Larry M. De Young, Ph.D.
Larry has extensive experience in helping biopharmaceutical and life science companies turn
their science into sales. Larry’s background includes drug discovery research, drug
development and new product planning. He held senior positions in each of these drug
industry areas during his 18 years at Syntex, and continued his new product planning career
as Vice President of two startup biotechnology companies and Vice President of New Product
Planning for the Healthcare division of Genencor International. Larry has had extensive
experience in global strategic marketing . He has provided these services to client companies
developing products in virtually all therapeutic areas. Link to CV
Brad Hayden, Ph. D.
Before joining F. Hoffmann - La Roche pharmaceuticals as a Regulatory Affairs
communications and documentation specialist, Brad was the former Executive Editor of the
Michigan Academy of Science, Arts, and Letters. He has worked with biopharmaceutical
executives as a consultant, practitioner, and mentor for 20+ years. His special expertise is
“Managed Scientific Writing,” a process that results in improved clinical design, more effective
regulatory documentation, and faster NDA filings and approvals. He is also experienced in the
facilitation of health authority interactions, such a FDA Advisory Committee preparation. Link to
Resume
Larry has extensive experience in helping biopharmaceutical and life science companies turn
their science into sales. Larry’s background includes drug discovery research, drug
development and new product planning. He held senior positions in each of these drug
industry areas during his 18 years at Syntex, and continued his new product planning career
as Vice President of two startup biotechnology companies and Vice President of New Product
Planning for the Healthcare division of Genencor International. Larry has had extensive
experience in global strategic marketing . He has provided these services to client companies
developing products in virtually all therapeutic areas. Link to CV
Brad Hayden, Ph. D.
Before joining F. Hoffmann - La Roche pharmaceuticals as a Regulatory Affairs
communications and documentation specialist, Brad was the former Executive Editor of the
Michigan Academy of Science, Arts, and Letters. He has worked with biopharmaceutical
executives as a consultant, practitioner, and mentor for 20+ years. His special expertise is
“Managed Scientific Writing,” a process that results in improved clinical design, more effective
regulatory documentation, and faster NDA filings and approvals. He is also experienced in the
facilitation of health authority interactions, such a FDA Advisory Committee preparation. Link to
Resume
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| Principal Partners' Background & Expertise |
| Strategic Affiliations |
Cynthia Rask, M. D.
DYH maintains a close working relationship with former FDA Division Director, Cynthia Rask,
M.D. This strategic alliance is designed to facilitate successful interactions between
biopharmaceutical development teams and regulatory authorities such as FDA.
Dr. Rask, a neurologist, has extensive experience in both drug development and regulatory
oversight of drug development, including more than 3 years working at FDA as a Division
Director, where she supervised clinical and preclinical reviews of all cell, tissue, and gene
therapies under IND for all clinical indications, including neurologic, oncologic, metabolic and
cardiovascular diseases.
Link to News Release
Link to Dr. Rask's CV
Norio Himori-san, Ph. D.
DYH recently announced a liaison in Japan, where the former head of the Department of
Clinical Pharmacology at Nippon Roche, Dr. Norio Himori, now represents DYH interests and
activities in Japan. A highly respected scientist and pharmacologist with a wide range of
experience in pharmaceutical development, Dr. Himori will work along side of DYH to
strengthen pharmaceutical developments in Japan by improving interactions with Japanese
regulatory authorities (the Ministry of Health, Labour and Welfare) and by applying processes
to shorten development times while strengthening label claims.
DYH maintains a close working relationship with former FDA Division Director, Cynthia Rask,
M.D. This strategic alliance is designed to facilitate successful interactions between
biopharmaceutical development teams and regulatory authorities such as FDA.
Dr. Rask, a neurologist, has extensive experience in both drug development and regulatory
oversight of drug development, including more than 3 years working at FDA as a Division
Director, where she supervised clinical and preclinical reviews of all cell, tissue, and gene
therapies under IND for all clinical indications, including neurologic, oncologic, metabolic and
cardiovascular diseases.
Link to News Release
Link to Dr. Rask's CV
Norio Himori-san, Ph. D.
DYH recently announced a liaison in Japan, where the former head of the Department of
Clinical Pharmacology at Nippon Roche, Dr. Norio Himori, now represents DYH interests and
activities in Japan. A highly respected scientist and pharmacologist with a wide range of
experience in pharmaceutical development, Dr. Himori will work along side of DYH to
strengthen pharmaceutical developments in Japan by improving interactions with Japanese
regulatory authorities (the Ministry of Health, Labour and Welfare) and by applying processes
to shorten development times while strengthening label claims.
Other Contacts & Associations
DYH works with a network of professional contacts around the world. We can supply highly
skilled, specialized expertise when needed at an effective cost in such areas as financial
modeling/forecasting, market research, scientific development (CMC, biologic, nonclinical,
statistics, and clinical), and clinical operations.
DYH works with a network of professional contacts around the world. We can supply highly
skilled, specialized expertise when needed at an effective cost in such areas as financial
modeling/forecasting, market research, scientific development (CMC, biologic, nonclinical,
statistics, and clinical), and clinical operations.
For Regulatory document management and e-publishing solutions for biopharmaceutical
project, DYH recommends Moonbay Technology.
project, DYH recommends Moonbay Technology.
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