Careers in Industry for PhysicianScientists

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Careers in Industry for Physician-Scientists

• Andrew Plump, MD, PhD
• Vice President
• Worldwide Basic Research Head, Cardiovascular
  Diseases
• Merck Research Laboratory

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Physician scientist roles in industry

• With the advent of healthcare reform and its
  dramatic impact on the traditional practice of
  medicine, physicians are increasingly opting to
  diversify their career choices. However, because
  of a lack of suitable information, physicians are
  frequently unaware of the broad range of ways
  that they can utilize their skills and knowledge
  within the healthcare industry. The
  pharmaceutical industry provides one such
  opportunity.

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Outline

• Drug Development 101
• Forces facing the pharmaceutical industry
• Future scientific opportunities
• Future industry business trends
• Physician-scientist roles in industry

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Rx Development 101
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Rx Development 101 - Overview
Discovery
Preclinical Development
Phase I
Registration
Phase II
Outcomes
Phase III
Phase IV V
Patients
Time
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Rx Development 101 Phases of Clinical Development
Discovery Target ID, Target Validation, Lead
ID, Lead Optimization
Preclinical development Production, Safety
toxicology
PhI Initial Safety, PK, Pharmacological POC,
Efficacy Signal
Go No Go
PhIIa Clinical POC
PhIIb Commercial POC
Go No Go
Go No Go
Phase III Pivotal Efficacy Studies/Outcomes
Knowledge about safety and efficacy
Time
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Drug development is hard and takes a long time
Preclinical
Clinical
Target Selection
12-24 Months
Phase 1
X Years (2-5?)
Phase 2 Clinical Proof of Concept
12-24 Months
Validation
Drug Lead Identification
Phase 3 Outcome Study (?)
3-5 Years
30 Months
Drug Lead Optimization
Therapy available to physician Prognostic
marker? Diagnostic marker?
Preclinical Development
12-24 Months
Total time 11-16 Yrs Cost 1-2bn
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DISCOVERY AND DEVELOPMENT
Estimated cost gt1 Billion USD
PHASES
V
POST-MARKETING SURVEILLANCE
MARKET LAUNCH FDA Review
15 10 5 0
IV
1
1
III
Y E A R S
2
2
CLINICAL TRIALS (HUMANS)
IIa, b
DEVELOPMENT
2 - 5
2 - 5
I
I
5 - 10
5 - 10
PRECLINICAL TEST (ANIMALS)
10 - 20
10 - 20
BASIC
3,000 - 10,000
3,000 - 10,000
RESEARCH
Number of Compounds
Source Based on PhRMA analysis, updated for data
per Tufts Center for the Study of Drug
Development (CSDD) database.
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Forces Facing the Pharmaceutical Industry
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BioPharma RD Productivity Declining Trends

• Notes
• Includes company-financed RD by PhRMA member
  companies
• Includes new therapeutics and other new biologics

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Forces facing the pharmaceutical industry will
drive big changes

• Declining industry revenues
• Biotech cannot compensate
• Rising costs risks
• Globalization

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Why are pharma industry revenues declining?

• Patent expiry
• Weak pipelines?
• More powerful payers (10 firms control 56 of
  managed care market)
• Payers make decisions reserved historically to
  physicians and have good (equivalent?) options
  that cost 10-fold less

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Generic competition will pressure industry revenue
Ex-US sales substantial!
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Why are costs and risks rising?

• Increased risk increased cost
• Costs and risks of developing new drugs are
  increasing because
• Low hanging fruit plucked
• Current emphasis on lesser validated clear
  genomic datasets
• Current targets are more complex and less
  tractable
• Increased failure rates and massive cost of
  failure particularly later in development
• Regulatory approval process
• Plaintiff favorable litigation environment
• Payer and physician shift to need for outcomes
  demonstration

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Failure rate in drug development is exceedingly
high
Overestimate other data suggest success rate lt11
Many compounds fail due to lack of efficacy or
demonstrated benefit
Source Kola and Landis (2004)- Nature
Reviews/Drug Discovery
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Biologics?
Ruiz-Garcia et al J Pharmac Sci 97(2) 654-690,
2008
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Globalization is the most powerful force
affecting the future of the pharmaceutical
industry

• Why globalization? No longer US and EU dominated
  market
• Who globalization? E7 - China, India, Russia,
  Brazil, Mexico, Indonesia, Turkey
• Globalization expands markets
• Economic growth is leading to an increased demand
  for health care and prescription medicines
• Majority of demand will be for generics, but
  based on sheer size they represent potentially
  massive markets
• Globalization expands RD capabilities
• Global labs increasing in sophistication -
  Populated by US EU trained scientists
• Ex-US labs can do the work cheaper
• Less adversarial regulatory regimes
• Intellectual property laws are maturing

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Future Scientific Opportunities
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Scientific opportunities for the indusrty in the
next decade

• Opportunities for the next decade
• Improving the efficiency of RD
• Early decision making as a cost cutting measure
• Focus on disease areas with greatest unmet
  medical needs such as
• Oncology
• CNS drug development
• Metabolic disorders
• Stratified medicine diagnostics

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Opportunities for the Next Decade Improving RD
efficiency reducing the cost of failure

• Basic research
• Biological networks to identify tractable targets
  for pathways involved in disease of interest
• Raise bar for moving only well validated targets
  into development
• Preclinical development
• Better predictors of toxicity
• Early clinical development
• Translational medicine biomarker driven
  decision making
• Late stage development
• Adaptive trial design
• Outcome demonstration
• Factorial outcome trial design

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Future Business Trends
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Future industry business trends will be driven by
3 forces

• Corporate restructuring
• Job reductions (100,000s)
• Further consolidation within the industry (1985 ?
  present, 51 ? 12 Pharma)
• Refocusing on fewer business lines
• Outsourcing (FIPCOs become FIPNETs)
• Adoption of risk reduction strategies
• Acquisition rather than development of new
  compounds
• 50 of current large pharma pipeline comes from
  acquisition trends increase
• Use of joint ventures research consortiums
• Evolution of drug marketing
• Increased focus on US payers
• Shift from physicians
• DTC Ads for disease and disease therapies rather
  than specific product
• Global marketization

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Will revenue decline force continued
consolidation?
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The future of Large Pharma?

• 2008
• Abbott
• Astra-Zeneca
• BMS
• GSK
• JJ
• Merck
• Novartis
• Pfizer
• Roche
• Sanofi-Aventis
• Schering Plough
• Wyeth
• (Genentech, Amgen)

• 2013-2015
• 7-9 remain???

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Physician-Scientist roles in industry
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Physician scientist roles in industry

• Basic Research, drug discovery, genomics,
  mechanism based science, classical disciplines
  (biochemistry, cell biology, etc)
• Translational Medicine, biomarkers, imaging,
  genomics with bench to bedside focus
• Clinical Development, strategy, clinical trials,
  team leadership
• Medical Services, responsibilities focus on
  medical information, marketing, and promotional
  activities
• Regulatory Affairs, key liaison between the
  company and the regulatory authorities
• Drug Surveillance or Drug Epidemiology, roles
  that are particularly suited for physicians with
  an interest and/or formal training in
  epidemiology. Responsibilities in these roles
  include the epidemiologic analyses of safety data
  in clinical and adverse experience databases,
  planning and conducting postmarketing
  surveillance, and other safety studies

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Physician scientist specific skills required

• Generic, communication, intelligence, social IQ,
  persistence, results-oriented, strong publication
  record
• Job specific
• Basic Research, basic science, strategic
• Translational Medicine, basic science and
  clinical expertise
• Clinical Development, strategic, pharmacology or
  disease area expertise, clinical trial design
• Medical Services, responsibilities focus on
  medical information, marketing, and promotional
  activities
• Regulatory Affairs, clinical and/or basic science
  expertise, strong writing and presenting skills
• Drug Surveillance or Drug Epidemiology,
  epidemiology

• For trained physician-scientists, many, if not
  all
• job specific skill sets can be learned on the job

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Timing of a move to industry

• It is not critical to pursue this professional
  move early in ones medical career. However, the
  longer the physician waits, the more difficult it
  becomes for the individual to enter the industry
  in a position that is commensurate with his/her
  level of professional experience. In general,
  most companies seek physicians who have, at the
  very least, about two years of clinical
  experience post-residency or post-fellowship
  training, up to about ten years.
• Very senior academic physician-scientists can
  enter industry at very senior levels but these
  jobs are very select

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Additional valued skill sets in the future pharma
world
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Industry pros and cons

• Pros
• Considerable intellectual challenges
• Great professional rewards
• Highly collaborative
• High impact
• Strategy
• Growth
• Resources
• Financial

• Cons
• Less direct patient contact
• Loss of autonomy
• Loss of hands on science role for purely clinical
  positions and for senior managers
• More travel (?)
• Teaching
• Financial