The Need for Regulatory Science
April 15, 2013
Judith A. Britz, PhD
Executive 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
Proteomics
Genomics
Therapeutics
Agriculture/Food
Biomanufacturing
Bioinformatics
Devices
BioDefense
Diagnostics
Environment
MD Life Science Community
Maryland Bio Facts: 2013
>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
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
•
•
•
•
•
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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
MD STEM Cell Research Fund
MD Innovation Initiative
Phase I
Phase II
Phase III
Tech. Commercialization Fund
Technology Validation Program
Patent Assistance Program
Angel Affinity Funds
Maryland Industrial Partnerships (MIPS)
Translational Research Award
KEY:
Biotechnology Commercialization Award
Biotechnology Tax Credit
TEDCO
Cybersecurity Tax Credit
USM
MBC
Research and Development Tax Credit
DBED
MD Venture Fund
Universities
Basic Research
Translational Research
Companies
Product Development
www.Bio.Maryland.gov
. . .to REVENUES