KOL Relationship Summit

Agenda

Day One  Monday, August 9th

Pre-Conference Workshop
8:00
Registration and Continental Breakfast


9:00
WORKSHOP – STRUCTURING A CENTRALIZED KOL ENGAGEMENT MODEL
New Approaches to Maintaining Value in the Current Compliance Environment

With health care environment and industry changes happening by the day, the interface between industry and academic thought leaders, or Key Opinion Leaders (KOL) has never been more threatened. One only has to read the latest Corporate Integrity Agreements with the Department of Justice to see the increased level of monitoring of commercial and clinical activities with KOL healthcare professionals and the impact it is having on internal changes toward centralized operations. And as the reins tighten further on KOL industry access, the need for external “expert advice” on drug development and strategic direction for disease targets has never been more critical to ensure significant clinical innovation. Combine that with the needs for market development and KOL involvement in product launches of new compounds, the business paradigm of KOL relationships and engagement with industry is changing dramatically. This workshop will be a hands on approach to understanding the environmental changes, challenges, but impantly, identifying solutions to help you develop a coordinated and structured KOL management model that is the “right fit” for your company. Topics that will be discussed include, but are not limited to:

  • Strategies for conducting an internal analysis to set the direction for the right model
  • Determining the appropriate operating model options for your company culture; realizing one size DOES NOT FIT ALL!
  • Determining the scope of the initial effort to globalize or not to globalize your KOL focus
  • Establishing the internal KOL management construct; policies, processes, IT systems and checks and balances for a stepwise approach that is action and metrics oriented
  • Internal hurdles and solutions for deployment success
  • An analysis of the impact of some recent CIAs, which are driving the business rationale for a centralized KOL management model for internal vigilance

Workshop Leader
Linda Harris
Consultant, Former Assistant Vice President, Opinion Leader Relations
WYETH PHARMACEUTICALS

Speakers:                                                                                                                                            Arthur Corrado, Esq.
Founder & Principal, PHARMACEUTICAL COMPLIANCE ASSOCIATES, LLC
Former Senior Compliance Officer
PFIZER (Formerly WYETH)

Kathy Presto
Vice President, Strategic Partnerships
ROCHE PHARMACEUTICALS

Michael E. Thase, MD
Professor of Psychiatry
UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE AND
PHILADELPHIA VETERANS AFFAIRS MEDICAL CENTER

 
10:30
Networking & Refreshment Break


12:00
Luncheon for Workshop Attendees

 

12:00                                                                                                                                                  Registration for Main Conference


Main Conference Begins

1:00
CHAIRPERSON’S WELCOME & OPENING REMARKS
Balancing Business Goals and Expectations with KOL Reputation Preservation

  • What are the hallmarks of a KOL
  • Approaching KOLs for on-boarding: do’s and don’ts
  • Emerging KOLs; working with the best and brightest – cultivating the emerging KOL
  • The role of granting and Investigator Initiated Trials for program/product business objectives and KOL relationships

Chair
Manley R. Finch, MS, MPH
Vice President, Clinical Research
SLEEPMED INC.


1:30
KOL IDENTIFICATION AND SELECTION
Profiling and Identifying Credible KOLs to Increase Product Education and Awareness

  • Who is responsible for choosing the KOL
  • The changing landscape of KOLs and the challenges they face
  • The power of peer-reviewed publications

Speaker
Marc Jensen
National Director, Pulmonary/Cardiology MSL
BAYER HEALTHCARE PHARMACEUTICALS


2:15
Networking & Refreshment Break


2:45
A THOUGHT LEADER'S PERSPECTIVE ON FUTURE COLLABORATIONS IN THE CHANGING REGULATORY ENVIRONMENT
Delivering Scientific Innovation through Partnerships Between Academia and the Pharmaceutical Industry

Hear an internationally renowned Thought Leader provide a perspective on past and future partnerships for contributions to scientific innovation, strategies in drug development and clinical research projects. Dr. Michael E. Thase, Professor of Psychiatry at the University of Pennsylvania School of Medicine and Philadelphia Veterans Affairs Medical Center, will provide commentary on the critical need to foster partnerships between academia and the health care industry, for the purpose of delivering better medical care options to patients. He will also provide considerations for strategies to appropriately manage through the regulatory changes impacting those relationships.

Speaker
Michael E. Thase, MD
Professor of Psychiatry
UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE AND
PHILADELPHIA VETERANS AFFAIRS MEDICAL CENTER


3:30
PANEL DISCUSSION  KOL RELATIONSHIPS
Managing and Communicating Properly to Improve KOL and Thought Leader Relationships

  • Effectively communicating from different internal departments to a KOL
  • Developing a successful relationship program and implementing an engagement plan
  • Fostering KOL involvement with current and new products that can enhance the treatment and care of patients

Panelists
Joseph Boyd
Director, Ophthalmic Medical Development
INSPIRE PHARMACEUTICALS INC

Brandon Howard, PhD
Sr Manager, Medical Science Liaison
TEVA BRANDED PHARMACEUTICALS R&D INC

Paul F. Weber, MD, RPh, MBA
Head, Medical Affairs
PTC THERAPEUTICS

Edio Zampaglione, MD, FACOG
Senior Director, Medical Affairs, Women’s HealthCare
BAYER HEALTHCARE PHARMACEUTICALS


4:30
ROUNDTABLE DISCUSSIONS
Therapeutic Areas Discuss the Importance and Projection of KOLs

Choose one table from different therapeutic areas and be part of an intimate discussion of KOLs and thought leaders through varying departments discussing the availability of KOLs, increasing product awareness, determining Fair Market Value (FMV), and ensuring compliance and accountability.                  

Different therapeutic areas include:

  1. Oncology
  2. Neuroscience
  3. Cardiology
  4. General Medicine
  5. Rare Diseases
  6. Women's Health
  7. Legal-Medical-Regulatory Review Process

Additional tables to be added!

Roundtable moderators include:
Joseph Boyd
Director, Ophthalmic Medical Development
INSPIRE PHARMACEUTICALS INC

Carrie C. Murray, MSN, NP
Director, Medical Affairs - Women's Healthcare Medical Science Liaisons
BAYER HEALTHCARE PHARMACEUTICALS

Paul F. Weber, MD, RPh, MBA
Head, Medical Affairs
PTC THERAPEUTICS

Edio Zampaglione, MD
Medical Director
BAYER HEALTHCARE PHARMACEUTICALS


5:30
Day One Concludes


Day Two  Tuesday, August 10th

8:00
Continental Breakfast

9:00                                                                                                                                                                           CHAIRPERSON’S RECAP OF DAY ONE & MODERATORS' KEY POINTS FROM ROUNDTABLE DISCUSSIONS
Brief Overview and Key Points from Roundtable Discussions

Chair
Manley R. Finch, MS, MPH
Vice President, Clinical Research
SLEEPMED INC.

9:15                                                                                                                                                                                                    COMMUNICATION THROUGH SOCIAL MEDIA
Learn How a Private, Online Community Can Improve & Strengthen Your KOL Connections

  • Through the use of an online community learn how to strengthen and foster emerging and existing KOLs
  • Provide valuable insights as well as complete visibility into therapeutic discussions
  • Enable more frequent HCP interaction on a 24/7 basis despite geographic locations

Speaker
Lance Hill
CEO
WITHIN3


10:00
CASE STUDY
How Independently Based Data Determination Allows for Better KOL Interaction and Disclosure

  • Independent oncology based KOL data
  • What information KOLs want from MSLs and the skill sets they appreciate
  • How often KOLs want to be seen and the type of setting preferred
  • The changing industry interactions on KOL policies, procedures, disclosures & reporting

Speaker
Jonas Hylton, PharmD, RPh, BS
Medical & Scientific Affairs
CEPHALON ONCOLOGY


10:45
Networking & Refreshment Break

11:15
KOL CHANGE MANAGEMENT
A View From the Vendor and Best Practices

Speaker
Matthew Phillips
VP of North America
HEARTBEAT EXPERTS

12:00
Luncheon

1:00
PANEL DISCUSSION  CREATING INTERNAL HARMONY FOR MEETING THE BUSINESS NEEDS WITH KOLs
Managing a Coordinated Approach to KOL Selection, Interactions, and Company Wide Communications Between Field Based & Headquarter Based Personnel

  • What are the hallmarks of a successful MSL?
  • MSLs goals & interactions with KOLs
  • Headquarter based goals & interactions with KOLs
  • Who are the future industry KOL speakers? The changing physician and industry interactions and implications, particularly within academia

Panelists
Linda Harris
Consultant, Former Assistant Vice President, Opinion Leader Relations
WYETH PHARMACEUTICALS

Brandon Howard, PhD
Sr Manager, Medical Science Liaison
TEVA BRANDED PHARMACEUTICALS R&D INC

Kathy Presto
Vice President, Strategic Partnerships
ROCHE PHARMACEUTICALS


2:00
THE COMPLEXITY OF COMPLIANCE
Understanding the Physician Sunshine Act & Analogous State Laws Impacting KOLs Interactions and Activities

  • Understanding the relationship disclosure
  • The litigation consequences of non-compliance
  • Defining the corporate integrity agreement
  • Maintaining Safe Harbor and the freedom of KOLs to discuss off label usage
  • Practicing and enforcing FDA Regulations

Speaker
Joseph McMenamin, Esq
Partner
MCGUIRE WOODS LLP


2:45
MARKETING TOWARDS TOMORROW’S KOLs
Product Commercialization and Patient Satisfaction Through a Marquee KOL

  • Successful marketing tools for enhancing current KOL position and product commercialization
  • Incorporating the use and application of international and regional marketing techniques
  • Learning to use social media channels to better market your product and KOL

Speakers
John M. Vieira
Senior Director, Marketing Operations and Strategic Services
DAIICHI SANKYO INC

H. Jürgen van den Woldenberg, DVM, PhD
VP Marketing
QUINNOVA PHARMACEUTICALS


3:45
Conference Concludes