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 ……
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
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
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
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 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/
