How True Open Innovation TM and its global network can expand the opportunity for drug development by increasing efficiency and decreasing costs Luca Rastelli, PhD Boston Strategics Corporation October, 2013

1. How True Open Innovation TM and its
global network can expand the opportunity
for drug development by increasing
efficiency and decreasing costs
Luca Rastelli, PhD
Boston Strategics Corporation
October, 2013

2. Pharmaceutical Industry Challenge
Continuous trend for
decreased productivity
and increased overall
investment to discover
and develop new drugs
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3. Innovation is coming from smaller Biotech
as opposed to Big Pharma
More and more, approved
compounds were born and
achieved PoC in a small,
biotech setting
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4. Big Pharma attempts of creating Open
Innovation, Biotech-like have mixed results
CEDD Center of Excellence for External Drug Discovery
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5. Big Pharma culture and structure impede
attempts to “…be more like Biotech…”
Big Pharma matrix-organization is culturally unable to support the
needed project-focus, project-based dynamics and decision-time
requirements. The functional unit-based priorities, planning (and
politics) will never be aligned with the project-based ones
Big Pharma structural complexity, both in people and physical plant
create an economical framework that does not support the correct
allocation of resources to the individualized need of a given project
At the same time, biotech-based innovation especially in Drug
Discovery and Early Development, is challenge by limited venture and
government investments.
A paradigm shift is required: what can we learn from other
industries like the Software and Social Networking
industries
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6. True Open Innovation TM
Complete Virtualization via the Creation of a
Pharmaceutical “Social” Global network
Patients
Foundation
Pharma/Biotech
Financial Resources
Academia
Concep
t
Innovative
Drug / Treatment
at Lower Cost / Risk
Physicians
Hospitals
True Open Innovation TM
Global Network
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7. Network leverage pools of intellectual
operational and financial resources Globally
Dedicated Experts
“BS Producers”
Discovery
Medicinal Chemistry
Biology (in vitro & in vivo)
Drug Metabolism (GLP)
PK/PD, Imaging
BS Global Network
External Experts
CROs and CMOs
Project
A
Analytical Chemistry (GMP)
Process Chemistry (GMP)
API Manufacturing (GMP)
Safety Pharmacology (GLP)
Toxicology (GLP)
Toxicokinetics (GLP)
Formulation (GMP)
Drug Product
Manufacturing (GMP)
IND
Clinical Studies (GCP)
Supply Chain Management (GCP)
Business Development
QA/Regulatory
NDA
Sales, Commercial
Virtual teams are assembled to move individual projects
through the Product Development phase
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Project
B
Project
C
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8. True Open Innovation TM benefits
• Wider spectrum of sources for concepts, herd and metoo mentality are limited if not eliminated
• No preexisting cultural inertia
• Non-project related or project-driven priorities
• Ability to chose the resources and people that best fit the
project, no attempts to “fit” the project within only
resources and people available to a given-organization
All of this results in faster and less expensive development,
permitting more ideas/compounds to be tested
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9. Boston Strategics
• Incorporated in 2012
• Located in the Venture Development
Center on the campus of University of
Massachusetts (UMass)
• Surrounded with innovative academic
collaborators, biotech/pharmaceutical
industry partners, and major venture
capital firms
• Dedicated to establish a True Open
Innovation TM network, generating
supportive feasibility examples
working both on internal and
external projects
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10. Management Team
•Keizo Koya, PhD – CEO and Founder. 30+ years of industry experiences, 25 years in pharma
R&D. Sr. Vice President, Drug Development, Synta Pharmaceuticals (ganetespib, Hsp90 inhibitor,
elesclomol, cancer metabolism); JSC member with GSK, Roche. Vice President R&D, Shionogi
BioResearch; Director, Drug Discovery & Development, Fuji ImmunoPharmaceuticals; Head
Pharmaceutical R&D, Fuji Film USA. Led anti-cancer mitochondria-target project Harvard DFCI; Chief
Scientist, Main Res. Institute, Fuji Film, Japan.
•Eita Kitayama, MS – President and Founder. Sr. Director, Preclinical Outsourcing & Strategy,
Synta Pharmaceuticals; Senior Program Manager & Senior Scientist, Covance Laboratories; 17 years
pharma Program Manager, Study Director, Chief of GLP Office, GLP Computer System Manager,
and Laboratory Scientist in Japan.
•Luca Rastelli, PhD – Head, Business Development & Translational Strategy. 20 years
pharma/biotech oncology drug development experience; Project Leader, EMD Serono for selective cMet inhibitors and Oncology Business Opportunities; Discovery Team Lead, Sopherion (peptides for
oncology and inflammation; CuraGen, Team Lead on Abgenix collaboration to mine the Human
Genome for novel oncology therapeutic antibody targets, completed the preclinical development
phase of the immunoconjugate antibody CR011 (CDX011).
•Linda Paradiso, DVM, MBA – Head, Drug Development. 30+ years drug development experience.
Worldwide development, approval and lifecycle management of 11 marketed anti-infective and
oncology therapeutics Viracept®, Penetrex®, Omnicef®, Doxil®, DepoCyt®, Treanda , Kepivance®,
Neulasta® Aranesp®, Vectibix® and NPlate®, and 30 INDs. Executive R&D management positions;
Tanox (now Genentech), Amgen, Pfizer La Jolla, Agouron (now Pfizer), Salmedix (now
Cephalon). $30M VC raised.
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11. Example of True Open Innovation TM
Original (Pharma company):
Boston Strategic (True Open Innovation) :
$4.2M, 18 month
$1.8M, 12 month
• Strategic Development Plan
• Traditional plan vs New development plan with world-experts
• CMC-API (long processes with expensive starting material SM)
• Long GMP process vs 3 steps GMP process
• Expensive SM vs Inexpensive SM with new process at good CMO in
China
• GPM in high containment vs CMO in Canada with 40% Tax Credit
• Lyo product vs Solution product at Canadian CMO with 40% Tax Credit
• GLP Tox and DMPK
• CROs in Japan vs high quality CROs in Canada with 40% Tax Credit
• Clinical Development (P1/2a) Plan
• Company driven plan vs Academic Oncologists driven plan
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12. Example of True Open Innovation TM
• Strategic Development Plan for Accelerated Clinical
development
• Worked with network of Academic Physicians to identify
real un-met medical need and real practice-based
Standard-of-care
• Clinical plan takes compound to Approval in less than
half the time and 1/3 the cost
• Innovative approach for Prelinical development
• Taken 2 compounds through high quality preclinical
development phase with substantial savings in time and
cost
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13. Components of True Open Innovation TM
World-wide partner network
i.
ii.
iii.
Japanese company entering new therapeutic area,
Oncology, with virtual organization of only 2 people
Chinese partners for accelerated preclinical and clinical
development to be leveraged outside of China
Canadian Project management company to leverage
Canadian Tax Incentives
Strategic Alliances with Academic Institutions
i.
ii.
MD Anderson Cancer Center
Beth Israel Deaconess Medical Center
Leverage of Public/Private Resource Pools
i.
ii.
Canadian and French Tax Incentives
Collaborations with Patient-driven foundations, MMRF, LLS
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14. Long Term Vision
BS will provide a New Concept Platform for Drug R&D by
“True” Open Innovation
• Anybody could submit concepts, candidates,
and resources
• BS can “produce” any new projects by
integrating global intellectual and financial
resources of the network
• Anybody could follow BS to create new drugs
with the “true” open innovation platform
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15. Thank you!
Luca.Rastelli@BostonStrategics.com (Email)
www.BostonStrategics.com (Internet)