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.
Dr. Novack’s presentations in 2014 include: FDA requirements for new drugs at Glaucoma 360 (Glaucoma Research Foundation), “Better Therapeutics in Glaucoma Through Drug Delivery” in the Innovator’s symposium at the American Society for Cataract & Refractive Surgery, and a Phase 2b study of AR-13324 in glaucoma and ocular hypertension at ARVO.
Dr. Novack continues to advise numerous companies on FDA interactions, including critical End of Phase 2 meetings, with frequent meetings with the FDA. Numerous investment firms have asked Dr. Novack’s advise on investments in innovative ophthalmic firms.
Dr. Novack has worked with advised numerous companies their FDA and EMA interactions on new drugs, including accompanying clients to their regulatory meetings.
In June 2013, Dr. Novack was officially thanked for his 16 years of service to the UC Santa Cruz Foundation, including serving as past president.
The year 2012 has been a great one for approvals for PharmaLogic. Four products on which we made substantial contributions were approved in the U.S. : iStent® Trabecular Micro-Bypass Stent, Jetrea® (ocriplasmin), Kyprolis® (carfilzomib), and Myrbetriq® (mirabegron).
Dr. Novack, UC Regent emeritus, was part of a delegation of California Public Higher education to the California State Legislature. Together with UCSC Chancellor Blumenthal, Cal State University San Jose President Qayoumi, and other higher education leaders, he visited with Assemblymember Beall (D-San Jose) and other legislators to advocate for support.