Management of Cell and Gene Therapy Clinical Trials

With the progress of advanced precision medicine over recent years, cell and gene therapies (CGTs) continue to develop and evolve, with their advancement and successes publicized extensively throughout the pharmaceutical industry. These therapies open new doors for the treatment of a growing range of previously untreatable conditions and offer a seemingly limitless variety of ways to treat diseases.

Experts from Caidya’s cell and gene therapy team were invited to discuss considerations for the management of CGT clinical trials. During this interactive webinar, the basic principles of CGT technologies and processes and the landscape of current technologies will be outlined, as well as practical topics such as investigative site selection and management, logistical and clinical management of the investigational products, high-level regulatory considerations, patient management and retention and patient follow-up requirements.

Dr. Adam Marsh, Director Clinical Development, Caidya

Adam has a diverse expanse of experience in clinical research over the past 15 years. His career began in an academic research setting within an IVF clinic, and from there moved into dermatological pharmaceuticals. Adam then began working in CROs where he gained clinical research management experience in a range of therapeutic areas including oncology, neurology, and many rare diseases including working in several pediatric indications. During this time he was involved in several gene therapy studies across a number of rare conditions to treat genetic disorders in children.

Dr. Dorota Poklonska, VP & Head, Global Study Start Up, Caidya

Dorota Poklonska leads study start up at Caidya. She is a board-certified internal medicine physician with 29 years of clinical research experience in various roles, including monitoring, project management, start up and leadership positions. She completed additional postgraduate studies in project management.