Transcript Career Development Workshop

Life in Pharmaceutical/Biotech Industries
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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
The common path:
From Concept to Market
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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
Major “Corporate” Function Groups
in Pharma/Biotech Companies in the US:
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IT
Legal
Finance
Human Resources
Production (Manufacturing)
Sales and Marketing
Business Development
Typical Major R&D Organization
Compliance
(QA)
Technical
Operations
Drug
Discovery
R&D
Medical
Affairs
Product
Development
Clinical
Research
Product Development Organization
Pharmaceutics
Drug Safety
(Toxicology)
Analytical
Chemistry
Product
Development
cGxP
DMPK
Project
Management
Regulatory
Affairs
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
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 AE’s, 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,
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
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
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
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
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
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
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
A few general comments:
• Value of networking
• Titles are for organization use
• No one is irreplaceable
• Be true to yourself