Discovery & Early Develpment
Project Management Team
Patricia Heath, MRCP FFPM
Dr. Heath has worked for twenty-five years as a pharmaceutical physician, covering all the major therapeutic areas, in particular, Rheumatology, Gastro-intestinal, Cardiovascular, CNS, Respiratory, Oncology, Metabolic, Urogenital and Sexual Medicine. Her experience spans through New Chemical Entities, New Biological Entities, Gene Therapy and Biosimilar development.
Dr. Heath has held senior management positions at Celltech, Novartis, Takeda and Plethora Solutions and has covered all phases of drug development, from Clinical Pharmacology, through Early and Late Phase Clinical Research and Regulatory Submission to Medical Marketing – plus Due Diligence assessments of both products and companies. She is currently an Independent Medical Consultant to the Pharmaceutical Industry.
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Leo James, MBChB, BSc (Hons)
Dr. James is a licensed pharmaceutical physician with over 15 years of UK, European and Global experience in clinical trials, medical affairs and pharmacovigilance to Senior Director level. He obtained degrees in Medicine and Biochemistry from the University of Edinburgh and has worked for small and large pharma and CROs. Therapy areas include oncology, anti-infectives, urology, transplant, pain, cardiovascular, endocrine and bone metabolism.
Dr. James is expert in the design, conduct, monitoring, analysis and publication of Phase I-Phase IV interventional and non-interventional clinical trials. His experience includes five years in a Phase I clinical trials unit conducting first-in-man, dose escalation, food effect, drug-drug interaction, pharmacodynamic, radiolabelled, bioequivalence, phototoxicity, pain models, anaesthesia and medical device studies, plus Phase III pivotal trials and six years of large-scale Phase IV trials. He has also been a Medical Director providing leadership to MA submissions, product labelling, product launches and analysis of clinical trial data to optimise product success.
Dr James also has a successful track record in the design and implementation of new/improved processes to enhance patient safety and clinical trial data integrity. He is currently an Independent Medical Consultant to the Pharmaceutical Industry.
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Martin A. Pue, BSc, PhD
Dr. Pue has over 30 years of international experience in the healthcare industry in established and evolving pharmaceutical and medical technology companies and has worked across all aspects of the drug life-cycle from discovery to commercialization operating in permanent, interim management and consultancy roles.
Starting out in drug metabolism and pharmacokinetics, Dr. Pue has worked in most areas of nonclinical and clinical drug development and registration. He has managed the nonclinical development through first-in-man and Proof-of-Concept clinical trials and subsequent Phase II / III clinical development of several new chemical entities and a medical device.
Dr. Pue has facilitated and led key long-term programme alliances with public and private companies in the USA, Europe and Asia, including new business development, due diligence and licensing deals. He has established effective working relationships with external commercial partners to achieve the successful European and North American launches of frovatriptan (for the acute treatment of migraine) and with internal organizations for the commercialization of apomorphine injection (Parkinson’s Disease).
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Tessa Beecher-Jones, BSc.
Mrs. Beecher-Jones is a pharmacologist with over 26 years’ experience in international clinical R&D, leading or supporting the development of product candidate to Proof of Concept, NDA, sNDA, MAA, or out-licensing. She gained her expertise in both operational and senior leadership roles in US and European biotech and start-up companies, as well as medium to large pharma, CROs and her own successful consulting business.
Mrs. Beecher-Jones has both strategic and hands-on operational leadership expertise from the project management of a single clinical project to full programme management of global cross functional and multi-disciplinary development teams. She has a passion for proof of concept and orphan disease studies, designing and delivering optimal, scientifically driven studies to answer the key questions needed to bring new treatments to patients in areas of unmet need. As an integral part of this Mrs. Beecher-Jones builds and maintains relationships with the Key Opinion leaders, running Advisory Board meetings, and engaging with Patient Advocacy groups.
Mrs. Beecher-Jones has a variety of indication experience including pain, arthritis, neurology, immunology and more recently has been focussed in hepatology and gastroenterology, bile acid therapeutics and diseases of high unmet medical need.
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Angus E. Donald, BSc (Hons), LLM
Mr. Donald has spent 30 years in the pharmaceutical clinical research arena and is now located in Florida where he has directed his own clinical research consultancy for the past 10 years. He is passionate about Clinical Project Management and the transferable skills that this offers across therapeutic borders. As an expert in GCP, informed consent and the legal aspects of Clinical Research, he has demonstrated proficiency in delivering high quality clinical trials (and documentation) acceptable to all regulatory agencies on time and within budget. Experience within the last 5 years in adaptive study designs and risk based monitoring strategies has ensured that he has been able to support the most cost-effective approach to study delivery.
Mr. Donald’s experience stretches over all elements of clinical research progressing from CRA to Head of Clinical Research for an International Organization, International Consultancy and, most recently, as a Project Director within Worldwide Clinical Trials focusing on CNS Disorders. He has experience in Phases I through IV studies in gastro-enterology, neurology (Parkinson’s Disease, Levodopa-Induced Dyskinesia, Dystonia, Schizophrenia, Neuropathic Pain and Alzheimer’s Disease), oncology, dermatology and respiratory medicine. He is proficient in project management software tools and the majority of Electronic Data Capture systems and trial master files.
Mr. Donald originally acquired a BSc (Hons) in Molecular Biology and Biochemistry from Durham University, UK in 1987. Later he obtained a Masters in the Legal Aspects of Medical Practice (LLM) from Cardiff University, UK. An honorary lecturer at Liverpool John Moore’s University, UK, Mr. Donald is also an Honorary Fellow of the Institute of Clinical Research.
Married with no children (who are far too expensive), Mr. Donald enjoys reading biographies, cooking, falling out of perfectly operating aircraft and other activities deleterious to his health.
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Alberto Lodola, PhD
Dr. Lodola is a toxicologist with more than 30 years experience. As a lecturer at the University of Kent, UK his research group focused on the development of in vitro techniques for use in mechanistic toxicology studies with a special emphasis on the use of isolated cells and on the role of Cyp P450 in toxicity. During a 20-year career at Pfizer he held a number a positions in the US and France. Most recently he was Head of General and Reproductive Toxicology at Pfizer, Amboise, France. During this time he contributed to a wide range of drug development projects (Amlodipine, Fluconazole, Sildenafil, Dofetilde, Eletriptan, Voriconazole, Darifenacin). Currently a consultant toxicologist he has published over 40 peer-reviewed papers since 1974, most recently a chapter on the nonclinical development of combination drugs development (CRC, 2010) and he has co-edited a book (Toxicology in Practice: A guide to nonclinical development) published by Blackwell in December 2010.
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Henk A. Tennekes, MSc, PhD, FRSM
Dr. Tennekes is a highly experienced toxicologist in non-clinical drug development and has worked for leading agrochemical and pharmaceutical companies. He has authored ground-breaking papers on chemical risk assessment. Furthermore, he was one of the first scientists to recognize the environmental hazards of neonicotinoid insecticides and the first scientist to demonstrate the absence of a threshold dose for the liver tumour-promoting insecticide dieldrin.
Dr. Tennekes was Secretary of the Toxicology Section of the Swiss Society of Pharmacology and Toxicology from 1992-1998 and a Member of the Board of Directors of the Swiss Register of Toxicologists from 1996-2000. He is an Overseas Fellow of the Royal Society of Medicine.
Steve Barton, MSc, DABT, ERT
Mr. Barton is a board-certified and Eurotox-registered toxicologist with more than 30 years experience, Mr Barton was Head of Reprotox at Charles River Laboratories (UK). He has a breadth of experience in the design, conduct and interpretation of developmental and reproductive studies, and has provided comments and advice to regulatory authorities when testing guidelines are being revised. Since 2009 he has been an independent toxicology consultant. He served for 3 years on the Council of the European Teratology Society, and served for 5 years on the editorial board of Reproductive Toxicology.
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Barbara von Beust, Dr. med. vet., PhD, DACVP, ECVCP
Dr. von Beust is a Swiss veterinarian who is board certified in veterinary clinical pathology and specialized in laboratory medicine. She received her PhD from Washington State University in veterinary cell-mediated immunology research (with a strong emphasis on molecular biology techniques). She is an experienced laboratory manager with a profound understanding of Good Laboratory Practice guidelines (as required by regulatory agencies) and their implementation in a real life setting. Based on her insights gained from planning, directing and monitoring numerous preclinical safety studies, she pursues high professional standards in clinical laboratory data analysis, interpretation and reporting. She has authored and peer reviewed numerous clinical pathology reports and assisted in the audits of clinical pathology laboratories in several leading European CRO’s.
Dr. von Beust is an expert in hematology and bone marrow data analysis, the interpretation of acute phase response parameters, and the scientific evaluation of cell-mediated specific immune responses (including cytokine profiles). As an invited guest lecturer at the university of Berne she had a chance to communicate and teach her comprehensive knowledge of the hemo- and lymphopoetic system. As one of the very few European veterinary clinical pathologists with significant experience in the pharmaceutical industry she is an active member of the regulatory affairs committee of the American Society of Veterinary Clinical Pathology. This allows her to maintain and further develop a strong professional network with her North American peers. Regular contacts and co-authorship of Best Practices publications allow her to be at the cutting edge of new developments in the global field of clinical pathology in preclinical safety and drug development.
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Maurice Cary, DVM, PhD, DACVP
Expert in regulatory nonclinical anatomic histopathology, drug safety assessment and outsourcing
Dr. Cary is a recognized expert in histopathology with a +30 year track record in preclinical development and safety assessment of pharmaceuticals/ biopharmaceuticals and medical devices, as well as +15 years of business and consulting experience. Dr. Cary has handled implementation of nonclinical programs, including problem solving/development issues, Expert Report preparation, regulatory documentation preparation for numerous projects (100s of studies) performed in Europe, USA and Asia involving biologics or NCEs. Somewhat unusual for a pathologist, he is also experienced in outsourcing as he was Head of Outsourcing (toxicology) in Europe for Novartis (Switzerland). This has led to his special interest in optimizing the performance and reporting of preclinical safety/risk assessment studies. Dr. Cary is the author of the chapter, “Contract Research Organizations” in the book, “Pharmaceutical Toxicology in Practice: A Guide for Non-Clinical Development” (John Wiley & Sons, Inc.).
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Monique Wells, VMD, MS, DACVP, DECVP, DABT, Eurotox-registered toxicologist
Dr. Wells is a Eurotox-registered toxicologist. She has worked for the chemical (Chevron), pharmaceutical (Rhône-Poulenc Rorer; currently Sanofi-Aventis) and cosmetics (L’Oréal) industries in the U.S. and in France prior to entering consulting in 2002. She has extensive experience in preparing expert reports and regulatory documentation for companies in North America, Europe and Asia. Her most recent first-author journal publications feature the investigation of vascular lesions of the skin in subcutaneous toxicity studies performed in rats. Dr. Wells is the author of the chapter, ”Data Analysis, Report Writing and Regulatory Documentation” in Pharmaceutical Toxicology in Practice: A Guide for Non-Clinical Development (John Wiley & Sons, Inc, 2011).
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Brad Bolon, DVM, MS, PhD, DACVP, DABT, FATS, FIATP
Dr. Bolon is an experienced pathologist (toxicologic neuropathology) with special interest in genetically engineered and developing animals. He has written or co-authored over 200 articles and book chapters, has edited or co-edited 4 books, and is a frequent invited speaker at national and international meetings on mouse pathology.
Dr. Bolon has B.S., D.V.M. and M.S. degrees from the University of Missouri, “enjoyed” an anatomic pathology residency (1986-1989) at the University of Florida, and obtained a Ph.D. (1993) from Duke University while completing postdoctoral training at the Chemical Industry Institute of Toxicology. He was employed by Pathology Associates International as associate director of the Molecular and Immunopathology Division (1993-1994) and later as staff pathologist at the National Center for Toxicological Research (1994-1996) before moving to Wyeth-Ayerst Research (1996-1997) as a senior scientist.
Dr. Bolon served as an experimental pathologist at Amgen (1997 to 2004) responsible for evaluating engineered rodents and the efficacy of novel biopharmaceuticals. He subsequently founded an experimental pathology consulting practice (GEMpath, for “Genetically Engineered Mouse Pathology”), working there from 2004 to 2011. Dr. Bolon worked for a time as an associate professor at The Ohio State University College of Veterinary Medicine (2011-2015), after which he returned to re-launch GEMpath (2015 to date). Dr. Bolon is a Diplomate of both the American College of Veterinary Pathologists (ACVP, anatomic pathology; 1991) and American Board of Toxicology (ABT; 1996, re-certified 2001, 2006, 2011, 2016) and is a Fellow of both the Academy of Toxicological Sciences (ATS; 2011) and the International Academy of Toxicologic Pathology (IATP; 2007).
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Jose Diaz-Romero, PhD
Dr. Diaz-Romero is a biomedical scientist within translational medicine. He has a PhD in immunology from the Complutense University of Madrid and solid experience with cell biology and cell-based therapies. With more than 20 years of combined academic and industry experience, Dr. Diaz-Romero’s key interest is to implement basic research approaches into clinical settings, bridging the gap between basic research and clinical applications through collaborations with clinical and industrial partners. Areas of experience include vaccines (National Centre for Microbiology, Spain), transplantation (Novartis, Switzerland), and cell-based therapies (University of Bern, Switzerland).
With state-of-the-art knowledge and hands-on expertise in multiple lab techniques, Dr. Diaz-Romero has a broad experience in uncovering biomarkers and establishing cell-based assays, development and validation of immunoassays, and exploring innovative technologies, models, and methods through the discovery and development process.
Sven P. Jacobsson, PhD, Prof.
Dr. Jacobsson has worked for 30+ years in analytical and pharmaceutical R&D. His experience spans through New Chemical Entities, New Biological Entities, Cell Therapy and Generics development.
Dr. Jacobsson has held senior management positions at KABI, Pharmacia, Astra and Astra Zeneca and has covered the Chemistry, Manufacturing and Control (CMC) phases from late pre-clinical to drug development, to submission of NDAs. He has performed Due Diligence assessments of both products and companies, quality audits of manufacturing sites, and contracting CMC for biotech companies. He is since 10 years ago an Independent Senior CMC Consultant to the Pharmaceutical Industry, as well as a service provider regarding storage and distribution of life science related materials and samples through the company ClinStorage.
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