CHIEF SCIENTIFIC OFFICER

A competent professional with 20+ years of experience in Formulation Development, Technology Transfer, Business Development, Project Management & Team Management in the Pharma Industry. Till-date, achieved 125+ product filings of varied complexity. Specialised in ANDA PARA I, II, III, IV, FTF PIV filings; CBE-0, CBE-30 & PAS; 505b2 route scheduled meeting with USFDA & filing; Patent review & strategising; USDMF / ASMF / CEP review; Well versed in development of all kinds of dosage forms like Tablets, Capsules, Powder for oral Suspension, Powder for oral Solution, SMEDDS, SNEDDS, Liquid filling into Hard Gelatin Capsules, Sterile Powder for Topical applications, Ophthalmics and Parenterals. Hands on experience in the preparation of manufacturing dockets for Exhibit, Scale up, Validation, Technology transfer / Site-transfer bridging trials and Commercial batches of ANDA, EU Dossier & ANADA. Sound knowledge in Formulation of New Chemical Entities (Preclinical- IND, Clinical trial Phase-I, II, III) as well as hands on experience in developing NDDS products (Controlled and Sustained Release Dosage Forms). Expertise in Spray Drying Technology for Taste Masking & Polymeric form conversion of active pharmaceutical ingredients. Hands on experience in Freeze Drying Technology for Solid orals and parenteral drug products. In my present company additionally as Head-Plant operations, realized full operation of facility within 1.3 years from the date of management's conceptualization. During Covid-19 pandemic, as part of “MAKE IN INDIA” campaign successfully developed and commercialized value-adding products for India market. The products include, Turmeric Chewables, Chlorine Dioxide based Fumigation technology (Effectiveness of this technology was recognised and approved by NIPER; Applied for ‘Product Commercialization Program Fund’ with BIRAC), Nitric Oxide based Nasal Spray, Nutritional supplement Tablets with essential inorganics for immune boosting and L-Acetyl Cysteine based Oral emulsion. Implemented "Pharmaco-economics" for efficient commercial operations (i.e. accounting total time from dispensing to palleting including clearance & change-overs). For a product of conventional mfg, an output of minimum 700 units per minute and for a product of complex mfg an output of minimum 100 units per minute is my target. The list of Platform technologies which were successfully non-infringed using cost-effective conventional approach include, CODAS®, SODAS®, GEOCLOCK®, GEOMATRIX®, MICROCAPS®, ADVATAB®, OROS®, ORASOLV®, ZYDIS®, MMX®, o INLAY® [OSDrC (One-Step-Dry-Coating) Technology], DBT®, TIOPCT® [3-in-1 Patented Capsule Technology], MELTREX®, MICROSPHERE TECHNOLOGYTM, o MNP® [Miscellar Nanoparticle Technology], SMP® [Solvent Microparticle Technology], o DCMS [Diffusion Controlled Matrix System], ECMS [Erosion Controlled Matrix System], DCRS [Diffusion Controlled Reservoir System], GRDDS [Gastro-Retentive Drug Delivery System] and PDPIHMRS [pH Dependent pH Independent Hybrid Matrix-Reservoir System]. 16 research publications on formulation of drug products involving varied complexity and challenges has been done. Member & Collaborator WITH IDMA, IPC, IPA, PCI, TNPC, NIPER FOR INDUSTRY-INSTITUTE PARTNERSHIP Forums and an active resource person in workshops of such forums. [IPA 2019 CHENNAI CHAPTER – TEACHER TRAINING PROGRAMME; IDMA 2021 KERALA CHAPTER – UG & PG TRAINING PROGRAMME; GUEST LECTURE SERIES 2022 TO UG, PG & Ph.D STUDENTS OF NIPER-HAJIPUR; UG TRAINING PROGRAMME 2022 DR KALAM COLLEGE OF PHARMACY ON QA & NDDS TOPIC]. Contributed to the development and growth of Pharmaceutical Sciences by, Providing expert opinion-2022 on ‘Value Addition Course’ in the B.Pharm curriculum of Annamalai University. Proposed for a course on “Intellectual Property Rights & Patent Law” with a full workable draft of 5 Chapters (Theory & Practical). Being a part of USP-NF online forum since 2015. Have suggested a) Inclusion of formulation scheme for novel drug delivery systems in USP general chapter; b) Inclusion of monographs for nano-materials, biological reference standards and excipients for biological preparations. Commented and suggested a framework on the draft policy entitled “Catalyze R&D and Innovation in the Pharma-MedTech Sector in India”. F.No. 50020/5/2020-NIPER, Department of Pharmaceuticals, Indian Ministry of Chemicals and Fertilizers, Dated. 25th October 2021. As of 2022 under my supervision, about 61 Undergraduates (Final B.Pharm) underwent In-plant training for a month; 38 Postgraduates (Final M.Pharm) underwent 6-8 months training for M.Pharm dissertation work and 7 Pharma Ph.D research scholars (Full-time) have availed drug, excipients and other resources for their doctoral research. Personally I have high regard and respect for “Industry – Institute Partnership or Collaboration”.