Medical Affairs Strategic Summit East

9:00am

KOL Engagement Seminar Opening Remarks

Tuesday April 14, 2020 9:00am - 9:15am

9:00am

Workshop A: Establish an Integrated Approach to Managing Medical Information and Medical Communications to Leverage Insights and Deliver Value to Patients

In the age of empowered consumers, medical affairs groups can play a central role in informing data needs and ensuring the delivery of relevant medical information and impactful communications that address the needs of patients.

Cultivate synergies in scientific communications and medical information services to provide useful resources to patients and healthcare professionals
Centralize scientific content creation for improved quality, speed, and reduced cost
Identify the need for resource development and align communication resources across field and internal medical affairs

Speakers

Mario Mendoza, MD, MS

BioExecutive-In-Residence, New York State Center for Biotechnology at Stony Brook University

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 →

Scott McConnell, Pharm.D.

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 →

Tuesday April 14, 2020 9:00am - 12:00pm

9:00am

Workshop B: Utilize Meaningful Metrics Tracked from Dashboards

Dashboards provide the opportunity to highlight the differential value MSLs bring to the organization, most effective dashboards are no longer than one-page, integrate the corporate vision, targeted to key stakeholders, including meaningful quantitative and qualitative data which is differentiated for the MSL role, and discussion on key metrics will include a number of variables: Trends of number of KOL interactions (face to face, email, phone, web-ex), research discussions, speaker training, and congress interactions. Qualitative measures such outcomes tied to MSL activity, monetized value associated with decreased cost (projects or study), insights informing publication strategy, interactions leading to specific requests for additional data, education informing data shared from a podium at a Congress and qualitative feedback after an MSL presentation. Presenters will share examples of different dashboards, and workshop attendees will provide feedback on best practices and challenges in their practice environment.

Speakers

Kate Pietrovito

Director, Medical 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 →

Tuesday April 14, 2020 9:00am - 12:00pm

9:15am

Future Proof your Medical Affairs Organization and your KTL Engagement Strategy

Build an internal key thought leader (KTL) community of practice
Align business strategy and objectives to drive medical affairs and KTL program
Develop a standardized policy that provides guidelines for KTL engagement strategy
Deliver strategic guidance, leverage clinical, scientific, and economic knowledge to drive meaningful innovations

Speakers

Kevin Appareti

Senior Director, Global Medical Science Liaison, Chief Medical Office, Key Thought Leader Program, Philips Healthcare

Kevin Appareti is Senior Director, Global Medical Science Liaison in the Chief Medical Office at Royal Philips. He leads the Key Thought Leader Program and works across Philips’ businesses, markets, and research to build strong internal and external relationships with key thought... Read More →

Tuesday April 14, 2020 9:15am - 10:00am

10:00am

Leverage Stakeholder Partnerships to Overhaul Clinical KOL Operations

Address a need for a shared strategy across the organization for KOL relations and operations by function and business segment.
Create turn-key tools and processes aligned with business needs and compliance requirements.
Deliver a world class “one-voice” to KOLs from the organization.

Speakers

Christina Stahler, MBA

Sr. KOL Operations Manager, Illumina

Christina L. Stahler is the Senior Manager KOL Communications at Illumina. Since joining Illumina in 2015 She has held positions in Ad Board Management, KOL Database Administration, and KOL Operations. Currently, Christina is building the infrastructure and communications strategy... Read More →

Holly Snyder, MS, LCGC

Staff Genetic Counselor, Illumina

Holly L. Snyder is a board-certified genetic counselor and is licensed in the state of Virginia. Before joining Illumina in 2012, she provided prenatal genetic counseling services at Kapiolani Medical Center for Women and Children in Honolulu, Hawaii, and Eastern Virginia Medical... Read More →

Tuesday April 14, 2020 10:00am - 10:45am

10:30am

30-Minute Networking Break

Tuesday April 14, 2020 10:30am - 11:00am

11:15am

Discover Tactics to Enhance Communication Between Medical and Commercial Teams

Discuss how to begin breaking down silos within the industry for higher efficiency and stronger bonds
Assess obstacles and hesitancies in communication and discuss methods for overcoming them
Define clear objectives for legal and other departments to ensure a smooth process flow
Work compliantly in the same space with supporting teams to increase efficiency

Speakers

Christopher Alfieri

Thought Leader Liaison, EMD Serono

Tuesday April 14, 2020 11:15am - 12:00pm

12:00pm

Luncheon for Seminar and Workshop Participants

Tuesday April 14, 2020 12:00pm - 1:00pm

1:00pm

Follow the Journey from Fellowship to KOL, A Case Study

- Dive into the importance of engaging physicians in training and how to effectively navigate the transition from fellowship to practice
- Identify emerging leaders within the space to determine future KOLs and how to better leverage their expertise
- Understand how to build KOLs and do this in a way that is a win-win for industry and the physician

Speakers

Ann Roen

Senior Director, Professional Relations and Customer Insights, Medtronic

ANN ROEN has 20+ years of experience within the healthcare and medical device industries, including 12+ years with Medtronic. She is currently the Sr. Director of Professional Relations and Customer Insights for Medtronic Cardiac Rhythm and Heart Failure business unit where she... Read More →

Tuesday April 14, 2020 1:00pm - 1:45pm

1:00pm

Workshop C: 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?

While the role of pharmaceutical companies to provide accurate scientific information to HCPs and the global medical community is well established, regulatory and compliance oversight continue. Pharmaceutical companies must consider a range of regulatory and enforcement statutes as well as actions taken by various government agencies with overlapping authority and often differing enforcement perspectives. The Medical Affairs function is being called upon to take a more proactive approach in helping to develop and implement policies regarding medical communication with both the external medical community as well as internal stakeholders (including Commercial, R&D, HEOR). This presentation will review the basic provisions of the FDCA as regulatory guidance's issued by the FDA and actions taken by the Office of the Inspector General (OIG) in enforcing the False Claims Act
(FCA) and the Anti-Kickback statute, among others, and discuss the need for a new paradigm relating to the role of Medical Affairs.

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

Speakers

Howard Dorfman

Distinguished Visiting Practitioner and Adjunct Professor, Seton Hall University School of Law

Tuesday April 14, 2020 1:00pm - 4:00pm

1:00pm

Workshop D: Examine How to Best Develop Your IIT Team and Processes To Ensure Effective Management And Contracting

When developing an IIT program, how you align your resources, staff the team, and develop your processes can greatly affect how quickly you can finalize any contracting necessary to support IIT trials. This workshop will discuss three overarching areas that affect contracting: 1) Processes such as IIT portals and hands-off IIT submission processes versus relationship-based models; 2) Staffing such as fully insourced IIT teams, outsourced or IIT teams staffed by Flexible Staffing providers, and IIT teams with set contracts. 3) providing valuable feedback to contracting teams to ensure the agreement is consistent with the purpose of the Medical Plan/approval.

Weigh the pros and cons of the different types of submission processes that pharmaceutical companies use to support their IIT program and discuss how they are looked at by a site contract and budget team
Review different staffing models and why companies may choose to use a specific model for their IIT program
Discuss how the different models may affect your contracting timelines
Discuss the importance of Medical Affairs involvement in the contract negotiations

Tuesday April 14, 2020 1:00pm - 4:00pm

1:45pm

Effectively Tier Thought Leaders to Determine the Fair Market Value of Patients

Select a range of metrics and criteria for developing a stratification model for KOL segmentation
Identify thought leaders based on level of experience and recognition
Craft compliant processes to collect and evaluate data in order to determine regional and international fair market value rates

Tuesday April 14, 2020 1:45pm - 2:30pm

2:45pm

30-Minute Netowrking Break

Tuesday April 14, 2020 2:45pm - 3:15pm

3:00pm

Position the Role of an MSL as a Valued and Credible Asset to the Payer and Provider Community

Address key takeaways of building basic relationships
Review the importance of the following up and following through strategy
Understand “what you do” vs. “what you can do” and where your KOL can collaborate within your organization

Speakers

Howard Berkowitz

Respiratory and Immunology, MSL, U.S. Field-Based Medical Affairs, Sanofi Genzyme

Howard has been employed in the pharma industry for over 25 years in various roles within Medical Affairs, including 5 years in sales as a clinical science consultant for BI. His experience includes roles as National Director of Medical Science Liaisons, Regional Medial Science... Read More →

Tuesday April 14, 2020 3:00pm - 3:45pm

3:45pm

Seminar Closing Remarks

Tuesday April 14, 2020 3:45pm - 4:00pm

4:00pm

Conclusion of Seminar

Tuesday April 14, 2020 4:00pm - 4:00pm

7:30am

Main Conference Registration and Continental Breakfast

Wednesday April 15, 2020 7:30am - 8:30am

8:30am

Chairperson's Opening Remarks

Wednesday April 15, 2020 8:30am - 8:45am

8:45am

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

Reina Benabou, MD, Ph.D.

Senior Vice President & Chief Medical Officer, Cognivue

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 care... Read More →

Wednesday April 15, 2020 8:45am - 9:30am

9:30am

Develop a Fit-for-Purpose Medical Strategic Plan

Establish a framework and standards
Shape learning strategies based on your organizational needs
Define Mission and what success looks like
Define MA Objectives and KPIs
Receive buy-in from your team

Speakers

Dan Hennessy

Vice President, Field MA, 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 April 15, 2020 9:30am - 10:15am

10:15am

30-Minute Networking Break

Wednesday April 15, 2020 10:15am - 10:45am

10:45am

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

Lance Hill

CEO, Within3

As Chief Executive Officer of Within3, Lance Hill brings his own brand of energy, leadership and vision to the company. With the belief that deeper engagement among healthcare professionals results in improved healthcare and better patient outcomes, Lance strategizes with global healthcare... Read More →

Wednesday April 15, 2020 10:45am - 11:15am

11:15am

Panel Discussion: Key Considerations for Building Medical Affairs Organizations Across Various Therapeutic Areas

Develop a framework for building a medical affairs organization across various therapeutic areas, considering corporate needs and the existing healthcare environment
Highlight methods, roles, and responsibilities of larger pharmaceutical and biotechnology medical affairs teams and how and when they can be replicated within different models
Assign cross-functional workstreams to MA team members that can be efficiently executed
Pinpoint communication channel issues that arise in large medical affairs teams and increase collaboration between field MSL and in-house teams

Speakers

Tehseen Salimi

Vice President of Medical Affairs and Real World Evidence, G1 Therapeutics, Inc.

Suzana Giffin, PharmD

AVP, Head of GMA Capabilities Global Medical Affairs, Merck

Peter L. Goldberg, Ph.D.

Field Medical Strategist, East US, Head of Medical Science Liaisons, East US, U.S. Medical Affairs - Rheumatology, UCB, Inc.

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 →

Wednesday April 15, 2020 11:15am - 12:00pm

12:00pm

Luncheon for Conference Participants

Wednesday April 15, 2020 12:00pm - 1:00pm

1:00pm

Track A: Opening Remarks

Track D: Opening Remarks

Speakers

Kimberly Cheshire-Kinney

Global Operations Head, IIS and Collaborative Studies-MAO, Global Clinical Development Operations, Janssen R&D

Kim is the Global Operations Head, IIS-Collaborative, Medical Affairs Operations (MAO) for Janssen. In her role she has primary global accountability for the IIS and collaborative study global framework (policy, processes, systems, vendors). She oversees harmonized global implementation... Read More →

Wednesday April 15, 2020 1:00pm - 1:15pm

1:15pm

Track A: Consider KOL Engagement for Various Organizations Sizes and Scenarios

Understand who the key players are and build KOL advocates whose beliefs align with your organization’s goals
Establish the challenges of educating the market on an unmet medical need
Plan a strategy for the prioritization and sharing of scientific information across a product life cycle

Speakers

Randall Kaye

Chief Medical Officer, Neurana Pharmaceuticals

Wednesday April 15, 2020 1:15pm - 1:45pm

1:15pm

Track B: Panel: Optimize Customer Engagement Through Use of Innovative Technology

Discuss changes in the role of Medical Affairs in interacting with the next generation of healthcare providers and their patients
Identify challenges and applied solutions, discuss potential opportunities for innovation
Share and discuss best practices in leveraging hardware, software, and apps to enhance clinical education and training to address the changing landscape of Medical Affairs

Speakers

Scott McConnell, Pharm.D.

Vice President, Medical Affairs, Chiasma

Jennifer Rupe Tontini

Vice President, Global Business Development, Educational Measures

Jennifer Rupe Tontini is recognized as a thought leader in strategic engagement and adult learning, focusing on onsite, virtual, and onsite/virtual hybrid event engagement planning and execution. Jenn is a certified Change Management Professional (CMP) and leverages her experience... Read More →

Wednesday April 15, 2020 1:15pm - 1:45pm

1:15pm

Track C: Build Out MSL Teams: Review the Difference Between U.S. and Ex-U.S. Scenarios

Discuss differences in regulations, and the role/understanding of the MA role becomes challenging when dealing with a company based outside of the U.S.
Review challenges in approval processes, position requirements and compensations are all difference once you move outside of the U.S. – with that, the process to develop a strong field medical team is slowed down

Speakers

J. Lynn Bass, Pharm.D

Senior Director and Head, Medical Science Liaisons, Mesoblast, LTD

Wednesday April 15, 2020 1:15pm - 1:45pm

1:15pm

Track D: 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

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 →

Wednesday April 15, 2020 1:15pm - 1:45pm

1:45pm

Track A: Tailor Global Medical Strategy Based on the Needs of Regional Partners

Identify unmet medical education needs for 5 target stakeholder groups
Prioritize medical education needs and align with cross-functional business strategy
Define medical education strategy and validate through an Advisory Board
Compliance for regional and mitigate risk
Leadership is affected

Speakers

Roberto Uehara

Vice President Medical Affairs, Emerging Markets, Pfizer Oncology

Roberto Uehara is a Medical Oncologist with clinical practice and academic experience in Solid Tumors, Hematological Malignancies and Bone Marrow Transplantation Fifteen years of experience in pharmaceutical industry in different therapeutic areas such as oncology, hematology, inflammation... Read More →

Wednesday April 15, 2020 1:45pm - 2:15pm

1:45pm

Track B: Case Study: 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

Jill Massey, PharmD, MBA, BCMAS

Senior Vice President, Medical Affairs, Melinta Therapeutics

Dr. Massey has 27 years of medical affairs experience in the commercialization and life-cycle management of pharmaceutical products across multiple therapeutic areas including cardiovascular disease, infectious diseases, neuroscience, pain management, women’s health, psychiatric... Read More →

Wednesday April 15, 2020 1:45pm - 2:15pm

1:45pm

Track C: Panel: How Medical Affairs 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

Speakers

Alan Polnariev

MSL, Ferring Pharmaceutical

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 →

Tommy Brock

Senior MSL, United Therapeutics

Josh Yoder, Ph.D.

Medical Science Liaison, uniQure

Luchy Hidalgo, M.D.

Medical Science Liaison; Medical Affairs Consultant - KOL Insights, Exact Sciences

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 →

Wednesday April 15, 2020 1:45pm - 2:15pm

1:45pm

Track D: Discuss Key Strategies for your Internal Investigator Initiated Study Operations

Understand all specifications needed for your proposal
Learn how to streamline your proposal submission process throughout your company
Close the gap between what is submitted vs. what your internal review committee needs

Wednesday April 15, 2020 1:45pm - 2:15pm

2:15pm

Track A: Establish a Medical Affairs Organization in a Start-up Environment

Discuss key considerations when designing and growing a medical affairs organization in a small-company environment
Compare and contrast medical affairs responsibilities in a small-company or start-up environment vs. larger or more established organizations

Speakers

Elizabeth Pash

Vice President of Medical Affairs, Gelesis

Elizabeth leads the execution of the overall medical affairs strategy and related decisions for Gelesis. Before joining Gelesis, she was Head of Medical Science for Abbott Nutrition. Prior to that, she served as Senior Director of Medical Affairs at Medtronic (Covidien). Elizabeth... Read More →

Wednesday April 15, 2020 2:15pm - 2:45pm

2:15pm

Track B: Case Study: Unite All Your Medical Affairs Grants for Medical Education

Speakers

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 April 15, 2020 2:15pm - 2:45pm

2:15pm

Track C: Manage MSL Teams within the Evolving Health Care Environment

Review the growing sophistication of pharmaceutical products, particularly genomics and orphan drugs, contributes to the increased need for MSLs with specialized scientific knowledge
Discuss the evolution of MSL strategies that continue to meet the needs of patients and health care professionals, as the healthcare environment changes
Identify new targets of influence and integration of technology and training to enhance scientific interactions through territory management
Demonstrate MSL value through documented outcomes and insights which influence strategy will be the key to growth

Speakers

Peter Ishak

Senior Medical Science Liaison, Daiichi Sankyo

Peter was born and raised in New Brunswick, NJ. He attended USciences, Philadelphia College of Pharmacy earning his Pharm.D. Upon graduation, he worked in the community pharmacy setting before going into the pharmaceutical industry. Prior to his current role as a Medical Science Liaison... Read More →

Wednesday April 15, 2020 2:15pm - 2:45pm

2:15pm

Track D: 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

Anton Ehrhardt, Ph.D.

Vice President, Medical Affairs, Spectrum Pharmaceuticals

Wednesday April 15, 2020 2:15pm - 2:45pm

2:45pm

30-Minute Networking Break

Wednesday April 15, 2020 2:45pm - 3:15pm

3:15pm

Track A: The Medical Affairs Paradox: How Our Selective Sidelining of Science is Holding Us Back

Consider the science of curiosity and learning that can invigorate creativity and productivity

Consider the science behind communication frameworks and tactics that don’t “feel” scientific
Discover how experimenting with or implementing these concepts can help Medical Affairs teams deliver on value propositions in a dynamic healthcare and human landscape

Wednesday April 15, 2020 3:15pm - 3:45pm

3:15pm

Track B: Establish the Value of Medical Affairs to Ensure Proactive Collaboration and Alignment with Functional Partners

Discuss how to bridge the gap when working a highly matrixed organization between preclinical, clinical operations, and medical affairs
Develop a culture of collaboration with open communications within cross-functional teams to allow for efficient channel management and rapid bidirectional information flow
Consider the types of personality traits that can be beneficial when building out a new team
Explore how to proactively manage your team’s career and continue their development

Speakers

Carol Hoang

Vice President, Medical Affairs, Adverum Biotechnologies, Inc.

Wednesday April 15, 2020 3:15pm - 3:45pm

3:15pm

Track C: Use Data Mining Techniques to Enhance Customer Engagement

How analytics drive your outreach strategy
Segment customer base and target them using data analytics

Speakers

Ariel Katz

CEO, H1

Ariel started his first company in college, ResearchConnection, to help connect students with research opportunities. That company grew to over 40 universities and was eventually acquired by the Bill and Melinda Gates Foundation and the Ewing Kauffman Foundation.Next Ariel started... Read More →

Dan Hennessy

Vice President, Field MA, EMD Serono

Wednesday April 15, 2020 3:15pm - 3:45pm

3:15pm

Track D: Panel: Sharing the 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

Speakers

Archie Stone, Ph.D., BCMAS

Sr. National MSL Director, Aurinia Pharmaceuticals Inc.

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 →

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 →

Wednesday April 15, 2020 3:15pm - 3:45pm

3:45pm

Track A: Panel: Explore Launch Planning for Organizations of Varying Sizes

Dive into key points to prepare for launch from a 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

Tehseen Salimi

Vice President of Medical Affairs and Real World Evidence, G1 Therapeutics, Inc.

Speakers

Georgea Pasedis, PharmD RPh

Head of Medical Affairs, Dompé

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 →

Jean Hubble

Vice President, Medical Affairs, Adamas Pharmaceuticals

Dr. Jean Hubble has dedicated much of her academic and industry career to Parkinson’s disease and Movement Disorders research and the advancement of patient care and treatment.Jean was a tenured associate professor of neurology at the Ohio State University and served as the director... Read More →

Peter L. Goldberg, Ph.D.

Field Medical Strategist, East US, Head of Medical Science Liaisons, East US, U.S. Medical Affairs - Rheumatology, UCB, Inc.

Wednesday April 15, 2020 3:45pm - 4:15pm

3:45pm

Track B: Streamline Efficiencies and Improve Techniques to Build and Run Advisory Boards

Learn how to manage your brand by prioritizing markets and considering their similarities and differences
Discuss key areas of strategic planning necessary to make decisions on the scope and reach of your advisory boards
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

Speakers

Scott McConnell, Pharm.D.

Vice President, Medical Affairs, Chiasma

Wednesday April 15, 2020 3:45pm - 4:15pm

3:45pm

Track C: Utilize Unbranded Scientific Exchange Programs to Ensure Effective Decision-Making

Discuss how your team can proactively engage customers through unbranded exchange programs
Ensure that you are clearly separating scientific exchange from promotional messaging
Use scientific and data-driven information to help HCPs make informed patient-care decisions

Wednesday April 15, 2020 3:45pm - 4:15pm

3:45pm

Track D: 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

Wednesday April 15, 2020 3:45pm - 4:15pm

4:15pm

Track A: Gather Medical Insights and Communicating the Value

Understand the value and sources of Medical insights
Learn best practices for documenting field-generated insights
Understand technology options to efficiently and consistently process the data

Speakers

Jason Jensen

Vice President, Scientific Commercialization

Wednesday April 15, 2020 4:15pm - 4:45pm

4:15pm

Track B: Review Artificial Intelligence for Medical Affairs through an External Industry Lens - A Tale of Connected Stories

Review a framework for cutting through the AI myst of fast-paced AI technology advancements driving the momentum
Relate medical affairs needs with use cases in Commercial, R&D, Manufacturing and in other industries
Consider challenges and opportunities in Implementing AI Solutions for Medical Affairs

Wednesday April 15, 2020 4:15pm - 4:45pm

4:15pm

Track C: Empowering Medical Science Liaison (MSL) Field Teams

Are you maximizing the impact of your MSL Field Teams?
WHy are MSL-KOL engagement skills key to a successful launch?

Wednesday April 15, 2020 4:15pm - 4:45pm

4:15pm

Track D: Review Best Practices for Proposing an IIT Program and Preparing a Study Proposal

Review strategies for identifying the best funding opportunities
Assess the stage in which you should start your IIT program
How to write a compelling and successful budget justification

Speakers

Atif Mohammad, Ph.D.

Medical Director, US Medical Affairs, Bristol-Myers Squibb

Wednesday April 15, 2020 4:15pm - 4:45pm

4:45pm

Networking Reception

Wednesday April 15, 2020 4:45pm - 5:45pm

5:45pm

Conference Day One Concludes

Track A: Provide a Framework for the Development of a Medical Plan

Review key questions to ask and common pitfalls/blind Spots to avoid when developing a medical plan
Explore the needs of the organization and when to build certain functions based on where you are in your life cycle
Hear how to coordinate across functional areas to avoid misalignment and confusing strategies with tactics
Ensure accountability and built-in temperature checks to monitor progress and/or course-correct when necessary

Speakers

Mario Mendoza, MD, MS

BioExecutive-In-Residence, New York State Center for Biotechnology at Stony Brook University

Thursday April 16, 2020 9:15am - 9:45am

9:15am

Track B: Develop and Define Strategic Metrics to Demonstrate the Value of the Medical Affairs Group

How to define, measure, and communicate the value of Medical Affairs to internal and to external stakeholders
Discuss how to measure and report both quantitative and qualitative measures of success for Medical Affairs
Define how to link meaningful metrics in Medical Affairs to desired outcomes

Thursday April 16, 2020 9:15am - 9:45am

9:15am

Track C: Panel: 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 to provide ethical, accurate and balanced off-label data while adding patient value in a compliant manner

Moderators

Peter Lee

Vice President, Chief Compliance Officer, Heron Therapeutics, Inc.

Peter Lee received his B.A. from the University of Michigan and his J.D. from Quinnipiac Law School. He has a master’s in health law from Loyola University of Chicago and almost 20 years of experience building compliance programs in healthcare for hospitals, managed care organizations... Read More →

Speakers

Anna Vichiendilokkul, PharmD MS

Director, Medical Science Liaison, GlaxoSmithKline

Jacqueline S. Armani, OD, FAAO, MSL-BC

Regional MSL Lead – North East, Medical Science Liaison – Metro NY and NJ, Clinical Development and Medical Affairs, North America, 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 →

Teresa P.M. Kelton, JD, PharmD, MPH

Executive Director, R&D and Quality Counsel, Alexion Pharmaceuticals, Inc.

Thursday April 16, 2020 9:15am - 9:45am

9:15am

Track D: Practical Considerations for Collaborative Research Between the Pharmaceutical Industry and External Investigators

Outline the differences between an industry-sponsored study and a non-industry sponsored study
Understand how employing a more collaborative approach to research studies can lead to more effective and safe treatments
Build consistency and transparency in approach across companies in collaborative research agreements

Speakers

Maureen Lloyd

Executive Director, LLOYDMJMC LLC.

Maureen specializes in orchestrating innovative strategies in global medical affairs, patient advocacy and foundations, risk management and compliance. Designs and executes creative pragmatic initiatives that facilitate Healthcare Industry commitment to open dialogue with physicians... Read More →

Thursday April 16, 2020 9:15am - 9:45am

9:45am

Track A: Discuss Patient-Centric Framework as a Foundation for Medical Affairs Strategy and Operational Effectiveness

Understand how patient well-being is key to healthcare sustainability
Examine how medical affairs can take a leading role in defining target patient segments for industry innovation and value for the patient
View patient centricity as an anchor for planning and executing medical affairs activities

Thursday April 16, 2020 9:45am - 10:15am

9:45am

Track B: Develop a Comprehensive Publication Plan Aligned with Corporate Strategy and Product Life Cycle

Prioritize certain data sets/types in the publication plan aligned with the product life cycle
Understand the importance of publication timing, authorship and journal selection
Ensure that the publication plan is integrated to the Medical Affairs field team strategy and tactics, as well as being flexible enough to address competitive intelligence feedback

Speakers

Jennifer Almekinder

Director, Global Aesthetics Scientific Communications, Merz

Thursday April 16, 2020 9:45am - 10:15am

9:45am

Track C: How to Effectively Collect and Synthesize MSL Insights

Understand organizational and key internal stakeholder needs
Discuss best practices for the collection of insights
Effective synthesis and prioritization of novel insights

Speakers

Nikki Irish

Director of MSL, MA, Adamas Pharmaceuticals

Thursday April 16, 2020 9:45am - 10:15am

9:45am

Track D: Optimize the ISR Process from Protocol Submission Through Study Completion

Change the way we look at our Book of Work and how we can change the conversation between Medical/MSL
Discuss implications, and importance, of metrics and management
Exemplify compliance and process improvements through case studies of internal audits
Increase consistency and standardization for execution to improve metrics

Thursday April 16, 2020 9:45am - 10:15am

10:15am

30-Minute Networking Break

Thursday April 16, 2020 10:15am - 10:45am

10:45am

Track A: 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

Speakers

Barry Lubarsky

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 →

Thursday April 16, 2020 10:45am - 11:15am

10:45am

Track B: 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

Aswin Chandrakantan, M.D.

Chief Medical Officer and Senior Vice President of Corporate Development, Komodo Health

Aswin Chandrakantan, M.D., is Chief Medical Officer and Senior Vice President of Corporate Development at 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... Read More →

Thursday April 16, 2020 10:45am - 11:15am

10:45am

Track C: 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

Thursday April 16, 2020 10:45am - 11:15am

10:45am

Track D: Use Technology to Enhance and Advance Investigator Initiated Trials

Simplify submissions through website and portal software
Use technology to enable good project management (PMBOK)
Learn how technology can improve the site experience (reporting enrollment, SAEs, budgets, etc.)

Speakers

Tarang Anthwal

Associate Consultant - IT, Eli Lilly and Company

I work with Eli Lilly & Company in the Medicines Development business unit. As the IT Execution lead, I manage the technology needs of the Investigator-Initiated Trials platform across Lilly.

Jeremy Keeton

ONC Investigator Initiated Trials Project Manager, Eli Lilly and Company

Started at Eli Lilly as an organic chemist in 2002. Spent majority of my career supporting pharma-sponsored ONC trials both in-house and field based roles.

Thursday April 16, 2020 10:45am - 11:15am

11:15am

Track A: Panel: Analyze the Involvement of Medical Affairs in Commercial Activities

Understand how to align strategically and keep tactics separate
Define the line between promotional activities and scientific exchange
Determine the appropriate firewall between medical affairs and commercial

Moderators

Mario Mendoza, MD, MS

BioExecutive-In-Residence, New York State Center for Biotechnology at Stony Brook University

Speakers

Scott McConnell, Pharm.D.

Vice President, Medical Affairs, Chiasma

Thursday April 16, 2020 11:15am - 11:45am

11:15am

Track B: Establish an Integrated Approach to Managing Medical Information and Medical Communications to Leverage Insights and Deliver Value

Cultivate synergies in scientific communications and medical information services to provide useful resources to patients and healthcare professionals
Identify the need for resource development and align communication resources across field and internal medical affairs
Centralize scientific content creation by collecting metrics and maximize them with technology to interpret and execute on the data in order to create an impact within your organization

Speakers

James Fratantonio

Medical Director, Medical Affairs, Alkermes

Dr. Fratantonio received his Doctorate of Pharmacy degree from the University of Rhode Island. He has been in many different roles within the pharmaceutical industry. Currently, he is a Medical Director in Medical Affairs Strategy at Alkermes. Some of his responsibilities and experiences... Read More →

Thursday April 16, 2020 11:15am - 11:45am

11:15am

Track C: Discuss the Implementation of Digital Strategy for Field MSLs

Understand how the use of digital technology can enhance field medical professionals’ processes efficiently and compliantly
Ensure field medical teams are connected towards the digital strategy through a seamless strategy roll-out
Look at the positives and negatives of integrating digital technologies into field medical’s daily operations

Thursday April 16, 2020 11:15am - 11:45am

11:15am

Track D: Explore How to Collaborate with MSLs and Field Medical for IIT Success

Minimize the risks associated with your IIT investment by having rigorous review standards
Guarantee a compliant investigation throughout the entire lifecycle process
Ensure cross-functional alignment on priorities and tactics

Speakers

Swati Pradhan-Bhatt, Ph.D.

Associate Director, Scientific Affairs, Mallinckrodt Pharmaceuticals

Swati Pradhan-Bhatt, Ph.D., is the Associate Director for Scientific Affairs at Mallinckrodt Pharmaceuticals. She leads the Scientific Affairs team and provides oversight over the management of clinical/pre-clinical research for approved and late-stage products. Her role provides... Read More →

Thursday April 16, 2020 11:15am - 11:45am

11:45am

Luncheon for Conference Participants

Thursday April 16, 2020 11:45am - 12:45pm

12:45pm

Track A: Establish a Roadmap to Develop a Successful Medical Affairs Strategic Plan

Discuss the value of having a comprehensive medical plan
Learn of common pitfalls and blind spots to avoid in the development of the medical plan

Speakers

Kimberly Cremers

Field Medical Strategist, Rheumatology West; Head of Medical Science Liaisons, Rheumatology West,, UCB

Thursday April 16, 2020 12:45pm - 1:15pm

12:45pm

Track B: Discuss Evidence Development, Publication Planning, and a Deep Dive into Strategic Processes

Use insights gathering to inform evidence generation and publication plans
Understand the need for communication of different types of data through a product lifecycle
Work with your cross-functional publications team to ensure that data and discussions are aligned with overall strategic objectives

Thursday April 16, 2020 12:45pm - 1:15pm

12:45pm

Track B: Panel: Communication Strategies: A Guide to Meaningful Conversations with HCPs, KOLs, Patients, Colleagues and Other Stakeholders

How to generate valuable insights and discuss prompted versus unprompted insights
How to bring value and focus of the company to KOLs
How to bring back insights that provide guidance on publications, educational modules, and developing strategies
Clarify technology challenges (such as online/social versus in-person), and review how you may leverage this technology

Moderators

Nikki Irish

Director of MSL, MA, Adamas Pharmaceuticals

Speakers

Howard Berkowitz

Respiratory and Immunology, MSL, U.S. Field-Based Medical Affairs, Sanofi Genzyme

Sheila Komara

Senior MSL, Mallinckrodt Pharmaceuticals

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 →

Keely Dahl

Medical Science Liaison, Aurinia Pharmaceuticals Inc.

Thursday April 16, 2020 12:45pm - 1:15pm

12:45pm

Track C: Consider Global Regulatory Compliance for IITs Across all Levels of Your Organization

Explore the different risks associated with investing in an IIT program
Review the differences in global regulatory guidelines
Assess considerations for setting up IIT programs internationally

Thursday April 16, 2020 12:45pm - 1:15pm

1:15pm

Track A: How to Best Leverage Social Media and the Digital Ecosystem in Patient Recruitment

Examine the use of social media in patient recruitment
Review what is and is not working in partnerships between patient social networks and pharmaceutical companies and CROs
Discuss key elements of a social media community dedicated to aiding patient recruitment

Speakers

Atif Mohammad, Ph.D.

Medical Director, US Medical Affairs, Bristol-Myers Squibb

Thursday April 16, 2020 1:15pm - 1:45pm

1:15pm

Track B: Develop a Streamlined Process for Gathering Clinical and Field Insights and Translate That Data Internally to Shape Medical Strategy

Discuss some of the challenges of leveraging CRMs to extract field insights in an intuitive manner
Review the different types of intelligence collected
Develop a process to collect field intelligence, tier it based on importance /urgency, and report it up the management chain accordingly
Use this process as a metric that tracks the frequency and quality of the feedback
reported by team members

Thursday April 16, 2020 1:15pm - 1:45pm

1:15pm

Track C: Panel: Provide a Compliance Perspective on Effective Advisory Board and Consulting Agreement Execution

Consider the legal and regulatory risks involved
Explore the need for compliance monitoring in advisory boards
Discuss the difference in perspectives between medical and commercial groups

Speakers

Peter Lee

Vice President, Chief Compliance Officer, Heron Therapeutics, Inc.

Thursday April 16, 2020 1:15pm - 1:45pm

1:15pm

Track D: Panel: Effective Strategies to Ensure Your Collaborative Research Study is Compliant and Advantageous: An Institutional Perspective

Strategies to ensure transparent communication between the investigator and sponsoring parties
Common compliance issues and how to avoid them
Checklist to ensure a forward-moving, goal-oriented study

Moderators

Kimberly Cheshire-Kinney

Global Operations Head, IIS and Collaborative Studies-MAO, Global Clinical Development Operations, Janssen R&D

Speakers

Nitasha Phatak, MD, Ph.D.

Regulatory Specialist (Investigator-initiated trials), Methodist Health System

Dr. Nitasha Phatak received her medical degree in ophthalmology and has eight years' experience in ophthalmic surgery from University of Mumbai, India. She also earned a PhD in biomedical sciences from the University of North Texas Health Science Center in Fort Worth. At the Methodist... Read More →

Thursday April 16, 2020 1:15pm - 1:45pm

1:45pm

Track A: 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

Rudy Christian, DrPH

Senior Medical Science Liaison, Alkermes, Inc

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 →

Thursday April 16, 2020 1:45pm - 2:15pm

1:45pm

Track B: Best Practice Process for Scientific Communication Platform (SCP) Development and Implementation

Discuss how discrepancies in data can lead to confusion and a weakened value proposition for a product
Develop a process of development, and ensure understanding of its most basic components, involved in a SCP
Implement cross-functional training of an SCP across functional teams
Determine challenges and establish solutions

Thursday April 16, 2020 1:45pm - 2:15pm

1:45pm

Track C: 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

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 April 16, 2020 1:45pm - 2:15pm

1:45pm

Track D: The Perils and Pitfalls of Clinical Research Collaborations

Discuss guidance from the FDA
Review the implications of drug supply shortages
Deep dive into monetary risks and miscommunication

Thursday April 16, 2020 2:15pm - 2:30pm

2:30pm

Conference Concludes

Thursday April 16, 2020 2:30pm - 2:30pm