The "Elevate" by MAPS Podcast

Kathryn Gann, Independent Consultant, serves as the moderator for this session on Global Communications. In this podcast, Robin Winter-Sperry, MD, President & CEO, Scientific Resilience, interviews Aimee Christian, Ph.D., Global Head of Communications, Specialty Care, Sanofi-Genzyme.At the end of this series of podcasts, the audience should be able to:·         Discuss the functions and activities of key internal partners·         Identify potential areas for compliant collaboration by MSLs with key internal partners

In this first of two episodes, John Pracyk, MD, PhD, MBA speaks with Patrick Vega of Vizient Advisory Solutions about ways that device companies can capitalize on the shift from inpatient surgical settings to hospital outpatient departments, ASCs and outpatient sites of care. Presenters hypothesize that device companies that better understand the outpatient setting can more effectively adapt their products, services and support to meet customer needs. 

External experts play a key role in the success or failure of the innovations delivered by the pharma/biotech industry. In today’s environment, restrictions continue to impede broad access to practicing physicians who in turn have less autonomy and it’s harder to gain access to them. At the same time, the complexity of the science behind future products increases the needs for diverse involvement aligned experts. Strategic engagement provides insights as new product develop, generate data, refine strategy and create relevant, credible and persuasive scientific communication. Thus relationships built and fostered through Medical Affairs are becoming more valuable in creating awareness and adoption. This podcast will explore how successful expert relationships reflect trust and needs in long-term cooperation from both parties.  

The Series Podcast Objectives are:  Understand how the medical affairs strategic planning process can drive decision making throughout the year  Gain insight into the value medical affairs bring across an organization when an effective, collaborative, aligned medical strategy plan is developed  Obtain a working knowledge of how cross-functional teams within medical affairs can reference strategic plans to inform decision making and assess impact of efforts  Monica DeAbadal, MD, MBA/HSA, Vice President, Medical Excellence at Ipsen and MAPS Medical Strategy & Launch Excellence co-lead, culled out highlights from the Medical Strategy Strategy Planning live session at the March 2020 Annual MAPS Conference.The session speakers who provided these critical intellectual components of Building the Medical Affairs Strategic Plan are: Peter Piliero, MD, Vice President & Head, Medical Affairs Americas at GSK Consumer Healthcare; Eileen K Sawyer, PhD, Vice-President, Global Medical Affairs, UniQure; and, Anna Walz, CEO of MedEvoke. 

In this second of two podcasts, Pete Piliero, MD, VP & Head, Medical Affairs Americas, GSK Consumer Healthcare, moderates a discussion on Global/Regional/Local Planning; Approach to MA Strategic Planning - Rare Disease & Oncology; and, Compliance Considerations.Panelists are: Tina Beaman, VP and Chief Compliance Officer, Karyopharm Therapeutics Ed Gudaitis, President & CEO Acerus Pharma Keith Johns, VP, Global Marketing and Alliance Management, Eli Lilly & Co Maria Rivas, Chief Medical Officer, EMD Serono/Merck KGaA

In this first of two podcasts, Pete Piliero, MD, VP & Head, Medical Affairs Americas, GSK Consumer Healthcare, moderates a discussion on Contributions Medical Affairs Makes to Asset Strategic Plans; and Time Horizon, Refreshing, and Resourcing of a Medical Affairs Plan. Panelists are: Ed Gudaitis, MBA, President & CEO Acerus Pharma Keith Johns, MBA, VP, Global Marketing and Alliance Management, Eli Lilly & Co; Maria Rivas, MD, Chief Medical Officer, EMD Serono/Merck KGaA 

Cerise James, MD, moderates this podcast presentation by the MAPS Evidence Generation Focus Area Working Group in which Neil Belson, JD, discusses Real World Evidence and its impact. The podcast objectives are: To define Real World Evidence, and to demonstrate RWE and its impact to Biotech/Pharma.Mr. Belson will address a variety of topics including: The significance of Real World Evidence for the pharmaceutical and medical device industry; and, how the FDA views Real World Evidence. This is the first podcast in a series.

In this second podcast on the EUMDR, panelists John Pracyk, MD, PhD, MBA, Worldwide Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, DePuy Synthes - Spine | Johnson & Johnson Medical Devices Companies welcomes Philip Desjardins, JD, Vice President, Global Regulatory Affairs Spine and Medical Device Regulatory Policy, DePuy Synthes | Johnson & Johnson Medical Devices Companies, and Drilon Saliu, PharmD, MBA, Head, Medical, Clinical and HEOR, Connected Care, Philips, continue their comprehensive discussion of: Covid’s impact on EUMDR; USFDA and EUMDR global regulator comparison; short and long term impacts; how Brexit might impact the UK’s regulatory oversight; the importance of investing in top talent; new capabilities that are required; the importance of leading with influence; and, evidentiary compliance planning and budget impact.

Host John Pracyk, MD, PhD, MBA, Worldwide Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, DePuy Synthes - Spine | Johnson & Johnson Medical Devices Companies welcomes Philip Desjardins, JD, Vice President, Global Regulatory Affairs Spine and Medical Device Regulatory Policy, DePuy Synthes | Johnson & Johnson Medical Devices Companies, and Drilon Saliu, PharmD, MBA, Head, Medical, Clinical and HEOR, Connected Care, Philips, to share insights into the importance of compliance with the new European Device Medical Regulation (EUMDR), including key deadlines for compliance. 

Hosts John Pracyk, MD, PhD, MBA, Worldwide Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, Depuy Synthes - Spine | Johnson & Johnson Medical Devices Companies and Marc Rubinstein, MD, Medical Director at Instrumentation Laboratory, welcome panelists Huub Kreuwel PhD, Vice President of Scientific and Medical Affairs at Octapharma, and Sean Lilienfeld MBBCh, MMEd(Neuro), FCP (Neuro), FAAN, a neurologist by training, and currently Vice President of Global Medical Affairs Clinical Operations, Pre-Clinical Research, and Clinical Strategy at Boston Scientific, two professionals who have successfully transitioned careers between MedTech and Pharma, and reciprocally, Pharma and MedTech.