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Therapeutic Expertise

Oncology

Our capabilities for quality and timely execution of Oncology clinical trials

  • Medical adviser/KOL with >3 decades of experience in the Oncology area
  • Multiple quality checks at each stage of clinical study
  • Access to sites with databases of Oncology patients with an excellent regulatory track record
  • Management of complex drug supply to multiple sites
  • Effective site distribution and naïve site development in competitive studies to avoid recruitment challenges

Experience

  • Metastatic breast cancer
  • Hodgkin’s lymphoma
  • Renal cell carcinoma
  • Colorectal cancer
  • Prostate cancer
  • Ovarian cancer

25+ early phase studies on complex injectable and solid oral formulations across 150+ sites

Ten 505(b)(2) programs ranging from early phase trials to complex phase III trials

Sample size ranging from 16 to 120 patients

Patient drop-out rate of <10%

Rescue PK study with start-up activities completed in <1 month

Scientific Advisory Board

Dr Ravi Patel
Dr Ravi Patel
Founder & Managing DirectorComprehensive Blood & Cancer Center
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Dr Ravi Patel

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.

Dr Chirag Desai
Dr Chirag Desai
Founder DirectorVedanta Institute of Medical Sciences
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Dr Chirag Desai

Dr Chirag Jyotiker Desai has achieved his MBBS, MD, DM (Oncology) from Gujarat University, Ahmedabad, India. Currently, he is the Consultant Medical Oncologist and Founder Director, Hemato-oncology Clinic at Vedanta Institute of Medical Sciences. Here he is involved in activities including Clinical care of the cancer patients, Clinical research activities and Educational activities.

Under Clinical Care, he is recognized as a KOL by the oncology fraternity and the industry. He has worked closely with a team comprised of surgical and radiation oncologists, radiology and pathology colleagues and other specialists as required as well as involved in planning the treatment and execution of chemotherapy protocols. He also plans institutional protocols for the treatment of cancer.

His clinical research activities include his role as a Principal or sub-investigator in more than 75 clinical trials, where most of them are for USFDA or EMEA submission. He has been a DSMB member of 5 industry-sponsored clinical trials including one study in vaccine and one in NCE. He is a Steering committee member for 3 industry-sponsored clinical trials including 2 early-phase trial of NCE/NBE and a Consultant/Advisor to 4 Indian CROs. He has played the role as a subject expert to 2 Indian Pharma companies in their biosimilar development. He has been invited as a subject expert by pharma companies while presentation to SEC at CDSCO office. He is a member of disease guideline committee for Lung Cancer and Tongue Cancer for Indian Council for Medical Research (ICMR) and also of Scientific Advisory Board of iBioAnalysis – a company in collaboration with Department of Science and Technology of Govt. of India.

His various Educational activities involve an invitation as a faculty for most oncology events in the country and the region. He is also involved as a moderator, debater, guest lecturer, a mentor for oncologists in training and the clinical research professionals working in pharma companies/CROs to train them in oncology therapeutic area and GCP. His mentorship has also been helpful to the medical and communication departments of Indian as well as multinational pharma companies for their existing products and new launches; investigators/ colleagues and ethics committee members in GCP. He is also a member of the editorial board of 4 Indian/Regional oncology journals. He has mentored about 35 MPharm or MSc Life Science students in their 4th term short research project for their thesis and played a role as an External Evaluator for PhD for Tata Memorial Center students.

Dr Desai is affiliated with CIMS Hospital, Ahmedabad since 2014. His past affiliations include Sterling Hospital – Ahmedabad, HCG Cancer Center – Ahmedabad and Apollo CBCC Cancer Center Ahmedabad.

Dr Desai has worked as an Advisor/Consultant – Oncology Therapeutic Area Programs, National Oncology Coordinator and Project Manager for Quintiles Spectral India Ltd, Ahmedabad. He has worked as a Director for VIBGYOR Scientific Research, Ahmedabad from 2006 to 2011.

At Vibgyor and Quintiles, being an in-house oncology resource person he was responsible for the evaluation of the projects, selecting the investigators, site selection, site initiation, training of the CRAs, overseeing the monitoring from the scientific viewpoint, making the budget and agreement with the sponsor and the sites, ensuring the clarity of the interpretation of the protocol with the sponsor and the investigators.

As his career objective, he believes that there is a large room for improvement in cancer therapy and the dire need of innovations. He wishes to be a part of the improvement in the therapeutics against cancer and allied diseases. Having the necessary background of internal medicine and oncology, with experience in clinical research and clinical practice, he believes that he is in the position to ensure the correct drug being investigated with the correct methodology. This includes a thoughtful protocol, effective route and schedule of administration, a realistic endpoint, feasible target in terms of efficacy, ensuring safety and recruiting an adequate number of patients.

He is the founder member of Indian Collaborative Oncology Network (ICON), an active member of the American Society of Clinical Oncology (ASCO) and a full member of European Society for Medical Oncology (ESMO). He is a life member of Indian Society of Medical and Pediatric Oncology, Indian Medical Association (Ahmedabad Branch), Association of Physicians of Gujarat and Association of Physicians of Ahmedabad.