David Heal, PhD, DSc, FRSC, FBPhS
David Heal is a co-founder and Executive Director of DevelRx Ltd, a consultancy company focussed on supporting the pharmaceutical industry in the discovery and development of new drugs for psychiatric and neurological diseases.
David is internationally known as a research leader with a strategic focus on psychiatric and neurological disorders, obesity and its co-morbidities. During his career in the pharmaceutical industry, he was a key member of the team which discovered and developed the anti-obesity drug, sibutramine, and the atypical antipsychotic, zotepine. More recently, as part of RenaSci he has supported pharma and biotech companies in the successful registration of eleven new drugs for the treatment of ADHD, binge-eating disorder, opiate withdrawal, opiate-induced constipation, Parkinson’s disease, epilepsy, and an ultra-short acting anaesthetic.
Previously he co-founded and was an Executive Director of RenaSci Ltd, a UK contract research organization that he grew into a multi-million dollar, global company which is internationally recognized for its innovative, high quality non-clinical services in diabetes, obesity, CNS disorders and drug abuse liability.
He is a leading expert on pre-clinical drug abuse evaluation and the development of new treatments for substance use disorders. David has had a long career in academic research starting the University of Oxford, followed by faculty roles at Chelsea College and University College, University of London, and currently, at the University of Bath.
David has been highly successful in leading international research project teams and collaborations. He has made innovative contributions to advancing research into drug abuse and dependence. He has a proven track-record in drug discovery, global drug development and registration with key roles in regulatory submissions in the USA (FDA), Europe (EMA), Canada and Japan, resulting in 13 new drug registrations.
David was one of three Executive Directors who founded the CRO, RenaSci, in 2001; a position that he held for almost 20 years prior to his current role at DevelRx. David was the Director of the Consultancy and Drug Abuse Groups. Under his leadership, RenaSci developed a world-leading reputation for its consultancy in the discovery and development of novel drugs for the treatment of psychiatric and neurological disorders, and obesity with its consequences on metabolic function. Its services were sought by pharmaceutical, biotech and virtual companies from USA, Europe, Japan and many other countries. As globally recognised experts on psychiatric and neurological disorders, regulatory drug abuse evaluation and the development of new treatments for drug dependence, the consultancy team established RenaSci as the pre-eminent CRO conducting this type of work.
As the Global Head of Obesity Research at Knoll Pharmaceuticals (BASF Pharma) from 1995-2000, David played a major role in the discovery, development and marketing of sibutramine (Meridia/Reductil) in USA, South America, Europe, Japan, Australia, New Zealand and Canada. He led a large research team with global responsibility for obesity research. During this time, he coordinated and managed a wide array of academic and biotech collaborations. Along with and five colleagues from Knoll Pharmaceuticals, he won the prestigious BASF Innovation Award for US registration of the anti-obesity drug ‘Meridia’ (sibutramine). From 1986 to 1995, David was Senior Section Leader at Boots Pharmaceuticals in Nottingham where he headed a group carrying out research on new drugs to treat depression, epilepsy, schizophrenia and Parkinson’s disease. These ventures included the in-licencing and co-development of the anxiolytic, lesopitron, with the Spanish pharmaceutical company, Esteve, and the in-licencing and European development of the antipsychotic, zotepine, in collaboration with the Japanese pharmaceutical company, Fujisawa.
David gained his BSc in Biochemistry and Chemistry and MSc in Analytical Chemistry from Chelsea College, University of London before embarking on a 12-year career in academic research in the Department of Clinical Pharmacology at the University of Oxford. As part of his research, he obtained a PhD investigating the role of cyclic AMP in the action of drugs that affect brain dopamine function. He has maintained an excellent academic profile with visiting faculty positions at Chelsea College and University College, University of London. In 1998, he was awarded a DSc by Kings College, University of London for his research on the role of monoamines in CNS disorders and their treatment. He was appointed as a Visiting Professor in Pharmacy and Pharmacology at the University of Bath since 2001 and he maintains strong teaching and post-graduate research collaborations with the university. He is a member of numerous international scientific societies including the prestigious American College of Neuropsychopharmacology. For his contribution to the discovery and development of new drugs, he was invited to become a Fellow of the Royal Society of Chemistry, and for his contributions to pharmacological research to be a Fellow of the British Pharmacological Society. He also has strong links with other opinion leaders in the field including Jack Henningfield (Pinney Associates and Johns Hopkins), Ed Sellers (DG Global Partners and University of Toronto), David Nutt (Imperial College, University of London) and Charles France (University of Texas, San Antonio). David has published over 160 peer-reviewed research articles, reviews and book chapters. He has co-edited four books and more recently has been the senior editor on three Special Issues of Neuropharmacology. He has presented more than 500 numerous invited lectures, talks and posters at national and international scientific symposia in the fields of CNS disorders, drug abuse and obesity. He regularly presents medical education lectures on the topics of drug abuse evaluation and treatment, ADHD and binge-eating disorder.
Sharon Smith, PhD
Sharon Smith is an expert in CNS drug research and development and her experimental and regulatory experience has contributed to the successful registration of 8 new CNS drugs and has supported many more that are currently in clinical development.
Sharon has more than 25 years of research and development experience from working in pharmaceutical, biotech companies and contract research organisations. Before joining DevelRx, she worked as a senior member of the CRO, RenaSci Ltd, for more than 16 years on both the consultancy and experimental divisions of the business. The most senior staff member in the Drug Abuse Evaluation and Consultancy Group after Prof Heal. Although she has undertaken a wide range of roles, her core expertise lies in the discovery and development of new drugs to treat a wide range of psychiatric and neurological disorders. Sharon has a comprehensive knowledge and experience of experimental techniques to evaluate novel CNS drugs to investigate their potential risks for abuse and liability to induce dependence. She has developed several innovative experimental approaches for evaluating the potential of new treatments for a range of substance use disorders. Sharon is internationally recognised for her research and has an extensive publication track-record in this field, as the co-editor on 3 Special Issues of Neuropharmacology, over 20 full publications and numerous poster presentations. She is a member of the British Pharmacological Society and the Society for Neurosciences (USA).
Prior to joining RenaSci Ltd, Sharon worked with a biotech on the Cambridge Science Park. Here she worked as a post-doctoral fellow on a project to develop mouse models of allergies and autoimmune disease for investigating the role of the Notch receptor in these diseases. Notch signalling has a major impact on elicitation of inflammatory response and its outcome.
In her role as a Principal Scientist at Knoll Pharmaceuticals (BASF Pharma), Nottingham she worked on a project to evaluate compounds for the treatment of obesity in rat and mouse models. The project involved the production of polyclonal antibodies to specific CNS receptor targets and administering them icv to rats to evaluate the effect of blocking these receptor targets in the models.
In the 1990s, Sharon was a Post-Doctoral Research Fellow in the laboratory of Prof Nancy Rothwell at the University of Manchester. She studied the role of brain amino acids in a rat model of cerebral ischaemic damage using intracerebral microdialysis with HPLC analysis. The project also evaluated the novel compound, BTS72664, as a potential treatment for stroke in a rat model of cerebral ischaemia. Sharon was an inventor on 2 patents for BTS72664.
Prior to that she was a post-doctoral research fellow at the Department of Collagen and Muscle Biochemistry at the University of Bristol, where she conducted research into the causes of scoliosis (curvature of the spine), using polyclonal antibodies to specific collagen molecules to study structural alterations at the light and electron microscopic levels.
She studied for a PhD from 1988-1992 as a post-graduate research assistant in the Department of Biochemistry at the University of Nottingham. The project was an investigation of markers of neurological damage in brain, cerebrospinal fluid and plasma using rat models of cerebral ischaemia and neurotoxic lesioning.
Sharon started her science career in1981 as a Scientific Researcher in the Laboratory of Molecular Biophysics at the University of Oxford. She worked on a project to determine the structure and function of the epidermal growth factor (EGF) receptor using monoclonal and polyclonal antibodies. Here she studied for a part-time BSc at the University of the West of England where she graduated with a II/1 Hons BSc in Applied Biology.
Jane Gosden is the Finance Officer, Senior Consultant and co-founder of DevelRx Ltd.
As a scientist and consultant, Jane is highly experienced in pharmaceutical R&D programs in the fields of psychiatric and neurological disorders, obesity and metabolic diseases. She gained her expertise as a career scientist starting with Boots Pharmaceuticals in the 1980s followed by Knoll Pharmaceuticals in the 1990s. In 2001, she joined the contract research organization, RenaSci Ltd, as a Principal Scientist where she was a senior member of the Consultancy and Drug Abuse Groups
With more than 30 years of experience in the non-clinical evaluation of abuse and dependence risks, she has a wealth of expertise on the design and conduct of these studies. In addition, she has held key roles in obesity and CNS R&D within pharmaceutical and CRO environments. She is highly experienced in the preparation of regulatory submissions having supported the successful registration of new drugs for the treatment of obesity, schizophrenia, ADHD, binge-eating disorder, opiate withdrawal, opiate-induced constipation, Parkinson’s disease, and epilepsy.
Jane has extensive experience in pharmaceutical R&D covering every stage of the process from early no-clinical research, non-clinical and clinical development, drug registration and Phase IV marketing. With outstanding IT skills, Jane has the expertise to construct complex regulatory submissions, and graphics for scientific publications, presentations and documents. With non-clinical abuse/dependence evaluations falling within Safety Pharmacology testing, her essential skills also include expertise in the implementation and management of Good Laboratory Practice (GLP). Jane’s ability in the use of complex software packages has enabled her to take on the additional role of Finance Officer for DevelRx.
Jane was a Principal Scientist at RenaSci Ltd from its inception in 2001 through to 2020 when she moved to her current role at DevelRx. At RenaSci, she was a senior member of the Consultancy and Drug Abuse Groups with responsibility for managing many of drug abuse testing activities including the drug discrimination and physical dependence evaluations. In addition, she also played a key part in providing experimental support in the discovery and development of novel drugs for the treatment for a range of psychiatric and neurological disorders, obesity and Type 2 diabetes. As part of the Consultancy Group, she helped to prepare regulatory submissions including abuse liability evaluations of drug-candidates, FDA Briefing Documents, 8-Factor Analyses, New Drug Applications (NDAs), Abuse Liability Assessment Documents, Market Authorisation Applications (MAAs) and for presentation at FDA and Psychopharmacologic Drugs Advisory Committee (PDAC) hearings. These efforts contributed to the successful registration of 10 new drugs.
From 1981-1995, Jane was a Scientific Researcher at Boots Pharmaceuticals, and following its acquisition by BASF in 1995, as a Senior Scientist at Knoll Pharmaceuticals (BASF Pharma) from 1995-2001. She managed and performed the drug abuse testing, and a range of in vivo tests used in the discovery and development of drugs to treat depression, anxiety, Parkinson’s disease, schizophrenia, obesity and Type 2 diabetes. She was a key member of the team which developed and registered the anti-obesity drug, sibutramine, worldwide and the atypical antipsychotic, zotepine, in Europe.
Jane has an excellent academic track-record having published 20 peer-reviewed research articles, reviews and book chapters. She has also co-authored reviews in three Special Issues of Neuropharmacology in her areas of expertise, i.e. “Central Regulation of Food Intake and Energy Expenditure” (2012), “CNS Stimulants” (2014) and “Psychedelics” (2018). Jane has also given numerous presentations at national and international scientific symposia in the fields of CNS disorders, drug abuse and obesity.