NDA Partners LLC, a consultancy of which I am a member, was featured in a news article in Business Worldwide.
The article notes that the pharmaceutical and medical device industry has the most complex regulations of any industry. They take at the unique consultancy services provided by NDA Partners.
The article notes: “…NDA Partners LLC, which provides product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide, has developed a new model of consultancy – the CDO or consulting and contract development organisation. And it’s a model that is entirely suited to small innovators and SMEs.” “NDA Partners distinguishes itself from other consultancies through its ability to assign top-tier expert consultants on all engagements. It provides the full spectrum of functional expertise needed to conduct complete product development programs from bench to marketing authorization”
NDA Partners includes as consultants:
- Three former US Food and Drug Administration (FDA) Centre Directors
- Fourteen former FDA Director or Deputy Director Division heads
- The former Head of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
- Three former EU regulatory agency senior staff
- The former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP)
- Dozens of highly experienced former biopharma and medical device industry executives
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.
Gary D. Novack at Sonoma Eye 2018
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.
The Dry Eye Workshop II (DEWS II) report, sponsored by the Tear Film and Ocular Surface Society, has now been published in the July 2017 issue of The Ocular Surface. There is an introduction, and 10 sub-committee reports, including the Clinical Trials and Regulatory Sub-Committee report of which Dr. Novack was the chair. This represents over 2 years work by 125+ worldwide researchers and clinicians. It supplants the 2007 report with the latest review of Dry Eye research. #TFOSDEWSII @aao_ophth