At the 3rd Annual Sonoma Eye, meeting, Dr. Novack chaired a symposium on two areas of interest – basic research in ocular inflammation and retinal disease and clinical outcomes. Dr. Novack presented current thinking on endpoints in approvals of novel therapeutics in ophthalmology. He also moderated the discussion on how to best use pre-clinical models to aid in drug development. Including Dr. Novack, there were 3 speakers from the University of California, Davis.
Pinterest recently stated that “..it would no longer return any search results, including pins and boards, for terms related to vaccinations, whether in favor or against them.” The firm noticed the majority of shared images on their site cautioned people against vaccinations. As I wrote in an article in 2017, “Anti-Science in the 21st century”. we have a safe, effective, affordable prevention of a terrible disease. Use it!
The U.S. FDA signaled strengthening of regulation of dietary supplements in remarks by FDA Commissioner Scott Gottlieb, M.D. He notes “…In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.”
FDA “sent out 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases.”
To some of us, the promotion of nutritional supplements by some firms goes beyond that allowed by law. Further, some firms prey upon patients’ unfounded belief that “If it’s natural, it must be safe”.
In a recent editorial in EyeNet on the importance of collaboration in successful research, past-president of the American Academy of Ophthalmology, Ruth Williams, M.D. cites Dr. Novack. Dr. Novack stated “…You cannot be successful unless you realize that you do NOT know everything”. Further she states that “…major breakthroughs usually require a multi-disciplinary approach, ophthalmic researcher must recognize and woo individuals who may not currently be working on vision research”. A prime example of this is the Glaucoma Research Foundation’s “Catalyst for a Cure”.
Please see the first issue of OIS Press with updates on novel ophthalmic therapies. I provide a perspective in recent US FDA approvals (Pages 9 and 11).
Gary D. Novack, Ph.D., was selected to be a fellow of the American College of Clinical Pharmacology (ACCP). ACCP consists of a full spectrum of clinical pharmacology professionals from academia, industry, government and clinical settings who span the scope from research and drug development to patient-related care and who remain dedicated to advancing clinical pharmacology with the ultimate goal of enhancing patient care. ACCP seeks to address the educational needs of its diverse membership and all healthcare professionals, covering a range of topics that span the entire area of the interaction between drugs and humans.
Dr. Novack’s article on pharmacological prophylaxis of myopia was published in a special issue of Eye and Contact Lens. This issue (Volume 44 / Issue Number 4, July 2018) features articles on Myopia Control: Current thoughts and future research. It was edited by Drs. Penny A. Asbell and Kazuo Tsubota. The publication is based upon a symposium held in November 2017 in Tokyo at Keio University. The issue includes authors from a wide variety of perspectives. All agree – myopia is an epidemic that will continue to take medical resources to deal with the increasing number of affected patients worldwide.
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.
Dr. Novack receives ARVO Roger Vogel award from Dr. Paul Sternberg
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