presentation for umass workshop

How True Open Innovation TM and its global network can expand the opportunity for

drug development by increasing efficiency and decreasing costs

Luca Rastelli, PhDBoston Strategics Corporation

October, 2013

2www.BostonStrategics.com

Pharmaceutical Industry Challenge

Continuous trend for decreased productivity and increased overall investment to discover and develop new drugs

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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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Big Pharma attempts of creating Open Innovation, Biotech-like have mixed results

Opened 2005 closed 2012

CEDD Center of Excellence for External Drug Discovery

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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

Big Pharma culture and structure impede attempts to “…be more like Biotech…”

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6CONFIDENTIAL www.BostonStrategics.com

Complete Virtualization via the Creation of a Pharmaceutical “Social” Global network

True Open Innovation TM

InnovativeDrug / Treatment

at Lower Cost / Risk

Pharma/Biotech

Academia

Physicians Hospitals

True Open Innovation TM Global Network

Concept

Financial Resources

PatientsFoundation


ProjectA

ProjectB

Network leverage pools of intellectual operational and financial resources Globally

Virtual teams are assembled to move individual projects through the Product Development phase

ProjectC

Dedicated Experts“BS Producers”

Discovery Medicinal Chemistry Biology (in vitro & in vivo)Drug Metabolism (GLP)PK/PD, Imaging

INDClinical Studies (GCP)Supply Chain Management (GCP)Business DevelopmentQA/RegulatoryNDASales, Commercial

Analytical Chemistry (GMP)Process Chemistry (GMP)API Manufacturing (GMP)Safety Pharmacology (GLP)Toxicology (GLP)Toxicokinetics (GLP)Formulation (GMP) Drug Product Manufacturing (GMP)

BS Global NetworkExternal ExpertsCROs and CMOs

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• Wider spectrum of sources for concepts, herd and me-

too 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

True Open Innovation TM benefits

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9CONFIDENTIAL www.BostonStrategics.com

• 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

Boston Strategics

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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 c-Met 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.

www.BostonStrategics.comCONFIDENTIAL


Example of True Open Innovation TM

• 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

Original (Pharma company): $4.2M, 18 month Boston Strategic (True Open Innovation) : $1.8M, 12 month

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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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World-wide partner network i. Japanese company entering new therapeutic area,

Oncology, with virtual organization of only 2 people

ii. Chinese partners for accelerated preclinical and clinical development to be leveraged outside of China

iii. Canadian Project management company to leverage Canadian Tax Incentives

Strategic Alliances with Academic Institutionsiv. MD Anderson Cancer Center

v. Beth Israel Deaconess Medical Center

Leverage of Public/Private Resource Poolsvi. Canadian and French Tax Incentives

vii. Collaborations with Patient-driven foundations, MMRF, LLS

Components of True Open Innovation TM

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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

Long Term Vision

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Thank you!

[email protected] (Email)

www.BostonStrategics.com (Internet)

presentation for umass workshop

Health & Medicine