Faculty – Medical Imaging in Clinical Research

Jianqing Chen
PET and Molecular Imaging, PFIZER

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Strong in applying molecular imaging in drug development in areas of neurology, immunology, oncology, cardiovascular, and inflammatory disease:

• Have worked on multiple clinical imaging studies as proof of mechanism (POM) in drug development in multiple disease areas; have about 20-year experience in applying imaging in drug development.
• Responsible in study design, documentation, and data analysis and report ensuring quantitative clinical imaging readout.
• Responsible in radioactive tracer development and manufacture, and CMC documentation for regulatory submission.
• As an imaging lead to maintain alignment with respect to programmatic goals across research unions, provide expert consultancy, and new clinical imaging solutions to drug development challenges.

3/1993-2/1997: Ph.D. Radiochemistry/Tumor Immunology
Departments of Radiation Physics, Tumor Immunology & Oncology, Medical Faculty,
Lund University, Sweden.

9/1984-8/1987: M.S. Pharmacology
Shanghai Nuclear Research Institute, Academia Sinica, China.

9/1979-8/1984: M.D. Medicine
SuZhou Medical College, SuZhou, China.

Neeta Fahey
Clinical Imaging Operations, Senior Clinical Protocol Manager, BRISTOL-MYERS SQUIBB

Timothy Ganey
Chief Scientific Officer, VIVEX BIOMEDICAL, INC

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Timothy Ganey serves as Chief Scientific Officer for Vivex Biomedical, and formerly was Research Director, Orthopaedic Surgery at Atlanta Medical Center. From 2000-2003, he was President of the US division of co.don Tissue Engineering, a cell-based therapeutic company from Berlin, Germany. In that capacity, the first worldwide pre-clinical and clinical studies for intervertebral disc repair using autologous disc chondrocytes were completed. To date, this is the only trial that has 10-year follow-up data with positive results. Dr. Ganey has published extensively in a broad range of fields including anatomy, biochemistry, electron microscopy, comparative morphology, cell biology, and electro-physics, and regularly reviews manuscripts for several international journals. His laboratory work has been supported by national, local, and society grants, with achievements that include outstanding papers and top research awards from numerous societies. Dr. Ganey has been instrumental in several technology development initiatives, among them the use of cell-based therapeutics, electric field transduction, and manufactured tissue-specific matrices for regenerative medicine. Patents include work stemming from pulsed-field delivery and artificial matrices for bone regeneration. Timothy Ganey received a BS/BA degree from the University of Illinois with a major in Chemistry and Biology, did post-graduate work in Electron Microscopy, and completed a Ph.D. at the University of South Florida. He understands the challenges of a shifting paradigm in medicine to regenerative treatment and supports engineering and scientifically-grounded marketing initiatives to support the transition.

Priya Guyadeen
Clinical Project Manager, Peripheral, PENUMBRA, INC.

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Priya has more than a decade of experience in clinical trial management. She has in-depth knowledge of both the pharmaceutical and medical device industries, and expertise in the Latin American market. Today, Priya manages clinical trials focused on peripheral vascular diseases at Penumbra Inc.

Dr. Christopher R. Hancock
Director of Neuroradiology, BLUE SKY RADIOLOGY

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Dr. Christopher R. Hancock is the director of neuroradiology at Desert Medical Imaging, bringing our patients the benefit of his active research interests in critical fields like dementia and Alzheimer’s disease, minimally invasive spinal surgery, and pain management. Dr. Hancock is a board-certified Diagnostic Radiologist with certification of added qualifications in Neuroradiology, holds a Level II Cardiac CT certification, and he takes an innovative approach to diagnosing and treating disorders of the brain and nervous system, head, neck, and spine.

After graduating Summa Cum Laude with a Bachelor’s degree in Genetics from the University of Georgia, he went to medical school at the Medical College of Georgia, where he conducted a two-year study of stem cell neurodevelopment. Following an internship at the Carolinas Medical Center, Dr. Hancock completed a four-year residency in diagnostic radiology and earned the position of Chief Resident at the University of Miami, where he also achieved fellowships in Neuroradiology and Musculoskeletal Radiology.

Later, Dr. Hancock accepted a position as Associate Program Director for the Mount Sinai Medical Center (MSMC) Department of Radiology residency program, then an appointment as Director of Neuroradiology at MSMC.

In addition to Dr. Hancock’s current position with Desert Medical Imaging as director of neuroradiology, he serves as a reviewer for The American Journal of Radiology, The Spine Journal, and Neurographics; as advisor for the Public Information Advisory Network; Chairman of the California Medical Association Young Physician Section; board member of the Riverside County Medical Association, and California Radiological Society; California Medical Association delegate to the American Medical Association; and counselor to the American College of Radiology.

Currently, Dr. Hancock practices orthopedic and sports medicine imaging, neuroradiology, and musculoskeletal imaging, and investigational regenerative therapies using stem cells taken from a patient’s own body to heal tissue damaged by disease or injury.

Sanjay Joshi
Chief of Technology, Healthcare and Life Sciences, IMAGING AND RADIOLOGY EXPERT – 25+ YEARS

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Sanjay Joshi is the Chief of Technology, Healthcare and Life Sciences at H2O.ai. Based in Seattle,
Sanjay’s 25+ year career has spanned the entire gamut of life-sciences and healthcare from clinical
and biotechnology research to healthcare informatics to medical devices. A “skunkworks” engineer,
bioengineer and informaticist, he defines himself as a “non-reductionist” with a “systems view of the

His current focus is a systems-level understanding of Healthcare, Genomics, Proteomics,
Microbiomics, Imaging and IoT processes and data infrastructures. Recent experience has included
data management and instruments for Electronic Medical Records; Proteomics and Flow Cytometry;
FDA and HIPAA validations; Lab Information Management Systems (LIMS); Translational Genomics
research and Imaging. Sanjay holds a patent in multi-dimensional flow cytometry analytics. He began
his career developing and building X-Ray machines.

Sanjay was the recipient of a National Institutes of Health (NIH) Small Business Innovation Research
(SBIR) grant and has been a consultant or co-Principal-Investigator on several NIH grants. He is
actively involved in non-profit biotech networking and educational organizations in the Seattle area
and beyond. Sanjay holds a Master of Biomedical Engineering from the University of New South
Wales, Sydney and a Bachelor of Instrumentation Technology from Bangalore University. He has
completed several medical school and PhD level courses (in Sydney and Seattle).

Dr. Johan Luthman
VP Neuroscience Clinical Development, EISAI

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Johan Luthman is Vice President & Head of Clinical Development, Neurology Business Group, Eisai Pharmaceuticals, where he is engaged in overseeing clinical development programs from preclinical development to phase 3, with current programs in Alzheimer’s disease & other dementing disorders, epilepsy, sleep disorders and obesity.

Before joining Eisai, Johan was VP & Franchise Integrator, leading translational medicine and biomarker activities in neuroscience as well as Senior Program Leader for Early Development Neuroscience & Ophthalmology at Merck Research Laboratories, based in PA, USA, overseeing projects from preclinical candidate to proof of concept in Phase 2. Prior to Merck, Johan lead GeNeuro SA, Geneva, as CEO during its build-up phase to stand-alone biotechnology company. Before then, Johan was SVP & Therapy Area Head of Neurology, Immunology & Inflammation Research and Head of PoC strategy in Neurology at MerckSerono, based in Geneva, CH. He joined Serono in 2005, as Head Neuroscience & Immunology Research. Johan began his pharmaceutical career in 1991 in Astra, Sodertalje, Sweden. In Astra/AstraZeneca he worked as project leader as well as director of research departments, before leading Translational Science in Neurology & Analgesia. During his years in the industry, Johan has been engaged in numerous Public-Private pre-competitive consortia efforts, including acting as chairman of the ADNI Industry group in 2012, and chair efforts within C-Path Institute.

Johan studied medicine and dentistry at the Karolinska Institute. In parallel with clinical practice, he obtained a Ph.D. in neurobiology in 1989. He continued as a Research Fellow in Pharmacology & Psychiatry at the University of Colorado. Johan was subsequently appointed associate professor in Neurobiology at Karolinska Institute and received an honorary professorship in pharmacology from the University of Chile. He obtained business training at SIMI, Copenhagen and Thunderbird and MIT/Sloan Management Institute.

Colin Miller
Editor, Medical Imaging in Clinical Trials

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Colin completed his undergraduate degree in Physiology and Zoology from the University of Sheffield, (UK) and his Ph.D. 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 Ph.D., 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 and joined Alacrita as a consultant (and also started his own analytics company, 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 25 years for the biopharmaceutical and device companies through Bioclinica, Bona Fide Ltd and now Alacrita. 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 both the Institute of Clinical Research and 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.

Youngho Seo, Ph.D.
Professor, Department of Radiology and Biomedical Imaging, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

Ira Smalberg, M.D.

Gary Ulaner, M.D., Ph.D.