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 Biomanufacturing Agriculture/Food Bioinformatics Genomics Therapeutics Proteomics Diagnostics BioDefense Environment Devices

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 UniversitiesCompanies 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 AwardBiotechnology Commercialization Award Biotechnology Tax Credit MD Venture Fund Cybersecurity Tax Credit Research and Development Tax Credit TEDCO USM MBC DBED KEY:

...to REVENUES