Archives: Speakers

For the past two years Nikolay has served as Project Manager responsible for the global implementation of BlueTeMS Project. Prior to this he was Quality Manager and Responsible Pharmacist of Merck Bulgaria.

Nikolay joined Merck in June 2015 from Sopharma AD where he, over a five years period, held several positions in the manufacturing of dry-ice, aseptic and solid dosage products, validation of processes and equipment, validation of computerised systems, administration of electronic Quality Management System, motoring and coordination of all deviations, complaints, change controls, CAPAs, etc.

Nikolay holds a master’s degree in pharmacy from Medical University of Sofia, Bulgaria.

Cécile Pascaretti holds a doctoral degree in Pharmacy from the University of Limoges, France. She is in Merck Healthcare for 22 years and was heading various quality positions locally in France and then globally covering GMP and GDP aspects.
Cécile is in charge of the Supply Chain and Distribution Quality Management for Merck Healthcare. In this role, she is taking care of all the GDP topics especially external supplier management and qualification – validation.
She is also Deputy Responsible Person for Merck Healthcare France.

Mike Keens leads operational performance and growth strategies for Anju Software. Mike brings more than two decades of experience in drug development clinical and commercial operations at organizations that include ADial Pharmaceuticals, Syneos, Firma Clinical Research, and Icon PLC. His expertise includes driving the rapid growth of Clinical Trial and DCT business units supporting studies in more than 60 countries. Keens holds an M.S. in Public Health Sciences and a B.S. in Biology & Psychology and has been recognized by PharmaVOICE magazine as one of the Top 100 Inspiring People in Pharma. He also holds memberships in the American Society of Clinical Oncology (ASCO) and the Association of Clinical Research Professionals (ACRP).

Dave is an entrepreneur and technology innovator. He is known for pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Patient Simulation (VPS).

Dave’s last company, TheraSim, launched the world’s first successful online VPS system for physicians and trained over 500,000 doctors in every country on Earth. TheraSim built the world’s largest network of computer-based clinical simulation sites in Africa in support of the USAID and the CDC’s HIV-treatment effort. TheraSim was acquired by WebMD in 2014.

Since then, he has focused his passion for technological innovation and learning systems in the field of clinical trials, helping sponsors make their studies more accurate and efficient through finding the right technology mix such as virtualization, performance management and applied behavioral sciences to produce the most effective, lasting, and engaging results for clinical trials.

Dave has always valued the interconnectedness of our vastly changing world, and has traveled to over 70 countries for his global health work and for cultural development outreach through music.