Saral Amarnani, M. Med., M. Pharm, PhD
Dean, School of Clinical Research
Dean, School of Clinical Research
B.S., College of Basic Sciences, Maharaja Sayajirao University, India
M.S., Medical Sciences, Medical College, Maharaja Sayajirao University, India
M.S., Pharmacology, Medical College, Maharaja Sayajirao University, India
Ph.D., Clinical Pharmacology, Medical College, Maharaja Sayajirao University, India
Dr. Saral Amarnani currently serves as Dean, School of Clinical Research at the American University of Health Sciences. She brings rich international background intertwined with academia and the private sector, serving in the field of Clinical Research for more than three decades. Dr. Saral has experience coordinating, monitoring, and managing global clinical studies for biochemical, pharmaceutical, biomedical device, and government agencies. Dr. Saral has enriched clinical research experience from Asia, the UK, and the USA, starting with an Asian Congress of Pharmacology Award as a Ph.D. student for her study on ‘Pharmacokinetic Profile of Rifampin and undernutrition in Tuberculosis. Thanks to many mentors, Dr. Saral brings 35 years of academic and private sector Clinical Research experience to AUHS, starting with her first pharmaceutical grant in 1985 from Sarabhai Chemicals, now, SUN Pharma, which is the world’s 4th largest specialty generic pharmaceutical company in Vadodara, India.
Dr. Saral earned her Medical Sciences degree (M.B.B.S. classes) from the Maharaja Sayajirao (MS) University and completed her Ph.D. in Clinical Pharmacology at Baroda Medical College, MS University. Dr Saral migrated to the USA to start as an NIH fellow at the Department of Pathology and Dept of Pharmacology , Washington University in St. Louis, MO and, also conducted clinical research studies as a Narcotic Inspector at Jefferson Barracks VA Hospital. Dr. Saral continued her Clinical Research at J. L. Pettis VA Hospital in the Department of Mineral Metabolism, as well as had earned the Seed Money Academic Grant Award from the Department of Pediatrics at Loma Linda University. Next, Dr. Saral joined as a visiting Assistant Professor at the Department of Pharmacology and Department of Ob/Gyn at UCLA, Los Angeles and continued as an Assistant Researcher at UCLA School of Medicine. In 2005, Dr. Saral moved to the private sector and has successfully performed various roles as a Clinical Research Coordinator, Clinical Research Associate, Clinical Trial Manager or a consultant at site management organizations, and Clinical Research Organizations.
Dr. Saral is also a driven professor who is passionate about teaching pharmacology and clinical research. Dr. Saral also believes that it is her time to ‘give back’ and restart in academics full time, so that her students’ foundations of clinical research knowledge and the skills they learn, help them develop into successful clinical researchers while serving the Clinical Research field.
1. Green tea and the risk of gastric cancer: Epidemiological evidence. World Journal of Gastroenterology, 2013 June 28; 19(24): 3713-3722
2. ‘Role of Dendritic Cell Phenotype, Determinant Spreading, and Negative Co stimulatory Blockade in Dendritic Cell-Based Melanoma Immunotherapy’. Journal of Immunotherapy. 2004, Jan 1; 27:354-367.
3. ‘T-cell responses to HLA-A*0201 immunodominant peptides derived from alpha-fetoprotein in patients with hepatocellular cancer’. Clinical Cancer Research. 2003, Dec 1;9(16 Pt .1):5902-8
4. ‘Determinant spreading associated with clinical response in dendritic cell-based immunotherapy for malignant melanoma’. Clinical Cancer Research.2003, Mar; 9(3):998-1008.
5. ‘Immunosuppressive effects of interleukin-12 co expression in melanoma antigen gene-modified dendritic cell vaccines’. Cancer Gene Therapy. 2002, Nov; 9(11):875-83.
6. ‘CD40 cross-linking bypasses the absolute requirement for CD4 T cells during immunization with melanoma antigen gene-modified dendritic cells’. Cancer Research.2001, Dec15; 61(24):8787-93.
7. ‘Immune deviation and Fas-mediated deletion limit antitumor activity after multiple dendritic cell vaccinations in mice’. Cancer Research. 2000, Apr 15; 60(8):2218-24
8. ‘Generation of T-cell immunity to a murine melanoma using MART-1-engineered dendritic cells’. Journal of Immunotherapy. 2000, Jan; 23 (1):59-66
9. ‘Effects of selected endothelium-dependent vasodilators on fetoplacental vasculature: physiological implications’. American Journal of Physiology. 1999 Aug; 277(2 Pt 2):H842-7:157-65
10. ‘Autocrine Regulators of MC3T3-E1 Cell Proliferation’. Journal of Bone and Mineral Research, Volume 8, Number 2, 1993
11. ‘Development of monoclonal antibodies to parathyroid hormone-induced resorptive factors from osteoblast-like cells’. Calcification Tissue International Journal. Mar; 50(3):237-44
12. ‘Insulin-Like Growth Factors and their Binding Proteins: Role in Pre and Post-Natal Growth and Development’. Inland Pediatrics, December, Vol. 6, No 5
Doctor of Philosophy in Genetics at the University of Madras in Chennai, India
Dr. Chandrasekhar Kesavan completed his Doctor of Philosophy in the field of Genetics from Dr. ALM Post-Graduate Institute of Basic Medical Sciences at the University of Madras in Chennai, India on January 2002. Upon completing his Ph.D., Dr. Kesavan joined Dr. Subburaman Mohan’s lab and Dr. David J. Baylink’s Musculoskeletal Disease Center Group for his Post-Doctoral training in January 2002. In due course of time, Dr. Kesavan became a research associate and then, as a scientist at VA Loma Linda Healthcare Center, joined Loma Linda University in 2010 as an Assistant Research Professor in the Department of Medicine. In 2016, Dr. Kesavan joined Dr. Richard Strong M.D., a group in the Gastroenterology Department at the VA Loma Linda Healthcare system as clinical study staff/investigator.
Dr. Kesavan’s research is focused on bio-medical basic science and clinical research. In the bio-medical field, Dr. Kesavan has 18 years of research experience in skeletal biology. His goal is to improve a patient’s quality of life by developing therapeutic agents and/or strategy to improve bone mass where bone development and maintenance are compromised (osteoporosis, fracture healing, bone metastasis, traumatic brain injury). Towards this goal, Dr. Kesavan has optimized and used various state-of-the-art technologies to study skeletal growth and maintenance using in vitro and in vivo models that translate most effectively into clinical situations. His research works led to publish more than 35 papers in the field of bio-medical science, in which his works presented several of his findings as oral, plenary and poster in the American Society of Bone and Mineral Research. As an independent investigator, Dr. Kesavan guided several students from diverse background towards their research project and has obtained extramural funds from the National Institute of Health and Department of Defense. Additionally, Dr. Kesavan has taught molecular genetic labs to post-graduate genetic students during his Ph.D. program and microbiology labs at Crafton Hills Community College. Dr. Kesavan also taught skeletal biology, drug designing and testing, and 3-D bio-printer application to diverse students of various levels (high school students, undergraduate, post-graduate and medical students) who are involved in the research project work at the VA Loma Linda Healthcare system. In clinical research, Dr. Kesavan has 4 years of experience focused on understanding how existing therapies are efficient in treating patients and identifying key elements associated with disease, which are critical towards developing precision medicine and to improving quality of life in patients. In view of this, Dr. Kesavan has collaborated with physicians involved in the prospective, observational, and retrospective studies of infectious disease and gastroenterology (angiodysplasia using endoscopy vs. endocuff assist, chronic diarrhea in the population of veterans) at the VA Loma Linda Healthcare system. Lastly, Dr. Kesavan also has 10 years of experience in serving as a member at the Institutional Biosafety Committee at the VA Loma Linda Healthcare system.
Basic and clinical research go together, and as scientific knowledge is increasing at an ever-expanding rate, new technologies, their applications and regulatory are constantly being developed. Based on his experience in the field of bio-medical science and clinical research, Dr. Kesavan would like to teach students how to develop study hypothesis, study design, study pitfalls and alternate strategies, writing an IRB protocol and SOP, research safety protocol, executing a study involving planning and resources, data collection and organization, data analysis and interpretation, and good clinical practice. Dr. Kesavan is also well-appreciated, teaching in skeletal biology, microbiology, in 3-D scaffold bio-printer applications in clinics, and he provides students bio-medical basic science project (drug testing on cells) work that are translated to pre-clinical studies. In summary, Dr. Kesavan would like to share the experience and expertise that he gained in his journal of life to students by teaching and training them in the field of bio-medical basic science and clinical research.
Medical Degree at Andhra Medical College in Visakhapatnam, India.
After receiving her medical degree from Andhra Medical College in Visakhapatnam, India, Dr. Buddha worked as a Research Assistant at Saint Louis University. During her tenure at Saint Louis, Dr. Buddha treated patients with Nonalcoholic Steatohepatitis (NASH). Many had elevated liver enzymes, for which few treatments were available. This always challenged her to the necessity of transformational clinical research that would determine new treatments for her NASH patients.
Dr. Buddha’s project “Activation of Insulin-PI3K/Akt-p70S6K Pathway in Hepatic Stellate Cells Contributes to Fibrosis in Nonalcoholic Steatohepatitis”, has provided insights into the genetic and genomic factors involved in gene amplification. She also gained more knowledge regarding human genetic variation and genome evolution, topics that are important for understanding the complexity of the human genome.
The high prevalence of chronic Hepatitis C among veterans (especially Vietnam War veterans) led to a study to develop safe and efficacious direct acing anti-viral medications. The large number of veterans needing this treatment stressed the resources of the Veterans Affairs Health Care System. Senator Burr specifically requested Dr. Daniel Chao to serve as PI on a study to provide a comparison of VA and non-VA (choice) care. With Dr. Chao, Dr. Buddha was also tasked to determine whether care provided through choice is timelier, cost-effective, and of better quality than care provided by the VA. We submitted an abstract to Digestive Disease Week and won an award for poster of distinction. Dr. Buddha has also worked at Loma Linda VA Hospital and conducted private sector sponsor funded clinical studies as well.
Working as a Clinical Research Program Manager at the University of California in Riverside, Dr. Buddha is providing support, coordination and leadership for industry sponsored along with government sponsored, and investigator initiated clinical research. Study management, preliminaries, protocol development, budget submittal and study start-up preparation for different types of phase II thru phase IV clinical trials in adult subjects are Dr. Buddha’s expertise. Dr. Buddha would like to teach MSCR students how to coordinate and conduct study initiation tasks such as preparation of study binders, study start-up documents in TMF, and sending out to multiple sites, review and file site approval documents, continuing communication with clinical sites regarding documentation issues and discrepancies, just to name a few.
Dr. Buddha also has enriched experience in assisting in external audits from regulatory bodies and undertaking other duties as delegated by senior management. Additionally, training medical students, graduate students, residents, new clinical research coordinators, the recruiters and schedulers, and other support personnel, coordinating research meetings and acting as a valuable resource are also part of Dr Buddha’s ongoing job description.
In summary, armed with expertise in both the concepts (cancer biology, human genetics and molecular evolution) and methodology (molecular biology, cell biology and genomics), Dr. Buddha is dedicated to teaching and the development of interventions for human diseases using diagnostic tools and treatments.
Bachelor of Science degree in Mechanical Engineering, PhuTho Technical Center/Saigon University
Bachelor of Science degree in Engineering, California State Polytechnic University, Pomona.
Mr. Tien Phuc Nguyen holds over 45 years of experience in medical devices, engineering research and development, project management, and process design improvement. As an engineering professional, he has worked in operations and the manufacturing of new and existing medical device products. In addition, he believes that innovation and dependency are several key components to becoming a successful professional in the clinical research field. Mr. Nguyen earned his Bachelor of Science degree in Mechanical Engineering from the PhuTho Technical Center/Saigon University and his Bachelor of Science degree in Engineering from California State Polytechnic University, Pomona. Professor Nguyen also received a total of 5 patents from the United States Patent Office through all companies. Professor Nguyen likes to teach Biomedical device classes to MSCR students.
Executive MBA from Drucker School of Management, Claremont Graduate University
MPH for Health Professionals, UCLA.
Residency in Urology, Lyon University in France
Bachelor of Medicine and Bachelor of Surgery’ (M.B.B.S.), Terna Medical College, Maharashtra University of Health Sciences, Mumbai
Dr. Khushbu Singh earned a ‘Bachelor of Medicine and Bachelor of Surgery’ (M.B.B.S.) medical degree from Terna Medical College, Maharashtra University of Health Sciences, in the city of Mumbai, India. Dr. Singh has extensive knowledge in medical sciences and patient care along with experience in global clinical trials management, both in academia and the private sector. Dr. Singh has passed ECFMG exams and is also certified as a Clinical Research Professional. She started her professional journey by serving as a physician at Holy Spirit Hospital in Mumbai, and also completed Post-Graduate training and received the Diplomates of National Board (DNB) form from one of the prestigious hospitals in the country. She continued her education in the U.S. and transitioned into the field of clinical research that provided her the opportunity to use her medical knowledge, experience and passion, and make her contribution in the field of clinical research. Dr. Singh began as a clinical research coordinator in pediatrics in the private sector at Ohio Pediatrics Group and then moved on to Pediatric Oncology as a clinical research associate at Stanford School of Medicine. She has also worked on the Endocrinology and Metabolic disorders clinical trials and has managed a busy clinical research site at Stanford School of Medicine. She currently holds a position as a Clinical Research Project Manager in Oncology at Moores Comprehensive Cancer Center at UC San Diego, which is one of the top 10 Hospitals and Oncology care providers in the United States and the only comprehensive cancer center in Southern California.
Dr. Singh is a highly motivated individual who strongly believes in continuing to learn without any means to stop while at the same time, wants to give back to the clinical research student community by providing them with the support, tools and resources that she can. She believes that a robust clinical research education program and mentorship is crucial in building the student’s foundation.
MSCR, American University of Health Sciences
MD, University of Sto. Tomas
BA, Adamson University
Gene Jose Dillague is currently a Senior Clinical Research Associate at one of the top global Clinical Research Organizations and an adjunct professor at the School of Clinical Research at AUHS since 2013. After he completed his MSCR from AUHS, he worked as a clinical research coordinator for the Transplant Research Institute in Los Angeles and was then hired as a Clinical Research Associate at Naurex in Evanston, IL. He has extensive experience in handling Phase I-III clinical studies and performing both site start-up and clinical research monitoring activities on behalf of major pharmaceutical companies. His clinical research experiences are on indications such as transplant research, rare diseases, psychiatric, and general medicine clinical trials.
Dr. Dillague is a Certified Clinical Research Associate in the Association of Clinical Research Professionals (ACRP) and a certified Family Physician in the Philippine Academy of Family Physicians (PAFP).