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This document provides an outline of a presentation and is incomplete without the accompanying oral commentary and discussion. Conclusions and/ or potential strategies contained herein are NOT necessarily endorsed by Pfizer management. Any implied strategy herein would be subject to management, regulatory and legal review and approval before implementation.
Better Biotech Innovation by Improving the Ecosystem
MIT Startup Exchange (STEX)
Feb 26, 2015
Tim Charlebois Pfizer BioTherapeutics Technology and Innovation
Pfizer 2010+ An Aggregation of 25+ Companies!
2000 Agouron Gene/Networks
Hickson Int’l Plc
Institute Farmaco Biologico Pagni
Plaistow
+ + + +
American Home Products
A.H Robbins
+
1989
American Cyanamid
+
1987–88 +
1992 +
1994
Animal divisions of:
Kabi Pharmacia
Pharmacia AB
Upjohn Company
Sugen
1990
1995
Kelco Chemicals (1994) (1985)
+
1993 + +
+
+ Kabi Vitrum
1990 1997 1998 1999 +
2009
2003
– SmithKline Beecham Animal Health (1995) – Restivo Italiana (1994 – through Roerig) – Koshin Medical KK (1992)
– Vicuron Pharmaceuticals Ltd (2005) – Idun Pharma (2005) — Apoptech (1994) – CSL Ltd Animal Health Unit (2004)
1999
Pharma’s Fundamental Problem: Increased spending, less output = Less R&D Productivity
4
0
20
40
60
80
100
120
140
160
Worldwide Total Pharmaceutical R&D Spend
WW
Ph
arm
a R
&D
Sp
en
d (
$b
n)
+10.6% CAGR 2002-08
+2.3% CAGR 2009-16
0
10
20
30
40
50
60
70
FDA Approval Count (NMEs & Biologics)
Total mol. NMEs Biologics
No
. of
Mo
lecu
les
Ap
pro
ved
Source: EvaluatePharma April 30, 2010
Unsustainable Need new innovation model
Even for biologics, only ~ 10% of candidates make it to market. Often go deep into clinical development before recognize futility
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Preclinical Phase 1 Phase 2 Phase 3 Registration
61%*
42%
18%
60%
85%
75%
56%
44%
79% 79%
Small Molecules Biotherapeutics
Succ
ess
Rate
by
Phas
e %
Source: KMR, Bernstein Analysis
*Percentage means the probability that a compound progresses to the next phase
Cost/candidate:$10’s of millions $100’s -1000s of millions
Accelerating Testing of Therapeutic Hypotheses Pfizer CTI: Partner & Enable Translational Research
6
CTI-Boston
CTI-New York
CTI-California
Cost/candidate:$10’s of millions
Effective integration of Science & Business in Deal Making: - Technical Diligence to be matched with appropriate partnering model
WRD’s Approach to External Partnerships: - Thoughtful integration of internal capabilities & external substrate
Evolution Towards an Entrepreneurial R&D Ecosystem
8
Academic Partnerships
Access to Proprietary Technologies and Compound Libraries
Venture Capital
Funding for Early Stage Products & Technologies
Joint Funding for Shared Interests
Disease Foundations
Public Partnerships
Pfizer Venture Investments
Co-Funding and Drug Re-Purposing
• Hospira: M/A to significantly enhance Pfizer’s Global Established Pharmaceutical Business with Injectable drug, infusion technology and biosimilars
• Redvax GmbH: M/A for hCMV vaccine and another vaccine as well as technology platform • OPKO: Long-Acting hGH-CTP for growth hormone deficiency and growth failure • iTeo Therapeutics: collaboration on discovery and development of IDO1/TDO2 cancer
immunosuppression targets • Baxter: Acquire portfolio vaccines NeisVac, FSME-IMMUN/TicoVac • Merck-KGaA; Global strategic alliance to accelerate presence in Immuno-Oncology • Kyowa Hakko Kirin: Collaboration on combo Immuno-Oncology of Pfizer 4-1BB antibody and
KHK’s CCR-4 antibody • InnoPharma: Build strong sterile injectable pipeline for oncology and CNS disorders • Merck: collaboration on study evaluating combo regimen between Pfizer’s crizotinib and axitinib
with Merck PD-1 antibody • MedGenesis Therapeutics: collaboration on development of GDNF using convection
enhanced delivery (CED) technology for potential treatments for Parkinson’s disease • Gliknik: Licensed Stradomer™ for autoimmune diseases • Philogen Therapeutics: Licensed Dekavil for autoimmune diseases
Recent Innovative Product Opportunities: We have been active!
Recent Innovative Technology Opportunities • Spark Therapeutics: To advance gene therapy for Hemophilia B; Launches Gene Therapy Unit
headed by Michael Linden from King’s College London • Cellectis: Global strategic collaboration on proprietary allogeneic CAR-T Therapy • Circle Pharma: Seed funding to develop cell permeable macrocyclic peptide therapeutics • 23andMe: Research genetics of Ulcerative Colitis and Crohn’s disease • X-CHEM: multi-target collaboration on the potential development of several small molecule
programs for the treatment of inflammatory and orphan diseases • BioRestorative Therapies: Collaboration to study human brown adipose tissue and cell lines • Second Genome: Collaboration on Microbiome research initiative in Obesity • Merck Serono/Broad Institute: Research collaboration to identify biomarkers relevant to future
therapies in SLE and Lupus nephritis • Neoantigenics: Pfizer Seed Fund to develop antibody-based therapeutics for cancer • Saniona: collaborate on ion channel platform to research and develop small molecule treatment
for neurological disorders • CytomX: Global strategic collaboration to develop/commercialize multi-Probody™-Drug
Conjugates in Oncology • BIND Therapeutics: Global strategic collaboration to develop/commercialize Accurins with
select small molecule targeted therapies • Halozyme Therapeutics: Collaboration to develop/commercialize Enhanze™ technology for
Pfizer molecules
Recent Innovative Foundation Opportunities • Colitis Foundation of America: Collaboration on identification and support of the potential
development and translation of research in IBD • Epilepsy Foundation: Collaboration on personalized drug discovery platform for Epilepsy with
Intellimedix technology to improve disease Dx, accelerate drug discovery and personized medicine
• The Lieber Institute for Brain Development (LIBD): Participate on research consortium to analyze RNA, the genomic and epigenetic data to brain disorders in the hope of identifying potential new treatments
• Science Foundation Ireland (SFI): Promote biotherapeutic breakthroughs through academic-inductry collaboration
• JDRF: Join novel translational research in Type 1 diabetes • MD Anderson: Access to MD Anderson’s immunotherapy platform • Cystic Fibrosis Foundation Therapeutics (CFFT): Collaboration to discover new drugs to
treat people with most common mutation of CF, Delta F508
Focus on Disease Areas With Strong Commercial & Scientific Potential
R&D Core Areas
CVMED1 Neuroscience Oncology
Specialized Areas
Biosimilars Pain & Sensory Disorders
Vaccines
Supporting Research Using Various Modalities…and interested in partnerships http://www.pfizer.com/partnering/areas_of_interest/research_and_development
Inflammation & Immunology
Orphan & Genetic Diseases
1 Cardiovascular, Metabolic and Endocrine Diseases
Indefinite
Drug Discovery Preclinical Clinical Trials FDA Review Scale-up to Mfg.
Postmarketing Surveillance
1 FDA-Approved
Drug
0.5–2 Years 6–7 Years 3–6 Years
Number of Volunteers
Phase 1
Phase 2
Phase 3
5 250 ~ 5,000 – 10,000
Compounds
Pre-
Dis
cove
ry
20–100 100–500
1,000–5,000
IND
Sub
mitt
ed
ND
A Su
bmitt
ed
High Risk Process + 10–15 years + $1-2 Billion
Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; DiMasi and Grabowski, The Cost of Biopharmaceutical R&D: Is Biotech Different?, Managerial and Decision Economics 28 (2007): 469-479.
Challenge: the risk profile is killing us… ..but we know we need to innovate!
Reflections on the Innovation Ecosystem in biopharmaceuticals- how is it evolving?
Academia Startups/biotec Biopharma
Scientific & technology innovation
Therapeutic product concepts and candidates Novel technology
Building value & developing
utility Products to
Patients
Who
Value
What
Clinical /technical development; supply Platforms and integration
Preclinical/early clinical trials ID applications & show feasibility
What is—and is not—working? Is risk appropriately distributed?
Academia Startups/biotec Biopharma
Scientific & technology innovation
Therapeutic product concepts and candidates Novel technology
Building value & developing
utility Products to
Patients
Who
Value
What
Clinical /technical development; supply Platforms and integration
Preclinical/early clinical trials ID applications & show feasibility
Most importantly, what are opportunities to improve?