Industry Insider is a timely chat with an ophthalmic industry thought leader.
Robin Smith Hoke is president and CEO of Leiters, an FDA-registered 503B outsourcing provider of hospital and ophthalmology compounded sterile preparations. Her previous leadership roles include chair of the board of directors and interim CEO of Ricerca Biosciences, a private equity-backed pre-clinical CRO, and president and general counsel of GeneraMedix Inc., a generic and specialty pharmaceutical company serving the acute-care market.
Ophthalmology Management: Leiters is an FDA-registered 503B outsourcing facility. What is the significance of this designation?
Robin Smith Hoke: As such a facility, we must follow the FDA’s guidance documents to produce medications that are manufactured according to current Good Manufacturing Practices. According to the federal Food, Drug and Cosmetic Act, the term “current good manufacturing practice” includes implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs and finished drug products. These regulations are critically important to ophthalmology practices and help assure physicians that the compounds were produced in such a way that they are free from microbial contamination and dangerous impurities.
OM: What types of medications does Leiters offer for ophthalmologists?
RSH: Leiters started as a compounding pharmacy in 1926, offering high-quality compounded medication solutions to ophthalmologists. Leiters is dedicated to serving the unique needs of ophthalmology providers and their patients today. In addition, once we registered as a 503B Outsourcing Facility, Leiters added FDA-compliant repackaged Avastin (bevacizumab, Genentech) services. Our products are used to assist ophthalmologists, retinal surgeons, anesthesiologists, cardiologists, directors of pharmacy and others to ensure the delivery of high-quality medicines used in health-care settings.
OM: How have compounded medications benefitted ophthalmology? What role do you see them playing in the future?
RSH: Ophthalmology has long required compounded medications to adequately treat their patients given the unique anatomy and physiology of the eye. According to many industry groups and physicians, the lack of readily available, direct-from-manufacturer ophthalmic medications for many eye conditions has resulted in a significant number of ophthalmologists relying on compounding pharmacies to fill the gaps to meet physician and patient needs. Further, to ensure the appropriate dosage and composition for use in the eye, changes to the drug concentrations or removal of preservatives are sometimes necessary. Ophthalmologists rely on compounded medications to fill the gap in providing critical, sight-saving drugs.
OM: What’s the significance of Leiters’ recent partnership with Besse Medical?
RSH: This partnership enables Leiters’ full suite of ophthalmic medications to arrive individually serialized, lot-tracked and integrated into Besse Medical’s inventory management solutions, with no additional printing, labeling or processing required. This collaboration helps drive efficient and cost-effective patient care by minimizing waste and cost through supply chain optimization. Our mission at Leiters is to provide better medicine to more people, and we are excited to work with Besse Medical to combine our high-quality ophthalmic medicines with their market-leading inventory management systems. OM