Adam Heathfield, PhD Senior Director, Worldwide Policy, Pfizer Inc.

1
Personalised Medicine an industry perspective
Adam Heathfield, PhD Senior Director, Worldwide
Policy, Pfizer Inc. September 25, 2013
2
The case for Personalised Medicine has been made
..and clearer safety signals too
3
Multiple domains and collaborations
4
Policy work is essential
Data handling Comprehensive, accessible and
interoperable datasets must be generated to
support the development of a new disease taxomony
and allow for its ongoing refinement and
application. Interdisciplinarity, participation
and translational research Emphasis must be
placed on stakeholder participation,
interdisciplinary interaction, public-private and
pre-competitive partnerships and translational
research in order to develop the frameworks that
support the vision of personalised medicine and
healthcare.
5
Diagnostics a key component
UK has good collaborative environment for
organising tests and sharing research data, but
other countries have higher rates of testing
Emerging findings in the Cancer Research UK
Stratified Medicines Programme Shaw et al (ASCO
poster)
6
PM impacts across care pathways
Unlocking the value of personalised healthcare in
Europebreast cancers tratification Walter Van
Dyck at al Health Policy and Technology (2012) 1,
6368
7
Early promise and rapid uptake or not?

• Crizotinib demonstrated marked clinical activity
  in advanced ALK NSCLC (ORR 60, median PFS 8.1
  months)1,2
• More than 90 of crizotinib patients achieved
  tumor shrinkage1

Results from an open-label, single-arm,
non-comparative Phase II study investigating the
safety, tolerability, pharmacokinetics and
anti-tumor activity of crizotinib in 261 patients
with advanced ALK-positive NSCLC progressed on
standard therapy. Patients received oral
crizotinib 250mg twice a day in 21-day cycles.
Efficacy endpoints included objective response
rate, disease control rate, duration of response,
time to response, overall survival and
progression-free survival.
Clinical Trial PROFILE 1005 (n 261 mature
patients)
7
References 1. Kim et al. Poster at ASCO, 2012
(Abstract 7533). 2. XALKORI Summary of Product
Characteristics.
8
Summary

• Lots of opportunities for collaboration
• Basic research
• Translational medicine
• Access and quality of real world data
• Diagnostic infrastructure
• Early access for patients
• Personalised Medicine has moved on from an RD
  topic
• Integrated approach needed for optimal care and
  future investment

9
Back Up
10
Diagnostic challenges
Evolving Personalized Paradigm
Traditional Paradigm
Metastatic disease (stage IIIB/ IV)
Metastatic disease (stage IIIB/ IV)
Multiple test options
Biomarkers can direct treatment towards targeted
therapy or clinical trials (where available)
Squamous cell carcinoma
Non-squamous cell carcinoma
EGFR
K-RAS
ERCC1
ALK
HER-2
TS
B-RAF

• More complex decisions involving more
  stakeholders beyond oncologist (surgeon,
  pathologist)
• Education required to integrate molecular
  diagnostics into treatment decisions
• Need for multiple molecular Dx creates
  competition for available tissue, budget,
  manpower
• Not a simple issue of a single drug-diagnostic
  combination

• Oncologist sole treatment decision maker
• Treatment decisions depend on histology