In Medical Affairs Unscripted we explore a range of topics related to the strategic role of Medical Affairs from the perspective of industry experts. Through these conversations with our guests we will share first hand experience to provide the listener with insights and knowledge about the evolving role of Medical Affairs.
Episode 10: “Medical Affairs Capabilities to Create a Competitive Advantage,” with guest, Tamas Suto
Leading Medical Affairs (MA) organizations have begun to strategically redefine their team’s requisite executional capabilities to enhance and tailor frontline engagement initiatives, to improve the impact of knowledge development (insights and evidence generation), and to further solidify their position as a vital leader rather than a support function within the biopharmaceutical industry. These executional capabilities ultimately accelerate the time to market, creating a competitive advantage as well as (and most importantly) maximizes the number of patients reached with life-saving treatments.
Dr. Tamas Suto is passionately dedicated to improving the lives of patients and public health as evidenced by his decades in not only direct patient care, but also in industry spanning the commercialization process from identification of a drug candidate through the end of the lifecycle of a compound. His extensive experience in large pharma as a global executive in MA leadership at Sanofi, Amgen, and Roche/Genentech prior to his current position as SVP., & Head of Global MA Oncology at Merck KGaA, Darmstadt, Germany underpins his well-founded and impressive vision of the critical capabilities of the MA team. Dr. Peg Crowley-Nowick, Founder and President of Zipher Medical Affairs, guides Dr. Suto in this podcast in sharing the paramount yet foundational competencies for impactful individual contributions in each of the four key elements of the MA team pursuits: insights, evidence generation, stakeholder engagement, and medical leadership.
Gathering, Understanding, and Leveraging Insights with Muriel Siadak, PAC
Our host Peg Crowley-Nowick, PhD, MBA, Founder & President of Zipher Medical Affairs and Muriel Siadak, PAC, Senior Medical Director at Seagen Inc., spotlight the ever-increasing value and impact of insights on product strategy, positioning, and tactics. As Medical Affairs (MA) teams are now more than ever asking deeper, multifaceted questions to gain insights about the drivers of patient and healthcare professional decisions, Ms. Siadak, shares her vast experience in MA to help us explore the importance of ensuring that insights are appropriately gathered, disseminated to and discussed with internal stakeholders, and leveraged cross functionally.
Contact Zipher at www.ziphermed.com/contact to learn how to develop a program within your organization.
Medical Affairs Launch Readiness: Building, Planning & Execution
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.
Executing Launch: Develop, Visualize, and Communicate
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 Medical Affairs
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 as a Strategic Equal and Maximizing a Virtual Launch
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.