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Tuesday, April 14
 

8:00am EDT

Breakfast and Seminar Registration
Tuesday April 14, 2020 8:00am - 9:00am EDT
  Networking

9:00am EDT

KOL Engagement Seminar Opening Remarks
Tuesday April 14, 2020 9:00am - 9:15am EDT
  KOL Seminar

9:00am EDT

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
avatar for Mario Mendoza, MD, MS

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 →
avatar for Scott McConnell, Pharm.D.

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 EDT
  Workshop

9:00am EDT

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
avatar for Kate Pietrovito

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 EDT
  Workshop

9:15am EDT

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
avatar for Kevin Appareti

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 EDT
  KOL Seminar

10:00am EDT

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
avatar for Christina Stahler, MBA

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 →
avatar for Holly Snyder, MS, LCGC

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 EDT
  KOL Seminar

10:30am EDT

30-Minute Networking Break
Tuesday April 14, 2020 10:30am - 11:00am EDT
  Networking

11:15am EDT

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
CA

Christopher Alfieri

Thought Leader Liaison, EMD Serono

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

12:00pm EDT

Luncheon for Seminar and Workshop Participants
Tuesday April 14, 2020 12:00pm - 1:00pm EDT
  Networking

1:00pm EDT

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
avatar for Ann Roen

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 EDT
  KOL Seminar

1:00pm EDT

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
avatar for Howard Dorfman

Howard Dorfman

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

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

1:00pm EDT

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 EDT
  Workshop

1:45pm EDT

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 EDT
  KOL Seminar

2:45pm EDT

30-Minute Netowrking Break
Tuesday April 14, 2020 2:45pm - 3:15pm EDT
  Networking

3:00pm EDT

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
avatar for Howard Berkowitz

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 EDT
  KOL Seminar

3:45pm EDT

Seminar Closing Remarks
Tuesday April 14, 2020 3:45pm - 4:00pm EDT
  KOL Seminar

4:00pm EDT

Conclusion of Seminar
Tuesday April 14, 2020 4:00pm - 4:00pm EDT
  Networking
 
Wednesday, April 15
 

7:30am EDT

Main Conference Registration and Continental Breakfast
Wednesday April 15, 2020 7:30am - 8:30am EDT
  Networking

8:30am EDT

Chairperson's Opening Remarks
Wednesday April 15, 2020 8:30am - 8:45am EDT
  Main Conference

8:45am EDT

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
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 EDT
  Main Conference

9:30am EDT

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
avatar for Dan Hennessy

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 EDT
  Main Conference

10:15am EDT

30-Minute Networking Break
Wednesday April 15, 2020 10:15am - 10:45am EDT
  Networking

10:45am EDT

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
avatar for Lance Hill

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 EDT
  Main Conference

11:15am EDT

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
TS

Tehseen Salimi

Vice President of Medical Affairs and Real World Evidence, G1 Therapeutics, Inc.
avatar for Suzana Giffin, PharmD

Suzana Giffin, PharmD

AVP, Head of GMA Capabilities Global Medical Affairs, Merck
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.
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 →

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

12:00pm EDT

Luncheon for Conference Participants
Wednesday April 15, 2020 12:00pm - 1:00pm EDT
  Networking

1:00pm EDT

Track A: Opening Remarks
Speakers
avatar for Kimberly Cremers

Kimberly Cremers

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

Wednesday April 15, 2020 1:00pm - 1:15pm EDT
  Track A: Medical Affairs Strategy

1:00pm EDT

Track B: Opening Remarks
Speakers
avatar for Kate Pietrovito

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 →

Wednesday April 15, 2020 1:00pm - 1:15pm EDT
  Track B: Medical Operations & Technology

1:00pm EDT

Track C: Opening Remarks
Speakers
avatar for Howard Berkowitz

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 →

Wednesday April 15, 2020 1:00pm - 1:15pm EDT
  Track C: MSL and Field Strategy

1:00pm EDT

Track D: Opening Remarks
Speakers
avatar for Kimberly Cheshire-Kinney

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 EDT
  Track D: Investigator-Initiated Trials

1:15pm EDT

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
avatar for Randall Kaye

Randall Kaye

Chief Medical Officer, Neurana Pharmaceuticals

Wednesday April 15, 2020 1:15pm - 1:45pm EDT
  Track A: Medical Affairs Strategy

1:15pm EDT

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
avatar for Scott McConnell, Pharm.D.

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 →
avatar for Jennifer Rupe Tontini

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 EDT
  Track B: Medical Operations & Technology

1:15pm EDT

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
avatar for J. Lynn Bass, Pharm.D

J. Lynn Bass, Pharm.D

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

Wednesday April 15, 2020 1:15pm - 1:45pm EDT
  Track C: MSL and Field Strategy

1:15pm EDT

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
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 →

Wednesday April 15, 2020 1:15pm - 1:45pm EDT
  Track D: Investigator-Initiated Trials

1:45pm EDT

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
avatar for Roberto Uehara

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 EDT
  Track A: Medical Affairs Strategy

1:45pm EDT

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
avatar for Jill Massey, PharmD, MBA, BCMAS

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 EDT
  Track B: Medical Operations & Technology

1:45pm EDT

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
avatar for Alan Polnariev

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 →
TB

Tommy Brock

Senior MSL, United Therapeutics
avatar for Josh Yoder, Ph.D.

Josh Yoder, Ph.D.

Medical Science Liaison, uniQure
avatar for Luchy Hidalgo, M.D.

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 EDT
  Track C: MSL and Field Strategy

1:45pm EDT

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 EDT
  Track D: Investigator-Initiated Trials

2:15pm EDT

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
avatar for Elizabeth Pash

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 EDT
  Track A: Medical Affairs Strategy

2:15pm EDT

Track B: Case Study: Unite All Your Medical Affairs Grants for Medical Education
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 April 15, 2020 2:15pm - 2:45pm EDT
  Track B: Medical Operations & Technology

2:15pm EDT

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
avatar for Peter Ishak

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 EDT
  Track C: MSL and Field Strategy

2:15pm EDT

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
avatar for Anton Ehrhardt, Ph.D.

Anton Ehrhardt, Ph.D.

Vice President, Medical Affairs, Spectrum Pharmaceuticals

Wednesday April 15, 2020 2:15pm - 2:45pm EDT
  Track D: Investigator-Initiated Trials

2:45pm EDT

30-Minute Networking Break
Wednesday April 15, 2020 2:45pm - 3:15pm EDT
  Networking

3:15pm EDT

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 EDT
  Track A: Medical Affairs Strategy

3:15pm EDT

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
avatar for Carol Hoang

Carol Hoang

Vice President, Medical Affairs, Adverum Biotechnologies, Inc.

Wednesday April 15, 2020 3:15pm - 3:45pm EDT
  Track B: Medical Operations & Technology

3:15pm EDT

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
avatar for Ariel Katz

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 →
avatar for Dan Hennessy

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 3:15pm - 3:45pm EDT
  Track C: MSL and Field Strategy

3:15pm EDT

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
avatar for Archie Stone, Ph.D., BCMAS

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 →
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 →

Wednesday April 15, 2020 3:15pm - 3:45pm EDT
  Track D: Investigator-Initiated Trials

3:45pm EDT

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
TS

Tehseen Salimi

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

Speakers
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 Yurek Paprocki, MD, MBA

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 Jean Hubble

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 →
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.

Wednesday April 15, 2020 3:45pm - 4:15pm EDT
  Track A: Medical Affairs Strategy

3:45pm EDT

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
avatar for Scott McConnell, Pharm.D.

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 →

Wednesday April 15, 2020 3:45pm - 4:15pm EDT
  Track B: Medical Operations & Technology

3:45pm EDT

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 EDT
  Track C: MSL and Field Strategy

3:45pm EDT

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 EDT
  Track D: Investigator-Initiated Trials

4:15pm EDT

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
avatar for Jason Jensen

Jason Jensen

Vice President, Scientific Commercialization

Wednesday April 15, 2020 4:15pm - 4:45pm EDT
  Track A: Medical Affairs Strategy

4:15pm EDT

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 EDT
  Track B: Medical Operations & Technology

4:15pm EDT

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 EDT
  Track C: MSL and Field Strategy

4:15pm EDT

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
avatar for Atif Mohammad, Ph.D.

Atif Mohammad, Ph.D.

Medical Director, US Medical Affairs, Bristol-Myers Squibb

Wednesday April 15, 2020 4:15pm - 4:45pm EDT
  Track D: Investigator-Initiated Trials

4:45pm EDT

Networking Reception
Wednesday April 15, 2020 4:45pm - 5:45pm EDT
  Networking

5:45pm EDT

Conference Day One Concludes
Wednesday April 15, 2020 5:45pm - 5:45pm EDT
  Networking
 
Thursday, April 16
 

8:15am EDT

Networking Breakfast
Thursday April 16, 2020 8:15am - 9:00am EDT
  Networking

9:00am EDT

Track A: Opening Remarks
Speakers
avatar for Kimberly Cremers

Kimberly Cremers

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

Thursday April 16, 2020 9:00am - 9:15am EDT
  Track A: Medical Affairs Strategy

9:00am EDT

Track B: Opening Remarks
Speakers
avatar for Kate Pietrovito

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 →

Thursday April 16, 2020 9:00am - 9:15am EDT
  Track B: Medical Operations & Technology

9:00am EDT

Track C: Opening Remarks
Speakers
avatar for Howard Berkowitz

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 →

Thursday April 16, 2020 9:00am - 9:15am EDT
  Track C: MSL and Field Strategy

9:00am EDT

Track D: Opening Remarks
Speakers
avatar for Kimberly Cheshire-Kinney

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 →

Thursday April 16, 2020 9:00am - 9:15am EDT
  Track D: Investigator-Initiated Trials

9:15am EDT

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
avatar for Mario Mendoza, MD, MS

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 →

Thursday April 16, 2020 9:15am - 9:45am EDT
  Track A: Medical Affairs Strategy

9:15am EDT

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 EDT
  Track B: Medical Operations & Technology

9:15am EDT

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
avatar for Peter Lee

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
avatar for Anna Vichiendilokkul, PharmD MS

Anna Vichiendilokkul, PharmD MS

Director, Medical Science Liaison, GlaxoSmithKline
avatar for Jacqueline S. Armani, OD, FAAO, MSL-BC

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 →
avatar for Teresa P.M. Kelton, JD, PharmD, MPH

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 EDT
  Track C: MSL and Field Strategy

9:15am EDT

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
avatar for Maureen Lloyd

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 EDT
  Track D: Investigator-Initiated Trials

9:45am EDT

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 EDT
  Track A: Medical Affairs Strategy

9:45am EDT

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
avatar for Jennifer Almekinder

Jennifer Almekinder

Director, Global Aesthetics Scientific Communications, Merz

Thursday April 16, 2020 9:45am - 10:15am EDT
  Track B: Medical Operations & Technology

9:45am EDT

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
avatar for Nikki Irish

Nikki Irish

Director of MSL, MA, Adamas Pharmaceuticals

Thursday April 16, 2020 9:45am - 10:15am EDT
  Track C: MSL and Field Strategy

9:45am EDT

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 EDT
  Track D: Investigator-Initiated Trials

10:15am EDT

30-Minute Networking Break
Thursday April 16, 2020 10:15am - 10:45am EDT
  Networking

10:45am EDT

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
avatar for Barry Lubarsky

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 EDT
  Track A: Medical Affairs Strategy

10:45am EDT

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
avatar for Aswin Chandrakantan, M.D.

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 EDT
  Track B: Medical Operations & Technology

10:45am EDT

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 EDT
  Track C: MSL and Field Strategy

10:45am EDT

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
avatar for Tarang Anthwal

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.
avatar for Jeremy Keeton

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 EDT
  Track D: Investigator-Initiated Trials

11:15am EDT

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
avatar for Mario Mendoza, MD, MS

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 →

Speakers
avatar for Scott McConnell, Pharm.D.

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 →

Thursday April 16, 2020 11:15am - 11:45am EDT
  Track A: Medical Affairs Strategy

11:15am EDT

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
avatar for James Fratantonio

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 EDT
  Track B: Medical Operations & Technology

11:15am EDT

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 EDT
  Track C: MSL and Field Strategy

11:15am EDT

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
avatar for Swati Pradhan-Bhatt, Ph.D.

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 EDT
  Track D: Investigator-Initiated Trials

11:45am EDT

Luncheon for Conference Participants
Thursday April 16, 2020 11:45am - 12:45pm EDT
  Networking

12:45pm EDT

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
avatar for Kimberly Cremers

Kimberly Cremers

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

Thursday April 16, 2020 12:45pm - 1:15pm EDT
  Track A: Medical Affairs Strategy

12:45pm EDT

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 EDT
  Track B: Medical Operations & Technology

12:45pm EDT

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
avatar for Nikki Irish

Nikki Irish

Director of MSL, MA, Adamas Pharmaceuticals

Speakers
avatar for Howard Berkowitz

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 →
avatar for Sheila Komara

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 →
avatar for Keely Dahl

Keely Dahl

Medical Science Liaison, Aurinia Pharmaceuticals Inc.

Thursday April 16, 2020 12:45pm - 1:15pm EDT
  Track C: MSL and Field Strategy

12:45pm EDT

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 EDT
  Track D: Investigator-Initiated Trials

1:15pm EDT

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
avatar for Atif Mohammad, Ph.D.

Atif Mohammad, Ph.D.

Medical Director, US Medical Affairs, Bristol-Myers Squibb

Thursday April 16, 2020 1:15pm - 1:45pm EDT
  Track A: Medical Affairs Strategy

1:15pm EDT

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 EDT
  Track B: Medical Operations & Technology

1:15pm EDT

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
avatar for Peter Lee

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 →

Thursday April 16, 2020 1:15pm - 1:45pm EDT
  Track C: MSL and Field Strategy

1:15pm EDT

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
avatar for Kimberly Cheshire-Kinney

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 →

Speakers
avatar for Nitasha Phatak, MD, Ph.D.

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 EDT
  Track D: Investigator-Initiated Trials

1:45pm EDT

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
avatar for Rudy Christian, DrPH

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 EDT
  Track A: Medical Affairs Strategy

1:45pm EDT

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 EDT
  Track B: Medical Operations & Technology

1:45pm EDT

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
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 April 16, 2020 1:45pm - 2:15pm EDT
  Track C: MSL and Field Strategy

1:45pm EDT

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 1:45pm - 2:15pm EDT
  Track D: Investigator-Initiated Trials

2:15pm EDT

Track A: Closing Remarks
Speakers
avatar for Kimberly Cremers

Kimberly Cremers

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

Thursday April 16, 2020 2:15pm - 2:30pm EDT
  Track A: Medical Affairs Strategy

2:15pm EDT

Track B: Closing Remarks
Speakers
avatar for Kate Pietrovito

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 →

Thursday April 16, 2020 2:15pm - 2:30pm EDT
  Track B: Medical Operations & Technology

2:15pm EDT

Track C: Closing Remarks
Speakers
avatar for Howard Berkowitz

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 →

Thursday April 16, 2020 2:15pm - 2:30pm EDT
  Track C: MSL and Field Strategy

2:15pm EDT

Track D: Closing Remarks
Speakers
avatar for Kimberly Cheshire-Kinney

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 →

Thursday April 16, 2020 2:15pm - 2:30pm EDT
  Track D: Investigator-Initiated Trials

2:30pm EDT

Conference Concludes
Thursday April 16, 2020 2:30pm - 2:30pm EDT
  Networking