Navigation Links
NDA Partners Introduces New Premier Expert Consultants
Date:6/7/2013

Madison, VA (PRWEB) June 07, 2013

Carl Peck, MD, Chairman of NDA Partners LLC (NDAP), today announced the addition of three senior industry executives to its roster of Premier Expert consultants. NDAP’s Premier Experts are top tier consultants whose expertise and professional stature allow them to bring extraordinary value to NDAP clients that face complex and challenging issues in the development, regulatory approval and commercialization of medical products. NDAP’s Premier Experts provide expert consulting in product development and regulatory strategies, expert reports and testimony in litigation disputes, and due diligence in investment decisions. As participants on NDA Partners project teams, they collaborate with the Partners and other Premier Experts to design and implement critical solutions needed to advance products through the development, regulatory and commercialization process.

Kathryn Stein, PhD – Dr Stein is a former Director of the Division of Monoclonal Antibodies (DMA) at the US Food & Drug Administration (FDA). She was lead or co-author on all of the guidance documents published by the FDA specific for monoclonal antibodies, a co-author of the FDA guidance on comparability and led the committee and co-authored the draft FDA-USDA Guidance for Industry on Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants. During Dr. Stein’s tenure as Director of DMA, 15 of the first 17 monoclonal antibodies were approved. She has 11 years of post-FDA industry experience in product development, regulatory affairs and biologics manufacturing.

Howard Lee, MD, PhD - Dr Lee is a Professor and head of the Clinical Trials Center, Seoul National University Hospital, Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine. He has formerly held positions as Associate Director for Research and Director of the Center for Drug Development Science (CD
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

Related biology technology :

1. ACORN Research, LLC Announces Partnership with AdeptBio, LLC
2. Dicom Systems and USARAD.com Announce Partnership and Introduce Beta Version of XMRI.com, New System by USARAD.com
3. Palatin Technologies to Present at Windhovers Therapeutic Area Partnerships Conference
4. Van Andel Institute Partners with UNCF to Recruit Students to Biomedical Research Careers
5. BioStorage Technologies Partners with Susan G. Komen for the Cure Tissue Bank at IU Simon Cancer Center to Raise Money and Awareness for Breast Cancer Research
6. Cowen Healthcare Royalty Partners Raises $1 Billion
7. Life Technologies Partners With DaAn Gene to Develop and Commercialize Molecular Diagnostic Assays in China
8. CoreLab Partners Opens Office in Tokyo, Japan
9. Unigene Receives 2012 Drug Delivery Partnerships Industry Achievement Award
10. JBT Corporation and Swisslog Enter Into Partnership for Automated Guided Vehicles
11. RiverVest Venture Partners Sells Four Successful Life Science Companies for More than $1 Billion
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/20/2015)... (PRWEB) May 20, 2015 Optivia ... assay services for Drug-Drug Interactions (DDI), Metabolism and ... a world leader in assessing impact of drugs ... Pharmacology supported by biosimulation, announced today that they ... allows both companies to expand their product and ...
(Date:5/20/2015)... May 20, 2015  HOSTING, the leading provider ... it is an official partner of the ... Cooperative Members Services Program. This unique collaboration ... cloud services and best practices derived from ... and service providers, enabling member healthcare organizations ...
(Date:5/20/2015)... May 20, 2015 (PRWEB) May 20, 2015 ... Computer Aided Engineering software, today announced the release of ... the 0D and 1D management and analyses of chemical ... Steve Portal, now features a library generation functionality ... new fuel blends and operating conditions for simulations with ...
(Date:5/20/2015)... The Honey Bee Health Coalition applauded the ... of Honey Bees and other Pollinators and the accompanying ... Obama’s Pollinator Health Task Force. The Strategy represents ... bees and other pollinators that support billions of dollars ... clear goals for pollinator health that underscore the importance ...
Breaking Biology Technology:Optivia Biotechnology Inc. and Rhenovia Pharma Sign Partnership Agreement 2Optivia Biotechnology Inc. and Rhenovia Pharma Sign Partnership Agreement 3HOSTING Named Partner of the CHIME Cooperative Member Services Program 2HOSTING Named Partner of the CHIME Cooperative Member Services Program 3CD-adapco’s New DARS v2.10 Release Enhances User Capabilities 2CD-adapco’s New DARS v2.10 Release Enhances User Capabilities 3Honey Bee Health Coalition Ready to Provide Leadership in Implementing National Pollinator Health Strategy 2Honey Bee Health Coalition Ready to Provide Leadership in Implementing National Pollinator Health Strategy 3Honey Bee Health Coalition Ready to Provide Leadership in Implementing National Pollinator Health Strategy 4Honey Bee Health Coalition Ready to Provide Leadership in Implementing National Pollinator Health Strategy 5Honey Bee Health Coalition Ready to Provide Leadership in Implementing National Pollinator Health Strategy 6Honey Bee Health Coalition Ready to Provide Leadership in Implementing National Pollinator Health Strategy 7
... use, reliability and ... convenience, ... availability of easypod(R), the first of its kind,automated device in the ... [somatropin (rDNA origin) for,injection], the company,s treatment for growth hormone deficiency. ...
... proteins in their natural environment and interactions inside ... advanced microscopy technique called cryo-electron tomography, researchers from ... proteins responsible for cell-cell contacts for the first ... publish the first 3D image of human skin ...
... (NYSE: SGP ) was honored by Scrip ... industry awards: Large Pharma Company,of the Year, Management ... Year for,Fred Hassan, Schering-Plough chairman and CEO., ... and achievement,within the pharmaceutical and biotech industries. Scrip ...
Cached Biology Technology:Video and Photo: EMD Serono Launches easypod(R), New Electronic Growth Hormone Injection Device 2Video and Photo: EMD Serono Launches easypod(R), New Electronic Growth Hormone Injection Device 3Video and Photo: EMD Serono Launches easypod(R), New Electronic Growth Hormone Injection Device 4The closest look ever at native human tissue 2Schering-Plough Wins Three of Scrip's Top Pharma Industry Awards 2
(Date:5/21/2015)... 2015 The Sync Project™ , a ... health, today announced a collaborative partnership with Berklee,s ... center on collaboration on original research, joint course development ... the collaboration, The Sync Project and BerkleeICE are exploring ... in the 2015-2016 academic year.  The ...
(Date:5/20/2015)... Conn. , May 20, 2015 NXT-ID, ... announces that its wholly owned subsidiary, 3D-ID LLC, a ... under Team Battelle for the biometrics technology portion of ... Suite Contract from the Department of the Army. ... recognition products developed for government, law enforcement and security ...
(Date:5/19/2015)... -- Technology is rapidly advancing, outpacing enterprises, ability to secure ... and their management are soon to be rendered obsolete ... as those developed by the FIDO Alliance™. With the ... BYOD, COPE, IoT, and mobile payments, the interconnected online ... In response to the call for seamless, secure, ...
Breaking Biology News(10 mins):The Sync Project Announces Partnership with Berklee College of Music's Institute for Creative Entrepreneurship 2The Sync Project Announces Partnership with Berklee College of Music's Institute for Creative Entrepreneurship 3NXT-ID, Inc Announces Participation as Member of Team Battelle for TIES Contract Award 2NXT-ID, Inc Announces Participation as Member of Team Battelle for TIES Contract Award 3HYPR Corp. Biometric Security Integration Kit Shields Applications and Devices Across the Internet of Things 2HYPR Corp. Biometric Security Integration Kit Shields Applications and Devices Across the Internet of Things 3
... last few decades in old-growth forests of the western United ... is regional warming, according to a U.S. Geological Survey-led (USGS) ... The study found that the increase in dying trees has ... variety of forest types, at all elevations, in trees of ...
... Medical System researchers have discovered there are differing taste ... for future smoking-cessation products. "We learned some ... postdoctoral fellow of the Duke Department of Neurobiology. "This ... taste pathways activated by nicotine, and how these pathways ...
... researchers have identified a cellular mechanism that could someday ... Stephen Helfand and Nicola Neretti and others adds another ... biology, molecular biology, cell biology and biochemistry, first discovered ... the Indy ("I,m Not Dead Yet") gene that can ...
Cached Biology News:Tree deaths have doubled across the western US 2Nicotine activates more than just the brain's pleasure pathways 2Scientists unlock possible aging secret in genetically altered fruit fly 2
... New Concept in Microarrays: Biomedical Photometrics Inc. ... GmbH (Jena, Germany) have collaborated to develop ... ArrayTube System. The DNAscope AT is ... new DNAscope AT automatically reads up to ...
Complement factor B (human)...
Best pricing for 100mg-1.0g scales. Phosphopeptides are our specialty....
... Capillary Electrophoresis Running Buffer was designed to ... demands of todays sequencing labs. As a ... to the gel-based sequencing community Sigma has ... to meet your buffer needs. Scientists at ...
Biology Products: