As the Associate Director of Cell and Gene Therapy at KCAS, Carrie Vyhlidal, PhD leads a team of scientists who support clinical trials and drug development in this field. One of the key service offerings of KCAS is molecular services, including qPCR and ddPCR, which are used for monitoring the exposure and efficacy of cell and gene therapies. Due to her expertise in this area, Carrie was invited to moderate this panel discussion at AAPS/NBC. The panel will focus on the challenges of bioanalytical method development and validation in these specific and related areas.
Who will be on the panel at the 2023 AAPS NBC?
The panel consists of several scientists from leading CROs in the clinical space who will address the common problems and pitfalls they have experienced, as well as the opportunities they have used to overcome those challenges. Along with Stephanie Pasas-Farmer from Ariadne Solutions, Carrie will lead the discussion with Lillian Falese from Spirovant Sciences, Inc., Kelly Colletti from Beam Therapeutics, Dave Kuhel from PPD Clinical Research, and Brian Bower from BioAgilytix Labs.
Who would benefit from attending the panel?
The audience for this panel includes anyone who is currently working within (or thinking about working within) the cell and gene therapy space. Currently, there are no regulatory guidelines for developing and validating PCR-based assays to support cell and gene therapy drug development, but a AAPS working group is working on developing guidelines and white papers to address these issues. Therefore, anyone who is doing PCR or considering it – or even looking for a partner to do PCR-based assays for their cell and gene therapy drug development programs – will benefit from this panel.
Carrie is excited to moderate the panel discussion with other experts in the cell & gene therapy field. The panel promises to be a valuable resource for those who are interested in or involved in cell and gene therapy drug development, providing insights into the common challenges faced and the opportunities available to overcome them.