Dr. Novack presented two oral papers at Sonoma Eye 2018, the second annual event held by the Foster Ophthalmic Immunology Society. One invited presentation was a brief summary of his 30-year perspective on how to evaluate a potential new therapy. The other dealt with the issue of drop size in ophthalmic medications – is it an issue or a non-issue. He had previously published on this issue. The meeting was a small, potent gathering of colleagues, allowing the opportunity to scientific interaction ala ARVO in the Sarasota days of the last century.
Gary D. Novack at Sonoma Eye 2018
I am proud to be a member of the University of California, Davis, Library Leadership Board. The Library Leadership Board plays an essential role in sustaining and enhancing the excellence of the UC Davis Library by advancing the library’s philanthropic goals and priorities. It is the primary volunteer leadership group for the library, which is ranked among the top academic research libraries in North America.
This student video on the 10-year plan for UC Davis, To Boldly Go, has a great plea from a student about 32 seconds in. The student is having trouble finding a place to study in the Library for an upcoming mid-term examination. This is one of the issues we are trying to help – for many students, the Library is the only place they can study. We’re working on other issues as well, including scientific methods for dealing with Big Data in our digital scholarship program.
In a conference by a leading U.S. health insurer lobbying group (America’s Health Insurance Plans, AHIP), US FDA Commissioner Scott Gottlieb, M.D. criticized “Kabuki drug-pricing constructs” that profit industry at the expense of consumers. He stated “Patients shouldn’t face exorbitant out-of-pocket costs, and pay money where the primary purpose is to help subsidize rebates paid to a long list of supply chain intermediaries,” . “Sick people aren’t supposed to be subsidizing the healthy.” Much of the cash flow in patient payments for prescription pharmaceuticals is not disclosed to either patients or physicians, as described in my 2016 article, “What determines how much your patient pays for their medication in the United States” in the American Journal of Ophthalmology. Note that current U.S. law does not allow the FDA to consider drug pricing in their regulatory actions. However, FDA’s actions may affect pricing – e.g., speed of review and approval of generic marketing applications (Abbreviated New Drug Applications).
There’s a lot of talk and confusion of the issues involved in the role of compounding pharmacies for topical ocular medications (eyedrops). Please see this interview in EyeWorld in which I am interviewed about regulatory issues. I address the special role which compounding pharmacies have played in the therapeutic process as physicians tailor therapies to individual patients. At the same time, I discuss the issues in the use of compounding pharmacies for larger populations crossing state lines.
I’m pleased to be part of NDA Partners Quantitative Drug Development Strategies Practice – providing drug development guidance to Sponsors.
Together with other senior industry and regulatory consultants, we will be providing expertise in quantitative clinical pharmacology, the application of Bayesian approaches in biostatistics and clinical trial design, and clinical trial modeling and simulation. NDA Partners will support the design and execution of clinical trials that can accelerate development programs and that produce high-quality regulatory packages containing the data needed to secure regulatory approval without delays.
FDA continues to be open during government shut-down, due in part to user fees paid for by industry
The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 46 new medical entities in 2017. This was a record high for the last ten years. PharmaLogic supported at least two of them, one of them considered to be a first in class.
Dr. Novack gave a presentation at the Second Annual Myopia Society of Japan on 24 November 2017. This was a joint symposium between the Myopia Society Japan and Eye & Contact Lens. The topic was “Controlling Myopia Progression: Where Do We Stand Today?”. In the concluding presentation of the event, Dr. Novack spoke about what it would in time and risk to develop a novel pharmacological treatment to prevent the development of myopia in children. A photo is provided. Dr. Novack is in the center of the back row. Also shown are Penny Asbell MD (Icahn School of Medicine) and Kazuo Tsubota, M.D. (Keio University).
RxSight, gained US FDA approved for a new type of Intraocular Lens for use after cataract surgery. It can be adjusted AFTER implantation in a patient. I was a founder of this firm which came out of University of California San Francisco (Dan Schwartz, M.D.) (originally named Calhoun Vision) many years ago.
Dr. Novack will be giving several presentations at the Annual Meeting of the American Academy of Ophthalmology in New Orleans in November 2017. On 9 November, he will lead a breakfast with FDA at the OIS AAO. On 11 November, he will give a talk at the Glaucoma Sub-specialty day on New Molecules in Glaucoma Development. On 14 November, he will give a talk on “An update on newly FDA-approved drugs and new drugs in clinical trials” at the Prevent Blindness America symposium. Finally, he will be part of a course on “Empowering glaucoma patients to take better care of themselves.”