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:8/18/2014)... TORONTO , Aug. 18, 2014 /PRNewswire/ - SQI Diagnostics ... and commercializes proprietary technologies and products for advanced microarray ... call on Friday, August 22 at 2:00 pm ET.  ... , CEO, will provide a brief review of SQI,s ... Pronovost , a diagnostics industry veteran recently appointed to ...
(Date:8/18/2014)... , August 18, 2014 ... Transparency Market Research "Life Science Reagents Market(Products- PCR ... Electrophoresis, Chromatography, In-Vitro Diagnostic Reagents and Others; End ... Institutions, Clinical Laboratories, and Forensic Laboratories)- Global Industry ... - 2019", the global life science reagents market ...
(Date:8/18/2014)... , 18. August 2014 ... in eine internationale klinische Studie auf, in ... Die Linse soll das Sehvermögen bei allen ... der Operation möglicherweise keine Lese- oder Gleitsichtbrille ... dem Namen FluidVision Accommodating Intraocular Lens ...
(Date:8/15/2014)... FOREST, Ill. , Aug. 15, 2014   ... world,s leading provider of injectable drugs and infusion technologies, ... Morgan Stanley Global Healthcare Conference on Tuesday, Sept. 9, ... The presentation is scheduled to begin at 11:45 ... will be available to all interested parties through a ...
Breaking Biology Technology:SQI Diagnostics Announces Investor Conference Call with Dr. Allan Pronovost 2SQI Diagnostics Announces Investor Conference Call with Dr. Allan Pronovost 3Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 2Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 3Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 4Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 5Implantation einer revolutionären akkommodativen Linse bei Katarakt-Patienten in deutschen Augenzentren im Rahmen einer internationalen klinischen Studie 2Implantation einer revolutionären akkommodativen Linse bei Katarakt-Patienten in deutschen Augenzentren im Rahmen einer internationalen klinischen Studie 3Implantation einer revolutionären akkommodativen Linse bei Katarakt-Patienten in deutschen Augenzentren im Rahmen einer internationalen klinischen Studie 4
... and economic development efforts here are taking shape with ... , ,The state is giving Wisconsin Indianhead Technical ... work with local businesses. With the grant, northern Wisconsin ... their workers in industrial maintenance, electrical, supervisory management, and ...
... for fishing enthusiasts may not guarantee you catching "the ... promising spots to cast a lure. , ,A newly ... topographical maps of about 1,000 Wisconsin lakes with global ... ideal fishing locations. The application requires only an Internet ...
... of this article is deliberately misleading. It feeds into ... a bunch of generational tribes engaged in rivalries and ... misunderstandings and tensions among workers born in different eras ... is overblown in my view. , ,Recently, I had ...
Cached Biology Technology:Superior receives funds for technical training 2Online fishing site introduces interactive maps 2Online fishing site introduces interactive maps 3Geezers, grungers, gen-Xers and geeks - a look at workplace generational conflict 2Geezers, grungers, gen-Xers and geeks - a look at workplace generational conflict 3Geezers, grungers, gen-Xers and geeks - a look at workplace generational conflict 4
(Date:8/19/2014)... and Network-Level Science, , Imagine if we had the ... was responding to global changes in real time. Such ... multiple decades of information about ecological responses to environmental ... of different ecosystem types. , In fact, this ... Network, which will soon celebrate its 35th anniversary. , ...
(Date:8/19/2014)... Two Northwestern University scientists have identified a biomarker ... aggressive carcinoma that is resistant to many types ... provides a smart target for new therapeutics designed ... breast cancer patient data taken from The Cancer ... Robert W. Tell used powerful computational and bioinformatics ...
(Date:8/19/2014)... Texas Health Science Center at San Antonio and The ... the awarding of more than $750,000 in grants through ... , Launched in 2003, SALSI is a model of ... health science center join forces for greater research and ... with a focus on public health issues and diseases ...
Breaking Biology News(10 mins):This week from AGU: Long-term ecological research, predicting cholera outbreaks 2Biomarker in an aggressive breast cancer is identified 2Biomarker in an aggressive breast cancer is identified 3San Antonio Life Sciences Institute awards $750,000 to innovators 2San Antonio Life Sciences Institute awards $750,000 to innovators 3
... effort led by The Burnham Institute's Gen-Sheng Feng has ... activity in the liver, and generated new findings about ... understanding the pathogenesis of type 2 diabetes. These results, ... made available to the scientific community by advance posting ...
... stem cell lines specifically tailored to match the nuclear DNA ... from disease or spinal cord injury. , The research is ... AAAS, the non-profit science society, on the Science Express website ... the study of human disease in cells in the laboratory. ...
... embryonic stem cell lines specifically tailored to match the nuclear ... suffering from disease or spinal cord injury. , The research ... by AAAS, the non-profit science society, on the Science Express ... enable the study of human disease in cells in the ...
Cached Biology News:Mouse with designer liver has enhanced glucose tolerance, insulin response 2Mouse with designer liver has enhanced glucose tolerance, insulin response 3SuperLigands - a database of ligand structures derived from the Protein Data Bank 2SuperLigands - a database of ligand structures derived from the Protein Data Bank 3SuperLigands - a database of ligand structures derived from the Protein Data Bank 4Scientists generate patient-specific stem cells, Science study says 2Scientists generate patient-specific stem cells, Science study says 3Scientists generate patient-specific stem cells, Science study says 4
... Chemicon Detergent-OUT Kit is a simple high ... solutions. Removes detergents without significant dilution ... protein solution on the Detergent-OUT Spin column ... columns are suitable for removing detergent from ...
... electrophoresis hood is a component ... Placed on the transilluminator, it ... and provides a darkroom environment ... lab bench. This 13 x ...
... Chemicon Detergent-OUT SDS Kit is a simple ... protein solutions. Removes detergents without significant ... the protein solution on the Detergent-OUT Spin ... Med columns are suitable for removing ...
... microarrays are derived from frozen embedded tissue ... control procedures to ensure the highest quality. ... in one block, sectioned at a thickness ... slides. Sections are large (3-5 mm in ...
Biology Products: