alexa Dev Prasad | Klus Pharma Inc
ISSN: 2329-6631

Journal of Developing Drugs
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Dev Prasad

Dev Prasad Dev Prasad Senior Scientist-I in Formulation Development Klus Pharma Inc., Monmouth Junction, New Jersey
Biography

Dev Prasad, M.S., Ph.D., Education Year Institute Degree Earned GPA Jan 2010 -May 2014 School of Pharmacy Massachusetts College of Pharmacy and Health Sciences, (MCPHS) University, Boston, MA, USA Doctor of Philosophy (Ph.D.) in Pharmaceutics and Drug Design 3.98/4 Sept. 2007 -Dec 2009 School of Pharmacy Massachusetts College of Pharmacy and Health Sciences (MCPHS) University, Boston, MA, USA M.S., Pharmaceutics & Drug Design 3.98/4 Sept. 2001 -July 2005 U.P. Technical University, Lucknow, India Bachelor of Pharmacy 3.5/4 Professional Employment June 2017 -present Senior Scientist-I, Formulation Development Klus Pharma Inc., Monmouth Junction, New Jersey AugMay 2014 -June 2017 Senior Scientist, Formulation & Product Development Fresenius Kabi USA, Skokie, Illinois May 2013 -Aug 2014 Ph.D. Co-op/Scientist I, Discovery Pharmaceutics Cubist Pharmaceuticals, Lexington, MA May 2011 - Aug 2011 Research Intern, Vertex Pharmaceuticals, Cambridge MA May 2010 - Aug 2010 Research Intern, Vertex Pharmaceuticals, Cambridge MA May 2008 - Aug 2008 Research Intern, Vertex Pharmaceuticals, Cambridge MA Oct 2004 - July 2005 Medical Detailing Officer Nestle, India Professional Experience Sept. 2007 -May 2013 Instructor/Teaching Assistant Massachusetts College of Pharmacy and Health Sciences, Boston, MA May 2011 -Aug 2011 Research Intern Vertex Pharmaceuticals, Cambridge, MA May 2010 -Aug 2010 Research Intern Vertex Pharmaceuticals, Cambridge, MA May 2008 -Aug 2008 Research Intern Vertex Pharmaceuticals, Cambridge, MA Dev Prasad 2 Leadership and Professional Activities Reviewing and Judging of Scientific Publications Manuscripts Peer Review Year Name of the Journal Role Manuscripts reviewed 2017 - present Current Drug Safety, Bentham Science Reviewer 1 2017 - present Frontiers Health Production, Frontier Reviewer 3 2016 - present Medical Science Monitor Reviewer 8 2016 - present Drug Delivery and Translational Research, Springer Reviewer 2 2016 - present The AAPS Journal Reviewer 1 2016 - present ADMET & DMPK/IAPC, IAPC Publishing Reviewer 1 2015 - present SOJ Pharmacy & Pharmaceutical Sciences, Symbiosis online publishing Reviewer 1 2015 - present Journal of Pharmaceutical Investigation, Springer Reviewer 18 2015 - present Talanta, Elsevier Reviewer 1 2015 - present AAPS PharmSciTech Reviewer 1 2013-Present AAPS Annual Meeting Abstract Reviewer 50+ Book Proposal Review Year Name of the Publisher Role 2017 Nanotechnology: therapeutic, nutraceutical and cosmetic advances, CRC press Reviewer 2017 Design of Experiments in Pharmaceutical Product Development: Fundamentals and Applications, CRC Press/ Taylor and Francis Group Reviewer Year Organizations Role 2012- present Sigma Xi, The Scientific Research Society Member 2012- present Rho Chi, The Academic Honor Society in Pharmacy Member 2011 American Association of Pharmaceutical Northeast- Regional discussion group (AAPS-NERGD) Planning committee member 2010 American Association of Pharmaceutical Scientists- Graduate Research Association for Students (AAPS-GRASP) Planning committee member 2011-2012 Graduate Student Association, MCPHS, MA President 2008-2010 Graduate Student Association, MCPHS, MA Vice-President 2007-08 American Association of Pharmaceutical Scientists-MCPHS chapter Vice Chair Dev Prasad 3 Others Year Name of the Awards Role 2017 CPhl Pharma Awards, Recognizing excellence in pharma Jury member 2016 CPhl Pharma Awards, Recognizing excellence in pharma Jury member Awards & Recognitions 2014 EUDRAGIT® Award 2014 for best peer reviewed research article by Evonik Health Care 2012 American Association of Pharmaceutical Scientists travel-ship award recipient- Formulation Design and Development (AAPS-FDD) section Research Interest: Senior Scientist-I, Formulation and Product Development Klus Pharma, Monmouth Junction, NJ • Developed generic (ANDA) injectable formulations in a cGMP environment. • Designed and developed sterile injectable solution, lyophilized product, and ready-to-use solution as a lead scientist. Executed packaging insert support studies (Photo-stability, Thermal cycling, LVP admixture compatibility study). • Process development of parenteral product for pilot and commercial manufacturing. • Responsible for preparing CMC regulatory filling submissions documents (3.2.P.2, P.5.6 etc.). • Works in interdisciplinary team with scientists from Analytical, Quality Assurance, Project Management, Regulatory Affairs, Manufacturing and Tech. Transfer teams to ensure timely completion of development and manufacturing activities Senior Scientist, Formulation & Product Development Fresenius Kabi USA, Skokie, IL • Developed novel 505 (b) (2) and generic (ANDA) injectable formulations in a cGMP environment. • Initiated feasibility of anti-cancer and anti-fungal compounds for value-added NDA formulation. Evaluated various drug delivery systems for parenteral formulation. • Developed and optimized lyophilization cycles based on Differential Scanning Calorimetry (DSC) and Freeze Dry Microscopy (FDM). Solved vial breakage and lyo cake collapse issue. • Responsible for process development, successful manufacturing of in-house lab scale and pilot scale batches and technology transfer of parenteral product to manufacturing plants. • Developed stability testing protocols (STPs) and executed stability studies for lab batches, pilot scale batches and exhibit batches. • Responsible for preparing CMC regulatory filling submissions documents (3.2.P.2, P.5.6 etc.). • Works in interdisciplinary team with scientists from Analytical, Quality Assurance, Project Management, Regulatory Affairs, Manufacturing and Tech. Transfer teams to ensure timely completion of development and manufacturing activities. Graduate (M.S. and Ph.D. Research) - Formulation of poorly water soluble drugs -Novel Drug Delivery • Explored the role of drug polymer interaction in improving amorphous state stabilization and dissolution rate in ternary solid dispersions formulations. • Conducted solid-state characterization and in-vitro dissolution studies of solid dispersion. • Evaluated different polymers for precipitation inhibition of drugs in solution and Dev Prasad 4 Systems development of their amorphous solid dispersions. • Developed Self Emulsifying Drug Delivery System (SEDDS) for poorly soluble drug. • Studied the effect of excipients on precipitation inhibition of indomethacin from upon in-vitro dilution from SEDDS. • Evaluated the stability of Vitamin B complex in the space retrieved tablets - NASA funded. Publications: Book Chapters (Total- 4; Citations- 13) 1. D. Prasad, A. Jain, S. Garad, “Oral delivery of poorly soluble drugs”, in Poorly Soluble Drugs: Dissolution and Drug Release, CRC Pan Stanford, DOI: 10.1201/9781315364537-6, Jan 2017, 125-186 Role: First Author 2. D. Prasad and H. Chauhan. "Excipients Utilized for Ophthalmic Drug Delivery Systems." In Nano-Biomaterials for Ophthalmic Drug Delivery, pp. 555-582. Springer International Publishing, 2016. Role: First Author 3. H. Chauhan, J. Bernick, D. Prasad, and V. Masand, “ANN on Target Validation as Robust Tool in Drug Discovery and Development”, Artificial Neural Network for Drug Design, Delivery and Disposition, Edited by Puri, Pathak, Sutariya, Tipparaju, Moreno, Release Date 22 Oct 2015, Academic Press, Print Book ISBN :9780128015599, eBook ISBN :9780128017449. Role: Co-Author 4. D. Prasad and H. Chauhan. "Nanotoxicity of Polymeric and Solid Lipid Nanoparticles” In Sutariya, Vijaykumar B., and Yashwant Pathak, eds. Biointeractions of nanomaterials. CRC Press, 2014. Role: First Author Citation: 13 Peer-reviewed articles (Total- 10; Citations- 111) 1. D. Prasad, H. Chauhan, E. Atef, “Role of Molecular Interactions for Synergistic Precipitation Inhibition of Poorly Soluble Drug in Supersaturated Drug-Polymer-Polymer Ternary Solutions”. Molecular Pharmaceutics, 2016 (13), 756-765. Impact factor: 4.384 Role: First Author Citation: 9 2. D. Prasad, A. Kuldipkumar, C. Gu. “Comparison of biorelevant simulated media mimicking the intestinal environment to assess the solubility profiles of poorly soluble drugs”. Pharmaceutical development and technology, 2016, 21(4), 511-517. Impact factor: 1.86 Role: First Author Citation: 1 3. D. Prasad, H. Chauhan, E. Atef, “Amorphous stabilization and dissolution enhancement of amorphous ternary solid dispersions: combination of polymers showing drug-polymer interaction for synergistic effects”. J. of Pharma Sciences, 2014, 103 (11), 3511-3523 Impact factor: 3.35 Role: First Author Citation: 34 4. F. Meng, A. Trivino, D. Prasad, H. Chauhan, “Investigation and correlation of drug polymer miscibility and molecular interactions by various approaches for the preparation of amorphous solid dispersions”. European J. of Pharm. Sciences, 2015, 71, 12-24 Impact factor: 3.350 Role: Co-Author Citation: 35 Dev Prasad 5 5. D. Prasad, H. Chauhan, “Key targeting approaches for pharmaceutical drug delivery”. American Pharmaceutical Review, Oct 2013 Impact factor: 0.35 Role: First Author Citation: none 6. D. Prasad, H. Chauhan, E. Atef, “Studying the effect of lipid chain length on the precipitation of a poorly water-soluble drug from Self Emulsifying Drug Delivery System (SEDDS) on dispersion into aqueous medium”, J. of Pharmacy and Pharmacology, 2013, 65 (8), 1134-1144. Impact factor: 2.264 Role: First Author Citation: 15 7. M. Chuong, N. Aggarwal, D. Prasad, S. Mashiana, A. Taheri, W. Albenayan “Particle shape descriptors and angle of repose of a bimodal distribution sample”, International J. of Pharmacy & Technology, 2012, 4 (2), 4484- 4492. Impact factor: None Role: Co-Author Citation: none 8. E. Atef, H. Chauhan, D. Prasad, D. Kumari, C. Pidgeon “Quantifying solid-state mixtures of crystalline indomethacin by Raman spectroscopy comparison with thermal analysis”, ISRN Chromatography, 2012,1-6. Impact factor: None Role: Co-Author Citation: 15 9. M. Chuong, D. Prasad, B. LeDuc, B. Du and L. Putcha, “Stability of vitamin B complex in multivitamin and multimineral supplement tablets after space flight”, J. of Pharmaceutical and Biomedical Analysis, 2011, 55, 1197-1200 Impact factor: 3.25 Role: Co-Author Citation: 2 10. D. Prasad “Review: Pharmaceutical Nanocarriers”, Pharma Review, 2010 Impact factor: Role: None Citation: none Presentations Podium Presentations 1. D. Prasad, “Effect of drug polymer interaction on precipitation inhibition and amorphous stabilization of ternary systems”, AAPS-North-East regional annual meeting, April 2013. 2. D. Prasad, “The effect of low concentration of molecularly interacting polymers on indomethacin precipitation and its amorphous stabilization”. MCPHS, Annual GRASP conference 2011. 3. D. Prasad, “Investigating the effect of various oils on precipitation inhibition of indomethacin from self-emulsifying drug delivery system (SEDDS) upon in-vitro dilution”. Campbell University, Annual GRASP conference 2010. Poster Presentations: 1. D. Prasad, H. Chauhan, E. Atef, “Stabilization of ternary solid dispersions at high drug load using molecularly interacting polymers”, AAPS annual meeting 2012. 2. D. Prasad, M. S. Nagarsenker, H. Chauhan, “Thermal characterization of solid lipid nanoparticles containing Gelucire 44/14 and Gelucire 50/13”, AAPS annual meeting 2012. Dev Prasad 6 3. D. Prasad, H. Chauhan, E. Atef, “Utilizing 1H NMR in understanding the effect of polymers, individual and in combination, on precipitation inhibition of Indomethacin and its solubility enhancement from solid dispersions”, ACS annual meeting 2012. 4. D. Prasad, J. Beniek, H. Chauhan, “In−silico predictions for the development of poorly soluble anticancer drugs as amorphous systems”, ACS annual meeting 2012. 5. D. Prasad, E. Atef,, “The effect of low concentration of molecularly interacting polymers on indomethacin precipitation and its amorphous stabilization”, AAPS annual meeting 2011. 6. D. Prasad, B. Song, “Estimation of drug polymer miscibility and solubility at room temperature”, Vertex fun and fear intern poster presentation, Vertex Pharma. Inc. 2011. 7. D. Prasad, A. Kuldipkumar, C. Gu, “Development of biorelevent simulated intestinal media mimicking the intestinal environment to predict the solubility profiles of poorly soluble drugs”, Vertex fun and fear intern poster presentation, Vertex Pharma. Inc. 2010. 8. E. Atef, D. Prasad, H. Chauhan, “Quantifying solid mixture of alpha and beta indomethacin using raman and differential scanning calorimetry”, AAPS annual meeting 2010. 9. D. Prasad, E. Atef, “Investigating the mechanism of indomethacin precipitation inhibition from Self Emulsifying Drug Delivery System (SEDDS) upon in-vitro dilution: Effect of various oils”, AAPS annual meeting 2010. 10. M. Chuong, D. Prasad, B. LeDuc, B. Du, L. Putcha, “Pharmaceutical stability of vitamin B complex in the outer space bio-environments retrieved multi-vitamin and multi-mineral supplements”, AAPS annual meeting 2009. 11. H. Chauhan, D. Prasad, E. Atef, “Effect of PVP K90 on indomethacin, dipyridamole and progesterone crystallization in solution at different supersaturations”, AAPS annual meeting 2009. 12. D. Prasad, S. Roday, “Development of amorphous solid dispersions systems using amino acids”, AAPS-NERGD regional annual meeting 2009. 13. D. Prasad, H. Chauhan, E. Atef, “Preparation and stabilization of amorphous solid dispersions using Eudragits”, AAPS-MCPHS poster day 2008.

Research Interest

Research Interest The research is an integral part of the academician. During my graduate pursue and industrial exposure, I have developed a keen interest in the preformulation and formulation aspect of the drug development. Presently, my research interests involve working on following areas but I am open to learn and collaborate on new ideas and concepts in the field of pharmaceutical sciences. 1. To improve the solubility of different poorly soluble drugs (having different physic-chemical properties) by using approaches such as Solid dispersion, Self emulsifying drug delivery system (SEDDS), Nano-crystal systems and Supersaturated system. The idea is to develop a robust solubilizing technique that can effectively be used during prefomulation and formulation studies for New Chemical Entity (NCE). 2. To explore and characterize Ternary Solid dispersion as an approach to increase solubility and stability. The focus is to explore the combination of potential, used available, safe, FDA approved, well studied polymers. 3. To focus on understanding the precipitation mechanism of poorly soluble drugs in absence and presence of polymers (primarily by drug polymer interaction). The idea is to establish a correlation of drug polymer interaction in solution and its effect on the stabilization of amorphous solid state along with In-Silico prediction of drug polymer interaction by using softwares like Gaussian and Jaguar. Overall, the goal of the study is to help in rationally screening the polymers for improving drug solubility and stability. 4. In the future, I would like to study the effect of important factors like physicochemical properties, crystal form, morphology, seeding, and level of supersaturation etc. of various poorly soluble drugs in presence and absence of different excipients. The idea is to understand the crystallization/precipitation process in detail and apply in above mentioned solubilization techniques. It can help in understanding drug delivery and dosage form design aspects as a lot of excipients are added in formulation during various stages of drug development. 5. Another area of research I wish to pursue is the liposome based delivery systems. These nanocarriers have been well studied across multiple scientific disciplines (medicine, immunology, diagnostics, cosmetics etc.) over the last several decades and are considered one of the most advanced drug delivery systems in terms of development as reflected in the commercialization of liposome delivery systems in the area of oncology. Along with anti-cancer agents, I want to extend the use of liposome in other therapeutic areas such as anti-infectives and anti-inflammatory. Also, pharmaceutical science is one of the interdisciplinary fields where thoughtful collaboration among researchers in academics as well as industry is very important. Through these collaborations a rapid advancement can be made to solve a problem, so I would love to collaborate and make progress in my chosen field.

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