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Marketing & Medical Affairs: Where is the Line in the Sand?
October 22, 2015
Mark A. DeWyngaert, PhD – Managing Director, Huron Consulting GroupBrian J. Conner- Global Compliance, ShireGlenna Shen – Executive Director of Compliance, Amgen Michael Labson – Partner, Covington & Burling LLP
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The opinions expressed in this presentation are solely those of the presenters and should not be construed to reflect the views of our employers or clients.
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◦
Broad outline of what we hope to accomplish
◦
General overview of legal and regulatory constraints on behavior of MSL’s and more broadly Scientific Communications
◦
Discuss Industry challenges and concerns
◦
Lessons learned about moving into the future and the role of Compliance at that intersection
◦
Questions for audience response and panel discussion
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Commercial Planning Spectrum
5© 2015 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Not for Distribution
• Disease analysis and indication sequencing
• Initial commercial opportunity assessment and revenue target
• Product concept/TPP testing
• Initial access environment assessment
• Long range forecast
• Market positioning strategy and messaging
• Access planning (payer needs, by country)
• HEOR requirements
• Field resourcing (sales, clinical, scientific support)
• Competitive monitoring and response
• Marketing strategy evolution
• New indications, formulations, publications
• Pre/peri LOE planning
• Franchise/portfolio planning
Medical Affairs Functions (Examples)
• Clinical Context/Expertise • Medical Education • Scientific Communications
• Investigator Management/IIS • MSL Management • Surveillance
• KOL Engagement and Relations • Publications • Trial Design and
Demonstration
6© 2015 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Not for Distribution
• More aggressive and sophisticated access management
• Outcomes metrics being used more broadly (indications, payers)
• Provider integration and IT investment as enabler of HECON--
and new payer audience
• Emergence of new decision-
makers (e.g. hospital admin, hospitalists, patients/ advocacy, etc.)
• Increasingly patient centric (and longitudinal) approach to care delivery
• Increasing biopharma and medtech reliance on emerging markets
Key Life Sciences Trends
• Address shift in definition of value and associated information requirements
• Engage new stakeholders and tailor content of communication accordingly
• Embrace “patient journey”
approach
• Understand and harness new, digital media channels where appropriate
• Build expertise and structure organization in a way that addresses needs (region specific)
…execute in an increasingly rigorous and transparent regulatory environment
Medical Affairs Imperatives
Promotion Scientific Exchange
AdvertisingPromotional “labeling”Other activities that show “intended use“(e.g., detailing)
Unsolicited medical information responsesGood reprint disseminationSupport for independent scientific/educational programsBona fide publications/ presentations in scientific foraBona fide research and advisor discussionsOther?
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8
1st A. Cases Outside Drug
Promotion
(2d Cir.) (S.D.N.Y.) (S.D.N.Y.)(S. Ct.)
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Separation of scientific exchange from promotional activitiesExpanding areas of customer facing engagement/activities
◦
Payers◦
IDNs◦
Professional Societies/Advocacy Organizations◦
HEOR◦
Observational/Interventional Research◦
Investigator Initiated Studies
Industry Challenges and Concerns
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Off-label/misbranding cases focus on “plus-factors”
◦
Prosecutors are interrogating the science◦
Manipulation of studies◦
Publication plans
Improper presentation of science can cause statements, which are otherwise accurate, to be misleading
Industry Challenges and Concerns
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Establish Policies & Procedures with Clear GuidancePersonal Scope – Are you Commercial or Medical? –It can’t be both.Definition of a KOL for R&D vs. CommercialScientific ExchangeProactive Disease State Education (PDSE)Responding to Unsolicited Requests for InformationProactive vs. ReactiveInteractions between Medical and Commercialo Strategic alignment of commercial and medical plans at high
level but executed separatelyo Appropriate medical affairs interactions with Commercial
Representatives
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A.
Yes B.
No
C.
Coordinated with commercial?
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A. B. C.
33% 33%33%
A.
YesB.
No
C. It Depends
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Yes
No
It D
epen
ds
33% 33%33%
A.
YesB.
No
15
Yes
No
50%50%
A.
Commercial Organization
B.
Medical AffairsC.
Other
16A. B. C.
33% 33%33%
A.
YesB.
No
17
Yes
No
50%50%
A.
YesB.
No
18
Yes
No
50%50%
A.
YesB.
No
19
Yes
No
50%50%
A.
YesB.
No
20
Yes
No
50%50%
A.
YesB.
No
21
Yes
No
50%50%
A.
Publications PlanningB.
Medical Information Responses
C.
Advisory BoardsD.
Grant RequestsE.
Two of the aboveF.
Three of the aboveG.
All of the above
22A. B. C. D. E. F. G.
14% 14% 14% 14%14%14%14%
A.
No ActionB.
Under EvaluationC.
On Line Tools Available
D.
Other
23A. B. C. D.
25% 25%25%25%
A.
NoneB.
Primary Contact
C.
Responsive onlyD.
Other
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A. B. C. D.
25% 25%25%25%
A.
CommercialB.
Medical
C.
BothD.
Other
25
Com
mer
cial
Med
ical
Both
Othe
r
25% 25%25%25%
A.
YesB.
No
26
Yes
No
50%50%
A.
with
commercial teams
B.
separate from commercial teams
27A. B.
50%50%
A.
Website B.
Presentations to Professional Groups/Patient Advocacy Organizations/Others?
C.
Information on status of research, MOA, clinical trial design, clinical trial results?
D.
None
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A. B. C. D.
25% 25%25%25%
Dr. Mark DeWyngaert has provided operational, clinical, managerial, consulting, and litigation services to various segments of the health care industry. Mark trained as a molecular biologist and has been actively involved in both research and business development roles at the executive level for over 25 years. He specializes in assisting medical device, pharmaceutical and
biotechnology manufacturers with identifying and mitigating regulatory risks surrounding medical and commercial practices and valuation of services and intellectual property.
Managing Director ‐
Huron Consulting Group
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Brian Conner is currently a member of Shire’s Global Compliance & Risk Management team in April 2012 as Sr. Director. Brian provides compliance leadership to
the Neuroscience and GI business units in the U.S. and Canada. He also provides primary compliance support to our aggregate spend efforts and team.
Brian possesses a wealth of cross functional biopharmaceutical
experience. He has held positions within the areas of corporate ethics and compliance, general management, regulatory affairs, quality assurance, manufacturing, sales/marketing and healthcare communications. He has worked for large and small companies like Merck, Saatchi and Saatchi, Stiefel Labs, and Genzyme.
Global Compliance ‐
Shire
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Mike is a member of the Food and Drug and Life Sciences practices at Covington & Burling LLP. Mike provides strategic advice to pharmaceutical and biotechnology clients in dealing with the FDA and other agencies. He has litigated a variety of life sciences cases, and works actively on corporate transactions and government investigations.
Mike graduated magna cum laude from Harvard College, and magna cum laude from Harvard Law School. He clerked for the Honorable David M. Ebel on the U.S. Court of Appeals for the Tenth Circuit. He is a Fellow of the American Bar Association, and a member of Covington’s Management Committee.
Partner Covington & Burling LLP
Glenna Shen
is Executive Director, Compliance with responsibility for the US Business and Global Functions at Amgen. Ms. Shen
joined Amgen in 2000, and has held various positions in the Law Department and with Worldwide Compliance and Business Ethics, most recently heading up the Compliance function at Onyx Pharmaceuticals, and Amgen subsidiary.
Ms. obtained her Bachelor of Arts degree in Biology from the University of Miami and her Juris
Doctor and Master of Business Taxation from the University of Southern California.
Executive Director, Compliance – Amgen
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