Transcript Alternative Careers in the Pharmaceutical and Biotechnology Industry

Alternative Careers in the
Pharmaceutical and Biotechnology
Industry
Martin A. Wasserman, Ph.D.
January 14, 2014
UTMB Career Development Workshop
TOP PHARMA/BIOTECH COMPANIES
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Pfizer
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Merck
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GlaxoSmithKline (GSK)
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Novartis
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Bristol-Myers Squibb (BMS)
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Hoffmann-La Roche (Roche)
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Eli Lilly
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Abbott
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Sanofi
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Amgen, Genentech, Biogen
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
THE PHARMA AND BIOTECH INDUSTRY
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Americans spend > $320B/year on medicines
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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)
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Technically complex, risky, costly, and regulated industry
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Creates jobs (employs > 300,000 workers WW) and invests
billions in R&D
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Takes risks on unknown opportunities for potential “breakthrough
blockbusters”; highly rewarding
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Orchestrates project progression across the Value Chain
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
PHARMACEUTICAL INDUSTRY
MYTHS AND MISCONCEPTIONS
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PhDs and MDs inferior to academic counterparts
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No publishing or meeting presentations required
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Only perform work as instructed by supervisors
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No academic adjunct appointments or external
collaborations permitted
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Keep breakthrough ideas to yourself
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No novel proposal (“grant”) writing expected
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Unlimited funds to do everything
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No opportunities to transfer to non-bench jobs
PHARMACEUTICAL INNOVATION
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Assessed at time of Market introduction
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Efficacy for a disease for which no drug is presently available
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Novelty is competitive and time-related
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Means “truly original”…not yet reduced to practice
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Should improve the practice of medicine
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Discovery of new approaches (Scientific Innovation), improves
QoL or convenience for the patient, or improved formulations
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Needs to be critically reassessed at each stage of the
Development Process
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 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” studies
THE DISCOVERY PROCESS
Toxicogenomics
Chemical
Genomics
Evaluation of
Lead Drug
Candidates
Manufacturing
Development
Pharmacogenomics
Actives, Hits,
Functional
Genomics
Lead Compounds
Target
Identification
& Validation
Evaluation of
drug efficacy
Assay
Development
PK
Safety
HTS
Genomic
research
Gene sequencing
Microarrays
Proteomics
3
4
Clinical Trials
Process
Development
Quality
Control
Medicinal
Chemistry
Establish role of
gene in biology
and disease
Manufacturing
5
2
6
Clinical
Evaluation
(safety, efficacy)
and new drug
application
NDA
Launch
1
Personalized
Medicine
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)
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!
KEY VALUES AND
OPERATING PRINCIPLES
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Urgency (focus on priorities, speedy delivery, flexibility, problem solving)
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Creativity (innovation, originality, new hypotheses & targets, thinking “out-of-the-box”)
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Courage (tenacity, decisiveness, tough decisions)
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Empowerment (personal accountability; responsibility)
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Teamwork (networking, partnership, sharing information, interactive)
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Integrity (ethical standards, honesty & fairness)
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Respect (trust, openness, listening, value diversity)
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
SOME CORE SKILLS IN THE
PHARMACEUTICAL INDUSTRY
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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
REQUISITE COMMUNICATION SKILLS
Verbal Presentations:
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Authoritative and Persuasive
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Team, Department, and Corporate
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National and International Meetings,
Conferences, and Symposia
Written Publications:
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Internal Technical and Final Reports
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Abstracts and Peer-Reviewed Manuscripts
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Invited Reviews and Book Chapters
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Research Feasibility Proposals (“Grants”)
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
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
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
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!