January 2018

Dr. Hampshire continues to be busy taking on approximately two new clients each month.  Requests to assist in the initial animal study design and FDA presubmission process dominate the case load.  Investigational Device Exemption preclinical narratives and responses to FDA deficiencies regarding preclinical and biocompatibility outcomes are also frequent requests.

Continued efforts involve study design to minimize overall animal use by leveraging large animal studies to replace rodent biocompatibility endpoints using the same methods, scientific principles, and endpoints from the ISO 10993 series.

An upcoming presentation on GLP requirements for preclinical studies is scheduled for the April 2018 meeting of SOCRA in Miami.

Dr. Hampshire to speak at Life Science Alley March 31, 2016

Dr. Hampshire will present information on how to prepare preclinical regulatory submissions, what to do if the results are not perceived to be perfect, how to approach risk and benefit from a preclinical standpoint. There will be a round table discussion following the presentation.  The meeting is being sponsored by Life Science Alley at the Surley Brewhouse on the evening of March 31, 2016.  Life Science Alley is non-profit life science and technology group based in Minneapolis, MN. 

Preclinical Acquisitional Due Diligence rises as a major focus of CPSRC

Rounding out the first business quarter, Dr. Hampshire reports that a majority of questions and problems large companies face is related to due diligence in examination and interpretation of preclinical data.  Common regulatory problems include lack of reporting full diagnostic information on adverse events in preclinical trials, a need for better animal health records, and a better focus on gross necropsy records and reports.

Dr. Victoria Hampshire founds CPSRC as exclusive metropolitan area preclinical animal consulting firm

After nearly three decades of public service, FDA veterinarian Victoria Hampshire has joined the private sector founding a preclinical review and consulting service Capital Preclinical Scientific Research Consultants, LLC (CPSRC, llc).  Dr. Hampshire departs her post of the last decade the FDA/CDRH Division of Cardiovascular Devices where she developed animal study guidance and procedures and also served in a lead review capacity for the Peripheral Vascular Devices Branch.  She formerly led adverse event monitoring activities at FDA’s Center for Veterinary Medicine and led NIH’s comparative animal biomedical animal research facility and 24-hour animal intensive care efforts.  Dr. Hampshire’s company will focus on assisting other consulting firms, legal entities, CROs, and animal programs with the regulatory strategy, design, preparation, conduct, and review of the preclinical submission.