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There are certain times when a company may need experienced consultants who can help you to determine the best strategies for biostatistics, well before the analysis stage.
Often the clinical project leader is very knowledgeable in his/her primary responsibilities, but may not be necessarily well-informed on Biostats, or may not have the time to oversee the detailed work that needs to be considered. Working with an expert Biostats team of Ph.Ds. at the outset of a trial will help to inform all the other stages of the trial.
You may need our consulting services on:
Our consultants are doctoral-level experts who offer our clients decades of experience in both pharmaceutical and government settings as well as a profound knowledge of the research and development process. Please read the bios of our esteemed colleagues below for more information.
Dr. Gil Fine joined SynteractHCR in 2015. Gil acquired 25 years of experience in the clinical development of medical products working in contract research, software systems management and biopharma companies. Gil has led discussions and participated in meetings with the FDA and EMA during several clinical development and approval processes including NDA, MAA, BLA and IND submissions and approvals. His most recent work has been regulated under CDER, but he has previously designed, managed and analyzed trials of biologics (CBER) and medical devices (CDRH).
Prior to joining SynteractHCR, Gil held senior director positions in Statistics and Data Management with SuperGen, Inc., and as senior statistician with Syntex Management Systems. Gil’s primary clinical drug development experiences have been in the field of oncology. Additional therapeutic areas in which he has worked include inflammation, acute pain and autoimmune disorders. He also has DSMB experience as both a blinded and unblinded statistician.
Gil earned his Ph.D in Biostatistics from the University of California, Los Angeles, as well as his previous BA and Masters degrees. Additionally, Gil holds credentials as an SAS® Certified Professional and has designed, programmed and managed CFR21, Subpart-11 compliant databases for many Phase I to III clinical trials. His most recent peer-reviewed journal publications have focused on the methods for handling delayed treatment effects when analyzing time-to-event endpoints. Current statistical applications and research focus on adaptive clinical trial designs, including estimating sample size and statistical power for group sequential designs.
Dr. Edward Lakatos has worked as a statistician in the medical industry for over 35 years, with particular expertise in group sequential methods, adaptive methods, biosimilar trials, protocol design and survival analysis. His background in research and management, as well as his deep knowledge of programming and statistical software development, make Ed well-rounded and well-respected in his field and a true asset to SynteractHCR. Ed’s involvement in the industry spans several decades and reflects his diverse interests and his sought-after expertise. He is currently an elected fellow of both the Society for Clinical Trials (SCT) and The American Statistical Association (ASA).
Ed holds a thorough knowledge of research and development from first-in-man through FDA/EMA approval and beyond. As Senior Director of Biostatistics for nearly a decade for Forest Laboratories, a pharmaceutical company that was acquired by Actavis in 2014 for $25 billion, Ed led a large team achieving many successful NDA submissions. Prior to joining SynteractHCR, Ed served primarily as an independent consultant for the pharmaceutical industry, representing clients to regulatory agencies including the FDA and EMA. He also has extensive experience with Data Monitoring Committees. He worked at the National Institute of Health and Heart, Lung and Blood Institute for more than a decade, where he collaborated closely with the National Cancer Institute and developed his seminal method for calculation of sample size for survival trials. In 2003 he was awarded a Grant from the NCI to develop a software package capable of using this methodology. Ed’s methods now are referenced in statistical packages such as SAS, PASS, NQUERY and POWER AND PRECISION, and were used extensively in clinical trials at the NIH and at large coordinating centers throughout the U.S.
With a Ph.D. in Mathematical Statistics from the University of Maryland, and his unique sample size methodology, Ed has earned esteemed recognition and awards in his field. He has an extensive publication record and has delivered many invited guest presentations and courses, as well as having written chapters for three books in just the last few years.
The adaptive trial group at SynteractHCR works under the direction of Dr. Greg Wei. Greg has more than 20 years of pharmaceutical and statistical experience and is an expert on biostatistics for regulatory issues. Greg has direct regulatory experience with the FDA and EMA, and has presented to both agencies on special protocol assessment and adaptive trial design, both of which are crucial areas for pharma and biotech companies as they are pressured to increase trial efficiency and reduce study costs. Greg has extensive experience and knowledge in both early and late stage clinical development in various therapeutic areas including: cardiovascular, metabolic disease, anti-infective, asthma/COPD, oncology, pharmacokinetics, PK/PD modeling. He has statistical expertise in adaptive designs, group sequential designs and trial monitoring, Bayesian theory and dose-finding techniques.
Prior to joining SynteractHCR in 2012, Greg amassed pharmaceutical experience at a wide range of international companies, including management experience as head of statistics at the China Research and Development Center, Pfizer, Inc.; as senior principal statistician of biostatistics at Boehringer-Ingelheim; and as director of biostatistics at Orexigen Therapeutics.
Greg earned his Ph.D. in Biostatistics from the University of Wisconsin-Madison. He has represented his companies and drug sponsors for FDA and EMA meetings, prepared for advisory committee meetings for NDA submissions and supported DSMB committees as the unblinded statistician.