Neil Singla, MD
Chief Scientific Officer
Dr. Neil Singla, a board-certified anesthesiologist, is the founder and Chief Scientific Officer of Lotus Clinical Research. Since its inception in 2001, Dr. Singla has served in several roles within the organization including: Research Coordinator, Sub-Investigator, Principal Investigator, Coordinating Investigator, and Chief Scientific Officer.
In his capacity as CSO for Lotus Clinical Research, Dr. Singla has had the opportunity to interact frequently with the FDA’s Analgesics Division on behalf of clients and to play a significant role in guiding development strategies for dozens of putative analgesic agents. In the company’s 18-year history, Dr. Singla and Lotus Clinical Research have played a significant role in bringing several molecules to market.
Dr. Singla has published extensively and is a frequent lecturer for physicians, pharmaceutical companies, and medical research institutes throughout the country. He currently chairs the Analgesic Clinical Trials Shared/Special Interest Group at the International Association for the Study of Pain (IASP), chaired the Clinical Trials Shared Interest Group at the American Pain Society (APS), chairs the annual Conference on Analgesic Clinical Trials, which aims to help experts advance best practices in analgesic drug development, as well as serving on the Clinical Research Committee at Huntington Hospital.
The main focus of Dr. Singla’s academic endeavors has been to analyze and understand how the inherent variability in subjective endpoint analgesic clinical trials can be minimized. As a result, he has developed novel techniques for patient education designed to minimize variability, reduce placebo response, and increase effect size.
Sonia Kaur, DO
Dr. Sonia Kaur is a board-certified physician with over 15 years of experience in analgesic research. She has served as the medical monitor, principal investigator, or sub investigator on over 200 pain studies. In her current capacity, Dr. Kaur provides medical oversight of the Lotus Clinical Research investigative team to ensure proper study conduct and optimal patient safety, and is responsible for liaising with the sponsor’s chief medical officer. She spearheads Lotus Clinical Research’s internal placebo response staff education training program. From 2008-2011, Dr. Kaur served as the chairman of the Glendale Adventist Hospital IRB.
Robert H. Dworkin, PhD
Director, Chronic Pain Research
Dr. Robert Dworkin is responsible for providing scientific leadership for the design and conduct of chronic pain programs, including clinical trials of analgesic treatments. He has published extensively, has served as a consultant to numerous pharmaceutical and device companies developing and evaluating analgesic and antiviral treatments, and has lectured globally at numerous professional meetings. He has received government and industry funding to conduct clinical trials in patients with painful diabetic peripheral neuropathy, low back pain, osteoarthritis, cancer pain, fibromyalgia, postherpetic neuralgia, acute post-surgical pain, and acute shingles pain.
Dr. Dworkin is currently Professor of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, Professor in the Center for Health + Technology, and Director of the Anesthesiology Clinical Research Center at the University of Rochester School of Medicine and Dentistry; Director of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the U.S. Food and Drug Administration (FDA); Special Government Employee of the FDA Center for Drug Evaluation and Research; and Associate Editor of Pain and a member of the Editorial Boards of Canadian Journal of Pain and Journal of Pain.
Lee Simon, MD, FACP, FACR
Principal Advisor, Osteoarthritis Research
Dr. Lee Simon is responsible for providing scientific leadership on the design and conduct of osteoarthritis clinical trials. Dr. Simon brings a breadth of experience and expertise in analgesic clinical research, as he has been a clinical Rheumatologist for 25 years and previously served as the Division Director of the Arthritis, Analgesic & Ophthalmologic Drug Product Division at the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research. He has experience as an NIH funded investigator and has served two terms on the Board of Directors of the American College of Rheumatology (ACR). Dr. Simon is on the editorial boards of multiple journals and has authored more than 110 original publications, reviews, and book chapters.
Vice President, Data Services
Jeanne has over 20 years CRO experience including leadership of Data Management, Biostatistics, Statistical Programming, Medical Writing, Interactive Response Technology and Document Management & Publishing departments globally. At Lotus, Jeanne is responsible for overseeing the Data Management, Biostatistics, Medical Writing and Systems Integration Teams. She spent her initial 16 years at a major pharmaceutical company and has experience in clinical trials from Phase I through IV, post approval studies and multitude of therapy areas. She has overseen operations on three continents and seven countries. Jeanne also has significant experience systems development, validation and implementation. Jeanne holds a BS in Biochemistry from Rutgers University and a Masters from Seton Hall University.
Chief Operating Officer
Anne Arriaga joined Lotus in 2008 and has since assembled a top-quality team of investigators, project managers, and study coordinators. She has managed the clinical operations and execution of over 500 trials, of which over 300 were analgesic trials. She has a bachelor’s degree in healthcare administration, a degree in nursing, and post graduate training in clinical research management and project management. Prior to joining Lotus, Mrs. Arriaga served for 10 years as the Vice President of Clinical Operations for a 120-bed Phase 1 unit.
Eric Guitard, PMP
Director, Systems Integration
Eric Guitard is responsible for managing the information technology team. His responsibilities include managing all GxP systems such as eTMF, CTMS, file management and desktop management. For seven years prior to joining Lotus Clinical Research, he managed the internal CRO functionalities of a biomedical company specializing in pain management. Mr. Guitard was responsible for all project management, data management, vendor management, and clinical program development. He holds a bachelor’s degree in business administration with a major in computer science from the University of Montreal and is also a Certified Project Professional Manager from the Project Management Institute.
Director, Quality Operations
Christopher Bowman has over 15 years of experience in clinical research spanning regulatory compliance, quality assurance, and clinical management of Phase I through Phase IV studies. Prior to joining Lotus, he held positions as the Director of Clinical Operations for a clinical and regulatory consulting firm and served as the Director of Quality Operations for a large Phase I-IV clinical trial center. Mr. Bowman has extensive knowledge in Federal Regulations and GCP/ICH guidance with over 12 years conducting GCP compliance audits including investigational sites, sponsors, CROs, clinical vendors, trial master files, IRBs, and FDA readiness visits both in the U.S. and abroad.
Jennifer Nezzer is responsible for the management of biostatistics team, providing technical leadership on the biostatistical aspects of numerous development projects in North America, as well as, serving as lead statistician on multiple global programs. Prior to joining Lotus, she served as a senior biostatistician for a bio/science company for eight years, was a member of the biostatistics leadership team of a global CRO for more than 10 years. Jennifer has supervised the statistical aspects of Phase I through IV clinical trials from design through analysis and reporting for both traditional and adaptive study designs in a broad range of therapeutic areas including analgesia. Jennifer has represented the biostatistics department with interactions with sponsor companies, in multiple NDA submissions, including developing ISS/ISE and eCTD submission ready documents, and represented multiple sponsors in both phone and face-to-face interactions with regulatory agencies including the FDA. She is a member of the American Statistical Association and earned her BA and MS in statistics.