Expanding the Global Health Impact of Biomedical Research and Technology

1
Expanding the Global Health Impact of Biomedical
Research and Technology

• An Introduction to Universities Allied for
  Essential Medicines (UAEM)
• 5/2/2006

2
Universities Allied for Essential Medicines

• The Problem
• Research Gap
• Access Gap
• Approaches to addressing the problem
• The UAEM story
• The proposed solution
• Equitable Access License/Neglected Disease
  License
• University Alliance
• UCSD and TechTIPS
• Getting Involved

3
Modern Medicine and Global Health

• A common assumption modern medicine continues to
  improve global health
• Smallpox eradication
• Polio rare
• Lots of money spent on basic and applied medical
  research
• Taxpayers (28.6 billion NIH budget for 2006)
• Pharmaceutical companies
• Trickle down effect

4
Is there a natural trickle-down?

• The truth
• Research Gap leads to neglected diseases
• Access Gap
• UAEM founded to bridge these gaps people should
  not die preventable deaths because they lack
  medication

5
The Research Gap

• Government follows taxpayer priorities
• Prioritizes western diseases, i.e. cancer
• Even with overlap, there are shortcomings
• Human Immunodeficiency Virus (HIV)
• Type I common in US, type II in Africa
• Lack of pediatric, heat-resistant formulations
• Low material cost is not a priority

6
The Research Gap

• Industry obeys the bottom line
• RD is expensive (gt 100 million, lowest
  estimate)
• Costs must be recouped by sales
• People in developed nations can afford to pay for
  drugs BUT people in poor countries cannot, even
  for vital drugs
• Therefore, pharmaceutical companies do not
  develop the drugs

7
The Research Gap

• Government follows taxpayer priorities
• Industry obeys the bottom line
• This leads to the research gap, and neglected
  diseases

8
Example Lymphatic Filariasis

• 40 million people permanently debilitated or
  disfigured by the disease
• 1/3 of cases in India, 1/3 in Africa, the rest
  scattered around LMI regions
• Worms transmitted by mosquito
• Most obvious manifestation is elephantitis.
  Debilitating and stigmatizing disease
• Limited treatment options

www.who.int
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Example - African Trypanosomiasis

• Sleeping Sickness
• Between 300-500K deaths/year
• Prevalence as high as 20-50 in some areas
• Pain, headaches, severe neurological disease
  confusion, sleep cycle disruption, etc.
• Without treatment - fatal

10
The Access Gap

• 10 million people die needlessly each year
  because they do not have access to existing
  medicines and vaccines
• Equivalent of San Diego every one and a half
  months

World Health Organization. Equitable access to
essential medicines a framework for collective
action. Geneva 2004.
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Research and Access Gaps
Pecoul, PLoS Med. 2004
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Approaches to aiding global health

• International trade policy and government
  lobbying
• Doctors without Borders (MSF) Campaign for Access
  to Essential Medicines
• Bono
• Philanthropic funding
• Bill and Melinda Gates Foundation - 650
  million/year
• Rockefeller Foundation

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Approaches to aiding global health

• International trade policy and government
  lobbying
• Philanthropic funding
• Non-profit pharmaceutical companies
• Industrial partnerships Drugs for Neglected
  Diseases Initiative (DNDi)
• University licensing policies and research
  priorities - UAEM

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Why the University?

• Philosophical commitment to public good over
  profit
• Held by most faculty and students
• Often included in university vision statements
• Good Public Relations
• Intellectual property ownership 50 of drugs
  start at the university

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The UAEM Story Yale and Stavudine

• Stavudine discovered as AIDS treatment at Yale in
  early 1990s
• In 2001, Doctors without Borders (MSF) asked Yale
  to not enforce its patent in South Africa
• Yale already granted an exclusive worldwide
  license to Bristol-Myers-Squibb
• After grass-roots advocacy campaign, Yale and BMS
  agreed not to enforce their patents
• Costs fell by 95, from 1600 to 55/yr
• UAEM formed as preemptive access campaign

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The UAEM Proposal The Equitable Access License

• Basic premise pharmaceutical companies recoup
  RD costs in developed countries, but allow
  generic competition in low- to middle- income
  (LMI) countries
• Automatic invocation
• Work at the level of the university technology
  transfer office, before licensing agreements are
  formulated

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The UAEM Proposal The Neglected Disease License

• RD becomes increasingly expensive because of
  royalties for research tools
• NDL allows for royalty-free use of technologies
  for ND research

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UCSD Biomedical Research

• 639 million in extramural funding in FY2004
• 78 Federal 13 non-profit 6 Industry
• 60 life sciences 30 physical
  sciences/engineering
• 20 million in royalties annually
• Infectious disease research
• Common diseases, i.e. HIV
• Neglected diseases

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UCSD Technology Transfer Office, TechTIPS
Alan Paau, Assistant Vice Chancellor

• Receptive to UAEM goals
• UCSD doesnt patent in LMI countries
• U.S., Europe, and Japan constitute 80 of world
  market for pharmaceuticals
• Downstream patents by pharmaceutical companies
  prevent access
• Importation/reimportation concerns
• UCSD cannot prevent downstream patents in
  developing countries patent misuse

20
UC Berkeley and Socially Responsible Licensing

• Maximize the societal benefit of technologies
  developed at UC Berkeley.
• Help for the developing world is a moral
  imperative.

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Does it hurt Berkeley financially?

• Inc. Magazine, Feb. 2006, Berkeley called one of
  Five Universities You Can Do Business With.
• Jay Keasling, Artemisinin, and the Gates
  Foundation

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Jay Keasling, Berkeley, and Artemesinin

• Artemesinin is recommended malaria drug, but
  manufacture is expensive
• Keasling developing method to make drug faster
  and cheaper
• 42.6 grant from the Gates Foundation
• Keasling basic research
• Amyris commercialization
• OneWorld trials and distribution

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UAEM_at_UCSD Next Steps

• Support from Associated Students and GSA
• Meet TechTIPS advisory committee, vice chancellor
  for research
• Encourage socially responsible licensing policy
• Meet UC-wide technology transfer advisory
  committee
• Meet interested researchers and professors
• Publicity
• Write TechTIPS newletter article for faculty
• Write in Guardian
• Booth at startup bootcamp