Shivkumar Madki

Mahendra Joshi

Yogesh Bhandari

Managing Director

Director Operations

Director of Strateygy & Finance

Experience: 18+ years, with 12 years in designing and conducting Phase I – IV clinical trials for small molecules and biosimilars. Shiv is a time-proven expert in conducting oncology- clinical trials. He has spearheaded the clinical development efforts for first-in-the-world Biosimilar – ‘mab’, and has led two major trials – one for long-acting erythropoietin analogue, and the other for long-acting growth factor. With his previous engagements, he has successfully established project management processes and systems, and formulated multi-level governance structure for strategic alliances. For over twelve years, Shiv has led multiple clinical trials for global development of clinical trials, with primary responsibility of design, planning and execution of the trials. He has been involved in developing four extended release formulations in GI, Diabetic, Cardiac and CNS segment. Additionally, he conducted multiple Phase II and III clinical trials for domestic filing with projects in the GI, Diabetic & Metabolic disorders and Cardiac segment. Further, he has conducted/overseen 100+ BA/BE studies for emerging & regulatory market filings, and for development of Novel Drug Delivery Systems. Shiv is an efficient technical interface between the medical and clinical operations teams, and is the co-author of three research publications, with numerous awards for his contributions. At present, at IDRS Labs, as a Managing Director of the company, Shiv is responsible for overall governance of the company and has direct reports of critical functions like Quality Assurance, HR, IT and PMO.

Experience: 17+ years, with experience in NCE, NDDS and generic formulation development. Mahendra is a noted inventor with multiple patents in area of pharmaceutical polymers and formulation development. He is an expert in formulating development strategies for enhancement of bioavailability of poorly or sparingly soluble drugs, and also in selection of suitable dosage form for FIH and subsequent clinical studies. Over the course of his career, he has led a team of formulation and analytical scientists to ensure pre-formulation, formulation development, scale-up, formulation ruggedness, process characterization and technology transfer for multiple NDAs, INDs for top global pharmaceutical organizations, and for generic product development for regulated and semi-regulated markets. He has played an instrumental role in establishing the pediatric product development expertise for his past employers, and is highly experienced in the formulation development for multiple NCE molecules for various phases of clinical trials. He also established a drup nano-crystal technology facility and was instrumental in the development of OSD products containing drug nano-particles. He has provided technical leadership for the successful development of multiple complex oncology gnerics for NCE-1 filing /FTF. Mahendra has been awarded for his notable contribution – like the BMS Crystal Award for Outstanding Technical Leadership enabling partnership with BMS to increase R&D productivity and Best Poster Award at Dr. Reddy’s Technical Conclave. He has published many national and international papers and also holds two patents to his credit.

Experience: 16+ years, with experience in many successful ventures in the pharmaceutical industry. Yogesh is an expert in finance, business strategy, logistics and supply chain management. He is a dynamic, second generation entrepreneur, adept at spotting unique value propositions and high-potential business opportunities. In the past, he has helped launch and scale up numerous ventures with the right balance of investment and execution. He brings substantial experience to IDRS in areas of finance, business strategy, and operations (including logistics and supply chain management).