Smooth Drug Development team
Smooth Drug Development team consists of individuals from local and global CROs, Russian and international pharmaceutical companies. Our unrivaled expertise helps us to find quick and optimal solutions for our Clients.
Dmitry Morozovsky, MD, EMBA
CEO, managing partner
Dmitry graduated from St-Petersburg State Medical Academy named after I.I. Mechnikov with a medical degree in general medicine. Dmitry started his career at a leading contract research organization PSI Intl. In 2006 Dmitry graduated from St-Petersburg Academy of Management and Economics with a degree in crisis management.
From 2008 to 2010 Dmitry was studying at St-Petersburg University of Economics and Finances and University of Applied Sciences Northwestern Switzerland. Dmitry received MBA degree in «Human resource management». During his education Dmitry received training at PricewaterhouseCoopers headquarters.
From 2005 to 2013 Dmitry worked as a CRA, SrCRA and Project Manager at a local CRO, OCT, and a global CRO, Quintiles. During that time Dmitry was actively engaged in the development of administration tools, educational programs and personnel trainings. In April of 2013 Dmitry joined Smooth Drug Development team as CEO.
“We are sure that a good team is a formula to success in any industry, especially in a rapidly developing pharmaceutical industry. We stake on professional, goal-oriented, devoted people, which helps us to provide our clients with the best solutions.”
Corporate Development Director, managing partner
In 2007 Julia Sardaryan graduated from St-Petersburg State University with a degree in the English language and translation.
Julia’s broad experience in clinical trials includes works at several contract research organizations (CRO).
In 2007 Julia worked as a clinical trials assistant at a global CRO, PSI.
In 2008 Julia joined a local CRO company, OCT, as a clinical trials coordinator.
In 2009 Julia was invited to join business development team at OCT. In 2010 Julia became Director of Business Development at OCT.
Julia responsibility included development of effective long-term relations with clients, identify clients’ needs, broadening of service spectrum, analysis of development strategies and company promotion at different markets.
In June of 2013 Julia joined Smooth Drug Development as a Corporate Development Director.
“Russia is far from realizing its potential in R&D sector. At Smooth Drug Development we are going to work in 3 directions- quality, speed and price. We are going to increase quality and speed and decrease clinical trials price.”
Non-executive Director, partner
Natalia Marchenko graduated from Moscow State University of tooling and machining. Natalia received a degree of economic manager in 2005.
In September 2004 Natalia joined Pfizer team as a clinical trials assistant. Natalia held numerous positions from assistant, CRA, SrCRA, safety specialist to Project Manager in clinical operations department. Natalia participated in more than 40 studies in different therapeutic areas including cardiology, pulmonology, psychiatry, inflammation, neurology, ophthalmology). As a project manager Natalia was responsible for high priority and most complex studies. Natalia was responsible for metrics assessment at the department. She was also engaged in quality improvement plan development in different areas.
In 2007 Natalia was in charge of new office opening in St. Petersburg. From 2007 Natalia worked as a line manager at the clinical operations department. From November of 2010 Natalia took the position of Head of Monitoring in Pfizer. During that time a professional team of 40 CRAs was created.
In June of 2013 Natalia joined Smooth Dug Development as Director of Pre-clinical, clinical and registration department.
“I can affirmatively say that I am proud of my work because we assist to make innovative treatment affordable to patients today! Every day we work with highly professional physicians, laboratory specialists and other members of study teams. Together we generate data which is 100% reliable.”
Karina Semenova, MD
Director, Quality Assurance and Trainings Department
Karina Semenova graduated from St-Petersburg Medical University named after I.P. Pavlov. Her career in clinical trials started in 1997 at a global CRO company, Quintiles, where she worked as a CRA, Lead CRA, Project Manager and Line Manager.
In 2006 Karina joined another CRO, ClinStar, where she worked as a QA and Training Manager till 2014. Karina responsibilities included:
- Leading of QA auditors’ team by providing clear team and individual goals and expectations
- Planning and conducting phase I to IV clinical study site audits in Russia, Belarus and Ukraine
- Audit of Trial Master File
- Drug Depot audit
- Preparation of clinical sites and accompaniment of the FDA/EMEA inspections
- Liaison with major international pharmaceutical company auditors at a local country level – accompanied audits in Russia and Ukraine
- Briefing of investigator study staff upon current GCP and Sponsor requirements
- Supplying GCP “Helpdesk” function for clinical research groups
- Development of Company SOPs
- Development of training program which included both clinical and non-clinical training sessions.
- Planning and performance of training sessions for clinical operations staff and QA auditors
- Planning and performance of external training session for clinical operations staff
- Planning and performance of co-monitoring visits for numerous therapeutic areas
In May of 2014 Karina joined Smooth Drug Development team as a Director of Quality Assurance and Trainings Department.
“Even small steps in direction of quality standards observance will lead to the achievement of big goals”.
Alexey Ladutko, MD, PhD
Scientific Department Director
In 2004 Alexey graduated with honors from Kuban State Medical Academy, medical faculty.
From 2004 to 2005 Alexey studied in clinical internship at the Department of neurosurgery and CNS diseases (the Specialty of neurology).
From 2005 to 2007 Alexey received postgraduate study at the Department of fundamental and clinical biochemistry of Kuban State Medical University.
In 2007 Alexey defended PhD thesis on «Special aspects of changes in blood plasma lipoprotein profile and erythrocytes in patients with atherosclerosis and possible ways of their diet correction».
From 2006 to 2012 Alexey worked as an Associate Professor at the Department of fundamental clinical biochemistry. In addition to that, Alexey supervised activities of postgraduate and undergraduate students (Student Research Society).
Alexey is an author of 80 scientific works. Alexey trained a candidate of medical science.
Alexey’s career in clinical trials started in 2012. Alexey took part in designing clinical documentation of novel and generic drugs. He has experience in phase I-IV studies in neurology, psychiatry, cardiology, pulmonology, phthisiopulmonology, infectious diseases, ophthalmology, oncology and etc.
In 2013 Alexey joined Smooth Drug Development team as a Head of Scientific Department.
Alexander Kochiev, MD
Clinical and Regulatory Operations Director
In 2002 Alexander graduated from Saint-Petersburg Pediatric Academy, Pediatrics Department.
In 2008 Alexander received a residency training in neurology, public health organization and clinical pharmacology.
From 2003 to 2007 Alexander worked as a Deputy of Chief Doctor at a medical institution.
In 2007 Alexander started his career as a clinical research associate at a leading contract research organization in Russia, «Evidence».
After that Alexander worked at several local and international clinical research organizations.
In 2012 Alexander started working as a Project Manager at a Russian leading biotech company, «Generium».
From 2014 to 2015 Alexander worked as the Head of the medical department at «Generium».
In September of 2015 Alexander joined Smooth Drug Development team as a Director of Clinical and Regulatory operations.
Business Development Director
Natalia has been active in the healthcare and pharmaceutical industry since 2010. In 2010, Natalia was making a 6-month internship in the German Parliament (the Bundestag) in Berlin as a Scientific Assistant to a Deputy (member of the Parliament), whose major focus was activities in the Healthcare Committee of the Parliament. Among many other activities, Natalia was responsible for preparing materials and reports on the Deputy meetings with healthcare sectors` representatives (e.g., hospitals, pharmaceutical companies, insurance companies), elaborating the following themes: risk structures equation, e-Health, telemedicine, corruption in healthcare, family doctor services system, etc.
In late 2010, Natalia joined an international clinical research organization, and has made a path from a Business Development Associate to Director for Business Development. Natalia was responsible for identification of potential business deals and its closure, project management up to contract closure with the client, participation in seminars, conferences and exhibitions (giving presentations, organizing face-to-face meeting, etc.), corporate development, etc.
In early 2014, Natalia joined the Smooth Drug Development team. Natalia`s activities include discussion of clinical research projects with clients and elaboration of the best implementation strategy, contract negotiation, market analysis, corporate development, international collaboration development, seminar and conference participation.
Natalia holds a Master degree in Sociology from St. Petersburg State University and a Certificate of Bielefeld University (Germany). Natalia also holds a Specialist degree in Philology (diploma with honours) from St. Petersburg State University.
"Being on the forefront of the medicine progress, both local as well as overseas R&D alliances, in many instances, need a reliable partner capable of managing the clinical project aimed at full development of the apple of their eye – their product. Here we are – Smooth Drug Development team to share our expertise with you, and bring your product to the in-patient and/or out-patient market sector."