Technology Development Funding Program Round 3

Transcription

1 Technology Development Funding Program Round 3 CWRU January 26,

2 Program Overview

3 NIH Center for Accelerated Innovations (NCAI) at Cleveland Clinic Mission to improve translation of basic science advances and discoveries into commercially viable products that improve patient care and advance public health. One of three inaugural NCAI s established by 7 year program beginning in 2013 to provide development funding, project management, and to develop commercialization expertise. Targeting heart, lung, blood and sleep disorders and diseases. Broad based funding $11.2M grant from NHLBI $ 1.5M grant from Ohio Third Frontier $ 0.3M grant from National Science Foundation

4 NCAI-CC Partners and Affiliates

5 NCAI Programs and Support for the Entrepreneurial Researcher Technology Development Program Active Engagement in Solicitation and Definition of Projects Funding for Commercialization-oriented Objectives Project Management Support by Industry-Experienced Personnel Facilitated Access to Federal and other Development Resources Commercialization Education and Skills Development Customer Needs and Product Definition Project Planning and Management Market Opportunity Analysis Clinical, Regulatory Strategy Cost/Reimbursement Strategy Business Strategy

6 Funding Rounds 1 and 2 Summary Round 1 Round 2 All CWRU All CWRU LOIs Received Full Applications Projects Funded 4 1 TBD TBD

7 Technology Selection

8 Project Candidate Profile Projects directed towards translating advancing early stage technologies towards commercial development. Not a continuation of research aims Fit within NHLBI Domain Heart, cardiovascular Lung, pulmonary, airway Blood Sleep Disorders To Develop Products and Solutions Diagnostic biomarker, test, device or system Therapeutic drug, biologic, or combination product Interventional or surgical device Healthcare information management tool

9 Greater Demand for De-risked Technologies Early Discovery Academic & Govt. Labs Basic Science: Identification of Molecular Pathways Target Identification Drug Discovery Hit to Lead Lead to Pre-clinical Candidate Pre-clinical Development Clinical Trials Commercial Interest Has Shifted Early Stage Research Discovery --> Pre-Clinical/Clinical Success Target Validation Assay Development > Validated Hits Lead Drug Candidate Biotech/Pharma Companies Preclinical and Clinical Development New Medicine IP Package Data Package Sources: Stewart, J., Campbell Alliance Dealmakers Intentions Survey 2012; Christini, A., Nat. Biotechnol. 30, (2012)

10 Therapeutics Target ID Validation Lead ID Lead Optimization Preclinical studies First in man R01 HTS Medicinal Chemistry Efficacy Studies NCAI ADME Pharmacokinetics In vitro Toxicology Two Species Efficacy Studies Large Animal Toxicology VC SBIR In vivo Toxicology Pre-IND

11 Devices Needs Identification Invention & Prototyping Pre-Clinical Clinical Regulatory Product Launch Prototype Iteration Bench Testing Simulated Use Testing Tissue Testing NCAI Acute animal Testing Chronic Animal Testing Human Cadaver Testing Biocompatibility Testing Human Clinical Testing

12 Solicitation Funding Opportunity Announcement Twice per year: January and July Full Request for Applications (RFA) created and posted on NCAI-CC website: Promote program and invite discussion, consultation 2 page Letter of Intent (LOI) plus references and biosketches of PI and up to 2 collaborators LOIs due February 10, 2015.

13 Selection All LOIs reviewed by 7-member CCF team for: Initial fit Phase Feasibility Accepted LOIs distributed among partner institutions for review and scoring. Top scoring projects invited to submit full applications March 3, 2015 Applicants encouraged to work with CC Innovations and NCAI team to develop project plan and application.

14 Selection, cont. Applications reviewed and scored by independent External Selection Committee. Comprised of science, clinical, financing, industry backgrounds Evaluation on prescribed set of scoring criteria. Finalists then advanced for final review by NHLBI NCAI Technology Review Committee. Comprised of NIH, FDA, USPTO, CMS members Final Award Decisions June 2015 Feedback

15 Solicitation and Selection Outreach, Scouting, Consultation RFA Feedback NHLBI Tech. Review Committee LOI Full Application External Selection Committee Funding Decision Two Phase LOI Review - Fit, Phase, Feasibility - Scoring vs. Eval. Criteria Two Phase Application Review - Scoring vs. Evaluation Criteria - NHLBI Program Alignment - FDA, USPTO, CMS Input

16 Technology Development

17 Project Planning and Management Milestone-Driven to Developing and Conducting Commercially-Oriented Development

18 Project Planning and Management

19 Resources

20 NCAI-CC Personnel Paul DiCorleto, PhD. Principal Investigator Geoff Vince, PhD. Co- PI Mark Low, Managing Director Ofer Reizes, PhD. Director, Skills Development Santhosh Vadivelu, PhD. Partnerships and Licensing Project Managers Marwane Berrada, MS, MBA. Devices Kelly Emerton, PhD. Devices R (Sakthi) Sakthivel, PhD, MBA. Therapeutics Suguna, Rachakonda, PhD, MBA. (Feb 10). Therapeutics

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