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

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Presentation on theme: "Alternative Careers in the Pharmaceutical and Biotechnology Industry Martin A. Wasserman, Ph.D. January 14, 2014 UTMB Career Development Workshop."— Presentation transcript:

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 Pfizer Merck Merck GlaxoSmithKline (GSK) GlaxoSmithKline (GSK) Novartis Novartis Bristol-Myers Squibb (BMS) Bristol-Myers Squibb (BMS) Hoffmann-La Roche (Roche) Hoffmann-La Roche (Roche) Eli Lilly Eli Lilly Abbott Abbott Sanofi Sanofi Amgen, Genentech, Biogen 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, HLRPharmaceutical 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 criteriaIndustry trends require key decision points, e.g., milestones and Go/No Go criteria R&D expenditures have dramatically increasedR&D expenditures have dramatically increased Longer cycle times across the value chainLonger cycle times across the value chain Generics have initiated price pressuresGenerics have initiated price pressures Globalization of marketsGlobalization of markets

4 THE PHARMA AND BIOTECH INDUSTRY Americans spend > $320B/year on medicines 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) 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 Technically complex, risky, costly, and regulated industry Creates jobs (employs > 300,000 workers WW) and invests billions in R&D Creates jobs (employs > 300,000 workers WW) and invests billions in R&D Takes risks on unknown opportunities for potential “breakthrough blockbusters”; highly rewarding Takes risks on unknown opportunities for potential “breakthrough blockbusters”; highly rewarding Orchestrates project progression across the Value Chain Orchestrates project progression across the Value Chain

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

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

7 PHARMACEUTICAL INNOVATION Assessed at time of Market introduction Assessed at time of Market introduction Efficacy for a disease for which no drug is presently available Efficacy for a disease for which no drug is presently available Novelty is competitive and time-related Novelty is competitive and time-related Means “truly original”…not yet reduced to practice Means “truly original”…not yet reduced to practice Should improve the practice of medicine Should improve the practice of medicine Discovery of new approaches (Scientific Innovation), improves QoL or convenience for the patient, or improved formulations 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 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 technologiesTo rapidly discover novel, innovative, breakthrough drug candidates to treat diseases using cutting-edge technologies To utilize early exploratory efforts to identify novel targetsTo utilize early exploratory efforts to identify novel targets To utilize state-of-the-art assay formats to identify “hits and leads”To utilize state-of-the-art assay formats to identify “hits and leads” Wherever possible, leverage “common mechanism” approaches to be opportunistic and synergistic to increase productivity and to reduce cycle time in pursuing a diverse set of targetsWherever possible, leverage “common mechanism” approaches to be opportunistic and synergistic 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” studiesTo recognize failing compounds EARLY (“kill early, kill often”) and conduct quick “proof-of-concept” studies

9 PersonalizedMedicinePersonalizedMedicine Pharmaco- genomics THE DISCOVERY PROCESS Genomicresearch Target Identification & Validation Actives, Hits, Lead Compounds Evaluation of Lead Drug Candidates ManufacturingDevelopment Clinical Trials NDA Launch FunctionalGenomics ChemicalGenomics Toxico-genomics Gene sequencing MicroarraysProteomics Establish role of gene in biology gene in biology and disease and disease Evaluation of drug efficacy drug efficacy HTS Medicinal Chemistry Chemistry AssayDevelopment PK Safety Manufacturing ProcessDevelopment QualityControl Clinical Clinical Evaluation Evaluation (safety, efficacy) and new drug application

10 SIGNIFICANT ADVANCES IN DRUG DESIGN Identification of new molecular targetsIdentification of new molecular targets Cloning of human receptors, enzymes, ion channels for structural elucidation of binding sitesCloning 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, NMRStructural analysis of drugs with their binding sites, e.g., X-ray crystallography, NMR Proprietary libraries of >10 7 chemical structuresProprietary libraries of >10 7 chemical structures Combinatorial chemistry techniques for rapid synthesis of selected drugs and related analoguesCombinatorial chemistry techniques for rapid synthesis of selected drugs and related analogues Automated HTPS for SAR (>10 5 compounds/week)Automated HTPS for SAR (>10 5 compounds/week)

11 REASONS DRUG CANDIDATES FAIL IN CLINICAL DEVELOPMENT Toxicity- 2%Toxicity- 2% Lack of efficacy- 31%Lack of efficacy- 31% The market- 6%The market- 6% Poor biopharmaceutical properties, e.g., formulation, pharmacokinetics, ADME- 41%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)Urgency (focus on priorities, speedy delivery, flexibility, problem solving) Creativity (innovation, originality, new hypotheses & targets, thinking “out-of-the-box”)Creativity (innovation, originality, new hypotheses & targets, thinking “out-of-the-box”) Courage (tenacity, decisiveness, tough decisions)Courage (tenacity, decisiveness, tough decisions) Empowerment (personal accountability; responsibility)Empowerment (personal accountability; responsibility) Teamwork (networking, partnership, sharing information, interactive)Teamwork (networking, partnership, sharing information, interactive) Integrity (ethical standards, honesty & fairness)Integrity (ethical standards, honesty & fairness) Respect (trust, openness, listening, value diversity)Respect (trust, openness, listening, value diversity)

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

14 SOME CORE SKILLS IN THE PHARMACEUTICAL INDUSTRY Pharmacology, Anatomy & PhysiologyPharmacology, Anatomy & Physiology Molecular and Cellular Immunology, GenomicsMolecular and Cellular Immunology, Genomics Cellular and Molecular BiologyCellular and Molecular Biology Biochemistry and EnzymologyBiochemistry and Enzymology Pathology & ToxicologyPathology & Toxicology Animal Model Development, Drug Delivery, FormulationsAnimal Model Development, Drug Delivery, Formulations Medicinal, Combinatorial, Analytical, Process ChemistryMedicinal, Combinatorial, Analytical, Process Chemistry ADME, PharmacokineticsADME, Pharmacokinetics Biostatistics, Statistical AnalysisBiostatistics, Statistical Analysis Scientific & Medical Intelligence, CommunicationScientific & Medical Intelligence, Communication Data & Knowledge ManagementData & Knowledge Management Networking, Opportunity IdentificationNetworking, Opportunity Identification

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

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

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

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

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


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