About Us:
Sharon A. Baughman, Ph.D. is currently an independent biotechnology consultant specializing in Pharmacokinetics and Drug Metabolism, GLP and GCP compliance, and regulatory submissions. Formerly, she was Executive Director in Global Research and Development Compliance at Amgen Inc. where she utilized her scientific knowledge to assess and ensure compliance in the Research and Development space. Prior to this position, she was Director of Pharmacokinetics and Drug Metabolism for 7 years at Amgen. In this role, she was responsible for managing up to 75 scientific professionals. The group included a protein bioanalytical group and a pharmacokinetics group who performed preclinical and clinical assays, data analysis and preparation of regulatory submissions for Amgen’s protein and small molecule therapeutics. Prior to joining Amgen, Dr. Baughman was Associate Director and scientist at Genentech Inc. for 9 years. During that time, Dr. Baughman worked on the development of many protein therapeutics, including Herceptin®, Rituxan®, Avastin®, Protropin®, Nutropin® and Pulmozyne®. She also worked on several collaborations with other companies and was responsible for all leading multiple Pharmacology Subteams. Her experience includes performing research and development of protein therapeutics throughout North America, Asia, Australia, and Europe. She has actively been involved with the FDA Critical Path Initiative and the development of biomarkers to improve the drug development timeline. Dr. Baughman received her Ph.D. in Chemistry from Rice University.
Micheal Schrag, Ph.D. has 18 years of experience in the pharmaceutical industry, with expertise in the fields of enzyme kinetics, drug metabolism, discovery and development ADME, pharmacokinetics and pharmacodynamics. He has worked in both in big Pharma (Pharmacia and Upjohn, Merck and Amgen), small pharma (Array Biopharma). While at Merck his group worked on ARCOXIA® and supported the filing and approval of this drug. Dr. Schrag received his doctoral degree in medicinal chemistry from the University of Washington, Seattle and completed an industry postdoctoral fellowship at Pharmacia and Upjohn, with an emphasis on enzyme kinetics, drug-drug interactions and drug metabolism. Dr. Schrag's recent focus has been on pharmacokinetic and pharmacodynamic modeling, as well as population pharmacokinetics.
Jinfang Li, M.S., Jinfang joined Propharma Services as an independent consultant in September, 2013. She supports PK and TK analyses for GLP and non-GLP studies as well as clinical studies, PK-related statistical analyses, SAS programming and clinical data management. Jinfang previously worked as an Associate Clinical Pharmacologist in the DMPKCP department at Array Biopharma, involved in late stage development studies including GLP tox through phase II clinical studies in the areas of oncology and metabolic disease. She served as the principle TK investigator for GLP tox. studies, and clinical Pharmacology lead for Phase 1 clinical studies. Jinfang provided PK and PK/PD analyses, PK-related statistical analyses, BA lab outsourcing, clinical PK data management, SAS programming and PK-related CDISC SDTM files. She reviewed and authored various documents, e.g. PK/TK reports, protocols, eCRFs, CSRs, SOPs, SAPs, and PK-related sections of regulatory documents. Before Array BioPharma, Jinfang worked at Replidyne as a Senior Research Associate in Biochemistry and Pharmacology, providing support from early discovery through NDA filing, including drug screening, in vitro ADME screening, statistical analyses, PK/TK analyses, pop-PK and PK/PD analyses, SAS programming and CDISC SDTM files. Prior to joining Replidyne, Jinfang worked at the Cellular and Structure Biology Department at the University of Colorado, School of Medicine with Dr. Sandy Martin, and received her M.S. in the Department of Pharmacology and Toxicology with Dr. Alan Eastman at Geisel School of Medicine at Dartmouth.
Kelly Regal, Ph.D., has been working as an independent biotechnology consultant with Propharma Services since June, 2011. During this time, she has worked on non-GLP TK reports as well as clinical PK reports, including the PK compilation for a 55 subject oncology Phase I study. Her background includes pharmacokinetics, small molecule metabolism, enzyme kinetics, and qualitative and quantitative (non-GLP) mass spectrometric analyses. Dr. Regal formerly worked as a Research Investigator and a Sr. Research Investigator within the DMPKCP Department at Array Biopharma on Discovery and Development programs, covering internal and collaboration projects as well as support of out-licensing activities. The work encompassed early screening programs through full DM characterization of clinical leads in Phase II studies in the therapeutic areas of oncology, inflammation, and the CNS. This also included writing and updating INDs and IBs as well as the associated DMPK reports. Prior to this, Dr. Regal worked as a Senior Scientist in the PKDM Department at Amgen, covering internal backup and collaboration projects as well as support of in-licensing activities, and prior to Amgen she worked at Merck as a Senior Research Chemist.
Dr. Regal did her postdoctoral work as an intern in the Safety Assessment Department at Merck Research Labs (West Point, PA) as well as in the Pharmacology Department at the University of Michigan-Ann Arbor in the labs of Dr. Paul Hollenberg. She received her Ph.D. in the Department of Medicinal Chemistry from the lab of Sidney Nelson at the University of Washington-Seattle.
Burgess B. Freeman III, PharmD
Burgess is a part time consultant for ProPharma Services. He has specific expertise in pharmacometrics and the pharmacotherapy / pharmacology surrounding adult and pediatric oncology, inflammatory disorders, infectious diseases, and rare diseases. Analysis of pharmacological data using well-described, conventional statistical and computer modeling techniques (pharmacometrics or PM). Use of commercially available software (e.g. WinNonlin, NONMEM, ADAPT, R, S-Plus, SAS, Monolix, MatLab, SAAM II, Berkley Madonna) to execute PM analyses. Interpretation of PM results and application of PM results in planning non-clinical or clinical experiments. Making strategic decisions regarding pre-clinical or clinical development of potential drugs based upon PM data. Conveying PM results, interpretations, and applications in documents such as reports or in presentations. Authoring, reviewing, and managing the publication of peer-reviewed manuscripts regarding PM activities in scientific literature, journals, posters, and abstracts. Burgess worked at Array BioPharma where he was responsible for preclinical and clinical PK/PD analyses of small molecules. He was a Lead Clinical Pharmacologist on 4 oncology-focused programs, with responsibility for life cycle management vis-à-vis PK/PD/ClinPharm, spanning discovery to early development. Prior to this he was Director of the Core Pharmacology Lab at the Nevada Cancer Institute, a postdoctoral research associate at St. Jude Children's Research Hospital, a pharmacy practice resident at the Ohio State University Medical Center, and received is Pharm D from the University of Pittsburg.
Sharon A. Baughman, Ph.D. is currently an independent biotechnology consultant specializing in Pharmacokinetics and Drug Metabolism, GLP and GCP compliance, and regulatory submissions. Formerly, she was Executive Director in Global Research and Development Compliance at Amgen Inc. where she utilized her scientific knowledge to assess and ensure compliance in the Research and Development space. Prior to this position, she was Director of Pharmacokinetics and Drug Metabolism for 7 years at Amgen. In this role, she was responsible for managing up to 75 scientific professionals. The group included a protein bioanalytical group and a pharmacokinetics group who performed preclinical and clinical assays, data analysis and preparation of regulatory submissions for Amgen’s protein and small molecule therapeutics. Prior to joining Amgen, Dr. Baughman was Associate Director and scientist at Genentech Inc. for 9 years. During that time, Dr. Baughman worked on the development of many protein therapeutics, including Herceptin®, Rituxan®, Avastin®, Protropin®, Nutropin® and Pulmozyne®. She also worked on several collaborations with other companies and was responsible for all leading multiple Pharmacology Subteams. Her experience includes performing research and development of protein therapeutics throughout North America, Asia, Australia, and Europe. She has actively been involved with the FDA Critical Path Initiative and the development of biomarkers to improve the drug development timeline. Dr. Baughman received her Ph.D. in Chemistry from Rice University.
Micheal Schrag, Ph.D. has 18 years of experience in the pharmaceutical industry, with expertise in the fields of enzyme kinetics, drug metabolism, discovery and development ADME, pharmacokinetics and pharmacodynamics. He has worked in both in big Pharma (Pharmacia and Upjohn, Merck and Amgen), small pharma (Array Biopharma). While at Merck his group worked on ARCOXIA® and supported the filing and approval of this drug. Dr. Schrag received his doctoral degree in medicinal chemistry from the University of Washington, Seattle and completed an industry postdoctoral fellowship at Pharmacia and Upjohn, with an emphasis on enzyme kinetics, drug-drug interactions and drug metabolism. Dr. Schrag's recent focus has been on pharmacokinetic and pharmacodynamic modeling, as well as population pharmacokinetics.
Jinfang Li, M.S., Jinfang joined Propharma Services as an independent consultant in September, 2013. She supports PK and TK analyses for GLP and non-GLP studies as well as clinical studies, PK-related statistical analyses, SAS programming and clinical data management. Jinfang previously worked as an Associate Clinical Pharmacologist in the DMPKCP department at Array Biopharma, involved in late stage development studies including GLP tox through phase II clinical studies in the areas of oncology and metabolic disease. She served as the principle TK investigator for GLP tox. studies, and clinical Pharmacology lead for Phase 1 clinical studies. Jinfang provided PK and PK/PD analyses, PK-related statistical analyses, BA lab outsourcing, clinical PK data management, SAS programming and PK-related CDISC SDTM files. She reviewed and authored various documents, e.g. PK/TK reports, protocols, eCRFs, CSRs, SOPs, SAPs, and PK-related sections of regulatory documents. Before Array BioPharma, Jinfang worked at Replidyne as a Senior Research Associate in Biochemistry and Pharmacology, providing support from early discovery through NDA filing, including drug screening, in vitro ADME screening, statistical analyses, PK/TK analyses, pop-PK and PK/PD analyses, SAS programming and CDISC SDTM files. Prior to joining Replidyne, Jinfang worked at the Cellular and Structure Biology Department at the University of Colorado, School of Medicine with Dr. Sandy Martin, and received her M.S. in the Department of Pharmacology and Toxicology with Dr. Alan Eastman at Geisel School of Medicine at Dartmouth.
Kelly Regal, Ph.D., has been working as an independent biotechnology consultant with Propharma Services since June, 2011. During this time, she has worked on non-GLP TK reports as well as clinical PK reports, including the PK compilation for a 55 subject oncology Phase I study. Her background includes pharmacokinetics, small molecule metabolism, enzyme kinetics, and qualitative and quantitative (non-GLP) mass spectrometric analyses. Dr. Regal formerly worked as a Research Investigator and a Sr. Research Investigator within the DMPKCP Department at Array Biopharma on Discovery and Development programs, covering internal and collaboration projects as well as support of out-licensing activities. The work encompassed early screening programs through full DM characterization of clinical leads in Phase II studies in the therapeutic areas of oncology, inflammation, and the CNS. This also included writing and updating INDs and IBs as well as the associated DMPK reports. Prior to this, Dr. Regal worked as a Senior Scientist in the PKDM Department at Amgen, covering internal backup and collaboration projects as well as support of in-licensing activities, and prior to Amgen she worked at Merck as a Senior Research Chemist.
Dr. Regal did her postdoctoral work as an intern in the Safety Assessment Department at Merck Research Labs (West Point, PA) as well as in the Pharmacology Department at the University of Michigan-Ann Arbor in the labs of Dr. Paul Hollenberg. She received her Ph.D. in the Department of Medicinal Chemistry from the lab of Sidney Nelson at the University of Washington-Seattle.
Burgess B. Freeman III, PharmD
Burgess is a part time consultant for ProPharma Services. He has specific expertise in pharmacometrics and the pharmacotherapy / pharmacology surrounding adult and pediatric oncology, inflammatory disorders, infectious diseases, and rare diseases. Analysis of pharmacological data using well-described, conventional statistical and computer modeling techniques (pharmacometrics or PM). Use of commercially available software (e.g. WinNonlin, NONMEM, ADAPT, R, S-Plus, SAS, Monolix, MatLab, SAAM II, Berkley Madonna) to execute PM analyses. Interpretation of PM results and application of PM results in planning non-clinical or clinical experiments. Making strategic decisions regarding pre-clinical or clinical development of potential drugs based upon PM data. Conveying PM results, interpretations, and applications in documents such as reports or in presentations. Authoring, reviewing, and managing the publication of peer-reviewed manuscripts regarding PM activities in scientific literature, journals, posters, and abstracts. Burgess worked at Array BioPharma where he was responsible for preclinical and clinical PK/PD analyses of small molecules. He was a Lead Clinical Pharmacologist on 4 oncology-focused programs, with responsibility for life cycle management vis-à-vis PK/PD/ClinPharm, spanning discovery to early development. Prior to this he was Director of the Core Pharmacology Lab at the Nevada Cancer Institute, a postdoctoral research associate at St. Jude Children's Research Hospital, a pharmacy practice resident at the Ohio State University Medical Center, and received is Pharm D from the University of Pittsburg.