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Speakers/
Panel Discussion Members for
2nd Global Biologics India
16-17 April 2025
Below is the list of speakers for April 2025 conference. This list is being updated on regular basis as we are adding more speakers. If you want to become a speaker or participate in panel discussion for our next conference please Click here
Speakers from Past conferences
Below is the list of speakers for April 2024 conference.
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.
Jakub Knurek
Renu Kundu
Renu Kundu, Co-founder of East Ocyon Bio, India’s one of the first Allogeneic Cell & Gene Therapy Research Company focused on Solid Tumors & Rare Diseases. East Ocyon Bio vision is to develop and commercialize NK and gamma delta T based cell therapies for difficult to treat tumors and auto-immune disorders. Her core expertise is Regulatory and Clinical Strategy.
Yogananth Rajendran
Yogananth Rajendran is the Head of Regulatory Affairs and Quality Assurance- Cell and Gene Therapy at Immuneel Therapeutics Private Limited. With over 19 years of experience, he is a seasoned Biologics Regulatory professional specializing in the CMC development, clinical advancement, and lifecycle management of biologics, biosimilars, and Cell and GeneTherapy Products.
Throughout his career, Yogananth has played a pivotal role in formulating global regulatory strategies for the commercialization of biologics, biosimilars, orphan drugs, and cell and gene therapy products. His expertise has significantly contributed to numerous biologics approvals across major markets, including EU and the USA.
Vinod Pantula
Dr Vinod Pantula holds a PhD in genetics and has over 18 years of experience in vaccine development, specializing in preclinical and early clinical development of vaccines. He has worked in major vaccine companies across India like Shantha, Panacea, BioE and Indian Immunologicals Ltd. He joined Dr Reddy’s Laboratories three years ago as the Head of Product Development – Vaccines focusing on novel mRNA vaccine development programs targeting cancers and chronic infections.
Harshit Shah
Name – Harshit Shah
Designation – MSAT Group Lead
Total Experience – 16.5 years
Core competency – Downstream Processing and Upstream processing for biologics (Process Development and MSAT)
Previous Organization – Intas, Zydus cadila, Cadila Pharma and Hetero Biopharma.
Kinchit Shah
Kinchit Shah is a seasoned biotechnology professional with over 17 years of experience in upstream bioprocess development, leading teams to advance biologic products from lab to commercialization. Currently serving as Assistant General Manager at Intas Biopharmaceuticals, he directs a team of scientists in process development, characterization, scale-up and technology transfer for biosimilars. He also served previously for companies like Zydus Cadila and Sun Pharmaceuticals.
Saranya Ganapathy
Saranya Ganapathy is currently heading the Cell Line development department for Biosimilars at Ipca Laboratories Ltd., Mumbai.
She has a PhD in Molecular Biology from Texas Tech University, USA. She has 15 years of Research and Product Development experience in Molecular Biology, Mammalian Cell line Engineering including Novel Vector and Platform Development, cGMP Banking and Characterization, Microbiology, Plant Biotechnology and Recombinant Protein production.
Her contributions in the domain have led to robust clones, with the highest production titer positioning them at the forefront of current industry benchmarks, for over 9 recombinant products. She has also been instrumental in successful technology transfer to Manufacturing.
In addition to her core competencies, she has taken a keen interest in supporting crucial activities such as regulatory (EMEA and PMDA) dossier submissions, and served as an SME during their facility audits. She has also had active interactions with MHRA-UK, US-FDA and EMEA agencies for advisory in Biosimilar product development.
Chandrashekhar KN
Chandrashekhar working at Biocon Biologics, is functional leader and responsible for Cell Culture Process Development.
He has a decade of rich experience in developing, scaling-up and characterization of upstream processes.
In his tenure at Biocon he has been part of successful development of molecules leading to approval of several biosimilars across globe.
Chandrashekhar holds a Bachelor’s degree in Computer Science (along with Life sciences) and Master’s degree in Biotechnology from University of Mysore.
Dipankar Das
Dr. Dipankar Das is presently designated as a Director and Head-Biologics at United States of Pharmacopeia, India. Dipankar holds a Bachelor’s degree in Chemistry, Master’s and PhD in Biochemistry, Post-Doctoral research experience from University of Alberta, Canada, Certificate in Bioinformatics from CGDN Canada and Certificate in Supervisory Leadership from University of Alberta, Canada. He is a skilled researcher with more than 25 years of hands-on experience in the research, product development and commercialization in the biopharmaceutical industries.
With more than 50 international publications in peer-reviewed journals (Nature, The Lancet, Mol. Pharmaceutics, etc) and 4 books chapters, he serves as a reviewer for several scientific journals. Before joining USP, Dipankar worked in University of Missouri-Columbia, USA, University of Alberta, Canada and in two vaccine manufacturing companies in India and was playing a leading role in CMC of several pipeline and commercial products. Dipankar participated in several collaborative studies with different national and international organization for establishment of biological reference standards.
Rohan Kamat
Rohan Kamat currently serves as the COO at Kodo Lifescience, a CDMO focused on catering to the Cell and Gene Therapy space globally. Prior to Kodo Lifescience, Rohan has worked with a Bangalore based organization and was involved in commercializing India’s second CAR-T therapy. His expertise lies in developing various aspects of CAR-T cell therapies, from critical raw materials to therapies.
Murali Addepalli
Murali Addepalli is a Co-founder & CSO of Lextro Labs having 21+ years of experience in the field of Drug Discovery & Development. After obtaining his PhD from Nagasaki University (Japan), he gained valuable experience at NIH, Bethesda (USA) as a Post-doctoral Fellow. He has a proven track record of creating therapeutic pipelines and generating a significant Intellectual Properties. Dr. Murali has been associated with 17+ discovery programs in various capacities spanning across immuno-oncology, metabolic disorders, autoimmune and infectious diseases. Some of these molecules are in advanced stages of clinical development. He has published 25+ research articles in prestigious journals.
Lextro Labs was established in the year 2022, at Genome Valley, a vibrant biotech cluster in the city of Hyderabad, India by Mr. Srinivas Akkina, as a Co-founder & Managing Director. Lextro Labs is a discovery stage biopharmaceutical company engaged in the development of first-in-class and best-in-class biotherapeutics through “Immune modulation and Cytotoxicity, (ImCy) a platform technology”. ImCy restores underlying homeostatic mechanisms such that long lasting responses are attained in indications such as Cancer, Autoimmune, Metabolic and Infectious diseases. By focusing on immune modulation and cytotoxicity, we seek to address the root causes of diseases and provide effective solutions for patients worldwide.
Sanjeeva Metikala
Sanjeeva Metikala is currently leading the R&D functional analytics for biosimilars at CuraTeQ Biologics Pvt. Ltd., Hyderabad.
He has a Ph.D. in Medical Physiology and Pathophysiology from Martin-Luther University, Germany. He also has post-doctoral research experience from various renowned institutes in the USA like Marine Biological Laboratory, USA, Cincinnati Children’s Hospital, USA and University of South Florida, USA. He has nearly 15 years of experience in research and development in molecular biology, developmental biology, gene editing using CRISPR/Cas etc.
Sanjeeva’s team not only develops, qualifies and transfers cell-based and cell-free release methods from R&D to QC, but also develops and qualifies extensive repertoire of functional characterization assays for large proteins and monoclonal antibodies. He is an expert in developing assays to demonstrate in vitro functional and immunogenicity similarity of biosimilars in line with expectations to regulatory agencies such as FDA, EMA, MHRA, etc.
G.S. Sameer Kumar
Dr. Sameer Kumar G.S is currently working as a Senior Manager & leading the Analytical team – in Biologics division, USP India. Dr. Sameer Kumar holds a PhD in Biotechnology from Kuvempu University. He has over 19 years of Biopharmaceutical research & Industry work experience. In his research career he has published 20 peer-reviewed international research publications (Cancers, Genome Biology, Nucleic Acids Research, Food Chemistry, Frontiers in Molecular Neuroscience, Clinical Proteomics etc) and application note.
In his current role at USP, he majorly focused on develop/modernize documentary standards (monographs & chapters), Reference Standard development and characterization Material characterization studies, development of MAM work flow, Method development and validation and Proof of concept (PoC) testing of different Biologics modalities. Sameer has a vast experience in analytical method development for various Biologics molecules using Chromatography, Mass Spectrometries (Triple Quad, Q-TOF & Orbitrap), CD, & SEC-MALS, Capillary Electrophoresis, etc. Sameer is a member of the Proteomics Society –India (PSI), India, Indian Society for Mass Spectrometry (ISMAS), India & Chromatographic Society of India (CSI), India.
Kamala Bhavaraju, Ph.D.
Dr. Kamala Bhavaraju is currently leading Clinical Bioanalytics group in the division of Clinical Development at Biologics, Dr. Reddy’s Laboratories Ltd, Hyderabad. Her group develops new methods to understand Pharmacokinetics, Pharmacodynamics and Immunogenicity of large molecules and therapeutic proteins to support phase 1, 3 and 4 clinical studies. Dr. Kamala received her master’s degree from University of Hyderabad, where she bagged two gold medals for her academic excellence. She received her PhD degree in Molecular and Cellular Physiology from Temple University, Philadelphia USA in 2010. She has received several travel grants and awards during her PhD, including prestigious “Erwin Margulies” Award for excellence in Thrombosis research. She has authored and reviewed peer-review journal articles and is the inventor in many patents. She joined Dr. Reddy’s in 2011 as post-doctoral research fellow and has steadily risen ranks within the company and continues to build strong research and innovation focused group. In her position at Dr. Reddy’s she also mentors new technical trainees and interns from various academic institutes. Research work by her group has been accepted and presented at international conferences and a recent publication in Bioanalysis journal. She was also conferred with Anji Reddy Excellence Award in the category of “Innovation Excellence” in 2020. Apart from being an avid and seasoned researcher she is also a certified Master trainer and Woman Safety Ambassador at Dr. Reddy’s where she conducts women safety awareness sessions. Her interests include reading, gardening and travelling and she is a staunch advocate of Diversity, equity and inclusion (DEI).
Vaibhav Patel
Vaibhav Patel is a highly accomplished quality assurance expert with over 13 years of specialized experience in drug development. As the Director of Quality Assurance and Regulatory Affairs at the University of Minnesota, he oversees robust quality systems for clinical production and ensures full compliance with FDA regulations. His extensive career spans multiple biopharmaceutical domains, including radiopharmaceuticals, nanomedicine, cell and gene therapies, and monoclonal antibodies. Vaibhav’s expertise lies in designing and implementing phase-appropriate quality management systems, leading quality assurance teams, managing IND product releases, and overseeing CDMOs across the U.S., China, and India. He has previously held pivotal roles at Elucida Oncology and Memorial Sloan Kettering Cancer Center, further solidifying his leadership in quality assurance and regulatory affairs. A certified Quality Auditor and Regulatory Affairs Certified professional. He holds a master’s degree in pharmaceutical manufacturing from Stevens Institute of Technology and a Bachelor of Pharmacy from Rajiv Gandhi University of Health Sciences, underscoring his deep technical expertise and commitment to advancing pharmaceutical quality standards.
Dinesh Khokal
Dr. Dinesh Khokal, as a Global Director of Regulatory GxP Intelligence & External Affairs in BeiGene, is responsible for supporting BeiGene’s compliance with regulations and industry trends and, for shaping external regulatory and GXP environment (Policy and Advocacy) in collaboration with industry peers and regulators.
He is an accomplished pharmaceutical professional with distinguished career of over 40 years of combined experience in regulatory agency, biopharmaceutical & diagnostic industries, and in academia.
Prior to BeiGene, Dinesh working in Amgen for 7 years as Director and Regional Lead of External Affairs covering Japan Asia Pacific and LATAM. Before this role, Dinesh was a regulator holding the position of Director of Therapeutic Products Branch at the Singapore Regulatory Agency, Health Sciences Authority (HSA). During his tenure in HSA, Dinesh held many different leadership positions including Senior GMP Inspector and Senior Regulatory Consultant. He has also played several key roles in multiagency consortiums and World Health Organization initiatives working towards capability building, regulatory harmonization, and mutual reliance.
Dinesh received his Ph.D. in Cell and Molecular Biology from the National University of Singapore. Dinesh is active in Scientific Organizations such as PDA, ISPE and In several Industry Associations. He is a recipient of 2020 PDA Distinguished Service Award.
Sweety Mathew
Sweety Mathew is a Senior Regulatory Affairs professional and a Global RA CMC Lead (Rare Diseases) working with Novo Nordisk. She has around 14 years of experience and has a broad expertise across biopharmaceutical drug development (Novel biologics, Biosimilars and peptides (synthetic & recombinant)) and providing regulatory strategies, signals and policies.
With a Cell and Molecular Biology background, the inspiration to join regulatory sciences was drawn from the fact that this function provided an insight on all stages of drug development to life cycle management and being that conduit between the company and the regulators, bridging science and business. Sweety has engaged in successful approvals of several biopharmaceutical drug candidates, from the early stages throughout the life cycle management across multiple therapeutic areas including metabolic disorders, oncology and rare diseases. Prior to joining Novo Nordisk, she was associated with companies such as Biocon Biologics, Biomarin etc. She has been an invited speaker in various international forums sharing the regulatory insights. She was an exchange student with Imperial University, London and pursued her postgraduation in Bioinformatics and Applied Biotechnology from the University of Westminster, London. She believes in nurturing an inquisitive and explorative culture to create a more scientifically advanced tomorrow.
Sattva Neelapu, MD
Dr. Sattva S Neelapu is a tenured Professor and Deputy Chair in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, Houston, Texas. He completed medical school at JIPMER, Puducherry in India, Internal Medicine residency in New York, and clinical fellowship in Medical Oncology and postdoctoral fellowship in tumor immunology and immunotherapy at the National Cancer Institute, Bethesda, Maryland. As a physician-scientist at MD Anderson, his research is focused on clinical and translational development of novel immunotherapies for B-cell malignancies. His work on the pivotal clinical trial of axicabtagene ciloleucel CD19 CAR T-cell therapy in aggressive B-cell lymphomas led to its FDA approval as the first CAR T-cell therapy for lymphoma. His laboratory is focused on developing CAR T-cell therapies against novel targets, understanding mechanisms of resistance to CAR T-cell therapy, and developing allogeneic cell therapy approaches. He is nationally and internationally recognized for his expertise in CAR T-cell therapy in B-cell malignancies and management of toxicities associated with CAR T-cell therapy. He has authored or co-authored over 300 publications.
Sabyasachi Halder, Ph.D.
Dr. Sabyasachi Halder is an experienced Biopharmaceutical Professional in CMC Analytical for Biologics/Biosimilars Process Development and Product Development. Currently he has been working as Head of Analytical Research and Development (R$D), CDMO Biologics, Aurigene Pharmaceuticals Service Limited,Hyderabad, India. He is versatile and highly skilled with Ph.D from India with 6 years Postdoctoral Research at United States of America (USA) in Protein structure/function and 10 Years Biopharmaceuticals Industry in the area of analytical Development and Characterization with various techniques for Biologics/Biotherapeutics development. Developed, managed and maintained several research projects on therapeutic proteins, monoclonal antibody, bispecific antibody etc. and delivered within Timeline. He has published his research work on academic and industry in peer reviewed international journals and also presented his work in International and National Platforms.
Kishore Kunapuli, Ph.D.
Dr Kunapuli has a Ph.D. from the German Cancer Research Centre in Germany. He also holds a Biotechnology Post Graduate degree. He possess more than 15 years of hands-on experience in Cell Biology and Immunology systems.
His expertise lies in devising innovative solutions for life-threatening infections, cancer treatment procedures, and diagnostics, utilizing state-of-the-art biotechnologies. Prior to joining the Pulse team, he gained valuable experience working at reputable organizations, including the Singapore Immunology Network in Singapore. During this time, he successfully completed multiple research projects.
Siva Sankar Mahamkali
Siva is a seasoned biopharmaceutical leader with 25 years of expertise in manufacturing operations, specializing in cGMP-compliant environments.
He currently serves as Director at Aragen Biologics Pvt Ltd in Bengaluru, India, where he brings extensive experience in the scale-up, technology transfer, and manufacturing of monoclonal antibodies (mAbs) and a wide range of biosimilar products.
Siva has worked in EMA, USFDA, MHRA, and ANVISA-approved facilities, overseeing both clinical and commercial product supply using 4X2KL single-use platforms. He has been instrumental in developing and executing CDMO business strategies, fostering long-term client partnerships.
He is skilled in designing, commissioning, and qualifying state-of-the-art process development labs and manufacturing facilities. His expertise also includes facility design, cGMP compliance, qualification, audit readiness, and process automation.
A champion of digital transformation, Siva has led initiatives to enable paperless operations through the integration of systems such as LIMS, e-BMRs, e-logbooks, and WMS.
Siva holds a Master’s degree in Biotechnology from Acharya Nagarjuna University. His professional journey includes key roles at Syngene International Ltd., Panacea Biotec, Dr. Reddy’s Laboratories Ltd., and Magene Lifesciences Pvt Ltd.
Amit Jogi
Amit Jogi heads the CDMO Biologics division at Aurigene Pharmaceutical Services Ltd., where he oversees the strategic planning, delivery, and execution of biologics projects within the CDMO framework.
With over two decades of comprehensive experience in the biologics sector, Amit has worked across CDMO and CMO environments, progressively advancing through roles of increasing responsibility. His expertise covers process development, manufacturing science and technology, as well as clinical and commercial manufacturing. Amit has made significant contributions to the development of monoclonal antibody (mAb) production techniques and has played a key role in scaling up these processes for large-scale commercial production. Over the course of his career, he has led more than 25 process development projects and contributed to the successful development of over 20 products for clinical and commercial manufacturing.
A trained bioprocess technologist, Amit holds a Ph.D. in microbiology, bringing both technical depth and practical experience to his leadership role. In addition to his professional accomplishments, Amit is an accomplished author and speaker. He has co-authored a book, published numerous research papers, and frequently presents at international conferences, sharing his expertise and innovations in biologics manufacturing.
Before Aurigene, Amit held prominent positions at leading organizations such as Syngene International Ltd, Xcelris Lab, Magene Life Sciences, and Cadila Healthcare (Zydus), where he further developed his expertise and laid the groundwork for his leadership in the CDMO biologics industry.
Derya
Derya serves as the Field Application Specialist for Incucyte, Sartorius, and she oversees operations in the BeNeLux and Turkey regions.
Based in Amsterdam, she has been a part of Sartorius for more than six years. Derya earned her PhD in neuroendocrinology from Université Nice Sophia Antipolis in France, where she conducted research on the onset of puberty in fruit flies.
Manish Singh
Manish Singh is the Director of Agile Bioscience, bringing over 17 years of expertise in the Biopharmaceutical industry with a focus on Analytical Development and Protein Characterization.
He has held key roles at leading organizations, including Intas Biopharmaceuticals, Dr. Reddy’s Biologics, Kemwell Biopharma, Thermo Fisher Scientific, and Bio-Techne. His contributions have been instrumental in advancing LC-MS methodologies, peptide mapping, glycoprotein analysis, and Higher Order Structure characterization. His work has significantly enhanced N- and O-linked oligosaccharide analysis and large molecule structural assessments.
Manish holds a Master’s in Biotechnology from Dehradun and an MBA in Pharma Business Management, blending deep technical expertise with strategic leadership. His vision continues to drive Agile Bioscience toward innovation and excellence in biopharmaceutical characterization.