Introduction to Discovery Partnerships with Academia (DPAc)
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This document provides an introduction to GSK's Discovery Partnerships with Academia (DPAc) model. Some key points: - DPAc allows academic researchers to partner with GSK scientists to translate innovative research into new medicines, with shared investment, ownership, and rewards if successful. - It focuses on drug discovery from early screening through to candidate clinical compounds. - GSK provides access to its drug discovery and development capabilities to help progress projects. - There are currently several active DPAc partnerships in Europe and North America focused on various disease areas.
Introduction to Discovery Partnerships with Academia (DPAc)
- 1. Introduction to Discovery Partnerships with Academia (DPAc) Alternative Discovery & Development GlaxoSmithKline R&D A new model for partnering with academia to discover innovative medicines
- 2. DPAc model is unique March 2015Introduction to DPAc Collaborative Invention Shared Ownership Risk Embracing Staged Pre-Clinical Research Support Development Milestones; - Candidate Clinical NME(s) - FTIH - Clinical PoC - Launch of medicine Build integrated partnerships that can translate innovative research into medicines to benefit patients A collaborative approach from GSK Giving academic researchers an opportunity to partner with GSK scientists, taking advantage of our expertise and technical resources
- 3. What do we seek? 3 Clear Therapeutic Hypothesis Coherent and supportable hypothesis that modulating a target will produce a physiological effect resulting in therapeutic benefit to particular patients March 2015Introduction to DPAc Defined Target Specific drug target identified and some understanding of type of pharmacology desired (Exclusive) Enabling Expertise Academic partner has know-how and / or expertise not (readily) found elsewhere for progressing the target Tractability Path to identifying a drug molecule can be defined Target knowledge suggests that a drug-like molecule can be generated Enabling GSK Contribution GSK has capabilities and expertise that will help progress the project
- 4. Key elements of DPAc Focus on the medicine • Collaborative partnerships focused on drug discovery • Starts at any point from initiation of early screening, finishes with the medicine Undertake the best science • Minimal infrastructure: undertake projects independent of location or disease area • Access to all GSK drug discovery and development capabilities Share in the investment, share in the reward • Both sides contribute – complementary match of skills where both academic institutions and GSK can contribute to success • Research funding synchronized with research goals • Post-research milestone payments and royalties • If partnership terminates, academic institution is free to progress 4March 2015Introduction to DPAc
- 5. Academic researchers who: • Want to be involved in turning their innovative research into medicines • Contribute effort and resources to making projects work • Are recognized experts in their fields • Bring unique capabilities to the collaboration Who is best suited for DPAc? 5March 2015Introduction to DPAc
- 6. DPAc partnership 6March 2015Introduction to DPAc • Co-authored and detailed work plan creates framework to promote rapid project initiation and execution • Work together via Joint Research Committee • Jointly invest time / energy / resources to progress project at both partner sites • Strong interactive relationships between project teams • Equitable approach to IP - Academic institution receives commercial rights if GSK terminates collaboration
- 7. Avalon/GSK Newcos Start a venture- capitalist-backed company, co-founded with GSK Pre-DPAc Funds for promising concepts that are too early for full DPAc agreement Discovery Fast Track Challenge Offers a chance to win a screening collaboration with GSK Multiple ways to collaborate with DPAc March 2015Introduction to DPAc Innovative medicines to benefit patientsFull DPAc YOU and your IDEAS
- 8. How DPAc projects operate Collaborative partnerships focus on drug discovery Start at any point from initiation of early screening to late lead optimization Consider any disease area Operate in any geography Seek complementary match of skills where both academic institution and GSK can contribute to success They are not ✗ Licensing or sponsored research agreements ✗ Support for exploratory work ✗ Focused on technology platforms ✗ Broad multi-project collaborations ✗ Open-ended funding streams 8XX March 2015An Introduction to DPAc
- 9. What capabilities can GSK bring to DPAc partnerships? 9March 2015Introduction to DPAc • Large-scale protein production • HTS capacity 2 million compound set • Medicinal chemistry and computational molecular design • Selectivity screening • PK-PD modelling • Flexible, high-tech assay platforms Lead Identification Late Lead Optimization Early Lead Optimization Assay Development Target Feasibility • Biopharm discovery platforms • Biopharm affinity maturation • Encoded Library Technology* >10 billion compounds • Synthetic & analytical chemistry • Preclinical development: safety, chemistry, pharmacy * Design, synthesis and selection of DNA-encoded small molecule libraries. Clark et. al. Nature Chemical Biology 5, 647-654 (2009)
- 10. Candidate Selection • FTIH Start • Clinical POC • Launch • Lead Identification Late Lead Optimization Early Lead Optimization Assay Development Target Feasibility Partnerships focused on drug discovery Planning all the way to the medicine 10March 2015Introduction to DPAc Lead Identification Late Lead Optimization Early Lead Optimization Assay Development Target Feasibility Phase I Phase IIIPhase IIPre-Clinical Early Drug Discovery Launch & Royalties Drug Discovery Initiated • Screen Initiated • Lead Identified in vitro • Lead Identified in vitro •
- 11. Typical GSK Activities Typical Academic Activities Shared activities between academia and GSK 11March 2015Introduction to DPAc Screening Chemistry Chemistry DMPK Safety Pharmacy Screening Chemistry DMPK Assay Development Assay Feasibility Tool Generation Physiological Assays Physiological Assays in vivo Models Physiological Assays in vitro and in vivo Assay Development Reagent Generation $ Value of GSK Internal Contribution $ Value of GSK Support to Academic
- 12. Early Lead Optimization Late Lead Optimization Lead Identification Tractability Assessment and Assay Development 6 months 9-12 months9-12 months 9-12 months Example activity plan 12 Assay transfer Physchem Pharmacy Compound profiling (selectivity) DMPK Toxicology Compound profiling (biological and biochemical) Medicinal chemistry Synthetic chemistry1˚ screen & selectivity ELT Automation/ robustness testing Reagent production 1° Assay transfer Reagent generation Assay development Compound profiling (phenotypic assessment) Develop in vivo PD assays In vivo models PK/PD MOA studies Structural studies Clinical PD assay development In vivo models efficacyDevelop cellular assay NIH screen Screen initiated Proof of in vitro biology Proof of in vivo biology Candidate GSK Academic Partner
- 13. Dr Jonathan Fallowfield University of Edinburgh Mark Bamford, GSK Seven active DPAc partnerships in Europe 13Introduction to DPAc Treating Fibrotic Liver Disease Preventing Multiple Organ Failure in Severe Acute PancreatitisMr Damian Mole, University of Edinburgh John Liddle, GSK Graft versus Host Disease (Biopharm) Prof. Nathan Karin, Rappaport Institute, Israel Jeremy Griggs, GSK Treating a1- Antitrypsin Deficiency using small molecule stabilisersProf. David Lomas, University of Cambridge Andy Pearce, GSK A disease modifying approach to the treatment of Huntington’s Disease Prof. Susann Schweiger, University of Dundee Iain Uings, GSK Prof. Sir Mark Pepys, University College London Duncan Holmes, GSK Stabilisers of Transthyretin as treatment for Transthyretin Amyloidosis Topical Therapy for Netherton Syndrome, Rosacea and Atopic DermatitisProf. Alain Hovnanian, Paris Descartes University John Liddle, GSK March 2015
- 14. Five active DPAc partnerships in North America 14Introduction to DPAc March 2015 Z Treatment of Cystic Fibrosis Prof. Christine Bear SickKids Hospital Toronto Jakob Busch- Petersen, GSK Treatment of Alzheimer’s Disease Prof. Paul Lombroso Yale University Dennis Yamashita, GSK Prof. Roger Cone Vanderbilt University David Becherer, GSK Treatment of Obesity Treatment of Triplet Repeat Diseases Prof. Christopher Pearson SickKids Hospital Toronto Debra Peattie, GSK Prof. Nicholas Tonks Cold Spring Harbor Labs Jon Collins, GSK Treatment of Obesity and Type 2 Diabetes
- 15. Discovery Fast Track Challenge • Innovative approach to sourcing new partnership ideas – inviting academic researchers to propose project ideas in a challenge-like format • Rigorous review and detailed face-to-face feedback and advice to investigators selected as finalists; up to 30 finalists will be selected in 2015 • Partnership with challenge winners (up to 12 in 2015) to perform high-throughput and encoded library screening of their target • Promising results may lead to an opportunity for the academic institution and GSK to collaborate via a full DPAc partnership or via supplied chemical probes 15March 2015Introduction to DPAc
- 16. For Discovery Fast Track Challenge winners • GSK will provide state-of-the-art capabilities • Devise optimal screening strategy (e.g. HTS, Encoded Library Technologies) • Adapt and scale biological reagents for screening • Miniaturize assays for HTS (~2M cpds) • Run screens, analyze output and "qualify" hits • Principal Investigator (PI) joins team of GSK scientists to execute the screen and follow up hits – often culminating in tests within PI's lab (e.g., complex cellular assays) • GSK may provide up to 3 chemical structures of selected chemical probe(s) to help further PI’s research and potentially lead to high-impact publications, subject to GSK’s existing internal and external obligations • Promising results may lead to a full DPAc collaboration with GSK to create a novel medicine with the DPAc team 16March 2015Introduction to DPAc
- 17. 2014 North American Discovery Fast Track Challenge results 17March 2015Introduction to DPAc 196 Proposals Submitted from 105 Participating Institutions 12 Finalists 6 Winners 40% Increase in proposals submitted from 2013
- 18. 2014 European Discovery Fast Track Challenge results 18March 2015Introduction to DPAc 232 Proposals Submitted from 131 Institutions 14 Finalists 9 Winners 24 Countries
- 19. DPAc and Discovery Fast Track Challenge collaborations 19March 2015Introduction to DPAc Discovery Fast Track Challenge 2013 Winner Institutions • Pennsylvania State University • Albert Einstein College of Medicine of Yeshiva University • Boston University and University of California, San Francisco • Harvard Medical School • University of Pennsylvania • Université de Sherbrooke • University of North Carolina at Chapel Hill (x2) Discovery Fast Track Challenge 2014 Winner Institutions • Mayo Clinic • Johns Hopkins • University of Pennsylvania • University of Texas Southwestern Medical Center • University of Iowa • University of Toronto • University of Milan • University of Cambridge (x3) • National Institute of Health and Medical Research • Research Center for Molecular Medicine • King’s College London • VU University Medical DPAc Partnership Institutions • University of Edinburgh • University of Dundee • University of Nottingham • University of Cambridge • University College, London • Université Paris Descartes • University of Dundee (University of Mainz) • Rappaport Family Institute, Haifa, Israel • Fred Hutchinson Cancer Research Center • Vanderbilt University • University of Toronto/Hospital for Sick Kids • Yale University
- 20. Discovery Fast Track Challenge proposals yield broad therapeutic coverage 20March 2015Introduction to DPAc Europe 2014 (232 total)North America 2014 (196 total)
- 21. Discovery Fast Track Challenge 2015 21March 2015Introduction to DPAc Challenge Opened Mar 23 Europe North America Registration Closes Apr 24 Europe North America TTO Approval Deadline May 8 Europe North America Finalist Presentations Jul 14-17 Europe (Stevenage, UK) Sept 28-30 North America (PA, US) Winners announced Jan 2016 Europe North America Investigator submits 1 page non- confidential proposal TTO approval required for GSK review GSK selects finalists, assigns mentors Expanded confidential proposals Material transfer and work-plan agreement s signed GSK scientist teams assigned to project, and work begins towards screening 1 2 3 4 5 Find more information at gsk.com/discoveryfasttrack
- 22. Who we are: dpac.gsk.com 22March 2015Introduction to DPAc Duncan Holmes European Head LONDON Mark Bamford Chemistry, LONDON Iain Uings Biology, LONDON & CALIFORNIA John Liddle Chemistry, LONDON Ann Walker Chemistry, LONDON Stephane Huet Biology, PARIS Jeremy Griggs Biology, LONDON Danuta Mossakowska Biology, LONDON Andy Pearce Biology, LONDON Colin Macphee Biology, PHL Jakob Busch-Petersen Chemistry, PHL Andy Pope Biology, PHL Carolyn Buser- Doepner Global Head, PHL Dan Paone Chemistry, PHL Dedicated team of scientists, each of whom has proven track record in drug discovery Your gateway to GSK’s global expertise and resources Jon Collins Chemistry, RTP, NC Katherine Widdowson Chemistry, CALIFORNIA Debra Peattie Biology, BOSTON Dave Parry Biology, CALIFORNIA Mike Bishop Chemistry, RTP, NC Dave Becherer Biochem , RTP, NC Dennis Yamashita Chemistry, BOSTON