DEEP EXPERIENCE IN DRUG DEVELOPMENT
Cabernet Pharmaceuticals has assembled an international team of professionals with deep experience across the spectrum of pharmaceutical research and development. The team draws from staff at Cabernet and its sister company Zinfandel Pharmaceuticals, from allied consulting firms, and from academic researchers. It includes scientists who have contributed to seminal work in identifying and using biomarkers to enable innovative clinical development and who have worked with regulatory authorities to incorporate new scientific understanding into clinical-trial design and analyses of safety and efficacy. These scientists have held direct or collaborative roles with large pharmaceutical corporations, biotechnology companies, and academic research institutions. They typically have at least 25 years of experience relevant to advancing new medicines to the marketplace. From this team Cabernet can flexibly match the right group of consultants to each client’s drug-development needs at each stage of the development process.
CABERNET & ZINFANDEL
Ann M. Saunders, PhD – President and Chief Executive Officer, Cabernet and Zinfandel Pharmaceuticals
Sonal Bhuta Halburnt
CABERNET & ZINFANDEL STAFF POSITIONS
Ann M. Saunders, PhD – President and Chief Executive Officer, Cabernet and Zinfandel Pharmaceuticals
Saunders brings to Cabernet Pharmaceuticals pioneering research experience in both academic and pharmaceutical-industry settings.
At Duke University Medical Center, Saunders was an integral part of the research teams that identified APOE (apolipoprotein E) as a major susceptibility gene for Alzheimer’s disease and then evaluated the effect on the age of onset of Alzheimer’s exerted by TOMM40 (translocase of outer mitochondrial membrane), a gene adjacent to APOE. She has also led or contributed to significant discoveries regarding mild cognitive impairment, Down-syndrome dementia, head trauma including stroke, and cerebral-glucose-metabolism changes that may begin decades before the onset of Alzheimer’s.
Her industry experience includes seven years as Director of Experimental Pharmacogenetics and Therapy Area Team Leader in Metabolic and Viral Diseases at GlaxoSmithKline. Among her diverse contributions was her part in conceiving and executing the pivotal global clinical trials of rosiglitazone in the treatment of Alzheimer’s, the first genetically stratified studies to examine efficacy and safety of an investigational compound in that disease.
In her position at Zinfandel Pharmaceuticals, Cabernet’s sister company, Saunders has taken wide-ranging roles including protocol development in the ongoing TOMMORROW study being conducted by the alliance of Zinfandel and Takeda Pharmaceutical Company Limited. TOMMORROW is evaluating an algorithm comprising the genotypes APOE and TOMM40 together with age as an indicator of risk for Alzheimer’s disease. The study is also testing the efficacy of pioglitazone in delaying cognitive impairment due to Alzheimer’s in cognitively normal but high-risk individuals. It has enrolled some 3,500 subjects at 58 study centers in 6 countries.
Saunders holds a PhD in Anatomy and Neurobiology from Duke and an undergraduate degree from Vassar College.
Arbuckle has broad research and development experience working in blue-chip pharmaceutical and start-up biotechnology companies.
He has been the project lead for a wide range of Phase I-IV clinical programs, including those that applied genetic technologies to drug development. For the TOMMORROW study being conducted by the Zinfandel-Takeda alliance, he has helped to guide delivery of the program while also mentoring the program-management team. In his role at Cabernet, he has worked with a major pharmaceutical company to include genetic technologies in the evaluation of its drug-development pipeline.
Arbuckle started his career as a scientist at the Novartis Institute for Medical Research. He then joined GlaxoSmithKline and assumed a series of research and management roles, including positions in which he integrated pharmacogenetics into drug-development programs and led collaborative external projects to investigate the genetic basis of adverse events associated with marketed compounds. He has also served as a consultant with Venebio Group LLC, where he provided broad scientific and administrative support to a UK start-up company, and with the International Serious Adverse Events Consortium, where he initiated and coordinated two international networks investigating the genetics of immunologically influenced adverse events.
He holds a BS (Hons) in Biological Sciences from the University of Leicester, UK.
Brewster currently serves as Director, European Regional Site Support Management, Zinfandel Pharmaceuticals, in the Zinfandel-Takeda alliance with oversight responsibility for several European clinical sites in the TOMMORROW study.
In this role, Brewster has led a team of neuropsychology experts in the linguistic and cultural adaptation of a neuropsychology battery acceptable for registration. Additionally, she has expanded patient registries by working with physicians to identify suitable participants for prevention and disease programs and developed a global training program to standardize trial administration.
She joined Zinfandel from GlaxoSmithKline, where as a Director with responsibilities for integrating pharmacogenetics into the development pipeline she helped to double patient participation in pharmacogenetic studies. Her experience includes leadership roles in applying genetic-enrichment strategies to studies in both central-nervous-system and respiratory disorders. She has managed multimillion-dollar program budgets and negotiated cost-effective contracts in collaborations between industry and academia.
She holds a BS (Hons) in Biochemistry and Chemistry from the University of London.
Burns has worked across the continuum of drug discovery and development and post-approval life-cycle management.
In his role at Cabernet, he is responsible for designing and implementing business strategies, overseeing daily operations, and ensuring efficient and effective management of resources to deliver value to Cabernet clients.
In a separate role at Zinfandel Pharmaceuticals, Burns has led a team in the alliance with Takeda Pharmaceutical Company Limited to design and execute the ongoing TOMMORROW study.
Prior to providing consultation services, Burns led in-house scientific departments at large pharmaceutical companies while also building successful collaborations with the biotechnology industry, government, patient-advocacy groups, and public-private partnerships. At GlaxoSmithKline, where he most recently served as Senior Vice President, Pharmacogenomics, he managed international line functions and took a leadership role in working across therapeutic areas to integrate pharmacogenetics throughout the R&D organization. He earlier held positions of increasing responsibility at Hoffmann-La Roche, Inc.
Burns has published widely throughout his career and has been an invited speaker at numerous scientific conferences including meetings organized by the US Food and Drug Administration, the National Institutes of Health, the Drug Information Association, and the Keystone Symposium.
He holds a BS in Biology, an MA in Zoology, and a PhD in Molecular, Cellular, and Developmental Biology from Indiana University. He did his post-doctoral research at Hoffmann-La Roche, Inc. investigating protein structure-function relationship.
Chiang, Director of Clinical Development, Zinfandel Pharmaceuticals, co-leads the clinical-science aspects, including protocol development and writing, of the TOMMORROW study being conducted by the Zinfandel-Takeda alliance.
Before his appointment to Zinfandel, he held positions of increasing responsibility at GlaxoSmithKline, again including clinical-protocol development. He served as a Global Study Leader for pivotal clinical trials of rosiglitazone in Alzheimer’s disease.
Earlier, at Cato Research Ltd., Chiang helped lead the early development of Myozyme®, an enzyme-replacement therapy for the progressively debilitating metabolic disorder known as Pompe disease. In addition to metabolic and neurodegenerative disease, his therapeutic-area experience includes migraine, depression, restless-legs syndrome, and oncology.
Chiang earned a BA in Biological Basis of Behavior from the University of Pennsylvania and a PhD in Neuroscience from Hahnemann University. He has completed postdoctoral fellowships at Hahnemann (preclinical studies of Parkinson’s disease and toxicity of beta-amyloid protein in brain) and The Neurosciences Institute, LaJolla, CA (in vivo investigations of the temporal-coding hypothesis of cortical function).
Sonal Bhuta Halburnt
Halburnt specializes in clinical trial execution, regulatory audit, and pharmacogenetics science.
She joined Cabernet from GlaxoSmithKline, where she advanced the adoption of pharmacogenetic procedures in international Phase I-IV clinical studies and developed process improvements that increased sample collection. She also contributed to pharmacogenetics educational materials and an alternative non-invasive DNA collection method.
Previously, she served as an Assistant Project Manager at Inveresk Corporation, a clinical-research organization, where she coordinated all aspects of clinical studies. She has also worked at Duke University Medical Center’s Human Vaccine Institute, studying genetic variation in the HIV virus, and in Memorial Sloan Kettering Cancer Center’s Developmental Tumor Vaccinology Group, doing studies of antibody response to cancer vaccines.
Halburnt holds a BS in Biology with a concentration in Microbiology from Northeastern University.
Haneline has served in numerous project-management roles with Zinfandel Pharmaceuticals in support of the Zinfandel-Takeda alliance conducting the TOMMORROW study.
His role at Zinfandel builds on his experience as a molecular biologist and project manager. He has been an early adapter and advocate for such technologies as bacterial fermentation-production of recombinant proteins, PCR, automated DNA sequencing, automated oligonucleotide synthesis, robotics, bioinformatics, SNP discovery, and SNP mapping.
He established pharmacogenetics program-management at GlaxoSmithKline, following his early management role in the company’s exploration of SNP genotyping to guide use of the HIV/AIDS medicine abacavir. He has also served as a project manager at the Duke Clinical Research Institute’s Advanced Biomarker Program.
Haneline has a BS in Biology and a MS in Microbiology from North Carolina State University and a Masters Certificate in Project Management from George Washington University.
Sundseth has applied pharmacogenetic analysis to drug development across multiple therapeutic areas and for diverse healthcare enterprises over the last 30 years.
In his role at Cabernet, he has consulted with clients to improve R&D pipeline management, secure regulatory approval, and enhance market acceptance of new medicines. His clients since the founding of Cabernet have included large pharmaceutical corporations, biotechnology companies, clinical-research and managed-healthcare organizations, and academic institutions.
Previously, during a 19-year career at GlaxoSmithKline, he served initially as a research scientist and then assumed positions of increasing management responsibility, including leadership of GSK’s disease-genetics collaborations with medical centers around the globe. He ultimately was Head of Pharmacogenetics for compounds directed at cardiovascular, metabolic, musculoskeletal, inflammatory, gastrointestinal, viral, and urogenital disorders. In that role, he led a team that designed and implemented pharmacogenetic strategies for key assets in all phases of clinical development.
Following his service at GSK and immediately prior to his arrival at Cabernet, he worked at the Deane Drug Discovery Institute of Duke University discovering and developing genetic diagnostic markers for disease prediction and prevention. He has published widely on disease genetics and pharmacogenetics.
Sundseth holds a BS in Zoology and an MS in Biochemistry from the University of Idaho, a Graduate Certificate in Change Leadership from American University (Washington, D.C.), and a PhD in Genetics from the University of Tennessee-Oak Ridge Graduate School of Biomedical Sciences. He did post-doctoral work at the Dana-Farber Cancer Institute, Harvard Medical School, focusing on the regulation of antineoplastic drug metabolism.
Swanson leads program management for Cabernet Pharmaceuticals, ensuring that appropriate and efficient methodological approaches are applied to each client’s needs and working to produce high-quality, submission-ready data.
He also serves as Development Program Manager, Zinfandel Pharmaceuticals, for the TOMMORROW study. In that role he has been instrumental in bringing the Zinfandel-Takeda alliance partners into a single team to achieve aggressive development goals for the 58 study sites. He joined Cabernet from GlaxoSmithKline, where he served as US Head of Pharmacogenetics Operations & Compliance and integrated pharmacogenetics into clinical-trial operations.
Previously, he served as Vice President, Program & Project Management, at First Genetic Trust, a start-up company producing research-collaboration software, and as Director, Program Management, for an early-stage, meat-industry consortium developing software to facilitate online commodity auctions and contract management.
Swanson holds a BS in Engineering from the University of Wisconsin and an MBA from the University of Houston.
Yarnall brings to Cabernet more than two decades of experience in sample management, genetic-data generation, and project management.
He has managed interactions with central clinical-data labs, diagnostic companies, and genomic-services providers. In addition, he has worked extensively with external genotyping companies on genetic-test optimization and medical-device regulatory requirements.
Yarnall came to Cabernet from GlaxoSmithKline, where he led a group responsible for designing and executing genetic experiments in support of corporate objectives. He also led efforts to identify and validate external vendors for generating genetic data.
He holds a B.S. in Microbiology and an M.S. in Immunology and Medical Microbiology from the University of Florida.
Maruyama is the President and Chief Executive Officer of KPY Consulting Ltd., based in Kanagawa, Japan. She has wide-ranging experience in the Asia Pacific region.
As a Regional Site Support Manager for the TOMMORROW study being conducted by the Zinfandel-Takeda alliance, she has played a key role in establishing study sites and implementing study requirements in Russia and Australia. She has also co-led all aspects of a Japanese ethnic-population study.
Maruyama started her career at Pharmacia & Upjohn Japan as a toxicologist. She then joined GlaxoSmithKline Japan, eventually heading the Clinical Genetics Asia Pacific office. There she led disease-susceptibility-gene projects and, working with country-office managements, integrated pharmacogenetics into Phase I-III trials. She managed research activities in Japan, China, India, Taiwan, Singapore, Malaysia, Thailand, and Australia.
Subsequently, she relocated to Singapore to work with A*STAR (Agency for Science, Technology, and Research) and start a translational-research institution called the Experimental Therapeutics Centre, where she headed the Business Development and Project Management division.
Maruyama holds a Veterinary Medicine degree from Nippon Veterinary and Life Science University in Tokyo.
Metz, the president of Metz Regulatory Consulting Services, provides regulatory-affairs support to Cabernet Pharmaceuticals. Over the course of his 43-year career in the pharmaceutical industry, he has contributed to the development and regulatory approval of medicines across several therapeutic categories
Previous to founding his current consulting firm, Metz served in regulatory-affairs and clinical-development roles at GlaxoSmithKline, most recently as Vice President, US Regulatory Affairs. He led the group providing regulatory support for GSK’s Centers of Excellence for Drug Discovery, overseeing the development, coordination, and execution of regulatory strategy across all discovery research and working with every Food and Drug Administration Reviewing Division. His role included pursuing opportunities for expedited drug development like Fast Track and Orphan Drug designations. He also assumed a leadership role in the development of the GSK Clinical Trial Register, which at its launch was the first clinical-data-disclosure vehicle of its type in the pharmaceutical industry.
In 2012 his many contributions to the pharmaceutical industry were recognized by the Drug Information Association with the presentation of its Outstanding Service Award.
Metz holds a PhD in Health Sciences from Columbia Pacific University.
Patrick Anthony Akkari
Akkari is a Professor of Industrial Pharmacogenetics, Murdoch University, Perth, Australia. His research and drug-development efforts have focused on the genetics of neuromuscular and neurodegenerative diseases.
He also has industry experience with Cabernet and GlaxoSmithKline. He has contributed to pharmacogenetic components in clinical trials from Phase I through Phase III, including studies in type 2 diabetes and respiratory disease as well as neurological disorders.
He has worked within the regulatory environments of both the US and Europe and with international Ethics Review Boards. Pharmacogenetic research programs he developed have been implemented in the US, the UK, Europe, and China.
Akkari holds a BA in Applied Science and a PhD in Neurogenetics from Curtin University, Western Australia, and has done post-doctoral work in neurogenetics at Duke University Medical Center.
W. Kirby Gottschalk
Gottschalk is an Assistant Professor of Neurology, Duke University Medical Center. He has an extensive background in metabolic physiology and biochemical genetics in both academic and pharmaceutical-industry settings.
At GlaxoSmithKline’s Metabolic Diseases Center of Excellence in Drug Discovery, Gottschalk directed research teams that defined the effects of genetic and pharmacological perturbations on gene expression and on biochemical, cellular, and physiological function. He helped incorporate genetics into the target-identification and validation process, and as a member of GSK’s Alzheimer’s team, he led the effort that discovered that PPAR-gamma agonists enhance cerebral-glucose metabolism.
Prior to joining GSK, Gottschalk held a faculty position at the University of Tennessee – Memphis Medical Center, where he researched insulin action, with applications to insulin resistance and molecular defects underlying type 2 diabetes.
He holds a BA and a PhD in Zoology from the University of Wisconsin-Madison and took post-doctoral training at UW-Madison and the University of Pennsylvania, focusing on the mechanism of insulin action.
Lutz is an Assistant Professor, Department of Neurology, at Duke University Medical Center. He has done extensive work in computational biology, bioinformatics, and biostatistics.
In collaboration with the Joseph and Kathleen Bryan Alzheimer’s Disease Research Center, he has taken a leading role in the analysis of collaborative studies to examine the genetic factors associated with Alzheimer’s and their specific effects on age-related cognitive decline. His co-collaborators are the Mayo Clinic and Mount Sinai Hospital and the Chaim Sheba Medical Center in Israel. His current research extends his work on genetic-variant identification to other diseases with the goal of elucidating gene variants that are associated with disease and response to pharmaceutical therapy.
Previously, Lutz held positions of increasing responsibility at GlaxoSmithKline, ultimately as Director, Computational Biology and Bioinformatics. Still earlier, he was an Adjunct Assistant Professor in Biomathematics at North Carolina State University.
He holds BS and PhD degrees from Duke University in Biomedical Engineering.
Welsh-Bohmer is a Professor and the Chief of Medical Psychology, Department of Psychiatry and Behavioral Sciences, and Director of the Joseph and Kathleen Bryan Alzheimer’s Disease Research Center, Department of Neurology, at Duke University Medical Center. She heads a medical-psychology unit comprising more than 200 academic psychologists.
Clinically trained and board-certified in neuropsychology, she focuses her research on delaying the onset of cognitive disorders. At the Bryan Alzheimer’s Center, she leads a multidisciplinary team devoted to discovering the biological basis of Alzheimer’s disease and developing methods to enhance early diagnosis and speed drug discovery.
Welsh-Bohmer oversees the neuropsychology operations of the TOMMORROW study being conducted by the Zinfandel-Takeda alliance. The methods her team has developed for this study fill an information void and have implications for accelerating global clinical trials in Alzheimer’s prevention. She has served as an advisor to numerous other pharmaceutical and biotechnology companies, among them Merck, Roche, and T3D Therapeutics, Inc.
Welsh-Bohmer led the Cache County Epidemiological Study of Aging and Dementia, which explored the genetic and environmental antecedents of Alzheimer’s and other cognitive disorders. She was also the Neuropsychology Co-Lead on the Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT), developing the neuropsychological methods applied in the time-to-event design.
Welsh-Bohmer earned a PhD in Psychology at the University of Virginia and did post-doctoral work in Clinical Neuropsychology at the University of Iowa. She is frequently an invited speaker at scientific conferences and has authored numerous papers and book chapters in her areas of scientific interest.