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:9/2/2015)... Research and Markets ( http://www.researchandmarkets.com/research/cqsxmg/gene_therapy ) ... "Gene Therapy - Technologies, Markets and Companies" ... therapy are difficult to estimate as there is only ... in China since 2004. Gene ... estimates are based on epidemiology of diseases to be ...
(Date:9/2/2015)... Biovista Inc. is glad to ... BeHEARD science challenge, a global competition hosted by the ... to the latest life science innovations and technologies. ... analytics capability to support Steven Laffoon and ... of Niemann-Pick Disease Type A (NPA), a rare and ...
(Date:9/2/2015)... , Sept. 2, 2015  Neurotech Pharmaceuticals, ... enrolled in the multicenter Phase 2 clinical trial ... long-term treatment of recurrent subfoveal choroidal neovascularization secondary ... is a unique vascular endothelial growth factor (VEGF) ... implant. "This landmark proof-of-concept study will ...
(Date:9/2/2015)... , Sept. 2, 2015 Aytu BioScience, Inc. ... treatments for urological and related conditions, announced today that ... private placement convertible note financing, raising a total of ... totaling $3.175 million. Josh Disbrow ... this private placement are intended to be used to ...
Breaking Biology Technology:Global Gene Therapy Market Study 2015-2024 - Technologies, Markets and Companies Analysis 2Biovista Sponsors Wylder Nation Foundation's Research on Acid Sphingomyelinase Deficiency 2Neurotech Announces First Patient Enrolled in Novel Anti-VEGF Encapsulated Cell Therapy Study 2Neurotech Announces First Patient Enrolled in Novel Anti-VEGF Encapsulated Cell Therapy Study 3Neurotech Announces First Patient Enrolled in Novel Anti-VEGF Encapsulated Cell Therapy Study 4Aytu BioScience Completes $5.175 Million Private Placement 2Aytu BioScience Completes $5.175 Million Private Placement 3
... , , ST. LOUIS, Aug. ... Board of Directors meeting held today, the Directors declared a quarterly ... on September 15, 2009 to shareholders of record on September 1, ... is a leading Life Science and High Technology company. Our chemical ...
... Baltimore Convention Center - September 21-23, 2009 ... will attract more than 1,200 experts from more than 25 countries ... speakers, including governors, federal officials, and top researchers and scientists and ... stories. This is your chance to meet and talk to ...
... Aug. 11 ValGenesis, Inc., a leading provider ... availability of Microsoft SharePoint Server integration with the ... productivity specifically for regulated Pharmaceuticals, Biotech and Medical ... access, retrieval and storage of corporate validation data ...
Cached Biology Technology:World Stem Cell Summit to Be Held in Baltimore 2ValGenesis, Inc. Announces Integration of ValGenesis Solution with Microsoft SharePoint Server 2
(Date:9/2/2015)... , September 2, 2015 ... security purpose implied in a system which uses ... voice, signature, iris, vein, DNA and finger print. ... forced to develop such system which provides high ... password, PIN, Patterns and tokens are vulnerable to ...
(Date:8/28/2015)... , August 28, 2015 ... and Training Market by Assessment Type (Pen & Paper ... Brain Training, Corporate Learning, Academic Research), Vertical and Region ... Assessment and Training Market to grow from USD 2.4 ... at a Compound Annual Growth Rate (CAGR) of 25.6% ...
(Date:8/24/2015)... Aug. 24, 2015  Based on its recent analysis of ... the 2015 African Biometrics Company of the Year Award. DERMALOG ... commercial success in Africa . It has ... it has implemented one of the largest biometric mass applications ... as the Central Bank of Nigeria ...
Breaking Biology News(10 mins):Biometrics Technology Market is Expected to Reach $13.8 Billion by 2015: Hexa Research Inc. 2Biometrics Technology Market is Expected to Reach $13.8 Billion by 2015: Hexa Research Inc. 3Biometrics Technology Market is Expected to Reach $13.8 Billion by 2015: Hexa Research Inc. 4Cognitive Assessment and Training Market Worth 7.5 Billion USD by 2020 2Cognitive Assessment and Training Market Worth 7.5 Billion USD by 2020 3Cognitive Assessment and Training Market Worth 7.5 Billion USD by 2020 4Frost & Sullivan Applauds DERMALOG's Rise as the Supplier of Best-in-class Biometric Solutions in Africa 2Frost & Sullivan Applauds DERMALOG's Rise as the Supplier of Best-in-class Biometric Solutions in Africa 3Frost & Sullivan Applauds DERMALOG's Rise as the Supplier of Best-in-class Biometric Solutions in Africa 4Frost & Sullivan Applauds DERMALOG's Rise as the Supplier of Best-in-class Biometric Solutions in Africa 5Frost & Sullivan Applauds DERMALOG's Rise as the Supplier of Best-in-class Biometric Solutions in Africa 6
... The Translational Genomics Research Institute (TGen), Scottsdale Healthcare and ... help cancer patients by stimulating the immune system. ... at TGen Clinical Research Services at Scottsdale Healthcare, a ... and at Mayo Clinic in Arizona. Dr. Ramesh ...
... that we can only learn how to do something by ... light of recent discoveries in neuroscience. It turns out that ... mirror neurons that fire in the same pattern whether performing ... an important role in learning motor tasks involving hand eye ...
... in The Netherlands will award an honorary doctorate to ... BioNanotechnology in Medicine, at Northwestern University, Chicago. He will ... Friday, 24 April 2009. Stupp (57) is being honored ... for complex molecular systems in biomedical technology. His findings ...
Cached Biology News:TGen, Scottsdale Healthcare, Mayo Clinic study new drug to stimulate immune system of cancer victims 2How mirror neurons allow us to learn and socialize by going through the motions in the head 2Samuel Stupp to receive honorary doctorate from TU/e 2
Request Info...
Ultra-sensitive, non-radioactive measurement of COX-I and COX-II activity...
Recombinant Ovine (Sheep) Growth Hormone, Ultra Pure...
Mouse Granzyme D MAb (Clone 190617)...
Biology Products: