specifications teach those skilled in the art to 'make and use' the claimed invention, or whether it must instead enable those skilled in the art 'to reach the full scope of claimed embodiments' without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial 'time and effort.'"Robert Rando, an intellectual property attorney who filed an amicus brief in the case, joined us to unpack the decision.Featuring:- Robert J. Rando, Partner, Greenspoon Marder LLP

Oscar Trimboli is an author, host of the Apple award-winning podcast Deep Listening and a sought-after keynote speaker. Along with the Deep Listening Ambassador Community, he is on a quest to create 100 million deep listeners in the workplace. Through his work with chairs, boards of directors, and executive teams, Oscar has experienced first-hand the transformational impact leaders can have when they listen beyond words. He believes that when leadership teams focus their attention and listening, they will build organizations that create powerful legacies for the people they serve  today and more importantly, for future generations. Oscar is a marketing and technology industry veteran working for Microsoft, PeopleSoft, Polycom, and Vodafone. He consults with organizations including American Express, AstraZeneca, Cisco, Google, HSBC, IAG, Montblanc, PwC, Salesforce, Sanofi, SAP, and Siemens. He is the author of how to listen - discover the hidden key to better communication - the most comprehensive book about listening in the workplace, Deep Listening - Impact beyond words and Breakthroughs: How to Confront Assumptions Oscar loves his afternoon walks with his wife, Jennie, and their dog Kilimanjaro. On the weekends, you will find him playing Lego with one or all his four grandchildren. Connect with Oscar Website - https://www.oscartrimboli.com/howtolisten/ LinkedIn - https://www.linkedin.com/in/oscartrimboli/ Connect with David UPCOMING EVENT 5 Day Real Estate Listings Challenge - https://www.davidihill.com/challenge Free Webinar - https://event.webinarjam.com/register/4/klx1gs Real Estate University - www.realestateuniversity.club Real Estate University 7-Day Trial - https://try.realestateu.club Health Mastery - www.healthmastery.club Website- http://davidihill.com Facebook- https://www.facebook.com/davidihill/ YouTube- https://www.youtube.com/davidhillcoach LinkedIn- https://www.linkedin.com/in/davidihill Book: https://www.amazon.com/Sales-Playbook-Simple-Strategies-Close/dp/1628652861 Free 30-minute Coaching Call: www.davidihill.com/strategycall David's Monthly Article – http://www.davidihill.com/5mistakes/ FREE GIFT - https://callreluctance.pathtomastery.net FACEBOOK COMMUNITY Please follow and join my Group- https://www.facebook.com/groups/ptmastery/ OUR LEAD PROVIDER SPONSORS VULCAN7 https://www.vulcan7.com/pathtomastery    

Dr. Neeraj Agarwal and Dr. Jeanny Aragon-Ching discuss the CLEAR study in renal cell carcinoma, a new exploratory analysis combining the TheraP and VISION trials in metastatic urothelial cancer, and compelling advances in prostate cancer and across GU oncology in advance of the 2023 ASCO Annual Meeting.  TRANSCRIPT Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, your guest host for the ASCO Daily News Podcast today. I'm the director of the Genitourinary Oncology Program and a professor of medicine at the University of Utah Huntsman Cancer Institute, and editor-in-chief of the ASCO Daily News. I'm delighted to welcome Dr. Jeanny Aragon-Ching, a GU medical oncologist and the clinical director of the Genitourinary Cancers Program at the Inova Schar Cancer Institute in Virginia.   Today, we'll be discussing some key abstracts in GU oncology that will be featured at the 2023 ASCO Annual Meeting.  Our full disclosures are available in the show notes and disclosures of all guests on the podcast can be found on our transcript at asco.orgDNpod.   Jeanny, it's great to have you on the podcast today. Dr. Jeanny Aragon-Ching: Thank you so much, Dr. Agarwal, for having me. Dr. Neeraj Agarwal: Jeanny, let's begin with Abstract 4502 regarding long-term updated results on the CLEAR study. The abstract reports the final, prespecified overall survival analysis of the CLEAR trial, a four-year follow-up of lenvatinib plus pembrolizumab versus sunitinib in patients with advanced renal cell carcinoma. Dr. Jeanny Aragon-Ching: Yes, I would be happy to. So, just as a reminder, the combination of lenvatinib and pembrolizumab was initially approved by the FDA in August 2021 for first-line treatment of adult patients with advanced renal cell carcinoma. So, this was based on significant benefits that were seen in progression-free survival, which was a primary endpoint, but also showed improvement in the overall response rates compared with sunitinib in first-line advanced renal cell carcinoma.   So this abstract reports on longer-term follow-up now at a median of 49.8 months, and PFS favored the combination lenvatinib and pembrolizumab compared to sunitinib across all MSKCC risk groups, and PFS benefit versus lenvatinib and pembro compared to sunitinib was maintained with a hazard ratio of 0.47. And even overall survival was also maintained with the combination with a hazard ratio of 0.79, and the overall survival favored the combination across all risk groups. If we look at the CR rate, it was 18.3% for the combination compared to 4.8% with sunitinib, unless patients in the combination arm received subsequent anticancer therapies, and that's intuitive. And the PFS2 was also longer with the combination at 43 months compared to 26 months. Now, it is important to note that grade III or more treatment-related adverse events did occur in about 74% of the patients in the combination of lenvatinib and pembro, compared to 60.3% in patients with sunitinib. Dr. Neeraj Agarwal: Jeanny, this is good news. So the main message from the abstract is that sustained results from this combination of lenvatinib plus pembrolizumab are being seen even after a longer follow-up of more than four years.  Dr. Jeanny Aragon-Ching: Yes, I agree. So now, moving on, Neeraj, to a different setting in the RCC space, let's look at Abstract 4519, which is titled “Efficacy of First-line Immunotherapy-based Regimens in Patients with Sarcomatoid and/or Rhabdoid Metastatic Non-Clear Cell RCC: Results from the IMDC,” which will be discussed by Dr. Chris Labaki. So, Neeraj, based on this abstract, can you tell us a little bit more about the impact of these adverse pathologic risk features in non-clear cell RCC?  Dr. Neeraj Agarwal: Of course. So, using real-world patient data, the IMDC investigators compared the outcomes of patients with metastatic non-clear cell RCC who were treated with immunotherapy-based combination regimens versus those who were treated with VEGF-TKIs alone. They also assessed the impact of sarcomatoid and rhabdoid features on response to IO-based combinations versus VEGF-TKIs. Of 103 patients with metastatic non-clear cell RCC who had rhabdoid or sarcomatoid features, 32% of patients were treated with immunotherapy-based combinations.   After adjusting for confounding factors, the authors show that those treated with a combination of two immune checkpoint inhibitors or an immune checkpoint inhibitor with a VEGF-TKI combination had significantly improved overall survival, which was not reached in the immunotherapy combination group versus seven months within the VEGF-TKI group. Time to treatment failure and objective responses were also prolonged, significantly higher, and better in the immunotherapy groups compared with patients who were treated with VEGF-TKIs alone. Interestingly, if you look at those 430 patients with metastatic non-clear cell RCC who did not have sarcomatoid or rhabdoid features, they didn't seem to benefit with immunotherapy-based combinations.  Dr. Jeanny Aragon-Ching: This is an exciting update, Neeraj. What are the key takeaways from this abstract? Dr. Neeraj Agarwal: So the main takeaway is if you see a patient with advanced non-clear cell RCC who has sarcomatoid and rhabdoid features, there appears to be a rather substantial and selective benefit with IO-based combinations. And in this context, I would like to highlight the ongoing SWOG 2200 trial also known as PAPMET2 trial, which is comparing the combination of cabozantinib plus atezolizumab. So immuno-therapy-based combinations versus cabozantinib alone in advanced papillary renal cell carcinoma setting. So this trial is being led by Dr. Benjamin Maughan and Dr. Monty Pal. And I like to encourage our listeners to consider referring their patients for involvement in this federally funded trial so that we can validate the data from this retrospective study in a prospective way. So, Jeanny, let's now move on to another important disease type which is urothelial carcinoma. There is a very recent accelerated FDA approval of the drug combination of enfortumab vedotin and pembrolizumab for cisplatin-ineligible metastatic urothelial carcinoma patients. This is Abstract 4505, which is being presented by Dr. Shilpa Gupta and colleagues. Can you please tell us more about this update? Dr. Jeanny Aragon-Ching: Yeah, absolutely. So, as you mentioned, Neeraj, the FDA just granted accelerated approval in April 2023 for this combination of enfortumab vedotin or EV, which is and ADC, antibody drug conjugate against nectin-4 and the PD-1 inhibitor pembroluzimab. So it's a combination for patients with locally advanced or metastatic urothelial carcinoma who are considered cisplatin ineligible. So this is nearly a four-year follow-up.   So as a reminder, this was a phase 1b/2 trial that included 45 patients and it had a primary endpoint of safety and tolerability although the key secondary endpoints included confirmed overall responses, duration of response, progression-free survival, and the resist criteria was investigated via investigator and BICRs which is in a blinded independent central review. Even overall survival was a key secondary endpoint.  So, the bottom line was the confirmed overall response by BICR was 73.3%, the disease control rate was about 84%, and the CR rate was 15.6% with a PFS of close to 13 months, and a 12-month overall survival rate of 83%. However, it is important to cite that there were treatment-related adverse events including skin reactions in 66%, neuropathy occurred in 62%, and ocular disorders in 40%. And there was a little bit of pneumonitis in close to 9%, colitis, and hypothyroidism, so there are side effects to watch out for.  Dr. Neeraj Agarwal: So, Jeanny this is great. What is the key takeaway from this trial?  Dr. Jeanny Aragon-Ching: So I think the most important thing is we now have a new combination of EV and pembro which shows very promising responses and survival in part which led to the FDA accelerated approval in the cisplatin-ineligible population of patients. However, we must note that the phase 3 trial of EV302 will ultimately establish which approach is really beneficial for all of our cisplatin-ineligible patients, either a carboplatin-based chemotherapy regimen or a non-platinum-based regimen such as EV and pembro. Dr. Neeraj Agarwal: Thanks Jeanny, would you like to discuss any other study in the bladder cancer space? Dr. Jeanny Aragon-Ching: Absolutely. I think Abstract 4508 from Dr. Seth Lerner and colleagues will be very relevant to our colleagues. This abstract is SWOG S1011, which is a phase 3 surgical trial to evaluate the benefit of a standard versus an extended lymphadenectomy performed at the time of radical cystectomy for muscle-invasive bladder cancer.  Dr. Neeraj Agarwal: Yes. So this trial, as you said, is an important trial which randomized in a one-on-one fashion 618 patients with muscle-invasive bladder cancer undergoing radical cystectomy, and these patients were randomized to either standard lymph node dissection or an extended lymph node dissection. And standard lymph node dissection included, as we know, external and internal iliac and operative lymph node. The extended lymph node dissection included lymph nodes up to aortic bifurcation which included common iliac, presciatic, and presacral lymph nodes. At a median follow-up of approximately 6 years, there was no disease-free survival or overall survival benefit in patients undergoing an extended lymph node dissection compared to standard lymph node dissection. And extended lymph node dissection was also associated with greater morbidity and preoperative mortality. Dr. Jeanny Aragon-Ching: Very interesting data, Neeraj. So these results, I think, will be very useful for a lot of our surgical colleagues in both academia and the community who may still be inclined to perform extended lymphadenectomy during cystectomy. This study shows that it's actually not necessary. Dr. Neeraj Agarwal: Absolutely. So now let's move on to another disease type, which is very important - prostate cancer. There are several practice-informing abstracts that are worthwhile discussing. The first of these involves Abstract 5002, which looks at the impact of the PSA nadir as a prognostic factor after radiation therapy for localized prostate cancer, which will be presented by Dr. Praful Ravi and  colleagues. Jeannie, can you please tell us more about this abstract? Dr. Jeanny Aragon-Ching: Yeah, definitely. So this abstract, as you mentioned, Neeraj, is a prognostic impact of PSA nadir of more than or equal to 0.1 nanogram per ml within six months after completion of radiotherapy for localized prostate cancer - an individual patient data analysis of randomized trials from the ICECaP Collaborative. Basically, it refers to an attempt to evaluate early surrogate measures to predict for long term outcomes such as prostate cancer-specific survival, metastases-free survival, and overall survival. So they looked at a big registry from the ICECaP collaboration that included 10,415 patients across 16 randomized controlled trials. And those men underwent treatment for intermediate risk and high risk prostate cancer treated with either radiation therapy alone in about a quarter of patients, or they got RT with short-term ADT in about 58% of patients, and 17% of them got RT with long-term ADT.  So, after a median follow-up of ten years, what they found was, if you had a PSA nadir that is over or equal to 0.1 nanogram per ml within six months after completion of radiation therapy, it was associated with worse prostate cancer-specific survival, metastases-free survival, and overall survival. For instance, the five-year metastases-free survival for those who achieved a PSA nadir of less than 0.1 was 91% compared to those who did not, which was 79%. Therefore, they concluded that if you achieve a bad PSA of 0.1 or above within six months after you completed radiation, you had worse outcomes.  Dr. Neeraj Agarwal: Jeanny, what is the key takeaway message from this study? Dr. Jeanny Aragon-Ching: The key takeaway from this ICECaP analysis is that this information would be very important to augment a signal-seeking endpoint, especially for clinical trial development, so that we can develop further strategies to de-escalate for those who don't need systemic intensification or therapy intensification versus escalation for those who really do. Dr. Neeraj Agarwal: So, my radiation oncology colleagues need to watch out for those patients who do not achieve a PSA of less than 0.1 nanogram per ml within the first six months of finishing radiation therapy. Very interesting data.  Dr. Jeanny Aragon-Ching: Yes, absolutely. So. Neeraj another important abstract for our fellow clinicians, switching gears a little bit now, is Abstract 5011, which is titled “Do Bone Scans Overstage Disease Compared to PSMA PET?” This was an international, multicenter retrospective study with blinded, independent readers. Can you tell us more about this abstract? Dr. Neeraj Agarwal: Yes, a relatively small retrospective study, but still pertinent to our practice. So I'll summarize it. This study by Dr. Wolfgang Fendler and colleagues evaluated the ability of bone scans to detect osseous metastasis using PSMA PET scan as a reference standard. So in this multicenter retrospective study, 167 patients were included, of which 77 patients were at the initial staging of prostate cancer, 60 had biochemical recurrence after definitive therapy, and 30 patients had CRPC or castor-resistant disease.  These patients had been imaged with a bone scan and a PSMA PET scan within 100 days. And in all patients, the positive predictive value, negative predictive value and specificity for bone scan were evaluated at different time points. They had bone scan and PSMA PET scan and both were compared. And what they found was interesting. All these three values - positive predictive value, negative predictive value, and specificity for bone scan were 0.73, 0.82 and 0.82 in all patients, and in initial staging, it was even lower at 0.43 and 0.94 and 0.80.  So, without getting into too much detail regarding these numbers, I want to highlight the most important part of the study, that at the initial staging, 57% patients who had a positive bone scan had false positive bone scans. The interreader agreement for bone disease was actually moderate for bone scans and quite substantial for the PSMA PET scan.  Dr. Jeanny Aragon-Ching: So, Neeraj, what do you think is the key takeaway message here for our audience?   Dr. Neeraj Agarwal: The key takeaway message is that positive predictive value of bone scan was low in prostate cancer patients at initial staging, with the majority of positive bone scans being false positive. This suggests that a large proportion of patients which we consider to have low-volume metastatic disease by bone scan actually have localized disease. So in the newly diagnosed patients with prostate cancer, patients should ideally have a PSMA PET scan to rule out metastatic disease.   So, let's move on to another abstract I would like to discuss, which has important implications in treatment, especially now that lutetium 177 is approved, but frankly not available widely. Dr. Jeanny Aragon-Ching: Yeah, that's actually very timely. So the abstract you're referring to is 5045, which is being presented by Dr. Yu Yang Sun and colleagues entitled “Effects of Lutetium PSMA 617 on Overall Survival in TheraP Versus VISION Randomized Trials: An Exploratory Analysis.” So, Neeraj, can you tell us more about the relevance of this exploratory analysis? Dr. Neeraj Agarwal: Definitely. In this abstract, Dr. Yang Sun and colleagues assess the effect of lutetium PSMA on overall survival in two different trials, TheraP and VISION trials. So, just for our listeners' recollection, the phase 2 TheraP trial compared lutetium PSMA and cabazitaxel in patients with mCRPC who had progression on docetaxel and had significant PSMA avidity on gallium PSMA pet scan, which was defined as a minimum uptake of SUV max of 20 at least one site of disease and SUV max of more than 10 at all sites of measurable disease.  In this trial, 20 of 101 patients in the cabazitaxel arm crossed over to lutetium PSMA, and 32 of 99 patients in the lutetium PSMA arm crossed over to cabazitaxel. In the VISION trial, patients with mCRPC who previously progressed on at least one ARPI and one taxane-based therapy and had a positive gallium PSMA scan, and here, positivity was not stringently pre-specified as it was done in the context of TheraP trial. So, positive gallium pet scans were randomly assigned in two to one fashion to receive either lutetium PSMA plus best supportive care or standard of care versus standard of care.  And I'd like to highlight that the standard of care comprised ARPIs and bone protecting agents and these patients were not allowed to have cytotoxic chemotherapy such as cabazitaxel in the standard of care arm. Now, overall survival was similar in the lutetium PSMA group regardless of whether they got lutetium PSMA in the VISION trial or TheraP trial. There was no difference in overall survival with lutetium in the lutetium arms of VISION and TheraP trial with a hazard ratio of 0.92. And there was no difference in the overall survival between the lutetium PSMA and the cabazitaxel group in the TheraP trial if you use counterfactual analysis, assuming crossover had not occurred. So, quite interesting in my view. Dr. Jeanny Aragon-Ching: Yeah, thanks Neeraj for that wonderful synopsis and discussion. So, what is the key take home message then? Dr. Neeraj Agarwal: The main message in this new exploratory analysis, which combined both the TheraP and VISION trials, is that lutetium PSMA and cabazitaxel seem to be associated with similar overall survival benefit in these highly selected patients with PSMA positivity. Additionally, the difference in the observed effect of lutetium PSMA and overall survival in the TheraP and VISION trials may be actually better explained by the use of different treatments in the respective control arms of these trials. And these results, in my view, are quite pertinent for those patients and providers who do not have access to lutetium-177 therapy.  Let's go to another abstract that is currently relevant to our practice, given many patients with advanced prostate cancer who have concurrent diabetes; I'm talking about Abstract 5066. Jeanny, can you please tell us more about this abstract?  Dr. Jeanny Aragon-Ching: Certainly, Neeraj. So this abstract will be presented by Dr. Amy Shaver and colleagues. So it's also very relevant, since many men who are diagnosed with prostate cancer frequently also have a concomitant diagnosis of type 2 diabetes mellitus. So, this was a SEER-Medicare population database analysis that looked at men who were treated with either abiraterone or enzalutamide and also had concomitant diagnosis of type 2 diabetes mellitus (DM). And they were identified using ICD-9 and ICD-10 codes and they were all tied in to acute care utilization. So they looked at CMS research data codes and ER hospitalization visits six months after treatment initiation was recorded. So all in all, they took a sample of 11,163 men, of whom close to 62% were treated with abiraterone and about 38% were treated with enzalutamide.  So, of these, about 27% of them had type 2 DM, of whom 59% received abiraterone and about 41% had enzalutamide. So, the bottom line is, compared to those without diabetes mellitus, those who had type 2 diabetes had worse acute care utilization, which was 43% higher than those who got abiraterone compared to enzalutamide, and also had higher overall mortality. Therefore, the bottom line is, having type 2 diabetes mellitus, unfortunately, portends worse outcomes in men with prostate cancer, so careful attention needs to be paid to those who are starting out already with such comorbidities. So Neeraj, any final thoughts you have regarding this abstract and overall before we wrap up on the podcast today?  Dr. Neeraj Agarwal: Absolutely. So it looks like, based on this very important pertinent Abstract 5066, which talks about the impact of diabetes on our patients, I think we need to be very watchful regarding the impact of diabetes on our patients who are being treated with abiraterone or enzalutamide, especially drugs which are known to make the metabolic syndrome and diabetes worse. I think close monitoring and close attention to control of diabetes is very important. So with that, I would urge the listeners to come and join us at the Annual Meeting, not only to celebrate these successes but also to help disseminate this cutting-edge data to practitioners and maximize the benefit to our patients across the globe.   And thank you to our listeners for joining us today. You will find links to the abstracts we discussed today on the transcript of this episode. Finally, if you value the insights that you hear on our ASCO Daily News Podcast, please take a moment to rate, review and subscribe wherever you get your podcast.  Disclaimer: 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. Find out more about today's speakers:  Dr. Neeraj Agarwal @neerajaiims Dr. Jeanny Aragon-Ching Follow ASCO on social media:   @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn     Disclosures:  Dr. Neeraj Agarwal:   Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences  Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, Crispr Therapeutics, Arvinas  Dr. Jeanny Aragon-Ching: Honoraria: Bristol-Myers Squibb, EMD Serono, Astellas Scientific and Medical Affairs Inc., Pfizer/EMD Serono Consulting or Advisory Role: Algeta/Bayer, Dendreon, AstraZeneca, Janssen Biotech, Sanofi, EMD Serono, MedImmune, Bayer, Merck, Seattle Genetics, Pfizer, Immunomedics, Amgen, AVEO, Pfizer/Myovant,  Exelixis, Speakers' Bureau: Astellas Pharma, Janssen-Ortho, Bristol-Myers Squibb, Astellas/Seattle Genetics.

Dr. John Sweetenham and Dr. Marc Braunstein discuss the role of maintenance therapy in high-risk multiple myeloma, advances in myelodysplastic syndromes in the COMMANDS study, the promise of bispecific antibodies in the pivotal EPCORE NHL-1 in relapsed/refractory large B-cell lymphoma, and improving outcomes for patients with chronic lymphocytic leukemia in the CAPTIVATE trial.  TRANSCRIPT Dr. John Sweetenham: Hello, I'm Dr. John Sweetenham, the associate director for cancer network clinical affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center, and host of the ASCO Daily News Podcast. My guest today is Dr. Marc Braunstein, a hematologist and oncologist at the NYU Perlmutter Cancer Center. Today, we'll be discussing key posters and oral abstracts highlighting advances in hematologic malignancies that will be featured at the 2023 ASCO Annual Meeting.   You'll find our full disclosures in the transcript of this episode, and disclosures of all guests on the ASCO Daily News Podcast are available on our transcripts at asco.org/DNpod.  Dr. John Sweetenham: So, Marc, thanks for returning to us and coming to join us on the podcast today. Dr. Marc Braunstein: Thanks for inviting me back. Dr. John Sweetenham: I'd like to start out with Abstract 8001. This is a study which is addressing the role of maintenance therapy in patients with high-risk multiple myeloma. Could you take us through this study and the key take-home points that you think are the most important ones? Dr. Marc Braunstein: Sure, absolutely. So, the first abstract that we're going to discuss is an oral abstract being presented by Dr. Nooka regarding maintenance therapy in high-risk multiple myeloma patients. Outcomes of patients with multiple myeloma are clearly improving, yet those with high-risk cytogenetic abnormalities, which represent about 10-20% of all multiple myeloma, tend to have poorer survival, and worst among these are those with what's called ultra-high-risk or double-hit multiple myeloma who have more than 1 high-risk cytogenetic abnormality. So, this study looked at maintenance therapy following stem cell transplantation in 26 high-risk patients, about 59% of whom had double hit disease, representing very high-risk disease. This was a phase II study looking at using carfilzomib, pomalidomide, and dexamethasone in high-risk multiple myeloma patients who achieved at least a partial remission following stem cell transplant. There were 26 patients enrolled. The median age was 60. Of note, about 59% of patients were Black, which is important because these patients tend to be historically underrepresented in studies. And what they found was that at study entry, about 24% of patients were in a complete remission or better, and that deepened to 79% while on the study. And the median time to best response was 2 months, which is fairly brisk. With a median follow-up of about 26 months, the 36-month progression-free survival was 63%, and the overall survival was 72%, which is impressive, again in the context of patients who have very high-risk disease. So, although it remains to be determined what the optimal regimen or duration of maintenance should be in multiple myeloma, clearly, combination therapy is effective and should be used in patients who have high-risk or ultra-high-risk multiple myeloma. Dr. John Sweetenham: Great. Thanks, Marc. So, as you say, I mean, clearly the take-home message is around the effectiveness of this type of maintenance therapy. I just have a couple of quick follow-up questions for you. The first of those is, where do you see this going next? I mean, in your opinion, what would be the next logical study with this combination or similar combinations? And then secondly, what do you see on the horizon for those patients with very high-risk myeloma, particularly the double-hit population that you just mentioned? Dr. Marc Braunstein: It's a paradigm in multiple myeloma that combination therapy tends to be more effective as long as we're able to manage the adverse events that come with additional combinations. And we've been able to succeed in that regard with quadruplet regimens, even now that we have monoclonal antibodies that tend to be better tolerated and more targeted in nature. In terms of maintenance therapy, single-agent lenalidomide has been the long-standing agent of use for the majority of patients. But we now understand that the combination of an immunomodulator like lenalidomide and a proteasome inhibitor like bortezomib or carfilzomib is more effective for patients with higher risk disease.   We also have data from various upfront studies of quadruplet regimens, such as the FORTE study, which looked at carfilzomib and lenalidomide maintenance after transplant that shows that we can improve progression-free survival in all comers with multiple myeloma following transplants. So, I think down the road we're going to be looking at more use of combination therapies and maintenance. And as far as for high-risk patients, whether that's going to be using monoclonal antibodies in maintenance or combination proteasome inhibitors and immunomodulators or even other immunotherapies like bispecific antibodies as maintenance in the future remains to be determined, but clearly, for high-risk patients, we should be using combination therapies. Dr. John Sweetenham: Thanks, Marc. Let's change gears a little now and take a look at Abstract 7003, which addresses patients with myelodysplastic syndrome. This study addresses the efficacy and safety results from a study of luspatercept versus epoetin alfa in low-risk myelodysplastic syndrome. I wonder if you could describe this study and the results to us and maybe also for the benefit of our listeners, just mention quickly the mechanism of action of the experimental agent here.  Dr. Marc Braunstein: This is an oral abstract being presented by Dr. Garcia-Manero looking at a phase 3 study, as you mentioned, called the COMMANDS study, and this is looking at an agent called luspatercept in patients with low-risk myelodysplastic syndrome (MDS). So, patients with MDS can have inferior quality of life and survival when they become transfusion dependent. An earlier study called the MEDALIST study, which was published in the New England Journal of Medicine in 2020, randomized low-risk or intermediate-risk patients with MDS who were refractory or unlikely to respond to erythropoietin stimulating agents to either luspatercept, which is an agent that binds to TGF-beta family members and helps stimulate erythropoiesis. Patients were randomized in the MEDALIST study to luspatercept or placebo. And that study showed that luspatercept could improve a degree of anemia and lead to transfusion independence in certain patients. So, the COMMANDS study is a randomized controlled study that randomized 354 patients with low-risk MDS who were transfusion dependent and naive to an erythropoietin stimulating agent to receive either luspatercept or the erythropoietin stimulating agent erythropoietin alfa with the primary endpoint of transfusion independence at some time between 12 to 24 weeks. So, patients were randomized 1:1 to receive either luspatercept or epoetin alfa, and the primary endpoint again was transfusion independence. So, 354 patients were randomized in the study and the median treatment durations were 42 weeks of luspatercept and 27 weeks of epoetin alfa. And transfusion independence occurred in greater quantity in the patients who got luspatercept. For example, in the patients who received luspatercept at 8 weeks, transfusion independence was achieved in 74 versus 51% in the epoetin alfa group. So, in terms of treatment-related adverse events, they were fairly similar between the groups and consistent with the classes -  they were reported in 30% in the luspatercept group and 17% in the erythropoietin group, with no difference in patients who progressed to acute myeloid leukemia.  So, I think when it comes to MDS in low-risk patients, it's really important to preserve their quality of life by limiting their transfusion burden. And I think this study demonstrates that luspatercept continues to be an important part of the management in these low-risk patients. And whether or not you would start a patient with low-risk transfusion-dependent MDS on an erythropoietin stimulating agent or luspatercept is really addressed by this study showing that you can achieve greater rates of improvement in anemia and transfusion independence with luspatercept.  Dr. John Sweetenham: Great. Thanks, Marc. A really interesting study. And I do have one question for you about this study, which I think will make it clear to you that I am an expert neither in myelodysplastic syndrome nor in erythropoiesis. But my question is based on the mechanism of action. Is there any rationale for combining these 2 agents in future studies?  Dr. Marc Braunstein: Yes, it would potentially make sense to use 2 synergistic mechanisms to improve erythropoiesis. We would have to see what the potential for adverse events are. I think epoetin alfa tends to be a fairly low burden in terms of its side effect profile. Luspatercept can have some potentially dose-limiting side effects, such as GI side effects, but you can make dose adjustments to both of these medications. So we may need to find the correct doses of either of them in combination. But from a theoretical standpoint, it makes sense that these could potentially be synergistic, especially in patients who are likely to respond to erythropoietin by having a baseline lower erythropoietin level. Dr. John Sweetenham: Okay, let's move on in another change of gear now. And for the rest of the podcast, we're going to be talking about some studies in lymphoid malignancy, beginning with Abstract 7535, which is a follow-up of the phase 2 CAPTIVATE study which now has significantly extended follow-up from the original report. So Marc, can you walk us through this study and the outcomes to date? Dr. Marc Braunstein: Absolutely. So this is a poster being presented by Dr. Barr and it is looking at CLL, which is a field that is really moving away from chemotherapy for newly diagnosed patients, thanks to the development of novel targeted agents. The CLL14 trial, which was published in the New England Journal of Medicine in 2019, showed that fixed-duration venetoclax plus obinutuzumab improved progression-free survival and rates of negativity of minimal residual disease, or MRD, when compared to chlorambucil and obinutuzumab. So building on the success of that study, combining a monoclonal antibody and a BCL2 inhibitor, the CAPTIVATE study is a phase II study, which examines venetoclax with ibrutinib, the BTK inhibitor, and previously untreated CLL. So it's kind of combining 2of the novel targeted therapies in a fixed duration, similar to what was done in the CLL14 study where patients received 1 year of therapy and then stopped treatment.   So in the CAPTIVATE study, 154 patients were enrolled. This was a phase 2 study that included about 56% of higher-risk patients who had unmutated IGHV, and the median time on the study was 50 months, with a CR rate of 58% at a 4-year follow-up and an overall response rate of 96%, which is quite high, especially considering that more than half of patients had high-risk disease. The progression-free survival was 79% and the overall survival rate was 98% at 4 years. And when they looked at patients who had undetectable minimal residual disease, the 4-year overall survival rate was 100%, which also suggests that MRD can help serve as a predictive marker of longer-term survival. So I think we have to also consider what the side effects are of combining these 2 agents and the most common adverse events were hematologic, which is expected based on what we know about the 2 classes. So I think the implication of the study is that giving 2 oral agents for a fixed period of treatment for 12 cycles is a rational approach that may spare patients indefinite therapy and can lead to positive outcomes, including in patients who have high-risk features with CLL.  Dr. John Sweetenham: Yeah, the other interesting observation that was made in the abstract, which I found to be really encouraging, was the fact that a number of these patients apparently have been re-treated successfully upon progression with ibrutinib again, which seems to be somewhat reassuring as well.  Dr. Marc Braunstein: That's right. There were 4 patients who started re-treatment in the study and perhaps we'll see the outcomes of that small subgroup are at the poster presentation. But I think when we discuss fixed-duration treatment, it also opens the door to potentially re-challenging patients when they relapse. We know that when we stop single-agent BTK inhibitors, which are historically given indefinitely in patients with CLL, those patients who stop, many will relapse, but you can potentially re-challenge them with the BTK inhibitor. So this study with the CAPTIVATE trial gives us some liberty to discontinue therapy, but also considering re-challenging upon relapse.   Dr. John Sweetenham: Yeah, absolutely. Moving on to aggressive B-cell lymphoma, now, the next abstract I'd like to discuss with you is Abstract 7525. I find this one particularly interesting as the continued excitement around CAR T cell therapy for relapsed aggressive lymphoma remains high at the moment. It's intriguing that t cell-engaging antibodies also have been reported, at least, to have remarkable activity in this set of diseases. So can you take us through Abstract 7525 and what they're reporting?  Dr. Marc Braunstein: Absolutely. Bispecific antibodies represent an emerging field in multiple hematologic malignancies, and this is a class of antibodies that bind to both the tumor cell as well as T-cells, and activate T-cell immunity against the tumor cell. So epcoritamab is a bispecific antibody that binds to CD3, which is expressed on T cells, and CD20, which is expressed on B cells. And Thieblemont et al published results in the Journal of Clinical Oncology last year in a phase I/2 study that looked at epcoritamab in patients with diffuse large B cell lymphoma following 2 prior lines of therapy, and this was given subcutaneously until progression of disease. In that study, at a median follow-up of about 11 months, the overall response rate was 63% with 39% complete remissions.   So the EPCORE NHL-1 study, which is being presented at this year's ASCO meeting, is presenting the updated results of that study looking at patients with diffuse large B cell lymphoma that includes a small population as well of patients with high-grade B cell lymphomas and primary mediastinal B cell lymphomas who had at least 2 prior lines of therapy. In this presentation, 157 patients were included in this study, and 61% had primary refractory disease, and actually, 39% had prior CAR T-cell therapy, of whom 75% progressed within 6 months. So these were patients who were not only refractory to treatment but also had prior T-cell therapy.   So at a median follow-up of 20 months, the overall response rate was 63% and the complete response rate was again about 39%, and the median duration of complete remission was 21 months. In terms of overall survival, the median was about 19 months, which is substantial for this group of patients who really wouldn't be expected to respond very well to conventional therapies.   As we know, T-cell-engaging therapies, such as these bispecific antibodies or CAR T-cells have the potential risk for certain immune-related adverse events, including cytokine release syndrome or icons, and a neurologic syndrome related to the therapy. And it's worth noting that the CRS in this study was predominantly low-grade. There were only 3% of patients who had grade III CRS, and 9 patients, or 6% had grade I to II icons. I think that also reflects how we're better managing those side effects and intervening earlier. So I think the results are impressive from the standpoint of the population studied, who were quite refractory to treatment and show relatively high rates of response. In fact, the median overall survival was not reached in the overall population.   So I think what we take away from this abstract is that bispecific antibodies are going to play a vital role in the relapse-refractory setting for large cell lymphoma and may also offer an alternative to patients who aren't necessarily fit for CAR T-cell therapy, which plays a vital role in patients who are both refractory to first-line therapy or relapse-refractory to subsequent disease. So these are very encouraging results, and I'm sure we'll see randomized data as well in the future, further supporting the use of bispecific antibodies like epcoritamab.  Dr. John Sweetenham: Yeah, I agree. Thanks, Marc. I think that's a great summary. And it's particularly exciting to me that the investigators were able to achieve this kind of level of response and progression-free survival with a subcutaneous treatment. It's really quite remarkable and really exciting to see that.  We're going to wind up with our final abstract today, which is looking at the utilization of circulating tumor DNA in, again, in patients with aggressive B cell lymphoma. This is Abstract 7523, so maybe you could walk us through this one, Marc.  Dr. Marc Braunstein: Absolutely. So this is a poster being presented by Dr. Herrera looking at a, I guess you could call it a biomarker in the blood using circulating tumor DNA in patients with newly diagnosed diffuse large B cell lymphoma in the POLARIX study. So the results of the phase 3 POLARIX study were published last year in the New England Journal of Medicine and showed improvement in progression-free survival with the addition of these anti-CD79b antibody polatuzumab to standard R-CHOP chemotherapy compared to R-CHOP alone. And this study actually led to the approval of first-line treatment that includes polatuzumab.   In the abstract being presented by Dr. Herrera, the investigators looked at the value of circulating tumor DNA as a potential marker to serve as a guide for prognosis and predicting longer-term responses, particularly when the blood is cleared of circulating tumor DNA. So the study involved 654 patients who had ctDNA results both at baseline and then with longitudinal assessment, and they used an assay called the CAPP-Seq assay to assess circulating tumor DNA and assess for its clearance. In the study, undetectable circulating tumor DNA was achieved in 57% of patients who got the polatuzumab R-CHP combination and 59% of the patients who got R-CHOP by cycle 5 and then 6% in the polatuzumab group at 67% in the R-CHOP group.  So the rates of circulating tumor DNA clearance were similar between the 2 arms. But what's notable is that patients in the polatuzumab arm who achieved a complete response at the end of treatment plus cleared their circulating tumor DNA had superior progression-free and overall survival compared to patients who achieved a CR but retained circulating tumor DNA in their blood.   And this has implications because it might help gauge, for example, if patients may need additional cycles to clear the circulating tumor DNA, although we still need more data to answer whether that's necessary or not. And it may help serve as a predictive marker for longer-term remission, particularly in patients who perhaps have higher risk factors at baseline. So I don't think this is necessarily ready for primetime to use in clinical practice, but it is intriguing to know that we could finally have a tumor-specific biomarker in the blood to help monitor patients and potentially predict their longer-term remissions.  Dr. John Sweetenham: Thanks, Marc. I agree. Great summary, and obviously there's still something to learn about the kinetics of the response and so on. And also, I suppose it raises the question of whether those patients who still have detectable levels should be switched at the end of therapy to some kind of preemptive second-line therapy. And these are obviously all questions for the future, but it's going to be very interesting to watch this space, I think, and see how this story develops. Dr. Marc Braunstein: Absolutely. And my colleagues in the solid tumor space are already using circulating tumor DNA, for example, in colon cancer, to help with surveillance. So perhaps this could be a tool to use to predict relapse also in patients who are on surveillance after their treatment. But again, as you alluded to, we need more data to address that.  Dr. John Sweetenham: Well, thanks so much, Marc, for sharing your insights with us today on a really interesting set of abstracts coming up at the June meeting. And thanks for joining us on the ASCO Daily News Podcast. Dr. Marc Braunstein: Thank you for inviting me.  Dr. John Sweetenham: And thank you to our listeners for joining us today. You'll find links to the abstracts discussed today in a transcript of this episode. Join us again after the annual meeting for key takeaways on the late-breaking abstracts and other key advances from the ASCO Annual Meeting. And finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: 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. Find out more about today's speakers:  Dr. John Sweetenham Dr. Marc Braunstein @docbraunstein   Follow ASCO on social media:  @ASCO on Twitter  ASCO on Facebook  ASCO on LinkedIn  Disclosures: Dr. John Sweetenham:Consulting or Advisory Role: EMA Wellness Dr. Marc Braunstein:Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb/Celgene, Adaptive Biotechnologies, GlaxoSmithKline, ADC Therapeutics, Janssen Oncology, Abbvie, Guidepoint Global, Epizyme, Sanofi, CTI BioPharma Corp Speakers' Bureau: Janssen OncologyResearch Funding (Institution): Janssen, Celgene/BMS

On November 4, 2022, the Supreme Court granted cert in Amgen Inc. v. Sanofi, a patent infringement case that involves the application of the statutory enablement requirement of Section 112 of the patent laws to what is referred to as a "genus claim" as it applies in the context of pharmaceutical applications. The two patents in dispute relate to antibody drugs that reduce low-density lipoprotein (“LDL”) cholesterol.The Court heard oral arguments in the case on March 27. Specifically at issue is "whether enablement is governed by the statutory requirement that the specifications teach those skilled in the art to 'make and use' the claimed invention, or whether it must instead enable those skilled in the art 'to reach the full scope of claimed embodiments' without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial 'time and effort.'"Robert Rando, an intellectual property attorney who filed an amicus brief in the case, joined us to break down the arguments.Featuring:Robert J. Rando, Partner, Greenspoon Marder LLP

In der heutigen Folge „Alles auf Aktien“ sprechen die Finanzjournalisten Anja Ettel und Holger Zschäpitz über die Rallye bei den FOMO-Aktien Palantir, Upstart, Nvidia, neue Impfhoffnungen bei Pfizer und Enttäuschung bei Alibaba und China-Aktien. Außerdem geht es um iShares MSCI China Tech (WKN: A3CU00), Invesco MSCI China Tech ETF (WKN: A3CMY8), UBS Solactive China Tech ETF (WKN: A2QJ9G), Xtracker MSCI China Tech 100 (WKN: DBX0RQ),  Walmart, Target, Sanofi, GSK, Moderna, AstraZeneca, Novavax, iShares Core DAX ETF (WKN: 593393), Deka Dax ETF (WKN: ETFL01), Xtrackers Dax (WKN: DBX1DA), RWE, Daimler Truck, Deutsche Telekom, Rheinmetall, Infineon, Siemens, Mercedes-Benz Group, Merck, Siemens Energy, Siemens Healthineers, Henkel, Beiersdorf, Adidas, BASF, Hannover Rueck, Continental, Vonovia, Symrise, MTU Aero Engines, Deutsche Bank, Root, Maui Land&Pineapple, PVH, NGL Energy, Federated Hermes, Western Alliance Bancorp, Seadrill, Intercorp Financial, Semantix, Coca Cola Femsa, Alcoa und Agora.

Audience questions from the live RNL 2023 meeting and the session on EVOLUTION AND ADVANCES IN VASCULITIS held on March 18, 2023. These sessions were sponsore by Sanofi. This POD (session) featured three excellent lectures: - Dr. Robert Spiera: Therapies for GCA and PMR - Dr. Anisha Dua: Assessment of GCA and PMR  - Dr. Carol Langford:  GPA Treatment Choices

Today's guest is Franck Rapaport, Director of Precision Medicine, Computational Biology and Data Science at Sanofi. Sanofi are an innovative global healthcare company, driven by one purpose: to chase the miracles of science to improve people's lives. Their teams across the world strive to transform the practice of medicine, turning the impossible into the possible for patients. They provide potentially life-changing treatments and the protection of life-saving vaccines to millions of people, and affordable access to their medicines in some of the world's poorest countries. Franck joined Sanofi in May 2021 and became the lead of the Precision Medicine and Computational Biology Data Science lab in July 202. His team applies machine learning to advance precision medicine and finds new treatment options for immunological, inflammatory, and neurological diseases. Previously, Franck's interest in computational biology led him to Institut Curie and Memorial Sloan-Kettering Cancer Center where he designed and implemented new computational methods for the analysis of expression and copy number data. In the episode, Franck will talk about: Their mission and work in the pharma sector, How they are applying Computational Biology and Data Science in precision medicine, Recent success of the team and potential impact in medicine, Team structure and day-to-day life of the team, Upcoming projects and what the future holds for Sanofi, Career opportunities and why they're a great place to work

It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: The US Senate grills insulin makers about keeping the price where it is, two studies look at the impact of faster-acting insulins, a new study looks out temperature and insulin storage, researchers examine CGM access and health outcomes, and more Check out Moms' Night Out with three new dates on the calendar! Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines happening now XX In the news is brought to you by Moms Night Out - Treat yourself to some time away with other moms who get it. Our next stops this fall in Providence, RI and Frisco TX. XX Our top story this week, big Senate hearing on insulin.. The three insulin makers recently cut their list prices by around 70%. The Senate Committee on Health, Education, Labor and Pensions pressed industry leaders and all three – Lilly, Novo Nordisk and Sanofi - committed to “keeping their drugs affordable,” But asked whether the companies would no longer raise prices on their existing insulins, only Lilly sai yes. The Sanofi and Novo Nordisk chiefs did not. Sen. Markwayne Mullin, R-Oklahoma, called PBMs “the fox guarding the henhouse,” going after the executives for essentially “rebating themselves." He said the situation “isn't working for America.” “This committee is going to stay on this issue," Senator Bernie Sanders said Wednesday. "We need profound change in the industry and in PBMs." https://www.fiercepharma.com/pharma/bernie-sanders-led-senate-committee-holds-pharma-chiefs-and-pbm-execs-feet-fire-insulin XX Not a big difference between fast-acting insulin aspart and standard insulin. New study using hybrid closed-loop insulin delivery system found that faster acting Fiasp did not offer any additional glycemic benefits compared with standard insulin aspart – Novolog - and participants had more cases of hyperglycemia with ketosis with the Fiasp. The study cohort had a baseline HbA1c of 7.2% and a time in range of 63.9% at the start of the trial. Of the cohort, 76% was using a hybrid closed-loop insulin delivery system at enrollment. There were no cases of severe hypoglycemia or DKA during either intervention. https://www.healio.com/news/endocrinology/20230508/time-in-range-similar-with-fastacting-vs-standard-insulin-for-young-kids-with-diabetes XX On the other hand, people with type 2 diabetes saw more time in range with faster acting insulin. These were adults with type 2 on basal bolus MDI along with CGM. The insulins here with Lyumjev and humalog. https://link.springer.com/article/10.1007/s13300-023-01400-w XX New study confirming that insulin doesn't have to be refrigerated as strictly at package instructions. These researchers took 6 different bands and types of insulins and stored them – quote - unopened for 1–4 months in non-refrigerated conditions in a real-world setting during the summer in India, all compared with control samples of each insulin, which remained refrigerated. Insulin vials were stored in watertight bags. Bags were placed in either an open plastic container stored on a high shelf or in a cupboard, or in clay pots with a separate water compartment. All storage containers were placed in shaded areas The temperature was measured every 15 min by electronic data loggers. The mean maximum temperatures were between 86 and 94 degrees. Most of the insulin stayed fine for two months and much of it for four months. Every study I talk about is linked up at this episode's homepage at d-c dot com with more specifics. https://www.thelancet.com/journals/landia/article/PIIS2213-8587(23)00028-1/fulltext?fbclid=IwAR1J2Y2JLZNHTvlPwtCo7t-wA60zhFMRvx2DEc7sujaFOX1pKc_-RbjhnL0 XX Not so shocking conclusion that increasing access to CGMs – regardless of ethnicity and insurance status – can improve outcomes. Despite higher rates of complications among T1D youths from lower-income backgrounds, diabetes technology is 50% lower among this group. Youths with public insurance have frequent interruptions to CGM access, which are associated with worsening HbA1C trends. Implicit biases and willingness to recommend diabetes technology to youths from underrepresented backgrounds are likely additional contributors to these disparities, according to authors. Authors concluded the results demonstrated in the study suggest equitable access to CGM soon after T1D diagnosis could be a first step to improve HbA1C for all youths, but acknowledge this access alone is, “unlikely to eliminate disparities entirely.” The authors add broader societal strategies to address structural drivers of disparities in diabetes care are required. https://www.contemporarypediatrics.com/view/equitable-access-to-glucose-monitoring-improves-hba1c-levels XX Interesting reminder that the seemingly obvious answer isn't always the right one comes from cataract research.. Cataracts—the clouding of the lens of the eye—are the number one cause of blindness worldwide and are a common complication of type 2 diabetes. The current hypothesis behind diabetic cataract development is coined “the sugar hypothesis” and suggests that high blood sugar—a hallmark of diabetes—precedes cataract development. The working assumptions underlying the sugar hypothesis describe higher levels of glucose in the lenses of people with diabetes convert to a sugar alcohol molecule called sorbitol, which induces structural changes to the lens of the eye that precede cataract development. While unproven, researchers rarely investigate this theory further due to cataracts' treatable nature. Now, after some animal studies, it looks like the damage actually starts before blood glucose rises above normal. The reseahres say it's still too early to tell what's going on but they hope ore study will bring the medical community a step closer to understanding the cellular mechanisms underlying the origins of diabetic complications during the pre-diabetic stage of the disease. Then, they say, they can search for ways to better prevent them. https://scitechdaily.com/sweet-deception-sugar-hypothesis-of-diabetic-cataract-development-gets-an-eye-opening-reality-check/ XX Very large study shows that GLP1 receptor agonists—a class of diabetes medications that include Trulicy and Ozempic —are associated with fewer major adverse cardiovascular events than another type of diabetes drug older veterans with no prior heart disease. The second drug type is DPP4 inhibitors with brand names like Januvia and Nesina. Apparently, the clinical trials showing cardiovascular benefits for these drugs were conducted in people who already had heart disease, so these researchers wanted to see if it would help those who did not. 100-thousand US veterans were included in this study. The median patient age was 67 years, and the median diabetes duration was 8.5 years. The researchers included variables such as age, sex, race, body mass index, blood pressure, laboratory values like hemoglobin A1c, and history of prior illnesses in the statistical analysis. https://medicalxpress.com/news/2023-05-diabetes-drugs-adverse-cardiac-events.html XX Ascensia expands it's Eversense PASS, a Payment Assistance and Simple Savings program designed to enhance affordability and access to the Eversense E3 CGM System. Under the new and improved program, more people with diabetes will be eligible for assistance paying for the system, which now includes increased savings for eligible first time users. Eligibility for the program has now been extended to all commercially insured people with diabetes across the country, including those who do not have coverage for the Eversense E3 system from their insurance provider. Eversense is an implanted CGM that lasts six months and has a removable smart transmitter. https://www.prnewswire.com/news-releases/ascensia-diabetes-care-expands-payment-assistance-and-simple-savings-program-for-eversense-e3-cgm-system-301818639.html XX Right back to the news, but first, I want to tell you about Moms Night Out! In the 16+ years since my son was diagnosed with type 1, I have attended dozens of diabetes conferences and events. Now I've taken the best elements from those events and created a brand new experience. We're going to have lots of diabetes technology for you to see and learn about, stress-relieving social time where you can meet other moms just like you, and speakers who will leave you feeling energized and ready to face the challenges of parenting a child with T1D. We had the first of these in January – I didn't realize it was the first I actually expect it to be a one and done – but it went to so well and the reaction was so good from moms around the country that I deided to keep going. Our next stops are Frisco TX and Providence RI, back to Charlotte in Feb and more cities to come in 2024. Join us – check out the very top of diabetes-connections dot com or click on the event tab. XX XX Garmin today announced expanded region availability of the Dexcom Connect IQ apps. Available for a wide range of Garmin smartwatches, the Dexcom Connect IQ app3 provides people with diabetes with a secondary way to view their glucose levels, right from their wrist. Connect IQ is the app platform for Garmin wearables, bike computers, and outdoor handhelds https://www.garmin.com/en-US/newsroom/press-release/wearables-health/people-with-diabetes-can-now-view-dexcom-cgm-data-on-their-garmin-smartwatch-or-cycling-computer/ XX XX On the podcast next week.. Neil Greathouse is a familiar face on social media – posting every day as “The Betes.” I'll catch up with Neil to talk about what motivated this every day connection – he has a real job not in diabetes – and more. Last week I spoke with The Marvelous Mrs Maisel's Austin Basis about managing T1D on set and off. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

Insulin is expensive. While it costs around 10-13 dollars for manufacturers to produce insulin, big pharma companies are selling it for $250-500 dollars per month. This is because America's warped pharmaceutical market allows three companies, Eli-Lilly, Sanofi, and Novo Nordisk, to dominate the insulin businesses and set insanely high prices for their drugs. Today I am talking to my friend Siara Patel, a freshman at Boston University and a Type 1 Diabetic. We learn about her journey living with Type 1 Diabetes and the economic challenges she and many other Type 1 and Type 2 diabetics face on a daily basis. After my interview with Siara, we will take a deep dive into why the price of insulin has grown so much in the past 20 years and how this life-saving drug has shifted so far way away from its initial altruistic intent. One of the founders of insulin, Canadian scientist Frederick Benting said, “Insulin belongs to the world.” But we seem to be living in reality far away from this statement. Additional resources and information:https://www.jdrf.org/https://civicarx.org/https://diabetes.org/https://openinsulin.org/https://www.youtube.com/watch?v=w_RQl1pK11g Support the show

Wema Hoover's Bio:Wema Hoover is an internationally acclaimed speaker and the CEO of Wema Hoover Advisors. She has dedicated her career to being a culture change agent advancing in diversity, equity, and inclusion across global markets through a system thinking approach, driving organizational change and development in people, processes, and products. Wema has worked with different multinational businesses such as Google, Pfizer, Sanofi, Bristol-Myers Squibb, and PwC. Episode Highlights:Our childhood experiences prepare us for our adult life. For Wema Hoover, her exposure to different cultures opened her up to working with multicultural spaces across the globe. Wema was born in New Jersey and has lived in different places worldwide. Today, Wema shares her journey to embracing limitlessness and harnessing her inner strength.Links:Website: https://www.wemahoover.com/LinkedIn: https://www.linkedin.com/in/wemahoover/Quotes:“When you're given the platform or influence to perform, you've got to see it as a time to deliver.”“Seize the moment, fulfil your potential whatever it may be, take action, and don't leave anything to chance if you're given the opportunity.”“When you don't believe in yourself, but others do - how much win that gives you!”“We're all on a learning journey every day of our life.”Take Aways:Childhood Incidents:Wema grew up in a society that was rich in diversity where she enjoyed many different experiences, traditions, ideas, and philosophies. They celebrated holidayssuch as the Chinese New Year, Yom Kippur, and many other cultural events. Wema recalls a time when she wasn't allowed to attend her Jewish friend's bat mitzvahbecause her friend's parents didn't want a black person at the event. This incident never affected the relationship between the two girls and they remained close.Influential Groups:Wema was raised in an African American community where everything revolved around hard work and living your potential. In their household, excellence was considered the norm, and seizing opportunities was the order of the day. At a young age, they were taught to understand that opportunities only come once.Temperament and Personality:Wema believes she was born with a love for people. As an extrovert, her energy stems from connecting with people and having meaningful connections.Cultural Epiphanies:Getting along with colleagues is one of the goals people strive to achieve in their workplaces. Some people do coffee dates; others go out for drinks or visit each other in their homes. When she took a job in France, Wema was initially taken aback by the separation of work and personal interaction. Wema tried to show kindness to her colleagues by taking dessert to their doorsteps, which landed her in trouble with the HR department. She couldn't understand how her colleagues were uncomfortable with her visiting them in their homes. Unlike Americans or Indians, the French are more concerned with protecting their personal privacy. Thriving Environment:For Wema to thrive she needs strong collaboration, openness, and exchange. This climate creates room for her to be at her best at work.Soapbox Moment:Wema Hoover invites us to check out Be Limitless Consulting to see how she makes an impact in the world.Tagline: How to harness your inner strength and achieve anything you want.Support the show

In this special episode organised and funded by Sanofi, I chat to not one but two guests – first up is Ben Anderson who is dad of five under nine, entrepreneur and can be found online as The Diary of a Dad and on his podcast of the same name.We chat about life with a large brood of kids, how he and his wife Sophie juggle running their business with family life and how unapologetic he is about them having three nannies to help them do it.Then we are joined by Dr Shireen, GP and mum of one, who we talk to about infant RSV - Respiratory syncytial virus – which is a very common and contagious virus which affects 90% of infants by the age of two. But it's something many parents aren't aware of, so Dr Shireen tells Ben and I about the symptoms and how to treat it if your child catches RSV.Find out more about RSV at www.togetheragainstRSV.com and you can follow Dr Shireen (@doctorshireen) on Instagram. Ben can be found on Instagram and his podcast The Diary Of A Dad can be listened to on all podcast platforms. If you enjoyed this episode then please leave a rating or review - and you can follow the podcast to ensure you don't miss future episodes. Thank you! Not Another Mummy Podcast is brought to you by me, journalist and author Alison Perry. I'm a mum of three and I love interviewing people about parenthood on the podcast. You can check out my other episodes and you can come chat to me on Instagram: @iamalisonperry or on Twitter: @iamalisonperry. You can buy my book OMG It's Twins now.Music: Epidemic SoundArtwork: Eleanor BowmerSupport this show http://supporter.acast.com/notanothermummy. Hosted on Acast. See acast.com/privacy for more information.

With Oscar Trimboli, an author, host of the Apple award-winning podcast Deep Listening and a sought-after keynote speaker. Along with the Deep Listening Ambassador Community, he is on a quest to create 100 million deep listeners in the workplace. Through his work with chairs, boards of directors, and executive teams, Oscar has experienced first-hand the transformational impact leaders can have when they listen beyond words. He believes that when leadership teams focus their attention and listening, they will build organizations that create powerful legacies for the people they serve – today and more importantly, for future generations. Oscar is a marketing and technology industry veteran working for Microsoft, PeopleSoft, Polycom, and Vodafone. He consults with organizations including American Express, AstraZeneca, Cisco, Google, HSBC, IAG, Montblanc, PwC, Salesforce, Sanofi, SAP, and Siemens. He is the author of how to listen - discover the hidden key to better communication - the most comprehensive book about listening in the workplace, Deep Listening - Impact beyond words and Breakthroughs: How to Confront Assumptions Oscar loves his afternoon walks with his wife, Jennie, and their dog Kilimanjaro. On the weekends, you will find him playing Lego with one or all his four grandchildren. Join us for this conversation where you will learn about the different qualities of listening, simple steps for doing better, key phrases you can use to demonstrate true listening, and what most people don't do when it comes to listening. To listen to our podcast and access the show notes, visit us at www.legalwebsitewarrior.com/podcast

Biopharma companies believe a draft law that seeks to overhaul European pharmaceutical policy for the first time in years is out of sync with innovation, Washington Editor Steve Usdin said on the latest BioCentury This Week. Usdin and colleagues assessed the EC's proposals in the legislation, as well as what's changed since a version of the draft was leaked earlier this year. BioCentury's editors also discussed the implications of FDA's acceptance of NfL as a surrogate endpoint for amyotrophic lateral sclerosis for companies with clinical neurodegeneration programs, plus the $5.9 billion takeout of geographic atrophy company Iveric bio by Astellas, and a deal by Sanofi to license rights to a Pompe therapy from Maze Therapeutics.

APAC stocks traded mixed with most of the major indices subdued amid the banking sector headwinds in the US and as participants digested a deluge of earnings releases.European equity futures are indicative of a weaker open with Euro Stoxx 50 future -0.3% after the cash market closed lower by 0.7% yesterday.DXY is lacking in direction, EUR/USD lingers around 1.1050, GBP/USD is back below 1.25, NZD outperforms peers.US House voted 217 vs 215 to narrowly pass the Republican debt ceiling bill; Biden has played down the chances of it becoming a law.Looking ahead, highlights include US GDP & PCE Prices Advance, CBRT Policy Announcement, ECB's Panetta, Supply from Italy & USEarnings from Delivery Hero, Hellofresh, STMicroelectronics, Deutsche Bank, TotalEnergies, Carlsberg, Sanofi, BASF, AstraZeneca, Unilever, LSE, Barclays, Amazon, AbbVie Exxon, Mastercard, Linde, Lilly, T-Mobile, Altria & Activision.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk

John Desmarais (Moderator), Desmarais LLP Judge Kathleen O'Malley, Irell and Manella LLP Lisa Pensabene, O'Melveny & Myers Jonathan E. Singer, Fish and Richardson

[English description below]Tập đoàn dược phẩm đa quốc gia Sanofi có trụ sở chính tại Pháp và hoạt động tại 90 quốc gia trên toàn thế giới, tập trung vào lĩnh vực khoa học đời sống toàn cầu. Sanofi luôn tích cực lan tỏa và nâng tầm khái niệm self-care trên nhiều phương diện: từ việc cung cấp các sản phẩm chăm sóc sức khoẻ chất lượng, cho đến việc chia sẻ kiến thức cho cộng đồng.Tại tập podcast Vietnam Innovators lần này, chúng ta sẽ cùng host Hảo Trần trò chuyện với Julie Van Ongevalle - Executive VP & Global Head of CHC Sanofi. Cuộc trò chuyện sẽ xoay quanh về lĩnh vực chăm sóc sức khoẻ tại Việt Nam và vị thế của Sanofi đối với hành trình đồng hành cùng ngành Y tế Việt.Cảm ơn Sanofi đồng hành cùng Vietnam Innovators!Sanofi là tập đoàn chăm sóc sức khỏe hàng đầu thế giới với 70 năm hình thành và phát triển tại Việt Nam. Ngành hàng Chăm sóc sức khỏe người tiêu dùng là một trong 3 lĩnh vực hoạt động chính của Sanofi, với tầm nhìn trở thành công ty FMCH hàng đầu thế giới và cho thế giới.Xem phiên bản video trên YouTubeNếu có bất cứ góp ý, phản hồi hay mong muốn hợp tác, bạn có thể gửi email về địa chỉ team@vietcetera.com---Sanofi, the multinational pharmaceutical company headquartered in France with operations in 90 countries around the world, is committed to promoting self-care across multiple dimensions. From providing quality health care products to sharing knowledge with communities, Sanofi is actively working to raise awareness on the importance of self-care.In this episode of the Vietnam Innovators podcast, host Hao Tran speaks with Julie Van Ongevalle, Executive VP & Global Head of CHC Sanofi, on the topic of healthcare in Vietnam and Sanofi's position in supporting the healthcare industry in Vietnam. Join the conversation to learn more about Sanofi's approach to building brand-love and its strategy for the healthcare industry.Big thanks Sanofi for making this episode possible.Sanofi is a leading innovative global healthcare company with 70 years of establishment and development in Vietnam. Consumer Healthcare is one of Sanofi's 3 business units, with a vision of becoming the best Fast-moving-consumer-healthcare in and for the world.Listen to this episode on YouTube Feel free to leave any questions or invitations for business cooperation at team@vietcetera.com

In der heutigen Folge „Alles auf Aktien“ sprechen die Finanzjournalisten Daniel Eckert und Nando Sommerfeldt über den drohenden Machtkampf bei Brenntag, satte Dividenden für Rübenbauern und deutsche Top-Arbeitgeber.  Außerdem geht es um Lockheed Martin, Johnson&Johnson, Intuitive Surgical, Südzucker, Mercedes Benz, Volkswagen, Porsche, BMW, BYD, Nio, SAIC, Tesla, Siemens, Microsoft, SAP, Bayer, Sanofi, Deutsche Telekom, Adidas, Airbus, Fresenius, Schaeffler. BASF, Roche, Amazon. Wir freuen uns über Feedback an aaa@welt.de. Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

“For the Epoch Times and NTD, what we have been doing, is although we keep an eye on the profit, we always follow the heart. That's when you know you're doing the right thing. And that's when you know that when you actually go through difficulties, you'll always have a likeminded team to fight with you and go through the difficulty with you, and there will be light at the end of the tunnel….That's our best business model, because if we can speak truth, we can always find the audience. And we have peace of mind in our hearts an the business is solid because of that.” Heart leadership is the most powerful and sustainable business model. The Epoch Times and NTDTV (New Tang Dynasty Television) are setting a prime example of how leading your business with heart not only changes the world, but also creates a solid foundation for your business and profits to grow. It's really such a simple principle that only calls on us to actively care about others. Joe Wang has seen the extreme opposite of heart leadership, growing up in communist China under the control of the Chinese Communist Party. On the surface, events like Mao Zedong's Great Leap Forward painted a picture of a powerful government that had the people's best interests at heart. But Joe's family and many others saw a very different view as millions died from hunger and disease. Motivated by these events, Joe worked hard to establish a career in the vaccine industry, eventually landing in Canada at the largest vaccine company of its time, Sanofi. After 10 years in the industry, it was clear that the structure of the vaccine industry business model was leaning more toward profits than people. During this time, Joe also began practicing Falun Gong (aka Falun Dafa), a meditation practice originating in China that brought health benefits to people and a higher quality of life. It became extremely popular in China in only a few years but in 1997, the CCP outlawed the practice and began persecuting what was, at the time, close to 100 million of its own citizens. These events inspired Joe to begin a new career in media, helping establish what would become NTDTV and The Epoch Times, so that people throughout the world would be informed of the truth and critical facts that should be available in a free society without interference from corruption. Joe is now the CEO of NTDTV Canada and a columnist for the Epoch Times. Go to EpochTimes.com and search for Joe Wang to read Joe's contributions to the Epoch Times. Also check out NTD.com including its news, drama series, and film programs. Expert action steps: In business, don't just chase money, following your heart is the most important. Be true to yourself and be truthful in your business. Have a realistic perspective about what's going on. Believe in humanity. Human beings are precious and we should believe in our communities so we can make our countries a better place and make our businesses more profitable. Visit eCircleAcademy.com and book a success call with Nicky to take your practice to the next level.

Episode #291: Today's show is focused on improving your communication, teamwork, and performance skills with my guest Oscar Trimboli. In this episode, Trimboli shares his expertise on the power of deep listening and how it can transform your personal and professional relationships. As a leading expert in the field of communication, Trimboli breaks down the importance of listening beyond the words being spoken and instead focusing on the intention behind them. He provides valuable insights into how we can all become better listeners and how this skill can have a profound impact on our ability to work effectively in teams, lead others, and achieve our goals. Whether you're looking to improve your own communication skills or enhance the performance of your team, this episode of Let's Go Win Podcast is a must-listen. With actionable tips and strategies, Ryerson and Trimboli deliver a powerful message that will inspire you to become a better listener and unlock your full potential. Don't miss out on this game-changing conversation!Bio:Oscar Trimboli is an author, host of the Apple award-winning podcast Deep Listening and a sought-after keynote speaker. Along with the Deep Listening Ambassador Community, he is on a quest to create 100 million deep listeners in the workplace. Through his work with chairs, boards of directors, and executive teams, Oscar has experienced first-hand the transformational impact leaders can have when they listen beyond words. He believes that when leadership teams focus their attention and listening, they will build organizations that create powerful legacies for the people they serve – today and more importantly, for future generations. Oscar is a marketing and technology industry veteran working for Microsoft, PeopleSoft, Polycom, and Vodafone. He consults with organizations including American Express, AstraZeneca, Cisco, Google, HSBC, IAG, Montblanc, PwC, Salesforce, Sanofi, SAP, and Siemens. He is the author of how to listen - discover the hidden key to better communication - the most comprehensive book about listening in the workplace, Deep Listening - Impact beyond words and Breakthroughs: How to Confront Assumptions Oscar loves his afternoon walks with his wife, Jennie, and their dog Kilimanjaro. On the weekends, you will find him playing Lego with one or all his four grandchildren. Contact Oscar:Website: https://www.oscartrimboli.com/listeningquizLinkedIn: https://www.linkedin.com/in/oscartrimboliTwitter: https://twitter.com/oscartrimboliYouTube: https://www.youtube.com/channel/UC_kkHeR0dGfAZGQ6AGHCvvg

On November 4, 2022, the Supreme Court granted cert in Amgen Inc. v. Sanofi, a patent infringement case that involves the application of the statutory enablement requirement of Section 112 of the patent laws to what is referred to as a "genus claim" as it applies in the context of pharmaceutical applications. The two patents in dispute relate to antibody drugs that reduce low-density lipoprotein ("LDL") cholesterol.The Court is set to hear oral arguments in the case on March 27. Specifically at issue is "whether enablement is governed by the statutory requirement that the specifications teach those skilled in the art to 'make and use' the claimed invention, or whether it must instead enable those skilled in the art 'to reach the full scope of claimed embodiments' without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial 'time and effort.'"Robert Rando, an intellectual property attorney who filed an amicus brief in the case, joined us to break down the arguments.Featuring:- Robert J. Rando, Partner, Greenspoon Marder LLP

On the latest BioCentury This Week podcast, BioCentury's editors assess the implications of the FTC's challenge to the $7.1 billion acquisition of cancer screening company Grail by next-generation sequencing company Illumina. They also discuss what's at stake as the U.S. Supreme Court weighs arguments in the patent dispute over anti-PCSK9 mAbs between Sanofi and Amgen, and how CEOs of gene therapy companies are thinking about the competitive landscape at a time when products with preliminary evidence of safety and efficacy are dropping out of clinical development across multiple indications. This episode is sponsored by Jeito Capital.

Intellectual Property: Must a patent enable those skilled in the art to make all or nearly all embodiments of the invention without substantial time and effort? - Argued: Mon, 27 Mar 2023 11:47:18 EDT

Join me, Amy Lynn Durham, with Nenuca Syquia, the CEO and Co-Founder of Better Organizations by Design, BOxD, a BIPOC, a women-owned and led firm that makes the people-side of business growth less chaotic and more efficient. In this episode, we  discuss great insight on transforming chaotic situations and energy into an opportunity for quantum leaps within your company. We also discuss how to be a wise and compassionate leader while recognizing how to lift those we lead to excel in their expertise.Today on Create Magic At Work®:Methods to lead when experiencing massive changes Leading through a change curveTraits of a wise and effective change agentHow your energy as a leader can affect team morale and innovationNenuca has transformed businesses large and small - from Sanofi to The San Francisco Ballet. She was born and brought up in the Philippines and is currently based in the San Francisco Bay Area. She proudly leads a diverse team of consultants, coaches and specialists, located across the US, Canada, Latin America and the Philippines.Nenuca provides unique perspectives on: leadership, team effectiveness, diversity, equity and inclusion and the design of healthy, prosperous organizations. She holds a Masters of Industrial and Labor Relations from Cornell University and a Masters of Science in Organizational Development from the University of San Francisco.Connect with Nenuca: https://www.linkedin.com/in/nenucahttps://www.boxd.usQuote“I think as leaders, they control the weather. That's the number one thing I always tell leaders. You are absolutely entitled to your emotions, and you should display emotions because it is who you are and it is authentic to the experience that you're having. We also have to be aware because as leaders, we are extremely visible. Our voices carry more weight than other people who are sitting in different parts of the organization. And so I'm not saying that we need to mask our emotions, but we have to be aware of the impact that our own emotions have. So depending on where the leaders themselves are in that change curve, they have to be aware that this could actually pull people towards that. So if somebody is angry about a change that is occurring, it will most definitely leak onto their teams.” - Nenuca SyquiaConnect with Amy: https://msha.ke/createmagicatwork

A case in which the Court will decide what an applicant for a patent must provide to meet the statutory requirement of a description of the invention that would enable a “skilled artisan” to “make and use” the claimed invention.

It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Insulin-maker Sanofi lowers its prices and also acquires Provention, clinical trials begin on an out-patient surgery that could help treat type 2 diabetes, a swimmer DQ'd for the tape on his CGM gets the systemic changes he'd pushed for and more! Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode Transcription: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines happening now XX In the news is brought to you by Athletic Greens ● AG1 is way more than greens. XX XX Provention Bio's been in a news a lot lately after the approval of Tzield to delay the development of type 1. Now French insulin-maker Sanofi has agreed to acquire it. The deal builds on an existing co-promotion agreement and gives Sanofi full ownership of the drug. Sanofi makes long acting Toujeo and Lantus. Interestingly, Sanofi has said they're gong to stop further work on type 2 diabetes and obesity drugs. They also joined Novo Nordisk and Eli Lilly in dropping the price of insulin in the US. https://www.reuters.com/markets/deals/frances-sanofi-acquire-us-based-provention-bio-29-bln-2023-03-13/ XX Insulin pricing staying in the news as Senators Bernie Sanders and Cori Bush introduced legislation to cap the price at 20-dollars. They point out the recent prices cuts don't apply to everyone and are still at the whim of the manufacturers. XX California signs up with Civica Rx to produce its own insulin and sell it at an affordable price. The $50 million investment will allow California to produce insulin to be sold at prices capped at $30 per vial and $55 for a box of five prefilled pens, Civica Rx said (PDF) in a release. The agreement is part of the state's CalRx Biosimilar Insulin Initiative. Utah-based Civica Rx is a nonprofit, social welfare manufacturer of generic drugs. This is a long way off.. Civica Rx still needs to gain approval for its biosimilar versions of Sanofi's Lantus (gargline), Eli Lilly's Humalog (lispro) and Novo Nordisk's Novolog (aspart). The cost of insulin would be same for all patients regardless of their insurance situation https://www.fiercepharma.com/manufacturing/california-invests-50m-partner-civica-rx-insulin-manufacturing XX XX (skip?) Millions of Americans with diabetes have cheered as drugmakers slashed the price of insulin, the lifesaving medication that treats the chronic disease. But those lower prices, which came amid government pressure to cap insulin costs and more competition from generics and biosimilars, are only one part of the cost of treating the disease, which causes elevated blood sugar that can damage the heart, eyes and kidneys if untreated. Over-the-counter medical supplies to monitor glucose levels and administer medications can make up the largest portion of a patient's costs. A 2020 JAMA Internal Medicine report found that children and adults with private health insurance spent more out-of-pocket on diabetes-related supplies than on insulin A person with diabetes who uses insulin typically spends $4,882 a year on treatment if they have insurance. Of that, $3,992 is spent on supplies, according to an analysis by GoodRx, or more than 80% of the annual expense of managing the disease https://www.usatoday.com/story/money/personalfinance/2023/03/19/cost-diabetes-supplies-worse-than-insulin/11472381002/ XX New trial of a technique to slow the progression of type 2 diabetes. It's a simple outpatient surgery conducted in the early stages of diagnosis. The procedure targets the doo-oh-DEE-num duodenum, the first section of the small intestine just past the stomach. This organ plays a key role in digestion, including regulating insulin and blood glucose levels. In patients with type 2 diabetes, the cells that line the duodenum have become damaged, and the trial's hypothesis is that removing these cells helps healthy ones to grow back, improving the regulation of blood glucose levels. Patients in the clinical trial would undergo an endoscopy to insert a device into the doo-oh-DEE-num duodenum, which removes those dysfunctional cells with a series of electrical pulses. The procedure itself is only minimally invasive – it takes about an hour, it's conducted under a general anaesthetic and the patient is discharged the same day. Early results seem encouraging. Patients who have undergone the procedure in recent months have already seen their blood glucose levels drop. BTW if you live near L-A they're still recruiting for this. You have to have a type 2 diagnosis and not yet need insulin injections. https://newatlas.com/medical/diabetes-prevent-slow-progression-procedure-clinical-trial/ XX Another study showing automated insulin delivery systems work well and are safe, this one the Tandem Control IQ in little kids. That's only approved right now for kids as young as six.. this study looked at children ages two to six. The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared to no change with standard care. Standard care here meant either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM. https://www.medscape.com/viewarticle/989673 XX Follow up! Two years ago we told you about Ethan Orr, a Colorado high school swimmer disqualified at a state meet because of the tape over his CGM. Orr's family filed a complaint with the department of justice and the US Attorney in Colorado took up the case. They weren't seeking any financial damages, just a change in policy, which they got. The changes include allowing medical tape with documentation, a way to evaluate requests from students with disabilities who might need reasonable modifications of rules, and a way for refs or coaches to seek on the spot reasonable modifications. - “I knew I'd have to fight my disease to swim, but I never imagined I'd have to fight discrimination to swim,” Ethan said, according to the news release from the law firm. XX Athletic Greens XX Today, JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, presented the inaugural Mary Tyler Moore Awards to three women leaders in Congress who have been instrumental in the fight against T1D. U.S. Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), co-chairs of the Senate Diabetes Caucus, were honored alongside Representative Diane DeGette (D-CO), co-chair of the Congressional Diabetes Caucus, for their longstanding support of the T1D community. The ceremony, held during JDRF's annual Government Day, honored the legacy of screen icon Mary Tyler Moore, who was diagnosed with T1D at the age of 33. As international chairman of JDRF from 1984 to 2017, Moore used her influence to bring government, scientists and people living with diabetes together to further T1D advocacy and innovation. JDRF (PRNewsFoto/JDRF) JDRF (PRNewsFoto/JDRF) One of Moore's most significant achievements as JDRF international chairman was increased Congressional funding for the Special Diabetes Program at the National Institutes of Health that has accelerated the pace of type 1 diabetes research. This long-term investment in diabetes research has led to significant scientific breakthroughs including Tzield, the first disease modifying treatment for T1D which can delay the onset of the disease by over two years. JDRF Government Day volunteers, more than 175 T1D advocates from across the country, will encourage members of Congress to renew the Special Diabetes Program when they visit lawmakers later today on Capitol Hill. https://finance.yahoo.com/news/jdrf-presents-inaugural-mary-tyler-110000226.html XX On the podcast next week.. . That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

This year kicks off the second decade of Fierce Medtech's annual Fierce 15 report. Not surprisingly, the startups featured on this year's list are raising the bar for medtech developers everywhere. Staff writer Andrea Park and Editor-in-Chief Ayla Ellison discuss a few of the 15 startups that made the cut.  Plus, in this episode, we cover Illumina and Carl Icahn's proxy battle, Sanofi slashing insulin prices and more of this week's top headlines.  To learn more about the topics in this episode:  Fierce Medtech's 2022 Fierce 15 Illumina, Carl Icahn trade jabs amid looming proxy fight over $8B Grail buy Biogen, Novartis deliver one-two punch to Sangamo, walking away from deals in quick succession AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump Gilead's Yescarta puts pressure on BMS' Breyanzi with overall survival win in large B-cell lymphoma Selecta, Sobi rout gout in pair of phase 3 trials that could challenge Horizon Sanofi answers the call, joining Eli Lilly, Novo Nordisk in cutting insulin prices California invests $50M to partner with Civica Rx on insulin manufacturing The Top Line is produced by senior podcast producer Teresa Carey and managing editor Querida Anderson. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

About Manny Montalvo:Manny Montalvo is SVP, Head of Digital Health & Innovation at Teva Pharmaceuticals since September 2021. Manny is responsible for overseeing the US Respiratory business, the US commercial innovation work, and the US and GLOBAL DIGIHALER® franchise. Manny's digital health team at Teva is entirely homegrown and has pioneered a class of digital pharmaceutical devices - a rarity in the pharmaceutical industry. Manny's charge at Teva is to encourage the use of digital therapeutics as part of the healthcare experience, making it seamless for both the healthcare providers and the patients they serve. With over 20 years of life-science experience, Manny Montalvo has held leadership roles in both Sales and Marketing, working in numerous therapeutic areas in the US and global markets, as well as in R&D and Commercial Operations. Prior to assuming his current role, Manny Montalvo served as the Vice President of Global Digital Health Marketing & Commercial Analytics at Teva Pharmaceuticals where he set the strategic direction for Teva's biologic program and Digital Health Marketing and transformation of Teva's Global Commercial Analytics. Manny joined Teva in 2013 to lead its R&D Innovation program as Vice President of Global New Therapeutic Entities (NTE) Innovation where he focused on the evaluation of the latest drug delivery technologies and drug development, adding more than 15 new products to Teva's specialty portfolio. Before joining Teva, Manny held leadership positions with P&L responsibilities at Sanofi and Johnson & Johnson. During his tenure at Sanofi and J&J, Manny worked in a variety of commercial roles including consumer marketing, driving growth for a range of portfolios including diabetes, dermatology, cardiovascular and primary care.  Things You'll Learn:Two out of five medicines in your cabinet are likely from Teva.A platform business has a feedback loop with customers.To innovate, one has to have a collaborative space supported by management.Teva Pharmaceuticals is partnering with Rimidi and HealthSnap, integrating their data as a step closer to fulfilling their mission. The more patients on Teva's platform, the better the technology gets.About 40% of Teva's digital space workers did not come from the traditional pharma industry. Resources:Connect with and follow Manny Montalvo on LinkedIn.Follow Teva Pharmaceuticals on LinkedIn.Visit the Teva Pharmaceuticals Website!Discover DIGIHALER here!

Treasury Secretary Janet Yellen testified on Capitol Hill that the economy is strong and the U.S. banking system is sound, despite the collapse of Silicon Valley Bank and the bailout of First Republic Bank. So what did the regulators miss, and what does Joe Biden plan to do about it? Plus, a decision on insulin prices by French drugmaker Sanofi could hold unexpected consequences for U.S. patients.  Learn more about your ad choices. Visit megaphone.fm/adchoices

En el caso de la soldado muerta, el ejército dice que hasta el momento no hay nada sospechoso y que se podía tratar de un suicidio.Tormentas severas en Dallas.Un tren derramó 5 mil galones de diesel tras descarrilamiento.En California las fuertes tormentas ayudan a combatir la sequía.Las familias de bajos recursos de Nueva York cuenta con una nueva herramienta para acceder a un apoyo financiero.Sanofi redujo el precio de Lantus.Pfizer retira del mercado 4 millones de envases de medicamentos para la migraña.¿Adiós al tacto rectal para el examen de próstata?EE.UU. emitir una orden para el uso de la aplicación en dispositivos del gobierno. 

The U.N. says global cocaine supply has risen to a record level. French drugmaker Sanofi plans to cut insulin prices in the U.S. by as much as 78%. Keith Collins hosts. Learn more about your ad choices. Visit megaphone.fm/adchoices

In der heutigen Folge „Alles auf Aktien“ sprechen die Finanzjournalisten Nando Sommerfeldt und Holger Zschäpitz über Profite bei Porsche, einen frechen Finanzinvestor und böse Kursverluste bei Buzzfeed. Außerdem geht es um Commerzbank, Deutsche Bank, Deutsche Post, Lufthansa, Fraport, Synlab, Sanofi, Pfizer, Seagen, Morphosys, Marathon Digital, Bitcoin, Banko Sabadell, Unicredit, Silicon Valley Bank, Signature Bank, First republic Bank, Keycorp, Truist Financial, US Bancorp, ARK Innovation (WKN: A14Y8H), Charles Schwab. Wir freuen uns an Feedback über aaa@welt.de. Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

James Gallagher asks whether a weight-loss drug on the NHS heralds a new era in tackling obesity? He meets Jan who lost nearly 4 stone after being part of a trial taking a weekly injection of Semaglutide for 15 months alongside advice on meals and exercise. However, when people stop taking the drug the weight starts to go back on. Add to that supply shortages with heightened private demand and some doctors think the drug is as controversial as they come. James unpicks the ethical and societal dilemmas against a backdrop of half the world's population projected to be overweight or obese by 2035. Producer: Erika Wright Declared interests Dr Margaret McCartney: "No conflicts to declare." Prof Sir Stephen O'Rahilly : "in the past has been a remunerated consultant and has had research collaboration with Novo Nordisk." Professor Naveed Sattar: "consulted for and/or received speaker honoraria from Novo Nordisk, Abbott Laboratories, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Merck Sharp & Dohme, Novartis, Pfizer, and Sanofi; and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. He was a co-investigator in lifestyle trials such as DiRECT and co-lead for STANDby."

Today's guest is a ground-breaking and ceiling-smashing transformational leader who knows a thing or two about guiding top-10 pharma companies through periods of great change. In this episode, we're joined by Eva Martins, the Global Head of Customer Engagement at Sanofi. Find out what she considers the greatest challenge in driving customer-centric global transformation. Learn how Sanofi uniquely tackles change management in delivering AI solutions globally. And hear how Eva has successfully navigated a male-dominated industry to reach professional pinnacles while inspiring and supporting women in life sciences and beyond. And don't miss “Eva Martins in Context” where we learn about Eva's secret aspiration of being a parachutist, her go-to music choices, and her ideal sushi dinner companions.

This episode's Community Champion Sponsor is Catalyst. To virtually tour Catalyst and claim your space on campus, or host an upcoming event: CLICK HERE---Episode Overview: Being deeply committed to transforming the way we approach clinical trials with the goal of bringing medical innovations to patients faster and more efficiently, our next guest has been a driving force in improving trial design and execution for over 25 years.Jane Myles, Vice President of Clinical Trial Innovation at Curebase, joins us to share the importance of collaborative problem-solving and openness to new opportunities that is at the heart of her personal success and what helped lead her to Curebase. She also discusses the integration of healthcare and clinical trials, and the potential benefits of data aggregation at scale, leading to more accurate results and avoiding unnecessary tests for patients.Join us as we explore Curebase's exciting journey toward better patient care, and learn how you can contribute to advancing the future of clinical trials. Let's go!Episode Highlights:Jane's journey to Curebase and the power of saying "yes"The DTRA initiative and the playbook for decentralized clinical trials at CurebaseCurebase's flexible solution for clinical trial data capture, patient engagement, and insightsThe tension between drug development organizations and regulatory requirements for population data in drug developmentThe new omnibus legislation driving Curebase's missionThe future of clinical trials and the importance of blending healthcare and clinical trialsData aggregation at scale and making hidden signals more visible About our Guest: Jane has focused on improving clinical trials and patient experience for more than 25 years. Her passion is driving innovation into the trial design and execution to get medicines to patients faster. Currently, she is the V.P. of Clinical Trial Innovation at Curebase, a DCT technology & services provider. She's also an initiative co-lead and a member of the DTRA leadership committee. She worked at Roche / Genentech for 17 years in many roles, including operational program manager for hematology, ultimately working on driving patient-facing technology into global trials. In prior lives, she held various roles in DCT optimization at LabCorp, and ranglobal trials at Lilly and Sanofi.Links Supporting This Episode:Curebase website: CLICK HEREJane Myles LinkedIn page: CLICK HERECurebase Twitter page: CLICK HEREMike Biselli LinkedIn page: CLICK HEREMike Biselli Twitter page: CLICK HEREVisit our website: CLICK HERESubscribe to newsletter: CLICK HEREGuest nomination form: CLICK HERE

Luciana Feo Mourelle y Laura Pomares son una diseñadora de servicios y una médica clínica especializada en nutrición y diabetes. Ellas trabajaron juntas en darle forma al Diabetón mobil. Este es un proyecto donde la Sociedad Argentina de Diabetes, Sanofi y DMO se unen para buscar juntos soluciones que puedan mejorar el buen vivir de la gente con diabetes. En esta entrevista nos cuentan los detalles de este proyecto, que empezó con una hackatón, un encuentro intensivo con médicos de todo el país, para llevar a cabo un proceso de diseño. Luciana y Laura nos cuentan sobre el proyecto elegido, que surgió en este encuentro, y que está en este momento en fase de desarrollo. Este proyecto elegido es el Diabemóvil: una herramienta educativa digital (un app para el teléfono movil) que utiliza la gamificación para empoderar a los pacientes. Hablamos de los diferentes niveles del juego, que se corresponden con provincias argentinas, y como el paciente puede aprender e interactuar con otros pacientes que también están usando el app. La educación diabetológica es clave para adherir al tratamiento y mantenerse en buen estado físico. En esta entrevista también pudimos hablar de la dupla médica-diseñadora, y cual es el rol de cada una durante un proceso de diseño de un app para la salud. Esta entrevista es parte de las listas: Diseño de servicios, Diseño UX, Salud y diseño y Argentina y salud.