Developing a Successful Clinical Research Career In Industry

1
Developing a Successful Clinical Research Career
In Industry

• Hal V. Barron, MD, FACC
• Executive Vice President, Head of Global
  Development Oncology, Inflammation, Virology and
  Ophthalmology.
• Chief Medical Officer- Genentech Inc
• Associate Professor Epidemiology/Biostatistics/Med
  icine- UCSF

2

• Hal needs to add a slide on
• How to Collaborate with Industry
• Participate as a site in clinical trial
• Enroll patients
• Get through IRB quickly
• Decrease hassle for them to do clinical trial
• Work to develop diagnostics (patient samples),
  devices, or therapeutics

3
Careers In Industry For Physicians

• Overview
• What do I do/How did I wind up at Genentech
• Types of companies one can choose
• The different types of jobs in industry
• The specific role of clinical scientist
• A career in industry The Pros and Cons
• How to be successful in industry
• Conclusions
• Question and Answers

4
How did I wind up at Genentech???
5
Types of Companies

• Biotech vs. Pharma
• Large vs. Small vs. Start-up
• Device vs. Therapeutic vs. Technology (i.e.
  Diagnostics, Imagining etc)
• Innovators vs. Follow-On therapeutics vs.
  Generics
• Science-based vs. commercially oriented

6
Types of Careers In Industry

• Preclinical Scientist (Discovery, Tox/PK/PD)
• Physician Scientist/Medical Monitor/Medical
  Director
• Leadership/Management
• Other Epidemiology/HCE, Business Development,
  Regulatory Affairs

7
Physician Scientist in Industry

• Builds on the foundation of an M.D.s clinical
  expertise and strategic thinking
• Develops new skills
• Mechanism of action, basic science
• Drug development, regulatory
• Business strategic planning
• Working in cross-functional teams
• Results in a steep learning curve!!
• Access to training and peer review/support are
  key success factors

8
Clinician Scientist Roles
I. Preclinical Development Candidate/Indication
selection
II. Clinical Development (Phase I-III)
Medical Directors
IV. Business/Strategic Planning
III. Post-Marketing/Commercial (Phase IV)
9
I. Preclinical Development
Consultant to Preclinical Research Teams
Identification of Indication/ Unmet medical need
Medical Director
Impact of ongoing clinical trials
Desirable properties of drug candidates
10
I. Clinical Development
Clinical Development Plan Investigator
interactions Meeting with FDA
Clinical Trials (Phase I-III) Strategic
Planning Medical Monitor
Safety Pharmacovigilance
Medical Director
Ongoing Education for Clinical Team Members
11
Clinical Development

• Clinical trial design
• Protocol development evaluation of unmet need,
  intended use and labeling
• Efficacy assessment and benefit/risk ratio in
  study design
• Statistical basis for study design, sample size,
  power calculations
• Integrated evaluation of dose selection
• Surrogate markers and clinical endpoints
• Development of various clinical R D strategies
• Ethical compliance in clinical trials the IRB,
  the informed consent

12
Clinical Development

• Interpreting clinical data - maximizing safety
  and efficacy by developing the right drugs for
  the right patients
• Bevacizumab in Lung Cancer
• Pertuzumab in Ovarian Cancer
• BRAF in Melanoma

13
II. Post-Marketing/Commercial
Medical Directors
Post-Marketing Studies (Phase IV)
Marketing/Commercial Team Support
External Physician Relationships
Sales Force Education/Support
14
III. Business /Strategic Planning
Strategic Portfolio Planning
Drug Development Partnerships
Medical Directors
Assessment of Business Development Opportunities
15
Roche Group early-stage development pipeline
As of 23 July 2009 1 Opt-in opportunity from
Chugai Pharmaceuticals 2 Opt-in opportunity from
BioTie 3 Preparing to initiate clinical trial 4
Participation through Chugai Pharmaceuticals NME
New Molecular Entity.
16
Roche Group late-stage development pipeline
17
A Career in Industry -The Pros

• Offers opportunity to work in a cross functional
  team environment
• Considerable interaction with basic scientist,
  clinical pharmacology, physiology
• Understanding of regulatory, legal and commercial
  perspectives on drug development
• Opportunities for leadership/management
• Offers opportunity to develop expertise in
  clinical trials
• Offers opportunity to interact with many
  investigators
• Offers opportunity to be academic
• Miscellaneous
• No grants
• No call
• Travel?

18
A Career in Industry -The Cons

• Inherent potential conflict of interest
• There is significantly less opportunity to
  practice clinical medicine
• The work can be less academic than academia
• May not be able to pursue your primary research
  interest

19
Developing a Successful Career (In General)

• You are most likely to achieve your potential and
  thus have a successful career if you are inspired
  by your institution and the people who work there
  
• Be open and honest in identifying the ideal
  institution and mentor
• Understand the mission of the institution and
  look for evidence that it has been successful in
  achieving it
• Dont forget about how the institution achieved
  it (core values are critical)

20
Developing of a Successful Career (In General)

• You must know what you want to accomplish
  (long-term view)
• You must be deeply committed to achieving this
  vision
• prioritize your activities in accordance (this
  means you know what you wont be doing as well as
  what you will focus on)

21
Developing a Successful Career (In Industry)

• Ideally complete a fellowship and experience
  several years as a faculty member
• Get great training in all aspects of clinical
  research while in academia
• Leave your ego at the door
• Realize translating science into medicine is a
  team sport (measuring your success is much more
  challenging than clinical medicine)
• Realize that helping patients comes in many
  flavors

22
A Career in Industry - Summary

• Industry is not for everyone
• In fact, Industry is not for MOST people
• It can, however, provide an opportunity for a
  very rewarding career in clinical research

23
Why did I Choose A Career in Industry

• Be at the cutting edge of medicine
• Continue Patient Care !!
• Improving treatment options for patients on a
  larger scale vs.. 1 at a time
• Enable future opportunities in other areas
  (Public Policy, Management, Investment World,
  Government, Academia)

24
Good Luck !