Malay Shah

A professional Pharmaceutical Scientist, Ph.D. In Pharmaceutical Science; total experience: 14+ years; over 12 years of industrial experience in formulation development, including strategy development and design, pre-formulation studies, formulation development, IVIVC for generics, complex generics, and NCE products. Proven leadership in 505(b)(2) and complex generic product development, leading projects from concept to clinical phase. Trusted by leadership for strategic input on high-budget, high-impact R&D programs, leveraging a foundation built on academic research in nanotechnology. Involved in several successful INDs, NDAs, ANDAs, and part of several CMC strategic meetings with the FDA.

•Long been associated with nanotechnology based drug delivery, from M.Pharm and PhD research

•Assigned to lead complex and high value 505(b)(2) programs with high commercial impact and strategic importance. 90% projects are complex in nature and high budget and high value products.

•Project often featured unique formulation, scale up and delivery challenges requiring customized designs and execution strategies.

•Liposome is an excellent example. One of the fastest developed complex product since its first experiment. Prototype is developed and animal PK sameness achieved in just 2.5 Years.

•Products are approved in US, EU, Canada, India and in other emerging markets.

• Scale up and technology transfer: Hands-on experience from R&D to GMP, clinical batch manufacturing, and site tech transfer
• Regulatory interactions: participated in multiple FDA meetings addressing CMC components Reviewing and drafting FDA query response. Authoring and reviewing development reports, formulating rationale, and writing CMC sections for IND, NDA, and ANDA
• Cross-functional collaboration (internal and external): responsible for liaising between R&D, regulatory, QA/QC, clinical, and manufacturing teams for project alignment and execution. Worked in collaboration with professors from international universities, international CROs like Eurofins, Quintiles, PPD, and vendors like Thermo Scientific, IMSTec, Cole Parmer, Cytiva, Merck, Lipoid, Avanti, and Evonik, and worked with vendors in developing special excipients, oversaw external partnerships for analytical testing, complex characterizations, critical raw materials, preclinical testing, and clinical batch supply
• Budget planning and control: accountable for planning and managing multi-crore budgets, ensuring scientific rigor without compromising cost efficiency
• Timeline and milestone management: defined and tracked project milestones from concept to manufacturing stage, and filing to launch stage, with on-time delivery focus. Prioritized activities, resolved conflicts, and ensured team alignment to meet aggressive timelines and regulatory expectations

• Internal Expert Advisor Across Multiple Product Development Initiatives: Reviewed and commented on clinical and PK study protocols, offering scientific insights to optimize study design. Delivered top line on demand scientific opinions and secondary reviews for internal decision making and strategy refinement.
• Project Feasibility Evaluation (Pre-PIF): Involved in project feasibility evaluation for introducing new project to the portfolio.·Responsible for evaluating in-licensing opportunities.
• In-licensing Opportunity Evaluations: Provided expert evaluations of in-licensing opportunities, including comprehensive assessments of CMC, Manufacturing, pharmacokinetic and clinical data to inform go/no go decisions.
• Successful Ideations: Led concept proposals from early ideation (1-pager) through detailed evaluations (up to 30 pager), supporting preclinical and clinical development. Project successfully commercialized.

• Approval of several products in US, Europe, ROW countries and in domestic markets.
• Star Research Award 2022 in Sun Pharma for excellent performance & leadership.
• Three times recipient of "Shining Star Award" in Sun Pharma for excellent performance & leadership
• Qualified GATE, IIT Kharagpur, 2006 with GATE Score 92.22%.
• Recipient of Merit Scholarship from AICTE in M.Pharm.
• Best Research Paper Award in an International Conference "Bangalore Nano 2007".
• Recipient of JRF and SRF Awards in PhD by Ministry of Home Affairs, New Delhi, Govt. of India.

Book Chapter

• Ajay J. Khopade and Malay Shah, Challenges for Commercial Translation of Nanomedicines: From Lab Scale to Production Scale, Commercial Scale Production of Nanomedicines, CRC Press, 2025.

Research Articles

• Ajay J. Khopade, Malay D. Shah, Bhushan Borole. A Novel Self-Assembled Paclitaxel Nanodispersion Facilitates Rapid In-Vitro/In-Vivo Dissociation and Protein Binding. AAPS PharmSciTech(2025) 26:9.
• Ajay J. Khopade, Malay D. Shah, Bhushan S. Borole, and Vinod Burade. Antitumor Efficacy of Paclitaxel Injection Concentrate for Nanodispersion in Patient-Derived Breast, Head and Neck, and Non-Small Cell Lung Cancer Mouse Xenografts. AAPS PharmSciTech(2025).
• Ajay J. Khopade, Malay D. Shah, Bhushan Borole.Development of Paclitaxel Injection Concentrate for Nanodispersion. AAPS PharmSciTech(2025).
• Ajay J. Khopade, Malay D. Shah, Bhushan S. Borole, Bharat Patel, Bharat Pateliya and Vinod Burade. Preclinical Toxicity and Pharmacokinetic Evaluation of Paclitaxel Nanodispersion.AAPS PharmSciTech(2025).Arindam Halder, Malay D. Shah, Bharat Pateliya, Vinod Burade & Ajay J. Khopade. A Gel-Free Reservoir System for Once-a-Day Ophthalmic Delivery of Timolol Maleate. Journal of Pharmaceutical Innovation. 29 November 2021
• M.D. Shah and Y.K. Agrawal, High throughput screening: An in silico solubility parameter approach for lipids and solvents in SLN preparations, Pharmaceutical Development & Technology, Pharm. Dev. Technol., 18(3), 582(2013).
• M. Shah and Y.K. Agrawal, Development of ciprofloxacin HCL based solid lipid nanoparticles using ouzo effect: an experimental optimization and comparative study, Journal of Dispersion Science & Technology, Journal of Dispersion Science and Technology, 34(1), 37(2013).
• M.D. Shah and Y.K. Agrawal, Ciprofloxacin Hydrochloride Loaded GlycerylMonostearate Nanoparticle: Factorial Design of Lutrol F68 and Phospholipon 90G, Journal of Microencapsulation, 29(4), 331(2012).
• Malay Shah, Namdeo Jadhav, Y.K. Agrawal. Carbon Nanotube as adsorbent for floating microsphere of Diltiazem Hydrochloride. Fullerenes Nanotubes and Carbon Nanostructures. 17:5, 528 - 547, 2009.
• M.D. Shah and Y.K. Agrawal, Carbon nanotube: a novel carrier for sustained release formulation, Fullerenes Nanotubes and Carbon Nanostructures, 20(8), 696(2012).
• M.D. Shah and Y.K. Agrawal, K. Garala, and A. Ramkishan, Solid lipid nanoparticles of a water soluble drug, ciprofloxacin hydrochloride, Indian J. Pharm Sci. 74(5) 434(2012).
• M.D. Shah and Y.K. Agrawal. Calixarene: A new architecture in the pharmaceuticals, Journal of Scientific and Industrial Research, 71, 21(2012).
• Jaydeep Patel Kevin Garala, Parth Joshi, Malay Shah, A Ramkishan. Formulation and evaluation of periodontal in situ gel, International Journal of Pharmaceutical Investigation, 3(1), 29(2013).
• K Garala, J Patel, A Patel, M Raval, M Shah, A Dharamsid, Development and Evaluation of Carbon Nanotubes Doped Sustained Release Microspheres of Metoprolol Tartrate, Current drug delivery, 2012.
• A Novel Swollen Micelles Microemulsion Based Formulation of Latanoprost. ARVO, 2017
• Studies on use of multiple walled carbon nanotubes in sustained drug delivery" was presented at 1st International Conference "Bangalore Nano 2007", Bangalore, December 2007
• Synthesis and characterization of Candesartan Cilexetil loaded functionalized Multiwall Nanotube adsorbates" was presented at International Conference on Advanced Materials and Applications (ICAMA -2007), Shivaji University, Kolhapur November 15-17, 2007
• Solubility: Techniques of solubility enhancement" in symposium on Recent Trends in Drug Discovery & Development, 28th March 2007, at Sangli
• Effect of Different Polymers on Diffusion of Drug from Transdermal Matrix Patches" in PCI sponsored two day orientation programme on Current Development in Pharmaceutical Technology and Practice, 16th &17th Feb 2008, at Pusad
• Studies on Carbon Nanotube adsorbates". Was presented at International Conference on Advanced Materials and Applications (ICAMA-2008), Shivaji University, Kolhapur December 9-11, 2008
• Presented Demonstration in National Level Competition on "Nanotechnology Based Model designing" organized by Institute of Research and Development, Gujarat Forensic Sciences University. Theme of my work is "Carbon Nanomaterials Based Swathe Outweighing Deodorants". 2010

• Certified training on "7 Habits of Highly Effective People" by Franklin Covey
• Leadership Development Program by IBS, Pune
• I-Dev Plus" an immersive 120 days learning & development journey from Jombay
• 21st Century Quality Program by Light Pharma
• QbD Training by Light Pharma
• Statistical Analysis in Pharmaceutical Product Development by Minitab Inc.

• Senior Research Fellow (June 2010-August 2011) Gujarat Forensic Sciences University, Gujarat, India.
• Junior Research Fellow (Nov 2009-June 2010) Gujarat Forensic Sciences University, Gujarat, India.
• Junior Research Fellow (June 2007-June2008) Bharati Vidyapeeth College of Pharmacy, Kolhapur.

Stabilization of Phenobarbital sodium for Injection (US Patent granted in 2023)

• Leadership & Decisiveness
• Proactive/Due Diligence
• Conflict Resolution Capabilities
• Quick Learner
• Coordinator
• Work Ethic
• Data Analyst
• Planning & Strategy