- Over 30 years in clinical research field and pharmaceutical industry.
Scientist/Researcher, Senior Pharma Executive, Drug Development, Clinical Trials (IND – Phase 4), Early Clinical Research, PK/PD Analysis, Globalization of Clinical Pharmacology, FDA Interactions (INDs, NDAs, sNDAs), Contracts/Budget Management
PhD in Pharmaceutical Sciences from State University of New York at Buffalo. An innovative leader in globalization of clinical pharmacology function and early clinical research, with nearly 50 author/co-author publication credits; patent-holder of sustained-release dosage form for water-soluble compounds.
Company President and Founder, MaierMetrics and Associates, LLC
Provide clients with a wide range of drug development expertise/services, from discovery to IND and NDA filing: clinical development plans/execution, clinical pharmacology, translational medicine, and regulatory and NDA submission. Project team of associates with more than 25 years of pharmaceutical experience and proven track records of success. Have filed numerous market applications to the FDA and global health authorities that led to products such as Lunesta®, Brovana®, and Xopenex® franchises (among others), as well as key regulatory milestone briefing documents. Well-versed and powerful advocates of model-based drug development and knowledge integration across all phases of the development process.
Vice President, Clinical Pharmacology, Sunovion Pharmaceuticals, Inc. (formerly Sepracor)
Managed and set scientific direction of all aspects of clinical pharmacology studies (IND through Phase 4) including bioanalytical and clinical pharmacokinetic functional groups as well as modeling and simulation efforts. Led globalization of Japan and US clinical pharmacology groups. Primary contact for early clinical research integration. Responsible for all model-based drug development activities across all phases of drug development from preclinical feasibility assessments to NDA submission documents. Accomplished global clinical pharmacology regulatory submissions, including numerous INDs, and drug development milestone briefing books, representing discipline at FDA meetings. Provided clinical pharmacology review of in-licensing candidates. Managed large budget and external contracts for bioanalytical and clinical pharmacology studies.
Research Leader, Clinical Pharmacokinetic and Metabolism, Sanofi Research Division (formerly Sterling Winthrop)
Provided scientific oversight and management of clinical and preclinical bioanalytical and pharmacokinetic functions and teams at US site and oversaw clinical PK outsourcing activities. Responsible for pharmacokinetic analysis of compounds in all phases of clinical development as well as for assay method development, validation, and toxicokinetic studies. Supported discovery programs and compound selection (PK/PD analysis).
Scientist/Researcher, Lederle Labs and Schering Plough
Participated in development of solid dosage forms, biopharmaceutics, and pre-formulation studies. Developed novel controlled-release drug delivery system for a water-insoluble compound that led to formulation patent for product used in clinical development studies. Utilized in-vitro/in-vitro convolution/deconvolution methods to direct desired dissolution release rates of novel products. Performed clinical pharmacokinetic analyses and report writing.