Formulation Leadership Summit Hyderabad 2026

Dr. Khalid Akhter Ansari is a global pharmaceutical R&D and Technical Operations leader with over 20 years of experience in biologics, sterile injectables, complex drug delivery systems, and pharmaceutical innovation. He currently serves as Senior Director – R&D & Technical Operations at Rising Pharmaceuticals.

He has held leadership roles at Rising Pharmaceuticals, Deva Holding, Novartis, Sandoz, Cipla, Biocon, and Dr. Reddy's Laboratories, leading global R&D organizations and innovation programs across India, Switzerland, Austria, Türkiye, and Italy. His expertise includes biologics, formulation development, CMC strategy, technology transfer, regulatory submissions, and digital transformation.

Dr. Ansari holds a Ph.D. in Pharmaceutical Technology from the Institute of Chemical Technology (formerly UDCT), Mumbai, has authored 12 scientific publications, holds 4 patents, and is a frequent speaker at international pharmaceutical conferences on Drug delivery systems, biologics, pharmaceutical packaging, and innovation.

Strategic R&D executive with over 23 years of leadership in Pharmaceutical Product Development across global organizations like Dr. Reddy’s and Ranbaxy (currently Sun pharma). Proven expert in steering multidisciplinary teams (comprising PhDs and Masters in Pharmacy) to deliver complex portfolios including Differentiated Formulations, , Complex Generics and Oral Peptides. A strategic architect of drug development from conceptualization to pre-clinical to commercialization, with a deep focus on Operations Excellence , Global CMC Strategy and Unbossed Leadership. Adept at navigating matrixed global alliances and managing multi-million dollar Projects and Capex/Opex budgets while fostering a culture of Innovation and Diversity and Inclusion.

Accomplished pharmaceutical executive and Regulatory Affairs Leader with over 20+ years of progressive experience driving global regulatory strategy, compliance, product development, and business growth across highly regulated international markets.

Possessing extensive expertise in Regulatory Affairs, Global GMP Audits (API & Finished Products), Pharmacovigilance, Clinical Research, and Product Lifecycle Management, with a proven track record of successfully leading complex regulatory submissions and market authorizations across Europe, Australia, Canada, South Africa, Brazil, and ROW / Emerging Markets.

Currently serving as Head of Regulatory Affairs, leading global regulatory operations and cross-functional technical teams encompassing Regulatory Affairs & GMP Compliance. Recognized for developing and executing regulatory strategies that accelerate product approvals, ensure compliance excellence, mitigate business risks, and support sustainable international expansion.

Highly experienced in Parenteral Preparations (SVP/LVP), Oral Solid Dosage Forms (OSD), and advanced pharmaceutical formulations, including Long-Acting Release (LAR) Injections, Suspensions, Liposomal, Nano, Micro, and Macro Drug Delivery Systems. Combines deep scientific expertise with strong commercial acumen to align regulatory objectives with corporate growth strategies and portfolio optimization.

A respected industry thought leader and global speaker, regularly invited as a keynote presenter, moderator, and panel expert at international pharmaceutical conferences, CPHI events, and technical symposiums. Also contributes to academic excellence as a guest lecturer at premier pharmaceutical institutions, mentoring future industry professionals and fostering innovation in pharmaceutical sciences.

Known for strategic leadership, stakeholder engagement, organizational transformation, and building high-performing teams that consistently deliver regulatory excellence, operational efficiency, and business success in competitive global markets.

Dr. Tathagata Dutta holds a B.Pharm., M.Pharm, and PhD in Pharmaceutical Sciences from Dr. Hari Singh Gour University, Sagar. He further pursued postdoctoral studies at the School of Pharmacy & Diamantina Institute for Cancer, Immunology, and Metabolic Medicine, University of Queensland, Brisbane, Australia, focusing on the development of RNAi therapeutics for cancer management. Additionally, he is an alumnus of IIM Calcutta.

Over the span of more than two decades, Dr. Dutta has held various esteemed positions, including President, Chief Scientific Officer (CSO), Executive Director, Managing Director & CEO, within several reputable multinational pharmaceutical companies worldwide. He is a pioneer in Dendrimer based drug and gene delivery, and Gene Therapy in India. His contributions to the field have been recognized with numerous National and International Awards and Honors. He has been featured in Cover Pages of few National and International Magazines and News Channels.

Dr. Dutta's research endeavors have led to the publication of several papers in renowned international journals, numerous patents, and authored book chapters. He serves as an editorial board member for several international journals focusing on drug discovery & delivery research.

His research interests span a wide array of topics, including novel drug delivery systems, dendrimers, liposomes, polymer bioconjugates, tissue-targeted drug delivery systems, nano drug delivery systems, gene therapy, vaccines, genetic immunization, depot injections, gene delivery, RNAi therapeutics, and Rare Diseases.

M.Pharm with 21 years of pharmaceutical industry experience in Operations and Quality functions. Held leadership positions at Sanofi, Fresenius Kabi, and Sun Pharma…. Currently serving as General Manager – Quality Assurance at Eugia Pharma.

Sripathy Venkata Siva Ganesh is a Chemical Engineer and pharmaceutical technology leader with over 22 years of experience across Manufacturing Science & Technology (MSAT), Technology Transfer, sterile manufacturing, oral solid dosage, process engineering, scale-up, and validation. His career includes significant experience with leading global pharmaceutical organizations such as Pfizer, Dr. Reddy’s Laboratories, Sun Pharma, Ranbaxy, Aurobindo Pharma, and Alembic Pharmaceuticals. He specializes in applying chemical engineering principles to pharmaceutical process scale-up, equipment parameter optimization, technology transfer, process validation, and troubleshooting. His experience bridges manufacturing operations, engineering, and MSAT, with a strong focus on developing robust, scalable, and commercially reproducible pharmaceutical manufacturing processes.

Dr. Nandkishore Yadav is a seasoned R&D leader with 20 years of industrial experience, specializing in formulation development for regulated markets, including compliance with global regulatory agencies such as USFDA, EMA, and other international authorities. Known for his strategic vision and hands-on technical expertise, he has successfully led numerous formulation projects from concept to commercialization, ensuring product efficacy, stability, and regulatory alignment.

Dr. Yadav is passionate about fostering a culture of scientific excellence and continuous innovation. His core strengths include solid dispersion techniques to enhance bioavailability and powder layering technologies, with a strong focus on successful scale-up and technology transfer. He remains committed to advancing patient-centric solutions through cutting-edge formulation strategies and collaborative leadership.

Veerraju Nalla is the Senior General Manager – Quality at Gland Pharma, with over 20 years of experience in sterile pharmaceutical manufacturing, quality systems, aseptic processing, validation, and global regulatory compliance. He leads Quality Assurance, Quality Control, Microbiology, and Quality Projects, supporting the development and commercialization of complex sterile injectable products while driving inspection readiness and operational excellence.

Veerraju has extensive expertise in contamination control, process validation, technology transfer, quality risk management, and compliance with US FDA, EU GMP, WHO GMP, and other international regulatory standards. Throughout his career, he has successfully led cross-functional quality transformation initiatives and supported multiple global regulatory inspections.

In addition to his corporate role, Veerraju serves on the Board of Directors of the PDA India Chapter, where he actively contributes to professional development initiatives, industry knowledge sharing, and fostering the next generation of pharmaceutical professionals. He is passionate about advancing quality culture, innovation, and best practices across the pharmaceutical industry.

Girish Kapur is currently the Senior Vice President,India Site Operations & Site Head,USP India and a member of USP’s Executive Team.In his role,Girish oversees all operations at USP’s India facilities,including Science,HR,Finance,Operations,Digital Product Engineering and IT and maintains connections with external stakeholders, including local, regional, and national authorities and customers in the pharmaceutical industry. 

His visionary leadership was key in transforming USP’s Hyderabad facilities from a lab-focused operation into a thriving team of more than 400+ staff, delivering critical operations in information services, quality assurance, customer experience, data analytics, human resources and finance.He was responsible for integrating and consolidating laboratory operations and navigated the challenges of the COVID-19 pandemic with a steady hand, expanded USP infrastructure by adding two additional sites,and led programs and initiatives focused on Diversity, Inclusion, Equity and Belonging.

During his career, Girish has acquired a wealth of knowledge and industry expertise.Prior to USP, he has held leadership roles at Novartis, Pfizer and Ranbaxy and led large cross functional teams with business-critical responsibilities.Girish has an overall pharmaceutical industry experience of 28+ years with strong formulation basics coupled with hands-on analytical knowledge. His core expertise lies in solving challenges related to Finished Dosage Forms.

He is a Distinguished leader and ardent believer of inclusive leadership and recipient of several awards during his career viz.Great Manager Award(Pfizer),Global Technical R&D Award, R&D Operational Excellence Award(Novartis),Indian Achievers Award etc. He is a regular speaker at National and International Conferences.

Girish holds a Doctorate in Operations Management, M.Pharm, B.Pharm, D.Pharm from DIPSAR, University of Delhi; MBA in Pharmaceutical Management and a Postgraduate diploma in Patents Law from NALSAR, Hyderabad and is a certified Lean Six Sigma Black Belt (LSSBB) professional. Girish is a member of National Advisory Council (NAC) of Analytica Lab India and a Member of Governing body of a pharmacy college. He is also a Life Member of IPA and IPGA.

Sandip Tarate is the Managing Director & COO of Tiefenbacher Laboratories (AET Labs). With over 25 years of pharmaceutical industry experience, he has held leadership roles across operations, manufacturing, quality, supply chain, and business transformation. He currently leads formulation development and manufacturing operations, driving innovation, operational excellence, and global access to affordable, high-quality medicines.

PROFESSIONAL PROFILE

Formulation development and drug product project leader with nearly 20 years of experience across pharmaceutical R&D, drug product development, GMP manufacturing, project leadership, and clinical supply strategy. Brings a strong scientific foundation in pre-clinical and clinical formulation development for NCE/NBE portfolios, with expertise in selecting formulation strategies based on physicochemical, biopharmaceutical, and drug substance stability considerations. Experienced in leading cross-functional drug product teams from early development through clinical supply readiness, including formulation design, QbD/DoE/FMEA, scale-up, GMP batch planning, technical documentation, vendor/CMO engagement, portfolio governance, budget/resource planning, and risk mitigation.

DRUG PRODUCT DEVELOPMENT FOCUS

• Formulation strategy and development for oral solid dosage forms, controlled-release products, pre-clinical formulations, and clinical formulations.
• Drug Product Project Leadership across early phase development portfolios, including formulation strategy, IND/NDA-enabling activities, GMP manufacturing support, clinical documentation, project planning, budget baselining, and stakeholder alignment.
• Hands-on and leadership experience in process development, scale-up, process verification, QbD, DoE, FMEA, stability data interpretation, technical report writing, and product development documentation.
• Strong ability to translate molecule properties, clinical needs, manufacturing constraints, and supply risks into practical drug product and clinical supply strategies.

CLINICAL SUPPLY PROJECT LEAD EXPERIENCE

• Currently leading clinical supply project strategy for global development programs, including long-term forecasting, early trial pricing, supply strategy selection, labeling, packaging, distribution planning, DS/DP alignment, comparator strategy, and supply risk mitigation.
• Acts as cross-functional business partner to align clinical, CMC, technical operations, supply chain, and formulation stakeholders on end-to-end supply readiness and clinical trial continuity.
• Supports project and portfolio governance through clear risk/mitigation planning, milestone visibility, budget oversight, resource planning, operational excellence, and leadership-ready updates.

PROFESSIONAL EXPERIENCE

• Novartis Healthcare Pvt. Ltd., Hyderabad – Clinical Supply Project Lead, Nov 2024–Present; Drug Product Project Leader, Sep 2013–Oct 2024.
• Dr. Reddy’s Laboratories, Hyderabad / DRL-GSK Joint Venture – Assistant Manager, Mar 2012–Sep 2013; solid oral controlled-release formulation design and prototype development.
• Panacea Biotec Ltd. (NDDS), Mumbai – Senior Executive, Feb 2011–Feb 2012; formulation R&D for solid dosage forms for regulated markets.
• Wockhardt Research Centre, Aurangabad – Research Associate, Jan 2006–Feb 2007; oral immediate-release formulation development, scale-up, patent search, and stability compilation.

CONFERENCE-RELEVANT EXPERTISE

• Drug product and formulation strategy
• Pre-clinical and clinical formulation development
• Oral solid dosage and controlled-release products
• QbD, DoE, FMEA, GMP and scale-up support
• Clinical supply strategy and trial readiness
• Cross-functional project and portfolio leadership

EDUCATION & INSTITUTES

• PhD in Pharmaceutics – Indian Institute of Technology, BHU, Varanasi, 2007–2010.
• M.Pharm. – Birla Institute of Technology and Science, Pilani, Rajasthan, 2003–2005.
• PMP® – Project Management Institute, USA, certified Feb 2022.

PUBLICATIONS & SCIENTIFIC CONTRIBUTION

• 9 international publications and 1 book chapter.
• Conference presentations: 5 national and 1 international.
• Publication impact: approximately 634 citations and h-index of 9.
• Journal reviewer for international journals in nanomedicine, drug delivery, formulation, metabolic disease, and pharmacy sciences.

MENTORSHIP & RECOGNITION

• PhD supervision through Novartis–Manipal Academy collaboration.
• Mentorship for mini-sabbatical, FPL and DPPL colleagues.
• Young Nano Scientist Award, BHU Varanasi, 2009; UGC Senior Research Fellowship; DST sponsorship for AAPS conference, USA.

Dr Meka Lingam. M. Pharm with Ph.D from prestigious University College of Pharmaceutical Sciences, Kakatiya University.

Having 23 yr of experience in formulation R&D

Previously associated with

• Dr Reddy’s Labs
• MSN Labs
• Apotex
• Lee Pharma and
• Currently with Graviti Pharma as Vice President-FR&D.

Handled various generic dosage forms (OSD, Parenteral, Oncology and Nutraceutical Products) and supported for ANDA/Dossier filing for major regulatory markets.

Experienced from bench scale formulation development activities to technology transfer, submission/commercial batches planning and execution, Leading the teams, project management, planning and team building.

Establishment of R&D centers

He published 10 research papers, 5 research presentations in national and international journals and filed 5 number of patents.

He received prestigious award from Indian Achievers Forum as “MAN OF EXCELLENCE AWARD-2022” in Pharmaceutical Sciences.

Umesh Setty is a formulation development leader with over 25 years of experience delivering complex generic and first-to-file products for the US, Europe, and rest-of-world regulated markets.

He currently serves as Senior Vice President, Formulation R&D at HRV Global Life Sciences, Hyderabad, where he holds end-to-end responsibility for dossier identification, portfolio development, filing, and commercialization, and has helped build a 300+ product portfolio for the company's virtual, asset-light platform.

Prior to HRV, Umesh spent over six years as Senior Vice President, Formulation R&D at Caplin Point Laboratories, Chennai, leading a team of 60+ scientists and developing more than 1,500 products for regulated and Latin American markets, a period during which company revenue grew from ₹450 crore to ₹2,000 crore.

His earlier career includes senior formulation leadership roles at Ajanta Pharma, Astron Research (Intas), Dr. Reddy's Laboratories, Torrent Pharmaceuticals, and Aurobindo Pharma.

Umesh's technical expertise spans extended-release, delayed-release, MUPS, pellet, and matrix technologies across tablets, capsules, softgels, and semi-solid dosage forms, with deep experience in bioequivalence, QbD/DOE-based development, and regulatory query resolution for USFDA, MHRA, and Health Canada.

He holds eight patents, including formulations of Duloxetine, Sertraline, Pregabalin, and Fesoterodine, and holds an M.Pharm (Pharmaceutics) from Gulbarga University.

Raj Kumar Patra is Vice President and Head of IT – Research Services at Syngene International, where he leads digital transformation across Discovery, Development, and Clinical Research. He partners with scientific teams to accelerate innovation through AI, advanced analytics, scientific data platforms, and next-generation digital capabilities that support drug discovery, formulation development, and translational research.

With over 20 years of experience across pharma, biotech, and consumer healthcare—including leadership roles at Reckitt, GSK, and global life sciences organizations—Raj has led large-scale technology modernization, data strategy, and AI-driven transformation initiatives. He is passionate about leveraging emerging technologies to improve R&D productivity, accelerate development timelines, and enable smarter therapeutic innovation.

A HotTopics CIO100 and Next100 CIO award winner, Raj holds an MBA from the Indian School of Business and certifications in Agile and AI strategy.

Gaurav Arora is a senior business and procurement professional with 27+ years of experience across Pharmaceuticals, Specialty Chemicals, Polymer & PVC, Biotech, and related industries. He brings extensive expertise in Strategic Sourcing, Global Procurement, Supply Chain Management, Contract Manufacturing, Supplier Development, Cost Optimization, and Business Partnerships.

Over the course of his career, Gaurav has managed global procurement and supply-chain ecosystems delivering significant cost savings through strategic sourcing, alternate vendor development, supplier negotiations, and supply-chain risk mitigation. His experience includes working with global suppliers and manufacturers across India, China, USA, Europe, LATAM, and APAC.

Gaurav currently serves as Chief Commercial Officer – Strategic Partnerships at BioPharma Centrum Private Limited, where he focuses on building strategic partnerships and global business opportunities across Pharmaceuticals, APIs & Intermediates, Agrochemicals, Cosmetics & Personal Care, Medical Devices, Biotech, and Generic Finished Formulations. His work also involves connecting global customers with reliable manufacturing and supply partners through trading, indenting, CDMO/CMO partnerships, contract manufacturing, and strategic sourcing solutions.

He is recognised for his ability to build robust global supply networks, identify cost-effective sourcing alternatives, develop reliable manufacturing partners, and create de-risked, compliance-oriented supply chains that support sustainable business growth.

Dr Kiran Singavruksham is a seasoned pharmaceutical R&D leader with over 19 years of experience in formulation development, product lifecycle management, technology transfer, and regulatory strategy for global markets, including the United States, Europe, and emerging markets.

As Chief Scientific Officer, he leads multidisciplinary teams in developing complex generic and specialty pharmaceutical products across sterile injectables, ophthalmic, topical formulations, oral solids, oral liquids, and respiratory drug products. His expertise spans product conceptualization, formulation development, process optimization, analytical strategy, scale-up, validation, commercial manufacturing, and post-approval lifecycle management.

Throughout his career, Dr. Singavruksham has successfully guided numerous development programs from laboratory research to commercial launch, with significant experience in ANDA development, Paragraph IV opportunities, 505(b)(2) products, CMC strategy, FDA regulatory submissions, technology transfers, and external CDMO collaborations.

Dr. Saurabh Gupta currently serves as Vice President & Delivery Manager – R&D at Dr. Reddy’s Laboratories Ltd. He brings with him over 21 years of extensive experience in Pharmaceutical Research and Development. Before joining Dr. Reddy’s, he held significant roles across several reputed organizations, including Zydus Cadila, Jubilant Life Sciences, Wockhardt Ltd., Medley Pharmaceuticals, and Intas Pharmaceuticals.

In his current role at Dr. Reddy’s Laboratories, Dr. Gupta is responsible for leading product development and driving end-to-end delivery of pharmaceutical formulations for multiple international markets, including the United States, Europe, Brazil, Russia, China, Canada, India, and various regions across the Rest of the World (RoW).

He oversees multiple development teams engaged in innovating and advancing a wide spectrum of dosage forms such as solid oral, liquid oral, topical, and nasal formulations. His leadership ensures alignment of scientific excellence, regulatory compliance, and timely execution to meet the organization’s global development goals.

Mr. Vijaykumar Kuvar is Deputy General Manager – Vaccine Research & Development at Biological E. Limited, Hyderabad, with over 16 years of experience in pharmaceutical and vaccine formulation development. He leads formulation development activities across multiple prophylactic vaccine platforms, including conjugate vaccines, live viral vaccines, and novel adjuvant systems. His expertise spans pre-formulation, process development, lyophilization, technology transfer, scale-up, and CMC development from early research through clinical manufacturing. His professional interests include formulation innovation, advanced drug delivery systems, vaccine development, and the application of data-driven approaches to pharmaceutical product development.