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Medical Affairs Strategic Summit 2021
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Monday, September 13
 

9:00am EDT

Morning Workshop – Medical Affairs Strategies for an Effective Product Launch
  • Feature insights on the transition to virtual from in-person for training and planning
  • Discuss the skilled required as we move forward in a hybrid environment, and how they differ in a virtual and in person scenario
  • Address any pushback from companies that do large trainings virtually to save costs and time missing out on the crucial team bonding

Monday September 13, 2021 9:00am - 12:00pm EDT

12:00pm EDT

Workshop Luncheon
Monday September 13, 2021 12:00pm - 1:00pm EDT

1:00pm EDT

Afternoon Workshop – The Challenges and Opportunities in Disseminating Medical Information: Do We Need a Redesign of the Role of Medical Affairs in Ensuring Compliant and Effective HCP Interactions?
  • Understand the evolution of the current enforcement environment
  • Discuss the interpretation and importance of FDA guidance documents including the FDA Reprint Guidance, the Draft Guidance on Unsolicited Requests for Off-Label Information, Drug and Medical Device Manufacturers Communications with Payers and Formulary, Committees, and Medical Product Communications Consistent with FDA-Required Labeling
  • Identify areas of concern for FDA and OIG as revealed through enforcement letters and Corporate Integrity Agreements (CIAs) as affecting company policies
  • Craft new policies to respond to current and future enforcement initiatives

Monday September 13, 2021 1:00pm - 3:00pm EDT
 
Tuesday, September 14
 

7:30am EDT

Networking Breakfast and Registration
Tuesday September 14, 2021 7:30am - 8:30am EDT

8:30am EDT

Chairperson’s Opening Remarks
Speakers
avatar for Mandeep Kaur, MD, MS

Mandeep Kaur, MD, MS

Vice President and Global Head of Medical, Arena Pharmaceuticals, Inc


Tuesday September 14, 2021 8:30am - 8:45am EDT

8:45am EDT

Keynote: How Medical Affairs Delivers Value Through Content Leadership
  • Understand the evolving ecosystem of healthcare and the important role of evidence
  • Discuss how Medical Affairs is uniquely positioned to shape and advance clinical practice

Speakers
avatar for Jing L. Marantz, MD PhD

Jing L. Marantz, MD PhD

Senior Vice President, Head of Medical Affairs, Acceleron Pharma
Jing L. Marantz, MD PhD, is SVP, Head of Medical Affairs at Acceleron Pharma and a board member at Krystal Biotech. Prior to Acceleron, Dr. Marantz has held leadership positions at Alnylam, Alexion, Biogen, ARIAD, and Millennium Pharmaceuticals across development, medical affairs... Read More →


Tuesday September 14, 2021 8:45am - 9:15am EDT

9:15am EDT

Shape How Virtual Engagement is Used to Navigate the World Ahead with Top Medical Affairs Trends
  • Explore best tactics to implement into your strategy in order to gain a competitive advantage
  • Discuss how virtual engagement improves internal and external stakeholder alignment
  • Share real-world success stories when leveraging compliant virtual technology

Speakers
avatar for Peter Gannon

Peter Gannon

SVP, Business Partnerships, Within3, Inc.
With more than 19 years diversified experience in the life sciences vertical, Peter has been involved in digital pharmaceutical communications since 1996. His leadership in strategic planning, revenue generation, and business partnering has established a strong and diverse client-base... Read More →


Tuesday September 14, 2021 9:15am - 9:45am EDT

9:45am EDT

Networking Break
Tuesday September 14, 2021 9:45am - 10:15am EDT

10:15am EDT

Panel: Emerging from the Pandemic: Finding a Proper Balance in Virtual vs. Hybrid Engagement
  • What does medical affairs look like in this new environment?
  • How to build your medical affairs strategy and build effective teams in this new environment
  • What does collaboration with commercial look like now?
  • How to maximize medical engagements in a hybrid conference setting?

Moderators
avatar for Kirk Shepard, MD

Kirk Shepard, MD

Chief Medical Officer & SVP, Head of Global Medical Affairs OBG, Eisai, Inc.

Speakers
CH

Camille Hertzka

VP, head of Oncology US Medical, AstraZeneca
avatar for Harmony P. Garges, MD, MPH

Harmony P. Garges, MD, MPH

Senior Vice President, Chief Medical Officer, ViiV Healthcare
Dr. Harmony P. Garges is the Chief Medical Officer at Viiv Healthcare, the only pharmaceutical company dedicated to HIV, and leads the Global Medical team. She is a physician with expertise in paediatric infectious diseases and spent nearly 20 years taking care of children living... Read More →
avatar for Leslie Meltzer, PhD

Leslie Meltzer, PhD

Senior Vice President, Global Medical Affairs and Clinical Operations, Orchard Therapeutics
Leslie Meltzer, PhD is a Medical Affairs and Clinical Development profession with over a decade of experience leading Medical Affairs teams across a range of therapeutic areas including ultra-rare diseases, hemophilia, multiple sclerosis, pulmonary hypertension, lysosomal storage... Read More →
avatar for Paul J. Rowe, MD, ATSF

Paul J. Rowe, MD, ATSF

Vice President, Head of Global Medical Immunology, Sanofi-Genzyme
Dr. Rowe has well over a decade of research experience spanning from pre-clinical to late phase innovative medical therapy development programs, primarily in respiratory (and cardiovascular) medicine within the pharma industry. He has been directly responsible for medical strategy... Read More →


Tuesday September 14, 2021 10:15am - 11:00am EDT

11:00am EDT

Presentation by CyberGrants
Tuesday September 14, 2021 11:00am - 11:30am EDT

11:30am EDT

Conference Chair Introduces Tracks
Speakers
avatar for Mandeep Kaur, MD, MS

Mandeep Kaur, MD, MS

Vice President and Global Head of Medical, Arena Pharmaceuticals, Inc


Tuesday September 14, 2021 11:30am - 11:45am EDT

11:45am EDT

Networking Luncheon
Tuesday September 14, 2021 11:45am - 1:00pm EDT

1:00pm EDT

Investigator-Initiated Trials Track Chair - Opening Remarks
Speakers
avatar for Bryan Bischel

Bryan Bischel

Medical Director, Hepatology, Mallinckrodt Pharmaceuticals
Bryan Bischel is an accomplished senior Medical Affairs professional with more than 20 years of progressively responsible medical affairs experience.  He is a strategic thinker skilled at developing and implementing programs to support medical affairs and corporate level objectives... Read More →


Tuesday September 14, 2021 1:00pm - 1:15pm EDT

1:00pm EDT

Medical Affairs Strategy Track Chair - Opening Remarks
Speakers
avatar for Mark Wildgust, PhD

Mark Wildgust, PhD

Vice President, Global Medical Affairs Oncology, Janssen Pharmaceutical Companies of Johnson & Johnson
Mark Wildgust has spent more than 20 years in the pharmaceutical industry working primarily in oncology, hematology and virology. He completed his undergraduate degree in Biological Sciences at the University of Plymouth, UK, and his PhD in Trace Metal Toxicology at the University... Read More →


Tuesday September 14, 2021 1:00pm - 1:15pm EDT

1:00pm EDT

MSL Best Practices Track Chair - Opening Remarks
Speakers
avatar for Monica Arora Sukhatme, PharmD

Monica Arora Sukhatme, PharmD

Executive Director/National Head, MSLs, Coherus BioSciences
Monica is currently the Executive Director and National Head of the MSL Team at Coherus Biosciences. Coherus is committed to the development of biosimilars in the field of oncology, ophthalmology, and other autoimmune diseases to make healthcare more affordable for patients and healthcare... Read More →


Tuesday September 14, 2021 1:00pm - 1:15pm EDT

1:15pm EDT

When to collaborate?
  • Delve into a team’s decision-making process when choosing an investigator-initiated study  
  • Weigh the benefits of taking on a smaller investigator study over a larger one based on company needs
  • Examine the process of fine-tuning research concepts


Speakers
avatar for Eric Shen

Eric Shen

Senior Scientist, Global Medical Affairs, United Therapeutics Corporation
Eric Shen is a Senior Scientist at United Therapeutics corporation. He has been working in pharmaceuticals, biotechnology, and research for 15 years and is passionate about generating and communicating scientific evidence in rare diseases. Eric graduated from Cornell University with... Read More →


Tuesday September 14, 2021 1:15pm - 1:45pm EDT

1:15pm EDT

Instilling Disease Awareness/Engagement in your Team
Speakers
avatar for Harmony P. Garges, MD, MPH

Harmony P. Garges, MD, MPH

Senior Vice President, Chief Medical Officer, ViiV Healthcare
Dr. Harmony P. Garges is the Chief Medical Officer at Viiv Healthcare, the only pharmaceutical company dedicated to HIV, and leads the Global Medical team. She is a physician with expertise in paediatric infectious diseases and spent nearly 20 years taking care of children living... Read More →


Tuesday September 14, 2021 1:15pm - 1:45pm EDT

1:15pm EDT

Building a MSL Team: Re-Strategize and Re-think How to Right-Size a MSL Team
Speakers
SS

Steven Stein, MD

Sr. Director, Global Field Medical Head, Arena Pharmaceuticals


Tuesday September 14, 2021 1:15pm - 1:45pm EDT

1:45pm EDT

Leveraging internal collaboration for mid-sized IST programs
  • Engaging with the Medical Science Liaisons (MSLs) to support scientific discussions and thought leader engagement 
  • Capitalizing on the therapeutic expertise of Medical Directors 
  • Overcoming limited resources by utilizing a rotation program (e.g. clinical operations) 



Speakers
avatar for Kathleen Long

Kathleen Long

Director Medical Affairs, Alkermes
Kathleen Long, MS has spent the past 15 years in various medical affairs, clinical operations and cooperative group roles. She is currently Director for Medical Affairs Operations at Alkermes, Inc. In this role, Kat heads external research programs across Alkermes’ portfolio of... Read More →
avatar for Stephanie Daub (Ebner), Ph.D

Stephanie Daub (Ebner), Ph.D

Director, Field Medical Excellence - Schizophrenia, Alkermes
Stephanie Daub, PhD has spent the past 5.5 years in various medical affairs roles. She is currently a Director of Field Medical Excellence at Alkermes, Inc. In this role, Stephanie is involved in medical strategy and continuing education for Alkermes’ team of medical science liaisons... Read More →


Tuesday September 14, 2021 1:45pm - 2:15pm EDT

1:45pm EDT

The Digital Transformation Journey of Medical Affairs
Speakers
avatar for Barry Lubarsky, PhD

Barry Lubarsky, PhD

Vice President, Medical Affairs Strategy, Alkermes
Barry Lubarsky, PhD, has spent more than 15 years in various medical affairs roles. He is currently Vice President of Medical Affairs Strategy at Alkermes. In this role, Barry leads the medical affairs medical director teams that drive the medical strategic plans in support of Alkermes... Read More →


Tuesday September 14, 2021 1:45pm - 2:15pm EDT

1:45pm EDT

Your Career: Drive or Be Driven. A Discussion on Professional Development & Strategic Career Planning
  • Self-Awareness –your true strengths/talents, skill/knowledge gaps, weaknesses, likes, dislikes
  • Your Why passion + purpose
  • Individual Development Planning – not just a check the box activity

Speakers
avatar for Elaine Nadeau, PharmD

Elaine Nadeau, PharmD

Director, Leadership Excellence & Field Development, EMD Serono
Elaine Nadeau is an experienced and enthusiastic Medical Affairs professional who has worked in the pharmaceutical industry for over a decade. She has held various roles within Field-Based Medicine, including Sr. Medical Science Liaison (MSL), MSL Training Lead, MSL Manager, and Field... Read More →


Tuesday September 14, 2021 1:45pm - 2:15pm EDT

2:15pm EDT

Panel: Implementing an Industry Standard for IIT Contracts
  • Identify common deliverables required from sponsors
  • Explore how the industry can come together to set standard guidelines to accelerate contracting timelines
  • Connect with research organizations to gauge areas in which need more focus

Moderators
avatar for Steven Zhang, MD

Steven Zhang, MD

Senior Vice President, Kala Pharmaceuticals

Speakers
avatar for Kasmin (Boswell) Delgado

Kasmin (Boswell) Delgado

Associate Director, MSLs, Kyowa Kirin


Tuesday September 14, 2021 2:15pm - 3:00pm EDT

2:15pm EDT

Panel: Discuss Optimal Information Exchange: By When and How? A Multi-Stakeholder Discussion



Moderators
avatar for Deborah Braccia, PhD, MPA

Deborah Braccia, PhD, MPA

Head of Global Medical Affairs Excellence, Kyowa Kirin

Speakers
avatar for Nami Pandit, PharmD, R.Ph

Nami Pandit, PharmD, R.Ph

Senior Director, Global Medical Affairs, Sanofi
Nami Pandit-Abid has 10+ years in Industry working across Pharma, Consulting, and Pharmacy. She currently works at Sanofi Genzyme and is responsible for new indication planning, Medical Education, Publications, Advisory Boards, KOL engagement, and cross functional synergies. Throughout... Read More →
CS

Chen-Sen (Samson) Wu, MD, JD

Vice President, Global Medical Affairs Excellence, GSK
avatar for Ina Shah, PharmD, BCMAS

Ina Shah, PharmD, BCMAS

Executive Director Medical Information, AbbVie
Ina Shah is currently the Executive Director, Global Medical Information at AbbVie. In this role, she is leading a global team that develop medical content and supports medical inquiries from customers. Prior to this, she has held various positions at Hoffmann LaRoche in clinical... Read More →


Tuesday September 14, 2021 2:15pm - 3:00pm EDT

2:15pm EDT

Panel: Define the New Role of the MSL / Reshaping the Role of MSLs
  • Impact of COVID on ways of working
  • Engaging virtually
  • Developing New relationships primarily in a virtual world
  • Transitioning back to in-person engagements
  • Is the MSL role just insight gathering?  If so, what constitutes an insight?

Moderators
avatar for Anne M VanBuskirk, MBA, PhD

Anne M VanBuskirk, MBA, PhD

Associate Director Medical Affairs, Takeda Oncology
Anne Van Buskirk PhD, MBA is an Executive MSL / Assoc. Director in US Medical Affairs- Oncology at Takeda Pharmaceuticals. She received her PhD in Immunology and Medical Microbiology from University of Missouri and her MBA with a concentration in ethical leadership from Marist College... Read More →

Speakers
avatar for Monica Arora Sukhatme, PharmD

Monica Arora Sukhatme, PharmD

Executive Director/National Head, MSLs, Coherus BioSciences
Monica is currently the Executive Director and National Head of the MSL Team at Coherus Biosciences. Coherus is committed to the development of biosimilars in the field of oncology, ophthalmology, and other autoimmune diseases to make healthcare more affordable for patients and healthcare... Read More →
avatar for Keely Dahl, PharmD, RPh

Keely Dahl, PharmD, RPh

Senior Medical Science Liaison, Aurinia Pharmaceuticals Inc.
Keely Dahl, PharmD is a Pharmacist and Medical Science Liaison (MSL) who aspires to enhance collaboration across healthcare industry for the betterment of people’s health and prosperity. She has served as an MSL since 2017 and works at Aurinia Pharmaceuticals, joining the pre-launch... Read More →
avatar for Vanessa Johnson

Vanessa Johnson

Senior Director, MSL Excellence, Bayer


Tuesday September 14, 2021 2:15pm - 3:00pm EDT

3:00pm EDT

Networking Break
Tuesday September 14, 2021 3:00pm - 3:30pm EDT

3:30pm EDT

Benefits of Incorporating Collaborative Study Models into Your Portfolio
  • How collaborative models can better meet the needs of a product in earlier life cycle stages
  • Have an active role in a study’s concept design to ensure it meets company standards
  • Creating an open dialogue with the sponsoring organization during data collection and publication ensuring successful equal ownership

Speakers
avatar for Swati Pradhan-Bhatt, Ph.D.

Swati Pradhan-Bhatt, Ph.D.

Director, Scientific Affairs, Mallinckrodt Pharmaceuticals
Swati Pradhan-Bhatt, Ph.D. is a medical affairs professional with 5 years of pharmaceutical industry experience and 10+ years of experience in academia.  She currently leads the Scientific Affairs function, which includes a team that supports Investigator-Initiated Research Studies... Read More →


Tuesday September 14, 2021 3:30pm - 4:00pm EDT

3:30pm EDT

Optimizing Medical Affairs Capabilities
Speakers
MO

Melissa Olivadoti, PhD, CMPP

Consultant, Scientific Commercialization LLC


Tuesday September 14, 2021 3:30pm - 4:00pm EDT

3:30pm EDT

MSL Rules of Engagement: Outlining best practices for your cross functional field teams
  • Provide a framework for establishing ways of working between MSLs and Commercial Field Teams
  • Define best practices when working together in the field and fielding requests for MSLs
  • Review of compliant ways to navigate common scenarios (e.g. Introductions, Medical Presentations, Clinical Trial Discussions, etc)

Speakers
avatar for Maria Urso, PhD

Maria Urso, PhD

Director, Medical Affairs Field Team, Exact Sciences
Maria has worked in Medical Affairs for over a decade. She has held roles as an MSL, MSL Manager, Director of Clinical Research, Director Medical Affairs and is currently the Director of the Medical Affairs Field Team with Exact Sciences. In those roles, she has had the opportunity... Read More →


Tuesday September 14, 2021 3:30pm - 4:00pm EDT

4:00pm EDT

What internal resources are needed to execute external research
  • Key learnings setting up a new IIT program 
  •  Impact on resource demand 
  •  Setting up your internal resources for success (MSLs, IIT coordinators, internal scientist/physicians, budgets, contracts, product delivery, and more) 

Speakers
avatar for Jeremy Keeton

Jeremy Keeton

Advisor ONC IIT,  Eli Lilly and Company
Jeremy Keeton has a degree from Indiana University in Biology and Chemistry, and a Masters in Organic Chemistry from Purdue University.  Jeremy has held several roles at Eli Lilly since 2002: chemist, project manager, clinical project manager, US site selection, and international... Read More →


Tuesday September 14, 2021 4:00pm - 4:30pm EDT

4:00pm EDT

KPIs/Metrics in Medical
Tuesday September 14, 2021 4:00pm - 4:30pm EDT

4:00pm EDT

4:30pm EDT

Panel: How Providing Additional Support to a Study’s Principal Investigator Can Lead to Easier Workflow Processes Throughout its Lifecycle
  • Understand the importance of properly training a PI in IIT overseeing operations
  • Ensure the research team is knowledgeable in protocol writing to avoid issues with submissions
  • Creating a plan for protocol implementation to maintain quality and ensure results

Moderators
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 →

Speakers
avatar for Alyssa Tra Truong

Alyssa Tra Truong

Associate Director, Global Scientific Affairs, Global Medical Affairs, Jazz Pharmaceuticals
Alyssa Truong is currently the Head of the Global Investigator Sponsored Trials Program at Jazz Pharmaceuticals, Inc., where she oversees an IST program consisting of two therapeutic areas, hematology/oncology and neuroscience, and six products. Her other areas of responsibilities... Read More →
avatar for Emilie Jade Misajon

Emilie Jade Misajon

Senior Global Trial Manager, Novartis
Emilie Jade Misajon, MSN, RN, CCRP is a Senior Global Trial Manager at Novartis with over thirteen years of experience in clinical research. She specializes in global trial management, creating and establishing novel programs, as well as training and managing research personnel to... Read More →


Tuesday September 14, 2021 4:30pm - 5:15pm EDT

4:30pm EDT

Panel: Being Strategic in Writing a Medical Plan
  • Understand the value of having a strategic Medical plan
  • Identify critical success factors and potential pitfalls in developing a medical plan that is impactful and complementary to cross-functional team plans

Moderators
avatar for Eva Gallagher, PhD, RN, ANP-BC

Eva Gallagher, PhD, RN, ANP-BC

Vice President, Head of Medical Affairs, Agios Pharmaceuticals
Currently serving as Vice President, Head of Global Medical Affairs at Agios Pharmaceuticals, Eva reports to the Chief Medical Officer. In this role she is responsible for oversight of Scientific Communications, Publications, Medical Information, Health Economics Outcomes Research... Read More →

Speakers
avatar for Debra Sierka

Debra Sierka

Head of Dermatology, US Medical Affairs, Sanofi Genzyme
MF

Melanie Fulton

Sr. Director, Medical Strategy and Operations, Global Medical Affairs, Arena Pharmaceuticals


Tuesday September 14, 2021 4:30pm - 5:15pm EDT

4:30pm EDT

Panel: Benchmarking Performance Metrics in a Hybrid Environment
Moderators
SG

Susan Giacalone, MSN, MSL-BC, BCMAS

National Director, Field Medical Affairs, Macrogenics

Speakers
SK

Sheila Komara

Former Senior Medical Science Liaison, Mallinckrodt


Tuesday September 14, 2021 4:30pm - 5:15pm EDT

5:15pm EDT

Investigator-Initiated Trials Track Chair - Closing Remarks
Speakers
avatar for Bryan Bischel

Bryan Bischel

Medical Director, Hepatology, Mallinckrodt Pharmaceuticals
Bryan Bischel is an accomplished senior Medical Affairs professional with more than 20 years of progressively responsible medical affairs experience.  He is a strategic thinker skilled at developing and implementing programs to support medical affairs and corporate level objectives... Read More →


Tuesday September 14, 2021 5:15pm - 5:30pm EDT

5:15pm EDT

Medical Affairs Strategy Track Chair - Closing Remarks
Speakers
avatar for Mark Wildgust, PhD

Mark Wildgust, PhD

Vice President, Global Medical Affairs Oncology, Janssen Pharmaceutical Companies of Johnson & Johnson
Mark Wildgust has spent more than 20 years in the pharmaceutical industry working primarily in oncology, hematology and virology. He completed his undergraduate degree in Biological Sciences at the University of Plymouth, UK, and his PhD in Trace Metal Toxicology at the University... Read More →


Tuesday September 14, 2021 5:15pm - 5:30pm EDT

5:15pm EDT

MSL Best Practices Track Chair - Closing Remarks
Speakers
avatar for Monica Arora Sukhatme, PharmD

Monica Arora Sukhatme, PharmD

Executive Director/National Head, MSLs, Coherus BioSciences
Monica is currently the Executive Director and National Head of the MSL Team at Coherus Biosciences. Coherus is committed to the development of biosimilars in the field of oncology, ophthalmology, and other autoimmune diseases to make healthcare more affordable for patients and healthcare... Read More →


Tuesday September 14, 2021 5:15pm - 5:30pm EDT

5:30pm EDT

Networking Reception
Tuesday September 14, 2021 5:30pm - 6:30pm EDT

6:30pm EDT

Conference Day One Concludes
Tuesday September 14, 2021 6:30pm - 6:30pm EDT
 
Wednesday, September 15
 

8:15am EDT

Breakfast
Wednesday September 15, 2021 8:15am - 8:45am EDT

8:45am EDT

Chairperson’s Opening Remarks
Speakers
avatar for Mandeep Kaur, MD, MS

Mandeep Kaur, MD, MS

Vice President and Global Head of Medical, Arena Pharmaceuticals, Inc


Wednesday September 15, 2021 8:45am - 9:00am EDT

9:00am EDT

Keynote: Fit for Purpose Launch
Speakers
avatar for Kirk Shepard, MD

Kirk Shepard, MD

Chief Medical Officer & SVP, Head of Global Medical Affairs OBG, Eisai, Inc.


Wednesday September 15, 2021 9:00am - 9:45am EDT

9:30am EDT

Partner Presentation TBA
Wednesday September 15, 2021 9:30am - 10:00am EDT

10:00am EDT

Networking Break
Wednesday September 15, 2021 10:00am - 10:30am EDT

10:30am EDT

Leveraging Real-World Evidence in the Development of Medical Strategy and Utilize this in the Field
Speakers
avatar for Andrew Rosen, PhD

Andrew Rosen, PhD

Director of Global Data Generation, Ionis Pharmaceuticals, Inc.
Andrew Rosen is a Medical Affairs leader supporting gene silencing therapies for patients with rare and severe diseases. Andrew is synergizing his experience in Field Medical Affairs, artificial intelligence, and signal processing to advance new strategies that bring value to clinicians... Read More →


Wednesday September 15, 2021 10:30am - 11:00am EDT

11:00am EDT

Panel: Explore Different Operating Models for Medical Affairs Groups and Discuss How an Organizational Structure Can Impact the Effectiveness of Your Activities
  • Describe examples of different operating models in Medical Affairs organizations, and how factors such as company structure, geography, therapeutic area, or other elements contribute to choices made around operating models
  • Present specific examples of fit-for-purpose structuring or restructuring of Medical Affairs organizations to meet company and business needs
  • Discuss how Medical Affairs leaders socialize new ideas around operating models and measure the effectiveness of different structures

Moderators
avatar for Leslie Meltzer, PhD

Leslie Meltzer, PhD

Senior Vice President, Global Medical Affairs and Clinical Operations, Orchard Therapeutics
Leslie Meltzer, PhD is a Medical Affairs and Clinical Development profession with over a decade of experience leading Medical Affairs teams across a range of therapeutic areas including ultra-rare diseases, hemophilia, multiple sclerosis, pulmonary hypertension, lysosomal storage... Read More →

Speakers
avatar for Heather Abourjaily, PharmD

Heather Abourjaily, PharmD

Head - Global Scientific Communications, Vertex Pharmaceuticals
avatar for Pannie Trifillis, PhD

Pannie Trifillis, PhD

VP and Head of Global Scientific Affairs, Global Medical Affairs, PTC Therapeutics, Inc.


Wednesday September 15, 2021 11:00am - 11:45am EDT

11:45am EDT

Conference Chair Introduces Tracks
Speakers
avatar for Mandeep Kaur, MD, MS

Mandeep Kaur, MD, MS

Vice President and Global Head of Medical, Arena Pharmaceuticals, Inc


Wednesday September 15, 2021 11:45am - 12:00pm EDT

12:00pm EDT

Networking Luncheon
Wednesday September 15, 2021 12:00pm - 1:00pm EDT

1:00pm EDT

Managing IITs on a Global Scale
  • How to navigate regulatory agencies when managing studies in multiple countries 
  • Applying a collaborative working model to guarantee valuable outcomes 
  • Break down the importance of understanding regulations and guidelines across continents

Speakers
AK

Ayman Kafal

Head of Medical Affairs & Pharmacovigilance, Aquestive Therapeutics


Wednesday September 15, 2021 1:00pm - 1:30pm EDT

1:00pm EDT

1:00pm EDT

MSLs and Diversity in Engagement
  • Navigating the many Types of diversity
  • Diversity and  “rules of engagement”  for virtual and in-person meetings

Speakers
avatar for Anne M VanBuskirk, MBA, PhD

Anne M VanBuskirk, MBA, PhD

Associate Director Medical Affairs, Takeda Oncology
Anne Van Buskirk PhD, MBA is an Executive MSL / Assoc. Director in US Medical Affairs- Oncology at Takeda Pharmaceuticals. She received her PhD in Immunology and Medical Microbiology from University of Missouri and her MBA with a concentration in ethical leadership from Marist College... Read More →


Wednesday September 15, 2021 1:00pm - 1:30pm EDT

1:30pm EDT

How Mid-Sized Pharma Can Utilize Technology to Optimize IIT Management
  • Shift from manual operations to an automated system to streamline daily functions  
  • Understand how digital processes can permit teams to take on larger number of studies, while also maintaining quality  
  • Adapting best practices used in big pharma in large portfolio management

Speakers
avatar for Temire Bob-Egbe

Temire Bob-Egbe

Senior Manager, Global IST Operations, Jazz Pharmaceuticals


Wednesday September 15, 2021 1:30pm - 2:00pm EDT

1:30pm EDT

Digital is here to Stay: Awareness, Education, and Scientific Engagement
Speakers
EP

Elizabeth Pash PhD(c), MS, RD, LDN

Vice President, Medical Affairs, Gelesis


Wednesday September 15, 2021 1:30pm - 2:00pm EDT

1:30pm EDT

2:00pm EDT

Panel: Explore Best Practices for Managing IITs within Small to Medium Sized Pharma
  • Monitor IITs with a limited pool of resources
  • Manage time appropriately to complete all functions and deliverables necessary for a study
  • Promote open communication with investigators to avoid complications and ensure positive outcomes

Moderators
avatar for Peter Shaw

Peter Shaw

Vice President, Medical Affairs & Chief Medical Officer, Bioventus
Peter Shaw is 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. Prior... Read More →

Speakers
KJ

Kathryn Josephs

Director, ISR/NRDG, Medical Affairs, Mirati Therapeutics
avatar for Scott McConnell, PharmD

Scott McConnell, PharmD

Vice President Medical Affairs, Chiasma
Scott graduated with a Pharm.D. from Creighton University. He then completed a one-year Pharmacotherapy Residency and a two-year Infectious Diseases Fellowship. He served on faculty at both the University of Arkansas and Creighton University Pharmacy Schools, teaching infectious diseases... Read More →
avatar for Kim Reed

Kim Reed

Senior Medical Director, Clinical Sciences, Ophthalmology, Regeneron Pharmaceuticals
Kim currently holds the position of Senior Medical Director in Ophthalmology at Regeneron Pharmaceuticals, where she is leading clinical development activities in wet AMD and Diabetic Macular Edema.  Previously, Kim was a Medical Director in Medical Affairs at Regeneron and a Shire... Read More →


Wednesday September 15, 2021 2:00pm - 2:45pm EDT

2:00pm EDT

Panel: Building Medical Affairs Capabilities for the First Time
Moderators
avatar for Norma Alonzo Palma PhD

Norma Alonzo Palma PhD

Head of Scientific and Medical Affairs, Kaleido Biosciences

Speakers
avatar for Brett Balzer

Brett Balzer

GM, Medical Affairs, Komodo Health
Brett has been responsible for the strategic direction, growth, and customer success of Komodo’s medical affairs practice for the past 8 years. He has collaborated on dozens of implementations across MI contact centers, medical portals, safety solutions, and mobile tools. Brett... Read More →
avatar for Sylvia Hanna, MD

Sylvia Hanna, MD

Executive Director, Critical Care, Mallinckrodt Pharmaceuticals
avatar for Johan Baeck, MD

Johan Baeck, MD

Senior Vice-President, Clinical Development and Medical Affairs, Jounce Therapeutics
Johan is a physician with more than twenty-five years of experience in the pharmaceutical industry as well as over fifteen years in Oncology clinical development and medical affairs. Focus has been on both targeted agents, small molecules as well as antibody therapies; in this in... Read More →
IO

Ike Ogbaa, MD

Executive Medical Director Cardiovascular and Renal MD US Medical Affairs, Bayer Pharmaceuticals


Wednesday September 15, 2021 2:00pm - 2:45pm EDT

2:00pm EDT

Panel: How to Gather and Optimally Manage Clinical and Field Insights to Help Shape Your Medical Strategy
The panel will review of methods of:
i. Tracking, monitoring, and acting on insights
ii. Best practices to “connect the dots”, create an actionable insights workflow, and track the lifecycle of insights
iii. Using insights and actions to support business decisions within medical affairs and the broader organization

Moderators
avatar for Maria Urso, PhD

Maria Urso, PhD

Director, Medical Affairs Field Team, Exact Sciences
Maria has worked in Medical Affairs for over a decade. She has held roles as an MSL, MSL Manager, Director of Clinical Research, Director Medical Affairs and is currently the Director of the Medical Affairs Field Team with Exact Sciences. In those roles, she has had the opportunity... Read More →

Speakers
avatar for Andrew Rosen, PhD

Andrew Rosen, PhD

Director of Global Data Generation, Ionis Pharmaceuticals, Inc.
Andrew Rosen is a Medical Affairs leader supporting gene silencing therapies for patients with rare and severe diseases. Andrew is synergizing his experience in Field Medical Affairs, artificial intelligence, and signal processing to advance new strategies that bring value to clinicians... Read More →
avatar for Davida J. White, MD

Davida J. White, MD

Lead, Global Field Medical Excellence and Operations, Organon
Davida J. White, M.D. is a health care leader with administrative and clinical experience in the government, academic, biopharmaceutical and medical device industry settings.  She currently is the Oncology Field Alignment Medical Affairs Director for Merck.  Prior to joining Merck... Read More →
avatar for Brant Jarrett

Brant Jarrett

Executive Director, Head of Field Medical Affairs, Mallinckrodt Pharmaceuticals
Brant Jarrett is the Executive Director of Field Medical Affairs at Mallinckrodt Pharmaceuticals. He entered Pharma as an MSL and has had various leadership positions in Medical Affairs including Regional Director, National Director, Medical Director, and Sr. Director Field Medical... Read More →


Wednesday September 15, 2021 2:00pm - 2:45pm EDT

2:45pm EDT

Investigator-Initiated Trials Track Chair - Closing Remarks
Speakers
avatar for Bryan Bischel

Bryan Bischel

Medical Director, Hepatology, Mallinckrodt Pharmaceuticals
Bryan Bischel is an accomplished senior Medical Affairs professional with more than 20 years of progressively responsible medical affairs experience.  He is a strategic thinker skilled at developing and implementing programs to support medical affairs and corporate level objectives... Read More →


Wednesday September 15, 2021 2:45pm - 3:00pm EDT

2:45pm EDT

Medical Affairs Strategy Track Chair - Closing Remarks
Speakers
avatar for Mark Wildgust, PhD

Mark Wildgust, PhD

Vice President, Global Medical Affairs Oncology, Janssen Pharmaceutical Companies of Johnson & Johnson
Mark Wildgust has spent more than 20 years in the pharmaceutical industry working primarily in oncology, hematology and virology. He completed his undergraduate degree in Biological Sciences at the University of Plymouth, UK, and his PhD in Trace Metal Toxicology at the University... Read More →


Wednesday September 15, 2021 2:45pm - 3:00pm EDT

2:45pm EDT

MSL Best Practices Track Chair - Closing Remarks
Speakers
avatar for Monica Arora Sukhatme, PharmD

Monica Arora Sukhatme, PharmD

Executive Director/National Head, MSLs, Coherus BioSciences
Monica is currently the Executive Director and National Head of the MSL Team at Coherus Biosciences. Coherus is committed to the development of biosimilars in the field of oncology, ophthalmology, and other autoimmune diseases to make healthcare more affordable for patients and healthcare... Read More →


Wednesday September 15, 2021 2:45pm - 3:00pm EDT

3:00pm EDT

Conference Concludes
Wednesday September 15, 2021 3:00pm - 3:00pm EDT