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The Need for Regulatory Science April 15, 2013

The Need for Regulatory Science April 15, 2013. Judith A. Britz, PhD Executive Director, BioMaryland Center. BIO Maryland 2020: 10 Year Strategic Plan.

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The Need for Regulatory Science April 15, 2013

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  1. The Need for Regulatory ScienceApril 15, 2013 Judith A. Britz, PhD Executive Director, BioMaryland Center

  2. 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.

  3. What is the Life Science Industry in Maryland?

  4. Maryland Biotechnology Industry Genomics Proteomics Therapeutics Bioinformatics BioDefense Diagnostics Biomanufacturing Agriculture/Food Environment Devices

  5. MD Life Science Community

  6. 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

  7. 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

  8. Who recognizes this Scientist?

  9. 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

  10. What will make Maryland (and the US) more Competitive? Getting more products to market faster!

  11. 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

  12. 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

  13. FREE Access to Market Research Resources BioMed Tracker • Frost & Sullivan • MedTrack • Recap • Synapse

  14. 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

  15. 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

  16. Maryland’s Funding Programs MD STEM Cell Research Fund MD Innovation Initiative Phase II Phase I Phase III Tech. Commercialization Fund Technology Validation Program Patent Assistance Program Angel Affinity Funds Maryland Industrial Partnerships (MIPS) Translational Research Award Biotechnology Commercialization Award KEY: Biotechnology Tax Credit TEDCO Cybersecurity Tax Credit USM MBC Research and Development Tax Credit DBED MD Venture Fund Universities Companies Translational Research Basic Research Product Development

  17. www.Bio.Maryland.gov

  18. . . .to REVENUES

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