The Need for Regulatory ScienceApril 15, 2013

Judith A. Britz, PhDExecutive Director, BioMaryland Center

BIO Maryland 2020: 10 Year Strategic Plan

In 2007, Governor O’Malley committed to invest $1.3 Billion to support the Biotechnology Industry in Maryland – the largest financial commitment of any State.

What is the Life Science Industry in Maryland?

Maryland Biotechnology Industry

Biomanufacturing

Agriculture/Food

Bioinformatics

Genomics

Therapeutics

Proteomics

Diagnostics BioDefense

EnvironmentDevices

MD Life Science Community

>500 BioCompanies- 50% Drug Development and Vaccines- 25% Devices and Diagnostics- 25% CROs and Research Tools Companies

>34,000 Employees- Average Salary: $91,100

>>$10 Billion in Revenues

Maryland Bio Facts: 2013

Who starts Life Science Companies in Maryland?

• Many Founders are Scientists • Originating from NIH, Johns Hopkins, or

University of Maryland• Many have not had product development

experience in industry• Most have not taken products through the

FDA

Who recognizes this Scientist?

HIV Blood Screening Test

• 1984: AIDS• New deadly virus: HTLV-III• June 1984: First experiments• May 1985: FDA licensed products• Among the best developed by Industry• Industry, Academia, and Government unified

by National Crisis

What will make Maryland (and the US) more Competitive?

Getting more products to market faster!

How?

• The University can act as a neutral party between FDA and industry– Offering training– Standards

• Better Regulatory Science!– Innovative Clinical Trial Designs– New uses of Statistics– Comparative Effectiveness

Increase Awareness

• Need to “Begin with the end in mind”• Understanding of basic regulatory practices

– Role of reimbursement

• Early requirement for Quality Systems– First Design Control documents

• Knowledge of regulations outside the US– Markets are worldwide– Harmonization does not yet exist

FREE Access to Market Research Resources

BioMed Tracker • Frost & Sullivan • MedTrack • Recap • Synapse

Career Opportunities

• Maryland has the highest concentration of PhDs in the United States

• Regulatory Science is a career pathway• Relevant curricula combined with real world

experience vital• Certificate programs ideal for rapid training

Maryland Innovation Initiative

• Purpose: Commercialization of University Research/IP

• Participating: Hopkins, University of Maryland (UMBC, UMB, UMCP),Morgan State

• 2012: $5.8M First Year Funding• 2013: $5M Followon• Companies who have licensed University Research

eligible• Administered by TEDCO

Maryland’s Funding Programs

Universities Companies

MD STEM Cell Research Fund

MD Innovation Initiative

Phase II Phase IIIPhase I

Basic Research Translational Research Product Development

Technology Validation Program

Patent Assistance Program

Tech. Commercialization Fund

Angel Affinity Funds

Maryland Industrial Partnerships (MIPS)

Translational Research Award Biotechnology Commercialization Award

Biotechnology Tax Credit

MD Venture Fund

Cybersecurity Tax Credit

Research and Development Tax Credit

TEDCO

USM

MBC

DBED

KEY:

www.Bio.Maryland.gov

. . .to REVENUES