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
Dr. Novack provided an update on novel therapies in pharmacotherapies in Ophthalmology Times. He reviews treatments in all phases of clinical development, and those recently approved. This is from anterior (dry eye, glaucoma) to posterior (wet AMD, etc).
Several groups have declared July 2017 as Dry Eye Awareness Month.
TFOS DEWS II™ highlights will be presented at a July 12 Congressional Briefing entitled Dry Eye: An Updated Definition, A Greater Impact on Vision Health—co-hosted by TFOS and the Alliance for Eye and Vision Research (AEVR)—to be held from 12 Noon – 1:15 pm in Rayburn 2168 (Gold Room). The Briefing will be bookended by a “Test Your Tears” Dry Eye Screening and Dry Eye Researcher Poster Presentation from 11:30 am – 2 pm. The vision community is making Congressional education about dry eye a priority since it impacts healthcare policy, as it is one of the most frequent causes of patient visits to eye care providers, and since federal research funding from the National Institutes of Health (NIH), including its National Eye Institute (NEI), is being used to study dry eye causes and develop treatments.
Also, stay tuned for the TFOS DEWS II report, due 1 July 2017 in The Ocular Surface.
Dr. Novack was a visiting Professor at the University of Wisconsin School of Medicine in Madison in May 2017. He presented a lecture in the Frontiers in Vision Research series about ophthalmic drug development and drug delivery.
Dr. Novack at University of Wisconsin, Madison, May 2017
Dr. Novack attended the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Baltimore, MD. This was his approximately 33rd ARVO meeting. He presented in the Special Interest Group on the TFOS Dry Eye Workshop II. As well he had two side-by-side posters in a glaucoma poster session- one on an investigational drug, and the other on a recently cleared minimally-invasive glaucoma stent (MIGS). He was also an author on a oral presentation of an investigational drug to treat elevated intraocular pressure.
Dr. Novack in front of his two, side-by-side, posters on glaucoma therapies
TFOS DEWS II Chairs (Dr. Novack is 5th from left)
With recent press releases by the Sponsors, there are at least five ophthalmic New Drug Applications (NDAs) under review by the U.S. FDA at this time (25 April 2017). Some of these were held up for chemistry issues in their original 2016 submissions.
PharmaLogic Development, Inc., a provider of strategic and operational services to the pharmaceutical and biomedical industries through the pharmaceutical, biologic and device development processes, today announced a new branding and logo to mark the company’s over 25 years of industry accomplishment, commitment to bringing new therapies to market, and vision for the future.
As PharmaLogic passed the quarter century mark, the company reached another major milestone: As of Q2 2017 PharmaLogic has contributed to 50 FDA product approvals and clearances.
“After 25 years as a leader in the industry, it was time for a new logo that reflects our brand identity,” said PharmaLogic President Gary D. Novack, Ph.D. “The new logo incorporates an eye, reflecting our extensive work in developing treatments for ophthalmic diseases, as well as the focused vision that enables us to serve clients with steadfast dedication. A clear vision helps PharmaLogic see through the complexities of clinical, business and regulatory considerations to move expertly and reliably toward our clients’ goals.” Dr. Novack is the author of over 250 peer-reviewed publications, and an active member and frequent presenter in professional ophthalmic organizations.
Christy L. Shaffer, Ph.D., General Partner at Hatteras Venture Partners said “I have worked with Dr. Novack for over 20 years, first as a CEO of an ophthalmology company, and now as a an investor in several ophthalmology companies. His expertise regulatory filings and strategies is quite useful for early-stage companies.”
Alan L. Robin, M.D., Professor, Ophthalmology, University of Michigan, and Associate Professor, Ophthalmology and International Health, Johns Hopkins University states “Dr. Novack is highly regarded for his scientific acumen, sound business ethics, and unmatched knowledge of regulatory strategy, – this combination has gained him global credibility by ophthalmologists and clients alike.”
Other accomplishments in PharmaLogic’s 25-year history include providing critical roles in development and approval of the first pharmacological treatment for macular degeneration, the first site-active corticosteroid, the first and second intravitreal drug delivery systems and the first neurological indications for botulinum toxins. Through thousands of projects, the company has served over 400 clients on four continents on and contributed to over 100 Investigational New Drug (IND) and Device Exemption (IDE) submissions. According to Dr. Novack, PharmaLogic’s consistent success and extensive experience have been the key to becoming a premier services provider to top specialty pharmaceutical and medical device clients.
About PharmaLogic Development, Inc.
PharmaLogic Development, Inc. delivers unique expertise at all stages of drug development and commercialization from preclinical data review to in-Market Medical Communication based on an unsurpassed track record of successful INDs, New Drug Applications (NDAs), and Agency interactions. PharmaLogic has enabled more than 400 clients on four continents to navigate the complex, risky world of product development, efficiently meeting milestones en route from early findings to approved product. For clients in ophthalmology, dermatology and neurology, the company provides full-range regulatory support services and representation, product research and development, clinical trial design and reporting, marketing and manufacturing. It has now contributed to 50 approved products and over 100 Investigational New Drug (IND) and Device Exemption (IDE) submissions. PharmaLogic serves all of its clients with principles of high ethical values, confidentiality, commitment to clients, quality service and technical expertise.
Allison Howell, Senior Account Director,
412-2281678, [email protected]
Three researchers published an article on research economics in Science on 7 April. Over a 27-year analysis period, while only 10% of NIH grants generate a patent directly, 30% generate articles that are subsequently cited by a patent. This “indirect” statistics suggests a greater impact of government funded research than previously thought. Oh, and there was no systematic difference between “basic” and “applied” research in these statistics.
Dr. Novack gave a talk on the preclinical needs for development of ophthalmic products at the Spring meeting of the Boston Area Pharmacology Toxicology Group (BAPTG). The meeting was hosted by Biogen at their facility in Cambridge, MA.
Dr. Novack, a 30+ year member of the American Society of Clinical Pharmacology and Therapeutics, attended the annual meeting in Washington DC in March 2017. He participated in several trainee events, including a trainee luncheon (pictured below) and a “speed mentoring” event. He was a co-founder of the latter for this society.