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
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

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:9/30/2014)... Sept. 30, 2014 (HealthDay News) -- There,s no genetic ... type 2 diabetes, a new study says. Some ... D might protect people against type 2 diabetes, raising ... and the blood sugar disease. In this study, ... vitamin D by focusing on genes that control blood ...
(Date:9/30/2014)... TUESDAY, Sept. 30, 2014 (HealthDay News) -- Children conceived either ... the birth of a sibling could be at increased risk ... study,s lead author and an outside expert agree that the ... in autism. "Most importantly, it is important that parents ... even when pregnancies are close together or far apart," said ...
(Date:9/30/2014)... Power plant standards to cut climate-changing carbon emissions ... substantial human health benefits, according to a new ... on the policy options included in the final ... prevent thousands of premature deaths and hospitalizations, and ... every year., In the new study, Health Co-benefits ...
(Date:9/30/2014)... Health Day Reporter TUESDAY, ... who are overweight or obese when diagnosed appear to ... weight-related cancer, new research suggests. , , The finding ... only the potential for developing other cancers associated with ... who reported being overweight or obese prior to diagnosis ...
(Date:9/30/2014)... breast cancer is the leading cause of cancer death ... why so many medical professionals encourage women to get ... only a minority of suspicious mammograms actually leads to ... needless worry for women and their familiesnot to mention ... ultrasounds and biopsies. , Recently, a different type ...
Breaking Medicine News(10 mins):Health News:Gene Study Finds No Proof Vitamin D Guards Against Type 2 Diabetes 2Health News:Spacing Between Sibling Births Tied to Autism Risk in Study 2Health News:Power plant standards could save thousands of US lives every year 2Health News:Power plant standards could save thousands of US lives every year 3Health News:Obesity Tied to Higher Cancer Risk for Colon Cancer Survivors 2Health News:Obesity Tied to Higher Cancer Risk for Colon Cancer Survivors 3Health News:'Virtual breast' could improve cancer detection 2
... I-Therapeutix, Inc. announced today that Mr. Richard Packard ... Unit, King Edward VII Hospital, Windsor, UK, performed the ... Mark approved I-ZIP(R) Adherent Ocular Bandage. All phacoemulsification ... Packard. Patients received a foldable IOL with wound-assisted ...
... to Benefit the IP - Over $2,200 In ... Donald Verger, award-winning photographer and philanthropist is taking ... it to help raise awareness for the nonprofit ... deeply grateful to Mr. Verger for using his ...
... 3 Zimmer Holdings, Inc. (NYSE: ZMH ; ... earnings conference call will be broadcast live over the Internet ... A news release detailing the quarterly results will be ... call.The live audio webcast can be accessed via Zimmer,s Investor ...
... save brain cells from ravages of neurodegenerative disease , , ... they,ve found a possible way to prevent brain cells ... , The work is still in the preliminary stages, ... work in humans. Still, a Huntington,s disease expert said ...
... ,s award-winning document management suite recommended for ... and human resourcesCLEVELAND, April 3 It,s no secret. ... at the right time allows for better patient care. ... is they don,t yet have the tools to operate ...
... When the need for speed is critical, how can ... sending alerts to help prevent or stop a public ... be notified about disease outbreaks, illness from food borne ... Researchers from the Regenstrief Institute, Inc. in collaboration with ...
Cached Medicine News:Health News:I-Therapeutix Announces First Commercial Use of I-ZIP(R) Adherent Ocular Bandage for Clear Corneal Cataract Incisions 2Health News:Acclaimed New England Photographer Donald Verger Holds 'Faces of Innocence' Charity Event for the Innocence Project 2Health News:Scientists Uncover New Weapon Against Huntington's 2Health News:American Hospital Association Expands OnBase Endorsement to All Hospital Departments 2Health News:American Hospital Association Expands OnBase Endorsement to All Hospital Departments 3Health News:American Hospital Association Expands OnBase Endorsement to All Hospital Departments 4Health News:Getting the word out when the need for speed is critical to public health 2Health News:Getting the word out when the need for speed is critical to public health 3
(Date:9/30/2014)... 30, 2014   Decision Resources Group finds ... anemic chronic kidney disease non-dialysis (CKD-ND) patients are ... medication. In addition, one-year persistency is similar between ... Other key findings from the report entitled ... Erythropoiesis Stimulating Agents in Late Stage Chronic Kidney ...
(Date:9/30/2014)... SAN DIEGO , 30. September ... Logo - http://photos.prnewswire.com/prnh/20130430/LA01948LOGO ... ein Medizintechnikunternehmen, das ein minimal-invasives 3D-Herzkammer-Bildgebungs- ... der Ursachen entwickelt, die zu komplexen ... aufrechterhalten, hat den Abschluss einer zusätzlichen ...
(Date:9/30/2014)... DIEGO , Sept. 30, 2014   ... developing a minimally invasive real-time 3D Cardiac Chamber Imaging ... that cause and / or sustain complex cardiac arrhythmias, ... $26.2M financing to continue developing its imaging/mapping system as ... The financing will allow Acutus Medical to complete work ...
Breaking Medicine Technology:Persistency is Low for Late-Stage Anemic CKD Non-Dialysis Patients Treated with Erythropoiesis-Stimulating Agents 2Persistency is Low for Late-Stage Anemic CKD Non-Dialysis Patients Treated with Erythropoiesis-Stimulating Agents 3Acutus Medical, Inc. schließt zusätzliche Finanzierungsrunde Serie B über 26,2 Mio. USD ab, um Portfolio-Erweiterung zu finanzieren 2Acutus Medical, Inc. schließt zusätzliche Finanzierungsrunde Serie B über 26,2 Mio. USD ab, um Portfolio-Erweiterung zu finanzieren 3Acutus Medical, Inc. Completes Additional $26.2M Series B Financing to Fund Portfolio Expansion 2Acutus Medical, Inc. Completes Additional $26.2M Series B Financing to Fund Portfolio Expansion 3
... Water Street Healthcare Partners , a strategic private equity ... it has acquired MarketLab, Inc.  Water Street,s ... specialty healthcare distribution sector.  The acquisition expands Water Street,s ... life sciences, medical devices and services to 13. ...
... -- Dehaier Medical Systems Ltd. (NASDAQ: ... in the development, assembly, marketing and sale of medical ... that it was granted three new patents by State ... ("SIPO"). The patent awards were related to the design ...
Cached Medicine Technology:Water Street Healthcare Partners Acquires MarketLab, Inc. 2Water Street Healthcare Partners Acquires MarketLab, Inc. 3Dehaier Strengthens Intellectual Property Portfolio 2Dehaier Strengthens Intellectual Property Portfolio 3
The DSL-05-01-MEM Measles IgM Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the determination of IgM-class antibodies to Measles virus in human serum. This assay is intended fo...
... determines osmolality at room temperature with the ... get are cryoscopic artifacts due to high ... interfere with freezing point determinations. The superbly ... Vapro osmometer has a much broader range ...
Rapid assay, results in 1 hours,Range 20-800 ng/mL; sensitivity 2.5 ng/mL,Can be used for animal sera; requires extraction protocol and steroid free serum...
... IMMULITE 2000 assays ... with the IMMULITE 2000, ... access immunoassay analyzer. IMMULITE ... through centralization, and a ...
Medicine Products: