Dynamic pharmaceutical R&D leader with over 20 years of expertise in formulation development, drug delivery systems, and strategic plant setup. Proven ability to establish and scale state-of-the-art R&D facilities, foster third-party collaborations, and drive business development initiatives that align scientific innovation with commercial success. Adept at leading large teams, managing cross-functional projects, and ensuring regulatory compliance across global markets. Passionate about advancing healthcare through innovative formulations and strategic partnerships that deliver value to patients and stakeholders alike. Spearheaded formulation development for oral solids, injectables, and novel drug delivery systems, achieving multiple successful launches in regulated markets (US, EU, ROW). Directed R&D plant setup projects, from concept design to commissioning, ensuring GMP compliance and operational efficiency. Established and nurtured strategic third-party collaborations with CROs, CMOs, and academic institutions to accelerate innovation and expand development capabilities. Partnered with business development teams to identify new opportunities, evaluate licensing deals, and support portfolio expansion strategies. Oversaw technology transfer, scale-up, and validation activities bridging lab innovation with commercial manufacturing. Collaborated with regulatory affairs to prepare IND, NDA, ANDA, 505(b)2 and global dossier submissions, ensuring compliance with FDA, EMA, and WHO guidelines. Implemented QbD (Quality by Design) and risk-based approaches to streamline development and reduce costs. Championed innovation initiatives, resulting in patents and proprietary formulations in sustained-release and bioavailability enhancement.

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Arshad Alam is Heading Manufacturing Science and Technology (MSTG) – Respiratory and part of Cipla Leadership Group up at Cipla Ltd. He has more than 17 years of diverse experience in pharmaceutical industries covering an array of roles in drug substance and drug product, development to manufacturing. His key focus is achieving product robustness in respiratory products by application of process engineering, technical subject matter expertise, advanced data analytics and new technologies. Prior to joining Cipla, Mr. Alam was associated with Dr. Reddy’s in the process engineering department for 7 years.

Mr. Alam is a chemical engineer with master’s degree in chemical engineering from IIT-Kharagpur. He is also certified six sigma Black Belt from Indian statistical Institute-Bangalore. He has been credited with two process patents for the development of amorphous drug substances. Mr. Alam is a well-known speaker in process robustness, QbD - process engineering and Process Analytical technology. He has presented his work in many national conferences.

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• Dr. Manoj K Singh hold over 30 yrs of professional experience of working with global pharma companies leading their Analytical labs to support different pharma work-flows.
• He holds a Ph.D. degree (Chemistry).
• He started his professional career in 1993 with Wockhardt and spent significant tenure at major pharma R&Ds like Lupin, Novartis, Orchid, Dabur, fressenius-kabi & Sentiss Pharma.
• Currently he is associated with MicroLabs Bangalore as Senior Vice President (ADL) leading team of Analytical Chemistry scientists to support formulation development, Validations and method transfer.

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M.Pharm., with 20 years of experience for Phase specific Formulation Development for NCE and Formulation Development for Generic products spanning from Prototype Formulation Development, Process Development and in manufacturing Science and Technology.

Currently working with Piramal Pharma Solutions – Associate Director and Head Formulation CDMO Vertica Clinical Manufacturing Operations since Sept -22

Previously worked with

• Sandoz Pvt. Ltd.- a Novartis Company as Formulation Scientist for 6.3 Years and thereafter as Assistant Manager – Manufacturing Science and Technology
• Colorcon Asia Pvt. Ltd, as Area Technical Manager.
• Dr. Reddy's Lab for 5 Years
• Team Leader – Manufacturing Science and Technology
• Tech Lead Formulation Research and development
• ar Formulations, Endo International company as Group Leader Formulation Development
• Dr Reddy’s Lab as Process Expert – Process Engineering and Formulations

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Seasoned Pharmaceutical Professional with over 26 years of experience in formulation development, specializing in Generic Product Development and Novel Drug Delivery Systems.

Expert in Product Commercialization with extensive experience in scaling up Solid Dosage, Suspension and Emulsion products, implementing Pellet Coating technology, and managing technology transfers.

Leadership and Team Management adept at designing product development strategies, managing a team of scientists, and coordinating cross-functional departments to ensure timely product delivery.

Academic and Industry Contributor with a PhD, active participation in conferences, and a role as an industrial guide and faculty member, fostering the next generation of pharmaceutical professionals.

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Dr. Bimlesh Ojha is a biopharmaceutical professional having 15 years of experience in academia and industry. Currently he is serving as an Assistant General Manager in Formulation Research Laboratory (FRL) at Advanced Biotech Laboratory (ABL) of Ipca Laboratories Ltd., Mumbai since 2025. He oversees the formulation development, drug product process development and technology transfer for scale-up and manufacturing of biosimilars. Previously, he has held lead positions in formulation and analytical development of biosimilars at GeneSys Biologics Pvt. Ltd., Wockhardt Ltd. (Biotech) and Dr. Reddy's Ltd. (Biologics). He holds a Doctoral degree in Biophysical Chemistry from Indian Institute of Technology Guwahati, Assam and Master degree in Organic Chemistry from Gauhati University, Assam

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PROFESSIONAL HIGHLIGHTS:

Pharmaceutical professional with 18+ year industry experience in Scientific and Management role. Expertise in various dosage forms like Nasal, Topical pharma, US Generic and OTC products, Aerosol, Oral care product formulation & manufacturing technologies for US/EU//Brazil/India/ROW Market. Proven track record in leading and managing projects from early formulation development through to commercialization, for both in-house manufacturing and external partnerships including CDMO, CRO, and CMO collaborations. Skilled in external site evaluations, third-party manufacturing assessments, and technology transfers, ensuring seamless execution and regulatory compliance and Due-diligence for external site and manufacturing plant Certified PMP® and PM (IIT) to lead & Management of project from initiation of development till commercialization for In-house manufacturing and CDMO/CRO/CMO

EXECUTIVE PROFILE:

Research & Development:

• Expertise in all types of products such as Nasal, Topical, US generic and OTC, Oral care, Ophthalmic, OSD, Personal care products, Aerosol and exposure to global regulatory requirements such as: US/EU//Brazil/India/ Emerging Markets/ROW etc.
• Successfully developed and commercialized Nasal product for Abbott, P&G, GSK, Walmart, Merck, Glenmark, DRL, Zydus, Cipla, Lupin and others
• Successfully developed, execution of scaleup batches and commercialization of Topical products with different study approaches like PARA IV, Q1/Q2/Q3, IVRT/ IVPT, Skin blanching, Biowaiver, CGT, DESI and Clinical study.
• Filed more than hundred for USA, Europe, Brazil as well as India market & received approvals
• Served as Head of Nasal Drug Delivery, providing strategic and technical leadership for nasal formulation development (Sava Healthcare Ltd)
• Lead a Team of 4 Vertical Manager and 22 Scientist for product development and scale up (Pontika).
• Managing & guiding laboratory execution, feasibility, optimization, scale up and exhibit batch manufacturing as well as trouble shooting at each stage
• Formulation development, optimization and Scale Up up to commercialization.
• Implementation of QbD concept and Design of Experiment (DOE).
• Review work progress to achieve project milestones and Successfully development, execution of scaleup batches and commercialization products.
• Handling of regulatory queries and providing support for the response submissions.

End-to-End Project Leadership: Driving formulation development from concept to commercialization for both internal and outsourced projects. Technology Transfer: Expertise in seamless tech transfer processes between R&D, pilot plants, and manufacturing sites (in-house or external).

CDMO/CRO/CMO Collaboration: Managing strategic partnerships for product development, scaleup, validation, and commercial manufacturing. Handled for national and international CMO and CDMO clients to support development and project transfers activities including project tracking and connecting to CFTs to meet the Clients project execution timelines.

External Site Evaluation: Conducting technical audits, capability assessments, and compliance reviews of third-party manufacturing sites.

Due Diligence: Evaluating potential partners for technical, operational, and regulatory fit to ensure robust outsourcing decisions.

Project management: Experienced in planning & project management from early stages to commercial stage for Abbott, GSK, RV Health Philippines, Sun Pharma, STADA, Dr. Reddy’s

CORE EXPERTISE:

Nasal Care Formulation – Nasal sprays, Nasal Drops, Nasal Mist, Saline-based solutions, Metered dose nasal and targeted nasal delivery for US/EU/DCGI/India Market Key achievement of Nasal Formulation:

Abbott:

• DCGI Metered dosed steroid products Approval within time frame
• Solspray (Isotonic Nasal spray_BOV Technology)
• Sodium chloride Metered dose nasal spray

Glaxosmithkline:

• Otrivin Nasal Advance metered Spray
• Otrivin Pedriatric Oxy nasal spray
• Otrivine Nasal Spray

PNG:

• Oxymetazolin+Dexpanthanol Metered Spray
• Oxymetazolin Nasal Spray

Wallmart:

• Equate Saline Nasal Spray
• Equate Saline Pediatric Nasal Spray

Merck:

• Nasivion Pedriatric Nasal Spray

Cipla:

• Neseline Nasal Spray

Lupin:

• Nesolup Nasal Spray

DRL:

• Nortriol nasal spray

Steroidal Nasal Products: For US/EU/Developed for Glenmark, Zydus, IH Development.

USFDA approval of CGT product Creams, Emulsions, Ointment, Gels, Foams, Sprays, Solution : US/EU/Brazil/ROW/India

• Worked on different topical bases for various drug molecules and filed for US/EU/Brazil/Row/India Market
• Successfully developed, execution of scaleup batches and commercialization of Topical products with different study approaches like PARA IV, Q1/Q2/Q3, IVRT/ IVPT, Skin blanching, Biowaiver, CGT, DESI and Clinical study.
• Received USFDA approval within timeline of Gold period (Within 10 M),
• USFDA approval of CGT product, USFDA approval of Para IV product and Successfully handled USFDA regulatory deficiencies and received approval of more than 30 Topical products

US OTC Product Development – FDA-compliant formulations Developed & commercialized multiple US OTC products, ensuring FDA compliance and successful market penetration

Liquids – Worked on Solution, Suspensions, emulsion as well as Microemulsion, Multivitamin, Syrup, Oral solution, Oral liquids etc.

Oral Care – Medicated toothpastes, mouthwashes, and mucoadhesive gels

Aerosol & Spray Technologies – Metered-dose sprays, foams, water-based aerosols, and continuous spray delivery

End-to-End Project Leadership: Driving formulation development from concept to commercialization for both internal and outsourced projects.

CDMO/CRO/CMO Collaboration: Managing strategic partnerships for product development, scale-up, validation, and commercial manufacturing.

Technology Transfer: Expertise in seamless tech transfer processes between R&D, pilot plants, and manufacturing sites (in-house or external).

External Site Evaluation: Conducting technical audits, capability assessments, and compliance reviews of third-party manufacturing sites.

Due Diligence: Evaluating potential

Regulatory & Quality Alignment: Ensuring all processes and sites (internal or external) meet cGMP, US FDA, EU, and other global regulatory requirements.

Cross-functional Coordination: Liaising with QA, RA, Supply Chain, and Commercial teams to ensure alignment and timely execution.

Cost Optimization & Efficiency: Identifying opportunities for cost savings, capacity utilization, and process efficiency across internal and partner facilities.

Present Organization: AGM Sava Healthcare

Total Experience: From Sept 2025 to till date

Past Organization: AGM Pontika Aerotech

Total Experience: From Feb 2023 to Aug 2025

Past Organization: Torrent Pharmaceutical (Manager)

Total Experience:From Aug 2015 to Feb 2023

Past Organization: Zydus Cadilla (Deputy Manager)

Total Experience: From March 2012 to Aug 2015

Past Organization: Glaxo Ltd, Nashik (Executive)

Total Experience: From Aug 2011to Feb 2012

Past Organization :Glenmark Pharmaceutical Ltd, Nashik. (Officer)

Total Experience: From July 2007 to Aug 2011.

Past Organization: Cipla Ltd. (Officer)

Department: Quality Assurance (ANDA)

Total Experience: From Jun 2006 to Jun 2007.

PhD (Doctor of Philosophy): Pharmaceutical Sciences in the faculty of Medicine from

Sant Gadge Baba Amravati University, Amravati, Feb 2015.

M.PHARM: Master’s Degree in Industrial Pharmacy from Sudhakarrao Naik Institute of

Pharmacy, Pusad. Dist- Yavatmal, Aug- 2004.

B. PHARM: Bachelor’s Degree in Pharmacy from Government College of

Pharmacy, Amravati (Amravati University, Aug- 2002).

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Dr. Mayur Sankalia is currently serving as the Senior Vice President of Research & Development at Invengene Pvt Ltd, bringing over 25 years of expertise in pharmaceutical product development, spanning conventional and specialty dosage forms.

Dr. Sankalia obtained his Bachelor's degree in Pharmacy from Sardar Patel University and went on to complete his Master’s and PhD in Pharmaceutical Sciences from The Maharaja Sayajirao University (MSU) of Baroda. His doctoral research commenced while he was a lecturer at MSU, later transitioning into a full-time Senior Research Fellow under the University Grants Commission (UGC) fellowship.

Post-PhD, he joined Sun Pharma Advanced Research Centre, where he played a pivotal role in the development of complex generic products and contributed to an innovative drug-complex conjugate, securing a world patent in his name. In 2009, he moved to the UK as a Postdoctoral Research Fellow at Queen’s University Belfast, focusing on topical hydrogel stability enhancement. He then joined Norbrook Pharmaceuticals, a global leader in veterinary and animal health medicines, contributing to novel formulation development.

Returning to India in 2011, Dr. Sankalia joined Mylan Laboratories Limited, leading the development of NDDS-based complex generic dosage forms, including oncological and non-oncological injectables, lyophilized formulations, dry powders, ophthalmic formulations, and more. In 2015, he transitioned to Dr. Reddy’s Laboratories, filing multiple products and facilitating technology transfer between the Netherlands and India for liposomal injectables. Subsequently, as Head of R&D at Celon Laboratories, he commercialized complex products such as peptide microspheres, albumin-bound nanoparticles, and oncology formulations.

Currently, at Invengene, Dr. Sankalia is spearheading the establishment of the injectable product development, overseeing R&D operations, regulatory affairs, and seamless technology transfer. His strategic leadership has led to multiple global regulatory approvals and successful commercialization of several formulations.

Dr. Sankalia has authored 24 publications in peer-reviewed journals and holds three granted patents.

Originally from Saurashtra, Gujarat, he is married to Dr. Jolly Sankalia and is a proud father of two daughters. In his leisure time, he enjoys reading, traveling, and photography.

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37 years of extensive professional experience for pharmaceutical product development for global market.

Developed and filed 100+ ANDAs, 20+ NCE-1 and 30+ PIV filings, 25+ NDA / 505(b)(2), Complex Generics for US, Europe and other Regulatory markets

1000+ products for Global Market including many first time launches in India and Regulatory markets.

Supported caring for life theme by timely introducing products during various pandemics globally.

HIV (30+ products), Swine flu, Hepatitis C, Malaria (5+ Products), Covid (5+ Products), TB (4+ Products)

Expertise in development of Complex Generics covering innovative technologies for various dosage forms such as :

• Oral solids : Tablets, powder, sachet (IR, XR, DR, OROS, Nano technology, Multilayered, Core Coat Tablets, effervescent, MUPS technology, amorphous solid dispersions, solid lipid technology, spray drying, continuous mfg)
• Hard gelatin / HPMC capsules (Palletization technology, Tablet in Capsules, mini tablets, sprinkles) and soft gelatin Capsules (micro emulsions, lipidic formulations, solution and suspension fill)
• Oral solutions, suspensions, emulsions
• Injectable (Liposomal Injections, nano particle suspensions, micro / nano emulsions, clear solutions, lyophilized,)
• Ophthalmics / Otic (nano emulsions, nano particle suspensions, solutions, suspensions,)
• Topicals (Creams, ointments, solution in airless package, foams, topical & transdermal sprays, transdermal creams, solutions, transdermal patches)
• Drug device combinations for oral, topical, injectable, nasal, ophthalmic products
• Nasal spray (solution and suspension)
• Vaginal products
• Suppositories, Pessaries
• Respiratory solutions

Filed 40+ Patents and Publications.

Successfully faced depositions for US products in the capacity of a formulator & company representative

Contributed towards setting up guidance for paediatric formulations at WHO as working group member in 2011.

Participated in Regulatory meetings and discussions with USFDA, EMA, DCGI and SFDA (Saudi Food and Drug Authority).

Successfully Implemented digitization platforms to support formulation development.

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I have 20 years of experience and leadership in generics research and development.

I am currently the General Manager and Head of R&D at Gracure Pharmaceutical Limited.

Career highlights

• In my 20 years of R&D experience have worked in many renowned organizations like Dr.’Reddy’s Lab, Zydus Cadila, Cadila Pharmaceuticals, J.B. chemicals as technical lead roles.
• In pharmaceutical generic development, I have developed many ANDAs, 505b2 and innovative patient centric products.

Expertise

I possess a deep understanding of R&D in generics, including optimizing organizational structure and improving productivity. My expertise extends to advancements in drug delivery technologies and formulation development, particularly in areas like generics, bilayer products, orally disintegrating tablets (ODT) and extended release products by design.

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Dr. Vandana B. Patravale , fellow of Indian National Science academy(INSA) and Indian National academy of engineers(INAE); is currently a Professor of Pharmaceutics at the Institute of Chemical Technology, Mumbai, India. She has more than 30 years of teaching and research experience.

She has over 200 refereed publications with over 15,000 citations 30 granted patents , 20 patents in pipeline and 2 trademark registries. She has published 5 books and 45 book chapters with international publishers. Dr. Patravale has been active in teaching, research and service throughout her career and is listed consecutively in top 2% of World Scientist’s in pharmacy on basis of publications and citations from the time the list is published by Stanford University.

Her areas of research include development of nanocarriers with major emphasis on infectious diseases, cancer and neurodegenerative disorders; medical device development, nanodiagnostics and nanovaccines. She was awarded Distinguished Aluminus Award, UDCT(2024),Most Iconic healthcare (Global) leader award 2023,Topmost healthcare leader Global award(education) 2022,Abdul Kalam Technology Innovation National Fellowship 2021,Fellow of Indian Chemical Society 2020, Kukreja Oration award 2020,APTIs Dr. Manjushree Pal Best Pharmaceutical Scientist Award 2019, Shri Amrut Mody distinguished researcher award 2018, OPPI women scientist award 2015, Bill Melinda Gates grant award 2015,Best Pharmaceutical Scientist award 2014, VASVIK award 2013, Veneto nanotech award 2013, APTI best teacher award 2012, Fellowship of Maharashtra Academy of Sciences, 2011and K.H. Garda Distinguished researcher award 2009.

She is Convener, APTI Women forum, President-CRS Indian chapter, Vice President-Paediatric Medicine healthcare initiative (PMHI),editor CRS IC and APTI women forum newsletters, Associate editor of Elsevier’s JDDST and on editorial board of many peer reviewed journals. She is actively collaborating with researchers as well as industries within country and abroad and has completed Indo-Swiss, Indo-Ireland, Indo-Japan, Indo-UK projects. She is executing all major grants from Indian Government focusing on product development besides projects from USA and Europe being currently undertaken. She has transferred about 20 + technologies to industry including drug eluting stents being marketed in more than 65 countries.

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Dr. Vaibhav Dubey is currently working as AVP at Kashiv Biosciences heading formulation, device and non-clinical development where he leads the initiative of development of drug/biologic device combination products and innovative biologic formulations. In his previous role, Vaibhav was General Manager at Alembic Pharmaceuticals where he led various cross-functional teams and initiatives in the areas of new drug/ biologic delivery systems and modalities for both sterile and non-sterile applications. He was also involved in development and commercialization of various ophthalmic and dermatological products. In the other roles, Dr. Dubey worked with Sun Pharma Advanced Research Company Ltd and Dr. Reddy’s Ltd, wherein he led the team of scientists working on 505 b(1)/ 505 b (2) formulation development approaches alongwith development of multiple generic pharmaceutical products for regulated markets. Dr. Dubey holds an M.Pharm and PhD degree in drug delivery from Dr. H.S. Gour University. He was also a Commonwealth Scholar at School of Pharmacy, University of London, and recipient of many awards and accolades at prestigious platforms. With numerous well cited publications and technology patents, he is a sought-after Key Opinion Leader in the areas of drug and biologic formulation and device development.

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A competent M. Pharmacy professional with 24 years of experience in Project Management, Formulation & Development in the Pharmaceutical industry.

Presently working as Sr. Dy. General Manager at Indoco Remedies Ltd.

Involved in various aspects of Project Management which includes Project Feasibility Study, Project Planning, Delivery Plan, Quality & Risk Management, Client Interaction/Conference Call.

Strong functional and technical knowledge of Research and Development of Pharmaceutical industry.

ACHIEVEMENTS

I am invited as a speaker at Bombay Institute of Pharmacy & Research to deliver a lecture on pathways to success in Project Management.

Also, I was invited as speaker to Savitribai Thite College of Pharmacy, Pune & at Shree Santkrupa College of Pharmacy, Sangli.

EDUCATION

M. Pharm 2002, Mumbai University Distinction. Advanced Post Graduate Diploma in Regulatory Affairs 2012.

WORK EXPERIENCE

Currently heading the Project Management team at Indoco Remedies Ltd

Taking care of the projects for all the business models (CDMO, CMO, Ext. Mfg projects, In-licensing project, Dossier extension) projects along with IH projects for all the territories.

Also, worked in Formulation development department at Sandoz Pvt. Ltd, Glenmark Research Centre, Ajanta Pharma Pvt. Ltd, USV Ltd.

CONFERENCES ATTENDED

• Attended CPHI, 2019 held at Frankfurt Germany.
• FDD Conclave conference, 2022 & 2023 held at Hyderabad.
• Attended Annual Pharma Project & Portfolio Management Summit in 2018, 2023, 2024 & 2025 held at Mumbai & Goa.
• Attended QBD workshop at Lonavala conducted by Sandoz Pvt. Ltd., 2012.

PAPER PRESENTATION:

“Combination drugs dispersible tablet development: Formulation and Analytical challenges” in Austria in 2010.

“Design and Synthesis of Some Possible 5 - HTIA Antagonists” at IPC, Delhi in 2001.

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Dr. Atul Kaushik is a distinguished leader in pharmaceutical formulation research and development, possessing more than 22 years of global experience. Throughout his career, he has been associated with renowned organizations such as Lupin, Hikma, Teva, Glenmark, Dr. Reddy’s, Ranbaxy, and Sandoz. Currently, Dr. Kaushik holds the position of Vice President at Lupin in Pune, where he oversees formulation R&D efforts for oral, ophthalmic, and dermatology products. His responsibilities span both generic and specialty portfolios, demonstrating his broad expertise and leadership in the industry.

Key achievement: Dr. Kaushik has successfully led the filing of over 100 dossiers for regulated markets, which includes numerous US Para IV submissions. In addition, he has overseen more than 150 filings across the MENA region, contributing significantly to the availability of affordable medicines for millions of individuals. Beyond his regulatory accomplishments, Dr. Kaushik is also an author, having written five textbooks for pharmacy students. He is an inventor with more than ten patent applications and has published multiple articles, reflecting his commitment to advancing pharmaceutical science.

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A strategic leader with over 25 years of experience in the pharmaceutical industry, I have successfully led techno-commercial functions, business development, and corporate strategy across global markets. My expertise lies in driving business transformation, scaling operations, and forging high-impact partnerships that fuel long-term growth.

As the Chief Executive Officer at Inventia Healthcare, I am committed to accelerating innovation, optimizing operational excellence, and expanding our global footprint. Leveraging Inventia’s strong legacy, my focus is on shaping the company’s next phase of growth while strengthening its position as a leading player in the industry.

Prior to this, I held key leadership roles at Mylan (US) and Mylan (India), where I spent 20 years driving R&D advancements, business development, and corporate strategy, and at NATCO Pharma, I served as Executive Vice President – Technical Operations and later as a Board Member, leading strategic initiatives that propelled organizational success.

I hold a Ph.D. in Pharmaceutical Sciences from the University of Iowa, a Pharmacy degree from Bombay College of Pharmacy, and an MBA from West Virginia University. Additionally, I have completed an Executive Course in Mergers & Acquisitions from The Wharton School, further strengthening my ability to drive high-stakes business decisions.

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Mr. Anand is a seasoned pharmaceutical scientist with over 16 years of specialized experience in the development of complex drug delivery systems, including PLGA microspheres, lyophilized drug products, and liposomal formulations. He brings together deep technical expertise and comprehensive regulatory insight, enabling successful product development across both regulated and highly regulated global markets.

Renowned for his systematic approach to problem-solving, he has consistently delivered solutions that advance projects from concept through scale-up and commercialization. His leadership and mentorship of core technical teams have been instrumental in driving innovation and ensuring execution excellence.

Throughout his distinguished career, he has earned multiple accolades that highlight not only his scientific acumen but also his unwavering commitment to organizational success and the advancement of pharmaceutical sciences.

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Vishwajit Bhide: Last assignment VP & Head –Inhalation R&D @ Mankind Pharma Ltd.

33+ years of Pharma BD and R&D experience, with Focus on Novel Drug Delivery systems

25 Years of dedicated experience in Inhalation Devices, nasal spray, MDIs & DPIs

Deep understanding of drug delivery devices, mechanical & material aspects along with the Formulation Development nuances

Innovator/Inventor of the very first non-infringing HandiHaler Generic device developed for Lupin Ltd., now approved and launched in the US.

A brand-new comprehensive Inhalation R&D setup at Mankind Pharma Ltd. followed by the development of a broad range of Respiratory / Inhalation pro ducts that are making strides in Indian Market.

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Presently leading the NCE & generic formulation development OSD scientific programs at Piramal and having around 18 yrs of rich experience in providing strategic direction and technical expertise throughout the product lifecycle. I aligned cross-functional teams and drove collaboration to overcome challenges and meet project milestones. Earned a Ph.D. in Pharmaceutical Science from IIT-BHU, Varanasi, and have previously held key scientific roles at Torrent, Wockhardt, and Lupin Pharma. Core competencies include Complex & Oncology OSD Product Development, Quality by Design (QbD) & Biopharmaceutics, Intellectual Property (IP) Landscape, Technology Scale-Up & Global Regulatory Submissions, GxP Compliance & Clinical Operations, Operational Excellence, CDMO/CMO Business and Stakeholder Engagement & Team Leadership.

Industrial Research Accomplishment:

• Successfully commercialized 09 generic products and technical support for 1 NDA & Led the development and clinical batch manufacturing of more than 35 products.
• Filed around 20 generic products for global markets and supported 5 IND submissions.
• Proven ability to translate R&D outcomes into commercial success, bridging innovation with regulatory and market realities.

Capacity Building & Leadership skill:

• Established GMP high-containment labs, Greenfield oncology facility and center of excellence for pediatrics product development.
• Led implementation of continuous manufacturing, PAT tools and digital system.
• Managing a team of 20+ scientists and driving patient awareness, operational excellence, and governance councils.

Awards/recognitions:

Best Research Poster 57th IPC, 2005 at Hyderabad ||Best Research Article IJPER, APTICON-2009, Hyderabad ||Qualified GATE 2003 ||JRF AICTE 2003||UGC SRF PhD, 2007||Recipient 2009 AAPS Drug Design and Dis travel ship award, Seattle, USA||Recipient DBT international grant for 2009 AAPS NBC, Seattle, USA, 2009 ||Recipient foreign travel grants CSIR, AAPS Annual meeting, LA, USA, 2009 ||Recipient of D. S. Kothari Post-Doctoral Fellowships, 2012

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As a seasoned pharmaceutical scientist with over 28 years of experience, I currently serve as Associate Vice President – leading strategic initiatives in complex generics, peptide therapeutics, and branded product development. Pioneered in the development and approval of the first complex generic liposomes and aerosols ( pMDI, DPI, Nasal spray and Nebuliser) and others across the globe.

Specialization: My expertise spans characterisation, reverse engineering, regulatory strategy, and lifecycle management with a strong foundation in hyphenated technologies advanced characterization techniques, along with foreign institutes. I’ve successfully led cross-functional teams in global product launches, method transfers, and regulatory submissions across US, EU, and emerging markets.

I’m passionate about driving innovation in analytical sciences, implementing digital and automation solutions, and fostering a culture of scientific excellence. My leadership philosophy centres on collaboration, compliance, and continuous improvement.

Research Interests: [6 publications, List of 2–3 research areas, e.g., bioavailability enhancement, QbD implementation, global regulatory compliance etc ]

Mr. Vipul Doshi has been in pharmaceutical Industry from more than four decades with diverse leadership and operational expertise across development, manufacturing, R&D, GXP quality assurance (QA) and manufacturing operations (parenterals, solid dosage forms, biotechnology, transdermal, biologics and vaccines).

He has been leading the Quality and Regulatory affairs function in the Pharmaceutical Companies of high credentials. Throughout his career he has been providing passionate global leadership and pioneered in guiding the companies to meet the Global Regulatory, Quality Standards and Compliance requirements.

He has been a Great Contributor in developing and implementing Quality attributes and Culture of Excellence based upon a set of core values and ethical practices, which integrate and improve business operations and enhance the compliance within the Organization.

He has been a leading advocate for Global Competitiveness and instrumental in due diligence for various acquisitions and mergers. He possesses great expertise in Projects and Engineering for developing Infrastructures for APIs and Drug Products (Sterile and Non Sterile). He has been actively involved with various professional associations like ISPE/PDA/AAM.

Associated with varied Roles and increasing responsibilities he is currently Chief Quality & Compliance Officer at Zydus Lifesciences Limited (Company has headquarters at Ahmedabad). He also Leads IRA, Research and Development functions for Active Pharmaceutical Ingredient, Environment Health & Safety and Pharmacovigilance.

Zydus Lifesciences Limited is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employees nearly 25000 people worldwide and is dedicated to creating healthier communities globally. The Product portfolio ranges from Complex generics Sterile and Non Sterile, Biologics and Vaccines and various dosage forms catering to global market.

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Dr. Sanjay B. Patil is an Associate Professor of Pharmaceutics at the School of Pharmacy and Technology Management, SVKM’s NMIMS (Shirpur), with over two decades of academic and research experience. He earned his M. Pharmacy and Ph.D. in Pharmaceutical Sciences from The Maharaja Sayajirao University of Baroda, Gujarat focusing on nasal mucoadhesive drug delivery. His research spans nanotechnology-based systems, nasal and ophthalmic delivery, gastroretentive platforms, and in situ gelling systems, with 60+ publications, book chapters with Elsevier, Springer, and CBS, and 1300+ citations with H-index of 18. Dr. Patil has guided 65+ M. Pharm. dissertations and 3 Ph.D. scholars, secured competitive grants (AICTE RPS, MODROB), and contributed as an editorial board member and reviewer across leading journals. He has delivered invited talks on DoE, optimization techniques, nanosuspensions, and product development, and has served on evaluation and advisory committees in India and abroad.

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M. Pharm. Ph.D 1994 from Bimbay College of Pharmacy. Started with Hoechst in drug discovery. Worked in Formulation Research and BE centre with companies like Alkem Indswift and Board of directors at Immacule & SRS life sciences. Currently Founder Director of Shuban Pharmaceuticals and Executive Director Gelnova Laboratories.

EXPERIENCE

2019 –Till Date | Director

Alicon Pharmaceutical Pvt. Ltd., Maharashtra

Alicon Pharmaceutical is a dynamic pharmaceutical company with commitment to manufacture high quality medicines, We at Alicon Pharmaceutical Pvt. Ltd. continually strive to excel in providing measurable, cost effective and path breaking improvements in output and quality in our products for our customers by delivering customer specific products with creative application of knowledge and innovative techniques.

2022 –Till Date | Director

Ganagveda Pvt. Ltd., Maharashtra

Ganagveda is budding company dealing in manufacturing, promoting and marketing of Indigenous medicines (Ayurvedic medicines). Gangaveda is established with motto that any community (or country) can flourish to its fullest by preserving, promoting and practicing Indigenous tradition. We are working to preserve and present our ancient Ayurvedic medicines in form that are comparable and acceptable to modern medicines

AWARDS

• Economic Times RE-Pharma Award ‘MSME company of the Year’ 2024
• National Excellence Award for excellence in Pharmaceutical Business 2023
• “Indian Achievers’ Award for Young Entrepreneur” by Indian Achiever’s Forum 2022
• “Udhyog Ratna Award” as woman entrepreneur by GPBS 2022
• “Pharma Leader of the year” as woman leader by NMCBI 2022

SOCIAL RESPONSIBILITY

2020 –Till date | Vice President

SATVAM Charitable Trust, Maharashtra

Satvam by its name inspired from Sanskrit word Sattva which is quality of balance, purity, harmony, positivity and serenity. The SATVAM Charitable Trust facilitates and supports towards an integral balance of human life by promoting sustainable social and economic changes. With its major activities in child welfare, we have vision that not a single child shall deprive of human rights, care and compassion. Trust is working for Nutrition, health and education of children.

EXPERTISE

• Entrepreneurial with commercial acumen and excellent management skills
• Strong leadership skills in broad governance
• Comprehensive understanding of financial management principles
• New Business development and strategic planning
• Research and development support
• Legal expertise

CERTIFICATION

2019 | Indian Patent Agent (IN/PA/3965)

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Dr. Pradeep Kumar Vishwakarma works at Cipla as Associate Director in Manufacturing Science and Technology. He holds a PhD in Pharmaceutical Technology. He brings 18+ years of global pharmaceutical experience (US/EU/RUSSIA/MALAYSIA/TURKEY). His expertise includes Formulation and Process R&D and digital transformation. Dr. Vishwakarma has published multiple patents and textbooks. He received the 2024 Express Pharma Rising Star Award. Outstanding performance By Dr. Reddy’s Lab, 2023/2024 in IPDO Manthan 1.0/2.0, Excellence in R&D By Dr. Reddy’s Lab, 2022 in IPDO. Young Scientist Award Career Point University, Kota, 2023, Top Research “Concept Note” Pharma Anvesha 2023 by PCI, Vigyan Bhavan New Delhi.

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