PharmaTalkRadio

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 Therapeutics

Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

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. Daly will discuss:

The feasibility and acceptability of remote monitoring in the post discharge setting for patients with cancerPatient perspectives for remote monitoring post hospital dischargeePRO versus device and challenges with implementationThoughts on the right data to collect and at what intervals

Speaker:

Robert Daly, MD, MBA, Assistant Attending Medical Oncologist, Department of Medicine, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center

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