Gunther Winkler

Consultant, previously Co-founder and CEO at Biometheus LLC, Senior VP at Biogen Inc.

Winchester, Massachusetts, United States

About

Biopharma experience: + Founder and CEO of biotech firm, www.biometheus.com ---> In the news: The Washington Post, Science, PBS and others. + International Commercial Operations / Asia Pacific + R&D Operations / Program Management + Corporate Administration / Global Government Affairs / Board Memberships Accomplished biotechnology executive and entrepreneur with 20+ years of in-depth, global operations experience, from R&D to Commercial. Built 100M business in Asia Pacific. Successfully developed and registered new products. Held leadership roles in Commercial Operations, Program Management, Corporate Administration, Clinical Research, Bench Research, and Government Affairs. Board member and recognized industry speaker. Specialties: Asia Pacific * Commercial Operations * R&D * Clinical Operations * Corporate Administration * Strategic Planning * Government Affairs * Regulatory Affairs * Business Development * Program Management

Experience

  • Principal at ASPB Consulting LLC
    2011 - Dec 2021 · 11 yrs

    Firm provides advisory/consulting services to global biotechnology and pharmaceutical companies. Specializations include commercial assessment, strategy development, government affairs, R&D, program management and financing.

  • Co-founder and CEO at Biometheus LLC
    Nov 2013 - Dec 2017 · 4 yrs 2 mos

    Firm develops technology and owns IP in the field of personalized and predictive medicine. www.biometheus.com Featured in The Washington Post, Science, BioCentury, PBS, EPVantage and the book "Suggestible You" by Erik Vance

  • Biogen (9 yrs 1 mo)
    • SVP, Asia Pacific and Global Government Strategy
      2007 - 2011 · 4 yrs

      Responsible for all commercial and R&D activities in Asia Pacific and accountable for 100M+ P&L. Developed, registered, and launched pipeline products in the region. Created and followed through on business development and corporate development opportunities with business valuations, due diligence, and deal negotiations. Delivered business plans for new ventures. • Formulated and successfully executed a comprehensive Asia Pacific business strategy resulting in strong growth with 40% CAGR in sales and accelerated profitability. • Built presence in new territories, such as India, China, Singapore, SE Asia, and NE Asia, and successfully integrated Japan affiliate and Australia/New Zealand affiliate into the organization. Hired and managed over 150 reports in the region. • Generated $264M in new global revenue over five years against emerging market demographic challenges. • Accelerated and significantly improved cost effectiveness of clinical development through integration of Asian countries into global clinical trials. Increased India’s participation from zero to the third largest within the company. • Head of worldwide Government Affairs with headquarters in Washington, DC and international operations, including EU, Asia Pacific, and Latin America. Created a global, unifying policy vision and lobbying strategy. Expanded the role of US Government Affairs within the company and built critical external alliances, both with governments as well as within the private sector. • Continued to be a policy leader for the biotech industry through company alliances and industry organizations, such as BIO, PhRMA EFPIA, EBE, RDPAC, and others.

    • VP, Strategic Initiatives (Chief od Staff for the CEO and Board of Directors)
      2002 - 2007 · 5 yrs

      • Appointed to manage activities for the Biogen and Idec merger and for the branding of the newly formed corporation. • Oversaw the planning for Executive Committee and Board meetings, compliance, and corporate governance. • Sponsored and implemented strategic corporate growth initiatives. • Built an effective US Government Affairs function. Defined the mandate and vision. • Periodically presented to investment community, including industry analysts, investment bankers, and VCs.

  • Biogen Idec (14 yrs 1 mo)
    • Program Executive (R&D Project Leader)
      1998 - 2002 · 4 yrs

      Responsible for developing and executing development strategy for Amevive®, including regulatory, pre-clinical, clinical, quality, and manufacturing. Fiscal responsibility for development programs. • Developed a novel biological therapeutic for treatment of psoriasis, Amevive®, from early pre-clinical to registration. • External leadership included meetings with national and international regulatory agencies including FDA and EMEA, and KOL interactions.

    • Director Medical Operations
      1991 - 1998 · 7 yrs

      Head of global Medical Operations. Clinical therapeutic areas and indications included multiple sclerosis, hepatitis B and C, glioma, unstable angina, angioplasty, rheumatoid arthritis, psoriasis and others. • Conducted worldwide clinical trials for all Biogen pipeline drugs, including registration studies for Avonex®.

    • Scientist
      1988 - 1991 · 3 yrs

      Conducted research and product development for treatment of HIV/AIDS. Filed three patent applications.