R&D Leadership
Susan Learned M.D., Pharm.D., Ph.D.
Head, Research and Development
Susan is an extremely accomplished research scientist, medicines developer and pharmaceutical executive with 25 years of pharmaceutical industry experience spanning all phases of drug discovery and development. Susan most recently was the SVP of Global Medicines Development at Indivior. Prior to this, she spent nearly 20 years with GlaxoSmithKline, including the role as VP, Medicines Development Lead and Franchise Head.
Susan is an extremely accomplished research scientist, medicines developer and pharmaceutical executive with 25 years of pharmaceutical industry experience spanning all phases of drug discovery and development. Susan most recently was the SVP of Global Medicines Development at Indivior, accountable for all discovery, development and life-cycle management strategy and operations across Indivior’s portfolio, as well as key supportive functions.
Prior to this, she spent nearly 20 years with GlaxoSmithKline, including roles as VP, Medicines Development Lead and Franchise Head, Stiefel, VP and Head, Discovery Medicine Unit in Shanghai, China, Head of Neuroscience Discovery Scientific Licensing for Worldwide Business Development, and Head of Neuroscience Discovery Medicine, North America.
Susan has led or been an integral part of more than 60 successful NDAs, sNDAs, and global regulatory submissions.
Frank Kondrad
Head, Project Management
A science-based business leader with a broad healthcare background. Former AstraZeneca Executive Director of Business Development and Licensing, Senior Director Clinical Development, Director of Managed Markets, Director of External Medical Relations, NEXIUM Managed Markets and HCP Brand Marketing Leader, CRESTOR Senior Market Research Manager, Global Strategic Planning Manager and Head of CMC Project Management and Regulatory Documentation.
John Wahlich, Ph.D.
Head, CMC/Pharm Dev/MFG
John Wahlich is a CMC professional specializing in oral formulations and the analysis of small molecules. He was formerly VP of Product Line Extensions and VP of Early Pharmaceutical Development in GSK where he worked for 25 years. He has been consulting for numerous companies over the past 10 years. He has a PhD in Pharmaceutics from the University of Nottingham (UK).
Fiona Randall, Ph.D.
Head, Pre-Clinical Neuroscience
Dr. Randall is a renowned neuroscientist, strategic alliance and business development expert with worldwide drug discovery and development experience in the pharmaceutical and biotechnology industry with Merck, GSK, Eisai and Vertex in the USA, UK, China and Japan. Dr. Randall has led multiple preclinical projects in neurology and is currently SVP of External Alliances and Scientific Strategy at Mindset Pharma Inc.
O'Neil D'Cruz
M.D., M.B.A., FAAN
Head, Neurology Clinical Development
Dr. D’Cruz is an experienced epileptologist and clinical investigator who consults with pharmaceutical companies and is on the External Advisory Board for NIH’s NeuroNext Program. Dr. D'Cruz is acting as an independent consultant for Shackelford Pharma. He was previously Professor of Neurology and Pediatrics at University of North Carolina-Chapel Hill, USA. Dr. D'Cruz's previous industry appointments include Medical Director, Neurology at UCB Pharma and Chief Medical Officer, Cyberonics. Member of Pediatric Epilepsy Academic Consortium for Extrapolation, Former BOD of American Society of Experimental Neuro-Therapeutics.
Rebecca Boone, B.S., M.A.
Head, Clinical Operations
Rebecca brings more than 30 years of clinical drug development experience to Shackelford. Previous roles include SVP of Clinical Operations at Asklepios Biopharmaceuticals and VP Global Development Operations at Theravance BioPharma.
Rebecca has worked across Phases I – IV and multiple therapy areas with expertise in strategic planning, global clinical operations, data management, financial planning and management, business process improvement, post-merger and acquisition integration, CRO and vendor management, personnel management, coaching, and leadership.
Diane Shoda
Head, Regulatory Strategy
Diane is a pharmaceutical industry veteran who is passionate about changing people's lives by helping groundbreaking drugs reach the global market. Previously, Diane served for more than 30 years in various leadership roles in drug development at Pfizer. She has a proven track record of innovative regulatory strategies, including the first approved “virtual” clinical trial. Diane developed and executed regulatory strategies for a broad portfolio of Pfizer’s blockbuster drugs, including Celebrex and Lyrica. Diane holds a B.S. in Chemical Engineering from MIT. She is currently an independent consultant, Greyscaling LLC, with interests in neuroscience, pediatrics, digital health, and working in the grey space of regulatory science.
Mike Kelly, Ph.D.
Head, Toxicology
Mike Kelly is a preclinical safety, disposition, and translational science consultant, supporting biotech, small and medium pharmaceutical companies, and academic drug discovery enterprises. Mike is also a visiting lecturer in the School of Life and Medical Sciences at the University of Hertfordshire (teaching pharmacology, drug discovery, drug safety and toxicology) and a course tutor for the British Association of Pharmaceutical Physicians and the British Pharmacological Society. He has worked in preclinical development since the mid-80’s in academia, CRO, biotech and large pharma. Mike has supported a wide range of treatment modalities (small molecules, vaccines and adjuvants, biopharm, oligos, medical devices and orphan drugs) and in multiple therapeutic areas (immuno-inflammatory, infectious disease, respiratory, metabolic and GI, oncology, psychiatric and neurology).
Susan Sisk, Ph.D., R.A.C.
Regulatory & Technical Writing Consultant
Susan brings over 25 years of experience in designing, writing, and reviewing clinical trial protocols, Investigational New Drug applications and annual reports, investigator’s brochures, clinical study reports (Phase 1-4), integrated summaries and other New Drug Application components, and packages for sponsor meetings with Food and Drug Administration personnel.
Judith Jaeger, Ph.D., M.P.A.
Clinical Development & Psychometrics Consultant
Judith Jaeger is a neuropsychologist with more than 35 years’ experience in clinical and experimental neuropsychology and psychopathology. She is owner and president of CognitionMetrics, LLC, a consultancy serving the pharmaceutical industry with expertise on cognitive and behavioural measurement in the context of drug development. She is Clinical Professor of Psychiatry and Behavioral Science at Albert Einstein College of Medicine, New York and the author of over 80 peer reviewed journal articles, several book chapters, co-edited books and hundreds of abstracts and presentations.
Judith Jaeger is a neuropsychologist with more than 35 years’ experience in clinical and experimental neuropsychology and psychopathology. She is owner and president of CognitionMetrics, LLC, a consultancy serving the pharmaceutical industry with expertise on cognitive and behavioural measurement in the context of drug development. She is Clinical Professor of Psychiatry and Behavioral Science at Albert Einstein College of Medicine, New York and the author of over 80 peer reviewed journal articles, several book chapters, co-edited books and hundreds of abstracts and presentations.
Previously she was Vice President for Clinical Trials at Cogstate, Inc. and Director of Clinical Development at AstraZeneca Pharmaceuticals where she served as company-wide cognition and psychometrics expert. These industry positions followed a distinguished academic career as an NIH funded research clinician and educator.
Since forming CognitionMetrics, she has advised numerous pharmaceutical companies on early phase and experimental medicine projects as well as pivotal and late phase clinical programs in Alzheimer and other dementias, neurodegenerative and neurodevelopmental diseases, ADHD, schizophrenia, bipolar disorder, major depression and oncology.
She has represented pharmaceutical clients in regulatory meetings including the FDA and Japan’s PMDA and has been a key presenter at an FDA Advisory Committee meeting.