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In this session, first recorded at the 2022 IO360° Summit, Dr Semenza will talk about how his work is impacting cancer immunotherapy. Dr Semenza’s groundbreaking discovery of hypoxia-inducible factors paves the way for the development of drugs that could kill cancer cells by cutting off the oxygen supply tumors need to grow and improve the response to immunotherapies. Key areas addressed include: Regions of intratumoral hypoxia are a common feature of advanced cancersHypoxia-inducible factors increase the expression of multiple proteins that mediate immune evasionHIF inhibitors stimulate anti-tumor immunity and improve the response to immune checkpoint blockade Gregg Semenza, MD, PhD, Director, Vascular Program, Institute for Cell Engineering and Professor of Genetic Medicine, Johns Hopkins University School of Medicine Learn more about the IO360° Summit at www.io360summit.com

Neoadjuvant (pre-surgical) immune checkpoint blockade may prevent cancer relapse and progression.This treatment approach is now FDA-approved for resectable triple-negative breast cancer, and hundreds of clinical trials in other cancers are ongoing.Surgical resection specimens collected after several weeks of neoadjuvant ICB offer vast opportunities for predictive biomarker discovery and understanding ICB response/resistance. Suzanne Topalian, MD, Associate Director / Professor of Surgery, Bloomberg~Kimmel Institute for Cancer Immunotherapy / Johns Hopkins University Learn more about the IO360° Summit at www.io360summit.com

Nouhad Husseini, MBA, SVP, Business Development and Corporate Strategy, Regeneron Pharmaceuticals with Allan Shaw, CFO / Founder & Senior Managing Director, Portage Biotech / Shaw Strategic Capital, LLC Learn more about the IO360 Summit at www.io360summit.com

What is the impact of targeted radiotherapy on the immune system?What are the implications for combination IO?Current approaches and future direction Moderated by: Michael Groaning, PhD, Global Medical Affairs Lead, Genitourinary, Amgen Panelists: Charles Glaus, PhD, Sr Director, Radiomics & Radiology Biomarkers, Bayer US-PharmaceuticalsJeff Legos, PhD, MBA, EVP, Global Head of Oncology & Hematology Development , NovartisMatthew Silva, PhD, CEO , InvicroOhad Ilovich, PhD, Senior Director, Translational Sciences, Curie Therapeutics Learn more about the IO360° Summit at www.io360summit.com

Learn more about the IO360° Summit at www.io360summit.com

In this podcast, you will hear a keynote fireside discussion with Dr Robert Langer, MIT, and Dr Ester Caffarel-Salvador, Chiesi USA, from the 2022 PODD Conference regarding current projects in the Langer Lab, how COVID affected the lab’s dynamics and collaborations, challenges in the drug delivery space, and exciting technologies in the pipeline,  To learn more about the PODD Conference, please visit PODDConference.com.  

This panel, first recorded at the 2021 Immuno-Oncology 360° Summit, will bring together chinese biotechs to share how they are partnering with additional IO companies to advance cancer treatments for patients. This will include partnering strategies and decision making. To learn more about the IO360° Summit visit, www.io360summit.com

In this session, GSK shares how they delivered on patient and caregiver engagements, especially with communities experiencing the highest COVID burden. They gained insights on study designs, educational pieces and captured patient experiences to enhance HCP/public COVID awareness. GSK will discuss: Value of COVID engagements Novel approaches and mechanisms for finding patients who don’t belong to an organized patient community Overcoming challenges How this initiative could be modeled to help find future patients when the pathway is not clear Patient Perspectives-In their own words Susan Burriss, Patient Engagement Lead, GSK Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

In this session, Janssen shares how they are collaboratively working with patients and sites to advance DCTs and will share engagement methodologies, what they have learned from the perspective of participants and sites, and the direction this has taken them in DCTs. Alyson Gregg, Director Patient Insights, GMA Commercial Operations, Janssen Morgan Wooten, Investigator & Patient Engagement Program Team Leader, Janssen Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

Merck’s iLab53 (a modular 39-foot mobile unit) was used to bring clinical research into community settings as an effort to increase clinical trial awareness and engagement. More specifically: How the iLab53 was created and implemented How Merck is continuing to work to help build trust within communities, and provide increased access to clinical research Challenges, learnings and successes to date How this initiative can be scaled and adapted Susan Manoff, MD, MPH, Executive Director, Office of the Chief Patient Officer, Merck Kai Bode, Director, Digital Innovation and Patient Strategy, Global Digital Analytics & Technologies Team, Merck Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

In this session, Sanofi shares how they created and implemented an end-to-end fully integrated patient informed R&D organization that works directly with patients as advisors in 100% of development staged programs from discovery and supporting research pipeline prioritization to registration. Key topics include: Aligning with the patient community’s most pressing needs Gaining insights that established clinical programs and studies and reshaped clinical trial designs and logistics Prioritizing early diversity & inclusion planning Generating patient relevant data that supports improved patient experience Victoria DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi R&D Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

In this podcast, you will hear a keynote presentation from Dr John Maraganore from the 2022 PODD Conference regarding lessons learned from his 19 years as CEO of Alnylam Pharmaceuticals, leading a team that conquered some very difficult drug delivery challenges.  To learn more about the PODD Conference, please visit PODDConference.com.  

Legal barriers exist for many good reasons, but can block our pathway in making the changes needed to help patients in the current climate. The panel addresses: Protocols that require approval from legal and complianceR&D and compliance, breaking down the silos and working jointly for patient needsHow to bring the patient voice to legal and compliance initiatives that impact patients?What are the next steps? What initiatives could legal/compliance be a part of with patient engagement to gain an understanding of the impact and urgency of their approvals? Led by: Marilyn Metcalf, PhD, Senior Director, Patient-Focused Development, Global Medical, GSK Panelists: Roslyn Schneider MD, VP, Scientific, Medical and Patient Affairs, Theravance Biopharma USParthena Psyllos, Senior Corporate Counsel, Clinical Development Legal, PfizerSue Gregory, Former Managing Counsel/Executive Director, GSKCandace Lerman, Patient Advocate and AttorneyKate Harr-Sponsler, Associate General Counsel – Global Commercial, Spark Therap

Learn more about the IO360° Summit at www.io360summit.com

In this session recorded at DPHARM 2021, Merck shares about their proprietary Site Monitoring and Reporting Tool (SMART), an iOS Apple iPad technology that enables “monitoring and deviation management” before, during and after COVID-19. Merck talks about how they got SMART. Merck developed a real-time “scorecard” for sites called Site Health Check, which allows them to see how they are performing in absolute and relative terms compared to other sites. Merck addresses how this really helped in COVID-19. Merck has engaged in project RESTART to help sites and to lock databases (~300 locked in 2020 and none missed in 2020 and 2021). Merck shares with the DPHARM audience how this worked.  Speakers Andrew Onikepe, Director, Monitoring Excellence – North America, Global Clinical Trial Operations (GCTO), MerckMerle Schneider, Director, Monitoring Excellence Innovation, MerckKatherine Taylor, MBA, Head, Risk Evaluation and Adaptive Integrated Monitoring (REAIM), Global Clinical Trial Operations (GCTO), Merck

In this session from DPHARM 2021, Gilead shares how they designed, developed and obtained Emergency Use Authorization and Full Approval for Remdesivir for the treatment of COVID-19 in record time. Key topics: How they built new capabilities at an extremely accelerated pace to design and execute the remdesivir trialsThe role of Real World Data (RWD) in remdesivir trials to understand the natural history of the disease, to inform study design and conduct, and support real world effectivenessManaging compassionate use programs and communicating with regulators at the peak of the global pandemicLessons learned and the impact on other therapeutic areas Speakers: Matthew Bryant, MBA, Head of Technology & Innovation Global Development and Clinical Operations, Gilead SciencesAnand Chokkalingam, PhD, Senior Director, Clinical Research, Gilead SciencesHassan Kadim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS

In this podcast, you will hear a presentation with Peter Skutnik, BD Medical-Pharmaceutical Systems and Wendy D Woodley, BD Technologies & Innovation, from the 2022 PODD Conference regarding challenges in combination product development, patient-centric device development considerations, as well as case studies in large volume subcutaneous formulations. To learn more about the PODD Conference, please visit PODDConference.com.  

In this session from DPHARM 2021, Regeneron's Bari Kowal sits down with Craig Lipset to discuss: Driving greater efficiencies in a pandemicA fresh look at solving problemsPrioritizing priorities Speakers: Bari Kowal, Senior Vice President, Head Development Operations & Portfolio Management, RegeneronCraig Lipset, Advisor and Founder, Clinical Innovation Partners

In this session recorded at DPHARM 2022, Memorial Sloan Kettering Cancer Center shares about their Connected Care protocol. Digital monitoring of patients has the potential to better the delivery of cancer care through improved patient-provider communication, enhanced symptom and toxicity assessment and management, and optimized engagement across the cancer continuum. Remote monitoring is especially crucial when patients are at high risk for experiencing symptoms or toxicities from treatment. During these episodes, patients and clinicians benefit from routine assessments of electronic patient-reported outcomes (ePROs) to identify symptoms early and prevent adverse outcomes. The Connected Care protocol provides remote monitoring to medical oncology patients for 10-days post hospital discharge as this is a high-risk period for patients due to a lingering symptom burden and a need for enhanced patient-clinician communication as symptom management shifts from the inpatient to outpatient team. Specifically, Dr. D

In this session recorded at DPHARM 2022, panelists from Pfizer discuss: Understanding the key steps Pfizer is taking to make remote clinical trials a reality for patientsExploring the cross functional team approach to scaling remote clinical trials across all therapeutic areasExamining the impact of adopting the light speed mindsetReviewing the key learnings and what the voice of the patient data reveals to date Speakers: Tim Joy, Executive Director, Head of Strategic Solutions, PfizerDaniela Graham, Clinician, Pfizer