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Innovation

About Us

Michael Klotsman
Michael Klotsman

Okava was founded by Dr. Michael Klotsman following a decade of diverse industry experience. Michael brings forth a combination of business acumen and scientific expertise that is an especially good fit for the startup, early-stage, or mid-size ventures whose innovations will define the future of BioPharma.

Michael began his career at GlaxoSmithKline, where he led ground-breaking 'Personalized Medicine' research in support of GSK's cornerstone respiratory franchise. His work focused on in-line product support (Advair for asthma and COPD), but also included development of early stage clinical compounds (e.g., target identification, defining TPPs). Michael tenure at GSK started in the World-Wide Epidemiology department where he had the dual responsibility of providing internal support to the Product Safety and Marketing & Strategic Planning groups.

Michael was then recruited by SDG Life Sciences, a preeminent strategy consulting firm renowned for its expertise in strategic decision-making, risk management, and shareholder value creation. At SDG, Michael worked on issues of strategic importance with both domestic and international clients. Representative project experiences include strategic growth option development, product & portfolio management, and licensing and acquisition assessments. Prior to founding Okava, Michael served as an internal consultant to Actelion Pharmaceuticals.

Michael believes in translating scientific advancements into viable clinical solutions. His vision is to see Personalized Medicine become a reality.

Professional Highlights

R&D Commercial
  • Pre-clinical target identification
    • Development of Target Product Profiles for new drug assets
    • Conceptualized, designed and successfully led a $250,000 study in collaboration with 10 leading academic centers to identify genetic causes of asthma
    • Designed and carried out genetic studies used to identify proprietary pre-clinical drug targets
  • Clinical Development & Pharmacogenetics
    • Designed, managed, and published numerous proof-of-concept studies with a consistent record of achievement
    • Project team leader for GSK's first genetic-based, 500+ patient randomized clinical trial
    • Fulfilled regulatory requirements by submitting pharmacogenetic data to FDA
    • Promoted life-cycle management of key drug assets in respiratory portfolio by designing clinical development plans
  • Epidemiology & Safety Studies
    • Designed and conducted observational studies, including claims database analyses, to support marketed drugs and developmental compounds
    • Characterize patient flows (e.g., diagnosis and treatment rates) for market planning purposes
    • Generate incidence and prevalence statistics to support orphan drug designation filings
  • Statistical Analysis
    • Analyses of large, population-based databases used to support FDA drug safety submissions and write peer-reviewed manuscripts
    • Intent-to-treat and other advanced statistical analysis of Phase I-III clinical studies
  • Corporate Planning & Forecasting
    • Developed and implemented a 'Personalized Medicine' strategy for three of the Top-10 pharmaceutical companies
    • Drove investment decisions by strategically assessing market entry opportunities for genomic-based diagnostics
    • For top-selling 'Specialty Rx franchise', developed budget and product and manufacturing forecasts in support of annual business plan
  • Business Development
    • In- and out- licensing due diligence experience includes asset valuation, drafting and financial modeling of term sheets, deal benchmarking, and assessment of partner fit
    • Successfully negotiated numerous research contracts with key academic and technology partners
    • Optimized business development, licensing transactions and alliance management processes for top-tier Biotech
    • Support and facilitate internal decision-making with respect to BD opportunities (e.g., assess trade-offs of deal)
  • Analytics & Market Research
    • Situational analyses and competitive landscape assessments to identify unmet medical need and market opportunities
    • Design and implementation of marketing metrics (e.g., product TRx and NRx “dashboards”) to monitor product launch and performance
    • Analyzed REMS data to measure ROI for marketing initiatives, and to formulate targeted sales strategies
    • Initiated proprietary market research to assess clinical genetic testing adoption rates
  • New Product Planning
    • Prioritized R&D funding and direction by performing a landscape assessment to identify and characterize areas of unmet medical need
    • Facilitated interactions between clinical, commercial, and regulatory to select indication (and therapy area) for company’s lead drug asset

Education

PhD The University of North Carolina at Chapel Hill, School of Public Health
Epidemiology
Awarded Traineeship Appointment in Cancer Training (National Research Service Award funded by NCI)
MBA Duke University, The Fuqua School of Business, Durham, NC
Master of Business Administration, Health Sector Management
MPH The University of Michigan, School of Public Health, Ann Arbor, MI
Master of Public Health in Epidemiology, Concentration in Public Health Genetics
Recipient of American Cancer Society's Grants for Students in Oncology, and a Public Health Scholarship
BA Clark University, Worcester, MA
Biochemistry and Molecular Biology (with High Honors)
Minor in Computer Science
Awarded Robert H. Goddard Scholarship, Dean's List, and graduated Cum Laude
 

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