Speakers

 

Edward Jensen, PMP Consultant to Chief Medical OfficerBiogen - USA

Edward is a hands-on executive and manager who brings more than 30 years of broad, in-depth experience of driving innovation, development and commercialisation in diverse global, multi-national environments with a proven track record of delivering on strategic business objectives. Edward has spent the last 17 years working in the pharmaceutical industry, initially undertaking business improvement initiatives at Pfizer and then running development programs and the CNS portfolio at AstraZeneca. Edward joined the Johnson & Johnson family of companies in 2001 where he ran a number of late-stage, pivotal trials and regulatory submissions for REMICADE®, then managed a Product Development Team for a stem cell therapy and subsequently managed the commercial team that launched ZYTIGA®, acclaimed as “the most successful oncology product launch ever” and now achieving world-wide sales of $2+ billion.

Edward was appointed Head of Operations at TransCelerate, the collaboration that was jointly established by 10 major pharmaceutical organisations, to accelerate and simplify the research and development of new therapies. In this role, Edward supported the Board of Directors and the Operations Committee to spearhead an aggressive agenda that sought to advance innovation in R&D, identify and solve common R&D challenges, with the goal of delivering more high quality medicines to patients

Edward returned to J&J to ran the EPREX®/PROCRIT® and VELCADE® franchises as well as 2 new compounds in early development. He is now a private consultant to the Chief Medical Officer at Biogen in Boston, as they adopt and implement a number of the deliverables produced as a result of Biogen’s participation on the TransCelerate collaboration.


Cristina Pentiuc, MD Market Access DirectorBristol-Myers Squibb

Cristina Pentiuc, MD, is Market Access Director for Bristol-Myers Squibb since 2010 and also co-leader of the Policy working group in the innovative industry local association ARPIM. She had different positions in clinical research and medical affairs. She brings a broad know-how into pharmaceutical business, deep understanding of regulations at both European and local level, as well as an empathic awareness patients needs to access best in treatment and healthcare services.


Tausif Monif, Ph.D Vice President
Clinical Pharmacology & Pharmacokinetics
Sun Pharma - India

Dr. Tausif Monif is Vice President in the Department of Clinical Pharmacology and Pharmacokinetics, Sun Pharmaceutical Industries Ltd., India. He has more than 20 years of industrial experience in the field of Generic drugs and is currently spearheading a group of scientists in the bio-pharmaceutics function. Dr. Monif provides strategic leadership and direction for conceptualization and execution of BA/BE studies for Generic dosage forms & New drugs thereby supporting the company’s product development activities and International regulatory submissions. His core activities and research interests include pharmacokinetics, bio-analysis, biostatistics, In-vitro In-vivo correlations and In-vitro release rate studies which enable providing valuable feedback towards optimizing formulation development. Dr. Monif received his Ph.D. in Pharmaceutics from Birla Institute of Technology, India in 1993. He has co-authored over 80 publications and served as a reviewer for multiple International and National journals. He is an active Member of International and National Scientific associations in the field of Pharmaceutical Sciences. He also mentors a number of students in their graduate programmes that includes direct supervision of several Ph.D. candidates.


Xavier Llop, MD Medical Director
Noventure - Spain

Dr. Llop is the Medical Director of Noventure (Ferrer Division), a company specialized in the treatment of gastroenterology and urology diseases, based in Barcelona, Spain. Before joining Noventure, Dr. Llop was Medical Manager at Boehringer Manheim. Dr. Llop has expertise in communication strategy based on clinical evidence. Also, he has expertise in the development of scientific content, market-oriented to the development of concepts and evidence-based messages. Dr. Llop has graduated Universitat Autònoma de Barcelona and he hold a license in Medicine.


Cristian Ducu, PhD General Manager
Centre for Advanced Research in Management and Applied Ethics - Romania

Cristian holds a PhD in Moral Philosophy from the University of Bucharest, magna cum laude. Since 2008, he is the General Manager of the Centre for Advanced Research in Management and Applied Ethics, an independent research and consulting NGO. He is also the General Secretary of the Ethics Commission, Lobbying and Advocacy Transparency Registry, Romanian Lobbying Registry Association, and, from 2010 until 2013, he served as a member of the National Committee for Bioethics, UNESCO-National Comission of Romania.

In the last 13 years, he specialized in Applied Ethics (mostly, Business Ethics, Communication Ethics, Bioethics, and Ethics in New and Emerging Technologies) and taught various classes in these fields at the University of Bucharest and National University of Political Studies and Public Administration. Between 2010-2011, he was part of team that did an ethical assessment for a national strategy on “Cell Therapies in Development of Regenerative Medicine” (PrioriStratec Project, National Institute of Research-Development in the Pathology Domain and Biomedical Sciences “Victor Babes”). In 2015, he delivered a special course on Ethics in Biomedical Research for “Carol Davila” University of Medicine and Pharmacy.

Since 2006, he promotes intensely the field of Ethics & Compliance Management in Central and Eastern Europe, and he is the conference manager of 2015 Romanian Ethics & Compliance Forum and 2016 European Ethics & Compliance Forum. Since 2007, he also coordinates the Ethics & Compliance Academy.


Teresa Diaz Garcia, RN Principal Clinical Research Manager
Europe 2 & intercontinental
Merck Group - Spain

Ms. Diaz brings more than 18 years of expertise in the clinical research field. Her responsibility is to ensure compliance with local/regional guidelines, GCP as well as alignment of systems and processes to Merck’s local and global standards. She is a line manager for Clinical Account Managers, Clinical Research Managers and Senior Clinical Research Managers, acting as an interface between Global Clinical Operations and local organization (Global Operations).Ms. Diaz is ensuring the management of independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment. She is working with multiple local and regional CROs to ensure local / regional trials are delivered within desired quality, timelines and costs.


Eduard Prisăcariu, MD Medical DirectorSanofi Aventis - Romania

Dr. Prisacariu has a sound governance and high standards of ethical behavior supported by an extensive experience of more than 20 years in the pharmaceutical industry. He held positions starting from leadership of Country Organization on Medical Affairs, Clinical Trials, Regulatory, Pharmacovigilance, Market & Patient Access and Quality Assurance to positions like CEE Regional Leadership on Drug Safety Operations and Compliance (EU and non-EU countries). He is Experienced with Strategic alignment of decision makers in Local Health Authorities: Ethics Committee, Health Insurance House, Ministry of Health and third parties (e.g. Patients' Associations) on a wide range of Therapeutic Areas and Clinical Projects. He leads the Local & Global Clinical Trials Operations, including Non- Interventional/ Observational Studies; being involved in Study Management, Contracting and controlling activities of CROs.


Jens Dollerup, MSc Independent ConsultantDenmark

Extensive knowledge as to the most prevalent diseases: Pulmonary, cardiovascular, metabolic and more, both as to classical RCT's but also as to "real life usages". Special interest in NON-interventional, quality assurance and register studies, which is of emerging interest of decision makers and payers in the health care sectors. Also regulatory institutions has shown an emerging interest in this. Efficacy versus effectiveness (real world data) will be a hot topic in the future, also real world studies will be an emerging discipline for CRO's, SMO's and more.

Since 1984 published many pear reviewed articles on these subjects, also including patents on concepts accepted.

More than 30 years of experience in the industry.


Marius Mărușteri, Pharm.D, MSc, PhD Head of Medical Informatics and Biostatistics Dept. Chairman of Academical Management & European Integration Dept. University of Medicine and Pharmacy Targu Mures - Romania

Prof. Dr. Marius Marusteri is the Head of Medical Informatics and Biostatistics Department at the University of Medicine and Pharmacy, Targu Mures, Romania. His research interests include fields like Large Medical Database Management, Molecular Databases, Medical E-learning, Advanced Wearable Medical Devices, Clinical Trials Design and Analysis, Applied (Bio)Statistics, Advanced Scientometrics and Bibliometrics etc.

Dr. Marusteri is the author of 6 books in the field of Medical Informatics, Biostatistics, Experimental Pharmacology and Research Methodology and of more than 80 scientific papers published in extenso in national and international journals. He is a statistical reviewer for 2 Thomson ISI indexed journals and is working also as a consultant in the field of clinical trials design and statistical analysis for various Romanian and International companies.

In the last years, he was awarded with 9 Awards and Medals for his educational and scientific activities, including a Silver Medal at The International Exhibition of Inventions, Lublijana, Slovenia -2010 and The Romanian National Order for Educational Merit, in the rank of Officer - 2004.


Sabina Marcu, MD Medical Director Boehringer Ingelheim - Romania

My name is Sabina Marcu and I am familiar with the Pharma Industry for almost 20 years. But this was not “my first love”! After graduating the University of Medicine in Targu Mures, i worked for a couple of years in the County Hospital in Brasov. But soon I was attracted by a domain which started to be built in Romania: the pharmaceutical industry. This was in 1995. Of course, the first job in this industry was as Medical Representative in GlaxoWellcome (at that moment!). During this period, I developed sales activities, promoted more then 20 company products and learned the ability to find solution to customer needs. The next step was somehow logical: in Marketing. As Product Manager I started “to feel the world of clinical research “by initiating, design and organizing clinical post-marketing studies Of course, developing the plan strategies for all activities related to assigned products, public relations activities, journal advertising, developing promotional materials were also my tasks.

After this period, a next development phase followed: as Medical & Regulatory Affairs Manager – first in Astra, then in AstraZeneca and after some years in Wyeth. Since 2006 I am the Medical director for Boehringer Ingelheim in Romania. Among multiple medical specific tasks, I offer the medical contribution to the preparation of CTA for phase III and IV clinical studies. And in Romania, Boehringer Ingelheim is conducting several clinical trials in 6 therapeutical areas.


Ivan Georgiev, MD ChairmanBulgarian Association of Clinical Research

Ivan Georgiev, MD is chairman of the steering committee of the Bulgarian Association of Clinical Research. He graduated medicine in 1996 in Medical Academy of Sofia and is board certified in internal medicine from 2003. He obtained master degree in Business Administration in Sofia University “ Sveti Kliment Ohrdidski”. His experience in clinical research dates back to 2001 in geographies like US, Europe and Middle East. He served as medical director for GSK Bulgaria during 2013 / 2014 and since 2014 is managing director of Quintiles Bulgaria.


Florina Prundaru, MD Clinical Research Director Romania & BulgariaMerck Sharpe & Dome - Romania

More than 16 years’ experience in Clinical Research arena bringing experience from different perspective academic research, WHO, CRO and Sponsor. Starting as Clinical Research Associate and moving to different positions, Quality Assurance, Project Management, Clinical Research Manager or Clinical Operation Manager enabled gamming in deep knowledge of all aspects related with Clinical Trial Implementation at country and regional level.

Active member of Clinical Trials Sub Working Group of ARPIM (Association of International R&D Pharma-industry affiliated to EFPIA), and one of the main contributors to ARPIM initiatives on clinical research and patient access to innovation.


Mihai Manolache, MS CEOCEBIS International

Mihai Manolache is CEO of CEBIS International, a full service European based Contract Research Organization. Previously, he served as Regional Manager CEE Clinical Research Operations covering the activities in all European Emerging Countries. During that period, he led the transformation of clinical research operations and significantly developed the operations in other adjacent countries. Mihai Manolache brings to the company a solid expertise for more than 14 years in clinical research and product life cycle management. His expertise in planning, managing and coordinating summarize more than 200 multinational and national clinical studies in multiple therapeutic areas.

Prior to joining CEBIS International, Mihai Manolache was Clinical Trials Operations Manager and Business Development Manager at a USA based CRO, where he managed the clinical operations for Romania and Poland. Mihai Manolache earned a Master degree in Biostatistics and also a PGP in Clinical Trial Management from University of Medicine and Pharmacy in Bucharest. He has graduated the Law School in Bucharest and he also graduated the Faculty of Economics and Administrative Sciences.


Daniel Da Costa,PhD Business Developer ManagerInoviem Scientific - France

Experienced scientist in molecular biology and experienced project manager within medtech and biotech companies as well as innovative project incubator.

Dr. Da Costa, graduated from Ecole Normale Supérieure de Lyon and holds a PhD from the University of Strasbourg.


Boyan Doganov, MD Ethics Committee forMulticentre Trials - Bulgaria

Dr. Doganov has high ethical standards supported by principles like trust, good behavior, fairness and kindness. All of this being consistent with an impressive experience of more than 30 years in the health-care. He held different positions, including top management positions in health care and member of the Bulgarian health care reform team. He was acting as local, regional and international expert in healthcare, working with international institutions like World Bank, Global Fund for HIV/AIDS and attending as a speaker international events in pharmaceutical management and project management. Dr. Doganov has graduated the Medical Academy in Sofia and his specialties include Infectious diseases and Epidemiology. He has graduated Pharmacoeconomics at Monash University, Australia. He is also a senior trainer in Good Clinical Practice, Medical Writing, Communication, Clinical Research Monitoring and Management. Dr. Doganov is currently deputy-chairman of the Ethics Committee for Multicentre Trials in Bulgaria.


Alexander Oscar, MD, PhD Ethics Committee for Multicenter Clinical Trials - Bulgaria

Dr Alexander Oscar is the acting Chairman of the Bulgarian Ethics Committee for Multicenter Clinical Trials. He has specialities in Neurology and Ophthalmology and works as a physician at the Clinic of Ophthalmology, University “Alexandrovska” Hospital and as an assistant professor at the Department of Ophthalmology, Medical University of Sofia, Bulgaria.


Cornelia Preda, MD Regional Ethics and Compliance Manager for Romania, Bulgaria and Baltic States

AbbVie

Dr. Preda brings more than 20 years of experience in the pharmaceutical industry, of which more than 7 years acting as a director of the medical department in AbbVie. She previously had multiple roles also in departments like marketing and sales and regulatory affairs. She is an active member of the Ethical Environment Working Group (EEWG) of ARPIM (Association of International R&D Pharma-industry affiliated to EFPIA) and Active Member of the Scientific Council of the Romanian Regulatory Authority (2 mandates) representing the Romanian Pharma Association. Currently, Dr. Preda is acting as a Regional Ethics and Compliance Manager for Romania, Bulgaria and Baltic States.


Pavel Tverdokhleb, MD Independent Consultant

Russia

Pavel Tverdokhleb graduated from the Moscow Pirogov Medical University in 1984 in speciality of biophysics and worked as a scientist in space medicine and biology until 1993. He joined the pharma industry in 1996, and over past 19 years Pavel worked at Quintiles, Pharmacia, Bristol Myers-Squibb, Pfizer, PharmaNet, i3 in clinical operations, safety, quality standards, compliance, GCP trainings. Recently, Pavel held a position of Senior Director Clinical Research at InVentiv Health Clinical. Now, Pavel is acting as an independent consultant to CROs and pharma companies in CEE and CIS regions..


Constantin Mircioiu, MD, MS, PhD University of Medicine & Pharmacy BucharestNational Committee for Bioethics – Romania

Academician Prof. Dr. Constantin Mircioiu is currently the Secretary of the National Bioethics Committee of Romania and a member of the Academy of Medical Sciences since 1996. He is Professor of Applied Mathematics and Biostatistics, University of Medicine and Pharmacy since 1990. His past positions were: Head of the Dept. of Applied Mathematics and Biostatistics, University of Medicine and Pharmacy "Carol Davila", Dean of the Faculty of Pharmacy, Bucharest, 2004-Head of Dept. of Pharmaceutical Technology and Biopharmacy, Army Center for Medical Research.

His main fields of specialization are: biopharmacy and pharmacokinetics, pharmaceutical technology and biostatistics. In terms of reseach publication, he was part of research published (56 in scientific journals and volumes) 4 books ("Pharmacological mechanisms at membranar interfaces", Romanian Academy Publ. House, 1994; Mathematics Applied in Pharmacy, 2000, Biostatistics 2005, associated editor for NBC Risks. Current Capabilities and Future Perspectives for Protection, NATO Science Series, Kluwer Academic Publishers, Dordrecht/Boston/London, 1999) or communicated ( 28 at international Conferences). He is a member of the New-York Academy of Sciences and member of the American Association of Pharmaceutical Scientists.


Joachim Linke , MD, MSc CEOCreative Clinical Research GmbH

Germany

Joachim is a physician and a statistician by education and holds a Master Degree in Applied Statistics from the Sheffield Hallam University, UK. More than 20 years of practical experience in Clinical Research qualify him as a senior expert in medical-scientific and statistical questions in the field of drug development. Joachim started his career in a worldwide active CRO followed by several positions in other health care industry sectors. His experience was supplemented by Clinical Research activities in a German private clinic chain (HELIOS, belongs to the Fresenius SE group). In his last position at Fresenius Kabi Deutschland GmbH (also belonging to the Fresenius SE group) he was responsible as Medical Director in the Business Unit "Parenteral Nutrition (PN)" for the development of new PN products and published also new creative analytical approaches of study data analyses together with Key Opinion Leaders of the PN science community.


Călin Gălăşeanu, MD General ManagerBristol-Myers Squibb - Romania

President of The Romanian Association of International Medicine Manufacturers (ARPIM)

Mr. Călin Gălășeanu, MD, has been General Manager of Bristol-Myers Squibb Romania since 2012 and the incumbent President of the Romanian industry association, ARPIM, for the second mandate in a row. With almost 18 years background in pharmaceutical business and 9 years in Bristol-Myers Squibb, Mr. Galaseanu has been successfully leading the Romanian operations of one of the most dynamic companies in the industry, striving to provide Romanian patients faster access to innovative treatments.


Adrian Udrea, MD, PhD Chief Medical Officer, OncologistMedisprof - Romania

As a PI, I have proven track record of professionalism, conducting over 30 successful clinical trials, a great number being conducted at Medisprof. During the past five years, Medisprof has become a landmark as a Romanian research site and is continuing to grow thanks to our qualified research team. Being Chief Medical Officer has shown me the difficulties of leadership but also the perspective of future achievements with the proper team.


Simona Olaru, MD Country Medical DirectorBristol-Myers Squibb - Romania

Simona Olaru, MD is currently Country Medical Director of Bristol-Myers Squibb Romania. With almost 9 years of Pharma experience, she had different positions in clinical research and medical affairs, mainly in MSD and formerly Schering-Plough. As background, she is physician with experience on immunology, infections diseases and palliative care for oncology patients.


Julian V. Platon, MD, PhD Global Medical Director, GastroIntestinal & Liver Health Established PharmaceuticalsAbbott Products Operations AG

Dr. Platon has been born in Bucharest, Romania in 1963. After his A Level in Bucharest he relocated to Germany in 1983 where he obtained the German Matura and studied Medicine in Cologne, London and Beer-Sheva. In parallel to his Conferral of Doctorate in Surgery he worked as a physician in Internal Medicine in Cologne, Germany.

Since 1994 Dr. Platon had different national and international, operational and executive medical positions in the Pharmaceutical, Medical Devices and Clinical Research Organization industry in Germany, USA and Switzerland. A special focus was addressed to Medical Affairs, Clinical Operations and Pharmacovigilance (incl. QPPV). Stations of his professional life were Isis-Pharma, Hoffmann-La Roche, Abbott Diagnostics, PharmaPart, Solvay and Alexion.

Dr. Platon is married, has three children and lives in Basel, Switzerland where he works for the Headquarters of Abbott Pharmaceuticals as Global Medical Director for Gastrointestinal and Liver Health (formerly also Women Health).


Bujor Almășan, MD, PhD Country ManagerQuintiles Romania President of the Association of the Companies Coordinating Clinical Trials in Romania

Bujor Almășan M.D., Ph.D is Country Manager since 2005 and President of the Association of the Companies Coordinating Clinical Trials in Romania. With more than 21 years of experience in the pharma industry, from which 14 years in the clinical research field, he had a significant contribution to develop and enlarge the type of services of the local organization, by striving to be the first research provider to patients, physicians and sponsor companies.


Alexandru Sîrbu, MD GCP InspectorNational Agency of Medicine and Medical Devices

Republic of Moldova

With more than 18 years of experience in the pharmaceutical industry and in the clinical research field in the Republic of Moldova, Romania and Ukraine, Dr. Sirbu has developed a strong ability to follow detailed processes and procedures and has close to perfect precision in executing his work with high attention to details.

His current work involves the review and compliance verification of quality systems throughout theclinical development process, from the design of the protocol to the final clinical study report.

Dr. Sîrbu's commitment to the highest standards of excellence, integrity and performance have helped him in conducting inspections in accordance with all applicable local regulations, ensuring timely and effective corrective action plans.


Marika Pečená, MD Clinical Research Consultant

Czech Republic

Marika Pečená graduated 2nd from Medical School at Charles University Prague, Czech Republic. Her postgraduate training is in clinical chemistry and immunology. She served as the Clinical Operations Manager, Phase II-III studies in oncology, rheumatology, virology and nephrology at F. Hoffmann La Roche, Czech Republic. She also served as the Senior Clinical Development Expert Sanofi Generics and was accountable for designing, conducting and assessment of clinical studies with PK and PD endpoints (namely bioequivalence studies) in EU and Russia.

Marika has broad knowledge of Russian environment in local clinical studies and registrations of generic medicines (selection, auditing and training of CROs, clinical sites and bio analytical laboratories, risk management, contracting, logistics, timekeeping, and designing the studies and assessment of pharmacokinetics results), and is actively connecting Russian and European counterparts in this field for more than 5 years.


Other profiles will be updated soon on our website.

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