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Archive

New Horizon /  (Page 3)

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October 2, 2022

Dr. Angela James is the Vice-Chair of Women in Bio and an accomplished scientist with expertise in drug development which she is currently applying in her role as Vice President, Head of Clinical Pharmacology, at MacroGenics Inc., a company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. Dr. James earned a B.A. in Biology from Rice University and a Ph.D. in Pharmaceutical Sciences with a research focus in Pharmacokinetic/Pharmacodynamic Modeling and Simulation from University of Maryland, Baltimore. She later received a M.S. in Pharmacometrics from University of Maryland, Baltimore. She is passionate about utilizing her scientific acumen and leadership abilities to bring novel therapeutics to patients who urgently need safe and effective drugs. Equally...

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October 2, 2022

Rachel G. Greenberg, MD, MB, MHS is a neonatologist and Associate Professor of Pediatrics at Duke University Medical Center and Duke Clinical Research Institute. Dr. Greenberg’s research focuses on improving safety and efficacy of drugs in infants and children, particularly through her efforts as co-Investigator for the NICHD-funded Pediatric Trials Network. She is also co-Investigator for the NCATS-funded Duke-Vanderbilt Trial Innovation Center, where she provides consultation to investigators developing multicenter studies. In addition, she has been principal investigator of multiple trials funded by the U.S. Food and Drug Administration, Centers for Disease Control, and National Institutes of Health....

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October 2, 2022

Lynne has over 30 years of biopharmaceutical and CRO experience providing strategic, clinical development and regulatory advice at all stages of product development. She has spent the last several years promoting innovative methods to accelerate pediatric drug development as VP of Regulatory Affairs and Pediatric Strategic Development at Synteract, and Sr. VP Regulatory Affairs and Clinical Development at KinderPharm. She has led numerous successful regulatory filings and agency interactions (e.g., Pre-IND, INDs, NDA/BLAs, EMA scientific advice, EOP2, and Pre-NDA)....

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October 2, 2022

Solange Corriol-Rohou, a pulmonologist and an immuno-allergist by training, joined AZ R&D in 2004 and is currently Sr. Director of Regulatory Affairs & Policy for Europe. Over the past 20 years, moving from the French Medicines Agency/EMA and a specialist physician position at the Hospital of Versailles to the pharmaceutical industry, she has gained strategic experience in drug development for different therapy areas, such as respiratory, inflammation and oncology. She is currently leading the AZ Paediatric Work Group. Solange, in her role as the chair of the Clinical Development Expert Group at the EFPIA, organized jointly with the EMA several workshops. Dr. Corriol-Rohou has recently been involved in critical issues, such as Complex Clinical Trial Designs, the use of Digital tools...

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October 2, 2022

Glen Clack graduated from the Royal Free Hospital School of Medicine, London, and after spending 5 years in the British National Health Service, joined Pharma in 1997. Glen initially gained Industry drug development experience in late clinical development with AstraZeneca’s endocrine portfolio, delivering 2 NDAs and an sNDA. Since 2002 he has been involved in translational medicine and has been accountable for the early development of anti-cancer compounds, from lead optimisation to clinical proof of concept in both solid and haematological malignancies i.e. small and large molecules, cytotoxic chemotherapy, anti-sense oligonucleotides and therapeutic vaccines. The relevant biological effect areas of these compounds include hormone manipulation, invasion, DNA damage repair, immune modulation, angiogenesis, CDKs, the MTOR/PI3K/AKT and WNT pathways, tumour genomic drivers....

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October 2, 2022

S. Y. Amy Cheung, PhD is a Senior Director in Integrated Drug Development with responsibility of Quantitative Sciences lead for the UK. She is a core member of the Pediatric Integrated Practice Area at Certara. She has over a decade of Pharma experience (AstraZeneca).  She obtained her PhD from the University of Manchester. After receiving her PhD, she worked at the Centre for Applied Pharmacokinetic Research (CAPKR) at The University of Manchester. Followed by a postdoc on mechanistic modelling. She has expertise in pediatric drug development, oncology, infection, CNS, vaccine, mAb, MIDD, PBPK, and extrapolation. She is a member of the IQ CPLG pediatric working group and chair of the IQ TALG CPLG Pediatric PBPK group. She is an affiliated...

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October 2, 2022

Currently the Drs. William F and Virginia Connolly Mitty Professor and founding head of the Division of Medical Ethics at NYU School of Medicine in New York City. Prior to coming to NYU School of Medicine, Dr. Caplan was the Sidney D. Caplan Professor of Bioethics at the University of Pennsylvania Perelman School of Medicine in Philadelphia, where he created the Center for Bioethics and the Department of Medical Ethics. Caplan has also taught at the University of Minnesota, where he founded the Center for Biomedical Ethics, the University of Pittsburgh, and Columbia University. He received his PhD from Columbia University. Dr. Caplan is the author or editor of thirty-five books and over 850 papers in peer reviewed journals. His most recent...

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October 2, 2022

Julie has over 10 years of drug development experience within the FDA and contributed to over 14 new molecular entity approvals. She has unique insights into pediatric development, PK/PD analysis and approaches for biologics, oncology dosing strategy, and development of breakthrough therapies and accelerated approvals....

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October 2, 2022

Felix Boakye-Agyeman is a Senior Director of Pharmacometrics at Certara. Prior to Certara, Felix was at Syntheract/Kinderpharm where he managed a team of scientists who conducted pharmacometrics and pharmacology consulting in adult and pediatric populations. Felix also worked at the Duke Clinical Research institute supporting early clinical development, small trials group and the pediatric trials network. Felix completed his Postdoctoral Fellowship in Clinical Pharmacology at the Mayo Clinic. He has broad knowledge in many subject areas including pharmacometrics, bioanalysis, and translational science. He has a particular interest in developmental PK, accelerating the drug development and labelling processes in pediatric populations....

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October 2, 2022

Samuel C. Blackman, MD, PhD is co-founder and Chief Medical Officer of Day One Biopharmaceuticals. Sam is a physician-scientist trained in pediatric hematology/oncology and neuro-oncology, and has led the early clinical development of more than 10 novel cancer therapeutics. Prior to founding Day One, Dr. Blackman held roles of increasing responsibility at both large pharmaceutical companies and smaller biotechnology companies include Juno Therapeutics, Seattle Genetics, Merck, and GlaxoSmithKline. Dr. Blackman was responsible for the pediatric development of dabrafenib, resulting in the first industry-sponsored pediatric oncology “basket trial”. Through roles at CureSearch and ACCELERATE, Dr. Blackman is an active leader in the pediatric oncology drug development community. Dr. Blackman is a graduate of the pediatric hematology/oncology fellowship program at the Dana-Farber...

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