Dr. Gary Novack was quoted in an article on ophthalmic drug delivery in the May 2018 issue of ASCRS‘s EyeWorld. Dr. Novack pointed out “…In considering what molecules might be most likely to succeed in a sustained delivery approach…this depends on the type of delivery system. If it’s a zero order, i.e., constant delivery with respect to time system, a molecule like brimonidine or timolol is most appropriate,” … “If it’s a pulsatile, i.e., peaks and troughs system, a molecule like the prostaglandins is the better choice.” Dr. Novack has published several articles on issues in ophthalmic drug delivery, and worked on a number of successful products in this area.
Gary D. Novack, Ph.D., received the Association for Research in Vision and Ophthalmology (ARVO)’s Dr. Roger Vogel award for drug development at the May 2018 annual meeting. He is shown here receiving the award from Paul Sternberg, M.D., ARVO Foundation President. This award honors Dr. Roger Vogel, who was in the ophthalmic pharmaceutical business for almost 30 years and led the development of many of the medicines now used by ophthalmologists. The award is given annually to an ARVO member whose research furthers the development of pharmaceutical treatments for ophthalmic diseases.
Dr. Novack states “Roger Vogel was my competitor, my client, my colleague and my friend for decades”. I am honored to be recognized by ARVO with this award named for him.”
At this annual meeting, Dr. Novack also spoke in a Members-in-Training session on drug development – specifically, how to file an Investigational New Drug exemption with the FDA. He also presented a poster on the safety findings of a novel ocular hypotensive drug.
In April 2018, the UC Davis School of Veterinary Medicine hosts joint grand rounds with the UCD Medical Center ophthalmologists at the Gourley Clinical Teaching Facility at the University of California School of Veterinary Medicine. This included lectures and live animal labs. Dr. Novack, shown here next to visiting lecturer Tom Kern DVM of Cornell, was a participant in this annual event. More generally, UC Davis takes advantage of ophthalmologists in both the medical and veterinary schools for frequent interaction on the optimal way to treat patients and research novel therapies. Dr. Novack is a faculty member of the Department of Ophthalmology at the UC Davis School of Medicine.
Photo by Don Preisler/UCDavis © 2018 UC Regents
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.
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.