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Medical Affairs Strategic Summit East (exl)

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Hyatt Regency New Brunswick

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New Brunswick, NJ 08901

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Welcome to the
Medical Affairs Strategic Summit East

April 9-11, 2018 | TBD | New Brunswick, NJ

Manage Medical Affairs, Communication, Information and Research Collaborations to Increase Strategic Positioning in the Marketplace


Four Tracks — One Location — All-Access



Medical Affairs Executive Strategy

Medical affairs teams are involved in nearly all aspects of communication in a pharmaceutical/biotechnology/medical device organization. Their scope and authority can vary depending on the size of the business. One of the biggest issues medical affairs teams have faced in recent years has been the need to establish standard operating procedures and quality control measures for social media posts. With Twitter, Facebook and other networks in use by virtually all employees, medical affairs teams need to pinpoint who regulates company posts, what information is released and how posts should be edited.

This track will address the management and communication concerns internal teams face as well as how to best improve current processes in order to comply with new regulations and the instant access to information.

This conference is designed for representatives from pharmaceutical, biotechnology and medical device organizations with responsibilities in the following areas:

  • Medical Affairs/Field Medical Affairs
  • Medical Science/Field Medical Science
  • Clinical/Scientific Affairs
  • Medical Strategy/Communications
  • Key Opinion Leadership/Thought Leadership/Opinion Leader Relationships
  • Research and Development
  • Medical Education
  • Publication Planning
  • Scientific Communication
  • Program Management
  • Quality Assurance
  • Scientific Engagements
  • Medical Science Liaisons
  • Develop a holistic and patient-centered evidence generation process to achieve optimal reimbursement
  • Transform your medical affairs team into a strategic partner by providing market-based input into portfolio management and field insights
  • Explore the role of social media and digital health in medical affairs
  • Navigate the regulatory landscape of off-label communication
  • Ensure the impact and value of medical initiatives to internal and external stakeholders is well understood



MSL Best Practices

The role of the medical science liaison (MSL) has continued to expand. Previously, MSLs served as the link between their respective organizations and key opinion leaders (KOLs). As subject matter experts, MSLs convey product information to educate the KOL, then relay information back to their own organization. While this has not changed, MSLs are now taking on a more hybrid role, encompassing account/relationship management responsibilities in addition to interacting with clinical and business teams. To maintain the expanding list of responsibilities, MSLs need to be continuously trained and assessed for regulatory compliance and other various roles.

Accompanying the growth of the MSL role, data indicates that KOLs and physicians increasingly prefer to work with MSLs instead of sales or account managers.

The MSL Best Practices track will focus on the MSL’s growing duties and on the exchange of MSL training and evaluation techniques in both small and large organizations.

This conference is designed for representatives from pharmaceutical, biotechnology and medical device organizations with responsibilities in the following areas:

  • Medical Science Liaisons
  • Medical Science
  • Medical Strategy
  • Scientific Communication
  • Medical Education
  • Key Opinion Leadership/Thought Leadership/Opinion Leader Relationships
  • Define meaningful KPIs for measuring the quality and impact of thought leader engagement
  • Create a process to collect, manage and communicate meaningful field insights back to the organization
  • Learn how to develop field medical excellence centers and operational models
  • Ensure effective coaching and training to build technical and leadership skills for maximum performance and long term succession planning
  • Maximize the value of field medical affairs for clinical trial success



Research Collaboration and Investigator-Initiated Trials

Research collaborations play a vital role in the discovery of new drug indications and the treatment of unmet medical needs. The growing collaboration between industry and academic investigators has led to increased funding and opened the doors to achieving promising clinical outcomes. Medical affairs professionals, MSLs, clinical operations and external research parties all work closely with investigators to achieve successful trials that can lead to new milestones in drug development. This collaboration between medical affairs, MSLs and clinical research teams is the backbone for successfully cultivating and communicating the value of treatments.

Standardization of terms, policies and procedures will help with vendor interactions and pave the way to more efficiently defining the lines of what is truly an investigator-initiated trial and what is a research collaboration.

The Research Collaboration and Investigator-Initiated Trials track covers all aspects of conducting trials — including ways in which investigators can efficiently reach out to industry professionals to foster supportive relationships — and addresses how industry optimizes and standardizes the discussion of clinical research to improve trial support and oversight. It also examines quality measures in detail to ensure compliance throughout the product life cycle.

This conference is designed for representatives from pharmaceutical, biotechnology and medical device organizations with responsibilities in the following areas:

  • Investigator-Initiated Research (IIR)
  • Investigator-Initiated Studies (IIS)
  • Investigator-Initiated Trials (IIT)
  • Investigator-Sponsored Trials (IST)
  • Research Collaborations
  • Medical Affairs/Global Medical Affairs
  • Medical/Clinical Operations
  • Clinical Project Management
  • Clinical Medical Affairs
  • Clinical Trial Monitoring
  • Research Grants
  • Clinical Outcomes and Publications
  • Regulatory Affairs
  • Successfully Integrate a Quality Component into Investigator-Initiated Trials
  • Prevent Non-Compliance and Steps to Take When It Occurs in Investigator-Initiated Trials
  • Develop an Efficient Process for Fair-Market Value Analysis of Budgets for Investigator-sponsored Trials
  • Field Medical Affairs in IITs: Leveraging Risk- Tolerance Models to Ensure Compliant and Strategic KOL Engagements
  • Examine How To Optimize The Approach To The ICH E6 (GCP) Addendum In Investigator-Initiated Trials


Agenda

MONDAY, APRIL 9, 2018 - Pre-Conference Workshops

8:00AM
Continental Breakfast
9:15AM
WORKSHOP A: BUILDING A MEDICAL AFFAIRS LAUNCH POWERHOUSE
Across the core launch phases, medical affairs teams play a critical role in preparing the market for a successful product launch. Developing a compliant, strategic launch plan through high-impact scientific activities that harmonizes all levels of your medical and commercial groups is crucial for a successful product launch.
Create a medical strategic and tactical launch plan that aligns with your organization’s business objective
Develop a meaningful scientific communication platform to communicate and differentiate the medical and scientific value clearly
Develop a comprehensive and actionable stakeholder (KOLs, clinicians, payers, advocacy groups, policy makers, etc.) engagement plan in a compliant way
Set clear strategy for data generation activities through identifying unmet medical needs and insights from stakeholder
Leverage medical information to educate healthcare practitioners
*This session contains a 30-minute networking break
RAMIN FARHOOD, PHARM.D., MBA, Vice President, Head of Global Medical Affairs, AVEXIS
WORKSHOP B: THE ROLE OF AN MSL ACROSS THE DIFFERENT PHASES OF A PRODUCT’S LIFE CYCLE
Depending on the therapeutic complexity and specific product being developed, there can be a range of activities in which an MSL can engage. This workshop will identify key activities across product life cycles that will help inform your organization of valuable field insights and prepare your team for market introduction.
Understand the MSL role as part of global medical affairs, in clinical trials, and during the FDA pre-approval phase
Design your annual operating plan to prioritize activities and develop a strategy to work within budget constraints
Understand what interactions are permissible with sales and marketing
Explore best practices for MSLs in pharmaceutical and medical device industries and examine some key differences
IIT Spotlight: Review the various types, functions, and interactions with clinical affairs; protocol submissions; and how MSLs can help solve current unmet needs
Patient Advocacy Integration
*This session contains a 30-minute networking break
LUCHY HIDALGO, M.D., Senior Medical Science Liaison — Nephrology/Transplant, HANSA MEDICAL
12:15PM
Luncheon
1:30PM
WORKSHOP C: ENSURE COMPLIANT COMMUNICATIONS DURING SCIENTIFIC EXCHANGE AND OFF-LABEL DATA DISSEMINATION
Regulatory bodies recognize the value of truthful and non- misleading scientific or medical publications on unapproved new uses of a product. However, the major challenges with off-label communications are being able to provide accurate scientific data and protecting the patient, all while extending the market for a particular product.
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 non-promotional
Develop tools and techniques to provide ethical, accurate and balanced off-label data, while adding patient value in a compliant manner
*This session contains a 30-minute networking break
DAVIDA WHITE, Head, Medical Excellence and Education, INDIVIOR
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 two 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.
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 timeline
*This session contains a 30-minute networking break
EARL KNIGHT, ESQ., Director, Contracting Sponsored Program Services, PURDUE UNIVERSITY

TUESDAY, APRIL 10, 2018 - DAY 1 PLENARY SESSIONS

7:30AM
Main Conference Registration and Continental Breakfast
8:30AM
CHAIRPERSON’S OPENING REMARKS
KIRK V. SHEPARD, M.D., Senior Vice President, Head of Global Medical Affairs OBG, EISAI
8:45AM
THE ROLE OF MEDICAL AFFAIRS FROM PRELAUNCH TO LAUNCH
KIRK V. SHEPARD, M.D., Senior Vice President, Head of Global Medical Affairs OBG, EISAI
9:30AM
Panel Discussion PANEL: EXPLORE DIFFERENT OPERATING MODELS FOR MEDICAL AFFAIRS GROUPS AND DISCUSS HOW AN ORGANIZATIONAL STRUCTURE CAN IMPACT THE EFFECTIVENESS OF YOUR ACTIVITIES
PANELISTS:
RUTH DU MOULIN, PH.D., Vice President, Medical Affairs, Head of Medical Communications, TAKEDA ONCOLOGY
TEHSEEN SALIMI, Head of Medical Affairs — Primary Care and Women’s Health, MERCK
KIRK V. SHEPARD, M.D., Senior Vice President, Head of Global Medical Affairs OBG, EISAI
ALAN WRIGHT, M.D., MPH, Chief Medical Officer, ROCHE DIAGNOSTICS

10:15AM
LEVERAGING ONLINE DISCUSSION PLATFORMS FOR OPTIMAL STAKEHOLDER ENGAGEMENT
LANCE HILL, CEO, WITHIN3
10:45AM
Networking Break

MEDICAL AFFAIRS EXECUTIVE STRATEGY
MSL BEST PRACTICES
RESEARCH COLLABORATION AND INVESTIGATOR-INITIATED TRIALS
11:30AM
Track Chair’s Opening Remarks
JASON BRADT, Executive Medical Director, Oncology, Americas Medical Affairs, Consultant, ASTELLAS PHARMA
Track Chair’s Opening Remarks
DAVIDA WHITE, Head, Medical Excellence and Education, INDIVIOR
Track Chair’s Opening Remarks
SHAILESH CHAVAN, M.D., Vice President Clinical Research, Drug Safety and Medical Affairs, BIOTEST PHARMACEUTICALS
11:45AM
CASE STUDY: How to Develop a Cutting Edge Medical Plan That Is Tailored to the Needs of Your Organization
RUTH DU MOULIN, PH.D., Vice President, Medical Affairs, Head of Medical Communications, TAKEDA ONCOLOGY
The Smartest and Most Effective MSL Teams Need Innovative Training and Tools
ARTHUR CHAN, PH.D., MBA, Head, MSL Capabilities, Development and Training, NOVARTIS
Best Practices for Managing Investigator-Sponsored Research Across Strategic Alliances
MARY VOEHL HIRSCH, M.SC., Senior Director, Investigator-Sponsored Trials, SANOFI
12:30PM
Luncheon
1:30PM
Navigate Medical Affairs in the World of Alliance Partnerships and Co-Promotions
POUSHALI MUKHERJEA, Executive Director, Global Medical Affairs, BRISTOL-MYERS SQUIBB
Medical Affairs and Emotional Intelligence: Not a Contradiction
BRYAN N. BISCHEL, PH.D., MBA, Senior Director, U.S. Field Medical Affairs, NOTAL VISION
The Perils and Pitfalls of Clinical Research Collaborations
CYNTHIA K. BARBITSCH, PHARM.D., Director/Team Leader, Clinical and Research Collaborations, External Medical Communications, PFIZER
2:15PM
PANEL: Explore Different Models for Managing Medical Affairs Activities in Co-Promotion Agreements, Strategic Alliances and Acquisitions
POUSHALI MUKHERJEA, Executive Director, Global Medical Affairs, BRISTOL-MYERS SQUIBB
Effective Strategies for Keeping Your Field Team Engaged
DAVIDA WHITE, Head, Medical Excellence and Education, INDIVIOR
PANEL: Strategic Considerations for Converting an IIT to a Research Collaboration
JENNIFER J. GASKIN, CCRP, CMQ-OE, Director, Investigator Sponsored Trials, KARYOPHARM THERAPEUTICS
3:00PM
Technology as a Clinical Coach: Real World Engagement
MICHAEL W. YOUNG, Vice President Strategic Accounts, SCIENCEMEDIA
Case Study The Difficulties of Launching a Product, Even If It Is a Groundbreaking Treatment
ALISON MCREYNOLDS, PH.D., Director, Medical Science Liaisons — Sleep, Medical Affairs, JAZZ PHARMACEUTICALS
Establish an Efficient and Compliant Process for Assessing the Fair Market Value (FMV) of IIT Budgets
KELLY WIMBLE LOUGHNER, Senior Associate Director, Site Enablement, BOEHRINGER INGELHEIM
3:45PM
Networking Break
4:15PM
Patient-Centricity in Rare Diseases: Opportunities for Real- World Evidence
SONAL BHATIA, M.D., Vice President, North America Medical Lead, Rare Disease, PFIZER
In-House Versus Contract MSL Teams – What is the Best Fit for Your Organization?
If you are interested in leading this session, please contact Eric Morrin at emorrin@exlevents.com or 212-400-6228.
Reconcile Your Data and Evidence Needs With Internal Stakeholder Expectations When Evaluating IITs
JOE KISHEL, PHARM.D., MBA, BCPS-ID, Team Lead (East), ID Research Scientific Directors, Global Center for Scientific Affairs, MERCK RESEARCH LABS
5:00PM
The World Is Flat: Enhancing Collaboration Between U.S., Global, and Regional Medical Affairs Teams
ROBERT WRIGHT, PHARM.D., Senior Director, Strategic Planning and Transversal Scientific Projects, Global Medical Affairs — Diabetes, SANOFI
PANEL: Effective Strategies and Models for Managing Contract MSL Teams
JAY ELLIOTT, PH.D., Regional Deputy Director, Medical Science Liaisons, BAYER HEALTHCARE
Ensure the Timeline for an IIT Meets the Needs of a Product and Clinicians in the Field
PETER SHAW, MBBS., DRCOG, Senior Director, Medical Affairs — Orthopaedics, FERRING PHARMACEUTICALS
5:45PM
Cocktail Reception
6:45PM
Day One Concludes

WEDNESDAY, APRIL 11 , 2018 - DAY 2 TRACKED SESSIONS

MEDICAL AFFAIRS EXECUTIVE STRATEGY
MSL BEST PRACTICES
RESEARCH COLLABORATION AND INVESTIGATOR-INITIATED TRIALS
8:00AM
Continental Breakfast
8:30AM
Track Chair’s Recap of Day One
JASON BRADT, Executive Medical Director, Oncology, Americas Medical Affairs, Consultant, ASTELLAS PHARMA
Track Chair’s Recap of Day One
DAVIDA WHITE, Head, Medical Excellence and Education, INDIVIOR
Track Chair’s Recap of Day One
SHAILESH CHAVAN, M.D., Vice President Clinical Research, Drug Safety and Medical Affairs, BIOTEST PHARMACEUTICALS
8:45AM
The Role of Medical Affairs in a Fast-Paced, Innovative and Engaged Space
ERIC PIERRE GUENIN, PHARM.D., PH.D., R.PH., Director of Medical Affairs, RECKITT BENCKISER
Effective Strategies for Collaboration With Medical Affairs When Executing Field Medical Activities
RIJU RAY, PH.D., U.S. Medical Affairs Lead, GLAXOSMITHKLINE
Best Practices for Managing a Single Versus Multicenter Investigator-Sponsored Clinical Studies
If you are interested in leading this session, please contact Eric Morrin at emorrin@exlevents.com or 212-400-6228.
9:30AM
Professional Development in Medical Communications: What It Takes to Bring You and the Industry to the Next Level
DHEEPA CHARI, Senior Director/Team Leader, Global Medical Communications, Oncology, PFIZER
Optimizing Field Intelligence: Getting the Right Information to the Right People at the Right Time
JAY ELLIOTT, PH.D., Regional Deputy Director, Medical Science Liaisons, BAYER HEALTHCARE
Effective Strategies to Increase Sponsor and Site Collaboration During Investigator-Sponsored Studies
EARL KNIGHT, ESQ., Director, Contracting Sponsored Program Services, PURDUE UNIVERSITY
10:15AM
Networking Break
10:45AM
Strategies for Medical Affairs to Work Effectively With Commercial to Navigate the Compliance Landscape
LESLIE MELTZER, Vice President, Head of Medical Affairs, KERYX BIOPHARMACEUTICALS
The Role of MSLs in Today’s Payer and Reimbursement Landscape
USMAN IQBAL, Senior Director, Medical and HEOR, TREVENA
Best Practices for Managing Large-Scale Global and Multicenter Investigator-Sponsored Trials With Limited Resources and Funding
JENNIFER J. GASKIN, CCRP, CMQ-OE, Director, Investigator Sponsored Trials, KARYOPHARM THERAPEUTICS
11:30AM
Effectively Demonstrate the Value of Investigator-Sponsored Research to Internal Leadership
JASON BRADT, Executive Medical Director, Oncology, Americas Medical Affairs, Consultant, ASTELLAS PHARMA
The Use of Data Analytics in Medical Affairs
SCOTT MCCONNELL, PHARM.D., Senior Director, Medical Affairs, ALKERMES
Develop a Focused Field Strategy That Ties Into Your Overall Medical Brand Plan
MICHAEL STEIDLE, PHARM.D., MBA, National Director, Medical Science Liaison Team, MELINTA THERAPEUTICS
12:15PM
Luncheon

INDUSTRY SPOTLIGHT:
THE EVOLVING ROLE OF MEDICAL AFFAIRS, MSLS AND INVESTIGATOR-INITIATED TRIALS IN THE MEDICAL DEVICE AND PHARMACEUTICAL INDUSTRY
1:15PM
NEW PRODUCT DEVELOPMENT
2:15PM
PANEL: EXPLORE HOW THE ROLE AND IMPACT OF MEDICAL AFFAIRS HAS EVOLVED AT MEDICAL DEVICE AND PHARMACEUTICAL COMPANIES
IDAL BEER, Vice President, Medical Affairs, Medication Management Solutions Office of Science, Medicine and Technology, BD MEDICAL
MARIANNE GILL, Vice President Medical Affairs, BD MEDICAL
MARK HUNTER, Manager, Medical Affairs, BD MEDICAL
3:15PM
Summit Concludes

Faculty

Cynthia K. Barbitsch, Pharm.D.
Director/Team Leader, Clinical and Research Collaborations, External Medical

PFIZER

Idal Beer
Vice President, Medical Affairs, Medication Management Solutions Office of Science, Medicine and Technology

BD MEDICAL

Sonal Bhatia, M.D.
Vice President, North America Medical Lead, Rare Disease

PFIZER

Bryan N. Bischel, Ph.D., MBA
Senior Director, U.S. Field Medical Affairs

NOTAL VISION

Jason Bradt
Executive Medical Director, Oncology, Americas Medical Affairs, Consultant

ASTELLAS PHARMA

Arthur Chan, Ph.D., MBA
Head, MSL Capabilities, Development and Training

NOVARTIS

Dheepa Chari
Senior Director/Team Leader, Global Medical Communications, Oncology

PFIZER

Shailesh Chavan, M.D.
Vice President Clinical Research, Drug Safety and Medical Affairs

BIOTEST PHARMACEUTICALS

Jay Elliott, Ph.D.
Regional Deputy Director, Medical Science Liaisons

BAYER HEALTHCARE

Ramin Farhood, Pharm.D., MBA
Vice President, Head of Global Medical Affairs

AVEXIS

Jennifer J. Gaskin, CCRP, CMQ-OE

Director, Investigator Sponsored Trials
KARYOPHARM THERAPEUTICS

Marianne Gill

Vice President Medical Affairs
BD MEDICAL

Eric Pierre Guenin, Pharm.D., Ph.D., R.Ph.

Director of Medical Affairs
RECKITT BENCKISER

Luchy Hidalgo, M.D.

Senior Medical Science Liaison — Nephrology/Transplant
HANSA MEDICAL

Lance Hill

CEO
WITHIN3

Mary Voehl Hirsch, M.Sc.

Senior Director, Investigator-Sponsored Trials
SANOFI

Mark Hunter

Manager, Medical Affairs
BD MEDICAL

Usman Iqbal

Senior Director, Medical and HEOR
TREVENA

Joe Kishel, Pharm.D., MBA, BCPS-ID

Team Lead (East), ID Research Scientific Directors, Global Center for Scientific Affairs
MERCK RESEARCH LABS

Earl Knight, Esq.

Director, Contracting Sponsored Program Services
PURDUE UNIVERSITY

Kelly Wimble Loughner

Senior Associate Director, Site Enablement
BOEHRINGER INGELHEIM

Scott McConnell, Pharm.D.

Senior Director, Medical Affairs
ALKERMES

Alison McReynolds, Ph.D.

Director, Medical Science Liaisons — Sleep, Medical Affairs
JAZZ PHARMACEUTICALS

Leslie Meltzer

Vice President, Head of Medical Affairs
KERYX BIOPHARMACEUTICALS

Ruth du Moulin, Ph.D.

Vice President, Medical Affairs, Head of Medical Communications
TAKEDA ONCOLOGY

Poushali Mukherjea

Executive Director, Global Medical Affairs
BRISTOL-MYERS SQUIBB

Riju Ray, Ph.D.

U.S. Medical Affairs Lead
GLAXOSMITHKLINE

Tehseen Salimi

Head of Medical Affairs — Primary Care and Women’s Health
MERCK

Peter Shaw, MBBS., DRCOG

Senior Director, Medical Affairs — Orthopaedics
FERRING PHARMACEUTICALS

Kirk V. Shepard, M.D.

Senior Vice President, Head of Global Medical Affairs OBG
EISAI

Michael Steidle, Pharm.D., MBA

National Director, Medical Science Liaison Team
MELINTA THERAPEUTICS

Davida White

Head, Medical Excellence and Education
INDIVIOR

Alan Wright, M.D., MPH

Chief Medical Officer
ROCHE DIAGNOSTICS

Robert Wright, Pharm.D.

Senior Director, Strategic Planning and Transversal Scientific Projects, Global Medical Affairs — Diabetes
SANOFI

Michael W. Young

Vice President Strategic Accounts
SCIENCEMEDIA

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