PhD, Director, Department of Drug Development, BioVectra Inc. Charlottetown.
|Atul Pathak, PhD Director, Drug Development BioVectra Inc (A Mallinckrodt Pharmaceutical Company), Charlottetown, PE C1E 0A, Canada Residential Address: 39, Holland Dr. Startford, PE C1B 1S9, Canada Mobile:(902) 916-0733 Email: [email protected] Date of Birth: : 03/26/1979 Sex: : Male Nationality: : Indian (Canadian PR) Education Post Doctoral Research: July ?2011, Children?s Hospital, Harvard Medical School, Boston, USA. Ph.D. (Pharm Sciences): Dec ?2008, CSIR-Institute of Genomics and Integrative Biology, Delhi, India. PGDIPR: July ?2007, Amity Law School, New Delhi, India. M.Pharm. (Pharmacy): Feb ?2003, Dept of Pharm Sciences, Dr. Harisingh Gour University, Sagar, MP, India. B.Pharm. (Pharmacy): July ?2000, Dept of Pharm Sciences, Dr. Harisingh Gour University, Sagar, MP, India. Professional Experience Apr 17 ? present Director, Drug Development (Injectable), BioVectra Inc. Charlottetown, Canada. ? Identifying and setting goals for the drug and product development group ? Leading the drug and product development group to insure efficiency, output, quality, customer service, and cost-effective management of resources ? Selecting correct design concepts and fundamental technology used for new products or improvement for existing ones ? Negotiating contracts with consulting firms to perform research or other applicable studies or support ? Planning and formulating aspects of research and development proposals such as objective or purpose of project, applications that can be utilized from findings, costs of project, and equipment and human resource requirements ? Designing and reviewing experimental plans particularly in regards to drug and product development, review and author reports and protocols ? Identifying and implementing initiatives to improve quality and efficiency in the drug and product development group ? Coordinating, prioritizing and managing multiple projects, including the work of various subordinates and/or team members ? Reviewing and approving documents/procedures/SOPs generated reports and other controlled documentation ? Developing, utilizing and reporting metrics for the performance of the product development group in the areas of efficiency & quality in order to properly identify and respond to trends & areas for improvement, & to set departmental goals Nov 14 ? Apr 17 Associate Director, Manufacturing Science and Technology (Sterile), Dr. Reddy?s Laboratories Ltd, Hyderabad, India. ? Leading formulation based scientific projects in a fast-paced, dynamic industrial setting focused on high quality R&D and cGMP manufacture of pharmaceuticals for global human health ? Experience with formulation technology absorption, transfer of sterile injectable products (including complex liposome and nanoparticle formulations) between in-house and external manufacturing sites for Dr. Reddy?s ? Participating in development/phase gate meetings to understand the process development technology and contributing in process optimization and finalization of critical process parameters of parenteral products (including complex injectable) ? Bridging with development and receiving, applying and further expanding the scientific information base established as part of the development process ? Coordinating and maintaining constant communication with project leadership and cross-functional development teams (R&D, plant, QA, RA & SCM) to ensure timely execution, filing and supply of finished goods to achieve milestones ? Leading life cycle management of parenteral products i.e. process improvements of parenteral products and related investigations including market complaints ? Filed four products for US, two for EU and two in EM ? Understanding of global regulatory strategy (i.e. IND, ANDA, CTD and complete product life cycle and sound knowledge of FDA and ICH guidelines) ? Providing training to team associates on the cGMP manufacturing, IPR, nanotechnology, process technology and critical process parameters of products Sep 13 ? Oct 14 Senior Scientist, Formulation Development, Novartis Healthcare (P) Ltd, Hyderabad, India. ? Led, planed, supervised and delivered NCE based pharmaceutical formulations (i.e. lipid based drug delivery system) for pediatric oncology ? Developed and characterized pre-clinical pediatric formulations for efficacy and early-stage toxicity studies ? Worked in collaboration with multidisciplinary and international teams (Novartis: Hyderabad, Basel and New Jersey) ? Knowledge and experience with the pharmaceutical development, regulatory standards, and guidelines for commercialization of new pharmaceutical products ? Responsible for identifying and advancing promising drug technologies from academia: assess technologies, preparing project plans and budgets, presenting project charter with cross-functional/interdisciplinary project teams ? Excellent team player, management, leadership, mentoring skills ? Contributed knowledge building session inside Novartis July 11 ? Aug 13 Deputy Manager, Formulation Development, Mylan Laboratories Ltd, Hyderabad, India ? Instrumental in initiating research on complex generics (such as liposome, PLGA microspheres) at Mylan ? Developed and characterized nanoformulations such as liposome and PLGA microsphere based long acting release formulations using DoE and QbD approaches ? Worked on developing, optimizing, technology transfer, scale-up, trouble shooting of parenteral formulations ? Well versed with process of pharmaceutical drug development, manufacturing and physico chemical characterization techniques ? Scaled-up peptide loaded microspheres formulation up to 200g batch ? Provided training to fellow scientists in various aspects of Intellectual property rights and novel drug delivery technologies Mar 09 ? July 11 Postdoctoral Research Fellow, Program in Cellular and Molecular Medicine, Children Hospital, Harvard Medical School, Boston, US ? Led a project to develop novel antibody conjugated liposome and PLGA based nanoparticles for targeted siRNA delivery to blood cancers including multiple myeloma in collaboration with Dana Farber Cancer Institute, Boston ? Investigated the ability of drug carriers (i.e. liposome and nanoparticles) to silence gene and suppress proliferation of cancer cells ? Studied therapeutic efficacy of siRNA/drug delivery by the nanoparticles ? Invited to present platform technology in a meeting hosted by the Leukemia and Lymphoma Society, NY, USA ? Presented findings of propriety Integrin targeted stabilized nanoparticles (I-TsNPs) drug delivery technology to various pharma and biotech companies Sep 04 ? Feb 09 Graduate student, CSIR Institute of Genomics and Integrative Biology, Delhi, India. ? Developed and characterized polysaccharides coated (i.e. Hyaluronic acid and Chondroitin Sulfate) and pegylated polymeric nanoparticles for efficient and site specific nucleic acids delivery ? Examined the in vitro cell cytotoxicity and transfection efficiency in various mammalian cells ? Evaluated in vivo ability of nanoparticles to target solid tumor in mice model ? Presented research work at conference organized by Institute of Bioengineering and Nanotechnology, Singapore ? Designed and set up a state-of-the art cell culture lab with a broad range of characterization capabilities 2000 Trainee, Alkem Laboratories Ltd, Mumbai ? Worked in various production departments both oral and solid dosage forms as well as chemical, instrumental and microbiological analysis of pharmaceuticals and final chemicals Awards 2006-09 ? Indian Council for Medical Research fellowship honor 2004-06 ? Lady Tata Memorial Trust fellowship honor Mentorship: CITYLAB ACADEMY, BOSTON UNIVERSITY MEDICAL CENTER, BOSTON, USA Mentor, (2010) ? Guided and assisted to students of Biomedical Science SMIRITI COLLEGE OF PHARMACEUTICAL EDUCATION, INDORE, INDIA Instructor, (2003-04) ? Taught, and graded exams for the following courses: Drug delivery and route of administration, Dosage forms, Pharmaceutical technology, Biotechnology Guest Editor 1. For upcoming special issue of Nano Reviews: Prevailing and imminent approaches in tumor, inflammation and fibrosis specific drug delivery. Archival Journal Referee for: Pharmaceutical Research, International Journal of Nanomedicine, Journal of Drug Delivery, Nanomedicine: Nanotechnology, Biology and Medicine, Biosimilars, Neuropsychiatric Disease and Treatment, Pharmacogenomics and Personalized Medicine, Research and Reports in Transdermal Drug Delivery List of Publications 1. Patnaik S. Arif M., Kurupati R.K., Pathak A., Kumar P., Gupta K.C. ?Crosslinked polyethylenimine-hexametaphosphate nanoparticles to deliver nucleic acids therapeutics? Nanomedicine : Nanotechnology Biology Medicine 2010: 6: 344-354. 2. Patnaik S., Pathak A., Arif M., Singh N. Gupta. K.C. ?In vitro and in vivo evaluation of PEI-alginate nanocomposites? International Journal of Pharmaceutics 2010: 385: 194-202. 1. Pathak A., Chutani K., Jain S., Mishra A., Vyas S.P., Kumar P., Gupta K.C. Gene expression, biodistribution, and pharmacoscintigraphic evaluation of chondroitin sulfate-PEI nanoconstructs mediated tumor gene therapy. ACS Nano 2009: 3(6): 1493-1505. (Featured in Nature July 2009) 1. Pathak A., Patnaik S., Gupta K.C. Polyethylenimine derived nanoparticles for efficient gene delivery. Nucleic Acids Symp Ser (Oxf). 2009: 53:57-58. 2. Pathak A., Patnaik S., Swami A., Choitani K., Jain S., Mishra A., Vyas S.P., Gupta K.C. Efficient Tumor targeting by polysaccharides decked PEI based nanocomposites. Journal of Biomedical Nanotechnology 2009: 5: 264-277. 3. Pathak A., Aggarwal A., Kurupati R.K., Patnaik S., Swami A., Singh Y., Kumar P., Vyas, S.P., Gupta K.C. ?Engineered polyallylamine nanoparticles for efficient in vitro transfection? Pharmaceutical Research 2007: 24 (8): 1427-1440. 4. Swami A., Aggarwal A., Pathak A., Patnaik S., Kumar P., Singh Y., Gupta K.C. ?Imidazolyl-PEI modified nanoparticles for enhanced gene delivery? International Journal of Pharmaceutics 2007:335:180-192. 5. Patnaik S., Swami A., Sethi D., Pathak A., Garg B.S., Gupta K.C., Kumar P. ?N(Iodoacetyl)-N'-(anthraquinon-2-oyl)-ethylenediamine (IAED): A new heterobifunctional reagent for the preparation of biochips? Bioconjugate Chemistry 2007:18(1):8-12. 6. Swami A., Kurupati R.K., Pathak A., Singh Y., Kumar P., Gupta K.C. ?A unique and highly efficient non-viral DNA/siRNA delivery System based on PEI- bisepoxide nanoparticles? Biochemical and Biophysical Research Communications 2007: 62:835-841. 7. Pathak A., Patnaik S., Gupta K.C. ?Recent trends in non-viral mediated gene transfer technology? Biotechnology Journal 2009: 4: 1-15. 8. Pathak A., Vyas S.P. Gupta K.C. ?Nano-vectors in liver specific gene transfer? International Journal of Nanomedicine 2008: 1:1-18. Invited Book 1. Pathak A, Gupta KC. ?Cationic Polymers based Non-viral Gene Carriers: Pharmaceutical Applications of Nano-vectors in Transfection Technology? LAP LAMBERT Academic Publishing GmbH & Co. KG, Germany. Patent 1. Novel Cross linked PEI nanoparticle based transfection reagents for delivery of Biomolecules. KC Gupta, P Kumar, A Swami, A Pathak. US Patent App 12/1/81,798,2008 Conferences ? Advances in technology and business potential of new drug delivery systems Controlled Release Society (February 2016),, Mumbai, India ? Antibody functionalized polyethyleneimine based nanoparticles for efficient RNAi mediated gene silencing. Recent advances in drug delivery (February 2011), Salt lake City, Utah, USA ? Immuno-nanoparticle for efficient siRNA delivery. Lymphoma and Leukemia Society Meeting (October 2010), New York, USA ? Development and characterization of antibody conjugated polymeric nanoparticle for siRNA delivery to target multiple myeloma. Immune Disease Institute Retreat (September 2010), Cape Cod, USA ? Chemically engineered polyallylamine nanoparticles: An efficient gene delivery system, International Conference on Bioengineering and Nanotechnology (August 2007), Singapore ? Swedish International Development Cooperation Agency, sponsored workshop on Cationic Amphiphiles-DNA Systems: Basics to Technology (February 2007) Goa, India References Available upon request|
|Drug development, Developed and characterized nano formulations, formulation technology absorption, Leading the drug and product development group.|
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