Catalyst Business Services
Catalyst Business Services
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Cross functional experience of over 30 years in managing research activities, coordinating with the project teams and enhancing bioprocess operations in R&D Molecular Biologist with demonstrated competence in wide range of functions viz. vaccine research, bioprocess development, analytical research, validation, quality control documentation and co-ordination of biotech drug development, especially monoclonal antibody-based therapeutics & fusion proteins.
He focused on CMC dossier preparation for successful filings in regulated markets (Japan, Europe, Australia and the US)
Overall responsibility for early-stage development of biosimilar drugs, including:
Development of bacterial clones: mAb fragments and non-mAb molecules cloned in bacterial systems using high cell density fermentation (>300 OD). Turn around for a mAb fragment product with highest productivity and yields in the industry and working on new molecules with high titers and reduced CoGs.
Development of mammalian clones: mAbs currently into development for regulated markets. High cell density, high titers with identified CQAs and addressed with establishment of biosimilarity index with the reference product. Improvisation of a mAb cell line to yield titers unmatched in the industry with the given quality.
Process Development: Improvement in process for two products using DoE approach for higher purity and recoveries.
Process Characterization: by qualification of scale-down model, determination of RPN for critical process parameters, OFAT and multivariate analysis for assurance of process robustness.
Process Validation: Seamless tech transfer of the developed process to manufacturing and assist in process validation.
Documents preparation and review for submissions to various regulatory authorities, especially PMDA, EMA FDA, & TGA.
Audit representation: Successfully faced audits from various international companies and regulatory agencies from R&D perspective.
Major contribution in dossier preparation (CMC section) and obtaining marketing approval in Japan and cGMP approval in Europe for Lupin’s flagship product.
Intellectual property assessment for product, process, formulation and method of use for various biosimilar molecules in the pipeline.
Project management with respect to product developmental timelines, budgeting, reduction in cost-of-goods and thereby increase return on investment.
Novel technologies evaluation and further development of pipeline.
Manpower development and optimizing FTEs.
He worked in various capacity for organisations like Avesthagen Ltd, Intas Biopharmaeuticals Ltd, National Dairy Development Board. Bestowed “Best Leadership” award by Intas Biopharmaceuticals, 2008-09
▪ Awarded Gold Medal by the Indian Veterinary Association for the best research article published in the Indian Veterinary Journal, 1993.
▪ Awarded Silver Medal for securing First Position in 2nd Year B.V.Sc. & A.H. by the Bombay Veterinary College in the year 1977.
Membership of Scientific Bodies
▪ Member (Life) – Society of Biological Chemists, India
▪ Member (Ordy) – Indian Dairy Association
▪ Member (Ordy) – Indian Society for Veterinary Medicine
▪ Member – Expert’s Advisory Committee constituted by the Govt. of Gujarat, for setting up a Bio-tech Park at Savli, Vadodara, India, 2002-03
▪ Member – American Association for the Advancement of Science, 1997
▪ Member – Research Advisory Committee of Biotechnology Division of National Dairy Development Board, 2002-2006
▪ Expert Nominee – Committee for the Purpose of Control and Supervision on experiments on Animals (CPCSEA), Ministry of Environment & Forests, Govt of India, 2003-04
▪ Member – Draft Biotech Policy Document of Gujarat, 2004-2005
▪ Member – Standing Committee on Animal Health (Mastitis) of the International Dairy Federation, 2004-2006
▪ Core Member – Institutional Biosafety Committee (IBSC), Intas Biopharmaceuticals Ltd., Ahmedabad, 2008-2010
▪ Member, Expert – Boards of Studies, M.S. University of Baroda, Vadodara, 2005-2011.
Publications / Patents / P
13 peer-reviewed publications in international and national journals.
▪ 1 book chapter published internationally.
▪ 1 editor, proceedings of an International workshop.
▪ 3 international patent applications filed (two granted)
Qualification: M.Pharm, PGDM, PhD
Premnath Shenoy is a senior consultant and has over 30 years of industry experience in the area a Pharmaceutical research, Regulatory Affairs and Quality assurance working for small, mid-size, and large pharmaceutical organizations. Dr Shenoy has extensive experience in Formulations, API/drug substance manufacturing, non-sterile and sterile product production, laboratory management, and performing compliance audits. He is an experienced trainer and has developed and implemented customized developmental and remedial programs. Dr Shenoy has also published research papers, technical articles and delivered presentations at industry meetings in India and abroad on topics such as GMP, Risk Assessment and Quality management systems and Regulatory Affairs. He has published a book “Handbook of Pharmaceutical Quality Assurance
Over 30 years of experience is in the area of Product Development, Quality Control, Analytical Research, Quality assurance, Regulatory Affairs and Safety, Health and Environment. Experience in both domestic (FDC Limited) and MNC pharmaceutical Companies (Cyanamid and AstraZeneca).
Authored over 30 research papers and published a book “Handbook of Pharmaceutical Quality Assurance
Professional and networking activities:
Recognitions/Awards
Dr. Subramanian .S. Iyer is a seasoned corporate executive with a proven record of success in both small and large pharmaceutical companies. His background is focussed on analytical chemistry and quality management systems. With over 25 years of corporate experience, Dr. Iyer held various roles of increasing responsibility at Mylan Laboratories in Analytical and Quality departments for nearly 15 years, the last position held was, Vice President, Head of OSD Quality – India R&D, where he was responsible for Compliance and Quality Systems. Prior to Mylan, Dr. Iyer served as Chief Scientist in Orchid Healthcare. Earlier he served as Senior Scientist in Ranbaxy Laboratories (currently Sun Pharma). Dr. Iyer started his career at Ipca Laboratories. He received his PhD in Chemistry from Bombay University and did his post-doctoral research work in State University of Ghent, Belgium and Delft University of Technology, Netherlands respectively. His research work was primarily on Separation Chemistry focussed on chromatography. He is a member of United States Pharmacopeia India Stakeholder Holder Forum, American Society for Testing and Materials, European Compliance Academy and Chromatographic Society of India. He has delivered several invited lectures and authored number of scientific articles in peer reviewed publications. His core areas of interest are Analytical Chemistry, Instrumentation, Training and Quality Management Systems.
Mr. Sunil Singhai is a highly qualified professional who has gathered more than three and a half decades of experience across pharmaceutical companies of repute. He possesses an innate understanding of the pharmaceutical industry and the technologies associated with the manufacturing and approval processes. In addition to these skills, Mr. Singhai has an enviable record of receiving regulatory approvals from international agencies like USFDA and MHRA. He has an experience of 28 years in designing and managing facilities for manufacture of Parenteral Products.
An in-depth understanding of Pharmaceutical manufacturing, Global Capacity Planning, Global Technology Transfer and Facility Projects with more than 35 years of experience in reputed Pharmaceutical organizations.
A hands on experience in Pharmaceutical and Biopharmaceutical Facility design with containment using modern concepts for Injectable and OSD formulations. in technology transfer; troubleshooting; manufacturing; facility design and construction; capacity planning; and regulatory approvals. He last worked as Vice President, Formulation Technical Operations Division for Dr. Reddy’s Laboratories Limited. His expertise areas include Responsible for Technical functions globally, which includes; Product transfers and validation, Cost improvement and alternate vendor development program, Analytical excellence, Capacity planning, packaging development, Troubleshooting, Techno-commercial negotiations, Facility and equipment qualification, Computer and cleaning system validation
Over the years, he has been associated with a number of leading pharmaceutical companies like Dr. Reddy’s Laboratories, Ranbaxy Laboratories and Parke Davis Limited in various high-ranking and responsible positions. His academic qualifications reflect his knowledge and technical prowess, as he was an All-India Gold Medalist during his B. Pharm. and has passed M. Pharm. with a first class too.
Mr. Singhai has been presenting papers and delivering keynote addresses on many technical topics. He has been a valued member of many Committees and Chapters, contributing towards its growth and stature.
Received “Chairman’s Excellence Award”, which is highest internal honor and recognition, under best team initiative category for the aforementioned project.
He completed transfer of 171 sales keeping units (SKUs) in a record time of 10 months from Betapharm Germany and created global benchmark.
He was awarded with “Chairman’s excellence award” for best team initiative, for the aforementioned project.
he was also involved in design and creation of one of the best state-of-art Injectable facility with fully integrated isolators and ball room design concept for the first time in Asia for complex injectable products.
He has rich professional experience of 26+ years in development and filing of different dosage forms. Filed about 250 ANDAs and 505(b)(2) NDAs with US FDA and 50+ generic products in Europe and 25+ in Australia. Experience of developing and filing various dosage forms including Solid Orals, Liquid Orals, Sterile dosage forms (Injectable and Ophthalmic), Topical and Transdermal Delivery system. Extensive experience on development of Modified Release dosage forms. He is very well versed with regulatory requirement of various countries. He has granted 29 patents in US and 150+ patents in Europe.
He was the member of team involved in development and scale up of Cipro OD in Ranbaxy which was out licensed to Bayer (US).
Development, scale up and launch of Metoprolol XL tablets in Wockhardt. It was second generic approved against Toprol XL in 2010. I was awarded Chairman’s Trophy for approval and launch of the product. Was involved in filing and approval of multiple FTFs
Since Sep 2020 Onwards he has started on his own Cochlea Pharma, they work as CRO for product development and also provide retainer services for a particular product (or set of products) and R&D.
He last worked in Slayback Pharmaceuticals Inc.as Senior Vice President and Head – Global R&D and Head – Indian Operations,
His responsibilities included guiding the team in development of various dosage forms; setting up various development and quality systems. Also coordinating with CROs and CMOs for various activities including costing.
He also worked in Alkem Laboratories Ltd, Taloja, Maharashtra as President R&D (Team size: 400+) The responsibilities included leading R&D at Taloja, Raigad, Maharashtra and R&D team at St. Louis, Missouri, USA.
Guiding all teams (formulation, analytical, packaging, process development, BE centre, regulatory affairs) in development, filing and launch of products for domestic, ROW and Regulatory markets (especially US, Australia and EU). The various dosage form includes Solid dosage forms (tablets, capsules, sachets, powder, dry suspensions) (Immediate release, delayed release, modified release, dual release etc.), liquid dosage forms (solutions/ suspensions), topical products, nasal solution, sublingual and buccal film and transdermal delivery system. Also involved in development of device for topical application.
Involved in evaluation and due diligence for acquiring a facility in US.
Filed 60+ ANDAs with USFDA and 25+ products each in Australia and EU. The products include FTF products and NCE-1 products.
35+ products approved by US FDA including topical products and nasal solution.
Preparing R&D budget and getting approval from management.
He also worked with organisations like Wockhardt Limited, Aurangabad, Maharashtra as Senior Vice President – Pharma Research He handled team size of 200+
He was the Head – Formulation Development and Analytical Research (formulation)
His responsibilities included
Teams at Aurangabad, Maharashtra and MGP – Chicago, Illinois, USA.
Guiding team of scientists for development of various dosage forms for ROW and Regulated markets. The various dosage forms included Solid dosage forms (tablets, capsules, sachets, powder, dry suspensions) (Immediate release, delayed release, modified release, dual release etc.), liquid dosage forms (solutions/ suspensions, Modified Release liquids) and sterile products (solution and lyophilised injections, depot injections and Ophthalmic products) Also involved in development of pen device.
Involved in development of formulations for NCEs (Solid orals and large volume injections).
More than 150 ANDAs filed with US FDA and more than 30 generic products in Europe.
Involved in due diligence for acquisition of overseas companies.
I was involved in planning of budget and taking necessary approvals from Chairman.
He also worked for Ranbaxy Research Laboratories, Gurgaon as Associate Director – NDDS
He handled responsibilities like Project conceptualization, Strategizing Formulation Development Plan, Project Management and timely delivery of products for various countries (especially advanced countries) by co-ordinating activities Development, Analytical, Clinical, Packaging and manufacturing groups. Filed many NDDS ANDAs including FTF with USFDA and generic products in Europe.
Assisting Vice President –NDDS in group activities including budgeting and planning.
Development of MR formulations of NCEs and filing INDs of NCEs
He was also senior Research Fellow, CSIR, New Delhi. Teaching of undergraduate classes along with Research Project.Lecturer, in different colleges including College of Pharmacy, Delhi
Examiner for M.Pharm (Part 1) Pharmaceutics, Univ. of Delhi (Session 2003-2004)
Dissertation (25+) submitted to various Universities including BITS Pilani, Manipal Academy of Higher Education, Tamilnadu MGR Medical University, Panjab University Patiala, RVS College of Pharmaceutical Sciences Sulur, RC Patel College of Pharmacy, under my supervision leading to award of M.Pharm degree.
His other extra-Curricular activities include
Member, Local Organizing Committee, 37th IPC, New Delhi, Dec 1985
Co-Chairman, Accommodation Committee, Local Organizing Committee, 45th IPC, Dec 1993
Joint Secretary, IPGA, 1992-1996
Educational Qualifications:
April, 1996: Ph.D. in Pharmacy, Univ. of Delhi. Thesis entitled “Development of Transdermal Drug Delivery System for Vasoactive Drugs” (thesis submitted in 1994)
He has ten Publications in various National and International Journals
Eight presentations in various National and International conferences and Seminars