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An introduction ...

Dr. Shruti Bhat. An introduction . Qualifications:. MBA in Business Administration and General Management from ITM-Southern New Hampshire University (SNHU) USA; Dec 2007. Patent Agent, Nov 1999

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An introduction ...

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  1. Dr. ShrutiBhat An introduction ...

  2. Qualifications: • MBA in Business Administration and General Management from ITM-Southern New Hampshire University (SNHU) USA; Dec 2007. • Patent Agent, Nov 1999 • Ph.D (Tech.) in Pharmaceutics- Industrial Pharmacy from K.M.Kundnani College of Pharmacy, India; Jan 1995 • M.Pharm. Sci. In Pharmaceutics from K.M.Kundnani College of Pharmacy, India; Jan 1991.

  3. Industrial work experience : Associated with many known companies of repute such as: • Pharmascience Inc., Canada, Director R&D. • Novartis Global Services, Group Head PHD- R&D • Unichem, General Manager PTD • Macleods, Manager R&D and Patents • Searle, Asst. Manager R&D • FDC, Executive R&D

  4. Summary of achievements : Shruti has an illustrious career spanning over 18 years. Her primary focus has been to efficiently lead and direct drug product development programs. She is self motivated, result oriented and has exhibited comprehensive business and technological competence to lead, direct and motivate teams. She has a thorough understanding of US, Canada, Brazil, European regulatory and WHO requirements as well as the comprehension of the inherent complexities between product development requirements for these markets. Shruti’s principal area of expertise include directing research of solid oral dosage delivery systems such as conventional and extended release tablets, capsules and pellets, strategy development, program & project management, technology transfer, trouble shooting & process improvement with a understanding of practical constraints and opportunities.

  5. She also has : • Excellent credentials as a problem solver and innovator. • Proficiency in guiding development of sterile products such as injections, ophthalmic drops and ointments, as well as novel formulations viz colon targeted, cyclodextrin and ion- exchange based therapeutic systems and DPI (inhalation) capsules. • Expanded her skills in directing development of cosmé-ceuticals, such as shampoos, creams, gels, lotions and dusting powders. • Guided development of more than 600 formulations (of 15 different therapeutic categories), now being sold in over 40 countries across the globe. • Extensively implemented statistical optimization designs, quality-by-design (QbD) and lean 6 sigma principles in research laboratories thereby shortening development lead times and generated savings as much as 30% in overall project expenses of drug product development programs.

  6. She also has : • Introduced practices of lean Six Sigma in clinical batch manufacturing operations, reduced overheads and increased capacity utilization by 20- 25 %. • Worked proactively in strategizing risk analysis tools and used process analytical technology (PAT) during scale-up & technology transfers of new products and generated savings up to 65 % during product transfers for commercialization. • Successfully steered and motivated large cross-cultural teams and led huge budget portfolios. She has also been particularly involved with strategizing and setting up as much as 60 M USD sophisticated product development research facilities. • Worked extensively with product due diligence, facility audits as well as advising ‘products of future’ for new business portfolios.

  7. She also has : • In addition to her scientific research pursuits, Shruti has hands-on experience with patent drafting and infringement opinions. • She has drafted several patents for Canada, US, Japan, India and PCT applications. Some of the patent applications drafted by her include subjects such as bulk drug substances, finished formulations, medicated devices, agro chemicals, intermediates and agro formulations. • Her skills as a research scientist further helps her in advising patent by- pass strategies to conduct research in Generic medicines, OTC, other consumer health care, cosmetics industry and medicated device manufacturers and also to advise Executive boards of pharmaceutical companies on intellectual property & patent/ contest strategies for business growth. • Besides performing an active role in industrial R&D, Shruti has also continued maintaining her ties with academic institutions. She has been examiner for M.Pharm and Ph.D students at university of Mumbai. She used to conduct lectures for post-graduate and doctorate students in the subjects of Industrial pharmaceutics, statistics and technology.

  8. Awards and accolades : • Pioneer – “Young Scientist Award 1997-98” by PAMDAL – COLORCON for significant contribution to research in Pharmaceutical Sciences. • GOLD MEDAL and alumni achievers award from Prin. K.M.Kundnani College of Pharmacy Worli. • INVENTOR for seven patents – including research on development of novel delivery systems of prednisolone, meloxicam and cefixime + probiotic and valdecoxib • RESEARCH SCHOLAR 1992-94 – Ministry of Human Resources Development, Govt. of India.

  9. Awards and accolades : • IDMA (Indian Drug Manufacturer’s Association) Research Award for the year 1991-92for best research paper published in the faculty of Pharmaceutics. • IDMA (Indian Drug Manufacturer’s Association) Research Award for the year 1992-93for best research paper published in the faculty of Pharmaceutics. • Late Smt. Jethibai H. Jagtiani Research Award and Certificate of Merit for – Sincerity, Quality and Quantity of Research work 1989-90. • Late Smt. KamlaBalwani Award and Certificate of Merit for - Advanced Research work in Hi-Tech areas 1992-93.

  10. Affiliations : • Member, Canadian Society of Pharmaceutical Scientists. • Member, Controlled Release Society, USA. • Registered Pharmacist- Pharmacy Council of India. • Registered Patent Agent, Govt. of India. • Life Member, Indian Pharmaceutical Association.

  11. Patents, papers and publications : Shruti has 10 patents and numerous papers and review articles published in pharmaceutical journals of repute. For further information, please visit : www.Pharm-Education.com www.QA-Expert.com www.innoworksltd.com

  12. Technical Expertise : • Product development of galenicals, NDDS and speciality products. • Therapeutic categories handled include- NSAIDS, antibiotics, anti-TB, anti- diabetics, cardiovasculars, CNS, anti- retrovirals, proton pump inhibitors, anti- malarials, vitamins, probiotics, herbal, steroids, anti-osteoporotic, anti-emetics, ORS, anti-glaucoma etc. • Dosage forms developed include- Tablets, capsules, pellets, injections, creams, gels, and eye drops. • Delivery systems handled include- Conventional , delayed release, controlled release, chewable, dispersible, fast-disintegrating, effervescent, colon targeted, buccal, gastro-retentive etc.

  13. Technical Expertise : • Bio-pharmaceutical classifications • Dissolution efficiency and improving bio-availability of poorly soluble drugs. • Quality-by- Design. • Statistical experimental designs. • Process improvement and trouble shooting. • Thorough knowledge of manufacturing and packaging equipments. • cGLP, cGMP and Good documentation practices. • Expert with patent filings, strategy design and application. • Worked with generic, innovative, OTC , bio-tech based and medicated cosmetic products.

  14. Managerial Expertise : • Good leadership skills. • Good strategy design and implementation skills. • Good budgeting skills (capital and operational) and cost control. • Hands-on with project management. • Good soft skills- Problem solver, motivator, team builder. • Good communication skills. • Successfully worked in a multi-cultural work environment. • Extremely adaptive with information technology usage in work place.

  15. Opportunities : Looking forward to do business with companies worldwide. Looking forward for DIO opportunities in : • Canada • Europe • Africa • USA and Latam. • S.E.Asia viz. India,China, Bangladesh etc. • Australia and New Zealand. Email : Contact@innoworksltd.com Email : drshrutibhat@gmail.com

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