• Dynamic, Result Oriented and Accomplished Business Leader, Clinical Researcher & Healthcare professional with an impeccable career record of 17+ years in the gamut of leading global teams across pharmaceutical / healthcare industry and start-up organizations.
• Proficient at Global drug development, Supply chain, Contract Manufacturing and Vendor management – assess, onboard, delivery quality & relationship management.
• Ardent Business leader, clinical researcher & healthcare professional competent to build & sustain business operating models (including off shoring & outsourcing), inspire people, drive transformation, innovation &OpEx.
• Demonstrable experience in continually engaging with stakeholders and key influencers to share ideas and plan alignment areas for Strategy, Operational Excellence and Process Improvements.
• Proven exposure of leading Portfolio, Strategy and Operations of global capability center for R&D business division.
• Deft at developing, implementing 3-5 years business strategy - drive growth and transformation.
• Lead strategic global projects for new capability development, business transitions, digital transformation & Robotic Process / Cognitive Automation.

• Senior pharmaceutical professional and physician, with > 23 years’ experience.
• Currently, Senior Vice - President Head - Global operations of clinical trials, Pharmacovigilance, medical writing, medico-regulatory & medical affairs (Discovery, Biologics, Generics) and & Head of Product ideation and Development (Generics) at Hetero group of Pharmaceuticals (2011 onwards).
• Earlier worked in leading pharmaceutical organizations including Dr. Reddy’s Laboratories, Vimta Labs, Indigene Alquest LLC, Accenture , Glenmark, Organon, Khandelwal Laboratories, before Hetero since 2000.
• Clinical Development Experience- DISCOVERY, BIOLOGICALS AND Generics- Led global clinical development of.
• New Chemical Entities (HIV {Hetero}), ONCOLOGY {Dr.Reddy’s & Hetero}),
• Biological/biosimilars (Rituximab, Bevacizumab, Adalimumab, Trastuzumab, Trastuzumab Emtansine, Tocilizumab, Tenecteplase, Erythropoietin analogues (Darbepoetin alfa & Erythropoietin), Sputnik vaccine, Insulins.
• Multiple branded generics- multiple therapeutic areas including COVID-19 drugs (Molnupiravir, Remdesivir, Paxlovid generic), Hepatitis- C(Sofosbuvir & combinations), Cardiology, Diabetology, oncology, gastroenterology, urology, haematology, orthopedics& rheumatology products.

Dr. Rajendar Burki is currently working as Associate VP, at R&D, Biological E Limited. Heading highly responsible parts of vaccines research, manufacturing (CMC) Drug Substance, Drug Product, and Analytical development.

Prior to BioE, he was associated with Indian Immunologicals, Intas Biopharmaceuticals, and Dr. Reddy’s Laboratories with different levels of responsibilities. He received Ph.D. degree in Bioanalytical/Biological Chemistry from Tohoku University (Japan), followed by postdoctoral training at the University of Alabama at Birmingham (USA).

Authored 10 patents, 20+ international publications, and delivered talks at National and international conferences.

His expertise includes Analytical development and characterization, conjugation of biomolecules with markers and polysaccharides including process development of biopharmaceuticals and vaccines.

A transformational leader with 19+ years of experience in Supply Chain Management with a hall-marked career in developing and managing complex Supply Chain Functions of diverse industries like Pharmaceuticals, FMCG, Medical Devices, Chemicals and Healthcare. Extensive experience in all the functions of effective supply chain through process improvement and cost reduction initiatives ensuring bottom line savings for the organization

Core competencies include -:

End to End Supply Chain Management - Supply & Demand Planning, Inventory Management, Vendor Development, Warehouse Management, Logistics, Strategic Sourcing, Procurement Operations, Spend Analytics, Change & People Management, Process Improvement and excellent Negotiation Skills.

Associated with some of the most prominent brands in the business namely, Virchow Biotech, KIMS Hospitals, Novartis, Merck Ltd. IPCA Laboratories, Dr. Reddy's Laboratories, Pidilite Industries, Phonak India and Piramal Enterprises.

An efficient team leader exhibiting strong leadership capabilities in managing complex business challenges, maintaining and enhancing customer & partner relationships and making high-stake decisions within fast-paced, high-pressure environments using experience-backed judgment, wisdom & strong work-ethics.

I am Dr. KRISHNA MURTHY BHAVANASI currently working as Vice President & HEAD – FR&D Department, NATCO Pharma Ltd. I am having total 24+ years’ experience in production, teaching, R&D consultancy and formulation research & development areas in India and Abroad. My previous organization was AUROBINDO pharma limited. Prior to Aurobindo, I have worked as R&D Consultant in Malaysian Pharmaceutical Industries, Penang Malaysia. During the last 17+ years of my stint at Aurobindo and Natco, I have handled various dosage forms viz. IR tablets, capsules. Oral liquid and dry syrups, suspensions, MR/ER/DR tablets & capsules, ODTs, sublingual tablets and liquid and lyophilized injectable dosage forms, prefilled syringes. To develop these dosage forms, various technologies have been adopted (solid dispersion by HME and Spray drying, spray coating, Lyophilisation, modified dosage forms usingMatrixing, reservoir technology, Nanonisationetc) to file ANDA, sNDA, and NDA’s in USA, Europe, Canada, Australia, Brazil, WHO and ROW countries. I have filed more than 25 patent publications in novel dosage forms for various molecules.

I have graduated from Andhra University and got Bachelor and Master of Pharmacy degree. I have got Ph.D. from School of Pharmaceutical sciences, University Science Malaysia, Penang, Malaysia.

Am recipient of many awards during studies and professional career. I was rewarded with Silver Jubilee award from Andhra University for being topper in M. Pharm, and Vice Chancellor Graduate fellowship from USM for academic excellence. Awarded consecutively two years for Best Patent publication in Aurobindo Pharma. In 2017 have received “outstanding achievement award” in Formulation Research & Development in FDD Conclave one of top scientists conclave across India.

Narendira specialises in Quality Assurance and has around 24 years of experience in pharmaceutical industry.He has been holding the position of “Senior General Manager & Site Quality Head” with Viatris, Hyderabad since July 2022. He worked in various capacities in companies like Dr. Reddy’s Lab, Orchid Pharma, Cipla Ltd & Tablets India Limited.

He spearheads “Quality Culture Excellence Program” across various sites to achieve “Quality Management Maturity”. He has vast experience in solid dosage forms, sterile products and Active Pharmaceutical Ingredients.

He is also a well-known trainer who regularly delivers speeches on different topics in various professional and academic institutes in home as well as in abroad.

Narendira is a life member in Indian Pharmaceutical Association (IPA) and member in “Regulatory affairs” Sub-committee of Indian Drug Manufacturer Association (IDMA).

He is co-authored ISPE’s guide on “Knowledge Management in pharmaceutical industry” and also he is co-authored Indian Pharmaceutical Alliance (IPA) guide on “Product Robustness”

Education -:

• PhD in chemistry from the University of Aurangabad
• Business management from NMIMS, Mumbai &
• lean Six sigma certification from Anexsa Europe

Professional summary -:

• Currently Dr. Nasir Ali is working with Aurobindo Pharma Hyderabad as Associate Vice President- API-R&D & previously he has worked with companies like Glenmark, Teva, Sandoz, Wockhardt & Lupin.
• He has more than 20 years of versatile experience in Pharma API research & development of Generic API Business.
• He has expertise in developing high potent, complex, synthetic & semi-synthetic APIsprocess & cost improvement for commercial APIs to sustain in competitive market by using computational tools throughout API life cycle development for regulated/non-regulated markets.
• More than20 patents applications in various area of APIs process & novel polymorphs.

Rithesh Phalaksha is currently the Digital solutions and Technology Acceleration Lead at Novartis Pharmaceuticals in Hyderabad. His current responsibilities include incubating and accelerating teams in driving business value by scaling innovation around the intersection of data, technology and process in Global Drug Development. He has been instrumental in setting up Mobility, Data Science & Analytics, Connected / Digital Health and emerging technology teams in India and across the globe. He has authored many articles on digitizing the drug development in Pharmaceutical Industry and also a keynote speaker and panel member in many international and local conferences.

He holds amaster’s degree from Massachusetts College of Pharmacy and Health sciences, Boston, and an Alumni of Harvard Business School (HBS).

Rithesh Phalaksha enjoys reading, exploring new places including historically significant places. Avid bike rider also yoga and meditation practitioner. His personal goal is to make a difference in 8+ billion people’s health on the earth, this goal keepshim going....

Founder Director, Pharmawisdom, a consultancy that focuses on clinical research, training and pharmacovigilance coaching

Qualification -:

• MD (Pharmacology), Mumbai University
• Diploma in Management, IIM Ahmedabad
• Over 35 yrs in pharma industry in medical department
• Responsible for Clinical research, regulatory & medicomarketing and pharmacovigilance in companies like Sarabhai, Cipla, FDC, Cyanamid/Wyeth, Organon, in local and regional roles
• Was also Head of Pharma delivery in TCS BPO
• Retired as India Head for Revogenex Inc

Additional professional activities -:

Chairman of the Ethics Committee of the Kaushalya Medical Trust Hospital Medical expert in Ethics Committee for Jaslok Hospital.

Ex-Chairman of Institutional Review Board of Bombay College of Pharmacy, Mumbai.

Ex Referee and examiner for M. Pharm. (Pharmacology) & Ph. D (Pharmacology) course of University of Mumbai.

Qualification -:

• Books Updates in Ophthalmology as editor
• Journals Over 45 publications in various therapeutic areas

Dr. B. Patro has done his Ph. D. in Chemistry from North-Eastern Hill University, Shillong. After that he joined in a Indo French collaborative project DNA Topisomerase I inhibitors and then he moved to Universtät Konstanz, Germany as an Alexander von Humboldt Fellow worked in the area of carbohydrate chemistry. Then he moved to University of Strathclyde, Glasgow, and worked in the field of radical chemistry and total synthesis of Vinblastine and Vincristine class of alkoloids.

Dr. Patro has started the entrepreneurial endeavor in 2014 and started GRK Research Laboratories and GRK Fine chem Pvt. Ltd. We are engaged in pharmaceutical, agro, veterinary products and material chemistry..

Prior to joining GRK labs, Dr Patro was Sr. VP and head of Chemistry Services, GVK Bio, CEO and Vice President, Chemgen Pharma Research International Pvt. Ltd. and Chembiotek Research Private limited, Kolkata.

He has gained expertise in the following

Research & Development Activities :

• Medicinal Chemistry: De novo Design and synthesis of novel compounds, identification of hits and leads, Lead optimisation.
• He has worked in different projects such as multistep target synthesis, synthetic studies and reagent development to name a few. He has also worked for pharmaceutical major clients for making scaffolds, important drug intermediates. He has a long list of publications to his credit. Around 40 publications in Peer reviewed journals. He has also written a book chapter with AP Press. He is also active in academic research with several PhD students registered under his guidance.

Scale up Chemistry & Manufacturing :

• Route Scouting .
• Novel Process development, Stability studies, Impurity profiling, Pre selection compounds, Seamless tech transfer from mg to Kg and higher scales.
• Presently we are having MOU with two plants one in Ankeleshwar and another GMP facility at Pune.
• We are engaged with both bulk product manufacturing and technology transfer to Indian counterparts.
• Analytical Chemistry: Covering both discovery and development analytical aspects.

Areas related to Material Scien :

• During all these years he has gained experience in developing, maintaining and expanding the infrastructure supporting R&D including capabilities, quality, procedures, strategy development and deliverables.

Smart technology development and future strategies :

• He has worked with more than 90 international clients in the field of Drug Discovery research and large scale synthesis.
• He participated as a core member in building two of the largest discovery CROs in India.
• Worked with service partners in Pharma, Agro and fine chemical sectors and active in the field and have a wide spectrum of contacts.
• We also have a good sales team who are getting many clients.
• Active research and worked with several chemists.

We see these advantages in both domestic and foreign market as an advantage.

Dr. BM Rao possess a Ph.D. degree in Chemistry and has about 33 years of work experience in pharmaceutical Analytical R&D and Quality Control functions in reputed organizations includes Dr. Reddy’s Laboratories Limited (~14 years), Janssen Pharma (pharmaceutical companies of Johnson & Johnson), Novartis, Zydus Cadila, Nicholas Piramal, and SOL Pharma. He has a sound practical knowledge and thorough understanding of “Data Integrity”, its importance in cGMP Analytical laboratories. He has exposure to various regulatory audits includes USFDA, EMEA, TGA, Health Canada etc. and worked with reputed international consultants in Quality remediation. He has about 80 scientific publications in reputed national and international journals and successfully guided eleven part-time Ph.D. candidates. During his professional career he has been recognized for his contributions at work and won awards including Chairman’s Excellence Award from Dr. Reddy’s Laboratories (Feb 2018 & Jan 2003), “Standards of Leadership” from J&J at Janssen, Mumbai site (year 2010) and Best New Leader Award at SAI Life Sciences Limited (year 2013). He has extensively travelled to USA, Mexico, Europe, Germany, Belgium, Singapore, Brazil, and Malaysia and interacted with several big and emerging biotech pharmaceutical analytical & quality experts. He is an international speaker on various topics like data integrity issues, Investigations, CSV, Nitrosamine assessments, and Inspection readiness. Since Oct 2022 Dr. BM Rao is working as C.E.O. of QDOT Associates, Hyderabad providing technical and quality consultancy services to various pharmaceutical companies.

Dr.Pawan Patinge is a Pharmaceutical Quality professional with vastindustry experience across different Departments of Clinical Research and Bioequivalence, Food analysis, Quality Assurance and Quality Control. He has supported the Techno commercial and Project Management teams to ensuremeeting business aspirations of Organizations.

Dr. Pawan Patinge is a doctorate in Organic Chemistry from Mumbai University under the guidance of Ex. Vice Chancellor of Mumbai University Dr. Suhas Pednekar. Through his dynamic and versatile career, He has worked with renowned Indianpharmaceutical and Public testing Laboratories in various Leadership roles in multi-disciplinary cross functions likeMacleod’sPharma, Scitec Labs Pvt.Ltd., Micro Labs, Cipla, Doctors Analytical Laboratories, Analytical Solutions, Choksi Laboratory.

He is well known in the industry as a chromatography expert in various hyphenated techniques used in quality control and research and Development sections. His contribution as an expertise in LCMS in the bioanalysis with various pharmaceutical formulation products with low detections limit molecules is remarkable.His diverse areas of experience and knowledge helped the industry to establish the invitro characterization of oncology formulations. With his guidance group leaders have accomplished the target oriented projects in new drug delivery systems in pharmaceutical sectors.

Apart from these multidisciplinary works, his main core area is pharmaceutical quality compliance. He has successfully led his teams during domestic and international Regulatory Audits and Inspections for pharmaceuticalorganizations. With his guidance many small scale laboratories have upgraded their analytical testing facilities as per national and international norms. With his core team of experts he has established extractable and leachable divisions for public testing laboratories. As a Pharmaceutical consultant he is now leading a team of experts having experience of API and formulation sectors to set up their divisions in India.

Currently he is being recognized as a sole proprietor of a training academy named ‘Academy of Analytical Instrumentation’ which is a vocational courses training institute. Through his own designed courses he has helped many industry aspirants to upgrade their knowledge in hyphenated techniques. His academy is bridging a gap between an industry and education institutions. Academy has helped their students to achieve the excellent career in all sectors including Pharmaceutical, Petrochemical, Food testing, Cosmetic testing, Fragrance,perfumery and flavors industry. Through his skilled development training programs and career guidance programs in collaborations with many institutionshelped students to select the right career path in industry.

Education -:

Ph.D. (Chemistry) from SRM Institute of Science and Technology -Chennai
M.Sc. Chemistry from University of Madras
B.Sc. Chemistry from University of Madras

A goal-oriented professional with over 27 years of experience in Corporate Quality, Cluster Head, Quality Assurance, Quality Control, AR&D, RA, Audit and compliances departments in API, CRAMS, Oncology API, Formulations-OSD, Biologics and Biologics- Injectable manufacturing company. Skilled in managing various regulatory Inspections like USFDA, Cofepris, EDQM, EUGMP, PMDA-Japan, WHO GMP and so on

Experience -:

Sep’21 Natco Pharma., Hyderabad, VP-QA

Jul’14 – Sep’21 SUN Pharmaceutical Industries Ltd., Chennai, Sr.GM-Quality (Head- Quality) (Cluster Quality Head for multiple sites)

Aug’13 – Jul’14 West Pharma P.Ltd., Head –Quality, India

Nov’09 – Aug’13 Piramal Healthcare Ltd., Head -Quality Control

Dec’95 – Nov’09 PharmaZell Pvt. Ltd., Chennai as Sr. Manager – QA/QC (Head- Quality)

“Lakshmi Narayana Dommarajula is passionate about building successful & empowered teams, leading transformation, and delivering results with proven track record of managing global and regional sourcing in complex matrix organizations.

He has 19+ years of experience and is currently an Associate Director leading Indirect Procurement -Opex with Aragen Life Sciences. He has managed various roles in Supply Chain Management (SCM), Category Management, Strategic Sourcing, Global Procurement, Project Procurement with Global & Indian MNCs - Aragen Life Sciences, Syngene, GSK, Novartis, Aventis Pharma.

He has experience in the sourcing and procurement of Raw materials, Chemicals, Solvents, Lab supplies, Lab services, Analytical testing services, Clinical research/CRO services, Capex - Process/Engineering and Lab equipment, CMOs (Contract Manufacturing Organizations), Pharma R&D including Pharma New Product Development (NPD), Biologics, REFS, Professional services and IT.

He has a Bachelor degree in Pharmacy and Master’s in management”

R. Chandi Prasad , Head - Packaging Development, Commercial Team at Aurobindo Pharma Limited , Hyderabad, India. Among the top 2 companies in India, APL is generic pharmaceuticals and active pharmaceutical ingredients manufacturing organization with exports to over 150 countries across the globe.

Chandi is having result driven, growth oriented career of multi-faceted experience over 3 decades in packaging development, quality control and quality assurance in reputed pharmaceutical organizations

As a Packaging Technologist with ability to define vision, focus on short-term and long-term goals of organization, accepting pivotal assignments, sets high expectations and produced results.

Had worked with Ranbaxy Laboratories Limited, Actavis Pharmaceutical Mfg. Limited and Natco Pharma Limited.

Established modern quality systems for 100% compliance in packaging development and artwork management system in driving team and achieving intended results in the organizations he is associated with. He believes in sharing knowledge is gaining knowledge and spoken in reputed seminars and conclaves on packaging technology.

Regular speaker in many national and international pharma packaging seminars. Visiting faculty to Indian Institute of Packaging, a member of WPO.

Elayaraja Natarajan is the Head of Research and Development at Lyrus Life Sciences Pvt Ltd in Bangalore, with nearly 18 years of experience in product development, IPR (Intellectual Property Rights), clinical, quality assurance, and technology transfer, including strong research experience with complex dosage forms, F2F products, and so on. Lyrus is a research and technology-driven global specialty pharmaceutical company with HQ in Bangalore, focused on research and development in the complex generic space and committed to developing differentiated and innovative products.

He holds a Master of Pharmacy with a specialization in Pharmaceutical Sciences and is pursuing a PhD in target-specific drug delivery systems in cancer therapy using artificial intelligence (AI) integration with nanotechnology, which includes AI-driven simulations and modeling to optimize drug dosage predictions and identify complex patterns in cancer genomics, thereby advancing drug development processes.

He was instrumental in the development of numerous innovative platform drug delivery systems, and also he holds over 50 international patents and research papers.

He was an Associate Director of Formulation development and Quality Assurance at Rubicon Research Pvt Ltd. before joining Lyrus. Before that, he was working with Shasun Pharmaceuticals Ltd (now Strides Shasun), Genovo Development Services, and Medreich Limited (now Meiji Medreich).

Senior Vice President & Head – Operations

Suven Pharmaceuticals ( Advent Portfolio Company )

Ramkumar comes with 25 years of rich and varied experience in pharmaceutical industry. His expertise lies in leading strategic level projects with expertise in API Manufacturing operations, project management (EPC), quality, engineering, technology transfer, CMO management, new product launch and EHS management.

Prior to joining Suven, Ramkumar, held various leadership positions with organizations like Aragen Life Sciences, Eisai Pharmaceuticals and Strides Shasun.

Manjeeth Singh Rawat , is Head of Supply Chain, CIS & Romania Markets for Dr. Reddy’s with expertise in Pharma Supply chain.

He has 15 years of experience in industry, ranging from Manufacturing of formulations to planning of APIs and heading regional supply chain in CIS markets.

Manjeeth has been recognized with Chairman’s Excellence Award – Best Team FY’23 for re-aligning supply chain and ensuring availability of essential and lifesaving medicines during ongoing Russia-Ukraine War.

He has been leading projects for the region like Legal entity establishment, deployment of demand planning software, digitalization,

Manjeeth completed MBA in Business Analytics from NMIMS and holds a Master of Science, Pharmaceutics from BITS Pilani.

In addition to , Manjeeth is also actively involved and regularly speaks as Alumnus on different topics to young pharmacy students.

Dr. Satya Moturi is a proven leader/mentor for complete value chain of Pharmaceuticals vertical including product development, Operations, Quality, Regulatory and Scientific Affairs. He received his Ph.D from JNT University Hyderabad in Pharmaceutical Chemistry and MBA in International Business from Andhra University. Having spent about 27 years in various pharmaceutical industries such as Dr. Reddy’s, Zydus, Sai Life Sciences, Granules India and Biological E. Ltd., he has huge number of successfulregulatory inspections to his account and has been recognized as subject matter expert for pharmaceutical Quality and Regulatory affairs managing the multi-site pharmaceutical Operations. His expertise include, Quality and Manufacturing operations, Regulatory and Scientific Affairs for INDs/ANDAs/DMF for all kinds of pharmaceuticals including APIs, Drug products (solid orals, Injectables, long acting Injectables, complex generics and peptides). Currently he is with Biological E. Ltd as Sr. VP and Head, Operations, Quality and Scientific Affairs.

Dr. Suresh Pathi Total Years of Experience : 20 + ( 10 years in API and 10+ years in Formulations in the areas of Production, Process Engineering, Technical services, R&D and Operational Excellence).

Qualification -: PhD Chemical Engineering

Certifications : Lean Six Sigma Black Belt from Indian Statistical Institute, Trained in Theory of Constraints (TOC)- with Goldratt India and certified in Maynard operations Sequence technique (MOST).

Domain -: Pharmaceutical

Organization : Hetero drugs, GVK Bio, Nuland Laboratories, Dr. Reddy’s and Granules India Ltd.

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), Vice President (R&D), Executive Director, Managing Director & CEO, within several reputable multinational pharmaceutical companies worldwide. His contributions to the field have been recognized with numerous National and International Awards and Honors.

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, and the development of RNAi therapeutics.

Dr. Ravichandra is a veterinarian and holds a post-graduation specialization in veterinary pharmacology & toxicology. He is also an American Board-certified Toxicologist (DABT), European Registered Toxicologist (ERT). In his current role, he is heading Department of Global Toxicology & Nonclinical Development at Amneal Pharmaceuticals. He is having 16+ years of total experience in integrated product development for different global markets in drug discovery and generic pharmaceutical firms with IND, NDA, ANDA - 505(j), 505(b2), DMFs. He is involved in the overall conduct and maanging the toxiciology, ADME, and Pharmacology studies for NCEs, generic drugs, special reformulated drug products.

He has been involved in different toxicological risk assessment involving impurity qualification, genotox assessment, in silico (Q)SAR, HBEL, E&L assessment, biowaiver strategies, etc. He was involved in different working groupd of veterinary ICH guidelines, Animal Health Institute, USA and Animal Health Europa. He was also a board member of The international Extractables and Leachables Safety Information Exchange (ELSIE) Consortium. He has 3 international patents and 19 publications in international journals.

• Currently serving as Senior Principal Scientific Officer at the Indian Pharmacopoeia Commission (IPC), Ghaziabad.
• Joined IPC as Senior Scientific Officer in 2016 and contributed in the development of monographs for the Indian Pharmacopoeia (IP).
• Also worked at National Institute of Biologicals (NIB), NOIDA to contribute in quality evaluation of biotherapeutics and development of their reference standards.
• Dr. Gaurav holds a master's degree in Biotechnology and Ph.D. on the topic of anti-mycobacterial drug resistance.
• Published 30 research articles in peer-reviewed journals.
• Contributed to IPC’s membership in the Pharmacopoeial Discussion Group (PDG) and recognition of the IP in foreign countries.

Mr. Gopi Reddy is currently Vice President and Head – Corporate Compliance and CQA, at Sun Pharma Ltd., responsible for leading and establishing Quality Systems for Biologics and Small Molecules, including Solid Dosage Forms, API and Injectables, from Development to Commercial Manufacturing. He is also responsible for ensuring that all manufacturing sites of Sun Pharma globally, contract manufacturing sites and all vendors, are compliant with current regulations and “anytime audit-ready”.

Gopi Reddy possesses almost 28 years of experience in managing quality operations, in leading companies like GSK India, Glenmark, Cipla, Syngene, etc., at various levels - from Executive to Sr. Vice President-level, with hands-on experience in manufacturing of solid Dosage forms, sterile formulations, as well as Biologics, and APIs.

Armed with a strong understanding of international Quality, Regulatory and Compliance standards (e.g., USFDA, MHRA, etc.), as well as the knowledge of manufacturing environment and guidelines of the Indian pharmaceutical landscape, Gopi Reddy has been leading interactions with regulatory agencies, and leading regulatory audits for successful outcomes.He also has hands-on experience in Site Remediation, and bringing a facility back into compliance.

During his career, he has demonstrated a track record of Quality leadership in a complex commercial-stage cGMP pharma manufacturing environment across 30+ sites with different dosage forms/different modalities, and has been Instrumental in creating leadership teams under his guidance to meet individual and organisational goals. As Quality Head, he has played an instrumental role in handling various greenfield projects, from start-up to commercialisation. He has also demonstrated able leadership to drive improvements in operational effectiveness across Quality operations, and has experience in managing external audits and teams across Quality Assurance and Quality Control operations.

Dr. Srinivas Arutla is a Chief Executive Officer at Zenara Pharma Pvt limited, Hyderbad, India, a US FDA and EU approved pharmaceutical manufacturing company.

Dr. Arutla’s current focus is on development and manufacture of niche products for rare diseases catering to unmet medical needs of global patients including India.He has authored several patents and research articles in national and international journals while directing the technical teams.

Prasad Satam brings3 decades of Industrial experience covering Packaging & Device development of all dosage forms such Solid and Liquid orals, Nasals, Topicals , Inhalations , Injectables and Ophthalmics for all markets.

He is Vice president & Head of Packaging Research & Development of Aurobindo Pharma Ltd.

Bharat Bhushan Rathi, Head Distribution and Logistics, Mankind Pharma.

Highly accomplished professional who worked across different industries With Key expertise in aligning corporate and global programs with regional and local functions. Have exceptional success record of 17 years spanning across roles involving Inbound/Outbound logistics Operations, Distribution, Warehouse Designing & management, Vendor Management, Purchase/ Procurement, Planning. Developed skills in successfully identifying and implementing innovative practices which lead to major cost savings besides optimizing the Supply Chain.

In the Indian Clinical Research industry, Dr. Kiran Marthak is one of pioneering leaders with a fabulous list of accomplishments and a rich experience of more than four decades. Dr. Kiran Marthak has conducted numerous Phase 1 studies including First in Human studies, and complex clinical trials and has held senior positions in several Indian and Global pharmaceutical companies such as Ciba – Geigy (Novartis), GSK, Pfizer and Ranbaxy. He has very rich experience in conducting clinical trials across several geographies including USA, UK, Europe, China, Japan and South Africa. Dr.Marthak is highly respected amongst regulatory authorities for his knowledge of international clinical research guidelines. He is one of the accredited members for GCP training by Clinical Development Services Agency (CDSA), India and contributed to the New Clinical Trial Rules implemented in March 2019.

Dr.Marthak is a qualified M.D. in Internal Medicine from Grant Medical College, one of the oldest premier and pioneer medical institution run having 175 years of existence in the country. Additionally, Dr.Marthak is a Fellow of American College of Clinical Pharmacology, Fellow of Royal Society of Medicine, U.K. and Fellow of Faculty of Pharmacology, University of London. He has been awarded with ‘VishistChikitsa Medal’ in 1994, by the Association of College of Chest Physicians, India, (“ACCP”) in recognition of his services and was accepted as the honorary life member of the ACCP.

Prasad leads and manages the Regions and Programs Operations (RPO) for USP’s South Asia region. He leads the key functions of strategic customer development, customer service, USP education, customer insights, scientific affairs, external and government affairs, strategic insights, data strategy and analytics and supports physical material programs.

As a regional leader of RPO, Prasad leads USP’s engagement with regulators, industry associations, academia, public and multilateral health organizations to leverage USP standards to bring more quality medicines to patients across the globe.

Prasad is a global healthcare thought leader, P&L champion and management professional from The Wharton Business School, University of Pennsylvania. He has more than 23 years of professional experience in general management, strategic partnership, business planning, marketing, brand management and business development. He has focused on the pharmaceutical and biotechnology industries, as well as healthcare, with specific domain expertise in health systems and healthcare providers, medical technology and devices. He has been a champion of ensuring women leaders thrive in their organizations and has been driving diversity, equity, inclusivity and belonging.

Prasad has held leadership roles in the Asia Pacific region, and emerging African and European regions to improve access to quality medicine and healthcare with leadership roles in global organizations.His specific interests include strategic planning, strategic partnership, P&L management , health access improvement, digital transformation , process improvements for increasing operational efficiencies in healthcare provider , pharmaceutical and medical technology 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, Commercial Operations, 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 300 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.He navigated the challenges of the COVID-19 pandemic with a steady hand, expanded USP infrastructure by adding two additional sites, and led Diversity, Equity, Inclusion and Belonging (DEIB) programs and initiatives.

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 25+ years with strong formulation basics coupled with hands-on analytical knowledge. His core expertise lies in handling challenges related to Finished Dosage Forms.

He is a Distinguished leader, ardent believer and follower of Diversity, Equity, Inclusion and Belonging philosophy. 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.Girish holds a Master’s degree in Pharmacy from the DIPSAR,University of Delhi;MBA in Pharmaceutical Management and a Postgraduate diploma in Patents Law from the NALSAR,Hyderabad.He is also serving as a Member of Governing body of a pharmacy college. He is a Life Member of IPA and IPGA.

Accomplished leader in digital transformation in the pharmaceutical industry in the manufacturing and supply chain domain, known for driving impactful organizational change and implementing cutting-edge solutions. Proficient in leveraging Industry 4.0 technologies to optimize manufacturing processes, with a focus on improving operational efficiency and reduce costs. In addition to my professional pursuits, I find joy in playing and watching cricket. This passion for the sport not only provides a refreshing break from the complexities of the digital transformation landscape but also instils in me valuable lessons in teamwork, strategy, and perseverance that I often apply to my professional endeavours.

In career spanning over two decades of leading global clinical development projects for novel drugs and vaccines, investigational new products. Was instrumental in obtaining market authorization for over 20+ products including vaccines and medicinal products across wide therapeutic areas. Led global teams across India, Europe, USA, South Africa and China in various companies working at various capacities at IQVIA, Syngene, Novartis.

Allergan and Ranbaxy with the team sizes ranging from 30+ to 1600+ professionals. Has 15 publications in reputed scientific journals as first author and expert signatory for 100+ clinical dossiers comprising of clinical study protocols and clinical study reports. Subhash Thuluva holds Doctorate in Clinical Pharmacology from University of Bonn, Germany.

Currently working with Biological E ltd, as Senior VP & Head- Clinical Development & Pharmacovigilance, Providing leadership and strategy for Clinical Development programs of investigational novel vaccines and responsible for all aspects of Clinical development including protocol design, clinical trials, execution and monitoring, Data management, Bio-statistics and Pharmacovigilance. At Biological E, Strategized and led the global clinical development for COVID-19 vaccine (CORBEVAX®) from Phase 1 to WHO Emergency Use Listing (EUL). Worked on from early Clinical Development until market authorization for Typhoid, Hepatitis- A, Pneumococcal Conjugate vaccines. Currently working on development of Polio, Bivalent Typhoid, Liquid Hexavalent, Pneumococcal 24 valent which are under various phases of Clinical development.

• More than 28 years of experience in Quality operations for regulatory compliance in Manufacturing of APIs, Solid Oral Dosage and Sterile Injectables products and worked with reputed firms such as Pfizer, Mylan, Perrigo, USP, Cipla, Dr. Reddy’s and Orchid Pharma.
• Certified Quality Auditor from American Society for Quality (ASQ-CQA, USA) and Trained ICH Q7 Auditor from European compliance academy (ECA, Germany). Working knowledge with Expert committee members in USP and Indian Pharmacopeia commission (IPC).
• Conducted several on-site audits (>100) in various countries like USA, Germany, France, UK, Norway, Ireland, Turkey, China, Malaysia, India and Bangladesh.
• Have Success records in handling USFDA, MHRA, MCC, EDQM, TGA and WHO-GMP inspections and Remediation hands-on experience with International Consulting Teams for FDA warning letters and achieving compliance status.
• Subject Matter Experts in Data Integrity Forensic Reviews of Manufacturing and Quality Control documents. Data Integrity Steering Committee Member to ensure DI Policy and Practices across the sites.
• SME for review of Nitrosamines risk assessment /confirmatory testing for several drug products and APIs.
• Conducted several Training Workshop on GMP topics and participated as a speaker in several regulatory conference.