Janet Flisak Clinical Program Leader
Oncology,
Global Clinical Operations Johnson & Johnson
Janet Flisak is currently a Director at Johnson and
Johnson Pharmaceutical Research and Development. She works
in the Global Clinical Operations (GCO) group as a
compound program lead focused on oncology development. She
is accountable for the successful execution of clinical
trials in her assigned programs. She has been with J&J
PRD for approximately 10 years. Before her employ at
J&J PRD she worked for another big pharma company as a
clinical scientist and medical writer.
Janet started her career as a registered nurse working in
the acute care setting. She moved to the pharma industry
ideally suited to manage trials with her clinical
background. She obtained an undergrad from the Wharton
School of Business at the University of Pennsylvania.
Thereafter she received her MBA from the University of
Phoenix.
Tomas Skacel MD PhD International Medical
Director Amgen
Dr Tomas Skacel has graduated as medical doctor from the
Palacky University Olomouc in Czech Republic. His
postdoctoral training included an internship in internal
medicine and surgery at the Birmingham and Palacky
University, as well as a residency in medicine and
hemato-oncology. Dr. Skacel has received a PhD from
Masaryk University Brno and currently serves as lecturer
at the Medical faculty Masaryk University Brno and Charles
University Prague. His research interests include clinical
trials in advanced cancer, cancer-induced bone disease,
development of novel agents in the oncology field and
optimization of current cytostatic therapy in breast
cancer and lymphoma.
From 1999 to 2003 Dr. Skacel has worked as oncology
clinical research physician at Eli Lilly. Since 2003, he
has joined Amgen International HQ and worked as European
and International R&D Director in Oncology area. Since
2008 he leads R&D organization in the Switzerland.
Dr. Marlene Llopiz President AMEIFAC
- Association of Medical Specialists in the
Pharmaceutical Industry
- Asociacion de Medicos Especialistas en la Industria
Farmaceutica,A.C.
Dr. Marlene Llopiz is President of AMEIFAC - Mexico for
the 2011-2013 term, Secretary for IFAPP and CEO of Clinica
Responsable Operativa Mexicana,S.C. Dr. Llopiz also serves
on the board of the Chamber of Commerce for the
Pharmaceutical Industry (CANIFARMA) in Mexico. For over 20
years, she has worked extensively in clinical research
conducting large global phase I-IV clinical trials with a
focus on Latin America. She has significant experience in
regulatory affairs, protocol writing, CRF design, and
managing monitoring activities. She has supervised global
studies in oncology, the nervous system, the respiratory
tract, the cardiovascular system, etc.
She was recently elected one of 100 of the most-inspiring
people in the life-sciences industry for the second
consecutive year as identified by the readers of
PharmaVOICE (August 2010 and 2011 edition). She is the
first Latin American woman to have received the award. In
2010, she received the 2010 Leadership Medal of Honor from
the Facultad de Ciencias de la Salud Universidad
Anáhuac - the first woman to receive this award.
She has a strong academic background and wide experience
in clinical research management and operations. She is
well known in the clinical research arena and keeps close
contact with renowned investigators and high officials of
the Ministry of Health for protocol approval and
assessment of clinical trial strategies. She has served as
a direct consultant for the Mexican Ministry of Health
Undersecretary of Innovation and Quality; was a recipient
of the 1999 Distinguished Alumni Award from Austin College
in Texas, and a two time recipient of the Fundación
México en Harvard (Mexico Foundation at Harvard)
full fellowship for the MPH degree program. She
holds a Bachelor of Arts degree from Austin College,
Medical Doctor degree from the Universidad Anahuac, and a
Master in Public Health degree from Harvard University.
She will serve as President and Chair for the 9th Latin
American Conference in Clinical Research together with the
Drug Information Association (DIA) to be held in October
2012 in Mexico City, Mexico as President of AMEIFAC –
Association of Medical Specialists of the Pharmaceutical
Industry. She has authored several articles and is
currently co-editor and chapter author of “Manual of
Pharmaceutical Medicine” to be published in 2012.
Anna Harringto-Morozova Executive Director RAPIEM (Regulatory
Affairs Professionals for Innovation in Emerging
Markets)
Anna Harrington-Morozova is a regulatory, drug development
and external relations professional with over 20 years’
experience gained in regulatory authority, academia and
industry environment.
Anna’s senior regulatory positions in global
pharmaceutical and health care industry in Russia and the
UK include Procter & Gamble, EISAI, GSK as well as
global CRO and regulatory consultancies PAREXEL, ICON
Consulting and PRA International.
Anna is an Executive Director of RAPIEM, non-profit
organisation Regulatory Affairs Professionals for
Innovation in Emerging Markets Ltd UK, which promotes
elimination of regulatory barriers for innovations in
development of new pharmaceuticals and medical
technologies via regulatory harmonisation and training of
regulatory professionals in Emerging Markets.
Dr. Alexander Siebel Executive Scientific
Adviser S & P Pharmaterra
Dr. Siebel has been pioneering clinical trials in Eastern
Europe since 1990. He was the one of the first to explore
the vast potential of Eastern Europe and Central Asia for
the pharmaceutical industry. Since 1995 he has lead the
S&P CRO Management Group.
Before the foundation of S&P Pharmatest Management,
Dr. Siebel worked in the German regulatory authority BGA
Bundesgesundheitsamt (later renamed BfArM). After this, he
was a Scientific Director at Farmitalia, Pharmacia and
Vice President of Parexel.
Dr. Siebel beings a wealth of experience to this congress,
having been involved in over 200 Eastern European and
Central Asian trials.
S&P Pharmaterra Management is a founding member of
Clinterra Research Network and offers the pharma industry
a unique service by utilizing local knowledge with a
global reach and view inside the landscape of clinical
trials.
Denis Mir,
MSc Senior Manager Eisai Global Clinical
Development
Denis first trained as
a chemist and Biologist. Upon completion of a master
degree in biochemistry, he entered the pharmaceutical
industry where he first worked in a marketing position.
Adding a statistics degree to his curriculum, Denis
moved to the Clinical Research area where he has worked
for several pharmaceutical and biotech companies
specialised in oncology. During this period he has been
involved in the management of large scale post-marketing
studies of well-established cytotoxic drugs to phase
I/II proof of concept studies for small molecules.
Denis Mir,
MSc