Privacy Symposium / HIPAA Summit

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Genomics and Privacy

• Privacy Symposium / HIPAA Summit
• August 20, 2008
• Stan Crosley (Eli Lilly)
• Dean Forbes (Schering-Plough)

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Discussion Outline

• Brief Background on IPPC
• Discussion on Genomics
• Questions Answers

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Background on IPPC
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Members

• The IPPC is an association of companies that face
  worldwide responsibility for the protection of
  personal health information and other types of
  personal data. Members of the IPPC include

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Mission

• The IPPC works to promote responsible privacy and
  data protection practices by the research-based,
  global pharmaceutical industry.
• Maintaining data confidentiality and subject
  privacy are essential to clinical research,
  pharmacovigilance, and other activities of the
  pharmaceutical industry.
• The IPPC seeks to increase awareness of privacy
  and data protection issues and to engage
  government in a dialogue about the need for data
  to support cutting edge biomedical research and
  other public health activities.
• The IPPC pursues opportunities to collaborate
  with government and other stakeholders to develop
  data protection practices that enhance data
  subject privacy.

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Goals

• The IPPC goals are to
• Engage government and stakeholders in the
  biomedical research and healthcare communities in
  a constructive dialogue on significant issues of
  privacy and data protection.
• Serve as a resource for sound analyses of privacy
  and data protection requirements and compliance
  tools tailored to the pharmaceutical industry.
• Serve as a forum for industry dialogue and
  promote responsible privacy and data protection
  practices.
• Promote consistent privacy and data protection
  standards that can be achieved on a worldwide
  basis.
• Remain on the leading edge of privacy and data
  protection.

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Scope of Activities

• The IPPC advances understanding of existing and
  emerging data protection and security rules in
  Europe, the US, and other key countries. The
  Consortium engages regulators and policymakers in
  the following areas
• Biomedical research
• Pharmacovigilance
• Sales and marketing
• Market research
• Human resources programs
• Other corporate programs

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Background on Genomics
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Blockbuster Business Model

• Future success of a pharmaceutical company
  depends heavily on the number and quality of
  drugs in the pipeline
• The industry has traditionally relied primarily
  on the blockbuster model, where a few key drugs
  make up the majority of the companys revenue
• Challenges presented by the blockbuster model
• Industry has fully exploited low hanging fruit
• Expiration of patent terms
• Pricing/reimbursement pressures

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Personalized Medicine Business Model

• Utilizes pharmacogenomics, which benefits from
  the recent advances of genomics/proteomics
  technology
• Potentially, reduced development costs shorter
  development time from discovery to launch
• Potentially, smaller clinical trials required to
  prove efficacy in target population (depends on
  regulatory requirements)
• Greater probability of clinical compounds
  reaching market
• Better safety profile
• Treat specific populations based on biomarkers or
  molecular diagnostics/imaging results
• Should not require blockbuster-sized sales to
  generate attractive returns on investment

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Drug Discovery and Development
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Protections Built into Biomedical Research
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Pre-Clinical Testing
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Phase I
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Phase II/III
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Post-Approval

• Need to identify patient populations for whom
  drug is indicated (and ensure that drug not taken
  by populations for whom contraindicated)
• Development of companion diagnostics
• Pharmacovigilance
• Phase IV studies

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Challenges of Information Based Medicine
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Key Privacy Issues

• Whats identifiable?
• Current law
• Developments in technology
• Reference databases
• Notice, choice, access amendment,
  confidentiality, anonymization
• Secondary research, biobanking
• Specific vs. general consent
• Risks of unauthorized disclosure
• Potential for discrimination in employment and
  insurance (elsewhere?)
• Psychological impact - stigmatization

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Questions

• Stan Crosley - Crosley_Stanley_W_at_lilly.com
• Dean Forbes - dean.forbes_at_spcorp.com

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Questions on IPPC?Please contact
Dede.Godstrey_at_dbr.com