2013 Annual Conference - BioOhio

2013 Annual Conference

Welcome!

Thanks to our Sponsors!

Thanks to our Sponsors!

Ohio’s Medical Corridor & Other Statewide

Collaborative Initiatives

Breakout Session 1

Statewide Pediatric Initiative and Collaborative Opportunities

for Companies

1:45 – 3:00

Moderated by

Greg Moody

Director The Governor’s Office

of Health Transformation

Nicole Robinson, Ph.D.

Assistant Vice President Center for Technology Commercialization

Cincinnati Children’s Hospital Medical Center

Matthew McFarland, RPh, Ph.D.

Director Office of Technology Commercialization

The Research Institute at Nationwide Children’s Hospital

Stephen Behm, MBA

Director, Technology Management, Center for Clinical Research and Technology,

University Hospitals Case Medical Center, Rainbow Babies and Children’s Hospital

Aris Eliades, PhD, RN, CNS

Associate Director, The Rebecca D. Considine Research Institute Director, Nursing Research, Akron Children’s Hospital

Carrie Baker

Director of Public Policy & Advocacy Ohio Children’s Hospital Association

Ohio: A Pediatric Powerhouse Leveraging Ohio’s Pediatric Healthcare Expertise

Ohio’s Pediatric Healthcare Landscape

Aggregating World-Class Research

• Ohio is home to the largest sum of NIH funded pediatric research in the entire United States

• We brought more than $245 million to Ohio in 2011 through federal grants, foundation or philanthropic grants and industry partnerships

• We are leading the development of groundbreaking research and technology that create jobs and save children’s lives

• Ohio is the only state in the US with a flagship children’s hospital within two hours of every child

• Three of the nation’s seven largest (by bed count) children’s hospitals are located in Ohio – Cincinnati Children’s Hospital Medical Center – Nationwide Children’s Hospital – Akron Children’s Hospital

• Ohio is a pediatric health care destination, serving children from all

88 counties in Ohio, all 50 states and dozens of international countries

Aggregating World-Class Care

• US News & World Report: 2013

Aggregating Our Rankings

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1

2

3

4

5

6

Top 10

Top 20

Top 30

Collaborative Track Record

• Through our OCHA partnership, Ohio’s Medicaid costs for children are below the national average

• We are leading the country in pediatric quality of care and patient safety through the Solutions for Patient Safety

• Successful research and clinical collaboration through the Governor’s Medical Corridor initiative

Accelerating Commercialization

FY08-12

Research $ $1,845,760,413

Invention Disclosures 1054

Patent Applications 427

Patents Issued 167

Start-Up Companies 17

Licenses 158

Revenues $90,794,990

• Tech Transfer is Accelerating Efforts

• Growing Pipeline of Opportunities

• Leveraging Infrastructural and Community Assets

• Commercialization Successes are on the rise

Future Considerations

• Payment Reform: paying for value not volume

• Provider Cuts: Innovation and commercialization cannot happen without adequate infrastructure

• ACA Implications beyond Medicaid Expansion: exchange, market share, access issues

Clinical Trials Network, Access to Hospital Purchasing,

why more Pharmaceutical Companies will come to Ohio, and more

3:00 – 4:15

Moderated by

Aaron Pitts

Managing Director Biohealth, Food Processing & Agribusiness

JobsOhio

James Chmiel, MD, MPH

Director and Chief Executive, Ohio Clinical Trials Collaborative, Associate Professor of Pediatrics, Case

Western Reserve University School of Medicine, Clinical Chief, Division of Pediatric Pulmonology and

Allergy/Immunology, Rainbow Babies and Children’s Hospital

Jim Chmiel, MD, MPH Director and Chief Executive, OCTC

November 5, 2013

Ohio Clinical Trials Collaborative A statewide coordinating agency.

Ohio Medical Corridor Governor Kasich’s Statewide Initiative

Goal •Create jobs •Attract Investors •Improve the health of the citizens of Ohio and beyond •Advance medical science

Purpose •Influence collaboration and build upon our collective strength •Leverage the scientific expertise at the major research institutions in Ohio •Convene job-creating medical institutions to spark ideas •Attract additional medical companies and jobs to Ohio

Ohio Clinical Trials Collaborative (OCTC) •May 2013, State approves $1.98M to support startup funding for year one

About OCTC Not-For-Profit Agency Serving Biopharma and Healthcare Industries

LAUNCHED MAY 2013

SERVES

LEADS

PROVIDES

AS A CENTRAL AGENCY THAT OVERSEES A ROBUST CLINICAL TRIALS NETWORK ACROSS OHIO AND FACILITATES ACCESS TO AND ACCELERATING THE PERFORMANCE OF CLINICAL TRIALS

BUSINESS DEVELOPMENT, GLOBAL SALES, MARKETING, AND COMMUNICATIONS EFFORTS

COST-EFFECTIVE, QUALITY-DRIVEN SOLUTIONS TO DRUG MAKERS, BIOTECHS, DEVICE MAKERS, CROS, AND PATIENTS

Ohio Clinical Trials Collaborative

3-Clinical and Translational Science Awards (CTSA) Network

Cincinnati Children’s Hospital Medical Center

Cleveland Clinic Foundation

MetroHealth Medical Center

Nationwide Children’s Hospital

The Ohio State University Wexner Medical Center

Practice Based Research Network

University of Cincinnati Medical Center

University Hospitals Case Medical Center


Founding Partners

Vision To establish Ohio as a national and global leader in attracting and successfully conducting clinical trials.

Mission To establish Ohio as one of the most efficient and effective states to test new medications and treatment strategies by simplifying and accelerating the delivery of innovative therapies and products to patients and build upon and expand the state’s biopharmaceutical sector.

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Ohio Clinical Trials Collaborative (OCTC) leverages $121M in NIH investment in

Ohio’s Clinical + Translational Science Awards Network


Biohealth Business in Ohio - A World Leader

1st in the Midwest and 7th Nationally

1st Most Improved Business Climate (Chief Executive Magazine, 2013)

3rd Lowest Tax Rate on New Capital Investment

1st in the US World-renowned Cleveland Clinic’s heart, nephrology, and urology programs

3 of 7 Top US Pediatric Hospitals The most comprehensive network of children’s hospitals in the nation

8th in Bio-related Patents

Top 10 in US in Biotechnology Strength Positioned for continued growth in medical device design, manufacturing, R&D

New $500M Global Center for Healthcare Innovation: Patient-centered innovation and

commercialization powered by biomedical discovery and enterprise

• Cost-effective, quality-driven solutions to drug makers, biotechs, device makers, and CROs

• Cost-efficient, successful navigation of the clinical trial continuum

• Education and supervision needed to assist the statewide network and its clinical trial sites to ensure quality and increase success rates for biopharma companies and CROs


OCTC Provides Industry Solutions

• Navigation of regulatory and ethical requirements of studies involving human subjects

• Accessing, recruiting, and retaining the desired patient populations

• Shortening the length of time it takes to start and complete trials

• Contracting

• Controlling rising financial costs


OCTC Provides Industry Solutions


Leadership Founder

Pamela B. Davis, MD, PhD Clinical and Translational Science Collaborative Case Western Reserve University, Cleveland, Ohio

Co-founder

Rebecca Jackson, MD The Ohio State University Center for Clinical and Translational Science Ohio State University, Columbus, Ohio

Co-founder

James E. Heubi, MD Center for Clinical and Translational Science and Training University of Cincinnati, Cincinnati, Ohio

Director and Chief Executive

Jim Chmiel, MD, MPH

Biomedical

Informatics and

Clinical Data

Management

Systems

Committee

(formerly ODP WG)

Chair

Philip Payne

Study

WG

Committee

(Chmiel)

Business

Development

(Ruscio)

Clinical Trials

Operations

(Hilliard)

Clinical and

Translational

Science Awards

Committee

CTSA Directors

and CRUs

Pediatrics WG

Chair

JP Clancy

PBRN WG

Chair

Jim

Werner

Oncology WG

Ohio Clinical Trials Collaborative Organizational Chart

Research

Administration

Committee

(Formerly IRB WG)

Chair: Phil Cola

Executive Leadership Group

Pamela Davis, MD, PhD CWRU

James Heubi, MD UC Rebecca Jackson, MD OSU

OCTC Director and Chief Executive

James Chmiel, MD, MPH

OCTC

Operations

(Peter)

External Advisory Committee

OCTC Central Staff

Director, Global Business Development: Bruce Ruscio, Dr PH (interim)

Manager of Network Operations: Joseph Peter, MA, MBA, PMP

Manager of Clinical Trials Operations: Kathleen Hilliard, BA, CCRC

Global

Communications

and Marketing

IRB

Study

Contracting

Study

Implementation and

Conduct WG

Chair: K. Hilliard

Study

Budgets

Performance

Monitoring

Study

Management

Quality Assurance

and Process

Improvement

Administrative

and Business

Management

Network

Communications

Meeting

Coordination

Education and Training

Government Relations + Strategic Initiatives

Bede Littman - State Contracts

Federal and State Funding Opportunities

Business

Solicitation and

Relations

MEMBERS CONFIRMED • Andrew Dahlem, PhD, Eli Lilly • Charles Johnson, MD, PhD, Vertex • Steven Landau, MD, HealthCare Ventures, LLC • Katherine Matthay, MD, UCSF • Mark Raupp, MD, Quintiles • Victoria Tifft, MBA, ClinicalRM, CRO based in Hinckley, Ohio • Jill Van Dalfsen, BS, MT, Cystic Fibrosis Foundation

Therapeutics Development Network

External Advisory Committee


Open Data Portal Philip Payne, PhD, OSU

Reliant IRB Phil Cola, CWRU

Oncology Clinical Research Network Stan Gerson, MD, CWRU

Pediatrics Clinical Research Network JP Clancy, MD, UC

Practice Based Research Network Jim Werner, PhD, MSSA, CWRU

Initial Statewide Working Groups


Chair, Philip Payne, PhD, OSU

A combined technology platform + governance model that overcomes current challenges to the effective + timely use of Linked Open Data

• Identifies subjects for recruitment • Ensures that OCTC develops trials that are representative of desired

patient populations

• Allows for heath analytics and in silico studies

• Potentially helps to focus efforts to attract pharma because of unique disease/outcomes, etc.

• Serves as a resource for biotech development when linked to biorepositories, etc.

Biomedical Informatics and Clinical Data Management Systems

Open Data Portal


Chair, Phil Cola, CWRU

IRB approval time from 72 days to 7-14 days • A common IT platform to exchange IRB documentation

• Facilitates review of protocols for approval at a primary site with rapid administrative review at each additional site

• Coordinates everything electronically

• Accelerates IRB approvals between institutions in Ohio

• Since July 2012, 22 protocols have gone through the reliant IRB. 6 multicity, 16 within the City of Cleveland

Reliant IRB


The integrated network is disease agnostic. Initial focus areas:

•Oncology Clinical Research Network

•Pediatric Clinical Research Network

•Practice Based Research Network

Statewide Clinical Trials Network


Chair, Jim Werner, PhD, MSSA, CWRU

Conducts clinical and comparative effectiveness research.

• Provides access to 277 medical practices

• Completed 2 requests for cost-estimates in less than 1 week

Practice Based Research Network


• Case Comprehensive Cancer Center

• The Ohio State University Comprehensive Cancer Center

Oncology Clinical Research Network


Pediatric Clinical Research Network

Chair, JP Clancy, MD, University of Cincinnati

• Cincinnati Children’s Hospital Medical Center (2nd in NIH funding), Nationwide Children’s Hospital (16th in NIH funding), Rainbow Babies and Children’s Hospital (7th in NIH funding)

• Development of NIH contract agreement templates for review by member institutions

• Development of CDA templates to facilitate information sharing across the Pediatric Network

• Pediatrics Network helped to attract March of Dimes funding


Looking Forward

• Continue to identify and meet with industry, CROs, biotechs, etc.

• Engage OCTC External Advisory Committee

• Marketing and business development

• Initiate clinical trials

• Establish common OCTC contracting language/template


Jim Chmiel

[email protected]

Cell: 216.212.7992

Joe Peter

[email protected]

OCTC Contact Information

Visit http://casemed.case.edu/ctsc/octc


Thank You

Ohio Clinical Trials Collaborative Accelerating cures. Creating jobs.


Jim Weisman

Vice President BioEnterprise / Choose Ohio

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BioOhio

November 5TH, 2013

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Cleveland Clinic

OSU Medical Center

Akron General

UC Health System

University Hospitals

Battelle

Nationwide Children’s

OhioHealth

Akron Children’s

Summa Health System

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• 5 quarterly meetings of companies and hospital purchasing departments via WebEx platform

• 15 companies selected to present from applicant pool of 50

• Outcomes to date are modest: 30+ requests for more information, 11 direct introductions and a successful study

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Keys to Success

• This is a sales opportunity

• Never sure who will be on the WebEx

• Provide good prep material

• Be brief, have questions of your own

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Disclaimer: Only Ohio-based life science companies with market-ready (completed) or in-

market products and services are eligible.

To find out more visit: www.bioenterprise.com/contact/choose_ohio

Santa Ono, Ph.D.

President University of Cincinnati

Professor, UC Department of Pediatrics Ohio Pharmaceutical Initiative

INFORMATION:

Email: [email protected]

Phone: 513-556-2201

mailto:[email protected]

2013 Annual Conference

Thank You!

2013 Annual Conference - BioOhio

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