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:6/25/2017)... ... June 25, 2017 , ... FCPX LUT Vintage Volume 2 for ... look. FCPX LUT Vintage Volume 2 contains 60 different color-grade presets, giving editors multiple ... vignettes and blurs to single out subjects, plus much more. FCPX LUT Vintage Volume ...
(Date:6/25/2017)... , ... June 25, 2017 , ... With a heatwave currently bearing down on Northern ... out at the pool. Being swimsuit ready is easy with laser hair removal. , ... again can be a burdensome routine when all you want to do is get out, ...
(Date:6/24/2017)... , ... June 24, 2017 , ... The weather is ... time outdoors. Home and business owners should be aware that the summer months provide ... In fact, mechanical locks and keys can be negatively affected from direct exposure to ...
(Date:6/23/2017)... ... June 23, 2017 , ... ... (BCRA), their proposed healthcare bill to repeal and replace the Affordable Care Act ... bill would make significant cuts to Medicaid, a public health insurance program for ...
(Date:6/23/2017)... ... June 23, 2017 , ... Everybody has their own personal preference when it ... it, and some people don't like it at all. FindaTopDoc took a look at ... Erotic literature can give readers a taste of their deepest, darkest fantasies and has ...
Breaking Medicine News(10 mins):
(Date:6/11/2017)... June 10, 2017  Eli Lilly and Company (NYSE: ... Phase 3 studies of galcanezumab, an investigational treatment for ... data on several key secondary endpoints for galcanezumab compared ... these studies (EVOLVE-1, EVOLVE-2 and REGAIN) will be presented ... meeting in Boston . ...
(Date:6/9/2017)... INDIANAPOLIS , June 9, 2017 ... In a further effort to help spread lessons learned ... condition, the International Diabetes Federation (IDF) and Eli Lilly ... together for the second phase of the Bringing Research ... 2), reaffirming their commitment to helping people with diabetes ...
(Date:6/8/2017)... MCKINNEY, Texas , June 8, 2017 ... Company"), a leading developer and manufacturer of ... industry, announced today that Cressey & Company ... investment firm, has completed a growth-focused investment ... acquired a majority ownership position from selling ...
Breaking Medicine Technology: