Postmarketing Study Commitment Trends for New Drugs: An Analysis of NMEs Approved in 2008
Given that the FDA Amendments Act of 2007 (FDAAA) took effect in late March 2008, the 2008 class of approved NMEs offered an early glimpse into how anxiously the FDA would wield its newly found powers regarding postmarketing requirements and risk evaluation and mitigation strategies (REMS).
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Anders Neil, Ph.D.
Anders Neil, Ph.D., Principal Consultant, European Early Stage Product Development, PAREXEL Consulting
Dr. Neil brought more than 30 years of experience in the pharmaceutical field when he joined PAREXEL in 2008, including positions with European regulatory authorities, academic research in pharmacology, and drug development activities for the pharmaceutical industry.
As Principal Consultant for European Early Stage Product Development, Dr. Neil works with a variety of PAREXEL clients to refine their pre-clinical development plans, with a focus on pharmacology, toxicology, and non-clinical regulatory issues in the European Union. He also provides specific expertise in orphan drug and pediatric investigation planning.
“Having worked for both the pharmaceutical industry and regulatory agencies, I feel that I’m in a unique position to understand both sides of the early-stage product development process,” Dr. Neil said. “With today’s market pressures and budget restrictions, product developers often have a relatively narrow base of pre-clinical data to present to regulators, and very little leeway in their development timeframes to produce additional data in response to unforeseen regulatory questions. At the same time, regulators are under increasing pressure to more closely examine safety data and ask for detailed explanations of unexpected findings. One of my most important jobs is to help our clients understand and anticipate regulatory expectations so that the needs of both sides are accommodated without impeding the development of novel therapies.”
Before he joined PAREXEL, Dr. Neil was a Principal Scientist at Biovitrum AB, in Stockholm, Sweden, where he was a scientific advisor on pharmacology and toxicology, as well as a core-team member for pre-clinical and clinical development projects. He also provided regulatory expertise on non-clinical topics. Prior to that, he was a Senior Expert with Sweden’s Medical Products Agency (MPA), where he assessed non-clinical pharmacology and toxicology in applications for pharmaceutical clinical trials and marketing authorisations, and reviewed more than 1,000 submissions, including more than 50 new compounds per year across all stages of development and therapeutic areas. Dr. Neil also served as an expert to the European CPMP and its Safety Working Party as a rapporteur on EU regulatory documents.
Dr. Neil holds a BSc. in Chemistry, Pre-Clinical Biomedicine, and Philosophy, as well as a Ph.D. in Pharmacology, from Uppsala University, Sweden, and is an Associate Professor in Pharmacology on the Faculty of Pharmacy of the same university. He has authored more than 35 published original research articles, reviews, and book chapters in the areas of opioid mechanisms, pain physiology, receptor pharmacology, pharmacokinetics, and regulatory issues.