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Presentation for UMass Workshop


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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

Published in: Health & Medicine, Business
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Presentation for UMass Workshop

  1. 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. 2. Pharmaceutical Industry Challenge Continuous trend for decreased productivity and increased overall investment to discover and develop new drugs CONFIDENTIAL 2
  3. 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 CONFIDENTIAL 3
  4. 4. Big Pharma attempts of creating Open Innovation, Biotech-like have mixed results CEDD Center of Excellence for External Drug Discovery CONFIDENTIAL 4
  5. 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 CONFIDENTIAL 5
  6. 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 CONFIDENTIAL 6
  7. 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 CONFIDENTIAL Project B Project C 7
  8. 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 CONFIDENTIAL 8
  9. 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 CONFIDENTIAL 9
  10. 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. CONFIDENTIAL 10
  11. 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 CONFIDENTIAL 11
  12. 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 CONFIDENTIAL 12
  13. 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 CONFIDENTIAL 13
  14. 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 CONFIDENTIAL 14
  15. 15. Thank you! (Email) (Internet)