Join us for our second live panel discussion with drug development industry veterans. During this 1-hour session, we’ll discuss:
- Regulatory impacts from a former FDA reviewer
- The latest impact on ongoing and planned clinical trials from a Phase 1 site
- How labs are adjusting to the crisis
- FAQs from our clients and colleagues
Meet the Panelists
Vice President, Global Clinical Research, Celerion
As Vice President of Global Clinical Research at Celerion, Phil Bach is responsible leading one of the top clinical operations networks in the industry. His 20+ years of experience have positioned him to lead Celerion’s clinical pharmacology business through the turbulent times caused by the COVID-19 crisis. As a member of the Senior Management Team, Mr. Bach’s extensive commercial research expertise has fueled the successful growth of the Celerion organization for over a decade. Mr. Bach will share some of the emerging strategies for ensuring the future success of early clinical trial research as new practices emerge.
Jenny Lin, M.S.
Chief Operating Officer, CMIC US Bioanalysis
Jenny Lin has 30 years of executive and lab management experience for bioanalytical and analytical laboratory operations in support of drug discovery, pre-clinical and clinical drug development. She also has expertise in small molecule, biologics, oligonucloetide and biomarker bioanalysis. Ms. Lin has directly led and participated in CMC and bioanalytical development for numerous IND/NDA filings. She is a selected member for Global Bioanalysis Consortium (GBC) making recommendations for global Bioanalysis harmonization.
Iftekhar Mahmood, Ph.D.
Senior Consultant, Clinical Pharmacology and Pharmacometrics, Nuventra Pharma Sciences
Dr. Mahmood has more than 25 years of experience in clinical pharmacology with the FDA. Dr. Mahmood has experience working in both CDER and CBER. At the FDA, besides his regular IND, BLA, and NDA review duties, Dr. Mahmood was also involved with clinical pharmacology research (both small and large molecules) and published more than 100 research papers in peer-reviewed scientific journals. His research mainly focused on allometric scaling, modeling, sparse sampling, and pediatric drug development.
Meet the Moderator
Geoffrey Banks, Ph.D.
Chief Executive Officer, Nuventra Pharma Sciences
Geoffrey Banks, Ph.D., founded Nuventra in 2008 and has led the company as both its CEO and as a principal consultant. He has nearly 20 years of extensive experience in large pharma, biotechnology, and specialty pharma and an established track record of clinical, regulatory, and entrepreneurial success within the pharmaceutical industry.