UC CAI University of California Center for Accelerated Innovation  Michael Palazzolo, MD, PhD UC CAI Center Director

NHLBI • Jodi Black, PhD, MMSc

–  Acting Director, Office of Translational Alliances and Coordination (OTAC),

–  Deputy Director, Division of Extramural Research Activities, NHLBI

• Bishow Adhikari, PhD –  Program Director, Division of

Cardiovascular Sciences

•  Ram Aiyar, PhD, MBA –  Entrepreneur in Residence, Office

of Translational Alliances and Coordination, Division of Extramural Research Activities

• Steve Flaim, PhD, FAHA, FACC

–  Special Advisor, Office of Translational Alliances and Coordination, Division of Extramural Research Activities, NHLBI

•  Eric Padmore, MHSA –  Program Analyst, Office of

Translational Alliances and Coordination, Division of Extramural Research Activities, NHLBI

•  Kathleen Rousche, PhD –  Program Director, NIH Centers for

Accelerated Innovations (NCAI), Office of Translational Alliances and Coordination, Division of Extramural Research Activities

Presentations •  UC BRAID Overview – S. Dubinett •  UC CAI Overview & Progress – M. Palazzolo •  Technology Solicitation and Selection Process – D. Gellene •  Tracking Progress and Needs Assessment – P. Davidson •  Skills Development and Education - V. Krishnan •  Tools – R. Dennis •  Project Management and Discussion – M. Palazzolo •  Emerging Technology – C. Chiu •  UCLA DGSOM Accelerator – M. Palazzolo •  Business Development Strategies – B. Boyle •  CTSI Clinical Research Laboratories – S. Dubinett •  UC Research Exchange and Los Angeles Data Repository – D.

Bell •  Drug and Device Discovery and Development – C. Tralau-Stewart

Overview

•  Goals •  Year 1 Progress •  Challenges Addressed •  Plans for the Coming Year •  Questions and Discussion Topics

Goals

Goal 1 •  Engage University of California heart lung

and blood disease innovators through a comprehensive education, training and mentorship program.

Goals

Goal 2 •  Solicit and select technologies with high

commercial potential that align with NHLBI’s mission and address unmet medical needs or significant scientific opportunity.

Goals

Goal 3 •  Incubate our most promising

technologies in accordance with industry requirements to facilitate their translation to commercial products that improve patient care and enhance health.

Goals

Goal 4 •  Create a high-performing, sustainable

infrastructure that will serve as a model to academic research centers.

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PROGRESS

Technology Development Pipeline •  Approved Projects

– Kennedy (UCD) “Nanophotonic detection of bacterial and fungal infections”

– Ganz (UCLA) “Diagnostic antibodies for Erythroferrone”

– Nishimura (UCSF) “Therapeutic antibodies for TGF-B”

•  Still Under Review – Chiu (UCSF) “NextGen Sequencing for

pulmonary differential diagnosis” •  Next RFA: late summer

Updates

•  Stephen Nishimura "Selective Targeting of TGF-β Activation to Treat Fibroinflammatory Airway Disease” Science Translational Medicine, June 18

•  Charles Chiu “Actionable Diagnosis of Neuroleptospirosis by Next-Generation Sequencing” NEJM, June 4

Skills Development •  Vish Krishnan

–  Resource catalog –  Technology Development Primer

•  Pamela Davidson –  Needs Assessment and Evaluation

•  Bill Boyle –  Insight into business development –  3 case studies

•  Therapeutic antibodies •  Digital health •  Diagnostic platform

•  I-Corps Hub application submitted June 2014

I-Corps Hub •  Leverage UCSF experience

-  Led by Stephanie Marrus •  Lean Launch Pad curriculum for life sciences

and health care •  Piloted in fall 2013

-  25 teams (7 therapeutics, 5 devices, 7 diagnostics, 6 digital health)

-  98% of participants would recommend to a colleague •  Trainers include venture capitalist, director of

digital incubator, entrepreneurship experts •  31 mentors with industry experience in

diagnostics, devices or therapeutics

External Advisory Board •  Consists of no fewer than 5 members •  Experienced business leaders •  Includes NHLBI Program Officer •  Advice about operations, project development

Catherine Mackey, PhD Former Senior VP, Pfizer

Founder, MindPiece Partners

Julie M. Cherrington, PhD President and CEO

Pathway Therapeutics

Jay G. Wohlgemuth, M.D. Senior VP, Medical, Science and Innovation, Quest Diagnostics

Lawrence Souza, PhD Former Senior VP, Amgen

Founder, Coastview Capital

Francis Duhay, MD VP Medical Affairs and CMD

Edwards Lifesciences

Business Review Panel •  Five members •  VCR on each campus appoints one member •  Evaluate Center’s progress toward sustainability

Bill Ouchi, PhD UCLA

Professor of Management and Organizations

Claudia Bird Schoonhoven UC Irvine

Professor of Organization and Strategy Director, Beall Center for

Innovation and Entrepreneurship

Toby E. Stuart UC Berkeley

Professor, Entrepreneurship and Innovation

Kimberly D. Elsbach UC Davis

Associate Dean and Professor of Organizational Behavior

Vish Krishnan UC San Diego

Endowed Chair, Professor of Innovation, Technology & Operations

Site Infrastructure •  UC Davis

–  Anuurad Erdembileg (Admin) –  Gabriela Lee (PM)

•  UC Irvine –  Randy Berg and Andria Pontello (Admin)

•  UCLA –  Denise Gellene, Anne Skinner (Admin) –  Elvira Liclican (PM)

•  UCSF –  Catherine Tralau-Stewart (Admin and PM)

•  UC BRAID –  Nate Buscher (Admin)

Center Infrastructure at UCLA

•  Administration –  Anne Skinner, Emily Sondergaard

•  Communications –  Denise Gellene, Jessica Byrne

•  Evaluation –  Terry Nakazono, Jim Morrison

•  Fund management –  Matt McPeck, Rachel Hintz

•  Website and software development –  Robert Dennis, Maryam Ariannejad, Paul Babin

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CHALLENGES ADDRESSED AND FUTURE PLANS

Challenges Addressed

•  Reviews – Quality control – Surveys and metrics

•  California Law 1090 •  Conflict of Interest in Reviews •  Integrate the effort across 5 campuses

Future Plans

•  Manage Projects launched – Project management – Business development

•  Identify issues and solutions on other campuses

•  Upcoming RFA •  Make the review process more systematic

What About Unfunded Projects?

•  Projects that didn’t get funded – Superalarm – Omics platform – metabolic diseases – Read through small molecules – muscular

dystrophy – Nanoelectric diagnostics

What Does a Successful Skills Development Program Look Like?

•  Broad educational system – Webinars – Courses – Simulation – But if the faculty is the target*

•  Skills development as business development – More like residency than medical school – Need to be data driven – Great variability between projects

For Consideration… •  Importance of keeping our investigators

engaged •  How do we define projects to be compatible

with NHLBI’s agenda? •  When is a project in the sweet spot? Not too

early, not too late? •  What is an exit? •  How many metrics should we be tracking? •  What is the best type of project

management?