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.
Mohit Kashyap, PhD, has experience in both academic and industrial pre-clinical research in the field of immunology and immunotherapy. Here at IQVIA, Orphan Drug Unit, his role includes developing regulatory strategy and preparing documents for pharmaceutical and biotech companies across the globe. Since joining the IQVIA Orphan Drug Unit team, he has worked on various projects such as US and EU orphan drug designations, FDA meeting packages, investigational new drug projects, breakthrough therapy and pediatric rare disease designations plus feasibility assessments and strategic reviews. He now leads a team of senior regulatory officers and mentors them on advising clients with advantages and risks of various regulatory pathways that can be encountered during the drug development process, thus establishing client relationships and bringing repeat business. In previous roles, Mohit 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. Mohit 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 IQVIA Orphan Drug Unit, 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 her MBA from Johns Hopkins University.
Irina Mikhailenko, PhD, has extensive US and EU regulatory experience and expertise in both preclinical and clinical research. Dr. Mikhailenko has proven record of developing winning regulatory strategies to achieve clients’ goals. She is very efficient in preparing and submitting regulatory documents to the authorities, communicating with FDA and EMA agencies on clients’ behalf.
Strong background in life and medical sciences; in-depth knowledge of FDA and ICH regulations, combined with her excellent communication, conflict resolution and interpersonal skills makes Dr. Mikhailenko a very successful regulatory specialist.
In previous roles, as a research scientist at the American Red Cross, the University of Maryland in Baltimore School of Medicine and at the National Institutes of Health, Dr. Mikhailenko developed pre-clinical and clinical research programs for advancing drugs from bench to bedside for such indications as hemophilia and deep vein thrombosis; cardiovascular diseases and muscular dystrophy; Alzheimer's disease and oncology.
Mikhailenko earned her Ph.D. in Biology from the Russian Academy of Medical Sciences and her M.S. degree in Biophysics from Moscow Institute of Physics and Technology. Dr. Mikhailenko is a certified Clinical Trials Project Manager, certification was received from Montgomery College of Maryland.
Rebecca Schell, MBS, has experience in business development and regulatory affairs. Rebecca interned with Coté Orphan during the summer of 2015 as a marketing intern, but quickly assumed increasing business development responsibilities. Rebecca joined Coté Orphan in the summer of 2016 as a business development manager, but switched over to the regulatory affairs team in January 2017 where she is now currently as a Senior Regulatory Affairs Officer. 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 of Science and Business from Keck Graduate Institute, also in Claremont
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.