Synergy partnerships and vendors oversight in small to medium size organizations: a risk management approach

Transcription

1 Synergy partnerships and vendors oversight in small to medium size organizations: a risk management approach Outsourcing in Clinical Trials Canada 2015 Roxane Aubray, Director Clinical Operations NEOMED Institute October 2015

2 2 Criteria for vendor selection (questionnaires, audits, DD) Specialties/services Geographic presence Availability Size of the CRO, financial condition (review of financial reports) Staff turn over Technology

3 3 Criteria for vendor selection, ctn d Project team members/experience Quality management (including third party partners) References, past experiences, due diligence History and reputation Legal & regulatory issues

4 4 Evaluate needs versus wants

5 5 Risk management a flexible approach in a highly regulated environment Compliant approach Collaborative approach Strategic approach

6 6 Risk management Identify threats Operational: improper services, data integrity, technology disruption Strategic: ability to execute, obtain attention, control over resources Financial: predictable expenses vs flexibility Regulatory: appropriate knowledge, liability Compliance: concepts, rules, regulations, laws and contract

7 7 Vendors oversight concept Ultimate responsibility of vendors and third party activities as if they were conducted internally Prior study starts: selection (existing relationship vs new) Appropriate contract details, build quality within every steps (R&R, KPIs, terms & conditions, payments structure, escalation procedures ) Must be familiar and knowledgeable with information to be reviewed Ongoing monitoring of activities: training, performance, costs, communication, escalation

8 8 Vendor oversight How does it translate in real life? Planning: governance, SOPs, contract Promote internal support if possible (QA, procurement) Vendors are your team s extension: training, support, resources Minimize the amount of partners for each project Communication & escalation Contingency plans

9 9 Thank you Roxane Aubray Director Clinical Operations

10 Company Overview October 2015

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12 About the NEOMED Institute The NEOMED Institute is a "one of a kind" Montreal-based company focused on transforming innovation into solid therapeutic solutions that address unmet medical needs Our mission & purpose is to address all aspects associated with taking promising molecules or biologics such as vaccines, from discovery through clinical proof-of-concept, thereby addressing a considerable gap between basic research and the commercialization of new drugs As a not-for-profit, the NEOMED Institute operates on funds from partnerships as well as the Ministère de l Économie, de l Innovation et des Exportations du Québec, and the Networks of Centres of Excellence (NCE) of Canada with all revenues reinvested into R&D programs 12

13 A novel model The NEOMED Institute is "unique in its multidisciplinary approach" to early drug development: 1. It operates similarly to a traditional biotechnology company with a healthy pipeline of promising programs from discovery through proof-of-concept 2. It fosters collaboration with pharma/big biotech on repurposing and/or advancing under resourced, yet promising programs on risk/reward share basis 3. It fosters collaboration with academia/research centers, on innovative ideas that address unmet medical needs 4. It contains two open access, fully integrated R&D hubs, that foster collaboration, innovation and creativity among the many independent companies who have taken up residence in these hubs 5. It provides a variety of bioanalytical and other services both to resident companies and external customers at very competitive rates 13

14 "Home" Canada Montreal NEOMED St. Laurent Inaugurated in November 2012 Former Astra Zeneca R&D labs Multi-tenant hub specialized in the development of small molecule therapeutics Home to 21 start-ups, biotechnology companies & others NEOMED Laval Inaugurated in April 2015 Former GlaxoSmithKline R&D labs Multi-tenant hub specialized in the development of biologics and vaccines Already home to 2 (and growing) start-ups, biotechnology companies, & others 14

15 Partnership opportunities We are actively looking to progress our programs through more traditional partnerships with Biotech/Pharma or spinout/company creation with VC/Investors 15

16 Current portfolio Lead Generation Lead Optimization Preclinical Phase I Human Proof of Concept NEO6860 TRPV1 ANTAGONIST NEO1940 CANNABINOID CB1/CB2 AGONIST TREATMENT OF OSTEOARTHIRITIS (OA) PAIN MULTIMODAL SUPPORTIVE CARE THERAPY FOR CANCER PATIENTS NEO5937 P2X3 ANTAGONIST TREATMENT OF OA PAIN, VICERAL PAIN, & CHRONIC REFRACTORY COUGH TTSP BLOCKER BROAD SPECTRUM TREATMENT FOR INFLUENZA Developed in collaboration with the Université de Sherbrooke BRD4 INHIBITOR EPIGENETIC MODULATOR FOR THE TREATMENT OF CANCER Developed in collaboration with Epigentix Inc. & the University of Miami HSP90 MODULATOR REDUCTION OF CARDIAC CELL LOSS AFTER MYOCARDIAL INFARCTION Developed in collaboration with the Université de Montréal P2X4 POSITIVE MODULATOR TREATMENT OF CARDIOVASCULAR DISEASES Partnered with Astra Zeneca and developed in collaboration with McGill University PARG INHIBITOR TREATMENT OF CANCER Developed in collaboration with The Lady Davis Institute at the Jewish General Hospital, McGill University 16

17 Pharma/Biotech collaborations We are actively seeking to collaborate with Pharma/Biotech on repurposing and/or advancing under-resourced, yet promising programs 17

18 What are we looking for Small molecule therapeutics and/or biologicals/vaccines Under-resourced, yet promising programs We will co-fund and resource these programs thus reducing your investment and risks associated with attrition Programs that remain of interest to our Pharma/Biotech partners i.e. are likely to be returned on having progressed to agreed-on milestones Collaborations are based on models and structures that make most sense to the parties 18

19 Academic collaborations We are actively seeking to collaborate with academic/research centers on innovative projects that address unmet medical needs and progress these to clinical proof-of-concept 19

20 What are we looking for Innovative approaches that fulfill an unmet medical need Any therapeutic indication Clear therapeutic benefit over standard-ofcare treatment Validated targets, strong scientific basis and compounds with best in-class potential Potential for strong IP protection 20

21 The Team The NEOMED Institute prides itself in having top caliber industry experts managing the day-to-day operations as well as on the Scientific Advisory Board, Board of Directors and as strategic partners 21

22 Thank you Daniel Böck VP Business Development