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Dr. Nathan Pennell and Dr. Cheryl Czerlanis discuss challenges in lung cancer screening and potential solutions to increase screening rates, including the use of AI to enhance risk prediction and screening processes. Transcript Dr. Nate Pennell: Hello, and welcome to By the Book, a monthly podcast series for ASCO Education that features engaging discussions between editors and authors from the ASCO Educational Book. I'm Dr. Nate Pennell, the co-director of the Cleveland Clinic Lung Cancer Program and vice chair of clinical research for the Taussig Cancer Center. I'm also the editor-in-chief for the ASCO Educational Book.  Lung cancer is one of the leading causes of cancer-related mortality worldwide, and most cases are diagnosed at advanced stages where curative treatment options are limited. On the opposite end, early-stage lung cancers are very curable. If only we could find more patients at that early stage, an approach that has revolutionized survival for other cancer types such as colorectal and breast cancer.  On today's episode, I'm delighted to be joined by Dr. Cheryl Czerlanis, a professor of medicine and thoracic medical oncologist at the University of Wisconsin Carbone Cancer Center, to discuss her article titled, "Broadening the Net: Overcoming Challenges and Embracing Novel Technologies in Lung Cancer Screening." The article was recently published in the ASCO Educational Book and featured in an Education Session at the 2025 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode.  Cheryl, it's great to have you on the podcast today. Thanks for being here. Dr. Cheryl Czerlanis: Thanks, Nate. It's great to be here with you. Dr. Nate Pennell: So, I'd like to just start by asking you a little bit about the importance of lung cancer screening and what evidence is there that lung cancer screening is beneficial. Dr. Cheryl Czerlanis: Thank you. Lung cancer screening is extremely important because we know that lung cancer survival is closely tied to stage at diagnosis. We have made significant progress in the treatment of lung cancer, especially over the past decade, with the introduction of immunotherapies and targeted therapies based on personalized evaluation of genomic alterations. But the reality is that outside of a lung screening program, most patients with lung cancer present with symptoms related to advanced cancer, where our ability to cure the disease is more limited.  While lung cancer screening has been studied for years, the National Lung Screening Trial, or the NLST, first reported in 2011 a significant reduction in lung cancer deaths through screening. Annual low-dose CT scans were performed in a high-risk population for lung cancer in comparison to chest X-ray. The study population was comprised of asymptomatic persons aged 55 to 74 with a 30-pack-year history of smoking who were either active smokers or had quit within 15 years. The low-dose CT screening was associated with a 20% relative risk reduction in lung cancer-related mortality. A similar magnitude of benefit was also reported in the NELSON trial, which was a large European randomized trial comparing low-dose CT with a control group receiving no screening. Dr. Nate Pennell: So, this led, of course, to approval from CMS (Centers for Medicare and Medicaid Services) for lung cancer screening in the Medicare population, probably about 10 years ago now, I think. And there are now two major trials showing an unequivocal reduction in lung cancer-related mortality and even evidence that it reduces overall mortality with lung cancer screening. But despite this, lung cancer screening rates are very low in the United States. So, first of all, what's going on? Why are we not seeing the kinds of screening rates that we see with mammography and colonoscopy? And what are the barriers to that here? Dr. Cheryl Czerlanis: That's a great question. Thank you, Nate. In the United States, recruitment for lung cancer screening programs has faced numerous challenges, including those related to socioeconomic, cultural, logistical, and even racial disparities. Our current lung cancer screening guidelines are somewhat imprecise and often fail to address differences that we know exist in sex, smoking history, socioeconomic status, and ethnicity. We also see underrepresentation in certain groups, including African Americans and other minorities, and special populations, including individuals with HIV. And even where lung cancer screening is readily available and we have evidence of its efficacy, uptake can be low due to both provider and patient factors. On the provider side, barriers include having insufficient time in a clinic visit for shared decision-making, fear of missed test results, lack of awareness about current guidelines, concerns about cost, potential harms, and evaluating both true and false-positive test results.  And then on the patient side, barriers include concerns about cost, fear of getting a cancer diagnosis, stigma associated with tobacco smoking, and misconceptions about the treatability of lung cancer. Dr. Nate Pennell: I think those last two are really what make lung cancer unique compared to, say, for example, breast cancer, where there really is a public acceptance of the value of mammography and that breast cancer is no one's fault and that it really is embraced as an active way you can take care of yourself by getting your breast cancer screening. Whereas in lung cancer, between the stigma of smoking and the concern that, you know, it's a death sentence, I think we really have some work to be made up, which we'll talk about in a minute about what we can do to help improve this.  Now, that's in the U.S. I think things are probably, I would imagine, even worse when we leave the U.S. and look outside, especially at low- and middle-income countries. Dr. Cheryl Czerlanis: Yes, globally, this issue is even more complex than it is in the United States. Widespread implementation of low-dose CT imaging for lung cancer screening is limited by manpower, infrastructure, and economic constraints. Many low- and middle-income countries even lack sufficient CT machines, trained personnel, and specialized facilities for accurate and timely screenings. Even in urban centers with advanced diagnostic facilities, the high screening and follow-up care costs can limit access. Rural populations face additional barriers, such as geographic inaccessibility of urban centers, transportation costs, language barriers, and mistrust of healthcare systems. In addition, healthcare systems in these regions often prioritize infectious diseases and maternal health, leaving limited room for investments in noncommunicable disease prevention like lung cancer screening. Policymakers often struggle to justify allocating resources to lung cancer screening when immediate healthcare needs remain unmet. Urban-rural disparities exacerbate these challenges, with rural regions frequently lacking the infrastructure and resources to sustain screening programs. Dr. Nate Pennell: Well, it's certainly an intimidating problem to try to reduce these disparities, especially between the U.S. and low- and middle-income countries. So, what are some of the potential solutions, both here in the U.S. and internationally, that we can do to try to increase the rates of lung cancer screening? Dr. Cheryl Czerlanis: The good news is that we can take steps to address these challenges, but a multifaceted approach is needed. Public awareness campaigns focused on the benefits of early detection and dispelling myths about lung cancer screening are essential to improving participation rates. Using risk-prediction models to identify high-risk individuals can increase the efficiency of lung cancer screening programs. Automated follow-up reminders and screening navigators can also ensure timely referrals and reduce delays in diagnosis and treatment. Reducing or subsidizing the cost of low-dose CT scans, especially in low- or middle-income countries, can improve accessibility. Deploying mobile CT scanners can expand access to rural and underserved areas.  On a global scale, integrating lung cancer screening with existing healthcare programs, such as TB or noncommunicable disease initiatives, can enhance resource utilization and program scalability. Implementing lung cancer screening in resource-limited settings requires strategic investment, capacity building, and policy interventions that prioritize equity. Addressing financial constraints, infrastructure gaps, and sociocultural barriers can help overcome existing challenges. By focusing on cost-effective strategies, public awareness, and risk-based eligibility criteria, global efforts can promote equitable access to lung cancer screening and improve outcomes.  Lastly, as part of the medical community, we play an important role in a patient's decision to pursue lung cancer screening. Being up to date with current lung cancer screening recommendations, identifying eligible patients, and encouraging a patient to undergo screening often is the difference-maker. Electronic medical record (EMR) systems and reminders are helpful in this regard, but relationship building and a recommendation from a trusted provider are really essential here. Dr. Nate Pennell: I think that makes a lot of sense. I mean, there are technology improvements. For example, our lung cancer screening program at The Cleveland Clinic, a few years back, we finally started an automated best practice alert in our EMR for patients who met the age and smoking requirements, and it led to a six-fold increase in people referred for screening. But at the same time, there's a difference between just getting this alert and putting in an order for lung cancer screening and actually getting those patients to go and actually do the screening and then follow up on it. And that, of course, requires having that relationship and discussion with the patient so that they trust that you have their best interests. Dr. Cheryl Czerlanis: Exactly. I think that's important. You know, certainly, while technology can aid in bringing patients in, there really is no substitute for trust-building and a personal relationship with a provider. Dr. Nate Pennell: I know that there are probably multiple examples within the U.S. where health systems or programs have put together, I would say, quality improvement projects to try to increase lung cancer screening and working with their community. There's one in particular that you discuss in your paper called the "End Lung Cancer Now" initiative. I wonder if you could take us through that. Dr. Cheryl Czerlanis: Absolutely. "End Lung Cancer Now" is an initiative at the Indiana University Simon Comprehensive Cancer Center that has the vision to end suffering and death from lung cancer in Indiana through education and community empowerment. We discuss this as a paradigm for how community engagement is important in building and scaling a lung cancer screening program.  In 2023, the "End Lung Cancer Now" team decided to focus its efforts on scaling and transforming lung cancer screening rates in Indiana. They developed a task force with 26 experts in various fields, including radiology, pulmonary medicine, thoracic surgery, public health, and advocacy groups. The result of this work is an 85-page blueprint with key recommendations that any system and community can use to scale lung cancer screening efforts. After building strong infrastructure for lung cancer screening at Indiana University, they sought to understand what the priorities, resources, and challenges in their communities were. To do this, they forged strong partnerships with both local and national organizations, including the American Lung Association, American Cancer Society, and others. In the first year, they actually tripled the number of screening low-dose CTs performed in their academic center and saw a 40% increase system-wide. One thing that I think is the most striking is that through their community outreach, they learned that most people prefer to get medical care close to home within their own communities. Establishing a way to support the local infrastructure to provide care became far more important than recruiting patients to their larger system.  In exciting news, "End Lung Cancer Now" has partnered with the IU Simon Comprehensive Cancer Center and IU Health to launch Indiana's first and only mobile lung screening program in March of 2025. This mobile program travels around the state to counties where the highest incidence of lung cancer exists and there is limited access to screening. The mobile unit parks at trusted sites within communities and works in partnership, not competition, with local health clinics and facilities to screen high-risk populations. Dr. Nate Pennell: I think that sounds like a great idea. Screening is such an important thing that it doesn't necessarily have to be owned by any one particular health system for their patients. I think. And I love the idea of bringing the screening to patients where they are. I can speak to working in a regional healthcare system with a main campus in the downtown that patients absolutely hate having to come here from even 30 or 40 minutes away, and they'd much rather get their care locally. So that makes perfect sense.  So, under the current guidelines, there are certainly things that we can do to try to improve capturing the people that meet those. But are those guidelines actually capturing enough patients with lung cancer to make a difference? There certainly are proposals within patient advocacy communities and even other countries where there's a large percentage of non-smokers who perhaps get lung cancer. Can we expand beyond just older, current and heavy smokers to identify at-risk populations who could benefit from screening? Dr. Cheryl Czerlanis: Yes, I think we can, and it's certainly an active area of research interest. We know that tobacco is the leading cause of lung cancer worldwide. However, other risk factors include secondhand smoke, family history, exposure to environmental carcinogens, and pulmonary diseases like COPD and interstitial lung disease. Despite these known associations, the benefit of lung cancer screening is less well elucidated in never-smokers and those at risk of developing lung cancer because of family history or other risk factors. We know that the eligibility criteria associated with our current screening guidelines focus on age and smoking history and may miss more than 50% of lung cancers. Globally, 10% to 25% of lung cancer cases occur in never-smokers. And in certain parts of the world, like you mentioned, Nate, such as East Asia, many lung cancers are diagnosed in never-smokers, especially in women. Risk-prediction models use specific risk factors for lung cancer to enhance individual selection for screening, although they have historically focused on current or former smokers.  We know that individuals with family members affected by lung cancer have an increased risk of developing the disease. To this end, several large-scale, single-arm prospective studies in Asia have evaluated broadening screening criteria to never-smokers, with or without additional risk factors. One such study, the Taiwan Lung Cancer Screening in Never-Smoker Trial, was a multicenter prospective cohort study at 17 medical centers in Taiwan. The primary outcome of the TALENT trial was lung cancer detection rate. Eligible patients aged 55 to 75 had either never smoked or had a light and remote smoking history. In addition, inclusion required one or more of the following risk factors: family history of lung cancer, passive smoke exposure, history of TB or COPD, a high cooking index, which is a metric that quantifies exposure to cooking fumes, or a history of cooking without ventilation. Participants underwent low-dose CT screening at baseline, then annually for 2 years, and then every 2 years for up to 6 years. The lung cancer detection rate was 2.6%, which was higher than that reported in the NLST and NELSON trials, and most were stage 0 or I cancers. Subsequently, this led to the Taiwan Early Detection Program for Lung Cancer, a national screening program that was launched in 2022, targeting 2 screening populations: individuals with a heavy history of smoking and individuals with a family history of lung cancer.  We really need randomized controlled trials to determine the true rates of overdiagnosis or finding cancers that would not lead to morbidity or mortality in persons who are diagnosed, and to establish whether the high lung detection rates are associated with a decrease in lung cancer-related mortality in these populations. However, the implementation of randomized controlled low-dose CT screening trials in never-smokers has been limited by the need for large sample sizes, lengthy follow-up, and cost.  In another group potentially at higher risk for developing lung cancer, the role of lung cancer screening in individuals who harbor germline pathogenic variants associated with lung cancer also needs to be explored further. Dr. Nate Pennell: We had this discussion when the first criteria came out because there have always been risk-based calculators for lung cancer that certainly incorporate smoking but other factors as well and have discussion about whether we should be screening people based on their risk and not just based on discrete criteria such as smoking. But of course, the insurance coverage for screening, you have to fit the actual criteria, which is very constrained by age and smoking history. Do you think in the U.S. there's hope for broadening our screening beyond NLST and NELSON criteria? Dr. Cheryl Czerlanis: I do think at some point there is hope for broadening the criteria beyond smoking history and age, beyond the criteria that we have typically used and that is covered by insurance. I do think it will take some work to perhaps make the prediction models more precise or to really understand who can benefit. We certainly know that there are many patients who develop lung cancer without a history of smoking or without family history, and it would be great if we could diagnose more patients with lung cancer at an earlier stage. I think this will really count on there being some work towards trying to figure out what would be the best population for screening, what risk factors to look for, perhaps using some new technologies that may help us to predict who is at risk for developing lung cancer, and trying to increase the group that we study to try and find these early-stage lung cancers that can be cured. Dr. Nate Pennell: Part of the reason we, of course, try to enrich our population is screening works better when you have a higher pretest probability of actually having cancer. And part of that also is that our technology is not that great. You know, even in high-risk patients who have CT scans that are positive for a screen, we know that the vast majority of those patients with lung nodules actually don't have lung cancer. And so you have to follow them, you have to use various models to see, you know, what the risk, even in the setting of a positive screen, is of having lung cancer.  So, why don't we talk about some newer tools that we might use to help improve lung cancer screening? And one of the things that everyone is super excited about, of course, is artificial intelligence. Are there AI technologies that are helping out in early detection in lung cancer screening? Dr. Cheryl Czerlanis: Yes, that's a great question. We know that predicting who's at risk for lung cancer is challenging for the reasons that we talked about, knowing that there are many risk factors beyond smoking and age that are hard to quantify. Artificial intelligence is a tool that can help refine screening criteria and really expand screening access. Machine learning is a form of AI technology that is adept at recognizing patterns in large datasets and then applying the learning to new datasets. Several machine learning models have been developed for risk stratification and early detection of lung cancer on imaging, both with and without blood-based biomarkers. This type of technology is very promising and can serve as a tool that helps to select individuals for screening by predicting who is likely to develop lung cancer in the future.  A group at Massachusetts General Hospital, represented in our group for this paper by my co-authors, Drs. Fintelmann and Chang, developed Sybil, which is an open-access 3D convolutional neural network that predicts an individual's future risk of lung cancer based on the analysis of a single low-dose CT without the need for human annotation or other clinical inputs. Sybil and other machine learning models have tremendous potential for precision lung cancer screening, even, and perhaps especially, in settings where expert image interpretation is unavailable. They could support risk-adapted screening schedules, such as varying the frequency and interval of low-dose CT scans according to individual risk and potentially expand lung cancer screening eligibility beyond age and smoking history. Their group predicts that AI tools like Sybil will play a major role in decoding the complex landscape of lung cancer risk factors, enabling us to extend life-saving lung cancer screening to all who are at risk. Dr. Nate Pennell: I think that that would certainly be welcome. And as AI is working its way into pretty much every aspect of life, including medical care, I think it's certainly promising that it can improve on our existing technology.  We don't have to spend a lot of time on this because I know it's a little out of scope for what you covered in your paper, but I'm sure our listeners are curious about your thoughts on the use of other types of testing beyond CT screening for detecting lung cancer. I know that there are a number of investigational and even commercially available blood tests, for example, for detection of lung cancer, or even the so-called multi-cancer detection blood tests that are now being offered, although not necessarily being covered by insurance, for multiple types of cancer, but lung cancer being a common cancer is included in that. So, what do you think? Dr. Cheryl Czerlanis: Yes, like you mentioned, there are novel bioassays such as blood-based biomarker testing that evaluate for DNA, RNA, and circulating tumor cells that are both promising and under active investigation for lung cancer and multi-cancer detection. We know that such biomarker assays may be useful in both identifying lung cancers but also in identifying patients with a high-risk result who should undergo lung cancer screening by conventional methods. Dr. Nate Pennell: Anything that will improve on our rate of screening, I think, will be welcome. I think probably in the future, it will be some combination of better risk prediction and better interpretation of screening results, whether those be imaging or some combination of imaging and biomarkers, breath-based, blood-based. There's so much going on that it is pretty exciting, but we're still going to have to overcome the stigma and lack of public support for lung cancer screening if we're going to move the needle. Dr. Cheryl Czerlanis: Yes, I think moving the needle is so important because we know lung cancer is still a very morbid disease, and our ability to cure patients is not where we would like it to be. But I do believe there's hope. There are a lot of motivated individuals and groups who are passionate about lung cancer screening, like myself and my co-authors, and we're just happy to be able to share some ways that we can overcome the challenges and really try and make an impact in the lives of our patients. Dr. Nate Pennell: Well, thank you, Dr. Czerlanis, for joining me on the By the Book Podcast today and for all of your work to advance care for patients with lung cancer. Dr. Cheryl Czerlanis: Thank you, Dr. Pennell. It's such a pleasure to be with you today. Thank you. Dr. Nate Pennell: And thank you to our listeners for joining us today. You'll find a link to Dr. Czerlanis' article in the transcript of this episode.  Please join us again next month for By the Book's next episode and more insightful views on topics you'll be hearing at the education sessions from ASCO meetings throughout the year, and our deep dives on approaches that are shaping modern oncology. 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. Follow today's speakers:     Dr. Nathan Pennell    @n8pennell   @n8pennell.bsky.social Dr. Cheryl Czerlanis Follow ASCO on social media:     @ASCO on X (formerly Twitter)     ASCO on Bluesky    ASCO on Facebook     ASCO on LinkedIn     Disclosures:    Dr. Nate Pennell:        Consulting or Advisory Role: AstraZeneca, Lilly, Cota Healthcare, Merck, Bristol-Myers Squibb, Genentech, Amgen, G1 Therapeutics, Pfizer, Boehringer Ingelheim, Viosera, Xencor, Mirati Therapeutics, Janssen Oncology, Sanofi/Regeneron       Research Funding (Institution): Genentech, AstraZeneca, Merck, Loxo, Altor BioScience, Spectrum Pharmaceuticals, Bristol-Myers Squibb, Jounce Therapeutics, Mirati Therapeutics, Heat Biologics, WindMIL, Sanofi    Dr. Cheryl Czerlanis: Research Funding (Institution): LungLife AI, AstraZeneca, Summit Therapeutics

Assistant Managing Editor Kerry A. Dolan sits with Co-CEO Maky Zanganeh of Summit Therapeutics.Zanganeh earned hundreds of millions as an investor and executive, speaks four languages (Farsi, German, English, French), survived breast cancer and runs, as co-CEO with Bob Duggan, Miami-based Summit Therapeutics, a Nasdaq-listed biotech that has minted her a $1.5 billion fortune of her own. That wealth has landed Zanganeh, now 54, on Forbes' list of America's Richest Self-Made Women (at No. 23) for the first time. She is one of 38 self-made female U.S. billionaires on the list, and one of just five to have made a billion-dollar-plus fortune in health care. See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In der heutigen Folge sprechen die Finanzjournalisten Anja Ettel und Holger Zschäpitz über eine Schreckensnachricht für Tesla-Aktionäre, einen neuen Rüstungs-ETF und gute Nachrichten vom IPO-Markt. Außerdem geht es um Bristol Myers Squibb, Pfizer, Summit Therapeutics, InstilBio, Rheinmetall, Hensoldt, Leonardo, BNP Paribas Easy Bloomberg Europe Defense ETF (WKN: A417F7), BNP Paribas Easy MSCI World Equal Weight Select ETF (WKN: A417BH), Invesco MSCI World Equal Weight ETF (WKN: A40G12), Xtrackers MSCI World ex USA (WKN: DBX0VH), Circle, BAE Systems, Saab, SAP, Merck, Salzgitter, Thyssenkrupp, Voestalpine und ArcelorMittal, Steel Dynamics, Nucor, Gerresheimer, Kongsberg Gruppen, Safran, Airbus, Rolls Royce, Leonardo, QinetiQ, Steyr Motors. Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter.[ Hier bei WELT.](https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html.) [Hier] (https://open.spotify.com/playlist/6zxjyJpTMunyYCY6F7vHK1?si=8f6cTnkEQnmSrlMU8Vo6uQ) findest Du die Samstagsfolgen Klassiker-Playlist auf Spotify! 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. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. Außerdem bei WELT: Im werktäglichen Podcast „Das bringt der Tag“ geben wir Ihnen im Gespräch mit WELT-Experten die wichtigsten Hintergrundinformationen zu einem politischen Top-Thema des Tages. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? [**Hier findest du alle Infos & Rabatte!**](https://linktr.ee/alles_auf_aktien) Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Pfizer has made a $6 billion bet on acquiring 3SBio's PD-1/VEGF antibody, despite being a late entrant to the space. This deal comes after Pfizer's partnership with Summit Therapeutics, causing some confusion about the pharma company's overall strategy. Meanwhile, the success of a CRISPR baby has highlighted the lack of FDA-approved treatments for the 15 million children with rare diseases. Most rare conditions do not even have a treatment pipeline. Bio-Rad is redefining antibody discovery through their Pioneer™ Antibody Discovery Platform, which accelerates programs and identifies clinical-quality candidates with industry-leading timelines. FDA Commissioner Marty Makary has expressed support for psychedelic therapies for neuropsychiatric conditions, noting significant benefits for patients. The most favored nation executive order issued by Trump may face legal challenges and unintended consequences for the healthcare sector and patient access. Overall, these developments in the pharmaceutical and biotech industries highlight ongoing challenges and opportunities in drug development and treatment for rare diseases.

Pfizer stole the headlines this week with a pact worth up to $6 billion with Chinese biotech 3SBio for a PD-1/VEGF candidate just three months after inking a clinical trials collab for a similar drug with Summit Therapeutics. It's the largest Chinese licensing deal in recent memory, as pharmas continue to turn to the country to fill their pipelines.  Also on Tuesday, the Department of Health and Human Services offered a smidge more detail on President Donald Trump's Most Favored Nation executive order. A press release explained that drug prices will be tied to the lowest price in certain countries with a GDP at least 60% that of the U.S. and that the effort will focus on branded drugs.   Over at the FDA, the strategy around COVID-19 vaccines is evolving. According to an editorial published in the New England Journal of Medicine Tuesday by FDA Commissioner Marty Makary and CBER director Vinay Prasad, future COVID-19 approvals will focus on adults over 65 and high-risk individuals six months to 64 years old—a strategy they say will better align the U.S. with other high-income nations. This is also in sync with the Novavax approval, which came in Friday after a few delays.   Meanwhile, the FDA's Oncologic Drugs Advisory Committee (ODAC) is currently in the midst of a two-day meeting, but acquiring the necessary expertise was “absolute chaos,” according to an agency insider who spoke with BioSpace. This is partly due to the decimation of an FDA office that includes staff responsible for screening scientific and therapeutic area experts for conflicts of interest.  Going back to last week—which seems like a year ago at this point—we were somewhat shocked to learn that the CEO of one of the world's most valuable pharma companies is on his way out. Friday morning, Novo Nordisk announced that CEO Lars Fruergaard Jørgensen will be leaving the company after eight years at the helm. After peaking last June at about $155 apiece, the obesity leader's shares are currently worth just $68. Novo said the decision for Jorgensen to leave was mutual, but Jorgensen was not made available to speak on a call following the announcement.  Finally, a couple of milestones are worth noting: First, the Alzheimer's space got a big win on Friday when the FDA approved the first blood-based test for the disease—news that could be a boon to Eli Lilly's Kisunla and Biogen & Eisai's Leqembi. And second, a nine-month-old boy named KJ with a disease called CPS1 deficiency that affects just 1 in 1.3 million U.S. babies was treated with a single-use CRISPR treatment created just for him. It's an incredible story that highlights just how far gene editing has come, but it also highlights a rare disease crisis, with these sorts of ultra- and nanorare diseases lacking the necessary financial incentive to motivate biopharma's focus.   

In his effort to onshore manufacturing, President Donald Trump issued an executive order on Monday afternoon ordering the FDA to ease permitting processes for new and expanded U.S. facilities. The announcement comes as more and more Big Pharma companies commit billions to expanding their U.S. footprints. Bristol Myers Squibb CEO Christopher Boerner announced this week that the company will pump $40 billion into its stateside operations over the next five years, even as the pharma executes a massive cost-cutting effort that involves shaving $3.5 billion from expenses by 2027 and cutting thousands of jobs, including another 516 in New Jersey, according to a May WARN notice.  In other policy news, the Department of Health and Human Services on Wednesday said it will require all new vaccines to be tested in placebo-controlled trials to earn FDA approval but some vaccine experts have raised concerns about this approach. Meanwhile, turmoil still envelopes the FDA, with staff cuts and rehires continuing at a dizzying pace. On Monday, several states sued HHS, saying that the cuts offload critical functions and costs onto the states and impede public health efforts.  As Q1 earnings season for Big Pharma begins to wind down, there are still headlines coming from the biotech sector. Vertex revealed last week that it is abandoning all of its adeno-associated virus vector work, while BioNTech on Monday announced that tariffs could get in the way of its ambitious plans for a closely watched PD-L1-VEGF therapy. Moderna, meanwhile, continues its fall from COVID grace, missing Q1 revenue expectations and announcing plans to reduce operating expenses by around $1.5 billion by 2027.   In the weight loss space, Novo Nordisk announced on Friday that the FDA has accepted the application for a pill version of Wegovy, with a decision expected this fall. Novo has also struck partnerships with CVS and Hims & Hers pharmacies to market injectable Wegovy, drawing the attention of Eli Lilly CEO David Ricks.   Also this week, check out BioSpace's deep dives into advances in base editing—a technology that's been touted as a “safer” CRISPR—and Summit Therapeutics' push to bring closely watched PD-1/VEGF immunotherapy ivonescimab to the U.S. market after its recent approval in China. 

Unser Partner Scalable Capital ist der einzige Broker, den du brauchst. Inklusive Trading-Flatrate, Zinsen und Portfolio-Analysen. Alle weiteren Infos gibt's hier: scalable.capital/oaws. Aktien + Whatsapp = Hier anmelden. Lieber als Newsletter? Geht auch. Das Buch zum Podcast? Jetzt lesen. Boeing, Intel & Kering zeigen: Jede Krise hat ein Ende. Oder auch nicht. Adidas, Philip Morris & Summit Therapeutics sind weiter High-Performer. BioNTech freut's auch. Börse freuen Statements von Trump. Kryptonerds zocken bei Stake & kriegen Zinsen bei PayPal. Gegen Friedrich Vorwerk (WKN: A255F1) ist sogar NVIDIA ein Low-Performer. Cantor Equity Partners (WKN: A40TTJ) soll das neue MicroStrategy werden. Upexi (WKN: A40PUJ) das MicroStrategy für Solana. Diesen Podcast vom 24.04.2025, 3:00 Uhr stellt dir die Podstars GmbH (Noah Leidinger) zur Verfügung.

In today's episode, supported by Summit Therapeutics, we had the pleasure of speaking with Xiuning Le, MD, PhD, about the use of ivonescimab (SMT112) in patients with PD-L1–positive non–small cell lung cancer (NSCLC). Dr Le is an associate professor in the Department of Thoracic/Head and Neck Medical Oncology in the Division of Internal Medicine at The University of Texas MD Anderson Cancer Center in Houston. The phase 3 HARMONi-2 trial (NCT05499390) investigated ivonescimab vs pembrolizumab (Keytruda) in patients with locally advanced or metastatic, PD-L1–positive NSCLC without sensitizing EGFR mutations or ALK translocations. At the preplanned interim analysis, at a median follow-up of 8.7 months (IQR, 7.1-10.3), the median progression-free survival was significantly longer in the ivonescimab arm (n = 198) vs the pembrolizumab arm (n = 200), at 11.1 months (95% CI, 7.3-not estimable) vs 5.8 months (95% CI, 5.0-8.2), respectively (stratified HR, 0.51; 95% CI, 0.38-0.69; 1-sided P < .0001). The objective response rates were 50% (95% CI, 43%-57%) and 39% (95% CI, 32%-46%) in these respective arms. In our exclusive interview, Dr Le discussed the rationale for the HARMONi-2 trial, key findings from the study, and where these findings position the potential role of ivonescimab in the PD-L1–positive NSCLC treatment paradigm.

Donald Trump's tariffs have headlined myriad news stories this week—including at BioSpace, where we reported Pfizer CEO Albert Bourla's claim that his company is prepared to reshore manufacturing if the president makes good on threats made last month. Eli Lilly also appears to be preparing, commiting $27 billion to boost its U.S. manufacturing capacity.   Meanwhile, another regulatory meeting has been canceled under new HHS Secretary Robert F. Kennedy Jr. Reuters revealed last week that an upcoming meeting of the FDA's external advisers for vaccine policy on March 13 has been canceled—just a week after the CDC Vaccine Advisory Board's first meeting of 2025 was postponed. Also on the policy front, BioSpace took a deep dive into priority review vouchers (PRVs) after Congress failed to reauthorize the rare pediatric disease PRV program at the end of 2024. Our reporting shows this will be painful for many biopharma companies who rely on funds from the sale of PRVs.   Speaking of money, AbbVie and Eli Lilly struck a pair of mid-size deals in hot spaces. AbbVie made a late obesity play this week, inking a licensing deal worth up to $2.2 billion with service provider Gubra to bring a long-acting amylin drug to the market, while Lilly hopped onto the hot molecular glue train, paying more than $1.2 billion in a licensing deal with Magnet Biomedicine.  Finally, we examined the somewhat lethargic immuno-oncology space, which has companies, including BMS, Roche, Summit Therapeutics and BeiGene, targeting TIGIT, VEGF, RAS and more in their quest to bring the next Keytruda—which led the way in 2024 as the world's best-selling drug—to the market.  

Jeffrey Meckler, CEO of Indaptus Therapeutics, is focused on using their decoy platform to activate the immune system to fight cancer and infections. This approach activates the innate and adaptive pathways in a controlled manner using a short-term pulsed dosing regimen and helps avoid the toxicity issues seen in other immunotherapies. The therapy is cleared from the system quickly, allowing the immune system to be modulated and potentially used with other cancer treatments. Jeffrey explains, "It's a very uncommon approach because we have, over the last several decades, really had a paradigm for treating cancer in immunotherapy, and that paradigm is turning one or a couple switches in the immune system to help fight the cancer. Again, as I mentioned before, the concept of doing too much, activating too much comes from this idea that you'll hit toxicities and, like I said, cytokine storm or whatever. What we do is go about it in a way that people are coming to. The big talk right now are these VEGF PD-1 bispecific antibodies and what they're actually doing. Part of this is that the VEGF activates innate immune pathways. The PD-1 activates adaptive immune pathways." "So there's a lot of talk about what's been going on with Summit Therapeutics, and everybody now is doing these VEGF PD-1. We're even broader than that. And more importantly, we're also in a short burst. We call our therapy pulse prime, but it's cleared in the system within a couple of hours. So it does this activation, but instead of keeping the foot on the accelerator the entire time, it lets up. And what we started doing is giving it weekly, and our preclinical models show that weekly administration in combination with other therapies is the most potent approach for us."  #IndaptusTherapeutics #Decoy20 #Biotech #Cancer #CancerResearch #Immunotherapy #LungCancer #BladderCancer #LiverCancer #PancreaticCancer #ColonCancer indaptusrx.com Download the transcript here

Jeffrey Meckler, CEO of Indaptus Therapeutics, is focused on using their decoy platform to activate the immune system to fight cancer and infections. This approach activates the innate and adaptive pathways in a controlled manner using a short-term pulsed dosing regimen and helps avoid the toxicity issues seen in other immunotherapies. The therapy is cleared from the system quickly, allowing the immune system to be modulated and potentially used with other cancer treatments. Jeffrey explains, "It's a very uncommon approach because we have, over the last several decades, really had a paradigm for treating cancer in immunotherapy, and that paradigm is turning one or a couple switches in the immune system to help fight the cancer. Again, as I mentioned before, the concept of doing too much, activating too much comes from this idea that you'll hit toxicities and, like I said, cytokine storm or whatever. What we do is go about it in a way that people are coming to. The big talk right now are these VEGF PD-1 bispecific antibodies and what they're actually doing. Part of this is that the VEGF activates innate immune pathways. The PD-1 activates adaptive immune pathways." "So there's a lot of talk about what's been going on with Summit Therapeutics, and everybody now is doing these VEGF PD-1. We're even broader than that. And more importantly, we're also in a short burst. We call our therapy pulse prime, but it's cleared in the system within a couple of hours. So it does this activation, but instead of keeping the foot on the accelerator the entire time, it lets up. And what we started doing is giving it weekly, and our preclinical models show that weekly administration in combination with other therapies is the most potent approach for us."  #IndaptusTherapeutics #Decoy20 #Biotech #Cancer #CancerResearch #Immunotherapy #LungCancer #BladderCancer #LiverCancer #PancreaticCancer #ColonCancer indaptusrx.com Listen to the podcast here

At the recent World Conference on Lung Cancer and European Society for Medical Oncology annual meetings, two packages of lung cancer data from a partnership between Akeso and Summit Therapeutics and another collaboration between iTeos Therapeutics and GSK showed much promise of disrupting the current standard of care. But they also drew some questions and debate.  In this week's episode of “The Top Line,” Angus Liu from Fierce Pharma and Gabrielle Masson from Fierce Biotech discuss the key issues behind those two readouts.    To learn more about the topic in this episode:  iTeos-GSK's TIGIT combo shows 30% more tumor shrinkage than Jemperli, but safety signals scare investors Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer 'Cooking with gas': Regeneron sees its Opdualag rival as next big thing for treating solid tumors ESMO: Bristol Myers moves Opdualag into phase 3 trials in competitive first-line lung cancer field See omnystudio.com/listener for privacy information.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Amazon has partnered with Talkspace to expand its digital health benefits program, which also includes Omada Health. Community Health Systems (CHS) subsidiary is acquiring 10 urgent care centers, following in the footsteps of other for-profit health systems. Steward Health Care auctioned off Glenwood Regional Medical Center for $500,000, but there are concerns about the continued involvement of hospital landlord Medical Properties Trust in operations. The text also includes sponsored content on safeguarding healthcare against ransomware and cybercrime, as well as information on trends in telehealth and strategies for improving provider data accuracy for payers. Healthcare Dive provides news and insights for healthcare leaders and is a publication operated by Industry Dive.Roivant's subsidiary, Dermavant, is being acquired by Organon, giving Organon access to a psoriasis and eczema cream called Vtama. This acquisition will provide Roivant with additional cash to fund its research and development plans. Meanwhile, biotech M&A activity has plateaued, with private company acquisitions continuing while public company acquisitions have slowed down. One biotech, Ratio Therapeutics, backed by Bristol Myers Squibb, is optimistic about the boom in radiopharma and the pharmaceutical industry's shift towards targeted radiation drugs. In other news, Novartis' Kisqali has received expanded FDA approval which could double its market for breast cancer treatment. Additionally, Express Scripts is suing the FTC over a report critical of pharmacy benefit manager business practices. The industry is also exploring new ways to deliver genetic therapies and improve clinical trial execution through systems thinking. Overall, the biopharma industry is experiencing exciting times with various developments and advancements in drug development and healthcare technology.Zimmer has decided to pull its hip implant off the market due to fracture risk, with plans to phase out its use by December. Merit Medical has acquired Cook's lead management business for $210 million, adding devices used in heart rhythm device procedures to its portfolio. Synchron has connected brain-computer interface technology to Amazon Alexa, allowing patients to control various functions without using their hands or voice. Senseonics has received FDA clearance for a one-year continuous glucose monitoring system, and Boston Scientific has closed its acquisition of Silk Road Medical. The wearables market is expected to grow by 13% annually between 2024 and 2030, highlighting the importance of adhesives in wearable device development. AI is increasingly influencing the value chain of medical device companies, and manufacturers are exploring ways to utilize AI throughout the product lifecycle. These developments reflect the ongoing innovation and evolution within the medtech industry.Roivant has sold Dermavant to Organon in a deal worth up to $1.2 billion, allowing Roivant to focus on their autoimmune-focused Immunovant and upcoming trials. Summit Therapeutics' bispecific for non-small cell lung cancer has shown promise against Keytruda but still needs more data. Other news includes the FDA approving Keytruda for pleural mesothelioma, Bernie Sanders claiming generics companies can offer a cheaper alternative to Ozempic, Novartis expanding Kisqali's use in breast cancer, and HRSA threatening sanctions against J&J. In the world of enzyme development, SignalChem Biotech offers tailored services. Additionally, new gene therapies for sickle cell disease are reaching patients, and the race for an obesity pill is heating up among companies like Novo, Roche, and Terns.The FDA is facing challenges with conducting overseas drug manufacturing inspections, with 42% of registered plants overdue for inspections. Indian drugmaker Zydus Lifesciences received a warnin

August inflation declining to its lowest level since February 2021, but some components of CPI don't seem to be budging. Why housing is so sticky, and how it could impact the Fed decision. Plus Summit Therapeutics surging nearly 100% this week on the back of new lung cancer treatment data. What it could mean for patients, and how it stacks up against the competition. Fast Money Disclaimer

Summit Therapeutics made headlines this weekend at the 2024 World Conference on Lung Cancer, revealing that its bispecific antibody outperformed Keytruda in first-line non-small cell lung cancer. Meanwhile, bispecifics are one of several therapeutic classes on the agenda at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona later this week. Last week, BioMarin held a public address intended to calm anxious investors after rounds of layoffs and pipeline changes—but many were left wanting. Also undergoing major upheaval is Lykos Therapeutics, which laid off 75% of its workforce after failing to secure approval for its MDMA-based post-traumatic stress disorder therapy and announced last week that CEO Amy Emerson is stepping down from her role. In Washington, D.C., Congress is back in session this week and wasted no time in reviewing the BIOSECURE Act, which passed a House vote on Monday.  And on the weight loss front, Terns Pharmaceuticals is moving ahead to Phase II after its investigational GLP-1 pill elicited positive results in Phase I, and Amgen is pushing MariTide into a broad late-stage development program that will test the obesity treatment in other weight-related conditions, such as heart, kidney and liver diseases.

Ohne Aktien-Zugang ist's schwer? Starte jetzt bei unserem Partner Scalable Capital. Alle weiteren Infos gibt's hier: scalable.capital/oaws. Aktien + Whatsapp = Hier anmelden. https://bit.ly/oaws-whatsapp Lieber als Newsletter? Geht auch. https://bit.ly/oaws-nl Das Buch zum Podcast? Jetzt lesen. https://amzn.to/3Mq9zXz Roche hat ein Verdauungsproblem. Merck hatte bei der Verdauung einer Übernahme einen 25-Milliarden-Glückstreffer. Summit Therapeutics will den wiederholen. Außerdem hat sich Boeing mit Gewerkschaft geeinigt, Trump verliert massiv Geld und Huawei faltet dreimal. Vergesst Umsatz, Gewinn oder KGV. Bei Bayer (WKN: BAY001) ist was ganz anderes entscheidend: Die erfolgreiche Lobbying-Strategie. Der Podcast-Markt hat geboomt. Der Podcast-Markt ist gecrasht. Der Podcast-Markt erholt sich wieder. Acast (WKN: A3CR3V) war immer dabei und ist auch jetzt wieder dabei. Diesen Podcast vom 10.09.2024, 3:00 Uhr stellt dir die Podstars GmbH (Noah Leidinger) zur Verfügung.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Candid, a startup, is investing $370 million to prove the worth of bispecifics in autoimmune diseases. Summit's lung cancer drug has shown significant benefits over Keytruda, a popular immunotherapy drug. Relay's breast cancer drug also showed promise in early trials. Biotech IPOs are crucial in the industry, and their performance is being closely monitored. Early study data on Terns, a potential contender in the obesity drug market, is also discussed.Summit Therapeutics has declared victory over Keytruda in advanced non-small cell lung cancer, with their drug Ivonescimab showing a 49% higher effectiveness in reducing disease progression or death in a late-stage study. GSK is set to approach the FDA with positive Phase III data for a long-acting asthma medication. Terns Pharmaceuticals' investigational GLP-1 pill has shown promising weight loss results. Sino Biological has launched a new center for bioprocessing, and various pharmaceutical companies are making advancements in their pipelines. The FDA tracker highlights Travere's full approval for an IgAN drug.The challenges faced in the cell and gene therapy industry as it grows in popularity among investors and innovators are discussed. Shortages of brand-name diabetes and obesity medications from Novo Nordisk and Eli Lilly, such as Ozempic and Mounjaro, are due to high demand. Efforts are being made to ramp up manufacturing and develop new medications. Lilly recently made a billion-dollar deal with Haya Therapeutics to develop genetic obesity medications. The revival of drugs for Huntington's disease after initial trial failures is mentioned. Challenges in turning new drugs into successful assets even after FDA approval are highlighted, along with a poll on which presidential candidate would support policies favorable to the pharma industry. Information on staying compliant with the EU GMP Annex 1 revision is also provided.

In Episode 213 of The Cardone Zone, host Grant Cardone fulfills his commitment to providing listeners with access to personalities who have reached the pinnacle of success but may not be widely known. Join Grant as he engages in a captivating conversation with Bob Duggan, CEO of Summit Therapeutics a true titan of success in the business world. Bob Duggan's journey to success is filled with invaluable lessons and insights that Grant Cardone is eager to share with his audience. From his innovative approaches to entrepreneurship to his unwavering commitment to excellence, Bob Duggan's story is sure to inspire and enlighten. Don't miss this exclusive opportunity to gain access to the wisdom and experiences of a true industry leader. Tune in to Episode 213of The Cardone Zone and discover the keys to achieving extraordinary success in business and beyond. Stay connected with us on all social media platforms and visit grantcardone.com or GCTV.com for additional resources and tools to support your personal and professional growth.

About Anne Heatherington:Anne Heatherington is the R&D Chief Data and Technology Officer at Takeda, a top biopharmaceutical leader in Cambridge, Massachusetts. With over four years at Takeda, Anne leads the Data Sciences Institute team, steering the data, digital, and technology strategy for Research & Development. Her diverse career includes key roles such as Senior Vice President at Summit Therapeutics plc and Vice President at Pfizer. After 12 years at Pfizer, Anne chaired the Technical Review Committee, showcasing her leadership. Anne holds a Bachelor of Science in Pharmacy from Queen's University Belfast, a Ph.D. in Pharmacokinetics from the University of Manchester, and is a Senior Research Fellow at the University of Washington.Things You'll Learn:Drug development is at a critical point where marrying traditional approaches with new innovations is crucial to avoid obsolescence, emphasizing the need for adaptability in the industry.Takeda aims to become the most trusted digital biopharmaceutical company, driving innovation in the healthcare sector.Achieving success in digitalizing drug development involves combining knowledge of regulations, a strong foundation in science, and a dedication to innovation.It's more impactful to solve real-world problems with AI rather than just following the hype.Takeda collaborates with MIT, leveraging AI to address business problems and develop solutions, such as using speech as a biomarker for diseases.Resources:Connect with and follow Anne Heatherington on LinkedIn.Follow Takeda on LinkedIn and visit their website.

Drs. Vamsi Velcheti and Jack West discuss ADAURA, KEYNOTE-671, and KEYNOTE-789 trials in NSCLC and the first pivotal study of sunvozertinib for the treatment of NSCLC with EGFR exon 20 insertion mutations. TRANSCRIPT Dr. Vamsi Velcheti: Hello, I'm Dr. Vamsi Velcheti, your guest host for the ASCO Daily News Podcast. I'm a professor of medicine and director of thoracic medical oncology at the Perlmutter Cancer Center at NYU Langone Health. My guest today is Dr. Jack West, a thoracic oncologist and associate professor in medical oncology at City of Hope Comprehensive Cancer Center. Today, we'll be discussing practice-changing studies and other key advances in lung cancer that were featured at the 2023 ASCO Annual Meeting.   Our full disclosures are available in the transcript of this episode and disclosures of all guests on the ASCO Daily News podcast are available at asco.org/DNpod.   Jack, there was a lot of exciting new data that emerged from the ASCO Annual Meeting, and it's great to have you back on our podcast today to talk about all the key updates in lung cancer.   Dr. Jack West: Absolutely. Thanks so much. It's always a high-energy meeting, and there was a lot to talk about in the lung cancer sessions this year for sure.  Dr. Vamsi Velcheti: Let's begin with LBA3, the ADAURA trial. This was presented in the Plenary Session at ASCO; we've heard previously the DFS updates from previous meetings, and overall survival updates were presented at the ASCO 2023 Annual Meeting. So, Jack, what was the highlight of the presentation for you? And could you put things in context for us? We have known about the DFS data for a while now. What gets you so excited about this study?  Dr. Jack West: Well, we've actually been focused on this trial for literally 3 years, since Dr. Herbst presented it at another Plenary presentation back in the ASCO Meeting in 2020 when we saw tremendous differences in the DFS data. Again, this was a trial of patients with resected stage 1b to 3a EGFR mutation-positive non-small cell lung cancer. Nearly 700 patients were randomized to after-surgery, and for many, but not all, patients undergoing chemotherapy, it wasn't mandated. But after that, they were randomized to get adjuvant, placebo, or osimertinib for up to 3 years. And we saw huge differences in the disease-free survival from the first presentation, with a hazard ratio in the range of 0.2.   We have notably seen significant improvements in disease-free survival before with other EGFR TKIs for this population after surgery, but nothing in this range. And it's also notable that in the various other trials of other EGFR inhibitors in the postoperative setting, we've seen a DFS benefit, but that didn't translate to an improvement in overall survival. So, seeing a press release that this was associated with a significant and, in fact, highly significant by report, improvement in overall survival, as well as DFS, was really notable.   What's also, I think, particularly important as a focus of this is that in the later presentations of this work, with longer follow-up last year, we saw that the DFS curves showed a drop in the DFS starting after these patients had completed 3 years of treatment. So, really suggesting that at least some, if not many or most of these patients who had been on adjuvant osimertinib were subject to a higher risk of relapse once they completed that. So, again, making the endpoint of overall survival particularly important. It's always been to me the endpoint we should care about most in a curative setting. Although the DFS was the primary endpoint of the study and it was powered and built around specifically focusing on the DFS difference, so overall survival was reassuring, I think, when we actually saw it, but not what the trial was centered around.    And what we saw was a very dramatic improvement in overall survival with a hazard ratio of 0.49. That was essentially the same for the patients with stage 2 to 3a disease, as well as the broader population with stage 1b to 3a disease. When we look at the absolute numbers for overall survival at 5 years, there was an improvement from 73% to 85% with osimertinib, and in the population from 1b to 3a, an improvement from 78% to 88%. So, many things to comment on here. Really remarkable to see an 88% 5-year survival in the osimertinib arm that includes patients with stage 3a disease.    I would say that there's still some controversy, some questions about this, and it really centers around a few things. One is, like many global trials, this one enrolled patients from many places that did not have the same standard of care staging that we follow in the U.S. There wasn't any specification or mandate for PET scans, which would be very routine in the U.S. And brain MRIs were not mandated either. And so there were almost certainly some patients with more advanced disease that was not detected that would be a big advantage for the osimertinib arm, but really not characterized. And also, the crossover was made possible to osimertinib starting in April of 2020, but only 38.5% of the patients on the control arm actually received osimertinib at the time of relapse. And even though many of the other patients who had a relapse did get another EGFR inhibitor, I don't think there's much question that osimertinib is the preferred and optimal EGFR TKI.   And so there were a couple of important factors kind of going for this trial. One is the long, long, long duration of treatment at 3 years, though with a drop-off, I think some questions about whether even that is enough, and we might be tempted to treat beyond 3 years. And then how much did the inability of most of the patients on the control arm to get osimertinib later contribute? My personal view is that it is a troubling aspect of this trial. But also so many other trials that they're run globally in places where we arguably perpetuate these disparities by running these trials that, in part, magnify the differences between the two arms because some patients just will not have access to what is our best standard of care in the U.S., or many other parts of the world, but weren't necessarily available to many of the patients on the control arm where it was conducted. So, I think that's always a concern. It's definitely an issue of this trial, but I would not say it's unique to this one.  Dr. Vamsi Velcheti: Very good points, Jack, and I completely agree with you. I think those certainly are concerns. But on the other hand, this is a pragmatic trial and that's the real-world scenario in terms of access issues, in terms of osimertinib globally, correct, in the stage 4 setting, even though we all agree that osimertinib is the best option for patients with metastatic EGFR-mutated lung cancer, I think that's obviously a reflection of global access issues and global disparities and changes in standard of care in terms of workup as well. So, it's somewhat of a pragmatic trial in some ways and I completely agree with you, I think that may have potentially had some impact on the overall survival.  Dr. Jack West: Well, I would clarify that I don't think that this really highly significant difference in overall survival is undermined completely by this. There's no question in my mind that with the huge difference in disease-free survival that we'd already seen for 3 years, it has become our standard of care really for this population at least to offer it, if not to strongly recommend it. But I would say that most of us have been quite inclined to recommend it, perhaps with caveats. And I would say that this overall survival benefit mostly corroborates that, even if there are some concerns about how these trials are done, but it's still an impressive difference that would lead me to only cement my practice of pursuing it in this setting. I just would love to re-examine how we conduct these trials and potentially potentiate disparities that exist and don't want to have our trials be more positive by capitalizing on that.   Dr. Vamsi Velcheti: Let's move on to the next abstract, LBA100; this is the KEYNOTE-671 trial. This was featured during the meeting's Clinical Science Symposium. This is a study of pembrolizumab or placebo plus platinum doublet followed by surgical resection and pembrolizumab or placebo for early-stage non-small cell lung cancer. Jack, what was the key message from this trial, and do you consider this as practice-changing?  Dr. Jack West: This has been an area where we've seen really dramatic evolution in our practice patterns, specifically, at least for patients who don't have a tumor harboring an EGFR mutation or ALK rearrangement. I would say that there has been some momentum toward preoperative neoadjuvant therapy, specifically based on the CheckMate-816 trial that gave chemo with nivolumab versus placebo and showed a significant improvement in the pathologic complete response rate at surgery as well as event-free survival. The overall survival looks encouraging but is still early and hasn't met the threshold for statistical significance, and that's FDA-approved.   But we still question whether there's a value to doing anything in the postoperative setting. And the CheckMate-816 trial did not include that as part of the trial. It allowed postoperative management at the judgment of the treating physician but didn't really prescribe anything. We now have the results of several trials in the last few months that have added a component in the postoperative setting in addition to three or four cycles of preoperative chemoimmunotherapy. And the first one that gave us a glimpse was the AEGEAN trial presented by Dr. John Heymach at AACR in April of this year that looked at chemo and durvalumab versus chemo placebo and then followed by a year of durvalumab versus placebo after surgery. That showed results in terms of major pathologic response and event-free survival that are significantly better with immunotherapy. Not clearly superior to what we would see with CheckMate-816.   And then even more recently, we saw a monthly Plenary presentation from ASCO with the Neotorch trial presented by Dr. Shun Lu of China. This was a Chinese trial only that presented results just for patients with stage 3 disease thus far. This included patients with stage 2 or stage 3, but what we saw is stage 3 results and that looked at chemo with toripalimab for 3 cycles versus placebo and then a year of checkpoint inhibitor or placebo. This also shows a benefit with the addition of immunotherapy, but not clear if that's better than what we can already achieve with neoadjuvant alone with the Checkmate-816 approach.   And then what we have now is a presentation and simultaneous publication by Dr. Heather Wakelee of KEYNOTE-671. And this is really almost the exact same trial design as AEGEAN. It's 4 cycles of platinum doublet chemotherapy and it is for patients with stage 2 to 3a disease. And this gave 4 cycles of chemotherapy with placebo or pembrolizumab. And then after surgery, patients would go on in the investigation arm to a year of pembrolizumab or to the additional year with placebo. And this shows a significant improvement in event-free survival with a hazard ratio of 0.58. It's most prominent in patients with high PD-L1, where the hazard ratio is 0.42. But there's still a benefit in patients with PD-L1 less than 1%, where it's 0.77. And there was a trend toward better overall survival here, hazard ratio of 0.73. It does not reach statistical significance at this early point. It's still preliminary but certainly looks encouraging. And there are also significant improvements in major pathologic response, where less than 10%, about a threefold difference from 30.2% with immunotherapy compared to 11% with placebo. And a very impressive improvement in pCR rate, which is 18.1% with the chemo and pembro compared to 4% with chemotherapy alone. Not surprisingly, when we look at event-free survival, it's best in the patients who achieve a pathologic complete response, but pembrolizumab improved outcomes in event-free survival even for those who didn't achieve a pCR.   The real question I would say is does the addition of a year of checkpoint inhibitor therapy postoperatively add to what we already achieve with those first three cycles with chemo-neo or 4 cycles with maybe one of these other options? And these trials can't answer that question because they just include them as a package deal. There's no way to tease apart right now the component of what incremental benefits you get from that. And it certainly adds a year of time coming in for every 3-week infusions. Even if you space that out, it's still a year of coming in and getting infusions, potential cumulative immune-related toxicities, and a lot of cost versus potentially being done. And I think that really is the big question at this point of do you want to recommend something when we don't really have a precedent for much benefit beyond the first 4 cycles? Perhaps. Certainly, we give maintenance pemetrexed and other immunotherapies and there can be benefit there. So, I wouldn't say you necessarily cap that. But if there is resistant disease after the first 4 cycles you've already given 3 cycles, how much benefit is there? How likely is it that you're going to eradicate the last cancer cells with more?   That said, I think many patients, and oncologists myself perhaps included, are going to be inclined to err on the side of possibly over-treating, but at least trying to give everything that is part of a widely studied, FDA-approved approach once these options become available. I just think it's going to end up as a careful discussion with each patient about whether they'd prefer to just say they're done or do that extra year and really feel that even if it comes back, they've done everything that made sense to try.  Dr. Vamsi Velcheti: Very good points, Jack. So let's move on to another abstract, which is the LBA9000. This is the KEYNOTE-789 trial. In my opinion, this is the most important negative phase 3 trial in lung cancer in a while. This is a trial looking at pemetrexed platinum with or without pembrolizumab in patients who have EGFR mutation-positive metastatic non-small cell lung cancer. So, what are your key takeaways, Jack?  Dr. Jack West: Well, I would say essentially we've been waiting to figure out what is the best treatment approach for patients with acquired resistance after osimertinib. And most of the patients had received osimertinib for their EGFR mutation-positive non-small cell. This is essentially KEYNOTE-189 being run in the EGFR mutation-positive patients after they've exhausted at least the major benefit of EGFR TKI therapy.   What we saw was a hazard ratio for progression-free survival of 0.8. It didn't quite make it across the threshold for efficacy, a significant difference. And so it missed that efficacy boundary. And overall survival, the hazard ratio is 0.84, also missing the efficacy boundary. When you look at the actual curves, they show modest separation, nothing eye-popping, certainly compared to some of the other trials we're talking about. But I wouldn't say they show no benefit. And I think that's, to me, why there's really still a role for a nuanced thought process and maybe some discussion about how negative this is. This is not, in my mind, stone-cold negative with no patients benefiting from immunotherapy. This is a trial that really suggests that there's a subset of patients who are benefiting from immunotherapy.   And we've also seen going back to subset analysis of the IMpower150 trial and also the ORIENT-31 trial with sintilimab and a bevacizumab biosimilar, another anti-VEGF inhibitor. These trials both really indicated a benefit in this population after EGFR TKI therapy of immunotherapy combined with VEGF. I think there could still be a value in there. I don't want to be a Pollyanna or too open-minded, but I think that there was at least a suggestion that this could still be a fruitful avenue. I think that this is still something we should do additional studies on that could bear fruit. I wouldn't close the door and categorically say this is just never going to translate to any benefit for any of these patients.   Dr. Vamsi Velcheti: The key thing, though, is, like in EGFR mutant patients I think in the previous studies as well, the response rates with single-agent PD-1 have been very minimal. And I think one of the things that's actually very important to highlight is in the operative setting, the early-stage setting, unfortunately, some of the trials with immunotherapy have included patients with an EGFR mutation. And now we have a treatment option for those patients within the adjuvant setting, especially osimertinib. We just heard from the ADAURA trial, which has a clear significant overall survival benefit. So I think it's really important to test for EGFR mutation in all stages. And if somebody with the early stage has an EGFR mutation, adjuvant immunotherapy, or perioperative immunotherapy may not be the best option for those patients.  Dr. Jack West: Right. I agree with that, although it is interesting that the KEYNOTE-671 trial did have some small population of patients with an EGFR mutation, and in that subset analysis, they seem to benefit from the pembrolizumab. I would not say that we should divert from ADAURA, but I'm just not as sure that our previous statement and mindset that immunotherapy just categorically doesn't work for patients with driver mutations is that simple.   First of all, there is some heterogeneity about which driver mutation, and the ALK-positive patients seem to really get no benefit. But I think there's still some questions about immunotherapy for EGFR. Certainly, patients with KRAS or BRAF V600E seem to benefit like the broader range of patients. And I would also say maybe it's different whether you're giving immunotherapy combined with chemotherapy versus as monotherapy. So that's why I'm just not that sure we really can characterize this that well yet.   The one additional point I would make about KEYNOTE-789 and the potential role of immunotherapy is that some experts in thoracic oncology and general oncologists alike may prefer to introduce chemotherapy at a time of progression, but keep the osimertinib going, maybe particularly for patients with brain metastases, whether current or a history of them, where we really feel that the osimertinib adds a critical component to CNS control. We don't want to ever give osimertinib or probably other EGFR TKIs concurrently with immunotherapy. So that's just a factor that we'd really want to consider when we're prioritizing where to fit in immunotherapy, if at all.  Dr. Vamsi Velcheti: Thank you, Jack. And let's move on to the next abstract, Abstract 9002. This is a pivotal study of results from the sunvozertinib, which is an EGFR exon 20 insertion site mutation drug. There's some very promising data. Jack, how do you feel this study is going to influence practice?  Dr. Jack West: Well, this is not an agent we have access to broadly yet, but I was quite impressed by it overall. I didn't mention it. We talked about it in the pre-ASCO discussion, and it was really one that I would mark as potentially practice-changing when we can get it. DZD 9008 or sunvozertinib is a potent inhibitor of exon 20 insertion mutations, and this was 97 patients, and the majority had had a couple of lines of prior therapy. They had to have gotten chemo, and the response rate was 60%, and it was really comparable efficacy with the different mutation subtypes.   I think that the main thing that I would want to clarify a little better in my own patient population is how well the drug is really tolerated. We talked about that there was not really much grade 3 toxicity and that's true, but diarrhea rates were 67%, even though it was grade 3 and just about 8%. But grade 2 diarrhea or grade 2 rash in patients who are on this therapy, we hope for a long time, I think is something we shouldn't minimize. And I think that particularly our mindset about toxicity needs to be different when we're talking about giving a treatment for 2 or 4 cycles and then being done with it versus something we hope we're going to be giving longitudinally. And we really don't want to minimize the potential impact on the quality of life of patients who are experiencing grade 2 rash, diarrhea, or paronychia for months and months, maybe more than a year at a time.   But that said, this is twice the response rate if not more than that of what we have already had for patients with this molecular aberration with an exon 20 insertion. So I think it's compelling and I think that it's going to be really valuable to offer to our patients. I just would like to clarify better how well patients who are actually on it are feeling when you incorporate the potentially chronic toxicity issues.  Dr. Vamsi Velcheti: Thank you, Jack. And let's move on to the last abstract. This the LUNAR study, LBA9005. This is a positive phase 3 study that looked at tumor-treating fields or TTF therapy with standard of care treatments in metastatic non-small-cell lung cancer following platinum failure. This has been talked about a lot at ASCO, and Jack I'm eager to hear your key takeaways about this study.  Dr. Jack West: Well, we knew from a press release several months ago, I think back in February, that there was a significant improvement in overall survival with the addition of tumor-treated fields. Again, this concept that electric fields can lead to antimitotic effect and potentially downstream induction of immunogenic cell death and enhanced immune response, that's at least the concept. And it's of course established, has utility in patients with glioblastoma, although kind of, I would say underutilized because it can be cumbersome. And I think that's one of the things we need to factor in is that this is not the easiest approach to pursue.   But we don't have that many therapies that improve overall survival significantly in previously treated patients with non-small cell lung cancer. So, I think there's good reason to focus on this and ask how beneficial it is. It was notable, it was pretty much an even split of patients enrolled on the trial, 276 patients total, but about half had gotten chemo but not gotten immunotherapy before. And then the other half, I would say the clear majority, had gotten immunotherapy as well as chemo and got docetaxel-based treatment.     And the overall survival benefit was significant for the intent to treat total population with a hazard ratio of 0.74 and a difference in 3-year survival of 18% favoring the addition of tumor-treating fields on the chest versus 7% in the patients who didn't. It really seemed to separate between the patients who had not had an immune checkpoint inhibitor and got tumor-treating fields with the checkpoint inhibitor where the hazard ratio is 0.63 and those who got tumor-treating fields with docetaxel where the hazard ratio was 0.81. So it really wasn't significant in this population.  Toxicity, no real surprises compared to what we already knew about tumor-treating fields. Mostly dermatitis, but I would say that one of the kind of unmeasured issues is that this is a device that people have to wear on their chest carrying a battery pack with them all day long. It's essentially all the waking day, and so I think that's at least cumbersome. I wouldn't call it prohibitive, but it's a challenge. And I think we need to really ask whether the juice is worth the squeeze, whether the benefit is that compelling. And I question that when we're talking about an agent that doesn't significantly move the needle against docetaxel alone.   Again, this is a population where in the U.S. we have ramucirumab to add to docetaxel. Not everyone does that. It's not uniform, but that has a statistically significant, though modest survival benefit associated with that. We don't do better than that with tumor treating fields. And so, I think that this is an option that merits discussion and some patients may opt for it, but I suspect that most of my patients would not find the absolute difference to be that compelling for the challenges it incurs. I don't know what your perspective is here.  Dr. Vamsi Velcheti: I completely agree, Jack. And I think the study design and just the fact that the standard of care has changed over the last 5, actually 6 years since the study has been open. And I'm not really so sure I could really make much sense of the data in terms of the standard of care combination with TTF providing more benefit. And I think there are more questions than answers here and I'm not so sure which populations would benefit the most. And I think, I hate to say this, but this is a nice proof of concept. I hate to say this because it's a phase 3 study and it's a positive phase 3 study, but it's clinical relevance with the current standard of care, I think, I'm not really sure how much of an impact this would really have.    Well, Jack, I've really enjoyed speaking with you about these key advances in lung cancer that were featured at the 2023 ASCO Annual Meeting. Our listeners will find links to all the studies discussed today in the transcript of this episode. Thank you so much, Jack, for joining us today.  Dr. Jack West: Always a pleasure. Thanks so much.  Dr. Vamsi Velcheti: And just like that, we've reached the end of another enriching episode. But remember, like all good things, this too must come to an end, but only until we meet again. We really would like your feedback on the podcast. If you enjoyed the podcast, please 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.   Follow today's speakers:   Dr. Vamsidhar Velcheti   @VamsiVelcheti   Dr. H. Jack West   @JackWestMD   Follow ASCO on social media:    @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn      Disclosures:    Dr. Vamsidhar Velcheti:   Honoraria: ITeos Therapeutics   Consulting or Advisory Role: Bristol-Myers Squibb, Merck, Foundation Medicine, AstraZeneca/MedImmune, Novartis, Lilly, EMD Serono, GSK, Amgen, Elevation Oncology, Taiho Oncology, Merus   Research Funding (Inst.): Genentech, Trovagene, Eisai, OncoPlex Diagnostics, Alkermes, NantOmics, Genoptix, Altor BioScience, Merck, Bristol-Myers Squibb, Atreca, Heat Biologics, Leap Therapeutics, RSIP Vision, GlaxoSmithKline     Dr. Jack West:   Honoraria: AstraZeneca, Genentech/Roche, Merck, Takeda, Mirati, Regneron, Amgen, Abbvie   Consulting or Advisory Role: AstraZeneca, Genentech/Roche, Merck, Takeda, Mirati Therapeutics, Regneron, Amgen, Abbvie, Summit Therapeutics   Speakers' Bureau: Takeda, Merck, AstraZeneca        

China's Akeso has made a name for itself on the world stage by cutting a potential $5bn licensing deal with US biotech Summit in December 2022. Michelle Xia, founder, chairwoman and CEO of the biopharma, is beginning to look beyond the deal, describing it one of the first steps for Akeso to develop and commercialize innovative drugs globally on its own. Time marks: Introduction Licensing deal with Summit Therapeutics (00:20) Latest progress of the partnership (01:33) Ivonescimab's potential breakthrough (03:21) Akeso's journey (04:51) Platform buildup and choice of targets (07:22) Cadonilimab versus PD-1 (11:32) Licensing prospects of cadonilimab (14:43) Bispecific antibody versus ADC (17:10) Rationale behind deal-making (19:50) Go global on its own (22:20) Closing Akeso's Xia Looks Beyond Summit Deal To Independent Global Development, Sales: https://scrip.pharmaintelligence.informa.com/SC147939/Akesos-Xia-Looks-Beyond-Summit-Deal-To-Independent-Global-Development-Sales

EPISODE SUMMARY In this episode of Chan with a Plan, Max Speaks with Dr. Maky Zanganeh, Author of the book The Magic of Normal and Co-CEO of Summit Therapeutics, focusing on improving patient outcomes for serious unmet medical needs. In this conversation Maky discusses her battle with cancer and her journey to writing her book and how all those challenges gave her a new outlook on life. QUOTES “You never know how strong you are until being strong is the only choice you have. At the end of the day, if you think that everything is possible they give you the opportunity to move. You keep going, going, going.” – Dr. Maky Zanganeh “But every time that shows me I do not have this mentality to give up. I love to continue because at the end I know I'm in a better position.” – Dr. Maky Zanganeh “I wanted to publish the book before my dad passed away and they did everything to get it done before and he saw the book and that was my biggest achievement related to this book.” – Dr. Maky Zanganeh TIMESTAMPS [00:51] Maky's career and book [04:33] Book writing process [05:32] Cancer diagnosis [07:29] Learning lessons through the challenges [09:48] Obstacles that got her where she is today [11:45] Quotes to live by [13:05] Women overcoming glass ceilings [15:12] Helping business thrive [16:29] Top tips to reach your dreams [17:45] How generosity helped Maky [18:58] Hardest chapter to write [20:07] Key takeaway from the book [21:09] Maky's challenge that shaped who she is   RESOURCES & RELEVANT LINKS Dr. Maky Zanganeh on Social Media:LinkedIn Twitter Chan With A Plan Max Chan on Social Media

Hosts Daphne, Josh, Tim and Otello are joined by special guest and biotech investor, Brad Loncar, to discuss the current M&A landscape, data announcements from the week and recent FDA and regulatory movements. Otello began the episode with his observations of trends in M&A including speedy execution of deals and lack of competition to get them. Daphne goes into detail about this week's deals, including a new, high-stakes partnership between Summit Therapeutics and Akeso to in-license a bispecific antibody, a deal that could be worth up to $5 billion. Brad reflects on the popularity of cell therapies in 2022, covering Gilead and Kite's announcement of a collaboration with Arcellx to develop its phase 2 cell therapy for multiple myeloma. Josh transitions the conversation to data, highlighting Nkarta's positive clinical data from its CAR-NK cell therapy for patients with non-Hodgkin lymphoma and how this approach compares to CAR-T treatments. Finally, the conversation turns to a discussion on the relationship between big pharma and biotech and where smaller companies should focus business development relationships. Community of experts and insiders joining Biotech Hangout (formerly known as Biotech Clubhouse) include Daphne Zohar, Josh Schimmer, Bruce Booth, Tim Opler, Chris Garabedian, Michal Preminger, Dawn Bell, Rob Perez, Otello Stampacchia and more.

Watch RICH TV LIVE PODCAST www.richtv.io to get exploding stocks 24/7 like Summit Therapeutics $SMMT #STOCKS #PENNYSTOCKS #TRADING #ALERT #MONEY #NEWS #BUSINESS #ENTERTAINMENT --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app Support this podcast: https://anchor.fm/richtv/support

Trust is the cornerstone of any relationship. Parents with their kids, friends, partners in business, co-workers, leaders, and their teams, if they don't trust each other, there is no way of creating a long-lasting, healthy, and productive relationship. If you'd have to guess, what would you say is the easiest way to build trust in a relationship?In today's episode, the inspiring Dr. Maky Zanganeh joins us to share her unique view on leadership, relationships, and courage. Maky is the Founder and CEO of Maky Zanganeh & Associates; she is the Co-CEO at Summit Therapeutics, a Board Member of Pulse Biosciences, and the author of "The Magic of Normal." Maky is also a mother, a breast cancer survivor, and one of the responsible for the second-largest biopharma sale ever in the industry, leading a struggling biotech company into a deal for $21 billion.We had a fantastic conversation about Maky's career in the pharmaceutical industry, the $21 billion deal with AbbVie Inc, and how she relied on her relationship-building abilities during that period. Maky also talked about her battle with breast cancer and how it changed her views on motherhood, family, and life.Plus, we talked about her book "The Magic of Normal," what moved her to write it, what it can teach us about overcoming challenges, and so much more. Tune in to Episode 357 and get inspired by the unstoppable force of Dr. Maky Zanganeh.Some Questions I Ask: How important is it, Maky, to build strong relationships? (6:30)You are a breast cancer survivor. Can you talk about that journey? (11:20)What do you hope others learn from your story and from reading "The Magic of Normal"? (17:52)Resources: About Maky's journey in the pharmaceutical industry and the $21 billion deal (4:13)Transparency's role in relationship-building (7:54)Using technology to break the barriers of time and geographical locations (12:53)The two ways of looking at challenges (17:19)Maky's view on how connections and how the way of connecting changed over the last couple of years (20:50)Resources: Dr. Maky Zanganeh websiteBook: Maky Zanganeh - The Magic of NormalConnect with Dr. Maky: LinkedInBecoming Your Best Resources: Becoming Your Best WebsiteBecoming Your Best University WebsiteBecoming Your Best LibraryEmail: support@becomingyourbest.comBook: Becoming Your Best: The 12 Principles of Highly Successful LeadersBook: Conquer Anxiety: How to Overcome Anxiety and Optimize Your PerformanceFacebook Group – Conquer Anxiety Hosted on Acast. See acast.com/privacy for more information.

Join Our Guests Camilla Graham MD Ri-CoDIFy: Ridinilazole's Phase 3 Trial for the Treatment of C. difficile and Reduction of Recurrence. . Dr.Camilla S. Graham is Vice President and Chief Clinical Information Officer at Summit Therapeutics as well as a staff physician at Beth Israel Deaconess Medical Center in Boston, MA, and on faculty at Harvard Medical School. Guest: Alba Muhlfeld, C. diff. Survivor - Sharing her C. diff. infection journey. Guest: Erik Dubburke, MD, MSPH discusses “Optimizing Prevention of Hospital-Onset Clostridioides difficile infection.” Dr. Erik Dubberke is an Associate Professor of Medicine at Washington University School of Medicine in St. Louis, where he has been a faculty member in the Division of Infectious Diseases since 2005. He is an Associate Hospital Epidemiologist at Barnes-Jewish Hospital, Presentations delivered live during the November 14th, 2020 8th Annual International C. diff. Conference & Health EXPO

Join Our Guests Camilla Graham MD Ri-CoDIFy: Ridinilazole’s Phase 3 Trial for the Treatment of C. difficile and Reduction of Recurrence. . Dr.Camilla S. Graham is Vice President and Chief Clinical Information Officer at Summit Therapeutics as well as a staff physician at Beth Israel Deaconess Medical Center in Boston, MA, and on faculty at Harvard Medical School. Guest: Alba Muhlfeld, C. diff. Survivor - Sharing her C. diff. infection journey. Guest: Erik Dubburke, MD, MSPH discusses “Optimizing Prevention of Hospital-Onset Clostridioides difficile infection.” Dr. Erik Dubberke is an Associate Professor of Medicine at Washington University School of Medicine in St. Louis, where he has been a faculty member in the Division of Infectious Diseases since 2005. He is an Associate Hospital Epidemiologist at Barnes-Jewish Hospital, Presentations delivered live during the November 14th, 2020 8th Annual International C. diff. Conference & Health EXPO

Welcome to Episode 6 of 6; of the 8th Annual International C. diff. Post-Conference Special series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics while focusing on the leading HAI - Clostridioides difficile We will hear from the following keynote speakers: Camilla S. Graham, MD, MPH, Ri-Co-DIFy: Summit's Ridinilazole Phase 3 Trial to Advance the Sciences in the Treatment of C. difficile and Reduction of Recurrence. Maureen Spencer, RN, M.Ed., CIC, Engaging Middle School Children In Infection Prevention Through the C Diff Foundation's Junior Infection Fighters Program. Alba Muhlfeld, C. diff. Survivor, Patient's Journey. Erik Dubberke, MD, MSPH, Optimizing Prevention of Hospital-Onset Clostridioides difficile Infection. Many of the presentation slides are available to view/download until January 14th, 2021 located on the dedicated conference website: www.cdiff2020.com

Welcome to Episode 6 of 6; of the 8th Annual International C. diff. Post-Conference Special series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics while focusing on the leading HAI - Clostridioides difficile We will hear from the following keynote speakers: Camilla S. Graham, MD, MPH, Ri-Co-DIFy: Summit's Ridinilazole Phase 3 Trial to Advance the Sciences in the Treatment of C. difficile and Reduction of Recurrence. Maureen Spencer, RN, M.Ed., CIC, Engaging Middle School Children In Infection Prevention Through the C Diff Foundation's Junior Infection Fighters Program. Alba Muhlfeld, C. diff. Survivor, Patient's Journey. Erik Dubberke, MD, MSPH, Optimizing Prevention of Hospital-Onset Clostridioides difficile Infection. Many of the presentation slides are available to view/download until January 14th, 2021 located on the dedicated conference website: www.cdiff2020.com

Welcome to Episode 5 of 6; of the 8th Annual International C. diff. Post-Conference special series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics as in leading annual collaborative events while focusing on Healthcare-associated infections (HAI), and the leading HAI -- Clostridioides difficile (Also known as C. diff., C. difficile, CDI, CDAD). We will hear from the following keynote speakers Barbara McGovern, MD, ECOSPORIII: A Phase 3 Double-blind, Randomized, Placebo-controlled Trial of the Efficacy and Safety of SER-109, an Investigational Microbiome Therapeutic for the Treatment of Patients w/Recurrent Clostridioides difficile Infection (rCDI). Glenn Tillotson, Ph.D., FRSM, FCCP, It's a Small World w/C. diff. - a One Health Perspective. Dayle Skelly, C. diff. Survivor, A Patient's Journey. Many of the presentation Slides are available until January 14th, 2021 on www.cdiff2020.com We hope you enjoy the presentations.

Welcome to Episode 5 of 6; of the 8th Annual International C. diff. Post-Conference special series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics as in leading annual collaborative events while focusing on Healthcare-associated infections (HAI), and the leading HAI -- Clostridioides difficile (Also known as C. diff., C. difficile, CDI, CDAD). We will hear from the following keynote speakers Barbara McGovern, MD, ECOSPORIII: A Phase 3 Double-blind, Randomized, Placebo-controlled Trial of the Efficacy and Safety of SER-109, an Investigational Microbiome Therapeutic for the Treatment of Patients w/Recurrent Clostridioides difficile Infection (rCDI). Glenn Tillotson, Ph.D., FRSM, FCCP, It's a Small World w/C. diff. - a One Health Perspective. Dayle Skelly, C. diff. Survivor, A Patient's Journey. Many of the presentation Slides are available until January 14th, 2021 on www.cdiff2020.com We hope you enjoy the presentations.

Welcome to Episode 4 of 6; of the 8th Annual International C. diff. Post-Conference special series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics as in leading annual, collaborative events while focusing on Healthcare-associated infections (HAI), and the leading HAI -- Clostridioides difficile (Also known as C. diff., C. difficile, CDI, CDAD). We will hear from three leading topic-experts: Mark Wilcox, MD, FRCPath, DNA Fingerprinting to Understand C. difficile Transmission in Hospitals. Caterina Oneto, MD, Patient Support; In-Person, and Through the Global TeleSupport Network. Sahil Khanna, MBBS, MD, Microbiome Restoration; Getting One Step Closer Every Day! Many of the presentation Slides are available until January 14th, 2021 on www.cdiff2020.com We hope you enjoy the presentations from the leading speakers of the 8th Annual Int'l C. diff. Conference & Health EXPO. This audio broadcast is sponsored by Summit Therapeutics

Welcome to Episode 4 of 6; of the 8th Annual International C. diff. Post-Conference special series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics as in leading annual, collaborative events while focusing on Healthcare-associated infections (HAI), and the leading HAI -- Clostridioides difficile (Also known as C. diff., C. difficile, CDI, CDAD). We will hear from three leading topic-experts: Mark Wilcox, MD, FRCPath, DNA Fingerprinting to Understand C. difficile Transmission in Hospitals. Caterina Oneto, MD, Patient Support; In-Person, and Through the Global TeleSupport Network. Sahil Khanna, MBBS, MD, Microbiome Restoration; Getting One Step Closer Every Day! Many of the presentation Slides are available until January 14th, 2021 on www.cdiff2020.com We hope you enjoy the presentations from the leading speakers of the 8th Annual Int'l C. diff. Conference & Health EXPO. This audio broadcast is sponsored by Summit Therapeutics

Welcome to Episode 3 of 6; of the 8th Annual Int'l C. diff. Post-Conference special series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics as in leading annual, collaborative events while focusing on Healthcare-associated infections (HAI), and the leading HAI -- Clostridioides difficile (Also known as C. diff., C. difficile, CDI, CDAD) with interconnected topics. In this episode, we will hear from three leading topic-experts: Teena Chopra, MD, Introduction to Infection Prevention. David Lyerly, Ph. D., Clostridioides difficile Infection; An Inflammatory Intestinal Disease. Dale Gerding, MD, FACP, FIDSA, Non-toxigenic C. difficile Is Back,. Presentation Slides are available until January 14th, 2021 on www.cdiff2020.com We hope you enjoy the presentations from the leading topic-experts ,key note speakers of the 8th Annual Int'l C. diff. Conference & Health EXPO. This audio broadcast is sponsored by Summit Therapeutics www.summitplc.com

Welcome to Episode 3 of 6; of the 8th Annual Int'l C. diff. Post-Conference special series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics as in leading annual, collaborative events while focusing on Healthcare-associated infections (HAI), and the leading HAI -- Clostridioides difficile (Also known as C. diff., C. difficile, CDI, CDAD) with interconnected topics. In this episode, we will hear from three leading topic-experts: Teena Chopra, MD, Introduction to Infection Prevention. David Lyerly, Ph. D., Clostridioides difficile Infection; An Inflammatory Intestinal Disease. Dale Gerding, MD, FACP, FIDSA, Non-toxigenic C. difficile Is Back,. Presentation Slides are available until January 14th, 2021 on www.cdiff2020.com We hope you enjoy the presentations from the leading topic-experts ,key note speakers of the 8th Annual Int'l C. diff. Conference & Health EXPO. This audio broadcast is sponsored by Summit Therapeutics www.summitplc.com

Welcome to Episode 2 of 6; of the 8th Annual Int'l C. diff. Post-Conference Special series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics as in leading annual, collaborative events while focusing on Healthcare-associated infections (HAI), and the leading HAI -- Clostridioides difficile (Also known as C. diff., C. difficile, CDI, CDAD) with interconnected topics. In this episode, we will hear from two leading topic-experts and one C. diff. Survivor: Dayle Skelly, C. diff. Survivor A Patient's Journey. Dr. L. Clifford McDonald, MD: Update from the Center for Disease Control and Prevention. Dr. Erik Dubberke, MD, MSPH: Optimizing Prevention of Hospital-Onset Clostridioides difficile. Presentation Slides are available until January 14th, 2021 on www.cdiff2020.com We hope you enjoy the presentations from the 8th Annual Int'l C. diff. Conference & Health EXPO. This audio broadcast is sponsored by Summit Therapeutics www.summitplc.com

Welcome to Episode 2 of 6; of the 8th Annual Int'l C. diff. Post-Conference Special series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics as in leading annual, collaborative events while focusing on Healthcare-associated infections (HAI), and the leading HAI -- Clostridioides difficile (Also known as C. diff., C. difficile, CDI, CDAD) with interconnected topics. In this episode, we will hear from two leading topic-experts and one C. diff. Survivor: Dayle Skelly, C. diff. Survivor A Patient's Journey. Dr. L. Clifford McDonald, MD: Update from the Center for Disease Control and Prevention. Dr. Erik Dubberke, MD, MSPH: Optimizing Prevention of Hospital-Onset Clostridioides difficile. Presentation Slides are available until January 14th, 2021 on www.cdiff2020.com We hope you enjoy the presentations from the 8th Annual Int'l C. diff. Conference & Health EXPO. This audio broadcast is sponsored by Summit Therapeutics www.summitplc.com

Welcome to Episode 1 of 6; 8th Annual Int'l C. diff. Post-Conference Special Series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics as in leading annual, collaborative event possessed while focusing on Healthcare-associated infections (HAI), and a leading HAI -- Clostridioides difficile (Also known as C. diff., C. difficile, CDI, CDAD) with interconnected topics. In this episode, we will hear from two leading topic-expert, and one C. diff. Survivor: Dr. Paul Feuerstadt C. difficile Infection; Foundation For the Conference. Mrs. Courtney Jones, Developing Next-Generation Microbioe-Based Therapeutics. and Alba Muhlfield, C. diff. Survivor ~ A Patient's Journey. Presentation Slides are available until January 14th, 2021 on www.cdiff2020.com We hope you enjoy the presentations from the 8th Annual International C. diff. Conference & Health EXPO. This audio broadcast is sponsored by Summit Therapeutics www.summitplc.com

Welcome to Episode 1 of 6; 8th Annual Int'l C. diff. Post-Conference Special Series Sponsored by Summit Therapeutics. This year's Live Online Conference had robust dynamics as in leading annual, collaborative event possessed while focusing on Healthcare-associated infections (HAI), and a leading HAI -- Clostridioides difficile (Also known as C. diff., C. difficile, CDI, CDAD) with interconnected topics. In this episode, we will hear from two leading topic-expert, and one C. diff. Survivor: Dr. Paul Feuerstadt C. difficile Infection; Foundation For the Conference. Mrs. Courtney Jones, Developing Next-Generation Microbioe-Based Therapeutics. and Alba Muhlfield, C. diff. Survivor ~ A Patient's Journey. Presentation Slides are available until January 14th, 2021 on www.cdiff2020.com We hope you enjoy the presentations from the 8th Annual International C. diff. Conference & Health EXPO. This audio broadcast is sponsored by Summit Therapeutics www.summitplc.com

Join Us With Guest Dr. Richard Vickers, Ph.D., Chief Scientific Officer at Summit Therapeutics joining us to discuss their research on a new antibiotic to treat a C. difficile infection. Learn more about Ridinilazole, clinical trials and the progress being made and moving closer to getting an urgently needed new treatment available for CDI to patients.

Join Us With Guest Dr. Richard Vickers, Ph.D., Chief Scientific Officer at Summit Therapeutics joining us to discuss their research on a new antibiotic to treat a C. difficile infection. Learn more about Ridinilazole, clinical trials and the progress being made and moving closer to getting an urgently needed new treatment available for CDI to patients.

Duchenne Muscular Dystrophy, a rare genetic disease, causes progressive muscle wasting that slowly robs people of abilities and leads to death. In recent years, much attention has focused on the use of antisense oligonucleotides to bypass defective portions of the exon that codes for the dystrophin gene to restore its production. Dystrophin is a protein that is essential to healthy muscle. Summit Therapeutics is taking a different approach. Instead of restoring dystrophin, Summit is developing a drug that activate utrophin, a related protein that serves a similar function to dystrophin during fetal development, but then shuts off. We spoke to Glyn Edwards, CEO of Summit, about the company’s utrophin activator ezutromid, its licensing deal with Sarepta Therapeutics, and why, unlike the exon-skipping drugs that target specific subpopulaitons of Duchenne patients, ezutromid could provide benefits to patients broadly.

Summit Therapeutics is a small-cap biotech company with two drugs in clinical trials at either end of the new drugs space: a low risk, lower reward antibiotic and a high risk, higher reward Duchenne Muscular Dystrophy cure. Does this make it an ideal biotech investment? Megan Boxall investigates. See acast.com/privacy for privacy and opt-out information.

1) Glucocorticoid-associated worsening in reversible cerebral vasoconstriction syndrome2) What's Trending: Upcoming changes regarding the Neurology® Resident & Fellow section 3) Topic of the Month: Neuromuscular topicsThis podcast begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the January 17, 2017 issue of Neurology. In the first segment, Dr. Andy Southerland talks with Dr. Aneesh Singhal about his paper on glucocorticoid-associated worsening of reversible cerebral vasoconstriction syndrome. Dr. Ted Burns talks with Dr. Roy Strowd about upcoming changes regarding the Neurology Resident & Fellow section for our “What's Trending” feature of the week. In the next part of the podcast, Dr. Ted Burns focuses his interview with Dr. Volker Straub on limb-girdle dystrophy. Disclosures can be found at Neurology.org.DISCLOSURES: Dr. Southerland serves as Podcast Deputy Editor for Neurology; receives research support from the American Heart Association-American Stroke Association National Clinical Research Program, American Academy of Neurology, American Board of Psychiatry and Neurology, Health Resources Services Administration and the NIH; has a provisional patent application titled: “Method, system and computer readable medium for improving treatment times for rapid evaluation of acute stroke via mobile telemedicine;” and gave legal expert review. Dr. Aneesh Singhal has served on the scientific advisory boards of Biogen and DSMB; has served on the editorial board of Medical Gas Research; has received publishing royalties for the book Reversible Cerebral Vasoconstriction Syndromes; has been a consultant to Biogen; has acted as an event adjudicator for the Thrombolysis in Myocardial Infarction (TIMI) Trial Group; has received research support from Boehringer Ingelheim, NIH-NINDS, the American Academy of Neurology, UpToDate, and Medlink; and has served as a medicolegal expert witness for individual cases concerning stroke. Dr. Burns serves as Podcast Editor for Neurology®; and has received research support for consulting activities with UCB, CSL Behring, Walgreens and Alexion Pharmaceuticals, Inc. Dr. Strowd serves on the editorial team for the Neurology® Resident and Fellow Section. Dr. Straub has served on the scientific advisory boards for Pfizer, Italfarmaco, Audentes Therapeutics, Bristol-Myer Squibb, Summit Therapeutics, Tivorsan, and the Nationwide Children's Hospital; has received travel funding and speaker honoraria from Sanofi Genzyme; has served on the editorial boards of Neuromuscular Disorders, the Journal of Neuromuscular Diseases, and PLoS Currents Muscular Dystrophy; has been a consultant for Sanofi Genzyme; and has received research support from Sanofi Genzyme, BioMarin, Ionis Pharmaceuticals, Sarepta Therapeutics, Ultragenyx, the European Commission, the UK Medical Research Council, Newcastle University, the Parent Project Muscular Dystrophy, the Association Fracaise Contre les Myopathies, the LGMD2I Research Fund, the Wellcome Trust, the Sylvia Aitken Charitable Trust, Muscular Dystrophy UK, and Action Medical Research.All other participants have no disclosures.

Today in FirstWord:

Join us as we discuss a promising and new treatment for a C. difficile infection. Summit Therapeutic's Ridinilazole, a microbiome preserving antibiotic will be introduced with updates by our two guests Dr. Kevin W. Garey, Chair, Department of Pharmacy Practice and Translational Research, Professor of Pharmacy Practice at the University of Houston College of Pharmacy, Houston, Texas and Dr. Richard Vickers, Chief Scientific Officer at Summit Therapeutics..

Join us as we discuss a promising and new treatment for a C. difficile infection. Summit Therapeutic's Ridinilazole, a microbiome preserving antibiotic will be introduced with updates by our two guests Dr. Kevin W. Garey, Chair, Department of Pharmacy Practice and Translational Research, Professor of Pharmacy Practice at the University of Houston College of Pharmacy, Houston, Texas and Dr. Richard Vickers, Chief Scientific Officer at Summit Therapeutics..