Tracy BioConsulting » BioConsulting Briefs

Mark Tracy Receives CRS Distinguished Service Award

Mark Tracy — Tue, 15 Oct 2013 02:47:10 +0000

Mark A. Tracy was awarded the prestigious Distinguished Service Award of the Controlled Release Society (CRS) at its 2013 Annual Meeting in Honolulu, Hawaii in July 2013. Established in 1994, the Distinguished Service Award is presented to a CRS member who has exhibited exceptional commitment and service to the society and is selected by the Board of Directors. ”It is a tremendous honor to receive the CRS Distinguished Service Award. The CRS is my home professional society so I am particularly grateful to the CRS for this recognition,” Dr. Tracy said after receiving the award.

Dr. Tracy receives the CRS Distinguished Service Award from CRS President, Prof. I. Tucker (left), and Immediate Past President, Prof. K. Kataoka (right), on July 22, 2013

For more see: http://www.controlledreleasesociety.org/about/Awards/Pages/DistinguishedService.aspx

Interview with Mark Tracy

tracywebmgr — Mon, 14 Oct 2013 23:10:45 +0000

Insights into the Biopharmaceutical Industry

Interspecies information website

Mark Tracy — Wed, 15 May 2013 02:02:33 +0000

This website is an excellent resource for physiological, anatomical and biochemical parameters for a variety of animal species and is helpful in design preclinical development programs: http://www.interspeciesinfo.com

Good review practices for INDs

Mark Tracy — Wed, 15 May 2013 01:44:58 +0000

A helpful new FDA document was recently issued describing the FDA’s good review practices for INDs. See this link: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM349907.pdf

Approval of Kynamro

Mark Tracy — Fri, 15 Feb 2013 19:54:34 +0000

The January 2013 approval of Kynamro (mipomirsen) marks the first systemically administered antisense oligonucleotide to reach the market:

http://www.fiercebiotech.com/story/fda-hands-sanofi-isis-approval-hofh-drug-kynamro/2013-01-29

New FDA guidance documents issued

Mark Tracy — Fri, 15 Feb 2013 19:53:40 +0000

Two useful guidance documents were recently issued by FDA: 1) a final ICH guidance on Development and Manufacture of Drug Substances: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf and 2) a draft FDA guidance on Immunogencity Assessment for Therapeutic Protein Products: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338856.pdf

RNA therapeutics

Mark Tracy — Fri, 15 Feb 2013 19:53:02 +0000

RNA therapeutics are coming of age with the approval of mipomersen and multiple classes of RNAs in the clinic. Here is a nice overview: http://www.xconomy.com/san-diego/2013/02/08/rna-therapeutics-are-coming-of-age/2/