Dr. Mukesh Garg, Vice President - Formulation Development and CMC
Dr. Mukesh Kumar Garg a Ph.D pharmaceutical scientist with 20+ years of experience in Research and Development, Formulation Development, Analytical Research, Pilot scale GMP manufacturing, Project Management and Regulatory CMC. He has worked with large cap pharmaceutical companies like Ranbaxy Laboratories Limited, Dr.Reddy’s Laboratories, Daiichi Ranbaxy and Sun Pharmaceuticals. He has extensive experience and working knowledge in formulation development of oral solids (tablets, capsules, softgels), semisolids and liquid dosage forms. He is experienced in generics, complex generics, NDDS, 505b (2), nanotechnology, and Innovative platform technologies. He has designed strategies for complex generic and innovative products for successful filings including the clinical design protocols for bioequivalence studies. He has over 30 technical publications and patents. Mukesh has implemented Qbd and risk assessment at various stages of product development to commercialization in collaboration with Daiichi Sankyo Japan and led various forums, conferences and workshops on Qbd.
Mukesh had executed projects successfully with contract research organizations (CRO) across globe with low variance. He had set up small GMP facility to manufacture proof of concept (POC) clinical studies in previous organization. In his experience, he had created and designed process maps to streamline procedure and has proven track record of building successful teams from scratch. He is known for technical expertise, creative problem solving and innovation skills along with motivational leadership. Mukesh in his previous roles had interacted with regulatory agencies (FDA, Health Canada, Europe, India) for Pre-Approval inspections, site inspections and has successfully worked on many approved drug product applications – e.g., NDA, ANDA submissions.
Shefali C. Khaladkar, AVP - Finance & Commercial
Shefali is a Chartered Accountant having over 18 years of experience in Pharma Industry and Big Four, Advisory & Assurance services. In addition to her professional grooming with the Big Fours, she has an international experience and has worked in cross-border multi-cultural work environments. She has been with global organizations, viz, Fresenius Kabi, PricewaterhouseCoopers, KPMG and Deloitte.
She has been a Key Managerial Personnel with Fresenius Kabi (India) and has held various key positions during her tenure ranging from CFO for India entity and Chief Controller for Region India for Oncology & Standard Solutions business to Head of Internal Audit and Leading Treasury Operations in India. Her specialties include Planning, Budgeting & Forecasting (Strategic & Operational) including dealing with special situations such as business turnaround, Developing and implementing operational plan tracking mechanisms through specific measurable KPIs, Developing and monitoring Business Plans, Mergers & Acquisitions, Business Restructuring, Leading Cost Efficiency programs, Developing & Implementing Tax Efficient Business Models (including business valuations), Financial Controlling & Reporting (IGAAP, USGAAP), Acquisition integration with Global Standards, Cash Flow Management and Process Excellence.
Dr. Shamik Ghosh, Senior Director - Biology and Pre-clinical Development
Dr Shamik Ghosh brings more than 15 years of leadership and biopharma expertise to scout and champion new product development both in academia and venture-funded set ups, building start-up organizations from the ground. He has played a critical role in Vyome Biosciences since its inception, driving the company’s innovative early stage research toward late stage product development and commercialization. Presently, he is the Senior Director of the Biology and Preclinical Development team at VTLwhere he mentors, trains and manages senior scientists and research fellows dedicated to the development of novel anti-microbials and small molecule drug discovery programs. Prior to joining VTL, Shamik held leadership roles in the New Venture team of Boston University Office of Technology Licensing where he helped a number of faculty members raise early stage funds from venture capitalists or secure co-development funding from big companies across the science discipline. He was also instrumental in raising seed fund and closing in-licensing deal with Brigham and Women’s Hospital, Boston for an early stage global oncology company.
Dr. Ghosh holds a PhD in Immunology from Jawaharlal Nehru University, India, followed by a postdoctoral stint at Harvard Medical School resulting in multiple peer-reviewed publications in international journals of high acclaim and a prestigious fellowship from American Lung Association. His mission has always been to nurture an ecosystem fostering responsible innovation, that not only advances science but also has a societal impact. In order to translate this intent into reality, he pursued an MBA degree from Babson College, Wellesley, USA focusing on entrepreneurship. He is an inventor on multiple international patents and believes in promoting convergence of fundamental and translational research in India.
Dr. Shilpi Jain, Director - Clinical Research and Medical Affairs
Dr. Shilpi Jain is a Clinical Research and Drug Development professional with about two decades of experience. She has experience in various therapeutic areas such as Neurology, Gynaecology, Radiology, Medical Devices, Vaccines, Biosimilars, Dermatology and Cosmetology . Her expertise ranges from implementation and management of end to end Phase I, Phase II (PoC, Dose Range Finding) and Phase III clinical studies, CRO selection, Project Management and New Drug Development .
Dr. Shilpi is a MBBS with Masters in Obstetrics and Gynaecology. She has played Leadership roles in FDA-IND, WHO Pre-Qualification and CDSCO-NDA submission for various NCE, ANDA , Vaccines and Drug. She has designed & executed multi-center, global clinical trials in LATAM, APAC, USA and India . She has been associated with various Pharma companies (Panacea Biotec Ltd, Zydus Cadilla and Fortis Clinical Research Ltd ) and involved in setting up new department, NDA and marketing approvals.
Kapil Mishra, Senior Director – Business Development
Kapil Mishra is a Corporate Strategy & Business Development professional with deep understanding of Industry. During his journey of close to 13 years with large companies like Dr.Reddy’s, Biocon and Consulting companies, he has driven several high value projects closely with C-level leadership of the industry envisaging different business objectives, geographies & cultures. Kapil led successful completion of licensing deals, M&A, long term strategic road-maps for different businesses including novel molecules, biosimilars and generic branded formulations previously with highly respected corporates. Kapil has got hands on experience of managing strategy for branded formulations business and commercial launches, portfolio in multiple therapy areas and go-to market plans. He is passionate about learning and exploring ever changing dimensions of global pharma / biotech business to increase patient’s access to healthcare.
Kapil has engineering degree in Biotechnology and management degree in business law with specialization in M&A and International Finance.
Geeta Ogra Bedi, In-Charge - Quality Assurance
Geeta Ogra Bedi is a Quality Management professional with a career spanning about 20 years in Pharma and Biotech industries. She has expertise in Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice and Good Pharmacovigilance Practice, and CFR part 11 compliance auditing. She has audited many pharmaceutical companies and Contract Research Organizations/Vendors globally for pre and post marketing programs especially IND directed studies in different therapeutic areas. She has managed and facilitated due diligences/ out-licensing of NCEs / NCE co-development programs and has experience in handling MHRA/FDA/DCGI inspections in GXP area
Prior to Vyome, she has global experience working with various leading multinationals, medium and small pharmaceutical / biotechnology companies in USA, Europe and Asia Pacific and lead quality assurance teams and as independent consultant viz Diachi Sankyo, Ranbaxy Research Labs, Zandu Pharmaceuticals. Johnson and Johnson, Abbott Healthcare, AB Science, Bionpharma etc providing quality management support.
Geeta hold a Masters degree in Pharmacology from Hamdard college of Pharmacy, New Delhi, India and is a member of Research Quality Assurance (RQA) society, UK. She has received appreciation award from Ex-President of India for the contribution in development of Synriam, an antimalarial in Asia and Africa.
Dr. Sumana Ghosh, Associate Director – Early Discovery
Dr. Sumana Ghosh has eleven years’ experience in synthetic organic chemistry, bio-organic and medicinal chemistry. She has been working from last spent eight years in pharmaceutical research and development division for developing new structural scaffolds for microbial infections, and engineering improved drug delivery technologies for delivering them at the infection site. She has obtained her MS and PhD degree in Bio-organic chemistry from Indian Institute of Science, Bangalore, followed postdoctoral training at Joseph Fourier University Grenoble, France and University of Massachusetts, Amherst USA. She has published her scientific findings in many peer-reviewed journals and patents. She is the inventor of many granted global patent applications on discovery work. She is an energetic leader with high integrity and proven skills in delivering project within stipulated time.