Dr. K S V Srinivas has 27 years of versatile experience in Pharmaceutical analytical services to method development, validation of analytical procedures, isolation & characterization, Structural Elucidation, solid state characterization, Extractables & Leachables(E&L), polymer chemistry, stability studies, reference standard program, Compounding analytical for both small & large molecules (including mABs),new product Development, regulatory filings & IPM. He currently heading Baxter Global Research Centre and the total size of the team is 230+ Analytical Scientists & supporting functions. Dr.Srinivas has completed his Doctorate from JNTU Hyderabad. He worked with pharmaceutical reputed Pharmaceutical companies such as Dr.Reddy’s Laboratories Ltd, Natco Pharma, Alembic Limited, Piramal Limited and Max India and has rich experience in supporting top MNCs in Pharmaceutical, Agrochemicals, Nutraceuticals and Discovery for various stages of drug development, previously worked with GVK Bio and currently with Syngene International Ltd.

Shivkumar Vishwanathan is a Chemical Engineer and a Packaging Technologist by training. He has close to 20 years of experience in the Manufacturing, R&D, Audit, Laboratory testing and consulting. He has worked in Multinationals like Clariant, Bureau Veritas, Ciba, BASF and Intertek. He started his own testing and consulting facility – GVS Cibatech in 2015 and continues to provide his expertise in both testing and consulting on pharmaceutical packaging including Extractable and leachables(E&L).
He has organized several training programmes on Extractable and leachables(E&L) and has been invited to speak at various national and international forums on this subject.

S.S Easwaran has a combined experience in Academia and Industry, helped 480+ Biosciences candidates to find meaningful jobs through job-skills based training modules offered though Biocon Academy. Mr.Easwaran is dean of Biocon academy, prior to this he was associated with organizations such as Biozeen, Merck, BIOMERIEUX with vast experience in research & development, regulatory services , process and method development, filteration, purification and chromatography for biopharmaceutical. Mr.Easwaran also have one patent under name on Multi-test retention also published 18 National and 4 international publications.

Balkrishna Agarwal is a Ph.D in Analytical Chemistry and MBA with 14 years of experience mainly in Contract Research & Manufacturing for International Clientele in the pharmaceutical industry. His core area of expertise lies in guiding and leading scientific team in the area of complex formulation method development, Screening of Genotoxic and Elemental Impurities as per PQRI and ICH guidelines and is well verse with hyphenated techniques.
Dr. Agarwal has been instrumental in the set up and execution of Extractable & Leachable laboratory during his journey in Piramal Healthcare, Mumbai.
His recent achievement is facing USFDA audit as a Head of Department without any major or critical observation’s.
In his 14 years of experience, Dr. Agarwal has been a part of reputed pharmaceuticals companies like, IPCA laboratories, Nicholas Piramal and GVK Biosciences. He is currently a part of Product Optimization Team and Global SME for E&L at GSK Consumer Healthcare, Hyderabad.

Dr. Srinivasarao has close to 18 years of Research experience and possess more than 11 years of Professional experience in the field of Analytical Research and Development in Pharmaceutical Industry .He is working extensively more than 10 years in the field of Extractable and Leachables and addressed various regulatory queries related to E&L for various drug product i.e Extractables testing of closer container systems, medical devices and manufacturing materials.Mr. Srinivasarao authored white papers to evaluate impact of a change on extractable using a risk-based approach submitted to USFDA. He established E&L laboratory in various organisation from grass route also involved in various Regulatory Audits. Mr. Srinivasarao expertise in various instruments like LC-MS/MS, GC-MS, ICPMS, GC, HPLC, DSC, TGA, TOC, IC, ICP-OES, NMR, AAS, FES. He is research guide for Universities like Andhra University, Gitam University, Pacific university etc. 4 students awarded Ph.D under the Guidance. Dr.Srinivas Rao published 78 papers in National and International Journals on different Research work including Extractable &Leachables and Genotoxic impurities. Involved in more than 380 genotoxic impurities in method development and validations.

Dr. Venkat Manohar is Director, Indian Institute of Chromatography & Mass Spectrometry (IICMS),Chennai, an institution set up to develop experts in Chromatography and Mass Spectrometry. He did his Ph.D. in Physics from University of Madras and has more than three decades of experience in analytical sciences. Prior to this assignment, he was Senior Vice President in Piramal Life Sciences Limited (PLSL), Mumbai, where his responsibilities involved setting up of state-of-the-art facility featuring LC-NMR-MS, LC/MS/MS, MALDI TOF/TOF MS systems to carry out GLP bioanalysis, analytical support for process development and drug discovery group, generating data for IND filing at various countries, training team of scientists in various aspects analysis so on. Dr.Manohar has also served Hindustan Unilever Ltd and Searle India Limited prior to joining Piramal Life Sciences. He has 30 publications and 5 patents to his credit

Dr. Shrikrishna Dadke is the Vice-President of VIMTA’s Analytical (large and small molecules) BU. He has extensive experience in both, academia and industry, (USA and India) for more than 22 years. Upon completion of PhD from Cancer Research Institute (ACTREC), Mumbai and India. Dr. Dadke worked at Abbott Laboratories, Chicago, USA in the Metabolic Disorders Program. He was involved in the identification and validation of novel targets in the area of Type II Diabetes. Post his tenure at Abbott Laboratories, Dr. Dadke joined Fox Chase Cancer Center in Philadelphia, USA, where he continued his research in the field of Diabetes. His research resulted in a Nature Cell Biology publication which was cited as a “hot article” by the journal for that year. Upon his return from the USA, Dr. Dadke worked at Dr. Reddy's Laboratories, Lupin, and Accutest Biologics Pvt. Ltd. He has valuable experience in bio-similar characterization (cell based and analytical) and mechanism of action studies. His work contributed to IND filings and involved evaluating both in and out-licensing deals in national and international regulatory markets.

Dr. K.S. Jaganathan is working as Dy. Director and Heads the Production Department [Liquid vaccine(s)] since November 2017 at Serum Institute of India focusing on Formulation development, Commercial manufacturing and Troubleshooting activities for vaccines and vaccine adjuvants. He obtained his Ph.D. in Pharmaceutical Sciences from Dr. H.S. Gour University, Sagar, India, in collaboration with Pasteur Institute of India, Coonoor. He did his post-doctoral studies at Tokyo University, Japan and worked in collaboration with Kowa Pharmaceutical Ltd, Japan. Prior to joining Serum, he worked for SANOFI group for about 14 years on various projects related to Human Vaccines, Monoclonal antibodies and Protein drug delivery. He has several refereed publications in National and International journals with many national / international awards, fellowships and patents, besides oral and poster presentations at conferences and symposia to his credit. Dr. K.S. Jaganathan has more than 20 years’ experience in academics and industrial research related to biopharmaceutical formulations.

Karthik graduated with a dual major in Pharmacy and Biological Sciences from BITS, Pilani, India in 1999. Subsequently, he graduated with a Ph.D. in Pharmaceutical Sciences from University at Buffalo, State University of New York, USA in 2005. After his doctoral training, Karthik relocated to India and established the Biologics formulation group at Biocon, Bangalore.He was also one of the founding members of the Devices team at Biocon. Karthik and his team have played a pivotal role in the development and approval of the first wave of Biocon’s biosimilars in US, Japan and EU, including the world’s first biosimilar Trastuzamab. Currently, he is a General Manager in the R&D division of Biocon Biologics. Karthik and his group is responsible for process development, technology transfer and scale up of biosimilar insulin analogues, drug substance and drug product to Biocon’s DP manufacturing facilities, as well as support the manufacturing of clinical and commercial supplies.

Karthik has several scientific publications to his credit in peer reviewed international journals and has also co-authored a book chapter. He also has two patents to his credit. Karthik has also been an invited speaker in national and international forums.

Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independent consultant providing advice in the area of extractables and leachables, after working for GSK in the area of extractables and leachables since the mid 1990’s.

Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority relating to the support that GSK has given to extractables and leachables (E&L). Before setting up Maven E&L Ltd, he was the director of a team of analytical chemists who are responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. This included; biopharmaceutical and small molecules including Inhalation, Parenteral and Cell & Gene Therapy use. He has had the pleasure of commenting on PQRI guidelines on E&L for GSK, the E&L section in EMEA guidelines on inhalation and nasal products and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.

Jason has been a member of several external groups concerned with the development of best practice guides for extractable and leachables issues these include; the IPAC-RS material working group, BPOG and continues as a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE. Currently he is working and commenting on risk- based approaches to E&L requirements, which he hopes will form part of an ICH guidance in the not too distant future.

Webside URL: www.MavenEandL.com
E-mail: Jason.Creasey@MavenEandL.com

R. Chandi Prasad is currently heading Packaging Development, Commercial Team at Aurobindo Pharma Limited, Hyderabad. Aurobindo Pharma Limited is a generic pharmaceuticals and active pharmaceutical ingredients manufacturing organization and features among the top 2 companies in India in terms of consolidated revenues with exports to over 150 countries across the globe.

He is having result driven, growth oriented career of multi-faceted experience over three decades in packaging development, quality control and quality assurance in reputed pharmaceutical organizations manufacturing formulations.

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.

In the long professional career, accomplished projects of selection of packages for product stability, quality, safety, compliance to regulatory and statutory requirements, technology transfer of packaging, packaging automation projects, vendor development and audit, driving and implementation of cost saving projects in packaging materials and productivity resulting in huge savings.

Established modern quality systems for 100% compliance in packaging development and artwork management system in driving the 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.

Awarded for Outstanding Achievement in pharmaceutical packaging by Express Pharma.