Shiri Diskin, Ph.D
Shiri holds a Ph.D. in cell, molecular and developmental biology from Tufts University and a B.Sc. in life sciences from Tel-Aviv University. She has been a medical writer since 2009. Shiri worked as a medical writer and medical writing team leader at Teva until 2014. Since then, she has been working as an independent instructor and consultant of medical writing. Shiri is experienced in managing medical writing projects of early and late phase product development. Her expertise encompasses study-specific documents such as protocols and clinical study reports, as well as development-program documents such as investigator’s brochures and summaries of efficacy and safety. Shiri is experienced in close collaboration with multi-disciplinary clinical development teams, specifically safety, biostatistics and data management aimed at producing the highest-quality, most regulation-compliant, clear and informative documents while adhering to timelines.
In addition to regulatory documents, Shiri is an expert in writing scientific journal articles. She writes and edits manuscripts and teaches workshops to medical doctors and scientists on this subject. Her book on the subject has recently been published worldwide
Nissim has recently joined Bioforum after working for TEVA Pharmaceuticals for the last 17 years. Nissim completed his MA degree in Biostatistics at 2008. In his last role at TEVA, he was a director of Biostatistics holding a managerial role of leading a group of biostatisticians in the MS and Neurodegenerative Therapeutic area. Nissim is coming to Bioforum with extensive experience in biostatistics for late and early phases in the drug development as well as with submissions to regulatory agencies in US, EU Canada and Japan. In addition, Nissim brings expertise in DMC/DSMB’s as unblinded statistician and extensive knowledge in trial design, innovative statistical methods, regulations, up to date guidelines and SOP’s constructions. At Bioforum Nissim will be in charge of all strategic biostatistical activities, fostering innovative methodologies and leverage and develop the biostatistical group.
Holds a M.Sc. in Epidemiology from Ben-Gurion University of the Negev, Beer Sheva, Israel. She has been a part of the Bioforum team for 7 years and is responsible for leading and overseeing all data management personnel, as well as directing and guiding the data management activities for the company. Irina develops and implements strategies and policies for data management that maximizes the quality, reliability, and efficiency of Bioforum’s services. She also ensures that our client’s requirements are always met to their standards and the industry performs its best practices.
Dafna has been a part of the Bioforum team for the last 8 years. She works in the area of data management, clinical programming, and regulatory submissions in all clinical studies phases, encompassing numerous therapeutic areas. Dafna holds a B.Sc. from the Hebrew University and an MBA from the College of Management Academic Studies, Bio-MBA Program.
Limor has over 20 years of experience in both manufacture and development of commercial and Investigational Medicinal Products within the pharmaceutical industry, quality management system, cGMP, GDP and local regulations. Certified by both the American and Israeli quality societies as a Certified Manager of Quality (CMQ), has served as a Quality Manager for LycoRed Bio and Nesher Solutions, companies specializing in development and production of sustained released micro-encapsulated, solid dosage forms. Prior to that, Limor held a position in QA of Starting Materials at RAFA Laboratories Ltd. Holds a MSc. Pharm in Pharmaceutical Chemistry and a BSc in Chemistry from The Hebrew University of Jerusalem in Israel. Limor is also QA Director at IMP, Bioforum’s Clinical Supply Services.