Navigation Links
Dr. Daniel Spyker, Former FDA acting Deputy Division Director of Cardiovascular, Respiratory, and Neurological Devices, Joins NDA Partners
Date:2/22/2017

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.

Contact
Earle Martin, Chief Executive Officer
Office: 540-738-2550
MartinEarle(at)ndapartners(dot)com

Read the full story at http://www.prweb.com/releases/2017/02/prweb14083870.htm.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... ... October 11, 2017 , ... ... and pregnancy rates in frozen and fresh in vitro fertilization (IVF) ... maternal age to IVF success. , After comparing the results from the fresh ...
(Date:10/10/2017)... ... October 10, 2017 , ... For ... has won a US2020 STEM Mentoring Award. Representatives of the FirstHand program travelled ... Volunteer Experience from US2020. , US2020’s mission is to change the trajectory of ...
(Date:10/10/2017)... ... October 10, 2017 , ... ... process optimization firm for the life sciences and healthcare industries, announces a presentation ... San Francisco. , The presentation, “Automating GxP Validation for Agile Cloud Platforms,” will ...
(Date:10/9/2017)... ... October 09, 2017 , ... At its national board meeting in North Carolina, ... Harvard University’s Departments of Physics and Astronomy, has been selected for membership in ... team for the 2015 Breakthrough Prize in Fundamental physics for the discovery of the ...
Breaking Biology Technology:
(Date:6/30/2017)... Today, American Trucking Associations announced Seeing ... and eye tracking software, became the newest member ... "Artificial intelligence and advanced sensing algorithms ... driver,s attentiveness levels while on the road.  Drivers ... fatigue and prevent potential accidents, which could lead ...
(Date:5/23/2017)... GENOA, Italy , May 23, 2017  Hunova, the first robotic ... and trunk, has been officially launched in Genoa, Italy ... Europe and the USA . The ... launched on the market by the IIT spin-off Movendo Technology thanks to ... view the Multimedia News Release, please click: ...
(Date:5/6/2017)... , May 5, 2017 ... just announced a new breakthrough in biometric authentication ... exploits quantum mechanical properties to perform biometric authentication. These ... smart semiconductor material created by Ram Group and ... finance, entertainment, transportation, supply chains and security. Ram ...
Breaking Biology News(10 mins):