Podcasts about shionogi

Join us for this two-episode mini-series featuring lead study authors, Mario Castro and Njira Lugogo, as they discuss key findings from the VESTIGE trial and their implications on asthma care.  Uncover: ·      The importance of patient phenotyping: How can biomarkers and imaging improve asthma management? ·      Mucus plugging and airflow obstruction: What does the latest research reveal? ·      Biologics and airway remodeling: What did the VESTIGE trial reveal about biologics and airway remodeling? ·      The role of imaging in clinical practice: How can CT scans provide new insights into asthma care? Speakers Mario Castro, University of Kansas School of Medicine, United States Njira Lugogo, University of Michigan, Ann Arbor, Michigan, United States Disclaimers: ·      This program is non-promotional and is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ·      The speakers are being compensated and/or receiving an honorarium from Sanofi and Regeneron in connection with this program ·      The content contained in this program was jointly developed by AMJ, the speakers, and Sanofi and Regeneron, and is not eligible for continuing medical education (CME) credits ·      See full US Prescribing Information for dupilumab ·      MAT-US-2412937 v2.0 - Pro1 Expiration Date: 04/21/2026 Speaker disclosures: ·      MC reports research support from the American Lung Association, AstraZeneca, Gala Therapeutics, Genentech, GSK, NIH, Novartis, PCORI, Pulmatrix, sanofi-aventis, Shionogi, and Theravance Biopharma, consultancy fees from Allakos, Amgen, Arrowhead Pharmaceuticals, Blueprint Medicines, Connect BioPharma, Genentech, GSK, Merck, Novartis, OM Pharma, Pfizer, Pioneering Medicines, sanofi-aventis, Teva, Third Rock Ventures, and Verona Pharmaceuticals, speaker fees from Amgen, AstraZeneca, Regeneron Pharmaceuticals Inc., and Sanofi, and royalties from Aer Therapeutics. ·      NLL reports research support paid to institution from Amgen, AstraZeneca, Avillion, Genentech, Gossamer Bio, GSK, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, consultancy fees from and participation on advisory boards with Amgen, AstraZeneca, Genentech, GSK, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, travel support from AstraZeneca, and honoraria for non-speaker bureau presentations from AstraZeneca and GSK. References: 1.        Castro M et al. Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging in patients with type 2 asthma (VESTIGE): a randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2025;13:208-20. doi: 10.1016/S2213-2600(24)00362-X.

Join us for this two-episode mini-series featuring lead study authors, Mario Castro and Njira Lugogo, as they discuss key findings from the VESTIGE trial and their implications on asthma care.  Uncover: ·      The importance of patient phenotyping: How can biomarkers and imaging improve asthma management? ·      Mucus plugging and airflow obstruction: What does the latest research reveal? ·      Biologics and airway remodeling: What did the VESTIGE trial reveal about biologics and airway remodeling? ·      The role of imaging in clinical practice: How can CT scans provide new insights into asthma care? Speakers Mario Castro, University of Kansas School of Medicine, United States Njira Lugogo, University of Michigan, Ann Arbor, Michigan, United States Disclaimers: ·      This program is non-promotional and is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ·      The speakers are being compensated and/or receiving an honorarium from Sanofi and Regeneron in connection with this program ·      The content contained in this program was jointly developed by AMJ, the speakers, and Sanofi and Regeneron, and is not eligible for continuing medical education (CME) credits ·      See full US Prescribing Information for dupilumab ·      MAT-US-2412937 v2.0 - Pro1 Expiration Date: 04/21/2026 Speaker disclosures: ·      MC reports research support from the American Lung Association, AstraZeneca, Gala Therapeutics, Genentech, GSK, NIH, Novartis, PCORI, Pulmatrix, sanofi-aventis, Shionogi, and Theravance Biopharma, consultancy fees from Allakos, Amgen, Arrowhead Pharmaceuticals, Blueprint Medicines, Connect BioPharma, Genentech, GSK, Merck, Novartis, OM Pharma, Pfizer, Pioneering Medicines, sanofi-aventis, Teva, Third Rock Ventures, and Verona Pharmaceuticals, speaker fees from Amgen, AstraZeneca, Regeneron Pharmaceuticals Inc., and Sanofi, and royalties from Aer Therapeutics. ·      NLL reports research support paid to institution from Amgen, AstraZeneca, Avillion, Genentech, Gossamer Bio, GSK, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, consultancy fees from and participation on advisory boards with Amgen, AstraZeneca, Genentech, GSK, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, travel support from AstraZeneca, and honoraria for non-speaker bureau presentations from AstraZeneca and GSK. References: 1.        Castro M et al. Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging in patients with type 2 asthma (VESTIGE): a randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2025;13:208-20. doi: 10.1016/S2213-2600(24)00362-X.

Japanese drugmaker Shionogi & Co. said Wednesday that it will acquire Torii Pharmaceutical Co., a unit of Japan Tobacco Inc., for about 160 billion yen.

Drs. Amy Mathers and Julie Ann Justo join Dr. Erin McCreary to talk all things Stenotrophomonas maltophilia, a water-loving organism and frequent colonizer. Hear from the experts on why this organism is so difficult to treat, which agents have in vitro activity, and how to optimize antimicrobial regimens, including the use of combination therapy, in the setting of true infections. This medical education was provided by an unrestricted grant from Shionogi. References: Infectious Diseases Society of America 2024 Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections. Clin Infect Dis. 2024 Aug 7:ciae403. doi: 10.1093/cid/ciae403. PMID: 39108079. Clinical challenges treating Stenotrophomonas maltophilia infections: an update. JAC Antimicrob Resist. 2022 May 5;4(3):dlac040. doi: 10.1093/jacamr/dlac040. PMID: 35529051. Alterations of the Oral Microbiome and Cumulative Carbapenem Exposure Are Associated With Stenotrophomonas maltophilia Infection in Patients With Acute Myeloid Leukemia Receiving Chemotherapy. Clin Infect Dis. 2021 May 4;72(9):1507-1513. doi: 10.1093/cid/ciaa778. PMID: 32544947. An Overview of the Treatment of Less Common Non–Lactose-Fermenting Gram-Negative Bacteria. Pharmacotherapy. 2020 Sep;40(9):936-951. doi: 10.1002/phar.2447. PMID: 32687670.

Join Dr. Mario Castro and Prof. Vibeke Backer as they discuss airway remodeling and airway hyperresponsiveness and their impact in the lives of patients with severe asthma. ADVENT is a medical education non-promotional resource for healthcare professionals organized by Sanofi and Regeneron. Learn more at ADVENTprogram.com.   This podcast is intended for healthcare professionals only.   Disclaimer: This program is non-promotional and is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. The speakers are being compensated and/or receiving an honorarium from Sanofi and Regeneron in connection with this program. The content contained in this program was jointly developed by the speakers and Sanofi and Regeneron and is not eligible for continuing medical education (CME) credits. Speaker disclosures: Mario Castro, MD, MPH, reports grants and research support from NIH, ALA, PCORI, AstraZeneca, Gala Therapeutics, Genentech, GSK, Novartis, Pulmatrix, Sanofi-Aventis, Shionogi, and Theravance. He receives consulting fees from Genentech, Teva, Sanofi-Aventis, Merck, Novartis, Arrowhead Pharmaceuticals, Allakos, Amgen, OM Pharma, Pfizer, Pioneering Medicines, and GSK. He receives payment for speaker bureau activities from Amgen, AstraZeneca, Genentech, Regeneron, Sanofi-Aventis, and Teva. He also receives stock options from Aer Therapeutics. Vibeke Backer, MD, has worked as an advisor, supervisor, and investigator of pharmaceutical studies and has received unrestricted grants from AstraZeneca, GSK, MSD & Schering Plough, ALK-Abelló, Nycomed, Chiesi, Novartis, Pharmaxis, Nigaard, Pfizer, Boehringer Ingelheim, Maribo Medico, Aerocrine, Teva, Sanofi, Regeneron, and BIRK NPC. © 2024 Sanofi and Regeneron Pharmaceuticals, Inc. All Rights Reserved. MAT-GLB-2401489 – 1.0 – 10/2024 MAT-US-2410093 v1.0 – P Expiration Date: 10/09/2026

In this episode of Life Science Success, we welcome Ani Sinha, the Vice President of Commercial Operations at Shionogi Inc. Ani brings nearly 15 years of deep commercial expertise in the pharmaceutical and biotech industries. She shares her inspiring journey from studying microbiology and biochemistry at Yale and Columbia to holding strategic leadership roles at companies like Pfizer, Bayer, and Celgene. We delve into her current role at Shionogi, exploring how she leads functions like Analytics and Insights, Market Research, and Field Operations. Ani discusses the innovative projects she's excited about and how they're contributing to Shionogi's mission. She also shares the greatest piece of leadership advice she's ever received and opens up about what inspires, concerns, and excites her in the world of life sciences. Tune in to gain valuable career insights and explore the dynamic future of pharmaceutical advancements.   00:00 Introduction to Life Science Success Podcast 00:42 Sponsor Message: D3 Digital Media Marketing 01:25 Interview with Ani Sinha Begins 02:08 Ani Sinha's Career Journey 05:18 Transition from Lab to Consulting 07:58 Skills Gained from Management Consulting 11:25 Joining Shinogi and Role in Commercial Operations 20:13 Future of Commercial Operations 22:21 Building a Team: The Land of Misfit Toys 23:02 Navigating Different Companies and Roles 24:05 The Evolving Role of Analytics and Insights 25:41 Challenges in Market Research and Operations 29:32 Addressing Trends in Biotech and Pharma 32:13 Greatest Leadership Advice Received 34:44 Inspiration and Concerns in the Pharma Industry 40:52 Final Thoughts and Farewell

MILANO (ITALPRESS) - Vent'anni di studi scientifici dimostrano l'efficacia, l'innocuità e la sicurezza degli estratti di polline e pistillo: un tipo di fitoterapia contro i sintomi della menopausa. SI tratta della fitosostanza che in assoluto ha un maggior numero di studi internazionali nell'arco di vent'anni. A parlarne in questo video dell'Italpress è la ginecologa e oncologa Alessandra Graziottin.abr/mrv/gsl

MILANO (ITALPRESS) - Nel quarantesimo numero di Focus Salute, format tv dell'agenzia Italpress, la ginecologa e oncologa Alessandra Graziottin parla della fitoterapia con estratti di polline e pistillo. sat/gsl

On this week's Biotech Hangout, hosts Chris Garabedian, Josh Schimmer, Brad Loncar, Eric Schmidt and Tim Opler kick off the episode with a spotlight on women's health, which was sparked by Bayer's Phase 3 data readouts for menopause symptoms. The group also cover Incyte's $2B share repurchase which leads into a discussion on stock buybacks and the ‘broken' R&D model. The group also recaps ASGCT 2024 and new gene editing technologies. In deals of the week, the hosts discuss deals and financings from the week, including Takeda and AC Immune's $100M license agreement, Uniquity Bio's $300M launch and J&J;s $850M purchase of Proteologix. In other data news, hosts discuss Merck's TIGIT/PD-1 Phase 2 safety concerns, Ionis/Biogen discontinue ALS treatment, COVID-19 data from Shionogi and AstraZeneca, and a look at obesity ‘limited data' versus Vertex's data transparency. Other topics include Bolt Therapeutics discontinuing its oncology asset, Dynavax denied expanded use by FDA, Recursion's stock surges with fastest supercomputer claim, and short selling and meme stocks in biotech. *This episode aired on May 17, 2024.

On this week's Biotech Hangout, hosts Eric Schmidt, Daphne Zohar, Josh Schimmer and Paul Matteis kick off the show with a look at M&A in the sector and debate whether we're in a “good market” for biotech, if the sector is overly dependent on M&A as an investment thesis and the therapeutic areas that are most attractive for M&A. The hosts also discuss “hot” targeted oncology modalities including radiopharm, ADCs and bispecifics, and predict which of these technologies will likely continue to benefit from M&A interest. Following earnings this week, the hosts cover Janux Therapeutics' stock price dropping 11.5% while CytomX stock moves +120% to -40% in a matter of minutes. Acelyrin's founder stepped down as CEO, which opens up a discussion amongst the hosts on how disruptive change at the top can be for an organization and when investors should and shouldn't care about CEO transitions. The group also discusses Bluebird and Vertex prepping for the first commercial use of sickle cell gene therapies. The episode wraps up with a review of other news from the week including Maze's deal with Shionogi for Pompe disease, Walking Fish shuts down, Denali's regulatory update, and FDA sets June date for Eli Lilly's Alzheimer's drug donanemab adcomm. *This episode aired on May 10, 2024.

Lawmakers' changes to the Biosecure Act create breathing room for U.S. biopharma companies to move on from Chinese CDMOs, Washington Editor Steve Usdin said. On the latest BioCentury This Week podcast, Usdin and his BioCentury colleagues discuss what the revisions mean for biotechs and what's next for the legislation, plus how WuXi AppTec is defending itself against the bill's allegations. Director of Biopharma Intelligence Paul Bonanos discusses last week's surge in venture activity, including the largest biotech round, a $200 million series C by Lonnie Moulder's Zenas BioPharma, as well as recent deals of note, including one for Maze Therapeutics. The biotech found a new partner for its Pompe disease program in Shionogi, months after Sanofi pulled out of a deal for the therapy amid FTC scrutiny. This week's podcast is sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/65240200:01 - Sponsor Message: Nxera Pharma03:24 - Biosecure Revisions09:34 - WuXi AppTec Responds14:42 - Venture Raises19:32 - Deals of Note

On this week's Biotech Hangout, hosts Daphne Zohar, Josh Schimmer, Eric Schmidt, Bruce Booth, Brian Skorney and Prakhar Agrawal discuss the latest biotech news, including the recent sector melt-up and what is driving the latest rally. When discussing the week's financing news, the hosts share different vantage points on wall-crossed PIPEs and the impact on stock performances. The group also discussed Viking Therapeutics soaring stock price on the heels of robust data for VK2735, its experimental weight loss drug. Other positive data discussed was from Akili and Shionogi announcing EndeavorRx met its primary endpoint and Shionogi has filed for approval with regulators in Japan, leading to a deeper discussion on digital therapeutics and issues around reimbursement. Additional topics covered include Chinese CROs back in the crosshairs and the implications for the sector, accelerated approvals for gene therapy and whether the FDA is getting too lenient on approvals, and a discussion on leadership in biotech. *This episode aired on March 1, 2024.

Dr. Sam Lee, Co-CEO of Cocrystal Pharma, discusses novel antiviral therapeutics to treat norovirus. This highly contagious virus causes acute gastroenteritis, and there is no known treatment or vaccine.  Cocrystal is developing a compound that targets the essential enzymes of the virus, showing promising results in inhibiting norovirus replication and showing possible use in treating human rhinovirus and enterovirus. The goal is to develop a protease inhibitor therapeutic for norovirus that can alleviate symptoms and potentially prevent infection spread in high-risk environments. Sam explains, "Let me step back and tell you how we approach the noro antiviral drug development. So, we're focusing on what we call direct-acting antiviral therapeutics. We're targeting viral essential enzymes, and we initiated this noro program looking at the essential genes such as RNA-dependent RNA polymerase. We have really exciting hits, but we also look at the protease. Norovirus has this essential protease, which is absolutely required for viral replication."   "During the COVID time, we focused on coronavirus protease and developed the coronavirus protease inhibitors for COVID. But at the same time, we have this drug discovery platform technology that looks at various viral proteases, including norovirus, human rhinovirus, and enterovirus. The list goes on, and we recognize that computational analysis now is the people who use artificial intelligence." "But we had a pretty good prediction that norovirus would be actually a good target, that our coronavirus inhibitors should innovate the norovirus protease. That's how we started. Then, from there, we quickly applied our platform approach and demonstrated that, in fact, our coronavirus protease inhibitors for COVID treatment actually work well against the norovirus. I just want to point out that we also evaluated the approved drugs such as Pfizer, coronavirus protease inhibitors, and Shionogi protease inhibitors. Those compounds do not have any activity against norovirus. This is where we could differentiate compounds from existing protease inhibitors. So we're very excited about this." #CocrystalPharma #Norovirus #RNAVirus #SuperVirus #Coronavirus  #HumanRhinovirus cocrystalpharma.com Download the transcript here

Dr. Sam Lee, Co-CEO of Cocrystal Pharma, discusses novel antiviral therapeutics to treat norovirus. This highly contagious virus causes acute gastroenteritis, and there is no known treatment or vaccine.  Cocrystal is developing a compound that targets the essential enzymes of the virus, showing promising results in inhibiting norovirus replication and showing possible use in treating human rhinovirus and enterovirus. The goal is to develop a protease inhibitor therapeutic for norovirus that can alleviate symptoms and potentially prevent infection spread in high-risk environments. Sam explains, "Let me step back and tell you how we approach the noro antiviral drug development. So, we're focusing on what we call direct-acting antiviral therapeutics. We're targeting viral essential enzymes, and we initiated this noro program looking at the essential genes such as RNA-dependent RNA polymerase. We have really exciting hits, but we also look at the protease. Norovirus has this essential protease, which is absolutely required for viral replication."   "During the COVID time, we focused on coronavirus protease and developed the coronavirus protease inhibitors for COVID. But at the same time, we have this drug discovery platform technology that looks at various viral proteases, including norovirus, human rhinovirus, and enterovirus. The list goes on, and we recognize that computational analysis now is the people who use artificial intelligence." "But we had a pretty good prediction that norovirus would be actually a good target, that our coronavirus inhibitors should innovate the norovirus protease. That's how we started. Then, from there, we quickly applied our platform approach and demonstrated that, in fact, our coronavirus protease inhibitors for COVID treatment actually work well against the norovirus. I just want to point out that we also evaluated the approved drugs such as Pfizer, coronavirus protease inhibitors, and Shionogi protease inhibitors. Those compounds do not have any activity against norovirus. This is where we could differentiate compounds from existing protease inhibitors. So we're very excited about this." #CocrystalPharma #Norovirus #RNAVirus #SuperVirus #Coronavirus  #HumanRhinovirus cocrystalpharma.com Listen to the podcast here

Jon Denny has been a National Executive Sales and Marketing Recruiter for over 24 years in the Pharmaceutical, Biotech, Medical Devices, and Medical Diagnostics Industries with leading national recruitment firm, Buckman Enochs Coss & Associates (BEC Search). Established in 1979, BEC Search specializes in helping the best Healthcare and Life Science companies find the best people for every level of their organization, Commercial, Med Affairs, Sales, and Marketing Executives - for Projects and Retained. They have partnered with leading companies such as Allergan/Abbvie, Biodesix, Amgen, Apellis, Cardinal Health, Dompe, Genentech, Lantheus, Shionogi, Inc., Supernus Pharmaceuticals, Takeda, Travere Therapeutics, Vertos Medical, and many others.  Before joining BEC, Jon spent over two years in Accounting and Finance Recruitment for a leading staffing firm and 4 years in College/University Recruitment.  In the last two decades, Jon has helped countless individuals in healthcare sales, marketing, and clinical roles find employment opportunities that have been life-changing and he has several current clients he helped early on in their careers. Jon attributes his transformative approach to a unique blend of business acumen, strong work ethic, empathy, and ability to connect with individuals. These traits find their roots in his competitive collegiate athletic background, where he played football for four years at his alma mater, Ohio Northern University. What you'll learn in this episode: The importance of human connection in leadership and recruiting The crucial role of preparation in the recruiting process, for both the candidate and recruiter Reasons why people leave their jobs and how they often relate to issues with management or a lack of development opportunities The impact of a transformational approach in recruitment for greater success How understanding a candidate's story and motivation reveals insights into their suitability The necessity of understanding a candidate's purpose and its connection to career aspirations The high value placed on intangible qualities such as character, integrity, and work ethic in potential hires Additional Resources:  Jon's LinkedIn Jon's Twitter/X  About BEC Search's Website: www.becsearch.com LinkedIn Facebook Instagram Twitter/X Listen to Episode 86 with Jon Denny

A new, real-world evidence study of patients with Gram-negative infections showed that early intervention with Fetroja® (cefiderocol) significantly reduced in-hospital all-cause mortality. This real-world evidence, drawn from a retrospective analysis of 275 seriously ill patients, emphasizes the critical importance of timely treatment.    The retrospective multicenter observational study showed earlier treatment resulted in a reduction in in-hospital all-cause mortality (IHACM) in patients with Gram-negative infections who previously received other antibiotics, including those with difficult-to-treat pathogens that were resistant to other antibiotics.   Here is a link to the press release with a summary of the results presented by Shionogi at ID Week in October.   We interview Thomas Lodise, PharmD, PhD, Associate Professor, Albany College of Pharmacy and Health Sciences, to delve deeper into these results. Dr. Lodise discusses the implications of this study for hospital pharmacists as it sheds light on the potential clinical utility of Fetroja in the treatment of difficult-to-treat adult patients with culture-confirmed Gram-negative infections. Time-to-Treat Proves to be Vital in Severely Ill Patients With Gram-Negative Infections https://urldefense.com/v3/__https:/www.contagionlive.com/view/time-to-treat-proves-to-be-vital-in-severely-ill-patients-with-gram-negative-infections__;!!DlCMXiNAtWOc!xSJ9qL-jtnTrARykD5XxP6jzP-M_Tt38Tki6NjQCLr2AStUrVu6HBFK3hTU5Y32uJwR2_8AQu_cWgSu7Z6Oep2zcAqnNBtu4BA$ New boost

Matt and Suzanne Monahan have an incredible partnership. They are a remarkable couple, parents to two wonderful children, and forefront leaders in challenging industries such as pharmaceutical and healthcare consulting.  Suzanne is a former collegiate athlete and two-time cancer survivor. She is passionate about the power of mindset, teamwork, and performance. Currently, she holds a commercial leadership position at Shionogi Inc., a biopharmaceutical company that leverages a science-based heritage to develop and commercialize pharmaceutical products to treat unmet medical needs.  She dedicates her time at Shionogi to building and leading the sales team for the US. Suzanne is committed to “raising up” cohesive and resilient teams both at work and on the field.  She believes in family first and enjoys giving back, serving as a girl's lacrosse coach, an advocate for patient-focused cancer care, and a mentor to future leaders.  Matt joined Genesys Health as Chief Strategy Officer in 2020 after leading the way as the National Practice Leader of an Insurtech benefits consulting firm where he was responsible for sales, service, and insurance operations for over 500 employers across the United States.  To know Matt is to be in the presence of an infectious energy. Matt sees the world differently; where others see a dead end, he sees an opportunity to connect, perfect, and solve. Matt isn't afraid to ask hard questions and challenge the norm, taking pride in disrupting systems before building them back stronger and more successful. Prior to that, he spent 15+ years at Aetna and GE, where he held multiple senior leadership roles at Aetna. Matt worked closely to bring innovative solutions to the market. In a consulting business where service and support are incredibly subjective, regardless of the situation any action he takes is making sure it is the right thing for that person on the other end. What you'll learn in this episode: Strategies for balancing thriving careers while nurturing a thriving partnership, all while staying true to your values How to  turn challenges into opportunities and maintain a positive mindset, even in the face of adversity The crucial role of communication in balancing individual careers, partnerships and relationship-building Strategies for compartmentalizing and focusing on controllable factors The importance of continually reassessing choices for personal and professional growth Why leaders should focus on the well-being of the people they serve and lead How to address conflict including giving space for perspective and resolution. The value of caring for others, solving problems, and maintaining a positive mental state Additional Resources: Suzanne's LinkedIn Matt's LinkedIn Shionogi's LinkedIn Genesys Health's LinkedIn Shionogi's Website:  https://www.shionogi.com/us/en/ Genesys Health's Website: www.genesys.health 

    Drs. Diwakar Davar and Jason Luke discuss KEYNOTE-716, KEYNOTE-942, RELATIVITY-047, and other key advances in melanoma, including the promise of mRNA vaccines in melanoma and potentially other cancers, as well exciting advances in neoadjuvant therapies across malignancies featured at the 2023 ASCO Annual Meeting. TRANSCRIPT  Dr. Diwakar Davar: Hello, and welcome to the ASCO Daily News Podcast. I'm your guest host, Dr. Diwakar Davar. I'm an associate professor of medicine and the clinical director of the Melanoma and Skin Cancer Program at the University of Pittsburgh Hillman Cancer Center. I'm delighted to have my colleague and good friend Dr. Jason Luke on the podcast today to discuss some practice-changing studies and other advances in immunotherapy that were featured at the 2023 ASCO Annual Meeting. Dr. Luke is an associate professor of medicine, the director of the Cancer Immunotherapy Center, as well as the associate director of clinical research at the University of Pittsburgh's Hillman Cancer Center.     You can find both of our disclosures in the transcript of this episode, and disclosures of all guests on the ASCO Daily News Podcast are available on our transcripts at asco.org/DNpod.   Jason, there was a lot of exciting data in the immunotherapy space highlighted at the Annual Meeting, and it's great to have you back on the podcast to discuss some of this work.   Dr. Jason Luke: Thanks for having me.    Dr. Diwakar Davar: So, the abstracts that we had selected have several key themes. We'll be covering some of the early advances in melanoma in the stage 2 and stage 2B/C space with KEYNOTE-716. I think this is a study that you know a little bit about seeing you are the presenting author and the principal investigator for the study, as well as the pivotal KEYNOTE-942 trial. And then going on to themes with using third-generation checkpoints, neoadjuvant therapy in non-small-cell lung cancer, and cutaneous squamous cell carcinoma.    But we'll start with KEYNOTE-716. So, this is LBA9505, the study which evaluated pembrolizumab versus placebo as adjuvant therapy in stage 2B and stage 2C melanoma patient population for which historically there was no real effective therapy other than remotely interferon. And these are the final results of the DMFS analysis from this phase 3 trial. So, Jason, what are your thoughts about this, and can you contextualize the results relative to the recent publication?   Dr. Jason Luke: Thanks. I think the important point to level set on this was just a few years ago; this was a population of patients that we didn't treat in clinic. In fact, sometimes they weren't even referred to medical oncology for evaluation. And that was despite the fact that we knew from historical data that the risk of melanoma-specific survival, death from melanoma, was just as high for this population of patients as it was for the patients with stage 3 melanoma, where obviously adjuvant immunotherapy has been a standard for quite some time. And so we launched this clinical trial, KEYNOTE-716. It was a global, randomized phase 3 study of almost 1,000 patients, randomizing patients to either get pembrolizumab or placebo. Importantly, these patients being those with deep primary lesions, stage 2B and 2C with negative sentinel lymph node evaluation.    People will recall that this study hit its primary endpoint on the first protocol-specified analysis at a year. And what we updated at ASCO this year was the final analysis of distant metastasis-free survival. Obviously, an important secondary endpoint because if patients eventually going to develop metastatic disease and pass away, it's the distant metastasis that we worry about. And what we saw in this trial with a landmark 36-month follow-up median of 39 months was that the benefit was increasing. In other words, the magnitude of the hazard ratio change was increasing over time as would be expected, such that at this analysis there was a 41% reduction in the risk of distant metastasis for patients treated with pembrolizumab versus placebo. And we saw a consistent benefit in the recurrence-free survival also out through that same period of time and importantly no change in the safety summary with of course the adverse event profile of pembrolizumab being what it is and well understood across oncology.    So I think these are very important data because they really kind of set the stage for the field. It is now the case that at least discussing adjuvant therapy for patients with stage 2B and 2C is the standard of care; it should be offered to all the patients. Of course, it's always a risk-benefit about whether or not patients want to pursue adjuvant therapy versus consideration of treatment at the time of recurrence. But in my clinic at least, many patients do prefer to try to eliminate the possibility of recurrence and distant metastasis as much as possible.    So I think these are very important data because they really level set the field for what to expect in this population of patients and then they also start to set the table for what's going to come after this. And that's going to be sort of the next step in our conversation here because the next generation of adjuvant studies in melanoma are now going to think about all of melanoma in the adjuvant setting as really one entity, starting from stage 2B going all the way through stage 4 resected. And that'll be relevant actually as we talk about the next abstract that will come in this discussion.   Dr. Diwakar Davar: Just to underscore, positive RFS data, positive DMFS data, and now this therapy has currently got regulatory approval in this investigation and is approved in the United States and certainly in Europe and Australia. One interesting point that we will probably have to contend with, and some of the listeners may be thinking about, is overall survival. So the last adjuvant study that demonstrated overall survival benefit was actually ipilimumab, and increasingly, the Illuminati in melanoma do not believe that we will ever see OS benefit in this disease going forward, even though it has to be an endpoint in all registration phase 3 trials. So, Jason, what are your thoughts about whether or not we'll have a positive OS readout, and even if we don't, why this is still a very important advance in this disease at this time?   Dr. Jason Luke: Your points are well taken. I think it's unclear, probably trending towards unlikely, that we would see an overall survival advantage in this trial given that we have not seen that in the stage 3 adjuvant studies. Now people can debate if, whether or not overall survival is the only meaningful endpoint for patients. I personally do not believe that's true. And to me, preventing recurrence has a value in and of itself, whether or not that's connected to overall survival. And part of the reason that I say that is that for an average patient, the median patient on a trial, of course, we can tell them treatment now, treatment later. It's a wash when you look at the overall study. And yet at the same time, for an individual person who's facing melanoma or cancer, generally they're not going to be the average patient; they're going to be one patient. And it's very possible they could end up with the type of recurrence that in fact is not highly treatable at that time.     So I think that's really the nuance that goes into those adjuvant discussions. The regulatory endpoints have been recurrence in melanoma for a long time. And I think it's important that patients understand the pros and the cons of each. The complexity in adjuvant therapy and neoadjuvant therapy is you don't necessarily know that you had to have it. You're only really going to know whether or not it didn't work if you recur later on. But to me and in my clinic, most patients are willing and interested to want to pursue those therapies in the perioperative setting to try to reduce the possibility of ever developing metastatic disease.    Dr. Diwakar Davar: Excellent. So I think key advance [is] positive DMFS data to add to the earlier reported RFS data and truly practice-changing.     So, moving on to the next study, LBA9503. This is the phase 2 trial of the Moderna vaccine. This is the trial that almost every medical oncologist knows intimately or has been called about by either the press or patients. So what is this study? This essentially is a phase 2 trial evaluating the personalized cancer vaccine PCV Moderna, made by Moderna, the mRNA vaccine, that is being studied in combination with anti-PD-1 pembrolizumab in the stage 3 BCD and stage 4 resected setting. And so there are really two very interesting results here because this is an update of the RFS data that was presented at AACR earlier this year, which was positive. What are your takes on the DMFS results, and maybe a quick blurb on how is this vaccine generated for those who may not be aware of this particular platform?    Dr. Jason Luke: Yeah, certainly. So this individualized neo-antigen therapy, as we're now calling it, is a technology platform that allows us to develop an individualized treatment for each patient based on their own cancer. So taking the actual tumor specimen, whole exome sequencing is performed to try to identify changes in the DNA, and then through a reasonably complex bioinformatic pipeline, those mutations that are likely to generate proteins that can be bound within class 1 MHC molecules are then identified in the computer and then synthesized with an mRNA, very similar to the way that the COVID vaccines were made. And then that becomes the actual drug.    So in the clinical trial, which was KEYNOTE-942, about 160 patients were randomized 2 to 1 to receive either pembrolizumab for a year as per standard adjuvant therapy but then with the addition of the individualized neoantigen therapy starting with dose 3 and throughout the rest of the year versus the control arm of pembrolizumab as the standard of care. As you mentioned, the recurrence-free survival were highly positive in this trial when it was first presented earlier this year, and at the updated ASCO we see the 18-month RFS in which the hazard ratio continues to be maintained. But I think most impressively is that distant metastasis-free survival, where we saw an even greater advantage for distant metastasis-free survival – hazard ratio here being 0.35. And so that's a huge advantage for distant metastasis-free survival in this population of patients.     And very interestingly in the clinical trial, when you follow the Kaplan-Meier plots, what you see over time is that they overlap almost the entire first year. And it's really at about a year, basically after the vaccine has had time to kick in and these neoantigens have been identified, that we then start to see the separation of the curve, which looks very flat over time. And so I think this is a very, very exciting kind of technology platform and very exciting results because there was minimal increase in toxicity – just at the site of the local injection – for the addition of the individualized neoantigen therapy.    And beyond that, hypothetically, this is not necessarily just a melanoma thing. So, of course, based on these phase 2 results, a phase 3 clinical trial called KEYNOTE-V940 is going to be launching later this year to compare pembrolizumab versus pembrolizumab plus this V940 individualized neoantigen therapy. And we're very, very excited in the field to see what those results will look like because the concept here is you could really, really enhance adjuvant therapy with this kind of an approach. Meanwhile, we're just about to talk in a little bit about all the exciting things happening in the neoadjuvant space as well. And with no increase in toxicity, obviously, that looks really good.    Suffice it to say that this technology is not specific to melanoma but rather could be applied almost to any cancer where we think about an adjuvant therapy platform. So I think the results are very, very exciting. It is a phase 2 study and it does have some caveats about not being the largest study and some other things, but you can't help but be impressed by the data that have been presented here so far.   Dr. Diwakar Davar: One important plug, I guess, in addition to that is that you mentioned that there's data using the platform in other diseases. And one really exciting paper that came out recently was Dr. Vinod Balachandran's paper; for those who haven't read it, it's in Nature, and really in a very provocative proof of concept study, they studied the platform, the vaccine plus checkpoint inhibitor therapy plus chemotherapy in a highly adverse tumor patient population. So these are patients with resectable pancreatic cancer who had the vaccine generated from pancreatic cancer that was resected after Whipple surgery. And extraordinarily, out of the 16 patients who had immune responses, 8 of them did not have relapse at a median follow-up of almost a year and a half, which is really quite extraordinary given the lack of really any effective drug outside of chemotherapy in that setting.     So, the point that you're making regarding the benefit of this therapy, suggesting that it could potentially be extended to not just melanoma, potentially other tumors such as highly immunogenic tumors, and potentially even nonimmunogenic tumors such as pancreatic cancer, really suggests that this is going to be a very exciting landscape. And potentially this area, adjuvant therapy and neoadjuvant therapy, like we'll talk about, is potentially an area in which other drugs and potentially combinations will be developed.    So next, we will be discussing 3 abstracts evaluating the theme of combinations, and these abstracts are 9501, 9502, and 4010. Abstract 9501 is an evaluation of the combination of fianlimab and cemiplimab anti-LAG-3 and anti-PD-1, respectively, in advanced melanoma, specifically focusing on the post-PD-1 experience in this disease by Dr. Omid Hamid. 9502 is the updated 2-year survival results from RELATIVITY-047, which evaluated nivolumab and relatlimab against nivolumab alone in frontline metastatic melanoma. And Abstract 4010 are the results from the MORPHEUS platform study, specifically looking at tiragolumab and atezolizumab in patients with advanced unresectable HCC.    But focusing on 9501 and 9502, Jason, what do you make of the combination of fianlimab and cemiplimab post-PD-1 setting?   Dr. Jason Luke: I think the data look very intriguing for this second combination of PD-1 and LAG-3 combination. When nivolumab and relatlimab, the approved LAG-3 inhibitor, kind of burst on the scene a couple of years ago, it was somewhat to the surprise of a lot of people in the community who had really come to think that while PD-1 and CTLA-4 were core molecules for therapeutics and cancer, that we just weren't ever really going to see something else come along in checkpoint blockade. And so nivo and rela got approved. We'll talk about them again in a second. But the data now coming forward for another PD-1 LAG-3 combination, again with cemiplimab PD-1 and fianlimab LAG-3, looks very, very promising.    So in Abstract 9501, they updated a phase 1 expansion cohort, phase 2 cohort looking at patients across the various different settings. And whereas in the treatment naive frontline metastatic setting they had previously described about a 63% response rate, they saw a similar level of response rate in patients who had previously gotten adjuvant anti-PD-1, had a period of time off treatment, and then were treated again. And that was reassuring because it suggested that this is still an active combination even with prior exposure to IO in the past.     Now, the thing that I found to be the most interesting about this combination was whereas with nivo and rela, at least from the RELATIVITY-047 phase 3 trial, it looked like there was less benefit in some of the high-risk population cohorts, at least for this combination in early testing for cemi and fian; like we talk about it sometimes, we saw there was a high response rate even in patients with liver metastases and some other high-risk features. And so I think this combination looks quite potent, and I'm very excited to see what the data will look like. I think it's very unlikely we'll ever actually get a randomized trial of two PD-1 LAG-3 combinations against each other. But suffice it to say that the data we've seen so far for fianlimab LAG-3 with cemiplimab PD-1 looks very intriguing. It certainly justifies the frontline metastatic phase 3 and the adjuvant phase 3 trials that are already in planning or ongoing.   Dr. Diwakar Davar: So one thing to consider is on the RELATIVITY-020 trial – the early trial that was led by Dr. Ascierto that really took a long time to read out – the response rate in patients with prior checkpoint inhibitor therapy was quite low. In fact, the data was quite surprising, as you'd mentioned that we had even seen this movement in the frontline setting because the response rate by BICR was only about 12%. So do you feel like the 2 LAG-3 inhibitors are fundamentally different? And if so, can you speculate as to why that might be? Again, with the caveat to the fact that these are very early data and we don't have enough information. And maybe we can also talk a little bit about the 2 pending trials that are ongoing in the advanced and adjuvant therapy landscapes perspective.   Dr. Jason Luke: I think we don't have enough data yet to truly understand whether or not they're really different. The trials that have been run so far are so different that it's hard to compare things back and forth. You can notice that the dose, the milligram dosage of fianlimab in terms of anti-LAG-3 is quite a bit higher, like a log fold higher almost than with relatlimab. And so there's some question of whether or not just merely more drug-blocking LAG-3 might in fact be more efficacious relative to the dose that's approved for relatlimab in melanoma. But beyond that, I think the data hold up very well for this new combination, again noting all the caveats about cross-trial comparison to, say, it looks to be at least as potent, possibly more potent than the relatlimab combination. But again, I think probably we need to see the data from randomized trials and how that fits into the landscape when the trials actually read out because there's a lot of things going on in melanoma that are likely to change between now and then.   Dr. Diwakar Davar: So just to draw people's attention, there are actually 2 ongoing pivotal phase 3 trials: fian plus cemi versus pembro in patients with advanced metastatic and locally advanced, previously untreated melanoma, as well as an adjuvant trial of the combination against pembrolizumab. Again, highly high-risk resected melanoma. These trials are ongoing. We don't have the results yet and we are looking forward to them.    Now, 9502, a 2-year RELATIVITY-047 result presented by Dr. Hussein Tawbi.    Dr. Jason Luke: So this is the study we were just alluding to before, the randomized phase 3 study of nivolumab versus nivolumab plus for relatlimab. To me, the most useful data sort of updating with this two-year survival follow-up is to show the maintenance of benefit between the 2 arms. And so, consistent with what we saw with nivolumab and ipilimumab, there seems to be a persistent delta between the arms for both progression-free and for overall survival out over that extended period of time, where we can see with that updated data now, at 2 years, that it's 52% of patients still alive on the relatlimab combo versus 42 with nivolumab. And it does seem like this is probably a higher-risk population of patients than participated in CheckMate-067.    So it's a little bit difficult to compare the landmarks except to notice that that difference between the control and experimental groups is consistent over a long period of time and that there were no new safety signals either, and so that was also reassuring. To me, the most interesting nugget of data in the abstract, though, is to look at what happened to patients after they were on the first-line treatment. So one of the big questions in our field is really “If patients get nivolumab and relatlimab upfront, what should they get after that?” Should they then get nivo plus ipi, or vice versa? And I think we don't have an answer clearly to that question just yet.    There was an important letter to the editor of the New England Journal now going on about a year ago by Alex Menzies and colleagues that suggested that the use of ipilimumab was attenuated, the utility of it, after a prior exposure to nivolumab plus relatlimab. They quoted a response rate on the order of only about 10% for patients who got an ipilimumab-containing regimen after initial LAG-3. In the data from Hussein Tawbi at ASCO, however, in a small number of patients, caveat, the response rate was more in sort of the low 20% range, 22% to 25%. And so that would be a much more meaningful and important sort of consideration. If we do have independent activity, then lining up sequential therapies and the toxicities associated with each will become increasingly important as we think about how to maximize these kinds of treatments for our patients, but important longer-term data to show that the benefit is holding up and it's safe, and some new insights into what to do after progression on one of these regimens.    Dr. Diwakar Davar: So, pivoting slightly to combinations, we are going to be discussing a combination of TIGIT plus checkpoints. So tiragolumab is the FC-active TIGIT inhibitor from Regeneron-Roche and this is currently in multiple pivotal phase 3 trials, several of which have been negative, including SKYSCRAPER-01 in non-small cell lung cancer and SKYSCRAPER-03 in small cell lung cancer. The MORPHEUS platform trial essentially is a platform study evaluating multiple different combinations, in this case in liver cancer. And so we have a very interesting Abstract 4010, which is giving us an early readout of the evaluation of tiragolumab plus atezolizumab along with bevacizumab in unresectable, locally advanced or metastatic hepatocellular carcinoma giving us a result that is a little different from what we had seen from the prior negative results of TIGIT. So Jason, what do you make of these early results in the advanced HCC setting?   Dr. Jason Luke: I think these are cautiously intriguing results to really highlight the point is the third checkpoint possibly being LAG-3, now a fourth checkpoint maybe with TIGIT, but with all the caveats that you talked about. In this study, the flow is that there's a continuously accruing control arm which in hepatocellular carcinoma is a combination of atezolizumab plus bevacizumab, and then other arms are added where you add in a third agent. In this case, it's the anti-TIGIT tiragolumab. And in an intriguing fashion, the response rate to the triplet was 42.5% compared to the doublet which was only 11%. So that's a pretty big difference in this population.     Now, it wasn't the largest study, only 58 patients, but it was a randomized clinical trial. And so I think those data really make people kind of open their eyes again. It's worth a little bit of a caveat here that HCC is an unusual cancer in that what is deemed to be unresectable and therefore amendable to systemic therapy is a moving target and that requires multidisciplinary evaluation of patients. And so I think a larger number of patients would really be needed to fully understand this. But certainly, a fourfold increase in the benefit or in terms of response rate looks quite intriguing.    I think the other piece of this is to be just cautious a little bit was when the initial data in non-small cell lung cancer in the CITYSCAPE study came forward, and they looked roughly sort of like this: There was more than a doubling in the PFS and the response rate, which is what triggered all of those phase 3 studies. So to me, this is enough to continue to be very interested in TIGIT as a therapeutic target. And there are many phase 3 trials already ongoing. And so I think, I'm cautiously optimistic that some of those actually will be positive and we could see more movement around TIGIT becoming a standard of care agent.    Dr. Diwakar Davar: To your point about TIGIT being an interesting target, recent data looking at the neoadjuvant landscape in melanoma from Merck, with Merck, also FC-active TIGIT and also some data from authors looking at that TIGIT also presented in this case at ASCO specifically from the ARC-7 study. So very interesting target. Several pivotal trials have been announced. Do you know of any trials that are ongoing in the adjuvant setting in other diseases?   Dr. Jason Luke: Well, as you alluded to, the vibostolimab data in melanoma for TIGIT in the neoadjuvant setting was interesting. And in fact, that has been enough to trigger a global, randomized phase 3 adjuvant study of pembrolizumab and vibostolimab versus pembrolizumab in melanoma. And that sort of takes us back to the beginning of our discussion here, building on the KEYNOTE-716 data. So, yes, TIGIT will be moving forward in the adjuvant space in melanoma and obviously at a static setting for several different tumor types with a PD-1 or PD-L1 backbone.   Dr. Diwakar Davar: So now pivoting towards neoadjuvant therapy and non-small cell lung cancer. The standard of care in this setting was established by the CheckMate-816 trial that essentially established nivolumab plus chemotherapy in the setting of resectable non-small cell lung carcinoma path. Response rate in this setting is approximately 21%. And we have several studies that are essentially looking at novel combinations or in this case, different PD-1 inhibitors in this setting. So Abstract 8500 essentially looked at nivolumab plus relatlimab from a NEOpredict-Lung trial. Jason, do you want to tell us a little bit about this?    Dr. Jason Luke: Yes, I think this is a very interesting study and that this is sort of our first peek at targeting LAG-3 in the context of lung cancer. So obviously we talked about LAG-3 for melanoma. Although the audience is probably aware that there have been neoadjuvant data for LAG-3 with relatlimab in melanoma that substantiated the phase 3 data for the metastatic setting. So one of the questions as we start to apply the LAG-3 in other diseases would be, “Do we see it hold up in both metastatic disease and in the neoadjuvant space?” But in this study, while there were no changes in the safety profile; it didn't impact on whether or not patients could have surgery. There really didn't look to be a big difference in this study between nivolumab and nivolumab plus relatlimab, with the major pathologic response as you alluded to right around 30% for both arms.    Now, it wasn't really the biggest study, but that's certainly quite a bit in contrast with what we've seen in melanoma, where with a PD-1 inhibitor you get again 25%-30%, but with adding on LAG-3, that pushes you up closer to 60%. So I think these were very interesting data that probably put a little bit of an eyebrow raise to say, “Well, let's see what happens in the metastatic setting in lung cancer with the addition of relatlimab LAG-3 on top of a PD-1.” I think it might not be quite so straightforward as what we saw in melanoma, but we'll look forward to those results because those phase 3 trials in metastatic lung cancer should be maturing sometime in the next year or two.   Dr. Diwakar Davar: The theme of neoadjuvant therapy non-small lung cancer, LBA100, which has again previously been discussed in an episode of this podcast by Dr. Jack West and Dr. Velcheti is KEYNOTE-671. And this is a study essentially that looked at pembrolizumab or placebo with platinum-based chemotherapy doublet and followed by resection. So again, a direct parallel to CheckMate-816. What do you make of the results that were reported by our colleagues in this setting, Jason?   Dr. Jason Luke: So not to rehash this, because our colleagues in the lung cancer group have already discussed this at length and obviously they're experts in that disease, but we'll just note that there was a threefold increase in major pathologic response, which turned into a major advantage for event-free survival. And so I think this is at least the third PD-1, PD-L1 combination regimen for neoadjuvant lung cancer that looks very, very promising. It certainly, to me, seems like neoadjuvant consideration really should be the standard of care already moving forward.   To me, what the big question that is left with is “Do we still need the adjuvant component after we give the neoadjuvant?” So, some of the trials are including neoadjuvant and adjuvant, some of them are only neoadjuvant. And I think that's going to be a really important question as we move into the future, both in terms of what is that contribution of the adjuvant component, and then again, going back to earlier in our discussion here, if there could be a major advantage to adding individualized neoantigen therapy, maybe it is important to have both. But I think that's one of the big questions we have to get teased out by the field over the next couple of years.   Dr. Diwakar Davar: And finally pivoting towards cutaneous squamous cell carcinoma. We have 2 abstracts discussing perioperative therapy. So cutaneous squamous cell carcinoma is a high-TMB tumor. The median tumor mutation burden in this disease is threefold that of melanoma. This is a disease in which checkpoint inhibitor therapy is approved as a single agent both with pembrolizumab and cemiplimab on the basis of nonrandomized phase 2 trials. And increasingly, there has been early development in the perioperative setting. The first data in this space came from our colleague Dr. Gross at MD Anderson, who reported in a small, nonrandomized phase 2 trial of 20 patients, a path CR rate with two cycles of cemiplimab at approximately 50%.    A larger multi-institutional phase 2 trial demonstrated that a longer duration of perioperative therapy of four cycles or 3 months of cemiplimab did not particularly improve the path response rates. The response rates were similar at approximately 50% as well. And what we have right now are 2 other trials. The first is the MATISSE trial, Abstract 9507 ,that evaluated nivolumab or nivolumab plus epilimumab in this disease. And the other one was the NEO-CESQ trial, or Abstract 9576, that evaluated neoadjuvant plus adjuvant therapy that's cemiplimab in the high-risk patient population. So we're starting with 9507. Jason, what do you make of the ipi and ipi-nivo data reported in this setting?   Dr. Jason Luke: So I think this is a really interesting study because I think part of the intent is the clinical aspect of how you manage patients with cutaneous squamous cell carcinoma. For those that don't do cutaneous oncology, many of these patients have the development of lesions, which can be actually quite difficult to resect in a way that's not otherwise mutilating or cosmetically quite problematic. And that was part of the impetus for this trial where, again, they looked at either monotherapy PD-1 or a PD-1 plus CTLA-4, and they saw great success. As was predicted based on the other data that you alluded to, response rates are more than 50% near 60%, with actually a substantial number of patients on the trial actually refusing to have surgery after they received their neoadjuvant therapy because they were so certain that they had had a good outcome.    So I think these data are quite reassuring in the context of all of this emerging data around cutaneous squamous cell carcinoma. We'll talk about this NEO-CESQ trial in just a second, but I think it really is emerging to be the standard of care very soon for the use of perioperative PD-1 for cutaneous squamous cell.   Dr. Diwakar Davar: What do you feel about the dose and schedule of checkpoint inhibitor therapy used here? So the dose of ipilimumab used was ipi-1 and not ipi-3, and they waited 4 weeks. So when patients only got two cycles of Q2 weekly nivo, and one cycle of ipilimumab, do you think the responses would have been deeper if they'd waited longer?   Dr. Jason Luke: I think it is possible that they might have been deeper, although I'm not totally sure about that. One of the other abstracts we're not directly mentioning here was a study in Merkel cell carcinoma which suggested that in fact, adding ipi and that also highly immuno-oncology-responsive tumor type did not add to the response rate. So I'm not totally sure about that. I think rather what would be most interesting here is sort of the sort of next generation of biomarker work.    As part of their presentation, the MATISSE trial team showed gene expression profiling that really strongly identified which patients were going to do well on the trial. And I think that's probably eventually going to be how we need to think about this. There are patients in the neoadjuvant setting who are going to do really well with anti-PD-1 alone. And then for those who aren't, that's where we probably really need to think about do we need combos, how long to give the treatment, etc. And I think we're really only on the cusp in the beginning of this, which is exciting as we think about moving into the future.    Dr. Diwakar Davar: Certainly, many combinations are being evaluated in this space and we are very excited for the data that it's about to hopefully come in the next couple of months to years.    So the NEO-CESQ – it's quite a puzzle as to how to pronounce this acronym – and this evaluated cemiplimab in the high-risk setting. So it's worthwhile noting that Dr. Gross's first trial looked at high-risk stage 2, 3, and 4 disease. So the context of cutaneous squamous cell carcinoma that's node-positive disease and distant metastatic disease that is in one location or patients with node-positive disease invention. And his multi-institutional cemiplimab trial of four cycles evaluated included patients with stage 2, 3, and 4 disease.    So here in a study just in stage 3 and 4 diseases, Dr. Ascierto reported the results of 2 cycles of cemiplimab and importantly, these patients had both the neoadjuvant and the adjuvant portion of cemiplimab. So, Jason, you mentioned earlier that one of the key aspects that we start thinking about neoadjuvant therapy is exactly how much do you need. Do you need both the pre-surgical therapy and the post-surgical therapy? Is the presurgical therapy enough? After all, neoadjuvant response equals cure. How much benefit are you getting from post-surgical portions? So what do you make of the results that they've seen here and what is the impact? How do you think we'll be disentangling the impact of the neoadjuvant and the adjuvant portion of the immunotherapy upon response and survival?    Dr. Jason Luke: So just to leverage those comments, I think these data are reassuring because in this higher-risk group of patients, they saw excellent outcomes very similar to what Gross et al had previously reported. So that's good. To your question about how we are going to disentangle this adjuvant versus non-adjuvant question, there's a trial in melanoma called the NADINA trial which is ongoing now in which the use of the adjuvant therapy is actually risk-adapted. So after patients have an initial neoadjuvant treatment they're evaluated, and if they have had a pathologic complete response, they're actually going to stop that treatment and they're not going to give the neoadjuvant therapy. And so I think obviously it's a slightly different disease, but those kinds of data, I think, will be very meaningful to help us sort this out.    And I'm not sure whether or not in cutaneous squamous we would need a different trial than in melanoma, although I think in a different tumor, maybe like, say, lung cancer, you probably would need a dedicated study to try to look at that because I think just the responsiveness to checkpoint blockade is going to vary quite a bit once you get outside of cutaneous oncology. But to summarize, reassuring that a similar pathologic response rate, and I think this question of adjuvant or nonadjuvant, I think that's the next question we've got to answer in the field.    Dr. Diwakar Davar: We have now come to the end of our back-and-forth discussion on these very, very exciting abstracts. So Jason, thank you for highlighting these advances and for engaging in a robust discussion.    Dr. Jason Luke: Thanks for having me.    Dr. Diwakar Davar: And thank you to our listeners today for taking the time to listen to this podcast. You will find the links to the abstracts discussed today in the transcript of this episode. Finally, if you value the insights that you hear in the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcast.    Disclaimer:   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Follow today's speakers:   Dr. Diwakar Davar   @diwakardavar   Dr. Jason Luke   @jasonlukemd      Follow ASCO on social media:    @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn      Disclosures:      Dr. Diwakar Davar:     Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences    Consulting or Advisory Role: Instil Bio, Vedanta Biosciences    Consulting or Advisory Role (Immediate family member): Shionogi    Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences    Research Funding (Inst.): Zucero Therapeutics    Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy    Dr. Jason Luke:      Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical , Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX    Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine    Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure    Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)    Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio        

Christina is the CEO of biotech startup Officinae Bio, and the former cofounder of the Innovation Lab of ViiV Healthcare, a joint venture between GSK, Pfizer, and Shionogi. Previously she held leadership positions at GSK and has spent her career at the forefront of healthcare innovation." Repeat guest Christina, and I discuss all things leadership, how to manage successful innovation initiatives and their teams, and the pitfalls which can present themselves along the way.

Suzanne Monahan is a wife, mother, and leader in the health sciences industry. As a former collegiate athlete, two time cancer survivor, and now a leader, she is passionate about the power of mindset, teamwork and performance. Currently, she holds a commercial leadership position at Shionogi Inc, a biopharmaceutical company that leverages a science-based heritage to develop and commercialize pharmaceutical products to treat unmet medical needs.  Today, she dedicates her time at Shionogi to building and leading the sales team for the US. Suzanne is committed to “raising up” cohesive and resilient teams both at work and on the field.  She believes in family first and enjoys giving back, serving as a girl's lacrosse coach, an advocate for patient-focused cancer care, and a mentor to future leaders.  What you'll learn in this episode: Knitty-gritty advice and tips for Pharma Sales leadership in the post-pandemic era How to handle a high-value employee leaving your team How to adapt to higher and higher levels of competition as your career develops Why being vulnerable is a competitive advantage The value of unorthodox methods (from the unofficial Queen of Unorthodox) Novel career paths in Pharma for uniquely talented individuals Additional Resources: Suzanne's LinkedIn Shionogi's LinkedIn Shionogi's Website

這裡是RSS音頻式網站智能播客的頻道 這一集的新聞標題為： Omicron 再添新藥！Shionogi 藥廠旗 […]

Dr. Juan Camilo Arjona Ferreira & Dr. Kalahn Taylor-Clark of Myovant Sciences discuss the current standard of care for uterine fibroids. According to the Baird et al paper, published in the American Journal of Obstetrics and Gynecology, by age 50, 80% of black women and 70% of white women will have uterine fibroids. While not every woman will be symptomatic, those who are will commonly experience heavy menstrual bleeding, which is often normalized and may result in delayed diagnosis.  **Thank you to Myovant Sciences for sponsoring this episode.** This podcast episode is intended to raise awareness and instill a sense of urgency, challenging the status quo in uterine healthcare, serving as a reminder that women can and need to advocate for themselves and their family members. We cover the following: Heavy menstrual bleeding & when it may be a sign of uterine fibroids Uterine fibroids symptoms & prevalence How uterine fibroids are diagnosed & how our healthcare systems' implicit bias might play a role in delayed diagnosis Uterine fibroid treatment options & how to know which is right for you Impact of uterine fibroids on women of color, specifically Ways to minimize uterine fibroids' impact on those suffering, their loved ones, and overall society “Patients with fibroids already live with a significant burden to manage their symptoms. The added financial impact increases the mental effects uterine fibroids can have on a patient. There are consequences over time on their health, self esteem, and careers. It's a substantial impact.” - Dr. Juan Camilo Arjona Ferreira “The normalization of women's heavy periods and pain have left many people without the tools to understand when their periods are abnormal. When to seek treatment and how to get a diagnosis can be confusing, and frankly difficult to navigate” - Dr. Kalahn Taylor-Clark Resources: Menstrual Health Spotify Podcast Playlist Uterine Fibroids with Dr. Jessica Opoku-Anane Episode The White Dress Project & The Fibroid Foundation Uterine Fibroids Toolkit: A Patient Empowered Guide by the Society for Women's Health Research If you liked this episode leave a review:  iTunes or Spotify.  Tell 2-3 of your friends!   **The information shared by Fempower Health is not medical advice but for information purposes to enable you to have more effective conversations with your doctor. Always talk to your doctor before making health-related decisions. Additionally, the views expressed by this episode's guests are their own and their appearance on the program does not imply an endorsement of them or any entity they represent, nor does it constitute an endorsement by Myovant Sciences of this episode. About Dr. Juan Camilo Arjona Ferreira He is the Chief Medical Officer at Myovant Sciences, a healthcare company aspiring to redefine care for women and men through purpose-driven science, empowering medicines, and transformative advocacy. He leads clinical development, including Myovant's clinical programs in prostate cancer, uterine fibroids, and endometriosis. Prior to Myovant, he was the SVP of Clinical Development at Shionogi and spent over a decade at Merck & Co. where he was Executive Director of Clinical Research in Women's Health. Dr. Arjona Ferreira earned his MD and completed his postgraduate specialist training in Obstetrics and Gynecology at Colegio Mayor del Rosario in Bogota, Colombia. About Dr. Kalahn Taylor-Clark, PhD, MPH She is Vice President & Head of Strategic Partnerships & Innovation at Myovant Sciences. Dr. Taylor-Clark oversees patient centered advocacy and digital innovation. Her team is responsible for driving transformative advocacy in the areas of women's health and prostate cancer, addressing health equity, and advancing digital innovation strategies to improve patient experiences and outcomes. She holds a BA in International Relations from Tufts University, an MPH from Tufts School of Medicine, and a PhD in Health Policy from Harvard University.

Dr. Diwakar Davar and Dr. Jason Luke, both of the University of Pittsburgh's Hillman Cancer Center, highlight key advances in early phase therapeutics and immunotherapy that were featured at the 2022 ASCO Annual Meeting and also address toxicities, including immune checkpoint inhibitor-associated myocarditis. TRANSCRIPT Dr. Diwakar Davar: Hello, and welcome to the ASCO Daily News Podcast. My name is Dr. Diwakar Davar, and I'm an assistant professor of Medical Oncology, specializing in melanoma and phase 1 therapeutics at the University of Pittsburgh's Hillman Cancer Center. I am the guest host of today's podcast. My guest today is Dr. Jason Luke, a colleague and the director of the Cancer Immunotherapeutics Center at the UPMC Hillman Cancer Center here.  Today, we'll be discussing advances in early-phase therapeutics and immunotherapy that were featured at the 2022 ASCO Annual Meeting.   You'll find our full disclosures in the show notes, and the disclosures of all guests on the podcast are available on our transcripts at asco.org/podcasts.  Jason, thank you for coming on the podcast today.  Dr. Jason Luke: Thanks so much for the invitation. It was a great ASCO, and I hope everyone had a good time.  Dr. Diwakar Davar: So, onto our abstracts. So, the first one that we'll be discussing, and Jason as you know we've done this before. We'll be rapidly transitioning between phase 1 therapeutics, melanoma, and advanced phase 2 and 3 trials, but you know this is something you do very well. So Abstract 2504, it's a phase 1 trial of TIM-3 inhibitor cobomilab immunotherapy and in combination with PD-1 inhibitors nivolumab and dostarlimab. The AMBER Trial that was presented recently, and in full disclosure, both you and I actually are on this abstract. So, what do you think of this abstract? What do you think of the data that is discussed, and how do we contextualize this in relation to what needs to be done in this space?  Dr. Jason Luke: So, I think this is an exciting abstract because it brings forward what may be the next high-priority immune checkpoint to try to target in clinical oncology. To level-set, I think everybody listening will know about PD-1 and CTLA-4 as immune checkpoints. In the last year, we've had LAG-3 come forward as now a standard of care element of armamentarium in melanoma, and we look forward to further studies of LAG-3 and other tumor types as we think it should be a good partner where PD-1 is otherwise approved.  So here now, we hear about TIM-3, which is another negative regulatory checkpoint on a number of different immune subsets. And in this abstract, the antibody targeting TIM-3 was cobolimab. So, TIM-3 is a very interesting molecule. It has, what you might call, pleiotropic effects in the immune system. So, while in the context of this abstract, it was being targeted as another immune checkpoint on T cells, it's important to point out that TIM-3 has other regulatory roles in other immune subsets such as myeloid cells and very particularly dendritic cells, and that's important because it might bring in another element of the innate immune system to try to drive anti-tumor responses. So, it's an exciting target because it might be able to expand the groups of patients who could benefit from immune checkpoint blockade.  So, in this abstract, we see initially the phase 1 data of combining cobolimab, anti-TIM-3 with anti-PD-1 of a couple of different flavors. And what you could take from this abstract is that in the phase 1 setting, the drug was well-tolerated and combined well, and had pharmacokinetic properties that would be consistent with what we'd expect for this kind of a monoclonal antibody. I think we have to marry this abstract, which is really the phase 1 data about safety in pharmacokinetic (PK) to another abstract presented in the melanoma session, which showed an expansion cohort of patients who got cobolimab plus nivolumab or dostarlimab.  And there we did see a 50% response rate, albeit that there was heterogeneity of patients being treatment naïve versus treatment-experienced. So, what I would say to this on a high level is that I think these data are preliminarily exciting, suggesting that further investigation into TIM-3 may be valuable in terms of expanding the population of patients initially in melanoma, but there will data coming soon in lung cancer and in other tumor types with another novel checkpoint. And I think if we think ahead into the future, the question is probably going to end up being, which combinations of checkpoints for which patients. That's pretty exciting to think about. We've seen a lot of data of PD-1 plus other molecules, and I think some future biomarker stratification really will be necessary to know which patient would benefit the most from which of these combos, but for the time being, this is exciting data to see where the field is going to go over the next couple of years.  Dr. Diwakar Davar: Great. And I guess, to your point, one important thing to highlight from the abstract is your point about the role of the different compartments. There was actually a very interesting dose-response relationship with the highest dose of the drug not necessarily being the most effective dose, suggesting that yes, as you escalate, you may have different effects in different compartments, and maybe therefore a broad selection of doses might be required to ensure that you have optimal engagement of the optimal target.  So, the next abstract is Abstract 3007. This is the tumor-agnostic efficacy and safety of erdafitinib. So, we now know that FGFR pathway aberrations are found from 77% of all malignancies, FGFR targets are now U.S. Food and Drug Administration (FDA) approved in cholangiocarcinoma with pemigatinib, infigratinib, and as well with erdafitinib metastatic urothelial cancer. We know that these agents are not necessarily effective tests in 1 tumor type because these alterations have risen in multiple tumor types. So, the RAGNAR trial, looking at this across multiple tumor types, what do you make of the interim analysis result presented by Dr. Loriot?  Dr. Jason Luke: So, I'd say that this is probably the future of targeted therapy. And so, I think that where we have activity in 1 disease, it's very likely we would have activity in others. So, the author has described this as the largest basket trial of a molecularly defined subset that's been pursued to date. There are upwards of more than 200 patients in the study. I think it's really important, as we think about the data, to realize, though, that all FGFR alterations are not exactly the same thing. And so, in this study, they gave erdafitinib to patients with solid tumors of any FGFR altered status. And so that's FGFR1, 2, 3, 4 mutations or gene fusions. And that's a lot of heterogeneity in there actually.  And in this study, there were two-thirds fusions and one-third mutations, mostly in FGFR2 and 3. That will become relevant as we start to think about the results. On a high level, I have to say that it is impressive in pan-cancer fashion, just selecting by FGFR alteration, there's about a 30% response rate observed. I think that no matter what, that's going to be valuable considering these were patients with refractory tumors with 3 lines of prior therapy on median. I think what we need to know more is the breakdown of which specific molecular alteration and FGFR in which tumor types drove most of the benefit.  So, for example, in bladder cancer where erdafitinib is already approved, that's almost entirely an FGFR3 fusion setting. So we know the drug is effective there. And so I think there will be a further breakdown of the data. As it matures more, you really start to tease out, is it really the case that any FGFR alteration can be treated or there are some that really ought to be the high priorities that we really ought to be going after. I think it would be remiss not to also note, however, that while there's excitement about this sort of pan-cancer approach, the current generation of FGFR inhibitors are not exactly the easiest drugs to take.  And so, the in-class, hypophosphatemia and stomatitis really does lead to dose reductions in a lot of the patients. And I think that that's probably really important to emphasize is that despite the pan-tumor activity, there's still a lot of potential in this field to refine further because it's almost certainly the case that if we had less off-target toxicity, so to say, we could improve the efficacy beyond that 30% that we saw here.  All the same, I think this is exciting for the concept of a pan-cancer tumor agnostic sort of approach, and we'll really look forward to more data to come from this study over the next, hopefully, few months.  Dr. Diwakar Davar: And I guess 1 corollary to that is that we now need to start looking for FGFR alterations in multiple tumor types. So, tests, tests, tests. All right, Abstract 3004, phase 1a/1b dose escalation and expansion study of the MDM2-p53 antagonist BI 907828 in patients with multiple solid tumors including advanced, metastatic, liposarcoma. So, we've recently had data of the previously undruggable KRAS, and now we've got previously undruggable p53, for which we now have targets. So, Jason, what do you make of the p53 targeting approach, in this case, using MDM2 and this particular drug from Boehringer Ingelheim?  Dr. Jason Luke: So, I think that this is an exciting abstract exactly for the reason that you mentioned, which is that p53 has been, and unfortunately, to some degree, still remains, one of those holy grails but undruggable targets in oncology. So MDM2, for those who are listening but might not be aware, is a negative regulator of p53. So, the concept here then is if you drug it, you might release p53 to reactivate activity in that pathway, and then p53 being the guardian of the genome, so to say, potentially leading to apoptosis of cancer cells.  And so, this drug binds MDM2 and MDM2 can be amplified as a resistance mechanism in p53 and several tumor types. And so here, they showed data for the early part of a clinical trial investigating the small molecule, BI 907828, but then they focus specifically in liposarcoma, which is a disease known to be an MDM2 amplified. And so, the results were pretty interesting. The toxicity of this kind of an approach, just to note, is really in class. It leads to some gastrointestinal (GI) toxicities as well as hematologic problems, and this goes again for most regulators of the cell cycle will have these effects, whether they're CDK inhibitors or MDM2 or p53 modulators.  But I think what was very interesting, this is a disease liposarcoma where chemotherapy, functionally speaking, has no role. We, unfortunately, give it to some patients sometimes, but it has almost no activity, and they observe that in poorly differentiated liposarcomas, the response rate was about 12%, but the stable disease was quite durable. And so, I think that really is potentially a big deal because this is an orphan disease. It really lacks any other treatment. But as you zoom out from that, if you start to think about targeting amplified MDM2 in other settings, I think the activity that we see here is intriguing, and potentially suggests that we may be coming to a future where we'll have multiple, sort of, orthogonal approaches after reactivating p53. There were actually other abstracts at ASCO Annual Meeting of other molecules that were less mature also along this line.  So, I think, very exciting to take away from this, one, a potential treatment for liposarcoma for all of those patients that anybody listening actually sees, but secondarily this concept of targeting p53, which I think we'll see a lot more of over the next couple of years.  Dr. Diwakar Davar: Excellent. Moving on to the Abstract 3002, this is a phase 1, two-part multicenter, first-in-human study of DS-6000a of an antibody-drug conjugate comprising the anti-CDH6 IgG1 monoclonal antibody that is attached to a topoisomerase I inhibitor payload via a cleavable linker. And so basically, a way in which you can give topoisomerase: (1) TOP1 inhibitor, (2) CDH6-expressing cells. This was studied in advanced renal cell carcinoma (RCC) and advanced ovarian cancer in this abstract presented by Dr. Hamilton. Jason, what do you think of the results and what do you think of this approach in general, this antibody-drug conjugate (ADC) approach using novel targets as well as novel payloads?  Dr. Jason Luke: I think this is one of those that you can't help but be pretty excited about, and I think in the context of the data shown at the plenary session in breast cancer for antibody-drug conjugates (LBA3), I think this is really where the field is going to start to go. So, you mentioned that this is an antibody-drug conjugate that targets cadherin 6 or CDH6, which people will remember from biochemistry class and medical school, or something is a cell-cell adhesion molecule, really a basement membrane protein. So, the concept of targeting it really is just to go after a latch mechanism to get the molecule into the tumor where you want. And CDH expression is very high in renal cell carcinoma, upwards of 80% of samples, also high in ovarian cancer, which is why they chose those 2 tumors to go after.  So, the ADCC, and you described its structure just a little bit, but it's essentially the same backbone as trastuzumab deruxtecan, which we saw this outstanding activity for HER2 and breast cancer on the plenary, with these 8 chemotherapies moieties attached to it, but here now, targeting it instead to HER2, with this molecule now to CDH6. And I think, again, you can't help but be impressed. There were treatment responses on almost every dose level of the dose escalation in this study. There's in fact only 1 patient whose tumor was not, at least, stable disease or a PR, and I think that that just goes to show the power of truly bringing the chemotherapy in a targeted manner into the tumor microenvironment. Responses were heterogeneous. They were not super deep responses per se, but the stable disease was quite durable in the study, and the patients were going out more than 7 months. And again, realizing this is at the lower dose levels as we're increasing the dose and move this in their earlier lives of therapy is likely to be even more effective.  They did show a waterfall plot of the reduction in CA 125 for the patients with ovarian cancer that really looked quite impressive. And given that that's our clinical biomarker that we commonly follow, it may actually even more indicative of the benefit we would see as opposed to resist.  Now, again, there is some toxicity. It is a chemotherapy moiety that's conjugated to the ADCs. So, the most common toxicities were nausea, vomiting, and low platelet counts, but these are kind of toxicities that we're quite accustomed to with chemotherapy. Just to summarize, I think there's a lot of promise for this kind of antibody-drug conjugate targeting, and I think it can only be impressive that they had this amount of activity in the dose escalation of the study. [I] very much look forward to the expansion cohorts in renal and ovarian, which we'll presumably expect to see later this year, early in the next year.  Dr. Diwakar Davar: And as you alluded to, this really was parallel that ASCO, by the standing ovation given to Dr. Modi when she presented the DESTINY04 data of trastuzumab deruxtecan in HER2-low breast cancer, basically now redefining breast cancer from 4 camps, now we have to think of not just HER2 amplified or HER2-high, but also HER2-low. So yes, really have to now rethink how we classify these diseases (LBA3).  So Abstract 2509, the efficacy of anti-PD-1/PD-L1 immunotherapy in non–small cell lung cancer dependent based on CD8 and PD-L1 status. So really Dr. Galon taking us into what he has now described as the immunoscore—really a way of characterizing tumors. A way of thinking about tumors that you've also championed, Jason, in terms of this T cell-inflamed and uninflamed hypothesis. So, tell us a little bit about how these jives with your work and how you would think about lung cancer patients responding and not responding to immune checkpoint inhibitors (ICI) therapy in this context?  Dr. Jason Luke: Yeah. I think the focus quickly here on the immunoscore, so the people are aware of that, I think is really important for diving into these specific results. You have to realize our fundamental underlying predicate for immune checkpoint blockade inhibitor response is that patients have mounted an adaptive immune response. So, CD8 T-cells have gone into the tumor where they elaborate chemokines and cytokines like interferon gamma, which upregulates the expression of PD-L1 in the tumor but also in the surrounding immune cells.  So, you realize that even though antibodies are targeting PD-1, it's really that we're targeting that tumor microenvironment. So, the more robustly we can measure that, and we understand it, the more likely we are to know whether or not the patient is going to benefit. So, this is where the immunoscore comes in. The immunoscore is actually a fairly simple test. It's one slide, immunohistochemistry slide where they can stain jointly for CD8 and PD-L1 on the same slide. And that allows them to do a number of different things beyond just testing the total level of PD-L1. They can test the CD8 density, the PD-L1 expression, but then also the interaction between CD8 T-cells, their distance from each other, from PD-L1 expressing cells, and so on and so forth.  And so really [this] can give us a much more robust analysis of what all is going on in the tumor microenvironment again, off of a single slide. So here then, in this abstract, for patients with non–small cell lung cancer receiving anti-PD-1, they then compared the utility of only PD-L1 testing versus doing the immunoscore. And so, it was actually quite a large set. They had about 250 patients in their analytical set and then split about 150 or 180 or something into the training and validation sets, and they compared the immunoscore against 2 different standard PD-L1 antibodies, the 22C3 as well as the SP263. And what they saw was a high concordance for expression between PD-L1 and the immunoscore.  That's good, because, again, they're measuring PD-L1 in both of those. And so that was a good, sort of, level set. The immunoscore, however, allows them to look to 7 different parameters, again, beyond just PD-L1, as I mentioned. So, CD8 density, interaction, distance, and this kind of thing. Then in these test and training cohorts, they were able to actually split out patients who are PD-L1 positive into further groups, those that were immunoscore low and that were high. And in so doing, they were actually able to sort of dramatically predict the likely progression-free survival on PD-1 checkpoint blockade in those different non–small cell lung cancer groups.  So why is this important? Selection of patients by PD-1 has been very useful in the field of non–small cell lung cancer, but it's hardly a panacea. You're not at all assured your patient is going to do well just because they're PD-L1. And here comes a second assay that can be done in a standard of care setting. So, the immunoscore is a test. You could just order it, and that really does give you much more predictive power about who's likely to do well and who isn't. And I think this test and more broadly multi-spectral imaging is really going to become a core component to how we risk stratify and predict outcomes to checkpoint blockade and lung cancer, but broadly in other tumor types over the next couple of years.  Dr. Diwakar Davar: Okay. Now, moving on from a biomarker for PD-L1 and PD-1 to a setting in which PD-1 was just recently U.S. Food and Drug Administration (FDA)-approved, so I'll give a brief background to the trial that you've actually developed and led. And so, this is KEYNOTE-716, the abstract in question is LBA9500 (late-breaking abstract) 9500, but this is the distant metastasis-free survival (DMFS) data readout. The DMFS, distant metastasis-free survival with pembrolizumab versus placebo in the adjuvant setting for patients with stage IIB or IIC, that is high-risk node-negative melanoma and the data from the phase 3 KEYNOTE-716 study.  So, this data, at least the recurrence-free survival (RFS) data was actually earlier published, you had presented it earlier last year and also more recently this year, but it was published recently in Lancet. And we know that 716 is a study in which, for the first time ever, we have an immune checkpoint inhibitor PD-1 that was studied against placebo with the high-risk node-negative setting in stage IIB and C melanoma, demonstrated a significant RFS benefit in the setting against placebo. And now we have the DMFS readout.  Maybe you could tell us a little bit about both the RFS and the DMFS data, and why this is such an important advance for these patients.  Dr. Jason Luke: Thanks. And I agree this really is a sea change in how we thought about stratification of patients with melanoma, but I think this broadly has implications for other tumor types as well. So, in melanoma, we've historically thought of its involvement of the lymph nodes—stage III as being the high-risk disease, but we also, if you look at the outcomes from the AJCC, we see the patients with stage IIB and IIC, so deep primary lesions, actually have similar bad outcomes as those patients with stage IIIA and IIIB. And so anti-PD1 and adjuvant therapy and melanoma were originally proved for stage III, but having understood that about 5 years ago actually, started to think, well, why not also treat the patients with stage II if they're at similar risk.  And we pursued KEYNOTE-716 as you mentioned, and it read out last year as a positive trial for recurrence-free survival. And the abstract here then was to look at the impact on distant metastasis-free survival. So, while the regulatory consideration for approval, and it is approved and it's available for patients now, was based on relapse, what we really want to be preventing is the development of metastatic disease because presumably that would correlate with the eventual death of the patient from cancer.  So, in the abstract here, we see the first update for DMFS, which also was positive on its first analysis, the hazard ratio at 0.64. And so, again, very similar to the RFS benefit, showing about a 35-36% reduction in distant metastasis-free survival. And this is a theme that we've seen across adjuvant studies in melanoma, all the adjuvant studies in fact, is that the RFS improvement, the relapse-free survival hazard ratio mirrors very closely the distant metastasis-free survival ratio. We saw that again here. I think it just emphasizes that anti-PD-1 immunotherapy is highly effective in melanoma no matter what stage it's in, but rather related to the risk of death for melanoma.  And so this really has a practice changing in the field of melanoma oncology. Patients need to be referred to medical oncology early for discussion around risk stratification and consideration of adjuvant therapy—I think even at the same time that they're having resection of their primary lesion, and it even calls into  question of whether or not we should even fully be doing procedures like sentinel lymph node biopsies any longer, considering we can make the decision to give adjuvant therapy now based on the primary—albeit that's a controversial area of discussion.  And I would just love for this to start to penetrate into other disease settings. We've seen more recently, approval for neoadjuvant therapy in lung cancer and we see in kidney cancer, bladder cancer. We see adjuvant therapy in—I think we're going to see immunotherapy starting to become an important part of the armamentarium in these hard-to-treat cancers, even at the time that perioperatively before or after surgery.  So definitely a major change in the way we're thinking about stratifying patients and emphasizes that you need to get those patients with melanoma in to have that discussion around adjuvant therapy probably at the time of the primary lesion resection.  Dr. Diwakar Davar: And finally, Abstract 2507, single-cell profiling of human heart and blood in patients with checkpoint inhibitor-associated myocarditis. So, this is data from the NGH Group, Dr. Villani and colleagues are presented by Dr. Blum. We know that myocarditis is an uncommon but very serious immune related adverse event (irAE), and here in this particular dataset, this group which has done a lot of underlying work to really uncover the role of certain key phenotypes, cellular phenotypes, in the development of myocarditis it's presenting the data in the context of ICI-related myocarditis. So, what do you think of this data, what do you think of the use of checkpoint inhibitors are now, as you've said, migrated linear in the lifecycle of the patient, what do we need to be thinking about and how does this improve our understanding of both the use of the drug and what we need to be worried about?  Dr. Jason Luke: I think the toxicities of immunotherapy, while, less frequent than, say, chemotherapy, can actually be more disastrous. In the rare patients, we have extreme immune-related adverse events, there is an incidence of actually life-threatening and fatal events. And so, myocarditis, associated with checkpoint blockade, is one of those things that could be seen, and here at ASCO Annual Meeting, we saw a couple of abstracts summarizing the experience from the National Cancer Institute following myocarditis events, and then this abstract in a translational level trying to better understand what is actually going on in terms of the immune response in those myocarditis cases.  And so, I thought this was actually a very interesting abstract. There was only a small number of patients. They had 13 samples from patients who had had endomyocardial biopsies in the context of immune-related myocarditis, and you might say, well, only 13 samples, but fortunately, this is quite a rare event, less than 1% of patients who get immune checkpoint inhibitors. And what they saw was relatively unsurprising, which is that in patients who were having myocarditis, they saw an increase in T cells and in K-cells, as well as activated CD8 and CD4 T-cells.  I think what was very interesting was when they started to dig into what were the phenotypes of the cells and what were the pathways that were turned on. Again, it was not especially surprising to see that they saw increased levels of interferon signaling and immune-receptor signaling as well as motility and adhesion, but this really, I think emphasizes that there are potentially interventions beyond just the general immune-suppression approaches that we give. They could be more nuanced but perhaps more efficacious because sadly, patients do pass away when they develop this. And in their cohort of 13 patients, 3 of those patients died. And specifically, in looking in those 3 patients, they actually saw that all 3 patients had a shared T cell cluster. And they can't exactly say what it is exactly yet, but I think it's very interesting to see that because it suggests that there's probably something about the T cell response in those patients that disproportionately triggered a fatal event.  And if we can understand that better, we then may be able to really tailor our interventions in a way that is more useful. Because, frankly, the way these patients usually present is they show up in the emergency room (ER), and they're seen by an ER doctor who thinks they're having acute coronary. They ship them off to the catheterization (cath) lab. They open him up, and then they get in there, and there's nothing going on. There's no plaque. And so now, all of a sudden, everyone is quite confused. And so, if we had better ways to search for that ahead of time to be aware of it, we might have better interventions because usually what happens right at that moment is everybody gets very confused and starts calling the oncologist, and we start slapping on steroids and other immunomodulatory agents, but sometimes it's late.  So, I think this is a great abstract. It's really starting to preliminary give us an idea of what is the actual biology that underpins these terrible events, and we can hope that we can build off that over time hopefully to eventually come up with better predictors and then obviously better interventions to try to avoid these outcomes in a small but real number of patients.  Dr. Diwakar Davar: Excellent. One other point is you and I are both involved in drug development, and as we start thinking of side effects. Side effects are really on the flip side of responses in drug development. So really 1 point to make of this is that when people start developing side effects rather than, as you say, putting your hands up in the air and waving them around, 1 of the things that we should be doing in drug development is possibly biopsying these patients because we could get new PD insights into how these drugs work, why they work, and particularly which sub-populations themselves they work on, particularly in the early-drug development setting when you oftentimes don't have that many responses.  With that, thank you, Jason, for sharing your insights with us today.  Dr. Jason Luke: Thank you.  Dr. Diwakar Davar: And thank you to our listeners for your time today. If you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. So, thank you for your attention, and we will sign out.      Disclosures:  Dr. Diwakar Davar:   Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences  Consulting or Advisory Role: Instil Bio, Vedanta Biosciences  Consulting or Advisory Role (Immediate family member): Shionogi  Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences  Research Funding (Inst.): Zucero Therapeutics  Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy  Dr. Jason Luke:   Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical , Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX  Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine  Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure  Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)  Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio  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.     

On the latest BioCentury This Week podcast, Washington Editor Steve Usdin details how the Advanced Research Projects Agency for Health is taking shape as the new U.S. agency seeks to deliver transformative science and the latest moves by Rep. Anna Eshoo to change its structure via legislation. The podcast team also explores the U.K. NHS's deal with Pfizer Inc. and Shionogi & Co. Ltd. on a subscription-based payment pilot for antibiotics, which could serve as an example for other payers considering similar initiatives; why an IP agreement by the WTO will do little to move the needle on COVID countermeasures; and top takeaways from Zai Lab CEO Samantha Du on The BioCentury Show. In addition, they call for members of the biopharma community to participate in a BioCentury survey on the talent crunch facing industry. All responses will remain confidential.

Giám đốc và kế toán trưởng của Trung tâm Kiểm soát bệnh tật (CDC) Hà Nội vừa bị bắt khẩn cấp chiều 10/6 theo quyết định khởi tố vụ án ‘Vi phạm quy định về hoạt động đấu thầu gây hậu quả nghiêm trọng' xảy ra tại CDC Hà Nội, một diễn tiến mới nhất liên quan đến đại án Việt Á. Xem thêm: https://bit.ly/3wSHe49 Tin tức đáng chú ý khác: Shionogi tiếp tục dự án COVID tại VN sau bê bối của đối tác và Bộ Y tế. Việt Nam tăng chỉ số minh bạch ngân sách, nhưng vẫn dưới trung bình thế giới. Quốc vụ khanh Thuỵ Điển thăm Việt Nam. Nhật chuyển cách ngoại giao để đáp ứng với thách thức bên ngoài. Hàng triệu dân Thượng Hải bị phong toả trở lại. Khai trương cây cầu nối liền Nga với Trung Quốc. LHQ ‘quan ngại' về án tử hình của 3 binh sĩ nước ngoài ở đông Ukraine. Thuỵ Điển tổ chức tập trận BALTOPS với các đồng minh NATO. Nếu không vào được VOA, xin hãy dùng đường link https://bit.ly/VOATiengViet1 hoặc https://bit.ly/VOATiengViet2 để vượt tường lửa

Giám đốc và kế toán trưởng của Trung tâm Kiểm soát bệnh tật (CDC) Hà Nội vừa bị bắt khẩn cấp chiều 10/6 theo quyết định khởi tố vụ án ‘Vi phạm quy định về hoạt động đấu thầu gây hậu quả nghiêm trọng' xảy ra tại CDC Hà Nội, một diễn tiến mới nhất liên quan đến đại án Việt Á. Xem thêm: https://bit.ly/3wSHe49 Tin tức đáng chú ý khác: Shionogi tiếp tục dự án COVID tại VN sau bê bối của đối tác và Bộ Y tế. Việt Nam tăng chỉ số minh bạch ngân sách, nhưng vẫn dưới trung bình thế giới. Quốc vụ khanh Thuỵ Điển thăm Việt Nam. Nhật chuyển cách ngoại giao để đáp ứng với thách thức bên ngoài. Hàng triệu dân Thượng Hải bị phong toả trở lại. Khai trương cây cầu nối liền Nga với Trung Quốc. LHQ ‘quan ngại' về án tử hình của 3 binh sĩ nước ngoài ở đông Ukraine. Thuỵ Điển tổ chức tập trận BALTOPS với các đồng minh NATO. Nếu không vào được VOA, xin hãy dùng đường link https://bit.ly/VOATiengViet1 hoặc https://bit.ly/VOATiengViet2 để vượt tường lửa

Hãng dược Nhật Bản Shionogi cho biết các dự án COVID-19 của họ ở Việt Nam vẫn đang tiến triển, sau khi xảy ra các vụ bê bối gian lận lớn liên quan đến đối tác của họ và Bộ Y tế Việt Nam, theo Reuters.

Almasa and I met in the pre-pharmacy program at The University of Toledo (Toledo, OH), where we earned our BS Pharmacy Degrees.  She earned her PharmD from The Ohio State University and completed a Clinical Research and Drug Development Fellowship at UNC Chapel Hill.  Over the years, she has worked for numerous drug companies, including King, Pfizer, Shionogi, and UCB.  Almasa enjoys the development side of R&D. Although Almasa is not employed in traditional clinical pharmacy practice, she keeps an active pharmacist license. Mentioned in this episode  Almasa's LinkedIn Profile Bosnia & Herzegovina Futures Foundation bhfuturesfoundation.org The University of Toledo College of Pharmacy (Toledo, OH) The Ohio State University (Columbus, OH) UNC Chapel Hill Clinical Research and Drug Development Fellowship (Chapel Hill, NC) King Pharmaceuticals (now part of Pfizer) Pfizer Shionogi UCB The Chicken Whisperer Podcast - What to do with all that chicken poop episode (Apple Podcasts Link) Almasa became successful in the pharmaceutical industry thanks to her pharmacy degrees, fellowship, on-the-job training, managers, mentors, and teams.  A Pharmacy Degree is a good foundation for a role in the pharmaceutical industry.  There are so many roles!  R&D, Clinical Development, Safety, Regulatory, Medical Affairs, and more.  Almasa has worked on pharmaceuticals in many drug classes.   There's more than one way to get a job in the pharmaceutical industry.  Apply first.  Once you're in, you can apply internally for a position or get recruited to fill a role.  Networking helps facilitate moving around.  There's more than one approach. Almasa is an advocate for the Bosnia & Herzegovina Futures Foundation.  As a refugee from the former Yugoslavia in the 1990's, she was displaced to Croatia, then immigrated to the US with her Mom, Dad, and younger sister.  As an adult, Almasa wanted to give back and help youth in Bosnia and Herzegovina.  Bosnia is more than just four large cities: Sarajevo, Mostar, Tuzla, and Banja Luka.  It's also made up of little cities, like her home town of Donji Vakuf.  Almasa mentored a young woman from the Bosnia and Herzegovina (BH) Futures Foundation.  Then, she advocated for a Makerspace in Donji Vakuf.   Sometimes, kids need a little push and good role models.  BH Futures Foundation empowers youth through education, technology, and leadership development.  The Donji Vakuf Makerspace is a place for young people to learn, develop, and try to solve problems.  BH Futures Foundation gives them the tools they need.  Building relationships with community leaders and getting their buy-in was an important part of founding the Makerspace in Donji Vakuf.  When it opened in August 2021, it was well-received by the community.   Almasa cares about kids in small towns having opportunities - not just kids in the big cities.  She wanted to give others a chance to make it as far as they can. What does Almasa do for fun?  Almasa has backyard chickens!  During the pandemic (summer 2020), she hired a carpenter to build a beautiful chicken coop in her backyard.  It looks like a red barn.  She has 4 lady birds (all 4 are different breeds).  They lay 3-4 eggs/day.  When she lets the roam, they like to walk around her yard.  She has learned a lot from the Chicken Whisperer Podcast, including how to compost chicken poop.  In the future, Almasa would like to try raised-bed gardening and use her compost to grow her favorite vegetables. Listen to the podcast for more about how Almasa avoids burnout and some of her favorite board games! Thank you for listening to The Pharmacist's Voice ® Podcast Episode 115!

GSK Australia has developed the GSK Graduate Researcher Program, with support from MTPConnect's Researcher Exchange and Development within Industry (REDI) initiative. The multinational pharmaceutical company gives PhD postgraduates a 12-month placement assigning them to lead on core projects in areas such as early product development, medical affairs and regulatory affairs. The idea is to build Industry capabilities of Australian researchers and establish their career foundations. MTPConnect hosts Caroline Duell and Jarrod Belcher, Director REDI program, catch up with Abraham Daniel, one of the graduate researchers selected for the first cohort in 2020, and his Manager Dr Lachlan Gray, a Medical Manager at ViiV Healthcare Australia, to find out more about the impact of this exciting program. ViiV Healthcare is an independent global specialist HIV company operating as a joint venture between GSK, Pfizer and Shionogi.

This podcast explores what the lasting change will be in how organisations will operate post the pandemic. Jim offers his insights on what the People function of the future should focus on to have more impact. We explore measurement and how to empower managers to inspire and engage their people so that they improve productivity and performance. This is a pragmatic yet thoughtful podcast where we explore the views of someone who has been making a difference for many years.

Dr. Juan Camilo Arjona Ferreira, Chief Medical Officer of Myovant Sciences discusses uterine fibroids and the recent FDA approval of MYFEMBREE® for the treatment of heavy menstrual bleeding associated with uterine fibroids. MYFEMBREE is also being studied in endometriosis. #MyovantSciences #MYFEMBREE Juan Camilo Arjona Ferreira, MD, Chief Medical Officer of Myovant Sciences. Dr. Arjona Ferreira was previously Senior Vice President, Clinical Development at Shionogi. At Shionogi, Dr. Arjona Ferreira was responsible for leading the company's U.S. Clinical Development organization and he served on the company's U.S. Senior Leadership Team and the Global Scientific Committee. Prior to joining Shionogi, Dr. Arjona Ferreira spent over a decade at Merck & Co. where he was Executive Director of Clinical Research in Women's Health. At Merck, he chaired the product development teams for all programs in contraception and women's health. Dr. Arjona Ferreira earned his MD and completed his postgraduate specialist training in Obstetrics and Gynecology at Colegio Mayor del Rosario in Bogota, Colombia.

Christina is the former cofounder of the Innovation Lab of ViiV Healthcare, a joint venture between GSK, Pfizer and Shionogi and focused entirely on HIV therapies. Previously she held leadership positions at GSK and has spent her career at the forefront of healthcare innovation. Learn why it is so important to “be in the game”, how leaders today need to operate in a two-track environment, and why fear is the major inhibitor for disruptive innovation inside a corporation.

Descarga este episodio HALLAZGO FENOMENAL: TUMBA DE MÁS DE 4000 AÑOS. Una tumba privada de más de  4000 años de antigüedad que contiene dibujos "excepcionalmente bien conservados" fue descubierta al sur de El Cairo, según el Ministerio de Antigüedades de Egipto. Khaled al-Anani, ministro de Antigüedades, dijo que la tumba se había descubierto en el sitio arqueológico de Saqqara y que pertenecía a la quinta dinastía de los faraones, que gobernó hace aproximadamente 4400 años MILENIO CONFIRMAN OTRA MUERTE TRAS PROTESTAS DE CHALECOS AMARILLOS. El ministro del Interior de Francia, Christophe Castaner, anunció en un tuit la muerte de una octava persona durante las protestas de los chalecos amarillos por quinto sábado consecutivo; las multitudes de inconformes insistieron en una de sus nuevas demandas: un referendo sobre las políticas de gobierno. EURONEWS | BBC | EL FINANCIERO MEDICAMENTO QUE CURA LA GRIPE EN 24 HORAS. Shionogi, una compañía farmacéutica japonesa, está llevando a cabo las pruebas clínicas finales, en humanos, de un nuevo medicamento capaz de eliminar el virus de la gripe en tan sólo 24 horas, al evitar que se replique dentro de las células que infecta. EXCELSIOR OFERTAS NAVIDEÑAS Sony Interactive Entertainment anunció que tienen la “Promoción para las Fiestas” en PlayStation Store que ofrece hasta un 70 por ciento de descuento en más de 500 juegos para PlayStation 4, PlayStation 3, PS Vita y hasta PSP. PLAYSTATION MUSEO, CON GARCÍA BERNAL, ESTRENA ESTE MIÉRCOLES. YouTube anunció que el filme Museo, la primera película en español de la plataforma de videos, se estrenará por YouTube Premium el miércoles, 19 de diciembre. https://www.cnet.com/es/noticias/museo-gael-garcia-bernal-youtube-19-de-diciembre/ EXTRAÑA FUNCIÓN APARECE A ALGUNOS USUARIOS DE NETFLIX. Algunos usuarios de Reddit; afirman que han comenzado a ver una extraña nueva función en su interfaz de Netflix. De pronto aparece un pop-up; donde pregunta al espectador si desea ver esa escena nuevamente. COSMOPOLITAN EL SINIESTRADO MUSEO NACIONAL DE BRASIL YA TIENE RECORRIDO VIRTUAL. Apenas unos meses después del incendió que acabó con toda la colección del museo, Google ha abierto una versión virtual del Museo Nacional de Brasil que podemos recorrer en Street View. CNN VUELOS EN TIEMPO RECORD YA SON UNA REALIDAD. Este domingo, el jefe de la corporación espacial estatal rusa Roscosmos, Dmitri Rogozin, anunció que los vuelos tripulados super rápidos de tres horas hacia la Estación Espacial Internacional comenzarán en un año y medio. Anteriormente, este trayecto duraba 50 horas. RT THE CURE CON NUEVO MATERIAL LUEGO DE UNA DÉCADA. The Cure ha confirmado que se encuentras listos más lanzar su primer álbum después de 10 años de silencio. El vocalista de al banda, Robert Smith, recientemente dio a conocer que se encontraban trabajando con material nuevo desde hace tiempo, pero el ser incluidos el día de ayer en el Rock & Roll Hall Of Fame ha inspirado al grupo a terminar su proyecto de estudio. ROCK AND POP Facebook Google+ Twitter LinkedIn WhatsApp Te pedimos que te tomes un pequeño tiempo para responder a esta breve encuesta. Nos sirve para mejorar.

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PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano LagravineseIn questa puntata parliamo di:Aziende: EMA, Chiesi, Roche, Società Marco Antonetto, AstraZeneca, Viela Bio, MedImmune, Icon, Shionogi, Seqirus, JSB Solutions, Syneos Health, Adecco.Persone: Massimo Scaccabarozzi (Farmindustria), Nuala Murphy (Icon).Nuove terapie: Xofluza, belimumab, emicizumab.Patologie: influenza, Lupus Eritematoso Sistemico, emofilia A.Lavoro: Quality Assurance Consultant, Clinical Monitoring Project Lead, CRA.Ogni mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su: www.telegram.me/pharmapillswww.facebook.com/pharmapills/Hai un dispositivo Apple? Seguici e abbonati al podcast tramite la app iPod http://nelfarmaceutico.link/pharma-apple

PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano LagravineseIn questa puntata parliamo di:Aziende: EMA, Chiesi, Roche, Società Marco Antonetto, AstraZeneca, Viela Bio, MedImmune, Icon, Shionogi, Seqirus, JSB Solutions, Syneos Health, Adecco.Persone: Massimo Scaccabarozzi (Farmindustria), Nuala Murphy (Icon).Nuove terapie: Xofluza, belimumab, emicizumab.Patologie: influenza, Lupus Eritematoso Sistemico, emofilia A.Lavoro: Quality Assurance Consultant, Clinical Monitoring Project Lead, CRA.Ogni mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su: www.telegram.me/pharmapillswww.facebook.com/pharmapills/Hai un dispositivo Apple? Seguici e abbonati al podcast tramite la app iPod http://nelfarmaceutico.link/pharma-apple

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Targeting the BART system once this week apparently wasn’t enough for Anonymous.  The hacking group says members focused on the transit system again, this time hacking into the Police Officers Association website.  The group claims to have the private information of more than 100 BART police officers. This next story proves that you can hack just about anyone, anywhere, even at McDonalds.  37-year old Jason Cornish of Smyrna, Georgia allegedly attacked his former employer, Shionogi, for revenge.  Cornish was an information technology employee at the Japanese drug maker but resigned because of company layoffs that affected his former supervisor and close friend. A British college student faces some very serious charges after he allegedly hacked into Facebook.  It took several tries before he was able to penetrate the social networking site.   According to reports, 25- year old Glenn Steven Mangham used “considerable technical expertise” to repeatedly bypass security. Also, tune in for the job of the day.