Spinifex Pharmaceuticals achieves operational diversity by bringing together a multidisciplinary team of pharmaceutical consultants and its own expertise.
Management and SAB
Executive Management and Scientific Advisory Board
Spinifex has a highly experienced Board and senior management team made up of individuals who have held senior positions in international pharmaceutical and biotechnology companies. Spinifex has also brought together a multidisciplinary team of pharmaceutical consultants to complement its own core internal expertise to assist in the development programs, thereby maintaining operational flexibility and diversity. Spinifex believes this approach ensures that the company consistently meets commercial and regulatory deadlines and all products are developed to the highest possible industry and regulatory standards.
In addition, Spinifex benefits from a very dynamic Scientific Advisory Board (SAB) which provides direct scientific and commercial contributions to the company on a regular basis.
Tom is Chief Executive Officer & Managing Director of Spinifex Pharmaceuticals. He has over 16 years experience in drug discovery and development and has been responsible for a variety of drug development programs under Investigation New Drug applications (IND) with the United States Food and Drug Administration (FDA) and other regulatory authorities. In addition to his role as CEO, Tom also oversees the CMC program for EMA401 and, with Alan Naylor (Spinifex SAB member), directs the AT2 receptor antagonist medicinal chemistry program. Tom’s prior positions include Vice President, Drug Development at Starpharma Pty Ltd where he was responsible for Starpharma’s projects from lead candidate optimization/selection through to IND submission and clinical trials. In this role he managed the development for SPL7013 Gel (VivaGel™) and was responsible for securing in excess of US$25M of United States National Institutes of Health (NIH) funding for Starpharma’s drug development programs. Tom completed a Bachelor of Science (Honours) degree and a Ph.D. in medicinal chemistry at Monash University in 1989 and 1993 respectively and has completed post-doctoral training at the University of Oxford.
Nuket is VP of Clinical and Regulatory Affairs at Spinifex Pharmaceuticals. She has over 18 years’ experience in Research and Development, Regulatory Affairs and Clinical Development within the pharmaceutical industry. Prior to joining Spinifex, Nuket was the Development Director at Antisense Therapeutics (ATL) where she was responsible for the management of the various stages of development of ATL’s products covering pharmaceutical manufacturing, regulatory affairs and clinical research. In this role Nuket managed the successful conduct of a multinational Phase IIa trial for the company’s lead compound indicated for the treatment of multiple sclerosis. The study met its primary endpoint and the compound was licensed out for further development. Nuket was a key company contact and member of the Central Steering Committee with the company’s licensing partner. Previously Nuket held positions in the Regulatory, Development and Commercialisation Division of Kendle Pty Ltd (now INC Research) and at CSL Limited in Research and Development, and Regulatory Affairs. During this time her work lead to the registration and maintenance of registration of several pharmaceutical products (including CSL’s plasma products) in Australian and international markets, and the development and commercialisation of three immunodiagnostic kits for human and veterinary use. Nuket holds a Bachelor of Science (Honours) degree from La Trobe University and a Master of Business Administration from Monash University.
Emile is Business Development Manager at Spinifex Pharmaceuticals and has over 7 years experience in the drug development sector. Prior to Spinifex, Emile was Business Development Manager at PharmaNet/i3, where he held responsibility for a number of countries in the Asia Pacific region. In this role, he was successful in building numerous productive relationships in previously un-penetrated markets. He also previously held a position in Business Development at Quintiles’ Phase I Drug Research Unit in London. Emile completed a BSc. (Honours) degree in Cell Biology and Human Genetics at the University of Cape Town, and holds an MSc. in Medical Diagnostics from the University of Cranfield, UK.
Geoff has gained a broad-based international perspective on drug development, from phase I to phase IV, experience of pre-clinical work, and regulatory requirements, since joining the pharmaceutical industry in 1988. He has been involved in the preparation of INDs, CTXs/CTAs, MAAs and other regulatory documents. He has experience in the development of individual clinical studies, clinical trial programs, running multinational clinical trials and developing clinical strategies. In the last few years he has taken 5 products through to first in man studies, and progressed products through to Phase II/III.
Geoff obtained his medical degree from the University of Nottingham and initially trained and worked in anaesthesiology and intensive care before joining the pharmaceutical industry with Syntex Pharmaceuticals Limited. In various roles at Syntex he worked in a number of therapeutic areas, primarily pain, but also including female health care and cardiology. He was instrumental in the approval of ketorolac in the UK and maintaining the approval throughout Europe. Prior to the take over of Syntex by Roche Geoff worked in the USA, overseeing all ketorolac clinical trials worldwide, including planning the 16,000 patients "SAMM" study undertaken in Europe at the request of he CPMP. Geoff then joined Yamanouchi Pharma as the UK Medical Director. Wishing to move to earlier clinical development he moved to Head of Clinical Development at Chiroscience and then to Director of Exploratory Development World-wide at Medeva.
Helen has 38 years of experience in the health sciences industry. Her corporate experience includes Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, and Technical Services at two of the Johnson & Johnson family of companies. During her career, Helen has been instrumental in the successful planning, preparation and submission of investigational and marketing applications to US and international regulatory authorities. Working together with Bridgette Kunst, Helen has been responsible for all the EMA401 submissions to FDA.
Helen has professional credentials in both business and scientific disciplines. She graduated from Fairleigh Dickinson University in Madison, New Jersey with a Bachelor of Science degree in Medical Technology and a Masters in Business Administration. Helen holds certification (RAC) by the Regulatory Affairs Professional Society (RAPS). Helen is an American Society of Clinical Pathologists’ board certified medical technologist. Her affiliations include membership in the Regulatory Affairs Professional Society, American Association of Pharmaceutical Scientists, Food and Drug Law Institute, Drug Information Association, and American Society of Clinical Pathologists.
Bridgette Kunst has 12 years experience in the pharmaceutical industry including Pharmaceutical Development, Drug Discovery, and Process Research and Development. Her areas of expertise are in CMC technical writing and medicinal chemistry. She has been responsible at Spinifex for providing regulatory CMC guidance and global submission strategy in support of the company’s applications to FDA and EMEA.
Bridgette graduated from Widener University in Chester, Pennsylvania with a Bachelor of Science degree in Chemistry. After working as a research chemist at Pfizer and then Bristol-Myers Squibb, Bridgette went to graduate school to further her education. She graduated from The University of Texas at Austin with a Masters Degree in Organic Chemistry. Her affiliations include membership in the American Chemical Society and Regulatory Affairs Professional Society (RAPS); she holds certification (RAC) by RAPS.
During his over 40 years career in the pharmaceutical and biotechnology sectors, Fred has provided scientific expertise in the areas of toxicology, preclinical aspects of drug and device development, strategies for product safety evaluation, and liaison with appropriate regulatory agencies. His experience includes; organizing and directing safety evaluation programs and interfacing with contract laboratories; providing scientific opinions on toxicology aspects of potential candidate compounds for licensing; and preparation of preclinical summariesfor U.S. (IND, NDA, IDE, PMA) and foreign pharmaceutical submissions. Working together with Colleen Johnson, Fred has led the IND enabling and subsequent toxicology program for EMA401.
Fred has Ph.D., Toxicology from Utah State University, M.S., Zoology from University of Nevada and B.S., Biology from University of San Francisco.
Colleen brings over 20 years of experience in the area of toxicology. She holds a M.S. in Toxicology from University of Arizona as well as Board Certification (D.A.B.T.) and specializes in the development of nonclinical toxicology testing programs for new drugs. Her activities include preparation of toxicology summaries for Spinifex’s submissions in support of our development candidates, develops study protocols and monitors the company’s toxicology programs.
Management and SAB
Chas is currently Chief Scientist, Structural Genomics Consortium, University of Oxford; Associate member of Department of Pharmacology, University of Oxford and Visiting Professor in Neuroscience and Mental Health, Imperial College. Also serves on Wellcome Trust Seeding Drug Discovery and MRC Development Pathway Funding Committees, chairs and sits on Scientific Advisory Boards and consults for biotech/pharma and venture capital groups.
His current research focus is elucidation of 3D structures of therapeutically relevant human proteins and chemical probe identification for epigenetic proteins and clinical target discovery.
In his previous role as Vice President and Head of Biology at GlaxoSmithKline he progressed several molecules into clinical studies in AD, MS, epilepsy, neuropathic pain, RA, OA, migraine, IBS, Functional Dyspepsia and acid related disorders. He played a major role in the development and launch of a novel treatment for IBS (Alosetron), and was the first to show the potential of neurokinin NK1 receptor antagonists as anti-emetics.
Chas has published more than 80 papers, 10 patents and has given more than 100 invited lectures on pain mechanisms, GI diseases, Drug Discovery, target validation, translational challenges, structural biology and epigenetic science. He has previously been visiting Professor in Translational Medicine and College lecturer in Physiology, University of Oxford and Visiting lecturer at University of Helsinki, Singapore and Surrey.
Chas, along with Tom McCarthy, sets the overall focus of the EMA401 development program and helps design critical non-clinical studies to support the clinical and commercial development of this compound.
Andrew is Professor of Pain Research at Imperial College London and Honorary Consultant in Pain Medicine at Chelsea and Westminster Hospital. He undertakes research and clinical practice in neuropathic pain, focussing on post herpetic neuralgia, peripheral nerve injury and HIV neuropathy. Andrew received his medical degree from the St. Mary’s Hospital Medical School in 1982 and his research doctorate from the St. Thomas’ Hospital Medical School (UMDS) in 1991. He underwent his specialist clinical training mainly in Oxford and at St Thomas’ Hospital, London.
He is an author of more than 90 scientific publications, sits on the editorial boards of Pain and PLoS–Medicine and is lead editor of the four volume “Textbook of Clinical Pain Management”.
He is currently Chair-elect (previously Secretary) of the International Association for the Study of Pain Special Interest Group on Neuropathic Pain (www.neupsig.org).
Andrew is Administrative Director of the Wellcome Trust funded London Pain Consortium (www.lpc.ac.uk) and the academic lead for the animal models work package on the EU Innovative Medicines Initiative grant “Europain”. He is also the link person between Europain and the corresponding US Food and Drugs Administration Critical Path Initiative: Analgesic Clinical Trial Innovations, Opportunities and Networks (ACTION).
He was the Michael Cousins lecturer at the Australian and New Zealand College of Anaesthetists (2009) and Covino Lecturer at Harvard University (2008).
Andrew led the protocol development team for the Phase 2 clinical trial of EMA401 in post herpetic neuralgia patients and, given his clinical leadership in the area of neuropathic pain, helps guide the overall development of EMA401.
Praveen is Professor of Clinical Neurology at Imperial College London, based at Hammersmith Hospital. His medical education was at the Universities of Oxford and Cambridge, UK, and post-graduate training was at the Hammersmith Hospital and the National Hospital for Neurology and Neurosurgery, Queen Square, London.
His research focuses on pathophysiological and molecular mechanisms in the human sensory neuropathies and chronic pain syndromes.
Collaborations with pharmaceutical companies are directed to translational projects and new techniques which bridge the gap between pre-clinical developments and successful clinical applications. The techniques of assessment have included contact heat evoked potentials (CHEPS) and molecular markers in skin biopsies.
Clinical trials have been conducted using novel compounds for pain and nerve regeneration with several companies, including GlaxoSmithKline, Genentech, Roche, and Amgen.
He has over 150 peer reviewed publications in journals including Nature, Nature Medicine, Nature Genetics, The Lancet, and Science.
Praveen is conducting fundamental pharmacology studies on the AT2 receptor in human tissue as well as providing clinical leadership into the Phase 2 program for EMA401.
Alan is an independent Drug Discovery consultant and a Medicinal chemist with over 30 years experience in Research and Development within GlaxoSmithKline. He previously held the position of Vice President and Director of Medicinal Chemistry within the GSK Drug Discovery organisation. Alan has lead strategic, matrix and line functions and has held significant international responsibilities. He has an extensive track record of delivery, across a wide range of therapeutic areas, having played a major role in the discovery of over 30 development compounds, and is a co-inventor of Serevent, a major advance in the treatment of asthma. Extensive academic interactions have resulted in him being appointed to two visiting chairs at the universities of Reading and Sussex.
More recently, as an independent consultant, he has been engaged in providing scientific and strategic advice and analysis to major pharma, biotechnology companies, academic groups, capital investment companies and funding bodies on a variety of issues within the drug discovery and healthcare sector.
Along with Tom McCarthy, Alan is leading the current medicinal chemistry program to identify new AT2 receptor antagonists.