- Comprehensive review articles in top journals:
- Novack GD. Pharmacotherapy for the Treatment
of Choroidal Neovascularization Due to Age-Related Macular Degeneration.
Ann Rev Pharmacol Toxicol 2008;48:61-78.
- Novack GD. Ophthalmic drug delivery: Development
and Regulatory Considerations. Clin Pharm Ther 2009;85:539-43.
- Participation at key pharmacology and ophthalmology
meetings:
- Invited speaker at AAO glaucoma sub-specialty
day on new therapies.
- Member, The Dry Eye Workshop (Pflugfelder
SC, Geerling G, Kinoshita S, et al. Management and therapy of
dry eye disease: Report of the Management and Therapy Subcommittee
of the International Dry Eye WorkShop (2007). Ocul Surf 2007;5:163-78.
- Invited speaker at NEI/FDA CDER Glaucoma
Clinical Drug Trial Design and Endpoints Symposium (Rockville
MD, Weinreb RN, Kaufman PL. Invest Ophthalmol Vis Sci 2009;50:1497-505.)
- Speaker and organizer: Using Pharmaceuticals
Off-Label: Be Concerned, Be Very Concerned: Symposium at ASCPT,
Washington, DC.
- Regulatory Issues in Ophthalmic Drug Development.
5th Annual Ophthalmic Drug Development and Delivery Summit, San
Diego.
- Moderator: Breaking news session at ASCPT,
Washington, DC.
- President, ASPET Drug Development Section.
- Among his volunteer activities, Dr. Novack
has been a leader in supporting public higher education at the University
of California:
- President, UC Santa Cruz Alumni Association
- Regent, University of California
- President, UC Santa Cruz
Foundation
- Invited speaker at the Inauguration of the
10th chancellor of the University of California, Santa Cruz
- Recent assignments:
- Develop scientific and regulatory material
and represent start-up company for pre-IND meeting for retina
indication.
- Develop scientific and regulatory material
and represent start-up company for pre-IND meeting for dry eye
indication.
- Represent start-up company for pre-NDA meeting
for anterior segment indication.
- Prepare IND for glaucoma indication.
- Prepare publication plan for new glaucoma
product.
- As we reflect back on our 20 years, some of our key accomplishments
are: Played a key role in the development of over 40 ophthalmic,
dermatologic, and neurologic approved products
- NDA Firsts: First treatment for macular degeneration, First soft
drug, First and second intravitreal drug delivery system
- Served over 350 clients in four continents on thousands of projects
- Contributed to over 100 IND and IDE submissions
- Organized and lead clients on scores of meetings with regulatory
agencies worldwide
- Serving as a director of a publicly traded ophthalmic pharmaceutical
firm, including raising over $100 million in financing
- Served as agent for a multi-million dollar licensing arrangement
- Created several business plans, including one funded at over $80
million
- Had our 160th paper printed in a peer-reviewed journal
- Published over 60 additional papers as medical writer, plus others
as editor for non-English speakers
- Performed 100’s of literature and patent searches, including support
for patent arbitration
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| Dr. Novack with
former
senior FDA officials at ASCPT Symposium |
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Dr. Novack chairing breaking news
session at ASCPT |
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| Dr. Novack presents young investigator
award at ASPET to Stephanie Piecewicz of MIT |
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| Dr. Novack speaker
at the Inauguration of the 10th chancellor of the University of California,
Santa Cruz |
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