*in Diabetes* or *Diabetes Initiative* * need some recognition of

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LEVERAGING MINNESOTA’S ASSETS TO

BECOME THE DIABETES LABORATORY

FOR THE WORLD

Minnesota Senate Finance Committee

May, 2013

Decade of Discovery in Diabetes

The Decade of Discovery (DoDD) was

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University of Minnesota to conquer a disease with devastating physical, economic and social impacts: diabetes.

Decade of Discovery aligns and integrates the significant resources and strengths of Mayo Clinic and the University through a disciplined, goaldirected approach to prevent, optimally treat and ultimately cure Type 1 and Type 2 diabetes.

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Leadership

Management Team

David D. Etzwiler, J.D., M.P.P. – Executive

Director

Former Vice President of Community Affairs and

Executive Director of the Medtronic Foundation

Maura Donovan, Ph.D. – Chief Technology

Officer

Former Vice President, Therapy R&D for

Medtronic Corporate Ventures and New

Therapies

Oversight Committee

Kathleen Blatz, M.S., J.D. — Co-chair; former Chief

Justice of the Minnesota Supreme Court

Vance Opperman, J.D. — Co-chair; Key Investment,

Inc., MSP Communications

Ann Albright, Ph.D., R.D. — Centers for Disease

Control and Prevention

Richard M. Bergenstal, M.D. —International

Diabetes Center, American Diabetes Association

(former President)

Jackie Casey —Juvenile Diabetes Research

Foundation International (JDRF), Minnesota Chapter

Frank B. Cerra, M.D. — University of MN

Elizabeth Seaquist, M.D. – Program Lead

President-Elect, American Diabetes Association, professor, Department of Medicine in Division of

Endocrinology and Diabetes at the University of MN

Steven Smith, M.D. – Program Lead

Medical Director for Patient Education, Mayo

Clinic, past Chair of Diabetes Core Group: Division of Endocrinology, Diabetes, Nutrition, and

Metabolism

Susan Crockett, Ph.D. — General Mills

Michael Gorman, M.B.A, J.D. — Split Rock Partners

Chris Schaeffer — American Diabetes Association,

Minnesota Chapter

Eric J. Jolly, Ph.D. — Science Museum of Minnesota

David M. Kendall, M.D. — Eli Lilly

Cindy Kent — Medtronic, Inc.

Dale Wahlstrom, M.S. — LifeScience Alley and the

BioBusiness Alliance of Minnesota

Diabetes Impacts: Health and Costs

• More than 25 million Americans have diabetes; 79 million have prediabetes

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DIABETES COSTS

$3.1 billion annually in MN

• Estimated to grow to $6.4 billion by 2025

$200 billion in 2010 in U.S.

• Estimated to be more than $500

billion in 2020

IN MINNESOTA

- Diabetes doubled among adults since

1995

- 290,000 adults with diabetes in MN

- 1.4 million adults with prediabetes

- Every year 20,000 Minnesotans diagnosed

- 6th leading cause of death

- Risk of heart disease and stroke is 2-4 times higher than for those without

- Leading complication among mothers giving birth

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The Vision: a “Moonshot”

Combining academic research with the best of industry

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Research

Strong , goal-directed research with a focus on “fast translation” to a cure, employing team science that incorporates the best of academia and industry working together toward a common, transformative goal

A “mission-driven” commitment to large-scale care delivery and prevention work with an understanding of system needs and the required alliances to impact those needs

Community

Prevention

Governance

Rigorous governance and program management across scientific and clinical themes with clearly defined milestones and metrics

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Discovery and Translation

Focus on Areas of Highest Promise

Drug discovery: identify targets for intervention based on key metabolic and autoimmune processes and physiological mechanisms that underpin type 1 and type 2 diabetes

Cell-biology based therapies: replace/sustain beta cell function through regeneration, reprogramming and replacement including beta cell biology, regenerative medicine, gene therapy, and transplantation

Devices: accelerate technologies by combining biological, mathematical and engineering knowledge to develop novel ways to treat and deliver cures for diabetes

Rigorous RFP Process to Identify Lead Programs

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Discovery and Translation

Portfolio Approach

Preclinical

(in vivo / animal studies) Discovery

Phase 1

(1 st human dose to 1 st patient dose)

Phase 2

(1 st patient dose to 1 st pivotal dose)

Phase 3

(1 st pivotal dose to reg. submission)

Regulatory

Submission

Probability of a substance moving to the next phase: varies varies ~55% ~25% ~70% ~95%

Approval

Many ideas will be brought into the program to increase the chance of success

Project plans will include go-no go criteria and well defined milestones

Progress against milestones will be regularly assessed

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Discovery and Translation

Leveraging Minnesota’s Strengths to be a Center of Excellence

#1 in Diabetes

&

Endocrinology

(2012 report)

Industry and academic partnering is a priority

Industry is looking for innovation

# of diabetes patents is decreasing while incidence is escalating

Historically, a majority of the novel pharmaceuticals comes from academia and biotech

Different partnering models are being pursued

All eyes will be on MN as a catalyst for innovation in diabetes therapy development

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Prevention Strategy

Minnesota Diabetes Collective Impact Initiative

Decade co-leads statewide coalition with mission to become the state with the lowest incidence and the healthiest outcomes for diabetes in the nation.

• Prevention Strategy

• Identify, prioritize and scale evidence based interventions with the highest benefit for participants and public/private payers

• National Diabetes Prevention Program

• MN poised to be first state in the U.S. to implement NDPP on large scale

American Diabetes Association

Courage Center

Collective Impact Participants include:

BCBS of Minnesota

Decade of Discovery

Centers for Disease Control & Prevention

Essentia Health

Governor’s Task Force/Health Care HealthEast

ICSI

HealthPartners

International Diabetes Center The Isuroon Project

LifeScience Alley

MN Community Measurement

Minneapolis Urban League

Mayo Clinic Health System Medica

MN Department of Health MN Health Action Group

Novo Nordisk Sanford Health System

SEIU Healthcare Minnesota

Southside Community Clinic

United Way

YMCA of the Greater Twin Cities

Stairstep Foundation

Ucare

University of Minnesota

Stratis Health

UnitedHealth Group

West Side Community Health

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The Goal: Improve Health, Save $

Through the Decade of Discovery,

Minnesota has the opportunity to play a

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 Improve public health by transforming the lives of people with diabetes

 Deliver multi-billion dollar savings to the health care system, to employers, government payers and families by reigning in the huge and growing costs associated with diabetes

 Stimulate significant economic development – creating new businesses and jobs from our research

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