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Liz (DVM), is a seasoned regulatory leader with strong track record of delivering IND, NDA and MAA submissions in various therapeutic areas with a focus on oncology. She is an exceptional cross-functional leader, bringing discipline and organizational boundaries to build committed teams delivering innovative solutions to complex submissions and/or regulatory authority review times with high quality and in compressed timelines.
Before becoming a managing partner of The Bracken Group, Liz held positions of increasing responsibility over the last 25 plus years, starting in USDA and at several small to mid-size companies including Sanofi, Novo Nordisk, Bracco, Kyowa Hakko Kirin, and Taiho Oncology.
Liz had responsibility for the implementation and direction of effective regulatory strategies and submissions as the global regulatory team enabling the earliest possible approvals of Phase I through Phase III applications. She and her teams tracked and evaluated governmental and international regulations and their impact relative to drug regulations and guidances. She built and maintained excellent relationships with global health authorities and corporate partners while advocating for the sponsor’s position. Liz’s combination of regulatory science experience, keen sense of cultural awareness while working with global cross-functional teams, German language skills, and understanding of the complexity of leadership in a multifaceted regulated scientific work environment can be leveraged in development programs leading to high value outcomes.
Liz holds a DVM from Tuskegee Institute (Tuskegee, Alabama) and interned at the University of Giessen (Giessen, Germany) before starting her career with the US Department of Agriculture’s Food Safety Inspection Service (FSIS) and Animal and Plant Health Inspection Service (APHIS) divisions.
Outside of her professional pursuits Liz enjoys her small farm with her husband and passion for driving carriage horses. Her current equine partners are Cleveland Bay Mares that she takes to traditional drives and small horse shows.
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Carey has a unique skill set in the Legal and Regulatory fields with an international perspective. Carey qualified as a lawyer in the U.K. where she was a Medical Malpractice and Product Liability Attorney for many years. Her legal career focused on the successful leadership of litigation involving maximum severity clinical malpractice and product liability cases, including multi-litigant cases for pharmaceuticals, breast implants, pacemakers and radiotherapy.
Carey brings those skills and experience to pharmaceutical and medical device regulation. With her recent experience in the Healthcare Software and Pharmaceutical industries, she will be an integral part of The Bracken Group ensuring that our clients receive cutting edge, dedicated and commercially-minded regulatory advice in today’s competitive and ever-changing regulatory world. Carey’s recent experience includes regulatory strategy, research and intelligence; key aspects of FDA submissions and approvals and Quality Management Systems.
Carey has a Law degree from the University of Birmingham, U.K., is a member of the U.K. Law Society and has held accreditation with the Law Society’s Clinical Negligence Panel. Carey returned to academia in 2006 and gained a Master’s Degree from the University of Manchester, U.K. She is a current member of RAPS (Regulatory Affairs Professionals Society).
Carey now lives with her family in Austin, Texas.
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Martin has almost 20 years of senior executive experience spanning a variety of organizations including medical communications, clinical research and patient engagement. Martin’s expertise spans across strategic planning, operational excellence, finance, business development and Information technology. Utilizing his deep understanding of the complexities across a range of therapeutic areas, Martin has led the due diligence, market analysis and competitive environment analysis for a number of organizations.
As a qualified Chartered Certified Accountant, Martin led the financial operations as Global Finance Director for Wolters Kluwer and CFO for Axis Healthcare, employing lean six sigma to re-engineer operational processes, post mergers, facilitating revenue acceleration, EBITDA growth, margin enhancement and international expansion. As Chief Operations Officer for both Medici Global and Bioclinica, Martin further developed his passion for helping people find solutions to their healthcare challenges. Recognized as a thought-leader in patient engagement and recruitment, Martin identified a number of challenges faced by the biopharma industry and has developed patient facing platforms to address these gaps and needs.
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Lisa D. Cooper
Lisa (PhD, RAC, CMWP), joins The Bracken Group (TBG) as an accomplished global regulatory affairs professional. She brings her depth of experience in leading the strategic regulatory pathway for drug and biologic products from pre-clinical through post-marketing stages to TBG.
Over the past two decades, Lisa has taken on increasingly responsible roles at small to mid-size biotechnology companies possessing a strong skill set which includes interpreting and applying applicable regulations and guidelines to successfully drive programs through innovative pathways. She is a skilled writer and an experienced communicator, leading discussions with health authorities, senior leadership, and business collaborators. Her therapy area experience encompasses immuno-oncology, oncology, pulmonary, auto-immune and infectious diseases.
Before joining The Bracken Group, Lisa was Director, Regulatory Affairs at Immunocore, where she applied her extensive knowledge to drive strategic regulatory approaches for lead product candidates to initiate clinical trials and maximize the probability of registrational success. Along with her work at TBG, she continues in her role with Xennials Therapeutics, a Chicago based biotech start-up, as Vice President, Regulatory Affairs and Quality Assurance.
A life-long learner, Lisa holds a B.S. in Biology from York College of Pennsylvania, a M.S. in Biology from Fairleigh Dickenson University, and most recently received her PhD in Corporate Leadership from Alvernia University.
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Jim (Ph.D, MSIB), received his Ph.D. in Pharmacology and Toxicology from the University of Connecticut (Storrs, CT) where his research focus was cardiovascular disease, in particular atherosclerosis. He continued his post graduate education at the Roche Institute of Molecular Biology where his post-doctoral research explored changes that occur in blood vessels during the development of hypertension.
Following his postdoc, Jim was a co-founder and an original employee of Unigene Labs. Unigene Labs developed cutting edge technology for the recombinant manufacture of peptide hormones as well as oral and nasal delivery technologies for peptide based therapeutics. Jim is a co-author on several of the manufacturing and formulation patents as well as journal articles on novel therapeutic peptides and their clinical utility.
During his tenure at Unigene he oversaw the entire spectrum of drug development activities, including pharmacology and preclinical activities, CMC, clinical Phase I-III, as well as US and international regulatory strategies. A tangible result of this broad based experience is reflected in the fact that Unigene was the first company to have a recombinant peptide product (Fortical®) approved via the 505(b)(2) NDA route.
Jim transitioned from R&D to business development (BD) and during this time obtained a Masters in International Business from Seton Hall University (South Orange, NJ). As VP for product and business development he established a biotech joint venture in China. His China experience lead to co-founding Herborium Inc., a company involved in the development of Botanical Therapeutics™. He was responsible for executing numerous feasibility and licensing deals with the Pharma Industry. As part of his BD responsibilities he worked frequently with investment bankers, venture capitalists, and brokers.
Following his time at Unigene Jim was a co-founder and CSO of Tarsa Therapeutics. Tarsa was responsible for completion of the Phase III ORACAL Study as well NDA submission and eventual commercialization of TBRIA® an oral formulation of recombinant salmon calcitonin for the treatment of postmenopausal osteoporosis.
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Colin (Ph.D, FIPEM, CSci), completed his undergraduate degree in Physiology and Zoology from the University of Sheffield, (UK) and his PhD through the University of Hull (UK) on the ultrasonic assessment of bone in the department of applied physics, while employed as a research assistant to an orthopedic surgeon. Following his PhD, Colin worked at Syntex Pharmaceuticals (now part of Roche) and Procter & Gamble Pharmaceuticals before moving to the USA in 1994 to start a new company, Bona Fide Ltd. which was sold to Bio-Imaging Technologies (now Bioclinica) 5 years later.
He was instrumental in supporting the growth of BioClinica from 35 people to over 1800 employees. As Vice President and later Senior Vice President Medical Affairs, for a publicly traded company he headed up sales for nearly 5 years, marketing for 7 years and scientific/medical/regulatory oversight of the company for 12 years. This also included handling regulatory affairs and supporting clients with their communication with the FDA.
In the last year at Bioclinica he was heading up strategic development. Colin resigned from Bioclinica in 2015 going into consultancy and starting the Bracken brand of companies (BrackenData and Bracken Marketing). He has been involved in supporting clients obtain marketing approval for numerous drugs/biologic’s and several devices across a range of therapeutic areas, including oncology, but specifically at the intersect of imaging and clinical trials.
Colin has been providing medical and scientific consulting for over 30 years for the biopharmaceutical and device companies through Bioclinica, Bona Fide Ltd and now The Bracken Group. He has been an advisor on several safety boards and Ad-com’s. He has become a recognized expert in the field of osteoarthritis for the biopharmaceutical industry and also in the use of novel analgesic medications and the safety effect on joints (anti-Nerve Growth Factors or aNGF’s).
He has presented at the FDA on several occasions and attended meetings in the development of the guidance documents, including Imaging in Clinical Trials and discussions on Progression Free Survival in oncology.
Since mid 2016 Colin’s consulting has been primarily focused on the area of nuclear medicine, both with a novel PET diagnostic but also the strategic development of a peptide receptor radionuclide therapy (PRRT). He is also providing strategic development for the regulatory pathway for a novel imaging companion diagnostic and FDA interaction.
Colin has over 70 peer reviewed publications and has published 3 books through Springer, the latest entitled “Medical Imaging in Clinical Trials” in 2014. He has 3 patents, all of which led to marketed products. He is a fellow of the Institute Physics and Engineering in Medicine and is a Chartered Scientist. When not working, Colin has a keen interest in aviation, holding a current pilots license. He also cycles, and enjoys kayaking, photography and travel when time allows.
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Brad is a recognized expert with more than twenty years of experience with clinical imaging studies. This includes the research and creation of novel, fit-for-purpose, imaging biomarkers and ensuring their correct deployment in trials for go/no-go decision making.
Brad spent ten years at Pfizer working across several therapeutic areas (including: oncology, Alzheimer’s, Parkinson’s, osteoarthritis, rheumatoid arthritis, pain, depression, atherosclerosis, pulmonary diseases such as COPD, NASH, and obesity) and imaging modalities (including: MRI, fMRI, CT, PET, SPECT, X-ray, and ultrasound). He is experienced in the strategy, deployment and delivery of all aspects of clinical trials including study design, protocol development, study documentation, CRO management, and working with Statistics and Data Management to deliver and interpret the study results.
After leaving Pfizer, Brad became the Vice President of Imaging and Clincial Development at ImaginAb where he was responsible for the development and clinical testing programs for novel PET tracers. His work also encompassed improving the internal processes by developing and implementing rigorous systems for developing Target Asset Profiles and for Project Management.
Further experience has included working for several medical device startups including software and hardware development, Quality Systems Regulations (QSR), 510k submissions and clinical testing. As a seasoned consultant, he has conducted multiple investment due diligences including technology, market and regulatory evaluations.
Brad earned his Ph.D. in biomedical engineering at the Johns Hopkins School of Medicine, prior to that receiving his B.S. at Brigham Young University and an M.S. at Northwestern in electrical engineering. He has published over 50 journal articles and has co-authored four patents.
Brad is comfortably nestled at the base of the Wasatch Mountains, Utah, where he enjoys skiing, snowshoeing, hiking and logging in for web meetings with his clients.