Preparing Your Institution for Gene Therapy
When introducing gene therapy into your organization, there are many considerations to keep in mind. These considerations range from administrative matters to the practical handling of gene therapy
To gain practical insights into the process of preparing an institution for gene therapy, we interviewed a group of pharmacy professionals, each with a different role, with direct recent experience in introducing gene therapy within their institutions. We asked them a series of questions covering the full scope of the process, and their answers provide real-world practical advice for those who are embarking on a similar journey while onboarding gene therapies
All responses were recorded on November 2–3, 2020
Dr. Theresa Mays is the Vice President of Investigational Drug Services at New Experimental Therapeutics (NEXT) Oncology in San Antonio, Texas, which is a specialist Phase 1 oncology outpatient center. She is also an Adjoint Assistant Professor at The University of Texas’ College of Pharmacy.
Theresa graduated from The University of Oklahoma Health Sciences Center with a Bachelor of Science in Pharmacy and Doctor of Pharmacy. She completed a specialty residency in oncology and hematology at Audie L. Murphy Memorial Veterans' Hospital and The University of Texas Health Science Center at San Antonio. She is a board-certified oncology pharmacist and has practiced in both Salt Lake City, Utah and San Antonio, Texas.
Theresa is a founding member of the Hematology/Oncology Pharmacy Association (HOPA) and has been a fellow of the American Society of Health-System Pharmacists (ASHP) since 2009. She is also a reviewer for a number of academic journals.
[Transcript of video]
Hello. I am Theresa Mays, and I am the Vice President of Investigational Drug Services at New Experimental Therapeutics, also known as NEXT Oncology, and we are an outpatient Phase 1 oncology center in San Antonio, Texas.
My experience with gene therapy began over a decade ago when we were approached to participate in a gene therapy protocol. At that time, I did not know a lot about gene therapy and safe handling guidelines, and I did quite a bit of research. I was surprised to find that there was not a lot of information out there, particularly in the pharmacy arena. After a significant amount of discussion with the whole clinical team, we opted not to go forward with that particular clinical trial.
However, recently, there has been a lot of innovations and gene therapy, and once again, we have been approached to participate in another Phase 1 clinical trial. So once again, I started doing research in trying to find information that was out there, and I was quite surprised that not a whole lot of additional information had been published in the past decade. Therefore, I started trying to find additional resources, and around that same time, I was also asked to participate in this educational piece, which was quite timely.
Mr. Petrich, MS, RPh, has directed Investigational Drug Services at the Cleveland Clinic for the past 22 years. During that time, his team has supported a wide variety of clinical trials across an international landscape. John routinely assists investigators in protocol development, while his day-to-day focus is on clinical excellence, regulatory compliance, quality improvement, and biosafety awareness.
The recent emergence of gene therapies has motivated John to enrich the guidance on gene therapy, particularly those involving safe handling, site preparedness, and risk evaluation. Accordingly, recent work by John has sought to provide much-needed direction to site pharmacies. In 2019, John authored a review in the Journal of Pharmacy Practice titled: Gene Replacement Therapy: A Primer for the Health-system Pharmacist, and he has presented nationally and internationally on the topic of gene therapy. John’s current interests include site education and assessment of facilities for gene therapies.
John received his pharmacy degree from The University of Toledo and his masters from Cleveland State University. He is a long-standing contributor to the American Society of Health-System Pharmacists (ASHP) and past President of the Society of Clinical Research Associates (SOCRA).
[Transcript of video]
Hello. I am John Petrich, and I am in charge of the Investigational Drug Services for the Cleveland Clinic Health System in Cleveland, Ohio. My primary institution is a tertiary care academic medical center, and we are affiliated with 17 other hospitals and numerous family health centers. Our total inpatient capacity is over 6,000 beds, and the yearly pharmacy drug budget exceeds $1 billion.
My experience with gene therapy began over 20 years ago with an angiogenesis trial in ischemic heart patients, and I can remember all the uncertainties we felt back then. Needless to say, our practices have evolved significantly since that time. A barrier that I encountered early on was the lack of relevant guidance to the health system caregiver on the biosafety and handling of gene therapies. And ever since, I have tried to add to the body of work around this void by presenting, publishing, and sharing our journey toward optimal site preparedness.
Dr. Jeff Wagner is the Assistant Vice President of Pharmacy and Respiratory Care at Texas Children’s Hospital in Houston, Texas. He is also an Adjunct Clinical Assistant Professor and Preceptor at the University of Houston’s College of Pharmacy. He holds various teaching appointments at Baylor College of Medicine and The University of Texas’ College of Pharmacy.
Jeff graduated from the University of Michigan’s College of Pharmacy with a Doctor of Pharmacy degree and The University of Texas with a Master of Public Health degree. He completed a pharmacy practice and pediatric pharmacotherapy specialty residencies at The Johns Hopkins Hospital in Baltimore, Maryland. He then moved to Texas Children’s Hospital, where he practiced as a clinical pharmacy specialist in pediatric critical care prior to completing a Health-System Pharmacy Administration residency. Dr. Wagner has since held various clinical, managerial, and leadership positions within the institution.
Jeff is a member of a number of professional associations, including the American Society of Health-System Pharmacists (ASHP), the Texas Society of Health-System Pharmacists (TSHP), and the American College of Clinical Pharmacy (ACCP). He has also published peer-reviewed journal articles and authored book chapters on various topics in the field of pediatrics and pharmacy practice.
[Transcript of video]
My name is Jeff Wagner. I am the Assistant Vice President with a responsibility for pharmacy and respiratory therapy at the Texas Children's Hospital in Houston, Texas. We are the largest free-standing children's hospital in the United States but also provide some maternal care as well.
My institution has been involved in gene therapy, and we do watch gene therapy development in the pipeline, knowing that these therapies are of value to the care of patients that we provide services to and that do seek care with us. We began gene therapy as soon as they have been approved by the FDA and have actually been involved in a few research studies as they have been developed.
Brian Yarberry is currently the Director of Pediatric Pharmacy Services for Norton Children’s Hospital, Norton Children’s Medical Center, and Norton Children’s Infusion Pharmacy in Louisville, Kentucky. Brian also covers operations for the Norton Children’s Hospital services offered at the Novak Center for Children's Health.
Brian is a graduate of Butler College of Pharmacy & Health Sciences and completed a PGY2 Pediatrics residency at the Nationwide Children’s Hospital, formerly Columbus Children’s Hospital, in Columbus, Ohio. Upon completion of his residency training, Brian returned to Louisville and practiced as a pediatric critical care clinical pharmacist at the Norton Children’s Hospital prior to his current role.
Brian is a long-standing member of the American Society of Health-System Pharmacists (ASHP), Pediatric Pharmacy Association (PPA), American Academy of Pediatrics (AAP), and Kentucky Society of Health-System Pharmacists (KSHP), serving on the board of directors and as a society president. Brian serves as a Clinical Assistant Professor of Pediatrics (Gratis) at the University of Louisville School of Medicine.
[Transcript of video]
Hi, I am Brian Yarberry, and I am the Director of pediatric pharmacy services as the Norton Children's Hospital, Norton Children's Medical Center, and Norton Children's Infusion Pharmacy, located in Louisville, Kentucky. Our institution specializes in the treatment of children with any disease state, within the areas of southern Indiana and Kentucky.
My experience with gene therapy began in 2017. Since that time, we have treated numerous patients with different gene therapy products.