Namdev Shelke
Hillsborough,NJ
Summary
A highly skilled, passionate scientist with proven FDA approved product track record experienced in the development of novel drug delivery technologies and translational clinical products.
Overview
22
22
years of professional experience
Work History
Group Leader
Novelstar Pharmaceuticals
Cranbury, NJ
07.2022 - Current
- Development of gastro-retentive/delayed-release drug delivery formulations; set up a new hot melt extrusion manufacturing facility for amorphous solid dispersion (ASD); development of injectables (generic), and working with various suppliers, such as West-Pharma and Schott-Pharma, to obtain syringe and vial supplies; performing R&D trials to develop topical ointments; preparation of lipid nanoparticles using microfluidics techniques for oral drug delivery applications.
- Monitoring and scheduling daily project activities, managing excipient inventory, procuring equipment for new projects, and assessing/drafting budgets and timelines for new projects.
Senior Scientist
Catalent Pharma Solutions
, Somerset
10.2021 - 07.2022
- Optimized process parameters and quality of the product by implementing the hot melt extrusion (HME, Leistritz 18 mm, 27 mm) technique for 505(b)(2) projects, set product specifications, in-process controls, prepared summary reports for clients, and audited pre-formulation and formulation activities of GMP projects. Supported in preparing CMC sections for FDA submission. The FDA approved the product in November 2024.
- Interacted with various, globally recognized pharmaceutical company clients on a regular basis to meet the requirements.
Senior Scientist
Kashiv Pharmaceuticals LLC
Bridgewater, NJ
06.2017 - 10.2021
- Led the project from pre-formulation through submission batch manufacturing, and CMC documentation preparation for the development of oral solid dosage gastro-retentive systems (GRS), bi-layer/tri-layer tablets, and pellet formulations for 24-hour drug release for the 505(b)(2) project.
- Troubleshooted various issues, provided crucial inputs, and the GRS project resulted in successful clinical trials, successful stability of exhibit batches, and the product was approved by the FDA.
- Authored 2 U.S. Patents for GRS, and one for pellet formulations (patents granted).
University Postdoctoral Fellow
UConn Health
Farmington, CT
08.2013 - 06.2017
- Development and evaluation of biomaterial-based devices for drug delivery and tissue engineering applications.
- Established a novel platform for mechanically competent biomaterial-based scaffolds for bone and nerve regeneration, and evaluated using cell differentiation and proliferation assays.
- Submitted grants as a principal investigator, taught drug delivery classes, and mentored undergraduate students.
Postdoctoral Fellow
University of Utah
Salt Lake City, UT
12.2009 - 08.2013
- Development of an intra-vaginal ring drug delivery device for anti-HIV and contraceptive agents on projects sponsored by CONRAD and USAID using the hot melt co-extrusion technique.
- Evaluated the pharmacokinetics of intravaginal ring devices and gel formulations in rabbit and sheep models.
- The product reached clinical phase 2/3 trials. Authored U.S. Patent (granted), published work in the PLOS One Journal, and presented work at various conferences.
Visiting Research Associate
UCD/UNMC
Aurora, Omaha, CO, NE
09.2007 - 12.2009
- Development of an injectable ophthalmic drug delivery microparticle formulation for a new chemical entity (NCE) for the treatment of age-related macular degeneration (ARMD), sponsored by TaiGen Biotech. Ltd.
- Evaluated the pharmacokinetics and efficacy of microparticle formulations and NCE in a rabbit model to treat ARMD and choroidal neovascularization (CNV), respectively.
- Prepared and evaluated VEGF-loaded, ligand-attached polymer nanoparticles for targeted drug delivery to treat ARMD.
Project Assistant
National Chemical Laboratory
Pune, India
09.2002 - 09.2004
- Development of controlled release polyurethane and natural polymer-sodium alginate-based microparticle formulations for pesticide delivery on projects sponsored by Asian Paints and the Indian Council of Agricultural Research, New Delhi (ICAR).
Education
Ph.D. - Polymers for Drug delivery applications
Karnatak University
Dharwad, India01.2007
Master of Science - Chemistry, Polymer chemistry
SRTM University
Nanded, MH, India01.2002
Bachelor of Science - Industrial Chemistry
Dayanand Science College
Latur, MH, India01.2000
Skills
Pre-formulation, R&D screening, GMP manufacturing (oral solid pilot and exhibit batches), documentation (batch records, protocols, summary reports), regulatory preparation of CMC sections module-3 (32P), reviewing of Module-3 (32S), clinical review of clinical protocols, animal studies, familiar with WinNonlin software, operations blender, tablet press, tablet/pellet coaters, granulators, hot melt extruder, IOQ/PQ, quality assurance GMP facility maintenance, environmental monitoring, project management timeline, tracking daily schedule, drafting budgets, new project assessments/setting up TPP, logistics excipient inventory management and procurement expertise in topical rings/gels, injectables (generic R&D), polymeric micro-nano particles-targeted delivery of small molecule/peptide, lipid nanoparticles (microfluidics)-peptide loaded, and various FRD&ARD analytical tools
Affiliations
Orthopaedic Research Society (ORS); American Association of Pharmaceutical Sciences (AAPS); Controlled Release Society (CRS); Society for Polymer Science (SPS); Reviewer of over 10 international scientific journals including Pharmaceutical Research, and Nanomedicine: Nanotechnology, Biology, and Medicine.
Accomplishments
FDA Approved Product: (1) PB ER 105 mg tablet formulation (505 (b)(2)) for once-daily oral administration approved October 2024 https://lnkd.in/ePXN7paP; (2) Oral solid IR tablets manufactured using hot melt extrusion.
US Patents (Granted): Extended-release compositions comprising pyridostigmine (for pellet/gastro-retentive tablets), US 10,925,833 B2, 2020; Extended release multi-particulate capsule formulation comprising trihexyphenidyl hydrochloride, US11684580B2, 2023; Gastro-retentive dosage forms for sustained drug delivery, US11318091B2, 2022; Intravaginal reservoir ring devices for drug delivery (WO Patent 2,013,013, 172).
Peer reviewed research articles: Role of plasticizer in membrane coated extended-release oral drug delivery system, Journal of Drug Delivery Science and Technology, 2018, 44, 231-243; Engineering a segmented dual-reservoir polyurethane intravaginal ring for simultaneous prevention of HIV transmission and unwanted pregnancy, PLoS ONE. 2014, 9(3), e88509; Intravitreal poly(L-lactide) microparticles for sustained retinal and choroidal delivery of TG-0054, a hydrophilic drug intended for neovascular diseases, Drug Delivery and Translational Research 2010, 1 (1), 76.
Book Chapters: "Polyurethanes" in “Natural and synthetic biomedical polymers” Elsevier Science, 2014, 123-144; “Polyester nano-and micro-technologies for tissue engineering” in “Handbook of Polyester Drug Delivery Systems” Pan Stanford Publishing 2016, Chapter 18, 595-650.
Additional Information
- VISA STATUS: , Green Card Holder
Timeline
Group Leader
Novelstar Pharmaceuticals
07.2022 - Current
Senior Scientist
Catalent Pharma Solutions
10.2021 - 07.2022
Senior Scientist
Kashiv Pharmaceuticals LLC
06.2017 - 10.2021
University Postdoctoral Fellow
UConn Health
08.2013 - 06.2017
Postdoctoral Fellow
University of Utah
12.2009 - 08.2013
Visiting Research Associate
UCD/UNMC
09.2007 - 12.2009
Project Assistant
National Chemical Laboratory
09.2002 - 09.2004
Ph.D. - Polymers for Drug delivery applications
Karnatak University
Master of Science - Chemistry, Polymer chemistry
SRTM University
Bachelor of Science - Industrial Chemistry
Dayanand Science College
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