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 (CDDS) at the UCSF and was Guest Medical Reviewer, Division of Cardio-Renal Products and Guest Researcher, Office of Clinical Pharmacology and Biopharmaceutics, FDA CDER.

In-Jin (Theo) Jang, MD, PhD - Dr Jang is a professor in the Department of Clinical Pharmacology at the Seoul National University College of Medicine and Director of the Department of Pharmacology at the Seoul National University Hospital.

According to Dr Peck, “Our new Premier Experts strengthen our position as one of the premier strategy consulting firms in the world in the area of medical product development. We are pleased with the extraordinary depth of expertise and accomplishment that they will bring to bear on the solutions we provide for our clients.”

About NDA Partners
NDAP 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 and investment funds. The highly experienced Principals and Premier Experts of NDA Partners include two former FDA Center Directors and an extensive international team of former pharmaceutical and medical device industry senior executives and regulators. Services include expert consulting, product development planning, regulatory strategy, advisory boards, product assessments and due diligence, litigation and patent support, and associated support projects.

Read the full story at http://www.prweb.com/releases/2013/6/prweb10806434.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

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:5/25/2016)... ... May 25, 2016 , ... Biohaven Pharmaceutical ... (FDA) has granted the company’s orphan drug designation request covering BHV-4157 for the ... granted by the FDA. , Spinocerebellar ataxia is a rare, debilitating neurodegenerative ...
(Date:5/24/2016)... ... May 24, 2016 , ... Media ... The new Media Cybernetics corporate branding reflects a results-driven revitalization for a company ... analysis. The re-branding components include a crisp, refreshed logo and a new web ...
(Date:5/23/2016)... 23, 2016 Oxitec CEO Hadyn ... at 10:15 a.m. ET before the United States House Committee ... mosquitos can play in controlling the spread of the ... virus.      (Logo: http://photos.prnewswire.com/prnh/20150630/227348 ) ... a self-limiting gene. Trials in Brazil , ...
(Date:5/22/2016)... ... May 22, 2016 , ... Doctors in Rome say micronutrients found in certain ... mesothelioma. Surviving Mesothelioma has just posted an article on the new research. Click ... of Clinical Sciences and Translational Medicine evaluated more than 150 studies on polyphenols in ...
Breaking Biology Technology:
(Date:4/26/2016)... and LONDON , April ... part of EdgeVerve Systems, a product subsidiary of ... today announced a partnership to integrate the Onegini ...      (Logo: http://photos.prnewswire.com/prnh/20151104/283829LOGO ) ... their customers enhanced security to access and transact ...
(Date:4/15/2016)... 2016  A new partnership announced today will ... decisions in a fraction of the time it ... high-value life insurance policies to consumers without requiring ... Force Diagnostics, rapid testing (A1C, Cotinine and HIV) ... pressure, weight, pulse, BMI, and activity data) available ...
(Date:4/13/2016)... , April 13, 2016  IMPOWER physicians supporting Medicaid ... setting a new clinical standard in telehealth thanks to ... leveraging the higi platform, IMPOWER patients can routinely track ... and body mass index, and, when they opt in, ... convenient visit to a local retail location at no ...
Breaking Biology News(10 mins):