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Medical Affairs Strategic Summit East — Virtual
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Monday, June 1
 

10:00am

Chairperson’s Opening Remarks
Speakers
avatar for Ashish Dugar, PhD, MBA

Ashish Dugar, PhD, MBA

Vice President, Global Medical Affairs, Sarepta Therapeutics


Monday June 1, 2020 10:00am - 10:15am

10:15am

Panel Discussion: Explore Launch Planning for Organizations of Varying Sizes
  • Dive into key points to prepare for launch from medical perspective best optimized for the company
  • Consider not the size but the nature and complexity of the patient community and the clinical & advocacy community that serve them
  • Obtain a true understanding of the underserved medical needs and how your company/products can serve these
  • Deliver optimized scientific communications & medical education to fit the needs of the audience and what your company/products can deliver

Moderators
avatar for Stanislav Glezer, MD, MBA

Stanislav Glezer, MD, MBA

Global VP, Medical Affairs, Diabetes Care, BD
Stan Glezer, MD, MBA is an industry physician, passionate about optimizing value of pharmaceutical innovation for the patients, through partnering with the healthcare system.With almost 25 years of industry experience, Dr. Glezer is a Global Vice President of Medical Affairs, Diabetes... Read More →

Speakers
avatar for Randall Kaye

Randall Kaye

Chief Medical Officer, Neurana Pharmaceuticals
avatar for Yurek Paprocki, MD

Yurek Paprocki, MD

MBA, Medical Lead Director, Novo Nordisk
Dr. Yurek Paprocki is responsible for development and implementation of Medical Affairs strategy for diabetes products at Novo Nordisk, Inc., located in Princeton, NJ. Most recently he has been responsible for the launch of Ozempic®, the fastest diabetes brand to reach a blockbuster... Read More →
avatar for Georgea Pasedis, PharmD RPh

Georgea Pasedis, PharmD RPh

Head of Medical Affairs, Dompé
Georgea Pasedis is a Doctor of Pharmacy graduate from MCPHSU Boston and is a licensed pharmacist in Massachusetts. Currently Georgea is the Head of Medical Affairs for Dompe Pharmaceuticals. She has extensive experience in Ophthalmics, CNS, Pain, Oncology and Cardiology. Having held... Read More →
avatar for Elizabeth Pash, MS, RD, LDN

Elizabeth Pash, MS, RD, LDN

Vice President of Medical Affairs, Gelesis
Elizabeth plays a critical role in shaping and executing the overall medical strategic plan and key operational decisions for Gelesis as their Vice President of Medical Affairs.  Before joining Gelesis, she was Head of Medical Science for Abbott Nutrition. Prior to that, she served... Read More →


Monday June 1, 2020 10:15am - 11:00am

11:10am

Leverage Online Discussion Platforms for Optimal Stakeholder Engagement
  • Identify the logistical and resource barriers to domestic and global stakeholder engagement
  • Learn about innovative communication solutions that leading organizations utilize to overcome these challenges
  • Discuss how to use these solutions to deliver improved engagement outcomes while maintaining regulatory compliance

Speakers
PG

Peter Gannon

Senior Vice President, Business Partnerships, WITHIN3



Monday June 1, 2020 11:10am - 11:40am

11:40am

Networking Break
Monday June 1, 2020 11:40am - 12:00pm

12:00pm

Panel Discussion: Streamline Efficiencies and Improve Techniques to Build and Run Advisory Boards
  • Discuss key areas of strategic planning necessary to make decisions on the scope and reach of your advisory boards
  • Utilize technology to optimize advisory board engagement
  • Explore the tactical implementation of advisory board management before, during and after each meeting
  • Review the involvement of key internal and external decision-makers necessary to optimize the advisory board



Moderators
avatar for Ryan Mazon

Ryan Mazon

Senior Vice President, Business Development, Educational Measures

Speakers
avatar for Oscar Segurado, MD, PhD

Oscar Segurado, MD, PhD

Chief Medical Officer, ASC Therapeutics
Executive veteran of the biopharmaceutical industry with extensive global leadership experience in medical affairs, clinical development and translational science.Chief Medical Officer for ASC Therapeutics, formerly for Symvivo, Myriad Genetics-Crescendo and CellMax Life, Vice President... Read More →
avatar for Scott McConnell, Pharm.D.

Scott McConnell, Pharm.D.

Vice President, Medical Affairs, Chiasma
avatar for Eddie Power

Eddie Power

Vice President, North America Medical Affairs, Hospital Business, Pfizer


Monday June 1, 2020 12:00pm - 12:45pm

12:55pm

Panel Discussion: How Field Medical Can Help Prepare the Market for a New Drug Launch
  • Review how Medical Affairs (including Field Medical) can support market readiness in terms of external stakeholder engagement

Moderators
avatar for Eddie Power

Eddie Power

Vice President, North America Medical Affairs, Hospital Business, Pfizer

Speakers
avatar for Luchy Hidalgo, MD

Luchy Hidalgo, MD

MSL, Exact Sciences and Medical Affairs Consultant, Independent Consultant; KOL-Insights
As a Medical Doctorate graduate of Universidad Autonoma de Santo Domingo, I completed a medical internship in my home country of the Dominican Republic and soon thereafter worked for a year in clinical research at the University of Massachusetts. Next, I joined the Pharma/Medical... Read More →
avatar for Alan Polnariev

Alan Polnariev

Senior MSL - Nephrology, AstraZeneca
Before becoming a Medical Science Liaison five years ago, Dr. Alan Polnariev spent nearly a decade as a clinical pharmacist for the Veterans Affairs Health Care System in several capacities, including their Pharmacy Benefits Management department. During his time at the VA, he received... Read More →
TB

Tommy Brock

Senior MSL, United Therapeutics
avatar for Josh Yoder, PhD

Josh Yoder, PhD

Medical Science Liaison, uniQure


Monday June 1, 2020 12:55pm - 1:40pm

1:40pm

Chairperson’s Day One Closing Remarks
Speakers
avatar for Ashish Dugar, PhD, MBA

Ashish Dugar, PhD, MBA

Vice President, Global Medical Affairs, Sarepta Therapeutics


Monday June 1, 2020 1:40pm - 2:00pm
 
Tuesday, June 2
 

10:00am

Chairperson’s Opening Remarks
Speakers
avatar for Kim Cremers

Kim Cremers

Field Medical Strategist, Rheumatology West, Head of Medical Science Liaisons, Rheumatology West, UCB
With almost 20 years of experience driving the development of impactful medical science liaison teams and strategies within the pharmaceutical industry, Kim is leading a team of Rheumatology liaisons at UCB as the Field Medical Strategist/Head of MSLs – West for US Medical Affairs... Read More →


Tuesday June 2, 2020 10:00am - 10:15am

10:15am

The Evolution of Medical Affairs: Playing a Leading Role in the Product Lifecycle Within the Healthcare Ecosystem
  • Key strategic team player with clinical research, development, commercial and compliance teams
  • Leading innovation through data generation & medical information/communication



Speakers
avatar for Reina Benabou, MD, Ph.D.

Reina Benabou, MD, Ph.D.

Senior Vice President & Chief Medical Officer, Cognivue, Inc.
Reina Benabou, MD, PhD is a Neurologist and Neuroscientist passionate about innovating and creating value to make a difference in patients’ lives.  She’s been the SVP & Chief Medical Officer at Cognivue since 2018 and is building a cognitive health platform within the health... Read More →


Tuesday June 2, 2020 10:15am - 11:00am

11:10am

Integrate HEOR into the Medical Affairs Product Strategy
  • Identify key roles/deliverables for the HEOR function
  • Organizational alignment -- Where should the HEOR function reside?  Making a case for residence in medical affairs
  • Discuss the increasing importance of HEOR-related evidence generation
  • Review data dissemination -- HEOR field activities and publication planning
  • Develop a HEOR strategy
  • Drive the importance of HEOR strategy integration into the medical affairs product strategy

Speakers
avatar for Rudy Christian, DrPH

Rudy Christian, DrPH

Managed Markets Director, Alkermes
Rudy Christian’s career includes more than 20 years of research management, medical affairs, health economics and managed markets experience. Therapeutic areas include cardiology, nephrology, mental health, critical care, surgery, non-opioid surgical pain management, business development... Read More →


Tuesday June 2, 2020 11:10am - 11:40am

11:40am

Networking Break
Tuesday June 2, 2020 11:40am - 12:00pm

12:00pm

Panel Discussion: Discuss the Benefits of Engagement from the Medical Affairs Team Early in the Product Lifecycle
  • Examine the increased responsibilities medical has taken over in the last decade and how they should be playing a leading role in the pre-launch phase
  • Understand how the success of engaging payers, generating costs and leveraging the patient journey is all predicated on how early medical is involved
  • Hear how to collaborate with clinical development and take an integrated approach to generate clinical evidence



Moderators
avatar for Mario Mendoza, MD, MS

Mario Mendoza, MD, MS

BioExecutive-In-Residence, New York State Center for Biotechnology ; Independent Healthcare and Medical Affairs Consultant, Stony Brook University; BorderBioMed LLC
Dr. Mario R Mendoza is a clinical anesthesiologist (practiced at the NIH), chemist, and currently an independent healthcare and pharma medical affairs consultant with over 13 years of combined experience in patient care, clinical development, R&D, medical affairs (Abbott, Pfizer and... Read More →

Speakers
avatar for Meg Duncan, MD, PhD

Meg Duncan, MD, PhD

Global Medical Lead, Medical Affairs, Vertex
avatar for Barry Lubarsky, PhD

Barry Lubarsky, PhD

Executive Director, Medical Affairs Strategy, Alkermes
Barry Lubarsky, PhD, has spent more than 15 years in various medical affairs roles. He is currently Executive Medical Director for Medical Affairs Strategy at Alkermes, Inc. In this role, Barry leads the medical affairs medical director teams that drive the medical strategy and provide... Read More →
avatar for Ashish Dugar, PhD, MBA

Ashish Dugar, PhD, MBA

Vice President, Global Medical Affairs, Sarepta Therapeutics


Tuesday June 2, 2020 12:00pm - 12:45pm

12:45pm

Chairperson’s Day Two Closing Remarks
Speakers
avatar for Kim Cremers

Kim Cremers

Field Medical Strategist, Rheumatology West, Head of Medical Science Liaisons, Rheumatology West, UCB
With almost 20 years of experience driving the development of impactful medical science liaison teams and strategies within the pharmaceutical industry, Kim is leading a team of Rheumatology liaisons at UCB as the Field Medical Strategist/Head of MSLs – West for US Medical Affairs... Read More →


Tuesday June 2, 2020 12:45pm - 1:00pm
 
Wednesday, June 3
 

10:00am

Chairperson’s Opening Remarks
Speakers
avatar for Kate Pietrovito

Kate Pietrovito

Director, Medical Affairs Operations, Varian Medical Systems
Kate Pietrovito joins us from Varian Medical Systems, where she has recently joined their newly created Interventional Solutions Division. Previous to her new role at Varian, Kate was Senior Director of Medical Operations at BTG, where she managed Medical Information, Medical Communications... Read More →


Wednesday June 3, 2020 10:00am - 10:15am

10:15am

Determine Next Steps Following the Development of Your Medical Strategy
  • Tips for effective strategy realization
  • Define Mission and what success looks like
  • Define medical affairs objectives and KPIs using SMART goals
  • The process and how to gain buy-in from your team
  • Utilize digital tools to monitor and track outcomes



Speakers
avatar for Dan Hennessy

Dan Hennessy

Vice President, Strategic Excellence, EMD Serono
Dan Hennessy, PhD, MS, MBA, is a VP of Strategic Excellence, North America Medical Affairs at EMD Serono and has over 18 years track record of significant contributions to medical affairs and clinical development of hematology/oncology and other specialty drug therapies. Specifically... Read More →


Wednesday June 3, 2020 10:15am - 10:45am

10:55am

Improving Lives by Harnessing the Power of Patient Journey Complete Encounters
  • Establish the ground truth of US health care to accurately track longitudinal patient journeys
  • Examine provider networks, equitability issues and disparities in access to novel therapies
  • Leverage AI/ML for predictive modeling of rare diseases to drive early detection, testing, and adoption of treatments
  • Applications of real-world data for evidence generation, accelerating clinical trials, and decision making

Speakers
avatar for Aswin Chandrakantan, M.D.

Aswin Chandrakantan, M.D.

Chief Medical Officer and Senior Vice President of Corporate Development, Komodo Health
Prior to Komodo Health, he was a senior leader in Google’s Global Operations and Strategy, which was responsible for the implementation and support for Google’s 240+ ad products sustaining $110B annually in revenue. He also brings in-depth healthcare and analytics experience from... Read More →


Wednesday June 3, 2020 10:55am - 11:25am

11:25am

Networking Break
Wednesday June 3, 2020 11:25am - 11:45am

11:45am

Leveraging Technology to Standardize Medical Grants Programs and Digital Outcomes
  • How to collect the right data to make informed benchmarking and meet program goals
  • How to design and implement a common global grant process platform
  • How to address the lack of consistency with global compliance requirements
  • How to manage different data sets for different global regions
  • How to incorporate a sound data model and digital framework to ensure consistent and accurate reporting for standardized outcomes

Speakers
avatar for Jeff Summers

Jeff Summers

Chief Revenue Officer, CyberGrants
Jeff Summers is on the executive leadership team at CyberGrants and oversees Marketing, Revenue, and Solution Architecture functions for the company. As the leading global provider of SaaS-based, Corporate Social Responsibility (CSR) and Grant Management software, CyberGrants connects... Read More →


Wednesday June 3, 2020 11:45am - 12:00pm

12:25pm

Review the Impact of Real-World Evidence on Medical Affairs Strategy
  • Discuss how to generate RWE with limited resources through product registries, demonstration projects, and investigator-initiated trials 
  • Discover how real-world evidence can address clinical unmet needs 
  • Understand the strategic role of medical affairs in generating and communicating RWE to all stakeholders



Speakers
avatar for Stanislav Glezer, MD, MBA

Stanislav Glezer, MD, MBA

Global VP, Medical Affairs, Diabetes Care, BD
Stan Glezer, MD, MBA is an industry physician, passionate about optimizing value of pharmaceutical innovation for the patients, through partnering with the healthcare system.With almost 25 years of industry experience, Dr. Glezer is a Global Vice President of Medical Affairs, Diabetes... Read More →


Wednesday June 3, 2020 12:25pm - 12:55pm

12:55pm

Chairperson’s Day Three Closing Remarks
Speakers
avatar for Kate Pietrovito

Kate Pietrovito

Director, Medical Affairs Operations, Varian Medical Systems
Kate Pietrovito joins us from Varian Medical Systems, where she has recently joined their newly created Interventional Solutions Division. Previous to her new role at Varian, Kate was Senior Director of Medical Operations at BTG, where she managed Medical Information, Medical Communications... Read More →


Wednesday June 3, 2020 12:55pm - 1:10pm
 
Thursday, June 4
 

10:00am

Chairperson’s Opening Remarks
Speakers
avatar for Peter L. Goldberg, Ph.D.

Peter L. Goldberg, Ph.D.

Field Medical Strategist, East US Head of Medical Science Liaisons, East US U.S. Medical Affairs - Rheumatology, UCB, Inc
Peter L. Goldberg, PhD. is an award-winning Field Medical Affairs Leader with proven professional experience in pharmaceutical medical affairs and leadership with abilities in strategic planning, field associate mentoring/coaching, aligning resources for maximum impact, and change... Read More →


Thursday June 4, 2020 10:00am - 10:15am

10:15am

The Ever-Elusive Balance of Quantity vs. Quality in MSL Goals and Metrics
  • Outline what the key activities or goals of MSLs should be in this ever-changing role
  • Review how we measure the success of those goals and ultimately the MSL
  • Discuss whether metrics are the same as goals and how to balance quantity versus quality
  • Determine what a valuable or ‘quality’ interaction should be and whether different types of events or activities should be weighted differently



Speakers
avatar for Kristin Ryan

Kristin Ryan

Field Director MSL, Medical Affairs, ASTELLAS
Kristin Ryan is the US Field Director for the Astellas Urology Medical Science Liaison (MSL) organization within Medical Affairs.  She has experience in the pharmaceutical industry covering 16 products across five therapeutic areas including devices.  Kristin is a leader known for... Read More →


Thursday June 4, 2020 10:15am - 10:45am

10:55am

Panel Discussion: Build the MSL Career Path with a Focus on Facilitating Team Retention
  • Discuss how to facilitate career growth and create advancement opportunities
  • Improve team morale and engagement through team-building strategies and exercises
  • Work with internal and external stakeholders to demonstrate the value of the MSL team

Moderators
DW

Davida White, MD

Head, US Medical Affairs, Indivior

Speakers
avatar for Daneen Schaeffer, PhD

Daneen Schaeffer, PhD

Associate Director, Clinical Research Scientist Oncology, Clinical Research, Janssen Research and Development, LLC.
Daneen Schaeffer, PhD, is an Associate Director, Study Responsible Scientist (SRS) in Clinical Development in R&D at Janssen Oncology, a pharmaceutical company of Johnson & Johnson (J&J). In her role as an SRS, she oversees two prostate cancer PARP (poly ADP ribose polymerase) inhibitor... Read More →
avatar for Keely Dahl

Keely Dahl

Medical Science Liaison, Aurinia Pharmaceuticals, Inc.
avatar for Nikki Irish

Nikki Irish

Director of MSL, MA, Adamas
avatar for Sheila Komara

Sheila Komara

Senior MSL, Mallinckrodt
Has been working in Medical Affairs for 20 years in a variety of roles as a Sr. Medical Science Liaison as well as a Regional Scientific Manager. Expertise includes Hepatology, Critical Care, Sedation, Delirium and Pain Management. Launching several drugs and working with late stage... Read More →


Thursday June 4, 2020 10:55am - 11:40am

11:40am

Networking Break
Thursday June 4, 2020 11:40am - 12:00pm

12:00pm

Panel Discussion: Dissemination of Off Label Information in a Compliant Manner
  • Explore the distinction between solicited and unsolicited queries and discuss regulatory expectations for medical affairs teams
  • Clarify how to provide scientific research and medical findings that are clearly nonpromotional
  • Develop tools and techniques

Moderators
avatar for Bryan Bischel, PhD

Bryan Bischel, PhD

Field Director, Hepatology, Mallinckrodt Pharmaceuticals

Speakers
avatar for Howard Dorfman

Howard Dorfman

Adjunct Professor, Founder, SETON HALL UNIVERSITY SCHOOL OF LAW; H.L. DORFMAN CONSULTING
avatar for Jacqueline Armani

Jacqueline Armani

Medical Science Liaison, Alcon
Jacqueline graduated from the CUNY Honors College (now known as Macaulay Honors) at the College of Staten Island in 2006. She continued her graduate degree at the New England College of Optometry, externed at Bascom Palmer and did her residency at the VA as a primary care and ocular... Read More →
avatar for Diana Stefani-Hunyady, MD, MBA, BCMAS

Diana Stefani-Hunyady, MD, MBA, BCMAS

Head of Global Medical Affairs, Viela Bio


Thursday June 4, 2020 12:00pm - 12:45pm

12:45pm

Chairperson’s Day Four Closing Remarks
Speakers
avatar for Peter L. Goldberg, Ph.D.

Peter L. Goldberg, Ph.D.

Field Medical Strategist, East US Head of Medical Science Liaisons, East US U.S. Medical Affairs - Rheumatology, UCB, Inc
Peter L. Goldberg, PhD. is an award-winning Field Medical Affairs Leader with proven professional experience in pharmaceutical medical affairs and leadership with abilities in strategic planning, field associate mentoring/coaching, aligning resources for maximum impact, and change... Read More →


Thursday June 4, 2020 12:45pm - 1:00pm
 
Friday, June 5
 

10:00am

Chairperson’s Opening Remarks
Speakers
avatar for Bryan Bischel, PhD

Bryan Bischel, PhD

Field Director, Hepatology, Mallinckrodt Pharmaceuticals


Friday June 5, 2020 10:00am - 10:15am

10:15am

Panel Discussion: Share Best Execution Practices for IITs in Different Therapeutic Areas
  • Discuss how to build a customized investigator-sponsored study program model that works for your company
  • Compare the challenges faced between pharmaceutical, biotech, and medical device companies
  • Evaluate the contrasting compliance/regulatory obstacles

Moderators
avatar for Steven Zhang

Steven Zhang

Vice President, Medical Affairs, Kala Pharmaceuticals

Speakers
avatar for Peter Shaw, MBBS, DRCOG

Peter Shaw, MBBS, DRCOG

Vice President, Medical Affairs and Chief Medical Officer, Bioventus
Peter Shaw is currently Global Vice President of Medical Affairs and Chief Medical Officer at Bioventus having spent the previous three years as Senior Medical Director in Medical Affairs at Ferring Pharmaceuticals where he was responsible for all US Orthopaedic and Specialty Products... Read More →
avatar for Don Rodriguez

Don Rodriguez

Sr. Manager, Scientific Alliances-Medical Affairs, SEATTLE GENETICS
Currently a Sr. Manager in the Global Medical Affairs department at Seattle Genetics. Manages the ADCETRIS (brentuximab vedotin) Investigator-Sponsored trial program which is about 50 studies. Below is a summary of his career:10+ years of clinical research experience in healthcare... Read More →
avatar for Sudeesh Tantry

Sudeesh Tantry

Vice President, Global Medical Affairs, Glenmark Pharmaceuticals Inc.
Dr. Sudeesh Tantry is currently responsible for global medical affairs at Glenmark Pharmaceuticals. He has extensive global medical affairs, clinical development/operational, business development/partnering and product marketing/launch related leadership experience accumulated over... Read More →
avatar for Archie Stone, Ph.D. BCMAS

Archie Stone, Ph.D. BCMAS

Senior National MSL Director, Aurinia Pharmaceuticals
Archie Stone, PhD, is Vice President of Medical Affairs at Alcresta Therapeutics, Inc. Archie has 18 years of experience across the pharmaceutical, medical device and biotechnology industries. His industry expertise covers many different therapies and technology including oral drugs... Read More →


Friday June 5, 2020 10:15am - 11:00am

11:10am

Effectively Demonstrate the Value of Investigator-Sponsored Research to Internal Leadership
  • Pinpoint key metrics used to evaluate IITs and how that can differ from leadership’s perspective
  • Balance the use of qualitative and quantitative analysis for investigator-sponsored research operations
  • Demonstrate value for both clinical and commercial goals within an organization

Speakers
avatar for Peter Shaw, MBBS, DRCOG

Peter Shaw, MBBS, DRCOG

Vice President, Medical Affairs and Chief Medical Officer, Bioventus
Peter Shaw is currently Global Vice President of Medical Affairs and Chief Medical Officer at Bioventus having spent the previous three years as Senior Medical Director in Medical Affairs at Ferring Pharmaceuticals where he was responsible for all US Orthopaedic and Specialty Products... Read More →


Friday June 5, 2020 11:10am - 11:40am

11:40am

Networking Break
Friday June 5, 2020 11:40am - 12:00pm

12:00pm

Establish an Efficient and Compliant Process for Assessing the Fair Market Value (FMV) of IIT Budgets
  • Understand what fair market value is, how it is determined, and when it is utilized in IITs
  • Explore scenarios when deviations to the FMV would be considered and how the process works
  • Learn how to avoid lengthy negotiations around budget requests, specifically those outside of the FMV

Speakers
avatar for Anton Ehrhardt, Ph.D.

Anton Ehrhardt, Ph.D.

VP, Medical Affairs, SPECTRUM PHARMACEUTICALS


Friday June 5, 2020 12:00pm - 12:30pm

12:40pm

Deep Dive into Best Practices for Negotiating Contracts to Improve Study Start-Up
  • Build a rigorous and consistent review process for your IIT proposal approvals
  • Consider fair market value and other factors when valuing your study
  • Engage in transparent, open communication about all expectations before beginning the study

Speakers
avatar for Michael Martineau

Michael Martineau

ISS Operations Lead, Global Medical Operations, Sanofi Genzyme


Friday June 5, 2020 12:40pm - 1:10pm

1:10pm

Chairperson’s Day Five Closing Remarks
Speakers
avatar for Bryan Bischel, PhD

Bryan Bischel, PhD

Field Director, Hepatology, Mallinckrodt Pharmaceuticals


Friday June 5, 2020 1:10pm - 1:25pm