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In this Internal Edition of the Zipher Medical Affairs Unscripted podcast series, Dr. Peg Crowley-Nowick, Founder & President of Zipher Medical Affairs is joined by Zipher’s own Julie Cahill, M.D., Vice President of Consulting and Medical Director Services to continue the conversation from Episode 4: Data Generation • The Intersection Between Medical Affairs and Clinical Development by expanding further on the need to identify data gaps and how organizations can work together to consider the full scope of research that can be used to fill those gaps. Dr. Cahill, an industry expert and a board-certified general surgeon, shares how Medical Affairs, though often overlooked in early data generation planning initiatives, can actually be a strategic partner in building a cross-functional data generation program. Our host and expert guest discuss the importance of early consideration of potential data gaps, what data/evidence generation means to different companies, and when Medical Affairs should start planning for data generation. They also take us on a detailed tour on how to coordinate the collective and complementary perspectives of each of the functional areas to create a prioritized and persisting, but pliable data generation program. Dr. Crowley-Nowick also asks Dr. Cahill to provide an overview of the advantages and disadvantages of using technology to conduct these planning workshops in our unprecedented times of the COVID-19 pandemic. Lastly, because of the ever-evolving organizational priorities and landscape of clinical care, the frequency in which a data generation program should be reviewed and refined is discussed as well as the value of developing a communication plan to ensure consistency in external messaging.

As the Medical Affairs Unscripted podcast series continues to distinguish Medical Affairs as one of the major pillars of biopharmaceutical organizations, Dr. Peg Crowley-Nowick, Founder & President of Zipher Medical Affairs hosts Dr. Adam Schayowitz, an industry veteran and current Vice President and Medicine Team Lead at Pfizer, to discuss the intersection between Medical Affairs (medical) and Clinical Development (development) with regards to data generation as medical continues its evolution as the third pillar in industry. Dr. Crowley-Nowick draws on Dr. Schayowitz’s expertise which crosses both medical and development to get his insight on the potential impact medical can have on development programs, in particular supporting the data generation program. He answers questions regarding cross-functional strategies for data generation, such as what and how medical contributes, when the development team should be engaging with medical, where medical can help accelerate development programs, and more. The host and expert guest discuss the advantages of using this broader team to identify, prioritize, and address data gaps. Also, Dr. Schayowitz shares his recommendations on how Medical Affairs intersects with Clinical Development in the planning and execution of a data generation strategy and its implementation throughout the lifecycle of an asset. Lastly, the podcast closes with Dr. Schayowitz’s experience in his shift from medical to development and the value of having medical aligned with both the development and commercial organizations with regards to data generation. For more information visit www.ziphermed.com or email us at info@ziphermed.com. 

Zipher’s Medical Affairs unscripted features Randi Goeckeler, an industry expert with over 25 years of experience and most recently the Executive Director of Global Stakeholder Relations at Allergan, who discusses how to build an integrated, strategic stakeholder relations program to accelerate availability of treatments for patients and ultimately help them have better outcomes. Host Peg Crowley-Nowick, Ph.D., MBA, Founder & President of Zipher Medical Affairs invites Randi to share her insights on the challenges that organizations are facing regarding stakeholder relations and how to ensure that engagements are innovative, intentional, interconnected, and impactful. As presented in her Stakeholder Relations Strategic Engagement Roadmap, Randi addresses the differences between transactional versus strategic engagements, and she also describes the required elements for designing a strategic framework for stakeholder relations, while maintaining compliance. Additionally, Dr. Crowley-Nowick asks Randi to share her experiences on how to fuse the focus of regional and global teams. The podcast closes with novel ways that Medical Affairs organizations can use digital media during the current COVID-19 disruption to accomplish objectives that were once carried out at face-to-face venues.

During this episode of Medical Affairs unscripted, Dr. Crowley-Nowick has a conversation with Holly Schachner, MD, former CMO of Specialty Medicine at Allergan to examine the business objective of Medical Affairs (MA) organizations and how MA can move closer to being identified as a strategic pillar within the life sciences industry alongside the Research & Development and Commercial organizations. Dr. Schachner, who has nearly 20 years of experience in the pharmaceutical industry after her work as a clinician and researcher, provides key insights for MA professionals on how to use their position and experience from industry and clinic to help drive internal strategies in alignment with external needs; the needs of the patient. She offers valuable guidance on how the MA organization plays an important role from early in the development of a molecule through to launch and beyond, and how MA is the link that can maintain consistency of the ‘why’ behind the cross-functional activities being conducted. Ultimately, Dr. Schachner shares her thoughts on the roadblocks to MA becoming the 3rd strategic pillar within life sciences organizations and how to overcome these challenges.    For more information visit www.ziphermed.com or email us at info@ziphermed.com.   

Peg Crowley, Ph.D., MBA, Founder & President of Zipher Medical Affairs meets with Dan Hennessy, Ph.D., MBA, Vice President of Strategic Excellence at EMD Serono to discuss a fresh look at the complexity of the matrix of stakeholders who play a critical role in the patient care cycle, including the layers of individuals in the clinics and hospitals, in healthcare economy, and in advocacy societies. Drs. Crowley and Hennessy, who combined have about 35 years of experience in industry, address the importance of maintaining scientific exchange between the stakeholders and Medical Affairs organizations during a pandemic, which has created an unanticipated interruption to former methods of engaging with stakeholders. They offer an overview of the challenges with the current channels of communication as well as suggestions on how to maintain previously established relationships and how to navigate the development of new engagements in our current landscape of communication. They also discuss the key risks of not engaging with stakeholders, and not building and maintaining those relationships effectively. Lastly, they examine the future of communication with stakeholders in the short-term and long-term and how to adapt with this constantly changing environment during a pandemic. For more information visit www.ziphermed.com or email us at info@ziphermed.com.