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SERVICES WHO WE ARE CONTACT RECENT PROJECTS |
 Sankaram Mantripragada, Ph.D. Founder
 Ann Donoghue, DVM, MS
 Kate Norton, PhD
Sankaram Mantripragada, Ph.D. - Founder Dr. Mantripragada is a pharma/biotech/drug delivery executive with over 15 years of industry experience. He has a Ph.D. in Molecular Biophysics from the Indian Institute of Science in Bangalore. As an Alexander von Humboldt Fellow and a Max Planck Fellow, he carried out postdoctoral research in the area of biological membranes at the Max Planck Institute for Biophysical Chemistry in Göttingen, Germany. Sankaram was an Assistant Professor of Biochemistry at the University of Virginia Medical School in Charlottesville, Virginia prior to moving to the industry. His pharma/biotech/drug delivery expertise was developed in senior scientific and management positions at DepoTech Corporation, SkyePharma Inc., Guidant Corporation and PR Pharmaceuticals. Sankaram has a proven track record in formulation development, analytical development, process development, CMC sections in IND/NDA filings, business development, drug delivery, liposomes, microspheres and drug-device combination products. His track record is evidenced by several FDA-approved products that originated from his contributions to their intellectual property and were guided through commercialization under his research and development leadership.
Ann R. Donoghue, DVM, MS In the 18 years Dr. Donoghue has been in the drug development field she has been involved in all aspects of new drug and diagnostic test development. She has led project teams in the successful approval of USDA licensed diagnostic test kits, an EPA registered pesticide and New Animal Drug Applications. Her current role has provided her with experience in human health pharmaceuticals, from project initiation through scale up to commercial GMP manufacturing. She co-led a successful FDA pre-approval inspection of a new GMP manufacturing facility; she has conducted GLP study site audits and has been the Sponsor Monitor for several GCP clinical trials. Her teams achieved an Orphan Drug Designation and completed a subsequent Investigational New Drug Application resulting in a successful Phase I clinical trial in less than one year from project initiation. Dr. Donoghue has participated in product development regulatory strategy and in face-to-face predevelopment conferences with the FDA and EPA. She has developed, written and instituted controlled document systems for GLP, GCP and GMP compliance. These experiences have provided broad project management knowledge spanning early research to finished product marketing. Dr. Donoghue received Bachelor of Science (animal science), Doctor of Veterinary Medicine and Master of Science (large animal clinical sciences - parasitology) degrees from Michigan State University. She served as the chief of the parasitology section of the MSU Animal Health Diagnostic Laboratory. Her employment has been with Hoechst-Roussel Agri-Vet Company, Heska Corporation and PR Pharmaceuticals, Inc. She is a regular reviewer for the Journal of the American Veterinary Medical Society and the American Journal of Veterinary Research and has been an invited continuing education speaker at 2 national veterinary conferences.
Kate Norton, PhD Kate Norton has over 11 years of hands-on pharmaceutical regulatory affairs experience encompassing all stages of drug development including nonclinical, clinical (Phases 1-4) as well as regulatory support of commercialized products. Dr. Norton has tremendous expertise in developing and implementing regulatory and development strategies to support clinical, nonclinical and CMC regulatory filings for a wide variety of conventional and unique dosage forms, as well as active pharmaceutical ingredients. Her regulatory experience includes coordinating, co-authoring and submitting INDs and international clinical trial applications and amendments as well leading marketing approval submissions in the EU, Australia, New Zealand and Canada. In addition to expertise in major regulatory filings, Dr. Norton brings experience in other critical regulatory activities including post-approval labeling and nonclinical, clinical and CMC variances, notifications, prior approval supplements, changes being effected supplements and annual reports for marketed products. She has reviewed and submitted adverse experience safety reports, labeling and promotional materials and has organized, conducted and lead meetings and teleconferences with FDA, DEA and international regulatory bodies. Dr. Norton enjoys working with R and D personnel on strategies regarding product and process design to maximize flexibility in product development and, ultimately, for commercial product (quality by design, design space and critical quality attributes). Additional skills gained over her career include Quality Assurance and Management to include writing standard operating procedures for GLP, CGP and GMP requirements, establishing electronic and paper document control systems, and overseeing Pre-Approval Inspections as well as routine GMP and DEA inspections. Dr. Norton earned her doctorate in Developmental Biology at the University of Cincinnati Medical Center. |