Life in Pharmaceutical/Biotech Industries - after NTUSP and More…

1. 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

2. 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 cyclemanagement

3. Major“Corporate”Function Groups in Pharma/Biotech Companies in the US: • IT • Legal • Finance • Human Resources • Production (Manufacturing) • Sales and Marketing • Business Development

4. Typical Major R&D Organization

5. Product Development Organization

6. 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

7. 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,

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. A few general comments: • Value of networking • Titles are for organization use • No one is irreplaceable • Be true to yourself