PharmaTalkRadio

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...

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 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 hi...

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,...

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 especial...

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...

This session was recorded at DPHARM 2022. As the life sciences industry’s focus on digital transformation advances at a rapid pace, the opportunity to understand how well your organization stacks up to the rest of the industry around digital maturity in clinical operations can be highly valuable. This session examines a new benchmarking effort to help pharmaceutical companies rank their digital ca...

This is a session recorded from DPHARM 2022. As the competition to recruit patients for clinical trials increases and sites are burdened by staffing shortages, technology shifts and more, how can innovative trial designs reduce patient, site and investigator burden? Designing for patient centricity – reducing the burden for patients, sites and investigatorsAddressing organizational implementation...

In this session recorded at DPHARM 2022, moderated by Pfizer's Amy Cramer, the panelists discuss patient data. Often the elephant in the room that hinders the advancement of innovation in clinical trials for the benefit of patients in the lack of structured, clean patient data. R&D executives know the ability to garner greater data value from all data sources [clinical trials, EHRs, claims dat...

In this session recorded at DPHARM 2022, Pfizer's Judy Sewards is joined by Patient Advocate Barry Nelson. Judy Sewards was one of the top 30 leaders who played a critical role in the success of Pfizer’s Covid-19 vaccine clinical trial program. In her role, she led patient and site communications and engagement. She was responsible for Pfizer’s relationships with the over 150 trial sites who condu...

About The Episode When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. Securing approval but lacking market access results...

In this podcast, you will hear a presentation from Dr Liping Zhou, AstraZeneca, from the 2022 PODD Conference regarding formulation techniques and developability considerations for LAI peptide delivery, with a case study example. To learn more about the PODD Conference, please visit PODDConference.com.  

In this session recorded at DPHARM 2022, Moderna discusses its recent partnership with CVS Health to bring its clinical trial closer to patients and expand patient access into more communities. Review the complexities of forming a new partnership and developing a model for implementation and executionExamine the model in terms of investigator strategy, shipping and logistics approach and overall q...

In this session recorded at DPHARM 2022, Bari Kowal, SVP & Head, Development Operations and Portfolio Management, Regeneron, moderates a panel discussion on: Examining how modernizations like the implementation of AI/ML, RWE, DE&I, DCTs impact the need for more flexibility clinical trial designBuilding protocols in tandem with study design and re-envisioning methods to execute trials Panel...

In this podcast, you will hear a keynote presentation from Dr Peter Cullis, UBC, from the 2021 PODD Conference regarding the path of discovery and innovation that led to the lipid nanoparticle delivery system driving one of the most successful vaccines against COVID-19. To learn more about the PODD Conference, please visit PODDConference.com.  

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

Evaluating single cell omics to understand the heterogeneity in immune and tumor cellsMulti-omic biomarkers for patient selection in solid tumor IO: is there a path to more personalized therapy? In an era of ‘targeted’ therapies against cell-intrinsic mechanisms (e.g. PARP, NTRK, BRAF) and surface molecules (Nectin-4, HER2), is there a path forward for pan-tumor biomarkers, or is multi-tumor more...

In this podcast, you will hear a presentation from Dr Barbara Lueckel, Roche Pharma Partnering, from the 2021 PODD Conference summarizing trends, approvals and pipelines within the drug delivery space. To learn more about the PODD Conference, please visit PODDConference.com.    

Dan Chen, MD, PhD, Founder, Engenuity Life Sciences Learn more about the IO360° Summit at www.io360summit.com

This panel, first recorded at the 2022 IO360° Summit, reported on advances in achieving more diversity and inclusion in oncology clinical trials. Moderated by: Adrelia Allen, PharmD, Director, Clinical Trial Patient Diversity, Global Clinical Trial Operations, Merck Research Labs Panelists: Chétna Rao, PhD, Head of Site Strategy and Operations, BMSRobert Vonderheide, MD, DPhil, Director, Abramson...

About The Episode With pharma’s focus on the extension of drug release windows, new technologies are needed that can lengthen that duration. Today, Zach Fletcher of Trelleborg Healthcare & Medical provides an insight into how the emerging field of long-acting implantables & polymeric drug delivery can address that need. He will be addressing: current applications of implantables and likely...

CAR T cells for solid tumors: Lessons learned from on-going clinical trials in glioblastoma. Interplay between CAR T cells and the endogenous immune systemNext-generation CAR designs to overcome barriers for solid tumor CAR therapy Christine Brown, PhD, Deputy Director, T Cell Therapeutics Research Laboratory, Beckman Research Institute, City of Hope Learn more about the IO360° Summit at www.io360...