Ravi Patel, MD, is a board-certified medical oncologist. He has done his MBBS from Government Medical College, India, and residency in internal medicine from the University of Illinois (affiliated to Ravenswood hospital). He completed his fellowship in Hematology/Oncology from Stritch School of Medicine, Loyola University alongside a combined affiliated program from the Foster G. McGaw hospital. The fellowship program included bone marrow transplantation training and a combined Hematology/Oncology program.
Dr. Patel founded Comprehensive Blood and Cancer Center (CBCC) that grew from a 1200 square feet office to a comprehensive, community-focused diagnostic, educational, and research-based cancer center. Dr. Patel planned to affiliate CBCC with the UCLA School of Medicine. Working with the UCLA research consortium, UCLA employees managed clinical trials alongside the center’s research staff. Several treatments that were tested at CBCC were profoundly successful and have been submitted to the Federal Government’s Food and Drug Administration (FDA) for approval. These breakthrough treatments have made it possible to manage and cure many forms of cancer globally.
For the last 30 years, Dr. Patel has been actively caring for his patients and has been serving as principal investigator in many clinical research trials at CBCC. He is globally involved with the leading pharmaceutical manufacturers and academic research programs to ensure that cancer patients in Kern County have access to the most cutting-edge medicines and treatments available across the world.
After completing his M.Sc. in Industrial Research from SP University – Gujarat, M.Sc. in Clinical Research, Cranfield University, and Diploma in Business Management from ICFAI, Manoj Vyas worked with Cliantha Research Pvt. Ltd. as General Manager – Business development for almost 6 years. His profile at Cliantha included Business Development of BA/BE, Clinical Trial, Dermatology, and Data Management Services in the domestic and international market.
He served as a Deputy Manager – Business Development at GVK Biosciences for 3 years. He was involved in the Business Development of BA/BE services in the domestic and international market, liaising and supporting management for study agreements.
At Vibgyor Scientific Research, he served as Officer – Business Development for 1 year. His role was to take care of Business development for clinical trials of medical devices, drugs, and ECG core lab projects, liaising with investigator and sponsor, and understanding and selecting appropriate ECG core lab systems.
At CBCC, he is involved in developing strategy, implementation of long term and short term plans, monitor and accomplish the principal risk of the company, manage the working of QA, BD, HR, and other functional areas, and oversee the company’s operation in-line with SOPs and applicable regulatory requirements.
She completed her M.B.B.S. and M.D. in Pathology from Shivaji University – Maharashtra, Fellowship in Cytology at the University of California – Los Angeles, and PGDBM, SLIMS Ahmedabad – Gujarat.
She has worked at Vibgyor Scientific Research as a Clinical Research Director and Co-investigator for almost one and a half years. She played a key role in establishing the site management organization and initiated various clinical research training certification programs. She was also responsible for overlooking the implementation of multiple clinical trial projects in line with service agreement and protocol, ensuring coordination with internal departments as well as external vendors. She has also worked as a Director for 6 years at Vibgyor Scientific Research. Here, she managed the overall responsibility for the service delivery and established ECG and image core (QCA, QVA, IVUS, CT Angio) laboratories.
At CBCC-Vibgyor Research, she started as a Director for 5 years. During this time, she overlooked all on-going projects to ensure they withstand all the regulatory and contractual expectations. She also established a Biorepository – a repository of annotated cancer tissue.
Currently, at CBCC, she is involved in Strategy planning for the overall growth of the organization and plays a key role in establishing early phase clinical development services, develops whitepapers/articles for publication in reputed journals/publications, actively seeks opportunities to represent the organization at national and international forums.
Jayadev Sureddi earned his Bachelor’s Degree in Pharmacy from Bangalore University, India, and received a Master’s Degree from the Tamil Nadu Dr. M.G.R. Medical University.
Before assuming his current role as Director- Early Phase Clinical Development at CBCC, he served as Head- Clinical Operations and Pharmacovigilance at Jeevan Scientist Technology Limited, where he contributed to the setup of Clinical Pharmacology Center and Pharmacovigilance departments. Jayadev was instrumental in developing organizations like GVK Biosciences Pvt. Ltd., Veeda Clinical Research Pvt. Ltd. Throughout his diversified career, Jayadev held several positions with increasing responsibilities.
With over 16 years of experience in clinical research, he oversees the Early Phase Clinical Operations of CBCC in the USA.
Sanjeev brings over 20 years of commercial experience in pharmaceuticals, medical practice, managed care, biotech, and technology. Most recently, Sanjeev was on the commercial team at Ora, focused on ophthalmic clinical research globally.
He has been a part of the growth or turnaround of various size companies from as large as Pfizer, Biogen, and Valeant, to mid-size organizations such as VisionCare Ophthalmic Technologies, Ophthalmic Research Associates (Ora), ISTA (part of Bausch Health), and Avanir Pharmaceuticals (part of Otsuka).
On the medical practice side, Sanjeev was VP of Corporate Development for NVISION Eye Centers and was responsible for the acquisition or divestiture of practices and entities within the NVISION practice.
On the technology side, he has worked with TrialCard (managing patient benefits), and for Sun Microsystems as well as a starting and advising multiple technology start-ups. He has served in senior commercial roles in Sales Management, Analytics & Operations management, and Marketing management in healthcare specialties ranging from Oncology, Ophthalmology, Women’s health, GI, Dermatology, and Neuroscience.
Mr. Nikhil Gandhi has completed his BS in Science and MS in Chemistry from Bombay University, India. He then worked with UPMC Shadyside Hospital as a lab supervisor for 11 years, where his responsibilities included hiring, training, scheduling, and payroll of approximately 60 employees.
He served as a Director – Business Development at Novum Pharmaceutical Research Services for 16 years and was instrumental in growing their business in the Dermatology area in addition to other therapeutic areas. He was focused on developing client relations/business opportunities with generic, pharmaceutical, and biotechnology companies in the United States and India. He coordinated all communications with Indian clients to ensure closure of the sale and was responsible for investigating potential trials and implementing the possibilities of developing clinical trial service offerings (Phase I through IV) in the United States & India.
At CBCC, we believe that with Mr. Gandhi as our Global SVP- Business Development, we will be able to support and advocate global biopharmaceutical companies in their clinical trials in the United States and India.
Neeraj is involved in leading the business development team for CBCC Global Research in the United States. His responsibilities include establishing and maintaining client relationships while working closely with the management and team members. He also provides valuable periodic reports and updates on the status of the plan and implementing recommendations to CBCC’s management.
In addition to this, he also manages multimillion-dollar investment portfolios and drives exponential growth across diverse capital markets for organizations in this cutting-edge healthcare and medical industry. He oversees and executes investment strategies for Global capital markets and healthcare (such as venture capital, private equity, and hedge funds) and specifically in the area of healthcare; he has cultivated, managed, and executed investments in emerging healthcare technologies.
He has served as the Chief Investment Officer of CBCC for the past 10 years. By sharing clinical data, he has helped enable the advancement of medical research in oncology research. In addition, Neeraj has a talent for building relationships with key stakeholders. Though his educational background is from the world of finance, he has remarkably gained familiarity with next-generation biotech, healthcare, and medical research.
Dr. Sandeep Singh is Vice President – Clinical Operations at CBCC Global Research. By qualification, he is a Medical graduate with Post Graduate Diploma in Clinical Research and has about 20 years of illustrious clinical trial experience.
He started his career in 2002 as a Medical practitioner. He joined industry in 2005 and worked as Cardiology Associate for one of the premier global CRO i.e. Iqvia (Formerly known as Quintiles). In Iqvia he was part of QECG lab and was responsible for QTc studies of global clinical trials.
He later joined Alkem Laboratories Limited, Mumbai in 2007 and worked as Sub-Investigator. His role was pivotal in obtaining maiden ANVISA certification for Alkem and executing submission studies for USFDA and EMA.
He later joined Unichem Laboratories Limited, Mumbai in 2009 as Deputy Manager – Clinical Research. He worked with Unichem for 6 years, earned two promotions and got relieved in 2015 as Senior Manager – Clinical Research. He was instrumental in building separate Clinical Research and Biopharmaceutics team and execution of BE studies for USFDA, EMA, ANVISA and emerging markets. He worked very closely with departments like patent, formulation development, analytical, Regulatory affairs on subjects like Biopharmaceutics, BCS based biowaiver, IVIVC etc.
Before joining CBCC, his immediate last assignment was Head – Biopharmaceutics and Project Management at Veeda Clinical Research. He joined Veeda in 2015 and worked for 1.5 years. He was instrumental in building separate Biopharmaceutics team and execution of BE studies for USFDA, EMA, ANVISA and emerging markets. He was responsible for study designing, Data evaluation, Project Management, Regulatory Affairs Protocol Writing, Report Writing, Quality Control, Pharmacokinetics and Biostatistics. He was also heading CRAMS department.
Dr. Sandeep Singh has rich experience in conducting BE studies for Regulated Markets, IVIVC, Biopharmaceutics, Generic Product Development Strategy, Bio-waiver strategy, Bridging Studies, Statistical Methodology, adaptive Clinical Study designs etc. He also had hands-on experience as a Clinical Investigator in BA/BE studies, Phase-1 Clinical trials and in ECG analysis, Interpretation & Digitalization. He had managed Outpatient departments during his active Medical Practice prior to joining Pharmaceutical Industry. He has remarkable experience in interacting with various Regulatory Authorities like USFDA, EMA, ANVISA, HPFB Canada, TGA etc.
He has completed his M. Sc. in Clinical Research from Cranfield University, UK, and he is a certified Project Management Professional (PMP) from Project Management Institution (PMI).
He has worked at Sun Pharmaceutical Industries Ltd. for 2 years as a Clinical Research Associate. He was involved in site feasibility, site initiation, site monitoring, closeout visits; acted as a Project Leader for conducting in-house Phase I studies (Mass balance studies, Safety studies, Bioavailability studies, Drug interaction studies) and Bioequivalence studies of different dosages forms.
He was associated as Clinical Project Manager at Veeda Clinical Research Pvt. Ltd. for 5 years. There, he was responsible for Client Management, Coordination with the business development team to identify the R&D facility for pilot batch development and Protocol Designing for Pharmacokinetic studies. Assist and support the Client team for timely submission of the data to different regulatory bodies.
At GVK Bioscience Pvt. Ltd., he has worked as Assistant Manager – Project Management for 1 year. There he was the primary and single-point interface with the sponsor and effectively managed all communications with the sponsor. He was involved in Periodic reporting to senior management regarding the status of projects, capacity utilization of the clinics I beds, analytical instruments, the feasibility of the project, and assisting in preparing proposals.
At Quintiles IMS, he has worked as Sr. Project Management Analyst for 2 years. He was responsible for Projects/Program delivering within Triple Constraints (Scope, Time & Cost), developing and maintaining the Project Execution Plan sections related to project tracking, trending, reporting, and changing control elements, Tracking the status of all Program/Projects, and presenting Dashboard to Senior Management.
At CBCC, he is responsible for projects’ delivery as per defined quality standards (as per protocol, service agreement, SOPs, GCP, and other applicable guidelines) and budget. Project feasibility and building site network. Review all project-related documents, including but not limited to project management tools as per CBCC SOPs.
Lokesh has completed his bachelors in pharmacy from Bharati Vidyapeeth, Poona college of pharmacy, and his postgraduate diploma in clinical research and executive program in business management from IIM, Kolkata.
He has nineteen years of experience in the pharmaceutical industry, of which he has dedicated 16 years to the Clinical Research Industry. He has extensively worked with global CROs such as Novotech Clinical Research India Pvt. Ltd., IQVIA, & PRA health sciences, Sanofi & Macleod’s pharmaceuticals.
Lokesh has experience in interacting with cross-functional departments to help streamline processes, and has vast experience in communicating with people directly and in project management. He has also helped decentralize different departments within clinical operations that helped increase the company’s revenue substantially. He initially started his career as a monitor and acquired substantial experience in regulatory submission, ethics committee submission, study start-up, investigator meetings, site selection, study initiation, monitoring, closeout, budget negotiation, adverse event monitoring, and site coordination for Phase II & Phase III global clinical trials. Lokesh also has experience in several therapeutic areas such as Oncology, Infectious Disease, Neurology, Cardiology, and Ophthalmology.
At CBCC, he is responsible for maintaining high quality of project deliverables (as per protocol, service agreement, SOPs, GCP, and other applicable guidelines), budgets, monitoring project feasibility, building site network, reviewing all project-related documents, including but not limited to project management tools as per our company SOPs.
He has completed his B. Pharm. and M. Pharm. in Pharmacology from L. M. College of pharmacy – Ahmedabad, Gujarat. He earned his Ph.D. in Pharmacy (Sub: Pharmacology) from S. K. Patel College of Pharmaceutical Education and Research, North Gujarat University.
He has worked at various Clinical trial sites, including Sterling Hospital, SAL Hospital, Lion’s Hospital as a part-time Clinical Scientist and Clinical Research Co-coordinator. There, he was involved in coordination with Investigator, Monitoring, and Sponsoring. He also took care of the Screening, Randomization, Investigational product handling & accountability. During his time at S. K. Patel College, he was involved in undertaking government granted pharmacology and clinical research projects, establishing research and technology laboratories, and other developmental work for the department.
He worked as Clinical Research Manager at Vibgyor Scientific Research for almost 2 years. He was involved in the design, conduct, project management, monitoring, audit, data analysis, and interpretation of medical device trials, Phase II, multicentric phase III-IV trials, and QT/QTC studies.
While at Sun Pharmaceutical Industries, he was in charge of the Phase I Clinical Trial Unit and responsible for clinical conduct of Phase I, Bioequivalence & Pharmacokinetic Studies. He also overlooked Clinical pharmacology facility setup, development, and expansion based on need, system designing, and SOP preparation.
At CBCC, he is responsible for the design, conduct, analysis, and interpretation of phase I Clinical Studies; preparation of various Regulatory Audit for approval; periodic renewal of the Phase I CPU of CBCC, protocol review, and clinical phase report review of phase I clinical studies.
He has completed his Bachelor of Science (B.Sc.) and Master of Science (M.Sc.) from Gujarat College, Gujarat University, Gujarat.
He was associated with GVK biosciences as Manager for 3 years. There, he was responsible for reviewing study protocol, method SOP, validation reports, and SOP’s related to the department. He also used to conduct regulatory audits, monthly planning for the department, and oversee laboratory operations.
He worked as Head – Bioanalytical at Jubilant Generics Ltd. for 8 years. His responsibilities included smooth operations of Bioanalytical functions, effective development of methods and process, review and approval of procedures in compliance with established guild lines, and BA/BE studies’ regulatory requirements. He also took care of compliance with predefined procedures, protocols, applicable regulatory requirements, coordination with Clinical, Regulatory, and Data Management as well as Administration departments for project execution.
At CBCC, he is responsible for overseeing all scientific and administrative functions of Bioanalytical, BA site selection, communications, inspection for regulatory compliance, audits to BA facility for MD, MV, and study sample analysis. He also overlooks Biorepository operations as the Director, where he is liable for the planning, development, organization, coordination, and management of all activities, including assignment of technical and administrative duties to Biorepository staff associated with oversight Biorepository.
Kinnari Gandhi has done her Bachelor of Pharmacy (B. Pharm) from K.B.I.P.E.R. Gandhinagar, Gujarat, and Master of Pharmacy (M. Pharm) from M.S.University, Baroda, Gujarat.
She has worked with Veeda Clinical Research as an Analyst (Bioanalytical Research) for 2 years and as Senior Auditor (Quality Assurance) for almost 8 years. As an analyst, she developed various molecules using HPLC and LC/MS/MS systems. Apart from these, she was responsible for bioanalytical method validation, its application in project sample analysis for BA/BE studies, operation of Chromatographic software for HPLC and LCMSMS.
As the company’s Senior Auditor (Quality Assurance), she was responsible for QMS setup plus implementation, regulatory audits, vendor audits, sponsor audits, CAPA management, deviation management, trend analysis, GAP assessment, risk management, and report submission. She was also into Software and IT infrastructure validation as well as a certified GCP/GLP trainer.
At CBCC, her role comprises everything from preparing and implementing an effective QMS system for all services offered by CBCC. It includes tasks developing as well as maintaining the GCP/ICH compliant process, scheduling and overseeing audits conducted to ensure all projects are executed as per GCP norms, protocol, quality system regulations, and ISO standards wherever applicable.
He received his Bachelor of Pharmacy from Veer Narmad South Gujarat University, Surat, and earned his Master’s in Clinical Research from the Cranfield University, UK.
He started his career with Cadila Healthcare Limited (Zydus group of companies) in 2007. He served as the program data manager of the early development business unit in immune-oncology at Novartis. He was responsible for leading a team of data managers for early development portfolios, including their development & mentorship. Before his role at Novartis, Nikunj also worked with various multinational organizations like Kendle (now Syneos), Tata Consultancy Services, and SIRO Clin-Pharm in increasing responsibilities in his career spanning more than a decade.
Having more than 12 years of experience in clinical research, he specializes in data management and related services. He is an avid believer in data science concepts and an expert in catering data-related services from therapeutic areas, including Oncology, Neurology, Pain, Osteoarthritis, Blood disorder, and Psychiatry. Currently, he manages a team of 10 members for on-going projects at various stages of execution.
He has completed his B. Pharm from Nirma University, Ahmedabad – Gujarat, and MBA from NMIMS, Mumbai – Maharashtra.
He has worked with GVK Biosciences as Assistant Manager – Business Development for 5 years. His responsibilities included driving business development efforts for BE studies in the US plus Asian countries and participating in annual strategy meetings with the management.
He served as Manager – Business Development at Veeda Clinical Research for 2 years. His role was to identify, evaluate, and prioritize potential clients for targeted business development efforts for BE studies in the US and Asian countries.
He was associated as Director – Business Development at Auram Solutions for 6 months. There, he was responsible for leading the business development efforts to meet organizational targets and overseeing all aspects of business development, including customer relationship management.
At CBCC, he leads the business development efforts and BD team to meet organizational targets. His responsibilities also include establishing and maintaining client relationships; working closely with management and team members. He also provides valuable periodic reports and updates on the status of the plan and implementation recommendations to CBCC’s management.
He completed his Bachelor of Chemistry from Mumbai University, India, and Master of Science (Clinical Research) from Cranfield University, UK.
He had worked with TCS (Mumbai) as Bid Manager for 3 years, wherein he was involved in preparing, coordinating & delivering solutions for RFQs, RFPs, and consultant questionnaires. He has actively participated in Bid defense meetings for various customers and designed competitive pricing for RFQ/RFP. He has organized several pre-proposal strategy sessions (e.g., win themes, SWOTS, and competitor assessments); prepared presentations and marketing materials.
He has served as Senior Manager – Business Development at Cactus Communications (Mumbai) for 5 years. There he was responsible for overall sales targets for the medical writing business (including US, Europe, and APAC markets). He has developed innovative and cost-effective solutions for enhancing competitiveness. He has adeptly identified revenue opportunities with existing and new clients; conducted internal liaising and coordination with teams for customer visits and presentations.
At CBCC, he is involved in handling PNL accountability for the business unit proficiently. Ivan is an active contributor to growth in business and managing client requirements. Additionally, he takes care of the recruitment of staff globally for the business unit. He also supervises QC checks and SOPs of all services for the unit.
He completed his Bachelor of Engineering in Computer Sciences from Saurashtra University, Gujarat, in 2004.
He later joined Cognizant Technology Solutions Infrastructure Service as an IT-Operations Executive in 2005. He played multiple key roles, such as Enterprise Systems Management Consultant, IT Infra Tower Head, IT-Service Head, Program Manager, Service Delivery & Finance Director, and Engagement Partner. During his 14+ year stint at Cognizant, he got extensive exposure to working with various customers belonging to domains like Global Shared Service, Media, Energy & Utility, Banking and Finance, and Retail spread across India, USA, UK, and the Nordics.
He shifted his base from the Nordic region when he moved to India and joined CBCC Global Research as Director – IT-Enabled Services. His key responsibilities in CBCC are to grow the Data Management business, help in Digital Transformation, and enhance the Clinical Trials Management System’s customer user experience.
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