Life in Pharmaceutical/Biotech Industries - after NTUSP and More

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Life in Pharmaceutical/Biotech Industries
- after NTUSP and More

• Big Pharma vs. Small Pharma Companies
• Innovator vs. Generic Companies
• Pharmaceutical vs. Biotech Companies
• Working for One vs. Own One
• Consulting for all of the above

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The common path From Concept to Market

• Lead Generation
• Lead Identification
• Lead Optimization
• Product Realization
• Technical Transfer
• Manufacture/Tech Ops
• Sales and Marketing
• Medical Affairs
• Portfolio Management

Discovery
Development
Commercialization
Life cycle management
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Major Corporate Function Groups in
Pharma/Biotech Companies in the US

• IT
• Legal
• Finance
• Human Resources
• Production (Manufacturing)
• Sales and Marketing
• Business Development

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Typical Major RD Organization
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Product Development Organization
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Analytical Chemistry
Pharmaceutics

• Qualification
• BS, MS, PHD in Pharmaceutics, Engineering,
  Chemistry, Material Sciences, etc.
• Roles and Responsibilities
• Formulation Process Development
• Method Development Validation
• Preclinical Clinical Supplies
• Stability Specification
• Scale-up Technical transfer
• SUPAC
• Key Performance Indicators
• Know-how
• Commercializable products
• Time to market
• Cost of goods

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Drug Safety (Toxicology)
DMPK

• Qualification
• BS, MS, PHD in Biological Sciences such as
  Toxicology, Microbiology, Biochemistry,
  Pharmacokinetics, Pharmacology, etc.
• Roles and Responsibilities
• Non-clinical safety evaluation - Qualification
  of API, and novel excipients
• Support clinical program toward target
  indications
• Early projection of AEs, Drug-drug interaction,
  etc.
• Key Performance Indicators
• Time to First-in-man
• Accurate prediction of clinical safety
• Ability to support the clinical program - Dose
  selection, PK/PD, Drug-drug interactions,

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Regulatory Affairs
Project Management

• Qualification
• No specific requirement of types of technical
  degrees
• Working experience in more than one functional
  areas
• Aptitude to work with conflicts and ambiguities
• Roles and Responsibilities
• Resource planning (people, time money)
• Portfolio management
• Regulatory submissions and interactions
• Compliance
• Key Performance Indicators
• Effectiveness of Development plans (time cost)
• Approvable submissions
• Compliance

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Clinical Research

• Qualification
• BS/BA in biological sciences/nursing (CRA, Data
  Management)
• MD/PhD (Monitor)
• Roles and Responsibilities
• Phase II-IV clinical trials
• Clinical trial protocols, clinical study
  reports, analysis plans, and
  publication/manuscripts
• Monitor study activities
• Key Performance Indicators
• Working knowledge of GCP and regulatory
  requirements
• Work independently and collaboratively on
  project teams
• Recognize safety and efficacy data trends

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Pharmacovigilance

• Qualification
• RN, PA, Pharm D, MD.
• Roles and Responsibilities
• Medical writing of safety reports, analysis
• Interpretation of safety issues from clinical
  trials and/or post marketing surveillance
• Evaluate serious adverse event reports
• Key Performance Indicators
• Familiar with safety regulatory guidelines
• Knowledge with PSUR writing and assemble

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Medical Affairs (home base)

• Qualification
• MD, Pharm D. PhD.
• Roles and Responsibilities
• Provide support to marketing and sales in
  medical strategy, medical education, medical
  communication, and clinical operation
• Conduct scientific advisory board meetings to
  identify new research opportunities
• Develop relationships with national and regional
  thought leaders
• Key Performance Indicators
• Sound advice based on clinical research
  experience
• Effective communication and presentation skills,
  both verbal and written

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Medical/Drug Information (home base)

• Qualification
• BS Pharmacy or Pharm D
• Roles and Responsibilities
• Provides product information to external
  customers
• Capture and report adverse event and product
  complaints
• Key Performance Indicators
• Knowledge of information technology
• Ability to integrate applications to assess
  medical information
• Understand diseases and pharmacotherapy
• Excellent medical writing skill

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Health Economics Research Outcomes

• Qualification
• Doctoral degree in Health Economics/Health
  Policy, or Pharmacy, plus MPH or MBA is
  preferred
• Roles and Responsibilities
• Demonstrate the economic value of Company's
  products to payers
• Design health economic protocols to conduct
  pharmacoeconomic studies on payer databases,
  retrospective databases, and registries
• Key Performance Indicators
• Expertise in statistical analysis/programming
• Understanding of clinical experimental designs
• Broad knowledge of the US health care system
• Knowledge in Managed Care Health Systems
  (Private and Government) preferred

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Medical Science Liaison (Field Based)

• Qualification
• Strong science/clinical background with advanced
  degree (i.e. MD, Pharm D, PhD)
• Roles and Responsibilities
• Translating scientific or clinical data into
  high quality medical information to help
  healthcare providers best serve their patients
• Key Performance Indicators
• Clear understanding of the clinical and
  regulatory requirements in the operations of a
  field-based medical liaison team
• Excellent communication and leadership skills
• Willingness to travel extensively

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A few general comments

• Value of networking
• Titles are for organization use
• No one is irreplaceable
• Be true to yourself

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