Scott Kraun's presentation on the added value Medical Liaisons (MLs) offer their organizations during times of controversy (product, legal/regulatory, corporate, etc.). As the primary initiators of relationships with clinical investigators, Key Opinion Leaders (KOLs), and other medical authorities, these teams warrant inclusion as “front-line” messengers in standing crisis communication plans.

1. www.diahome.org
BrEaKiNg NeWs!
Media Mania: Anticipating and preparing for the
onslaught!
What does Medical Communications need to do to successfully
manage inquiries resulting from product-related media coverage?
DIA 19th Annual Conference on Medical Communications
Buena Vista Palace, Orlando, FL, USA
March 9-12, 2008

2. www.diahome.org
Managing Product Controversy: A
Medical Liaison Point Of View
Scott Kraun
Vice President, MSL Programs
SOS

3. www.diahome.org
BrEaKiNg NeWs!

4. www.diahome.org
What’s This All About…..
• “The ultimate measure of a man is not
where he stands in moments of comfort
and convenience, but where he stands
at times of challenge and controversy.”
[Martin Luther King]

5. www.diahome.org
Types of Product Controversy
• Safety Issues Related to Marketed
and/or Investigational Products
• Labeling Revisions
• Product Quality Issue
• Regulatory Hurdles
– Approvable Letter
– Non-Approvable Letter
• Landmark Government Funded Study
Publications

6. www.diahome.org
Discussion Topics
• Controversy as an opportunity
• Role of the Medical Liaisons (MLs)
– HQ strategy development team
– KOL/customer relationships
• Communications and challenges
• Information flow

7. www.diahome.org
An Opportunity In Disguise?
• A proactive, informative, empathetic ML
contact initiative can:
– build or enhance Key Opinion Leader
(KOL) and other customer group (i.e.
managed markets) relationships
– reinforce Healthcare Professional (HCP)
confidence in drug, company, and industry
– help reestablish trust

8. www.diahome.org
Importance Of The MLs
• Serve as the field-based scientific “eyes
and ears” of the company
– May become aware of situations arising
during clinical trial or commercial stages of
the product lifecycle
• “Conduit” between corporate and KOL
audience

9. www.diahome.org
MLs And HQ Strategy Development
• Key contributions can include:
– External perspectives on controversy, i.e.
“word on the street”
– Scientific resource identification, research
and data interpretation, and patient impact
– KOL-spokesperson relationships
– Standard response letters, medical slide
decks, dossier updates, scientific sales
force training

10. www.diahome.org
MLs And Controversy Control
• Have relationships with top-tier and
media-savvy KOLs
• Can quickly and effectively disseminate
accurate data
– Statistical interpretation
– Appropriate drug utilization
– Targeted patient groups

11. www.diahome.org
Communication Challenges
• Misinformation and disinformation
– Speculation
– Competitor-generated
• Responsible communications
– Data integrity, patient safety

12. www.diahome.org
ML Customer Communications
• KOLs and other customer groups
respect fair-balanced information from
corporate clinical representatives, often
MLs
• Personal attention demonstrates
responsibility

13. www.diahome.org
ML Customer Communications Cont’d.
• MLs should:
– Prioritize contacts to quickly maximize
message reach
– Be responsive to questions
– Show compassion to concerns

14. www.diahome.org
ML Customer Communications Cont’d.
• MLs should:
– Reiterate corporate responsibility, steps,
and timelines
– Ensure Adverse Event Reports (AEs) and
Product Quality Complaints (PQCs) flow to
HQ for thorough data compilation and
further analysis

15. www.diahome.org
Information Flow
• ML:KOL interactions and information
exchange will impact messaging to
other HCPs
• Thorough explanation of accurate data
– not competitor, media, or rumor-mill
generated – will build assurances

16. www.diahome.org
Maximizing Relationship Marketing
ML
Medical Info
Available
Speakers
Regional KOLs
Speakers
Global/US KOLs
INFLUENCE
INFLUENCE
High
Volume
Prescribers

17. www.diahome.org
Summary
• ML role in managing product controversy:
– Communicate with top KOLs to ensure data
understanding and protect integrity
– Protect patient safety through appropriate
identification and drug usage guidelines
– Provide KOL feedback to HQ strategy
development team
– Serve as a ongoing KOL resource for question
response and other informational needs

18. www.diahome.org
Quote
“A definitive source and a ‘zero hour’ of
first-hand disclosure for complex
scientific data help to limit
misinformation.”
Sidney Taurel
Taurel, Sydney. “The Media on Drugs.” The Wall Street Journal 27 Nov.
2007: A19.