Navigation Links
Dr. Daniel Spyker, Former FDA acting Deputy Division Director of Cardiovascular, Respiratory, and Neurological Devices, Joins NDA Partners

NDA Partners Chairman Carl Peck, MD, announced today that Dr. Daniel Spyker, PhD, MD former Acting Deputy Director in the FDA CDRH Division of Cardiovascular, Respiratory, and Neurological Devices and Medical Officer in CDER’s Pilot Drug Evaluation Staff has joined the company as an Expert Consultant.

In Dr. Spyker’s accomplished career, he held positions as Senior Director of Drug Safety and Pharmacovigilance at Alexza Pharmaceuticals; Director, Pharmacokinetics and Pharmacodynamic Sciences, Genentech, where he established the clinical pharmacology unit; and Senior Medical Director, Clinical Risk Assessment and Coordination Department at Purdue Pharma.

Dr. Spyker was a member of the Internal Medicine faculty in the Division of Clinical Pharmacology at the University of Virginia for 10 years, where he fostered and nurtured the Blue Ridge Poison Center. He was also founder and CEO of a software company specializing in poison center data collection and Bayesian pharmacokinetic applications.

“Dr. Daniel Spkyer’s knowledge and expertise of cardiovascular, respiratory, and neurological devices at FDA and in the Industry, in addition to his expertise in quantitative clinical pharmacology and toxicology, make him an excellent addition to NDA Partners. He will bring great value to our medical device clients and we are very pleased to welcome him,” said Dr. Feigal, who heads NDA Partners’ Medical Device Practice.

Dr. Spyker earned his PhD from the University of Minnesota in Electrical Engineering and Mathematics, his MD from the University of Virginia, and MS from Purdue University. He is board certified in Internal Medicine, a diplomate of the American Board of Medical Toxicology, and diplomate of the American Board of Clinical Pharmacology.

About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.

Earle Martin, Chief Executive Officer
Office: 540-738-2550

Read the full story at

Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved

Related biology technology :

1. Industry Leaders DuPont & Archer Daniels Midland Win Platts Global Energy Breakthrough Solution of the Year Award
2. Danielle Vitiello, MD of Fertility Centers of New England, Named New Medical Director
3. Danielle Vitiello, MD of Fertility Centers of New England, Named Top Doc in Infertility Diagnosis and Treatment by NH Magazine
4. Global Regulatory Affairs Expert Daniela Drago, PhD Joins NDA Partners
5. Novira Therapeutics Announces Appointment of Brian F. Daniels, M.D., to its Scientific Advisory Board
6. XBiotech Adds Daniel Vasella to its Board of Directors
7. Tarsa Therapeutics Secures $10 Million And Adds Industry Veteran Daniel Soland As A Director
8. Dr. Daniel Von Hoff Joins Lixte Biotechnologys Scientific Advisory Board
9. GenoSpace Expands Its Management Team by Appointing Daniel Meyer as Chief Financial Officer
10. Repetitive Head Injuries May Not Cause Movement Problems for Former NFL Players
11. Dr. Deborah Wenkert Pediatrics Expert and Former Amgen Clinical Research Medical Director, Joins NDA Partners
Post Your Comments:
(Date:10/11/2017)... ... October 11, 2017 , ... Singh ... orphan drug designation to SBT-100, its novel anti-STAT3 (Signal Transducer and Activator of ... SBT-100 is able to cross the cell membrane and bind intracellular STAT3 and ...
(Date:10/10/2017)... (PRWEB) , ... October 10, 2017 , ... ... Science Center’s FirstHand program has won a US2020 STEM Mentoring Award. Representatives of ... award for Excellence in Volunteer Experience from US2020. , US2020’s mission is to ...
(Date:10/10/2017)... SANTA CRUZ, Calif. , Oct. 10, 2017 /PRNewswire/ ... SBIR grant from the NIH to develop RealSeq®-SC (Single ... preparation kit for profiling small RNAs (including microRNAs) from ... Cell Analysis Program highlights the need to accelerate development ... "New techniques for ...
(Date:10/9/2017)... Oct. 9, 2017  BioTech Holdings announced today ... which its ProCell stem cell therapy prevents limb ... The Company, demonstrated that treatment with ProCell resulted ... saved as compared to standard bone marrow stem ... resulted in reduction of therapeutic effect.  ...
Breaking Biology Technology:
(Date:5/16/2017)... May 16, 2017  Veratad Technologies, LLC ( ... age and identity verification solutions, announced today they will ... 2017, May 15 thru May 17, 2017, in ... International Trade Center. Identity impacts the ... in today,s quickly evolving digital world, defining identity is ...
(Date:4/18/2017)... Inc., a global expert in SoC-based imaging and computing solutions, has ... features the company,s hybrid codec technology. A demonstration utilizing TeraFaces ® ... be showcased during the upcoming Medtec Japan at Tokyo Big Sight ... Las Vegas Convention Center April 24-27. ... Click here for an image of the ...
(Date:4/11/2017)... Apr. 11, 2017 Research and Markets has ... report to their offering. ... The global eye tracking market to grow at a CAGR of ... Eye Tracking Market 2017-2021, has been prepared based on an in-depth ... market landscape and its growth prospects over the coming years. The ...
Breaking Biology News(10 mins):