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Gene therapies have gained momentum due to accumulation of early successful clinical studies. Currently, there are two gene therapies that are FDA-approved in the United States, but there are over 800 cell- and gene therapy programs currently in clinical development, including for previously untreatable diseases such as Duchenne’s muscular dystrophy and Huntingdon’s disease. This educational session will inform clinicians of the basics of gene therapy, as well as the current landscape of products and what is coming in the pipeline. The presenter will also evaluate pharmacoeconomic and supply chain considerations as these products begin to mature in the market.

Learning Objectives for pharmacists  |  At the end of this session, participants should be able to:

1. 1. Recall the basics of genetics as related to gene therapy products.
   2. Summarize the conceptual differences in ex vivo and in vivo gene therapies surrounding administration, mechanism of action, vectors, and diseases treated.
   3. Evaluate the currently available gene therapies in the market and the development pipeline.
   4. Identify pharmacy operations considerations when handling and administering gene therapies.
   5. Analyze current pharmacoeconomic considerations for gene therapies and hypothesize cost considerations as more products become approved and readily available to patients.

Learning Objectives for pharmacist technicians  |  At the end of this session, participants should be able to:

1. 1. Distinguish gene therapy products from other pharmaceutical products.
   2. Describe the importance of the safe handling and transportation of gene therapy products as compared to other pharmaceutical products.

Presenter:

Kyle Herndon, PharmD, MBA, BCPS  |  PGY-2 Corporate Pharmacy Leadership  |  HealthTrust

Target Audience:  Pharmacists, Pharmacy Technicians, Nurses, Nurse Practitioners, Physicians, Physician Assistants

Continuing Education Information:  1.0 contact hours approved for Pharmacists and Pharmacist Technicians. Belmont University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The ACPE Universal Activity Numbers for this activity are 0863-9999-20-024-L01-P and 0863-9999-20-024-L01-T . The activity is approved for 1 hour (.1 CEUs) of continuing education credit to pharmacists and pharmacy technicians who attend the webinar and complete the online evaluation.

Note about CE credit: If you plan to obtain credit, stay until the end of the presentation to receive the verification code you will need to obtain your continuing education credit. A reminder that CE credit is individual. No group credit is available. Each person must register for this session and attend the webinar for 40 minutes or longer in order to receive an email after the event with instructions on how to apply for continuing education credit. Please do not share the code or forward the email you receive to others who did not actually attend the program. If they are not able to be verified on our webinar provider reports and registration list they will not receive credit. Also, please note: If you are joining only by phone, you will not be eligible for credit. You must also log in and join the visual portion of the webinar to be part of our CE provider-required reporting.

Effective June 1, 2019: Belmont College of Pharmacy will no longer issue paper/electronic statements of credit for CE activities. ACPE (our accrediting body) policy states paper and/or electronic statements of credit may no longer be distributed directly to learners as proof of ACPE credit. The official record of credit may be located in the learner’s e-profile in CPE Monitor at www.nabp.net.  A participant, sponsor, faculty member or other individual wanting to file a grievance with respect to any aspect of a program sponsored or co-sponsored by the Belmont COP may contact the Dean of Belmont University College of Pharmacy in writing at david.gregory@belmont.edu. The grievance will be reviewed and a response will be returned within 45 days of receiving the written statement. If not satisfied, an appeal to the Dean of the College of Pharmacy can be made for a second level of review.