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Our Speakers for
Global Biologics India, April 24-25, 2024
Below is the list of speakers for April 2024 conference. If you want to become speaker for our next conference please Click here
Vishwas Kaveeshwar
Incharge/Asst Professor
Central Research Lab, SDM Medical College
SDM University, India
Sanjeev Gupta, Ph.D.
Sanjeev Gupta has obtained Ph.D. in Molecular Biology/Cell Line Engineering and M.Sc. in Applied Microbiology and Biotechnology. At present working as Vice President and Head, Advanced Biotech Lab (Biosimilar Division-R&D and Mfg.), Ipca Laboratories Ltd., Mumbai, India.
Dr. Gupta carries over 23 years of industrial experience and has been working since 2000 on the development of “Biosimilars” including monoclonal antibodies and other therapeutic proteins. His core expertise lies into Molecular Biology, Cell Line, Cell culture, Upstream process, Bio-analytical, Regulatory as well as Tech Transfer to the GMP for Clinical and Commercial manufacturing. He is actively involved in dossier submission, approval and interaction with different regulatory agencies such as EMA, MHRA-UK, CDSCO and USFDA for Biosimilar launch in overseas markets.
Till date, he developed and contributed for over Fifteen (15) recombinant molecules, of which Nine (09) biosimilars are already launched in the various markets and the rest are in the developmental or clinical phase, and are expected to be launched in near future.
He delivered talks on Biosimilars in various national and international conferences organized by IBC, Terrapin, BioTrain, IMAPAC, CphI, Biopharma, Informa and UBM. He also chaired/Moderated couple of sessions in international forums/platforms for conducting the biological conferences.
He has published several Research articles (13), Book chapters (06), Magazines (06) and Patent (01) in lieu of the Biosimilar development.
During his professional tenure, he worked at various position in reputed Indian biopharmaceuticals industries such as Zydus-Ahmedabad, Wockhardt-Aurangabad, Panacea-New Delhi, Intas-Ahmedabad and at present with Ipca Laboratories, Mumbai.
Shawn Smith
Shawn was one of the early members of the cell culture bioprocessing community, having led various functions with then-GIBCO/Invitrogen to focus exclusively on the industrial applications of cell culture technology as that market began expanding in the mid-1990s. His 30-year career working for such influential bioprocessing companies as GIBCO (Life Technologies/Invitrogen), Kerry, HyClone (then-Thermo), Pall (now Danaher), Irvine Scientific (now Fujifilm) and Millipore-Sigma focused on developing process solutions and providing customer support for biopharmaceutical end-users involved with cell line development, media selection and optimization, single-use bioreactor utilization, outsourced CDMO services, and overall facilities design.
After receiving a BS in Biochemical Pharmacology, he continued his education in graduate curricula in the sciences and in business. Shawn has spent his entire career in the Life Sciences market, transitioning from an analytical bench chemist to various roles within cGMP (medical device) manufacturing before ultimately spending the past 20+ years in commercial functions of increasing responsibility, culminating as President & CEO of ZeptoMetrix, a molecular diagnostics company that doubled in size and was sold to private equity under his leadership
Arun Singhal
Arun Singhal has worked at leading cell culture companies in various commercial positions, including Hyclone (now Cytiva), Gibco (now Thermo Fisher) and Irvine Scientific (now FujiFilm) to develop markets in different regions, including South East Asia, Australia and South America. He has spent a considerable amount of time with the Indian biotech industry, where his innovative customer-focused approach complemented by his scientific background yielded tremendous success in penetrating over 90% of potential companies with targeted products/services in just a matter of a few years.
He has a Ph.D. in Biotechnology and MBA. Dr Singhal is one of the pioneers in the field of Gene Therapy. He has published over a dozen scientific articles in leading journals along with chapters in books in Gene Therapy. He contributed to a book, “Gene Therapeutics”, which was published 30 years ago. Most of his work focused on liposome-based targeted gene therapy and control of gene expression using various types of promoters. He has also extensively worked on different cell lines (both primary and stable) and commonly used biotechniques for his research.
BN Manohar
Manohar has been associated with the Manipal Education & Medical Group (MEMG) for the last 14 years and has taken up the role of CEO at Stempeutics in August 2007. He is responsible for making Stempeutics a leading stem cell company in Asia. He is responsible for developing innovative stem cell products addressing major unmet medical needs with an India first global next approach. His responsibilities include implementing strategies which will shape future business delivery and contribute to the achievement of the Company’s objectives both strategic and financial. Under his leadership Stempeutics has crossed various milestones including successful conduct of Phase 2 clinical trials in India and Malaysia, obtaining ATMP & ODD classification in Europe, getting patents from USA, Japan, ANZ and China. Prior to this assignment, Manohar has handled multiple assignments in the MEMG – starting Manipal Infocom a BPO Organization and successfully migrating it to Manipal–Omega Healthcare BPO JV, taking over a startup Distance Education business and growing it to US$ 18M, establishing and propping up the new Education Services business. Prior to Joining Manipal Group, Manohar has had 12 years successful stints at Wipro GE Medical Systems. At GE Medical he has handled multiple senior assignments including Vice President – Customer Service and as Chief Operating Officer of IT Joint Venture – GE Medical Systems Information Technology, at Hyderabad. Manohar has done his B.E. from Regional Engineering College, Trichy and M.E. from Guindy Engineering College, Chennai.
Shaligram Rane
Result oriented career spanning over three decades in Quality Assurance / GMP / Quality Control and 2 years in academic with focus on streamlining & managing operations with proactive planning, building quality culture. Introducing new concepts for Top-notch companies with consistent contribution to increased performance. He believes in success through faster decisions by considering techno-commercial risk factors.
SYNOPSIS:
He completed Ph.D. in Applied Chemistry from M.S. University, Baroda, M. Sc. in Organic Chemistry from Poona University and M. Ed. from Uttar Maharashtra Vidyapeeth, Jalgaon. He proved his domain expertise in Quality and GMP department at various renowned organizations. Currently, heading Quality Unit of Lupin Ltd. (Biotech Division), Pune. Prior to Lupin, he associated with organizations like Intas, Dishman, Cadila, Glenmark, Sun, Aarti and Govt. Polytechnic College.
Major areas of expertise in Quality system, GMP activities, SAP-ERP system, Designing of quality system according to various country specific regulatory guidelines e.g. USFDA, EMA, GCC, MCC, ANVISA, MHRA, Schedule M and TGA etc. He handled successfully more than 200 different types of inspection e.g. Regulatory, Customer,
Business partners, various organization and inspected more than 200 inspection at various pharma industry / laboratory. He delivered talk on technical and GMP topics in various workshops and conferences. Always providing strategic direction. Ability to get the best out of existing teams to win desired operational and strategic results. An excellent communicator coupled with exceptional interpersonal, managerial and documentation skills.
Sudarshan Reddy
Founder and CEO of Oncosimis Biotech Private limited and an accomplished leader in drug discovery and innovation in the field of metabolic and neuromuscular diseases. Received post -doctoral training from Harvard Medical School, Boston, USA, where his research focused on the development of therapeutic strategies for major neurodegenerative diseases and oncology. He has secured certificate in Healthcare Innovation and Commercialization, Best Business Start-up Pitch award at Harvard University and also got nominated for the AAAS/Science Program for Excellence in Science.
Under the able leadership of Sudarshan Reddy, Oncosimis Biotech has achieved notable milestones includes more than 30 patents to-date, apart from being recognized by several honors, grants and awards, which include BIG, NBM grant, Bio-Asia Best startup award, X-PRIZE for Covid testing, Biocon Innovation Excellence (NBEC), StartupIndia Pharma Grand Challenge and Syngene Emerging Biopharma award to name a few.
RamPrakash Gupta
Dr Ram Prakash Gupta has expertise in Process Development and Manufacturing of Gene Therapy Vectors, Biosimilar Mabs & other recombinant Therapeutic proteins. Currently he is associated with MedTherapy Biotechnology as Assistant General Manager (Gene Therapy – Vectors). He has a PhD degree in the field of tumor developmental genetics, genomics and epigenetics from Indian Institute of Technology Kanpur, India. He is keen in networking and sharing knowledge and experience with the people working in the field of Cell & Gene Therapy and other Biologics.
Ranjit Ranbhor
Accomplished professional with 18 years of impactful experience in biopharmaceutical research and intellectual property strategy. PhD holder from IIT Bombay, postdoc at Georgetown University, and Indian Patent Agent. Pioneered protein folding theories, leading to groundbreaking discoveries. Developed advanced methodologies and cutting-edge software for protein design. Expert in biosimilar development, patent portfolio management, and strategic collaborations. Talented at building high-performing R&D teams as well as crafting IP portfolios that support business goals. Unique blend of scientific acumen and business savvy. Editorial board member, reviewer for renowned journals. Recognized speaker and panelist. AAAS and ACS member.
Mike Coleman
Dr. Michael Coleman has more than 28 years of experience as a research scientist and executive in the biotechnology, medical device, and pharmaceutical industries. He received his baccalaureate and doctoral degrees at Texas A&M University and The Pennsylvania State University and did postdoctoral research at Baylor College of Medicine. During his career, Dr. Coleman has led the development of gene therapies, medical devices, and regenerative medicine products in the USA and EU. He has been continuously involved in the development and commercialization of regenerative medicine products since 2006. He is currently CEO of Metaclipse Therapeutics, an Atlanta-based biotech company developing immunotherapies for cancer and vaccines for infectious diseases.
Narahari Prasad Reddy
Dr Narahari Prasad Reddy leads CadilaPharma’s Biologicals R&D and Tech-transfers.
Dr. Narahari’s ~23 yrs. Of Biotech experience, covers product development (concept to product) of monoclonal antibodies, Biosimilar glycoproteins, Vaccines, technology transfers, biological testing apart from manufacturing. The technological areas he worked on are:
- Vaccines: mRNA vaccines including Lipid Nano Particle technology, Inactivated, Live attenuated, Subunit, Split , Viral vectors,VLPs & conjugate vaccines
- Recombinant Biologics: Monoclonal antibodies, Glycoproteins, Fusion proteins, Single domain antibodies, half-life enhancers.
Previously, Dr Narahari worked with Kashiv Biosciences, as Sr. Director/Lead- Vaccines & microbial biologicals where he established mRNA platform. Prior to that, he was associated with IAVI (International AIDS vaccine Initiative) dealt with implementation of IAVI’s novel HIV antibody portfolio. Between 2009-
2019, associated with Panacea Biotec, leading product development. He also led the WHO prequalified biologics manufacturing unit at Panacea Biotec Ltd., dealing with bacterial, viral (egg& cell culture based) and mammalian cell culture-based products, successfully faced WHO audit and CDSCO audits.
Prior to Panacea Biotec, Dr Narahari was associated with several Biotech & Vaccine firms such as Shantha Biotech, Reliance Life sciences, Advinus Therapeutics, Avesthagen limited as Sr. Scientist and Program/ Platform Manager for around10 years.
Sanjay Shah
Sanjay Shah has three decades of experience with prominent multi-national biopharmaceutical and engineering consulting organizations. Sanjay is recognized SME in technical operations, strategic infrastructure planning, capital projects management, process engineering and automation, technology transfer, commissioning & qualification. His experience spans the entire life-cycle of biopharma operations: from facility inception, design, start-up, GMP commercial operations, tech transfers, and compliance.
Sanjay has spent 16+ years in the US, and is in India since 2010. As process engineering lead at Eli Lilly in New Jersey, Sanjay supported large scale biopharmaceutical projects and operations. He was lead engineer for Amgen’s Enbrel® BioNext project. In 2010 he relocated to India, joined Dr. Reddy’s Labs as Director, and was tasked with setting up a new Plant & Process Engineering Department. He later worked as Director & Head of Biologics operations at Syngene (Biocon group) where he led CDMO operations serving Syngene’s global clients. Subsequently, he joined Intas Biopharma as VP and Head of Manufacturing Operations & Site Engineering. Sanjay served as Vice President, Global Engineering at Pfizer, supporting the Asia-Pacific sterile injectables network, and oversaw remediation of legacy Hospira sites. He was recently with Hyde E+C, US-based engineering consulting organization, as a Principal Consultant and VP Global Engineering.
Sanjay holds MS in Chemical Engineering. He is an active member of ISPE and PDA.
Prashant Kumar
Prashant Kumar is the General Manager at Bharat Serums & Vaccines Ltd, Navi Mumbai, India, where he leads a team for Cell Line Development & Upstream Process development. He earned an MS degree in biotechnology and has over 23 years experience in the health care segment with 2 years international exposure in the subsidiary company BSV Biosciences Inc. USA. He has an industrial expertise on the development of “Biosimilars” including monoclonal antibodies, Biosimilar glycoproteins where his core expertise lies into Cell Line Development, Cell culture, Upstream process and Technology Transfer to the GMP for Clinical manufacturing
Ganesh Sangle
Dr Ganesh Sangle has an outstanding track record of 17+ years in leading the discovery and development of NCE’s, 505(b)2, and biosimilars/biobetter products. Core competencies include an excellent and broad scientific background with proven expertise in multiple therapeutic areas such as rare diseases, oncology, pain, and metabolic diseases. Dr Sangle earned a master’s in pharmacy degree with a specialization in pharmacology from the Dr MGR Medical University (Chennai, TN, India) and a Ph.D. degree in Physiology & Pathophysiology, with a focus on diabetes-associated cardiovascular complications, from the University of Manitoba (Winnipeg, Canada). In addition, he was a postdoctoral fellow in the Department of Physiology at the University of Toronto (Toronto, Canada).
Ravindra Patel
Ravindra founded OmniBRx Biotechnologies Pvt Ltd. in the year 2016 after spending about decade in the biopharma industry. As Chief technical officer, he is the driving force behind all the new ideas and innovations at OmniBRx. His vision is to bring easy-to-use, cost-effective, and efficient bioprocessing technologies to the global market.
He has always been fascinated by the field of bioprocessing and his vast work experiences in biotech field including working as a bioprocess scientist at Reliance Life science, Synergy International and Zydus Cadila healthcare has helped him identify many potential challenges that can be solved using innovative bioprocessing solutions that are being developed at OmniBRx.
He served the industry with patented single use bioreactor systems which are linearly scalable, efficient and cost effective.
Ashok Mishra
Dr. Ashok Mishra is a process development expert for biosimilar product for global markets. He is currently heading R&D Downstream department, Biotechnology division of Lupin pharma, and providing direction to cross-functional process and analytical teams. He has extensive experience of designing Drug substance manufacturing process, process characterization, Virus clearance validation, scale up, refolding, PEGylation, and technology transfer for process validation and commercial manufacturing.
Prior to Lupin, Dr. Ashok has worked at Intas Biopharmaceutical. There he was responsible for Downstream process development for the several biosimilar molecules based on bacterial and mammalian platform, development of PEGylated product and novel formulations. He was also responsible there for the plasma fractionation and development of the various plasma products.
Prior to Intas, Dr. Mishra has worked at Bharat Serums & Vaccines. There he was responsible to develop the purification process of several tumor markers, antigens from plural fluid, plasma, and card blood for diagnostics purpose.
- 10 approved biosimilar, 3 approved plasma products and 8 commercialized proteins from plural fluid, urine and card blood.
- 08 Patents and 01 publication.
Kolli Sarath
Sarath Kolli is the founder of Boltzmann Labs, which provides AI solutions to accelerate Drug Discovery and empower scientists & researchers in the pharma industry. Sarath has more than 7 years of experience in AI research. Coming from a computer science background, he has developed an entrepreneurial passion for accelerating scientific research.
Sarath is currently working on Transforming how drugs will be discovered, with the goal of Reducing clinical trial failures and reducing the costs associated with pre-clinical discovery.
Sarath Kolli noticed a vast vacuum in the Indian drug discovery ecosystem and the technology adoption in drug discovery to reduce human bias and decided to Automate the process of discovery using an AI-first data-centric approach.
Sarath has spent 7 years in various AI R&D teams and has mastered AI solutions creation for any industry. Sarath graduated from IIT Bombay, a top technology university in India.
Gargi Redker-Ginde
Dr. Gargi Redkar-Ginde is a skilled professional in Chromatographic Process Development for diagnostic and therapeutic proteins and phytochemicals. She holds an M.Tech and a PhD (Tech) in Bioprocess Technology from the Institute of Chemical Technology, Mumbai. During her tenure as a Senior Research Scientist at d-Technology, she played a pivotal role in establishing analytical methods and IPQC protocols for impurity profiling and nutritional supplements and development of extraction and purification processes for biosubstrates. Currently, she is associated with Courtyard Attorneys as a Patent Research Analyst, where she analyzes pharma patent trends, conducts prior art searches and performs patentability assessments for PCT applications.
Shindhura Rajakumar
Dr. Sindhura B R, Manager- Sales and Applications at NanoTemper Technologies India with eight years of industry experience in various roles including associate scientist, application scientist and manager. I enjoy using my skills to contribute for bringing cutting edge solutions to help scientists to tackle their research challenges. I received my PhD in Biochemistry from Karnataka University Dharwad, worked on studies on Remusatia vivipara lectin and its application in medicine. Recently, I pursued MBA in Marketing to enhance my management & leadership skills.
Kaushal Joshi
Mr. Kaushal Joshi is an experienced IP & Legal professional with expertise in Pharma/Biopharma Patents & corporate legal. He is heading a global IP and Legal of Kashiv Biosciences LLC.
His practice focus on Life sciences patent issues, Biosimilar litigation, Biosimilar pre-litigation strategy, IP generation, IP filing strategy, prosecution, IP due diligence & other legal issue impacting the pharmaceutical and Biotech industries.
Mr. Kaushal’s expertise lies in designing of IP strategy for Biosimilars (first and second wave biosimilars), new biologics (Antibody, vaccine) prosecution & Litigation. He has participated in litigation, opposition proceeding in India, Europe and USA including BPCIA litigation. He has drafted more than 100 patent applications & prosecuted several applications pertaining to biologics & small molecules in several jurisdictions.
He has a hands on laboratory experience in protein purification & vaccine which makes him more competent to creates comprehensive road-map of scientific technology, solving legal & scientific issues and device fruitful IP strategy to meet business objective.
He worked in Cadila Healthcare, Glenmark and Lupin Pharma before joining the Kashiv.