Victoria

Victoria Hale, Ph.D.
Chief Executive Officer

University of California San Francisco, PhD, Pharmaceutical Chemistry (1990)

University of Maryland Baltimore, BS Pharmacy, High Honors (1983) 

University of Maryland Baltimore, Honorary Doctor of Science (2019) 

University of Southern California, Honorary Doctor of Science (2012) 

Mount Holyoke College, Honorary Doctor of Science (2010) 

Highly decorated global health/reproductive health social entrepreneur
Strategic, visionary leader/executive 

Multi-sector career: FDA/government, academia, corporate and nonprofit 
>25 years of product development experience (small molecules, biologics, drug-device combo, vaccines, digital health) 

Founded and led two successful nonprofit pharmaceutical companies
Secured $230M in philanthropy to develop new medicines (Gates & Anonymous   Funds) 
Pivotal Phase 3 clinical trials in US and developing countries
Regulatory approvals in US and developing countries 
Access programs in US and developing countries
Successful enduring partnerships w/ WHO, government, corporate, NGOs, universities

Awards and Honors:

National Academy of Medicine, induction (2007)  

MacArthur Fellowship (2006) - John D & Catherine T MacArthur Foundation 

Distinguished Alumna of the Year (2015), Graduate Division, UCSF 

Most Outstanding Social Entrepreneur (World Economic Forum) (2004)  

Schwab Foundation for Social Entrepreneurship (Geneva, Switzerland)

Skoll Award for Social Entrepreneurship (2005) – Skoll Foundation 

Ashoka Global Fellow (Social Entrepreneur) (2006) – Ashoka Foundation 

Founding Pharmapreneur Award, University of Maryland Baltimore (2017)

 

Biomedical Research Leadership Award (2008)

California Biomedical Research Association 

California Society for Biomedical Research 

President’s Award of Distinction (2006), American Assoc of Pharmaceutical Scientists 

World Technology Award (2006) – World Technology Network

Biopolicy Award (2006) – World Academy of Art & Science 

IP3 Award (2005) – Public Knowledge

Laureate in Health:  Technology Benefiting Humanity (2003) – 

Tech Museum of Innovation (San Jose, California) 

Fellow, World Academy of Art & Science (2003)  

Award for Leadership in Women’s Health Worldwide (2015), Academy of Women’s Health

Woman of the Year (2005) – Women Health Care Executives

Leadership Foundation Fellow (2003) – International Women’s Forum (Washington, DC) 

Innovator of the Year (2005) – Professional Women’s Healthcare Alliance 

Business Leader of the Scientific American 50 (2004) – Scientific American 

Glamour Woman of the Year (2007) - Glamour magazine

The Economist Innovation Award for Social and Economic Innovation (2005)

The Economist

Esquire Executive of the Year (2005) – Esquire magazine 

Best Problem Solver, Best of America (2005) – Reader’s Digest

Product Development Award (3) (1995-1997) – Genentech, Inc.  

Public Health Service Group Recognition Award (1993) – US FDA 

 

Consulting (2016 – present)

  • Infectious disease, women’s health, alternative/complementary medicine, psychedelics

Medicines360 (San Francisco, CA) www.medicines360.org 

  • Founder (2009)
    President (2009-2015)
    CEO (2009-2015)
    Director (2009-2016) 
  • Founded and led hybrid non-profit/for-profit pharmaceutical company  
  • Highly effective contraception: developed a levonorgestrel intrauterine device (IUD); FDA approval 2015 (Liletta®) 
  • Pivotal 29-site, 7-year Phase 3 trial (US); 3000 subjects
  • $82M philanthropic funding (Anonymous donor; 1 grant) 
  • $175M commercial & manufacturing agreement (Activis/Allergan) 
  • Staff peak 45; budget peak $21M 
  • Self-sustaining hybrid ($120M in reserves [2016]) 

OneWorld Health (San Francisco, CA)

https://www.nytimes.com/2006/07/31/health/31charity.html
Founder (2000)
President (2000-2008)
CEO (2000-2008)
Chair (2000-2008)
Chair Emeritus (2008-2011) 

  • Founded and led the first non-profit pharmaceutical company in the US 
  • $150 million philanthropic funding (Bill & Melinda Gates Foundation; 8 grants)
  • Visceral Leishmaniasis: development & regulatory approval of IM paromomycin (2006); pivotal 4 site, 667 patient Phase 3 trial (partners: WHO, Gov’t of India, Drug Controller General); Bangladesh; https://www.nejm.org/doi/full/10.1056/NEJMoa066536 
  • Malaria:  synthetic biology (yeast) targeted to reduce the cost of artemisinin anti-malarials 10-fold (partners: UC Berkeley, Sanofi Aventis) 
  • Cholera: discovery, R&D of novel anti-secretories to be used in conjunction with oral rehydration therapy (partners: UCSF, Novartis, Roche) 
  • Chagas (American trypanosomiasis): preclinical safety 
  • Malaria vaccine (attenuated sporozoite): manufacturing process accepted by FDA 
  • Staff peak 100; budget peak $35M 
  • Merged with PATH (Seattle, WA) in 2011

University of California San Francisco (UCSF) https://bts.ucsf.edu/

    Department of Bioengineering and Therapeutic Sciences
        Adjunct Professor (2016-present)
        Adjunct Associate Professor (2002-2016)

  • Presentations to graduate students, post docs & faculty 
  • Without salary position

Genentech, Inc (South San Francisco, CA)

Product Development Department 

Scientist (1995-1998) 

  • Neurotrophic growth factors, cytokines 
  • Special project to examine PK in lymph (pigs) 

US Food & Drug Administration (Rockville, MD)

Center for Drug Evaluation & Research 

Reviewer and Senior Reviewer (1990-1995)

  • Pilot Drug Evaluation Staff & Neuropharmacology Division
  • Two Commissioner-level projects

Documenting exclusion of women from clinical trials, resulting in 1998 Rule

Relabeling of nicotine replacement products for use in pregnancy 

BOARD SERVICE 

 US Government/National Academies: 

  • National Academies of Science, Engineering & Medicine, Making Medicines Affordable: A National Imperative; (2016-2017) – Committee Member 

http://www.nationalacademies.org/hmd/Reports/2017/making-medicines-affordable-a-national-imperative.aspx

  • National Academy of Science, Engineering & Medicine (NASEM), Vaccine Priorities Committee (Stage 2); National Academies of Sciences, Engineering, and Medicine, Health & Medicine Development (2012-2013) – Committee Member 

http://www.nationalacademies.org/hmd/Global/Topics/vaccines.aspx

https://www.youtube.com/watch?v=ZZ5t52gLsrc&feature=youtu.be

  • National Institutes of Health, Cures Acceleration Network Review Board, National Center for Advancing Translational Sciences (2012-2015) – Board Member 
  • National Academies of Science, Engineering & Medicine, Vaccine Priorities Committee (Stage 1); (2010-2012) – Committee Member http://www.nationalacademies.org/hmd/Global/Topics/vaccines.aspx

https://www.youtube.com/watch?v=ZZ5t52gLsrc&feature=youtu.be

  • National Institutes of Health (NIH), Advisory Committee to the Director of NIH, Working Group on the National Center for Advancing Translational Sciences (NCATS) (2010-2011) – Board Member 

University: 

  • Board of Visitors, University of Maryland Baltimore (2017-present)
  • University of California San Francisco, Clinical and Translational Science Institute, External Advisory Board, Board Member (2010-present)
  • UCSF, Global Health Sciences Advisory Council, Advisor (2009 – 2011) 
  • UCSF, Alumni Association, Graduate Division; President (2003-2006) 

Technical: 

  • Public Library of Science – Neglected Tropical Diseases, Editorial Advisory Board, 

Board Member (2007 – 2010)

  • California Institute for Quantitative Biosciences (QB3); University of California,  

Industry Advisory Board 

Board Member (2006-2008)

Professional Associations: 

  • Task Force on Global Health; American Association of Pharmaceutical Scientists 

Member (2008-2010) 

  • Commission on Intellectual Property Rights, Innovation and Public Health; (CIPIH), United States Pharmacopeia (USP) 

Member (2007-2008) 

Global Organizations: 

  • World Economic Forum, Global Agenda Council on Population Growth 

Council Member (2010-2011) 

  • World Economic Forum, Global Agenda Council on Social Entrepreneurship

Council Member (2009-2011) 

  • World Health Organization (WHO): Strategic Initiative to Develop Capacity for Ethical Review (SIDCER), WHO/Tropical Disease Research Unit 

Member (2003-2005)

US Nonprofits:  

  • www.MAPS.org , Multidisciplinary Association for Psychedelic Studies; Board of Directors; Director (2019-present)
  • Forest Trends, Board of Directors; Director (2018-2019)
  • www.IDEO.org , External Advisory Board; Director (2012-2013) 
  • Medicines360, Board of Directors; Director (2009-2016)
  • OneWorld Health, Board of Directors; Chair (2000-2008) 

Chair Emeritus (2008-2011) 

  • Quan Yin Healing Arts Center, Board of Directors; Director (1998-2000)