presentation for umass workshop final 2

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

2www.BostonStrategics.com

Pharmaceutical Industry Challenge

Continuous trend for

decreased productivity

and increased overall

investment to discover

and develop new drugs

CONFIDENTIAL


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

CONFIDENTIAL


Big Pharma attempts of creating Open

Innovation, Biotech-like have mixed results

CEDD Center of Excellence for External Drug Discovery

CONFIDENTIAL


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…”

CONFIDENTIAL

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

Concep

t

Financial Resources

Patients

Foundation


Project

A

Project

B

Network leverage pools of intellectual

operational and financial resources Globally

Virtual teams are assembled to move individual projects

through the Product Development phase

Project

C

Dedicated Experts

“BS Producers”Discovery

Medicinal Chemistry

Biology (in vitro & in vivo)

Drug Metabolism (GLP)

PK/PD, Imaging

IND

Clinical Studies (GCP)

Supply Chain Management (GCP)

Business Development

QA/Regulatory

NDA

Sales, 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 Network

External Experts

CROs and CMOs

CONFIDENTIAL


• 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

CONFIDENTIAL

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

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 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

CONFIDENTIAL


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

CONFIDENTIAL


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 Institutions

i. MD Anderson Cancer Center

ii. Beth Israel Deaconess Medical Center

Leverage of Public/Private Resource Pools

i. Canadian and French Tax Incentives

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

Components of True Open Innovation TM

CONFIDENTIAL


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

CONFIDENTIAL

Thank you!

[email protected] (Email)

www.BostonStrategics.com (Internet)

presentation for umass workshop final 2

Business

biotechbased innovation

given project

projectbased dynamics

drug development

pharma attempts

needed projectfocus

smaller biotech

cultural inertia nonproject