Navigation Links
Cato Research Presents at OMICS Group Conference, 3rd International Conference on Pharmaceutical Regulatory Affairs
Date:10/21/2013

Durham, NC (PRWEB) October 21, 2013

Cato Research regulatory expert William Lee, Ph.D., R.A.C., Vice President of Regulatory Affairs at Cato Research, will present in San Francisco, California at the OMICS Group Conference, 3rd International Conference on Pharmaceutical Regulatory Affairs.

Dr. Lee's presentation is titled: "Regulatory Roadmap for Initiating a Gene Therapy Drug into Clinical Trials in the United States."

Abstract of Presentation:
Exciting progress has been made in the development of gene therapy, and experimental research has brought forward novel treatment opportunities for viral vectors, DNA vectors, and gene-modified cell therapies. Clinical development of a gene therapy drug is challenging, requiring understanding of controlled manufacturing, relevant nonclinical pharmacology and safety studies, and clinical risk factors. For initiating clinical trials in the United States, regulatory requirements for investigational gene therapy drugs are more stringent than those with other investigational biologics (recombinant antibodies or recombinant proteins).

This talk will highlight these requirements, including the following:
(1) Submissions to regulatory authorities
(2) Manufacturing
(3) Nonclinical studies

Dr. William Lee received his B.A. from The Johns Hopkins University and his Ph.D. from Cornell University Graduate School of Medical Sciences. Dr. Lee has 20 years of research and industry experience. His focus is on gene therapy with retroviral vectors, adeno-associated viral vectors, and DNA vectors. He spent 9 years at the gene therapy start-up firm Viagene, Inc., followed by 2 years at Chiron. In 1999, he joined Cato Research, in Durham, North Carolina, where he is currently Vice President, Regulatory Affairs. His projects have included the design of Phase 1 and Phase 2 protocols for a gene therapy drug and interactions with the FDA and NIH/OBA. Currently, he manages projects involving regulatory strategy and submissions of investigational new drug applications and marketing applications for biologics and drugs.

For more information about this event, please visit: http://www.cato.com/events.shtml.

About Cato Research
Founded in 1988 by Dr. Allen Cato and Lynda Sutton and headquartered near Research Triangle Park, North Carolina, Cato Research is a full-service, global contract research and development organization providing strategic and tactical support for clients in the pharmaceutical, biotechnology, and medical device industries. Services range from design and management of preclinical and clinical studies to submission of regulatory documents required for marketing approval. With a staff of approximately 300 and offices located in the United States, Europe, Canada, Israel, and South Africa, the Cato Research team consistently demonstrates an unsurpassed level of responsiveness, flexibility, attention to detail, and passion for bringing their clients’ products to market with speed and cost-effectiveness.

For more information, please contact:
Cato Research
Phone: 919-361-2286
http://www.cato.com

Read the full story at http://www.prweb.com/releases/2013/10/prweb11247724.htm.


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

Related medicine news :

1. Medical Waste Disposal Services Procurement Research Report Now Available from IBISWorld
2. Colleen’s Dream Foundation Gifts $10,000 to The University of Texas MD Anderson Cancer Center to Support Ovarian Cancer Research
3. Smartphones, GPS part of UH scientists smoking cessation research
4. Trauma Fixation Market Analysis and 2019 Forecasts in New Research Report at RnRMarketResearch.com
5. Lean On Life Supports New Research That Reveals Coconut Water’s Popularity
6. Orthopedic Market: Contract Manufacturing, Trauma Devices, Bracing & Supports 2016 Forecasts in New Research Reports at ReportsnReports.com
7. Skid row cancer study has implications for treatment today, Penn researcher says
8. Gallo Research Center announces new round of awards for $20m US Army-funded research program
9. Research shows genetic anti-inflammatory defect predisposes children to lymphoma
10. Researchers launch first-ever phase II safety study of rectal microbicide to prevent HIV
11. CWRU researchers probe brain implant failure and countermeasure
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... , ... May 04, 2016 , ... Dr. Elyson and ... tooth removal surgery at their office. Wisdom tooth removal, a common dental procedure, is ... problematic, they often are improperly erupted, resulting in risks of complications. By providing wisdom ...
(Date:5/4/2016)... ... May 04, 2016 , ... ... that supports cellular and metabolic health. This synergistic combination of omega-3 fatty acids ... along with 150 mg of reduced glutathione and 200 mg of N-Acetylcysteine (NAC). ...
(Date:5/4/2016)... ... 04, 2016 , ... Francesca Loparco, Co-Founder of Queen City Dream Cars, an ... same-day LASIK procedure at Christenbury Eye Center. The entrepreneur struggled with her computer, ... the same day as her in-office consultation and eye exam. Francesca’s eyesight was restored ...
(Date:5/4/2016)... ... May 04, 2016 , ... Pharmacy Times ... that it was chosen as the Pharmaceutical News Provider of the Year in ... acknowledge the hard work and dedication of community members who strive to make ...
(Date:5/4/2016)... ... 04, 2016 , ... Bayco Products has announced the introduction ... flashlights in models NSP-9842XL and NSR-9844XL . , First previewed at SHOT ... 2 included CR-123 batteries to produce up to 650 lumens in a variety ...
Breaking Medicine News(10 mins):
(Date:5/3/2016)... , May 3, 2016 ... heute bekannt, dass sie einen entscheidenden Meilenstein ... haben: Ein Aufruf zum Handeln, um Patientenresultate ... Veröffentlichung trägt zu Fortschritten im Verständnis der ... hervor, ein Bewusstsein für Hepatische Enzephalopathie in ...
(Date:5/2/2016)... Leading Economies with Fastest Real GDP Annual Percentage Change, 2015  ... 7.8 India 7.3, , Source: IMF and TechSci Research   ... Brazil , Russia , India ... , registered the fastest GDP growth during the first decade of the 21 ... in Brazil and Russia , along ...
(Date:5/2/2016)...  While nearly three-quarters of Americans (71%) are aware ... health, only about half report taking any steps to ... a new survey announced today by Hologic (Nasdaq: ... Osteoporosis Month, Hologic is raising awareness of this major ... Americans. Osteoporosis is a disease that causes ...
Breaking Medicine Technology: