Medical Affairs Unscripted

Drs. Crowley-Nowick and Keir set the stage for a successful launch as they consider the key components of a MA Team and their contributions on the road to launch and beyond, from the formation and training of the Medical Science Liaison Team (MSLs) to the early inclusion of Medical Information, to developing best practices for Scientific Communications while also engaging with Patient Advocacy groups as part of the planning process. They also address the importance of a robust Data Generation program with the Medical Director at the helm gaining insights and trends from these data which allows the organization to pivot as necessary.

In this eighth episode of Zipher’s Medical Affairs Unscripted, our host Peg Crowley-Nowick, PhD, MBA, Founder & President of Zipher Medical Affairs met with Chris Keir, MD, MS. Dr. Keir’s extensive experience and understanding of the dynamic nature of the peri- and post-launch environment has lead to successful outcomes.  He was instrumental in leading the launch of the first globally, commercialized CART-T cell therapy, tisagenlecleucel-T, for Novartis.  Most recently, he built a medical affairs organization for Array BioPharma, Inc., and led the US launch of binimetinib and encorafenib in combination for advanced BRAF-mutated, unresectable, or metastatic melanoma.  During the acquisition of Array BioPharma by Pfizer, Dr. Keir was responsible for the medical transition while also preparing for a second launch for encorafenib in combination with cexutimab in BRAF-mutated colorectal cancer. Dr. Keir has recently shifted into the diagnostic space as the V.P., of MA at GRAIL, Inc., and is leading the launch of their new technology for early cancer detection.

Starting from the clinical trials and ending with meeting the regulatory demands across various countries, bringing a product to market successfully has become increasingly difficult. Therefore, it is critical that an overall launch strategy is established and executed. Developing an integrated and comprehensive launch roadmap is the first step in preparing for launch. Delivering the Medical Affairs program on time, on target, and on budget is essential for success. A solid program management function and systems ensures that progress is monitored, measured, and communicated and adjustments to the course based on internal and external insights are clearly visible to the entire organization.

In this seventh episode of Medical Affairs Unscripted, our host Peg Crowley-Nowick, PhD, MBA, Founder & President of Zipher Medical Affairs had the opportunity to meet with John Walsh, MD who is not only leading the Medical Affairs organization as Senior Vice President at Ardelyx, Inc., but is also a practicing clinician in the areas of Family Medicine, Urgent Care, Telemedicine, and Pre-Hospital Emergency Medicine. Because of Dr. Walsh’s unique position as a physician in industry and practicing clinical medicine, he provides valuable insights on what drives a successful launch. Additionally, he discusses how to prepare for and manage the operations of an effective launch. He and Dr. Crowley-Nowick discuss the use of visualization and tracking tools to easily measure progress, ensure organizational alignment, meet desired communication cadence for management and teams, and ensure tactics are driven by overarching priorities.

Measuring the impact of the Medical Affairs (MA) organization is not as straightforward as it is for other functions (e.g., increase in revenue or market share for Commercial) and remains a challenge for most pharmaceutical companies today. There have historically been no simple metrics to evaluate the influence of MA, so our host Peg Crowley-Nowick, PhD, MBA, Founder & President of Zipher Medical Affairs met with Meg Heim, RN, MBA, previously Vice President, Global Head of Scientific Engagement Strategy, Operations and Program Management at Sanofi and currently President at Heim Global Consulting, to discuss a methodology she developed and employed to truly measure the effectiveness of the Medical Affairs (MA) organization.

After briefly touching on Meg’s experience in advocacy and policy and its importance in advancing MA, Dr. Crowley-Nowick asks Meg to explain what MA has to do to demonstrate impact. The conversation focused on how to measure impact over time and ensure that this resonates throughout an organization. Additionally, Meg addresses the importance of working with vendor partners to fill in gaps in expertise and to provide support services that can prove to be incredibly valuable for insights, decision making, and refining strategy (e.g., data on key opinion leaders). 

Medical Affairs (MA) continues to shed its historic role as a support function and establish itself as a critical pillar alongside Commercial and Research & Development (R&D). However, shifting from independently, operating functional areas to strategic, cross-functional, business-wide partnerships remains a challenge for MA.

Zhen Su, MD, MBA, the current Senior Vice President and Global Head of the Oncology Franchise for Merck KGaA, Darmstadt, Germany offers novel approaches for modernizing perspectives at an individual level regarding the role of MA, by fostering an appreciation and internal mindset of MA as a strategic, partner, while still maintaining the ever-important compliance boundaries.

Dr. Su has over 20 years of experience in academic and pharmaceutical medicine across Clinical Development, MA, Commercial and Business Development consequently allowing him to provide personal insights regarding the value and impact of improving cross collaboration and synchronizing focus across the business.  

Host Peg Crowley-Nowick, Ph.D., MBA, Founder & President of Zipher Medical Affairs invites Dr. Su to also share his thoughts on navigating product launches during the COVID-19 era and beyond. Drs. Crowley and Su close the podcast with a discussion about how to ensure that teams work together in this new virtual environment.

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.

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.   

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 [email protected].