Malia Segar, MS, has experience in regulatory affairs, consulting, medical/regulatory writing, and project management. In previous roles, Segar developed skills and knowledge of nonclinical drug development and preparation of nonclinical sections of regulatory documents, including INDs and NDAs/BLAs (CTD and legacy format). At Coté Orphan, Segar is a portfolio/project manager and a lead regulatory writer. She earned her Master’s in Biotechnology/Biodefense from Johns Hopkins University, her Undergraduate Bachelor’s Degree in Biology from Elon University, and earned the Regulatory Affairs Certification.
Susan Carter, MS, has experience in regulatory affairs and clinical operations in both drugs and biologics. Here, at Coté Orphan, her role includes preparation and submission of FDA/EMA orphan drug applications, IND/NDA/BLA/CTA/MAA applications, pre-IND meeting requests/briefing packets, EMA pre-submission meetings, breakthrough therapy designation applications, and regulatory strategic reviews, as well as leading FDA/EMA meetings/interactions. Additionally, she prepares clinical protocols and investigator brochures. Carter attended the University of Maryland School of Pharmacy for a Master’s degree in Regulatory Science and Indiana University for a Bachelor’s degree in General Science.
Mohit Kashyap, PhD, has experience in both academic and industrial pre-clinical research in the field of immunology and immunotherapy. Here at Coté Orphan his role includes developing regulatory strategy and preparing documents for pharmaceutical and biotech companies across the globe. Since joining the Coté team, he has worked on eighteen different projects that include orphan drug designations, preIND meeting packages, and strategic reviews. In previous roles, Kashyap has trained and worked closely with scientific experts in a Government agency as well as in the biotech field on development of pre-clinical research programs for advancing drugs from bench to bedside. Kashyap earned his Ph.D. in Microbiology & Immunology from Virginia Commonwealth University (VCU) School of Medicine, his M.S. degree in Biology also from VCU and his Undergraduate Bachelor’s Degree in Biochemistry from University of Wisconsin-Madison.
Julia Pinkhasov, PhD, is an outcome-focused scientist with over ten years of research experience and contributed novel insights within multiple research disciplines, including plant biotechnology, immunology, and autoimmune pathology. Here, at Coté Orphan, LLC, Pinkhasov develops regulatory strategies by compiling scientific data in support of the orphan drug candidate(s) in order to obtain regulatory approval. Pinkhasov authors regulatory documents for the U.S. FDA and E.U. EMA including orphan drug designations, briefing meeting documents, breakthrough therapy designations, pediatric rare disease designations, and strategic reviews. In her previous role as an Assistant Research Professor at UCLA School of Medicine, Pinkhasov established an independent research program and conducted pre-clinical and clinical studies to examine novel therapeutic targets on T cells in lupus mouse models and patients. She has a Doctorate in Philosophy from Arizona State University and is pursuing her MBA at Johns Hopkins University.
Bruna Blauth has experience working with neglected tropical diseases and orphan drug development programs in both preclinical and early clinical stages. Here at Coté Orphan she authors, prepares, and submits regulatory documents to both FDA and EMA in support of orphan drug development programs. Blauth earned her Bachelor of Science degree in Biochemistry with a minor in Chemistry from Virginia Tech and is currently pursuing a Master of Science degree in Biotechnology with a concentration in Regulatory Affairs.
Irina Mikhailenko, PhD, has experience in biomedical and clinical research. Here at Coté Orphan, Mikhailenko's role includes developing regulatory strategy and preparing regulatory documents for the U.S. FDA and E.U. EMA, tailoring these documents for submissions to stakeholders and regulatory authorities. In previous roles as a research scientist at American Red Cross, UMB School of Medicine and at NIH, Mikhailenko developed pre-clinical and clinical research programs for advancing drugs from bench to bedside for hemophilia and deep vein thrombosis; cardiovascular diseases and muscular dystrophy; Alzheimer's disease and oncology.
Mikhailenko earned a Ph.D. in Biology from the Russian Academy of Medical Sciences; a M.S. degree in Biophysics from Moscow Institute of Physics and Technology, and certification in Clinical Trials Project Management from Montgomery College in Maryland.
Rebecca Schell, MBS, has experience in business development and regulatory affairs. Schell is the territory manager for the Southeast and Midwest regions of the United States. Schell interned with Coté during the summer of 2015 as a marketing intern, but quickly assumed increasing business development responsibilities. She earned her bachelor's degree in neuroscience from Scripps College in Claremont, CA, specifically focusing on neuropharmacology and the area of drug addiction and earned her Master's in Bioscience from Keck Graduate Institute, also in Claremont.
Kerri Burson, MA Biology, has over ten years of research experience within multiple research disciplines, including agricultural biotechnology at Monsanto and cell line development, molecular biology, and genomics at MedImmune. In her previous regulatory positions at MedImmune and Novavax, she focused on biologics and vaccines CMC sections for submissions, including IND, BLA, IMPD, MAA, and Post-Approval. At Coté Orphan, her role includes: preparation and submission of FDA and EMA orphan drug applications; IND, NDA, BLA, CTA, and MAA submissions with an emphasis on CMC; and pre-IND meeting requests/briefing packets. Burson her M.A. in Biology from Washington University in St. Louis.
Vian Yousify, MS, has over ten years of work experience in academic, laboratory and clinical research settings. Here at Cote Orphan, her role involves providing regulatory strategies to pharmaceutical companies and preparing applications for the FDA and EMA orphan drug designations and pediatric rare disease designations. Yousify previously coordinated bioanalytical and clinical studies (Phases I-IV) in the field of immunology, infectious diseases and vaccine development. In earlier roles, Vian managed early-development PK and ADA studies, and provided final reports for IND/NDA/BLA submissions. In the clinical setting, Vian performed community education functions, patient evaluation and clinical data extraction for various drugs and biologics. Vian earned her master’s degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University and has an a bachelor of science degree from Washington State University, with a double major in Neuroscience and Psychology.
Nirmit Kumar, MD, has experience in bio-pharmaceutical and healthcare management consulting. In previous roles, he focused mainly on designing drug development strategies and cultivating relationships with KOLs in various therapeutic areas to build clinical strategies and increase scientific and clinical knowledge of product pipeline. At Coté Orphan, he specializes in developing regulatory strategies by analyzing scientific data in support of the orphan drug(s) in order to obtain regulatory approval. Dr. Kumar authors regulatory documents for the U.S. FDA and E.U. EMA including orphan drug designations, briefing meeting documents, fast track and breakthrough therapy designations, pediatric rare disease designations and strategic reviews. Dr. Kumar graduated from the University at Buffalo with a B.S. in Biophysics and earned his M.D. at Jagiellonian University Medical College. Following medical school, he was awarded the Imperial Scholars Fellowship to train in Personalized Medicine