Where is the Line in the Sand?

Marketing & Medical Affairs: Where is the Line in the Sand? October 22, 2015 ` Mark A. DeWyngaert, PhD – Managing Director, Huron Consulting Group...
Author: Guest
0 downloads 0 Views 2MB Size
Marketing & Medical Affairs:

Where is the Line in the Sand? October 22, 2015

`

Mark A. DeWyngaert, PhD – Managing Director, Huron Consulting Group

`

Brian J. Conner- Global Compliance, Shire

`

Glenna Shen – Executive Director of Compliance, Amgen

`

Michael Labson – Partner, Covington & Burling LLP

2

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.

3

◦ 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 4

Commercial Planning Spectrum • Long range forecast

• Disease analysis and indication sequencing

• Market positioning strategy and messaging

• Initial commercial opportunity assessment and revenue target

• Access planning (payer needs, by country)

• Product concept/TPP testing

• HEOR requirements • Field resourcing (sales, clinical, scientific support)

• Initial access environment assessment

• 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

© 2015 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Not for Distribution

5

Key Life Sciences Trends

Medical Affairs Imperatives

• More aggressive and sophisticated access management

• Address shift in definition of value and associated information requirements

• Outcomes metrics being used more broadly (indications, payers) • Provider integration and IT investment as enabler of HECON-and new payer audience • Emergence of new decisionmakers (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

© 2015 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Not for Distribution

• 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 6

ƒ ƒ ƒ

Advertising

Promotional “labeling”

Other activities that show “intended use“ (e.g., detailing)

ƒ ƒ ƒ

ƒ

ƒ ƒ

Promotion

Unsolicited medical information responses Good reprint dissemination Support for independent scientific/educational programs Bona fide publications/ presentations in scientific fora Bona fide research and advisor discussions Other?

Scientific Exchange 7

8

1st A. Cases Outside Drug Promotion

(S. Ct.)

(2d Cir.)

(S.D.N.Y.)

(S.D.N.Y.)

9

Industry Challenges and Concerns

ƒ

ƒ

Separation of scientific exchange from promotional activities Expanding areas of customer facing engagement/activities ◦ ◦ ◦ ◦ ◦ ◦

Payers IDNs Professional Societies/Advocacy Organizations HEOR Observational/Interventional Research Investigator Initiated Studies

10

Industry Challenges and Concerns

ƒ

Off-label/misbranding cases focus on “plusfactors” ◦ Prosecutors are interrogating the science ◦ Manipulation of studies ◦ Publication plans

Improper presentation of science can cause statements, which are otherwise accurate, to be misleading

11

ƒ

ƒ ƒ ƒ ƒ ƒ ƒ ƒ

Establish Policies & Procedures with Clear Guidance

Personal Scope – Are you Commercial or Medical? – It can’t be both. Definition of a KOL for R&D vs. Commercial Scientific Exchange Proactive Disease State Education (PDSE) Responding to Unsolicited Requests for Information Proactive vs. Reactive Interactions between Medical and Commercial o Strategic alignment of commercial and medical plans at high level but executed separately o Appropriate medical affairs interactions with Commercial Representatives 12

33% A. B. C.

33%

33%

Yes No Coordinated with commercial?

A.

B.

C. 13

33%

 It  D ep en ds

C.

 N o

B.

33%

Yes No It Depends

Ye s  

A.

33%

14

50%

No

B.

Yes No

Ye s

A.

50%

15

A. B. C.

Commercial Organization Medical Affairs Other

33%

A.

33%

B.

33%

C. 16

50%

No

B.

Yes No

Ye s

A.

50%

17

50%

No

B.

Yes No

Ye s

A.

50%

18

50%

No

B.

Yes No

Ye s

A.

50%

19

50%

No

B.

Yes No

Ye s

A.

50%

20

50%

No

B.

Yes No

Ye s

A.

50%

21

A. B. C. D. E. F. G.

Publications Planning Medical Information Responses Advisory Boards Grant Requests Two of the above Three of the above All of the above

14%

14%

14%

14%

14%

14%

14%

A.

B.

C.

D.

E.

F.

G. 22

25% A. B. C.

D.

25%

25%

B.

C.

25%

No Action Under Evaluation On Line Tools Available Other

A.

D. 23

A. B. C. D.

None Primary Contact Responsive only Other

25%

A.

25%

25%

B.

C.

25%

D. 24

25%

25%

Ot he r

Bo th

  ca l ed i M

D.

l

C.

cia

B.

25%

Commercial Medical Both Other

Co m m er

A.

25%

25

50%

No

B.

Yes No

Ye s

A.

50%

26

50% A. B.

50%

with commercial teams separate from commercial teams

A.

B. 27

A. B.

C.

D.

Website Presentations to Professional Groups/Patient Advocacy Organizations/Others? Information on status of research, MOA, clinical trial design, clinical trial results? None

25%

A.

25%

25%

B.

C.

25%

D. 28

Managing Director ‐ Huron Consulting Group 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.

30

Global Compliance ‐ Shire 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. ` 31

Partner Covington & Burling LLP  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.

Executive Director, Compliance – Amgen 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.

33