Gilbert N. Lam is a Pharmacokinetist with more than 30 years of experience in the pharmaceutical industry. As President and Chief Scientific Officer of MicroConstants, he is responsible for overseeing the direction of the company and its overall operations.
Prior to founding MicroConstants in 1998, Gil was the Executive Director of Preclinical Safety and Drug Disposition at CoCensys, a neuropharmaceutical company. During that time, he was responsible for preclinical and clinical pharmacokinetic development programs of new chemical entities proprietary to CoCensys. Gil began his career at DuPont Pharmaceuticals where he supported various discovery and research activities. In 1994, he became the Director of Preclinical Pharmacokinetics and Metabolism at DuPont and was responsible for the development efforts in IND and NDA applications.
Gil received his bachelor’s degree in Pharmaceutical Sciences from the State University of New York (SUNY) at Buffalo and his Ph.D. in Pharmaceutical Sciences from the University of Illinois Medical Center in Chicago, Illinois. He has co-authored more than 40 peer-reviewed publications and is a member of the American Association for Pharmaceutical Scientists (AAPS) and the International Society for the Study of Xenobiotics (ISSX).
David F. Beyerlein has over 15 years of experience managing laboratory operations, is an experienced analytical chemist, and is highly skilled in the use of the mass spectrometer. David co-founded MicroConstants with Dr. Lam in 1998. As the Vice President of Global Operations, he is responsible for overseeing and managing all laboratory operations, project and sample management, information technology, and purchasing.
Prior to co-founding MicroConstants, David was part of the mass spectrometry group at Covance’s facility in Madison, Wisconsin. Before joining Covance, he was a Senior Research and Development Scientist in the Bioanalytical/Mass Spectrometry group at the Madison facility of PPD-Pharmaco where he started their Bioanalytical LC/MS/MS Department. David received his bachelor’s degree in Chemistry from the University of Wisconsin - Eau Claire.
Jose V. Buenviaje has over 20 years of research, analytical, and manufacturing experience in the biotechnology industry and more than 18 years of experience with Quality Assurance Compliance related to cGLP and cGMP regulations. As the Vice President of Quality Assurance and Regulatory Compliance, Jose serves as the executive quality authority in all interactions with Regulatory representatives. He is also responsible for the creation, compliance, and deployment of MicroConstants’ global quality system, including internal GLP policies and procedures consistent with internationally recognized standards.
Prior to joining MicroConstants in 1999, Jose Buenviaje was the Quality Assurance Supervisor at Syntron Bioresearch, a licensed Medical Device Establishment in Carlsbad, California. While at Syntron, Jose implemented, standardized, and supervised the QA Department and participated in the FDA 510K submission for medical devices designed to measure drugs of abuse. Before Syntron, Jose spent five years working in the field of forensic chemistry and has testified as an expert witness in the field of toxicology for numerous cases for the state of California. Jose received his bachelor’s degree in Biology/Psychology from the University of California, San Diego.
David Johnson has over 13 years of experience implementing and managing preclinical drug discovery contract research services. In 2000, he joined MicroConstants establishing the Drug Metabolism group which is responsible for preclinical drug metabolism research and non-GLP discovery bioanalytical research.
Previously David was the Drug Metabolism Product Development Manager for the Pharmazyme division of Immune Complex Corporation. During that time, he conceived, designed, and developed an in vitro drug metabolism contract research program utilizing recombinant cytochrome P450s and other drug metabolizing enzymes. Prior to Pharmazyme, David was a Research Assistant at Hybritech where he developed methods to automate the radiolabeling of monoclonal antibodies for use in medical diagnostic kits. He received his bachelor’s degree in Chemistry from the University of California, San Diego and his Ph.D. from the University of Minnesota, Twin Cities.
John Marcelletti has over 20 years of drug development experience and has spent many years directing regulated bioanalytical lab operations. As Senior Director of Immunology, he oversees the development and validation of large molecule immunoanalytical drug methods in support of regulated pharmacokinetic and toxicokinetic (PK/TK) analyses of preclinical and clinical biological samples. He also directs similar activities concerning drug immunogenicity studies, including methods for antidrug antibodies (ADA) and neutralizing antibodies (NAb).
Before joining MicroConstants, John was Senior Lab Director at Tandem Labs (LabCorp) from 2012-2015, during which time he directed the firm’s San Diego bioanalytical immunology lab in support of regulated preclinical and clinical pharmacology studies. Prior to that, he held a variety of positions directing translational medicine operations in oncology and autoimmunity, mostly focused on incorporation of biomarkers into clinical studies as PD and CDx tools for drug development. He has also served as a private consultant where he specialized in drug development and precision medicine in preclinical and clinical study designs, bioanalytical issues and medical writing. He is affiliated with the American Association of Immunologists, American College of Rheumatology, and American Association of Pharmaceutical Scientists. John received his Ph.D from the Department of Immunology and Microbiology, Wayne State University School of Medicine in MI. He also holds an MBA from The Haworth College of Business at Western Michigan University. His bibliography includes 65 scientific publications and patents, primarily in immunology, drug development, and use of biomarkers in precision medicine.
Richard Egolf has over 8 years of business development experience offering contract research services to pharmaceutical, biotech and medical device companies. He joined MicroConstants in 2014 as Director of Business Development. In this role, Richard is responsible for developing new business opportunities in the Southwestern United States.
Before joining MicroConstants, Richard was a Business Development Manager at Absorption Systems where he was responsible for building new business and growing existing client base in the Southeast, Northeast and Western United States territories representing all areas of service; DMPK, ocular, biologics and medical device. He received his bachelor's degree in Microbiology from The Pennsylvania State University in University Park, Pennsylvania.
Jeff Hoffman has more than 18 years of experience in the contract research and pharmaceutical industries. He joined MicroConstants in 2004, and currently serves as a Principal Investigator for the Bioanalytical Chemistry and Formulation Analysis departments. In this role, he oversees the day-to-day operations of the Bioanalytical and Formulation departments and offers hands-on leadership in the areas of method validation and analytical sample analysis.
Previously, Jeff was at Dermtech/Pracs Institute where his responsibilities included analytical method development, method validation, and supervision of the transdermal laboratory operations. Prior to that, he was an analytical chemist in the Toxicology Department at PoisonLab. Jeff received his bachelor’s degree in Biology and Zoology from Humboldt State University in Arcata, California.
Mike Kennedy has more than 15 years of experience in the contract research and pharmaceutical industries. He originally joined MicroConstants in 1999 as an Associate Scientist. After 5 years, Mike branched out from the CRO realm to the pharmaceutical world. Since returning to MicroConstants, he currently serves as a Senior Manager of Bioanalytical Chemistry. In this role, he oversees the day-to-day operations of the Bioanalytical department and offers hands-on leadership in the areas of method validation and analytical sample analysis.
Previously, Mike was at Dart NeuroScience where his responsibilities included analytical method development and PK analysis. He was also the DMPK lead representative on several discovery and development project teams. Prior to that, he was at Hollis-Eden Pharmaceuticals where his responsibilities included analytical method development, method validation, and the generation of PK calculations. Mike received his bachelor’s degree in Chemistry from the University of California, San Diego.
Michelle Mason joined MicroConstants as an Administrative Assistant in 2002. That same year, she was promoted to become a Project Coordinator responsible for working with clients to coordinate the development of project plans. Michelle is now the Manager of Project Operations and responsible for overseeing day-to-day project operations, implementing strategies to enhance client services, and identifying opportunities to improve efficiency throughout the company. Michelle also manages the Project Management, Sample Management, and Specimen Collection Kit departments. She earned her bachelor’s degree in Psychology from San Diego State University in California.
Mary P. Gil has more than 7 years of experience in quality assurance compliance related to GLP regulations. She joined MicroConstants in 2003 as an Analytical Scientist in the Drug Metabolism group. She spent three years in the lab before transitioning into the Quality Assurance (QA) Department in 2006. In her current role as Quality Assurance Manager, Mary is now responsible for developing, implementing and maintaining regulatory and quality programs to ensure compliance with FDA, OECD and MHLW Good Laboratory Practice (GLP) regulations. She also supervises the day-to-day operations of the Quality Assurance, Document Control and Archive departments and interfaces with clients and external regulatory agencies regarding quality audits or other regulatory requirements. Mary received her bachelor’s degree in Biochemistry and Cell Biology from the University of California, San Diego.