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Successful US FDA and EMA Inspection of Pivotal Global Studies

About

 

Company Profile

Excel Life Sciences (ELS) is a US-based, India-focused provider of comprehensive clinical trial management services. ELS is built around passionate and experienced individuals working alongside our clients to accelerate clinical research and delivery of new drugs and medical devices to the markets, while maintaining high standards of quality. We are also committed to improving and expanding the clinical research enterprise, evident through our presentations at industry conferences, publishing in industry trade magazines and journals and through visiting professorship at academic institutions. Here are some basic facts about ELS:
  • US based Delaware Corporation with a fully owned Indian subsidiary focused exclusively on clinical research
  • Over 22 operational locations across India and US offices in Chicago and Boston
  • Clinical operations team is one of the most experienced and respected in India with over 280 years of collective experience
  • Team has conducted more than 350 global and domestic trials at hundreds of sites and with thousands of patients
  • Trained over 1,500 clinical research personnel in India
  • Executive team has spoken at an estimated 175 conferences and has been published over 50 times in industry trade journals and magazines
  • Management team brings experience from some of the most respected and recognized companies within the clinical trials industry and the world, including: Sandoz, Upjohn, Thomson Corporation, CenterWatch, Quintiles, PPD, Unilever, D. Anderson & Company, Microsoft, American Express and Marriott Intl
Our extensive domain knowledge helps us understand the expectations and needs of biopharmaceutical and device companies in the US and Europe. Our India operations team and our strategic partners internationally ensure the most cost effective and efficient execution of global drug and device development programs.

Leadership

Dr_Vijai
Dr. Vijai Kumar, M.D.
President and Chief Medical Officer
 

Dr. Vijai Kumar has over 40 years of experience in Global Drug Development, Strategic Relationship Building, Business Development and various other aspects of clinical research and the pharmaceutical industry. He is responsible for starting the concept of site management organizations in Asia. Prior to that, Dr Kumar worked as President and CEO, Neeman Medical International and as Medical Director, Sandoz and Regional Director, Asia for The Upjohn Company, where he was responsible for contributing to more than 25 NDA submissions. Dr. Kumar has experience as a clinician, investigator, pharmaceutical physician, consultant and service provider. He has served as a Member of the expert committee constituted by the Drugs Controller General (India) to develop GCP Guidelines in India and as a member of the Board of Governors for the Institute of Clinical Research, India. Dr Kumar has personally been involved in the conduct of over 200 clinical trials in various therapeutic areas such as, Infectious Disease, Neuropsychiatry, Cardiovascular Disorders, Metabolism and Rheumatology, Ophthalmology in Asia, Europe and the USA and has presented numerous papers on various aspects of clinical research across the globe. Dr Kumar holds an M.D. in Internal Medicine and an M.B.B.S. from Armed Forces Medical College, Pune.

Dr. Kumar was recently recognized by an audience of his peers as a most inspiring leader in the drug development and life sciences industry. Dr. Kumar's long time passion, dedication and contributions to clinical research were highlighted in a special profile within the PharmaVoice Magazine special issue -"100 of the Most Inspiring People". He was featured in a dedicated profile within the magazine in a section titled "The Clinical Specialists" Dr. Kumar is the Advisory Board member of Life Science World.

Dr. Das
Dr. Saurendra Das, M.D.
Executive Director
 

Dr. Das has over 14 years of experience in coordination of all phases of global and domestic clinical trials. Prior to joining Excel Life Sciences, Dr. Das was personally responsible for establishing two major SMOs and one CRO in India. He has led large clinical operations teams and brought many innovations to the field including strategies, systems and processes for faster enrollment and increased retention. Dr. Das has vast experience includes designing and reviewing clinical trial related SOPs and WPDs, designing SOPs for Ethics Committees, budgeting for clinical trials and setting up of central pharmacies. He managed the clinical trials at two sites that successfully passed the first US FDA inspection in India and also managed clinical trials at two sites that successfully passes the EMI inspection . As an active trainer, he worked closely with faculty from Harvard Medical International developing a global training program and has personally trained more then a thousand professionals of pharma, CRO, SMO, Central lab and sites in ICH-GCP and clinical research. Dr Das has worked on the faculty of the CDSCO, WHO and ICRI. Dr. Das holds an M.D. in clinical pharmacology from M. K. C. G. Medical College in Odisha, India.

Mohit

Mohit  Mehrotra
Founder, Chief Operating Officer
   

Mohit was most recently the General Manager, New Product and Platforms for American Express where he led a global servicing team based out of the US, Canada and India. Previously, he was the Co-Founder and Interim Chief Executive Officer of Workadia. Before Workadia, Mohit had been at American Express for over 10 years, most recently as Vice President in its Interactive Business Development group, where he was the founding member and business leader for Workadia, which was spun off from within American Express. He played a key role in transforming the corporate travel industry from a manual labor-intensive operation to an online, highly automated and efficient environment.

His experience in leveraging technology and labor arbitrage to reduce operating costs and accelerate product development led him to found Excel Life Sciences, which helps customers accelerate drug development and improves patient care and satisfaction, while lowering costs for pharmaceutical companies, hospitals and medical research organizations. In addition, Mohit also wants to focus on the humanitarian aspect of bringing leading lines of treatment to a patient population that does not necessarily have access to healthcare. This humanitarian aspect is an integral part of the Excel Life Sciences mission. Mohit holds a Bachelor's degree in Business from University of Allahabad, India and a Master of Science from the University of Massachusetts, Amherst.

Carl
Carl Scheunemann
Chief Financial Officer
 

In the last 10 years, Carl has been the senior financial executive of a number of tech start-ups, either as the in-house CFO or a consulting CFO. These firms have been in a range of industries from consulting to software to opto-electronics and healthcare. Previously, Carl had spent over ten years in various financial and strategic roles in the US and Europe at Global 100 manufacturing firms. His roles included merger and acquisition due diligence on several transactions ranging from $10 to $300 million, developing the business case for a number of joint ventures, and subsequently moving two of those joint ventures from start-up to profitability as the financial executive. Carl holds a BA in Economics and an MBA Finance from the University of Illinois.

Strategic Alliance

Theorem Clinical Research and Excel Life Sciences form strategic relationship

(King of Prussia, PA; July 15, 2014) — Theorem Clinical Research and Excel Life Sciences (ELS) have formed a strategic relationship to bolster Theorem’s clinical development offerings in India, including local site management expertise. ELS has long-standing relationships with more than 1,000 hospitals and research centers across 25 cities throughout India, covering a broad range of therapeutic disciplines.

ELS complements our own strategic offerings in the region and around the globe and extends our clinical trial capabilities,” said Marc Hoffman, M.D., Theorem senior vice president and general manager of biopharmaceutical development. “Collaborating together we can offer sponsor companies access to a wealth of high-quality research centers in India, a well- established research team with a strong understanding of ICH-GCP and, most importantly, the local knowledge for successful conduct of studies in country. There are obvious benefits for all: for sponsors, more robust patient recruitment and retention and, for patients, access to cutting- edge therapies and research programs.

ELS has developed one of the largest networks of investigators and investigative sites within India.

Site management services from Excel Life Sciences help take the burden off investigators so they can focus on patient care and ensure that the study is conducted to the highest standards for quality, ethics and performance,” said Vijai Kumar, M.D., president and chief medical officer of ELS. “This support ensures collection of high-quality study data necessary for the U.S. Food and Drug Administration, the European Medicines Agency and other global regulatory and product approval agencies. Operationally, our site management focus has translated into India patient enrollment and retention numbers that are significantly higher than comparative global performance for the same study.