Management Team PKPD Inc.

Martin Graham
Professor Martin Graham PhD is the Founder of PKPD Incorporated and serves as the Chairman of the Board of Directors. Prof Graham is a graduate of Leeds University, UK (Pharmacology and Microbiology BSc, Joint Honors) and obtained his PhD from the University of London (Institute and Cancer Research, Royal Marsden Hospital, London UK). He conducted post-doctoral research in anti-cancer drug development at the Beatson Institute (University of Glasgow) before joining Sterling-Winthrop Pharmaceuticals (now Sanofi-Aventis) in both the UK and the US. He has held positions of increasing responsibility during his career and was Director of Pharmacokinetics at Centocor Corporation (Johnson and Johnson), and VP of Research and Development at Gemin X Biotechnologies before founding PKPD Incorporated in 2004. He was President and CEO of PKPD until June 2006 and now serves on the board directors as company Chairman. Dr Graham has extensive R&D experience with both small molecules and protein therapeutics from IND to NDA/BLA and has been involved in numerous regulatory filings in both the US, Japan and Europe for a wide variety of products including Oxaliplatin, Rasburicase, Mitoguazone, Tirapazamine, Alfuzosin and Remicade. Prof Graham is an Honorary Professor of Pharmacokinetics and Pharmacodynamics at the University of Bradford, Yorkshire, UK and is specialist in PK/PD modeling clinical trial simulation. He is the author of a text book on the “Pharmacokinetics of Cancer Chemotherapy” and has a substantial publication record in the area of pharmacokinetics, drug metabolism and clinical pharmacology.

Laurence H Patterson
Professor Laurence H Patterson is a member of the Board of Directors and consults in medicinal chemistry, drug metabolism and pharmacokinetics for PKPD Incorporated. Prof Patterson is a graduate of University of Hertfordshire, UK (BSC (hons) Applied Biology) and obtained his PhD from the University of London (Chelsea Dept of Pharmacy). He spent several years in the pharmaceutical industry as a senior scientist in R & D with Fisons Pharma (now Astra Zeneca). Subsequently he held several academic positions at DeMontfort University progressing to Professor of Pharmaceutical biochemistry and then on to Professor of medicinal chemistry and Head of the Department of Pharmaceutical and Biological Chemistry at The School of Pharmacy, University of London. He is currently Director of the Institute of Cancer Therapeutics (ICT), University of Bradford and is a Fellow of the Royal Society of Chemistry. He has published over 100 papers and patents concerned with the discovery and development of new drugs with particular interest in the oncology field. He consults widely with pharmaceutical and biotechnology in the areas of drug discovery, medicinal chemistry, drug metabolism and pharmacokinetics. Prof Patterson is responsible for the discovery of AQ4N, a tumour hypoxia activated agent in Phase 1/II Trials. He is also a founding director of Biostatus Ltd with substantial interest in the development of live cell probes. (lpatterson@pkpdinc.com)

Jeffrey S. Barrett, Ph.D., FCP
Dr. Jeffrey S. Barrett is a consultant for PKPD Inc., specializing in PK/PD modeling, population pharmacokinetics and clinical trial simulation. Dr Barrett is Research Associate Professor of Pediatrics, University of Pennsylvania and is the Director of the Laboratory for Applied PK/PD in the Division of Clinical Pharmacology and Therapeutics at the Children's Hospital of Philadelphia (CHOP). He is an Associate Scholar in the Center for Clinical Epidemiology and Biostatistics at The University of Pennsylvania. Dr. Barrett serves as the Principal Investigator for CHOP's Pediatric Pharmacology Research Unit and heads the Kinetic Modeling and Simulation core of the Penn/CHOP Clinical and Translation Science Award. He received his BS from Drexel University in Chemical Engineering and his Ph.D. in Pharmaceutics from the University of Michigan. Dr. Barrett spent 13 years in the pharmaceutical industry with Aventis and was involved with clinical pharmacokinetic and pharmacodynamic aspects of clinical drug development. He is a Fellow of the American College of Clinical Pharmacology (ACCP) and the American Association of Pharmaceutical Scientists (AAPS) and received the Young Investigator and Clinical Pharmacology Mentorship Awards from ACCP in 2002 and 2007 respectively. He is a member of the FDA Clinical Pharmacology Advisory Committee and on the Board of Directors of the Metrum Research Institute. Dr. Barrett’s research interest is focused on investigating sources of variation in pharmacokinetics and pharmacodynamics. He applies clinical pharmacologic investigation coupled with modeling and simulation strategies to pursue rational dosing guidance. Dr. Barrett also focuses on the development of pharmacometric approaches to advance PK/PD, medical informatics and disease progression modeling.

Paul Loadman
Dr Paul Loadman is responsible for Pharmacokinetic data analyses at PKPD Incorporated and is a consultant in drug metabolism and bioanalysis. Dr Loadman has a honours degree in Applied Biology (Pharmacology and Immunology) and obtained his PhD from the University of Bradford, UK, studying the pharmacokinetics and metabolism of anti-cancer drugs. Dr Loadman is an expert in the bioanalysis of drugs and has studied a wide range of clinically available and novel small molecules including antimetabolites, platinating and alkylating agents, peptides and antivascular compounds. Dr Loadman is actively involved in the design, analysis and reporting of pre-clinical and clinical pharmacokinetic studies and acts as a pharmacokinetic and drug metabolism consultant for numerous US and European pharmaceutical and biotechnology companies. (ploadman@pkpdinc.com)

Kevin Adams
Dr Kevin Adams is responsible for business development activities at PKPD Incorporated. Dr Adams is a graduate of the University of Leeds (BSc (Hons) in Genetics) and was awarded a D.Phil. by the University of York. After a period of post-doctoral research in Genetic Toxicology at Swansea University and the Zentrum fur Tumorforschung at the University of Essen (Germany), he moved into industry at Huntingdon Life Sciences (HLS). In 14 years at HLS he held a variety of positions including Head of Cellular and Genetic Toxicology before moving into a more commercial role as Bioscience business development manager. After leaving HLS, he spent two years in a European sales and marketing role with BD Biosciences before moving to the University of Bradford to manage their Bio-Incubation programme. In his various roles Dr Adams has developed a range of skills and experience covering laboratory and project management, Good Laboratory Practice, regulatory toxicology and business development. Dr Adams is also closely involved with a number of new businesses through Bradford University’s Bio-Incubation programme. This has included supporting business incorporation, business planning, fund raising, grant writing, business development and PR. (kadams@pkpdinc.com)

Stuart Nelson
Mr Stuart Nelson, BSc (Hons) is responsible for Project Management and Business Development at PKPD. Stuart is a graduate scientist with a BSc Honours degree in Biotechnology, obtained at the University of Strathclyde in Glasgow, Scotland. After graduation he worked at the University of Sheffield, UK studying the role of Epstein Barr Virus in skin lymphoma. From here he moved to the Centre for Ecology and Hydrology in Huntingdon, UK. With a strong background in molecular biology Stuart moved into industry in 1995 with a commercial supplier in the biomedical research field. As Director of Scientific Services his role was to develop the scientific division of the Company and set-up molecular biology, embryology and transgenic technology laboratories. He was also responsible for business development, project management and contract negotiation. More recently, Stuart has been involved in a similar role as Commercial Manager for the Institute of Cancer Therapeutics at the University of Bradford, UK. As well as business development, his role involves the management of projects for the evaluation of novel therapeutic compounds, including preclinical evaluation as well as pharmacokinetic and pharmacodynamic analysis. (snelson@pkpdinc.com)

Dr Gerald Fetterly Jr., PhD
Dr Fetterly is consultant pharmcokineticist for PKPD and Director of the PK/PD Core Facility at the Rosswell Park Cancer Institute. Prior to joining Roswell Park Cancer Institute, Dr. Fetterly worked at Cognigen where he performed population PK/PD modeling among other projects, and provided consulting services for both industry and academia to assess the impact of patient factors that are sources of variability in not only pharmacokinetics but also the PK/PD relationships for both efficacy and safety, mainly for oncology and neuropharmacology drugs. At Cognigen, he led and managed interdepartmental projects in Clinical Pharmacology, provided sparse sampling designs for clinical pharmacology trials, provided clinical pharmacology services for regulatory strategy during Advisory Board and Sponsor/FDA meetings, reviewed the non-clinical as well as clinical pharmacology development sections of various INDs and NDAs, as well as assisted in the interpretation of preclinical data and extrapolation of implications for human clinical development utilizing PK/PD modeling approaches.

From 2000-2002, Dr. Fetterly was a clinical pharmacology and biopharmaceutics reviewer at the FDA. The experience of working with the agency has allowed him to supply insight, about the necessary components for a successful IND and NDA submission, along with guiding dose selection during the drug development process.

Dr. Fetterly received his doctoral degree in Pharmaceutics from the University at Buffalo in 2000. He possesses considerable expertise in developing oncology agents and the liposomal encapsulation of drugs. Specifically, his doctoral work and subsequent publications focused on an extensive comparison of the PK/PD relationships of various anticancer drugs, such as liposomal paclitaxel, trabectedin, and mTOR inhibitors.

Jason H. Williams, Ph.D.
Dr. Jason H. Williams is a consultant pharmacokineticist for PKPD Inc and supports the analysis and reporting of the pharmacokinetic aspects of clinical trials. Dr. Williams is a Postdoctoral Fellow in the Laboratory for Applied PK/PD in the Division of Clinical Pharmacology and Therapeutics at the Children’s Hospital of Philadelphia. He is a member of the American College of Clinical Pharmacology (ACCP), and the American Association of Pharmaceutical Scientists (AAPS) and serves as Adjunct Clinical Pharmacologist for CHOP's Pediatric Pharmacology Research Unit. He received his BA in Biology from Johns Hopkins University and his PhD in Pharmacology and Physiology from Drexel University. His current research project utilizes modeling and simulation to quantify disease progression and to develop Population-Pharmacokinetic models used to guide dosing and trial design. He has received three ACCP trainee awards pertaining to his preclinical and clinical research focused on the disease Spinal Muscular Atrophy.

Mary Ann Mascelli, Ph.D.
Mary Ann Mascelli, Ph.D. has over 20 year of experience in biologic therapeutic development – her primary areas of expertise are early clinical development and biomarker / translational sciences strategy. Dr Mascelli recently held the position of Senior Director, Respiratory Inflammatory Autoimmune (RIA) Translational Sciences at MedImmune. Prior to MedImmune, Dr. Mascelli held the position of Director and Head Experimental and Translational Medicine group at Clinical Pharmacology and Experimental Medicine, Centocor, Inc. In both positions, Dr Mascelli’s group was responsible for the design and integration of biomarker / translational sciences strategies into the development plans for respiratory and autoimmune indications. During her tenure at Centocor, Dr Mascelli made significant contributions to the successful regulatory filings of the cardiovascular / autoimmune biologic therapies - abciximab, ustekinumab and golimumab.

Dr Mascelli was the first Herman Vander Berg Fellow, Cancer Research Institute and is an elected Fellow of the Council on Arteriosclerosis, Thrombosis and Vascular Biology of the American Heart Association and a member of the American Society for Pharmacology and Experimental Therapeutics. She was an invited speaker at numerous American Society of Clinical Pharmacology and Therapeutics Annual Meetings. Dr Mascelli has authored or co-authored over 50 peer-reviewed / review articles in the areas of thrombosis and hemostasis, cardiology, infectious disease, rheumatology and autoimmune disorders, with an emphasis on development and application of biomarkers to establish proof of concept in early clinical development.

Dr. Mascelli earned her Ph.D. in biochemistry at Temple University School of Medicine and was post-doctoral fellow at the Fox Chase Cancer Institute. She holds a Bachelor of Sciences from University of Scranton.