“Fortune favors the prepared mind.”  Louis Pasteur

Category Archives: BioConsulting Briefs

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Mark Tracy Receives CRS Distinguished Service Award

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 ……

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Interview with Mark Tracy

Insights into the Biopharmaceutical Industry

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Interspecies information website

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

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Good review practices for INDs

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

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Approval of Kynamro

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

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New FDA guidance documents issued

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

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RNA therapeutics

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/