1 / 18

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.

corine
Download Presentation

The Need for Regulatory Science April 15, 2013

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related