Alternative Careers in the Pharmaceutical and Biotechnology Industry

1. Alternative Careers in the Pharmaceutical and Biotechnology Industry • Martin A. Wasserman, Ph.D. • January 14, 2014 • UTMB Career Development Workshop

2. TOP PHARMA/BIOTECH COMPANIES • Pfizer • Merck • GlaxoSmithKline (GSK) • Novartis • Bristol-Myers Squibb (BMS) • Hoffmann-La Roche (Roche) • Eli Lilly • Abbott • Sanofi • Amgen, Genentech, Biogen

3. THE WORLD IS CHANGING… AND SO MUST WE • Pharmaceutical and biotechnology company M&A are increasing competitive pressure, e.g., Sanofi, GSK, Merck, Pfizer, Novartis, BMS, AZ, HLR • Industry trends require key decision points, e.g., milestones and Go/No Go criteria • R&D expenditures have dramatically increased • Longer cycle times across the value chain • Generics have initiated price pressures • Globalization of markets

4. THE PHARMA AND BIOTECH INDUSTRY • Americans spend > $320B/year on medicines • For-profit, highly government-regulated business which innovatively discovers, tests, manufactures, and distributes a wide range of novel, safe, effective and quality-controlled medicines to prevent, treat and cure human diseases (a noble profession) • Technically complex, risky, costly, and regulated industry • Creates jobs (employs > 300,000 workers WW) and invests billions in R&D • Takes risks on unknown opportunities for potential “breakthrough blockbusters”; highly rewarding • Orchestrates project progression across the Value Chain

5. INDUSTRY VS. ACADEMIA • Less differences and more similarities • Long hours and much is expected • Expectations to advance science, innovation, and to foster career growth are similar; personal accountability • Novelty and scientific freedom are encouraged • Mentors and supervisors encourage collegiality (“Team Membership”), consistent productivity, and communication • Regular feedback on performance • Job security linked to performance and funding • “Publish or perish” pertains to both • Flexibility and adaptability are imperative in the industry; expect and conform to change

6. PHARMACEUTICAL INDUSTRYMYTHS AND MISCONCEPTIONS • PhDs and MDs inferior to academic counterparts • No publishing or meeting presentations required • Only perform work as instructed by supervisors • No academic adjunct appointments or external collaborations permitted • Keep breakthrough ideas to yourself • No novel proposal (“grant”) writing expected • Unlimited funds to do everything • No opportunities to transfer to non-bench jobs

7. PHARMACEUTICAL INNOVATION • Assessed at time of Market introduction • Efficacy for a disease for which no drug is presently available • Novelty is competitive and time-related • Means “truly original”…not yet reduced to practice • Should improve the practice of medicine • Discovery of new approaches (Scientific Innovation), improves QoL or convenience for the patient, or improved formulations • Needs to be critically reassessed at each stage of the Development Process

8. DISCOVERY RESEARCH MISSION AND STRATEGY • To rapidly discover novel, innovative, breakthrough drug candidates to treat diseases using cutting-edge technologies • To utilize early exploratory efforts to identify novel targets • To utilize state-of-the-art assay formats to identify “hits and leads” • Wherever possible, leverage “common mechanism” approaches to be opportunistic andsynergistic to increase productivity and to reduce cycle time in pursuing a diverse set of targets • To recognize failing compounds EARLY (“kill early, kill often”) and conduct quick “proof-of-concept” studies

9. Toxico- genomics Chemical Genomics Pharmaco-genomics Evaluation of Lead Drug Candidates Manufacturing Development Actives, Hits, Lead Compounds Evaluation of drug efficacy Manufacturing Functional Genomics Clinical Trials Assay Development Process Development PK Target Identification & Validation Safety HTS Quality Control NDA Clinical Evaluation (safety, efficacy) and new drug application Medicinal Chemistry Establish role of gene in biology and disease THE DISCOVERY PROCESS 4 5 3 Genomic research Launch 2 Gene sequencing Microarrays Proteomics 6 Personalized Medicine 1

10. SIGNIFICANT ADVANCES IN DRUG DESIGN • Identification of new molecular targets • Cloning of human receptors, enzymes, ion channels for structural elucidation of binding sites • Structural analysis of drugs with their binding sites, e.g., X-ray crystallography, NMR • Proprietary libraries of >107 chemical structures • Combinatorial chemistry techniques for rapid synthesis of selected drugs and related analogues • Automated HTPS for SAR (>105 compounds/week)

11. REASONS DRUG CANDIDATES FAIL IN CLINICAL DEVELOPMENT • Toxicity- 2% • Lack of efficacy- 31% • The market- 6% • Poor biopharmaceutical properties, e.g., formulation, pharmacokinetics, ADME- 41% • Note: For every 20 compounds entering Phase I clinical trials, only 1 may become a marketed drug!

12. KEY VALUES AND OPERATING PRINCIPLES • Urgency (focus on priorities, speedy delivery, flexibility, problem solving) • Creativity (innovation, originality, new hypotheses & targets, thinking “out-of-the-box”) • Courage (tenacity, decisiveness, tough decisions) • Empowerment (personal accountability; responsibility) • Teamwork (networking, partnership, sharing information, interactive) • Integrity (ethical standards, honesty & fairness) • Respect (trust, openness, listening, value diversity)

13. WHAT COMPANIES LOOK FOR • Candidates who: • Are driven and motivated • Are ambitious • Are risk takers • Can follow instructions and take directions • Can work independently and as a Team Member • Can cope with stress and failure • Have the ability to manage and resolve conflict

14. SOME CORE SKILLS IN THE PHARMACEUTICAL INDUSTRY • Pharmacology, Anatomy & Physiology • Molecular and Cellular Immunology, Genomics • Cellular and Molecular Biology • Biochemistry and Enzymology • Pathology & Toxicology • Animal Model Development, Drug Delivery, Formulations • Medicinal, Combinatorial, Analytical, Process Chemistry • ADME, Pharmacokinetics • Biostatistics, Statistical Analysis • Scientific & Medical Intelligence, Communication • Data & Knowledge Management • Networking, Opportunity Identification

15. REQUISITE COMMUNICATION SKILLS • Verbal Presentations: • Authoritative and Persuasive • Team, Department, and Corporate • National and International Meetings, • Conferences, and Symposia • Written Publications: • Internal Technical and Final Reports • Abstracts and Peer-Reviewed Manuscripts • Invited Reviews and Book Chapters • Research Feasibility Proposals (“Grants”)

16. DIVERSE CAREER OPPORTUNITIES I • Drug Discovery and Design; Innovation Strategy and • Implementation • Preclinical Research and Biomarker Development • Patents, Intellectual Property (IP) • Non-Clinical Analytical ADME (DMPK) • Pathology & Toxicology • Clinical Pharmacology • Clinical Trial Design and Data Management • Business Development • Licensing, Alliance Management (JVs), M&A • Medical Writing and Medical Communication

17. DIVERSE CAREER OPPORTUNITIES II • Lab Automation • Product Formulation and Drug Delivery • Biostatistics • Scientific, Clinical, Medical Affairs • Medical Science Liaison (MSL); Identify KOLs • Competitive Medical & Scientific Intelligence • Technology Transfer; Identify & Interact with CROs • Regulatory Affairs Worldwide, e.g., FDA • Drug Safety (Pharmacovigilence) • QA/QC; Manufacturing; Process Development

18. INTERVIEWING TIPS FOR SUCCESS • Prepare, Prepare, Prepare • Research the Company and the Key Players • Be Aware of Your Strengths and Weaknesses • Differentiate Yourself, e.g., Experience, Expertise, and Accomplishments • Demonstrate Evidence That You Meet the Job Specs • Focus on Quantifiable, Specific Actions & Results • Tailor Responses to the Job Opportunity • Show Interest and Enthusiasm • Demonstrate Likability and Competency

19. SUMMARY • Role, mission and strategy of the industry • Complex, risky, costly, highly-regulated industry • Are there differences from an academic career? • Put to rest common myths and misconceptions • Cutting-edge drug design technological advances • Industry values and operating principles • Potential candidates and core skills • Diversity of career opportunities in the industry • Richly rewarding noble profession!