Jerry
Buysse
Chief Scientific Officer and SVP, Research
Relypsa Inc
Dr. Jerry Buysse is
Chief Scientific Officer and Co-founder of Relypsa,
Inc., which was formed in October, 2007.
Previously, Dr. Buysse was Vice President of
Preclinical Research and Development at Ilypsa,
responsible for chemistry, lead discovery, preclinical
development and pharmacology.
Dr. Buysse joined
Ilypsa in May, 2003 following seven years at Microcide
Pharmaceuticals (1996-2003) where he was Vice
President of Discovery Biology, responsible for
screening and lead discovery in Microcide’s
antibacterial and antifungal programs. Dr.
Buysse was a Senior Research Scientist at Pharmacia
& Upjohn (1992-1996) and contributed to
preclinical and early clinical development of
Linezolid (Zyvox). He was a National Research Council
Fellow and Senior Research Microbiologist at the
Walter Reed Army Institute of Research (1984-1992),
working on vaccines for enteric bacterial
infections.
Dr. Buysse received
his BS in Microbiology at The University of Michigan,
Ph.D. in Immunology and Microbiology from Wayne State
University School of Medicine and completed
postdoctoral studies at Tufts University School of
Medicine.
Dr
David Kallend
Global Clinical Leader and PD Group Medical Director
F. Hoffmann-La Roche
Dr David Kallend
trained in medicine at King’s College London and King’s
College Hospital, qualifying with an MBBS from the
University of London in 1988. Following this he
trained in surgery, predominantly at the Royal
Postgraduate Medical School in London where his final
post was as a Research Fellow in the Department of
Surgery. During this time his research interests
were mainly the use of imaging modalities for diagnosis
of surgical conditions.
In 1995 he left medical
practice and joined Schering AG in Berlin where he spent
3 years working on MRI diagnostics of soft tissue tumors
and the vascular system. In 1998 he joined Zeneca where
he worked on the development of Rosuvastatin from early
Phase II into Phase IV. In this post he was initially
involved in the phase III program and regulatory
activities. Later, as Lead Rest of World Brand Physician
he was involved in designing and overseeing many of the
Galaxy studies as well as working on the regulatory and
marketing strategy for the life cycle of
Rosuvastatin.
In 2005 he moved to
Switzerland to work for Roche and for the last 6 years
has been the Global Clinical Leader for the development
of Dalcetrapib, a CETP modulator currently in late stage
development. In this role he is a key player in
developing the strategy for the development of
Dalcetrapib and is involved in regular Regulatory
Authority interactions globally.
Dr CN Ramchand President and CEO Laila Pharmaceuticals
Pvt. Ltd
Dr CN Ramchand, is
currently the President and CEO of Laila Pharmaceuticals
Pvt. Ltd., a Drug Discovery Company based at Chennai
with the Head Office at Vijayawada. Previous to this
position, Dr. Ramchand was the Director, at KEMIN
Pharma, India ( A subsidiary of Kemin Pharma
Belgium BVBA) and was holding a simultaneous
position as Director of Research and Development, Kemin
Industries South Asia Pvt. Ltd., a part of Kemin
Industries Inc, Desmoines, USA. Dr. Ramchand also was a
WW executive team member at Kemin Industries. Prior to
the assignment at Kemin Industries, Dr Ramchand
was with Sun Pharmaceuticals, currently the largest
Pharma company in India ( as per ORG marg) as its Vice
President and Head of Drug Discovery Research (
Biological Research Programme) (1999-2004). He was
closely involved in the setting up of a multimillion
Drug Discovery centre including design and development
of laboratories. Currently, Dr Ramchand is an
Honorary Visiting Professor to European Nanotechnology
consortium at University of Newcastle, UK.
Dr. Ramchand is a PhD
in Biochemistry from MS University Baroda. He also
served as assistant professor (1982-84) at MS
University. He has also obtained his M Phil from
the same university. He did his Bachelors degree in
Chemistry at S.D College, Alleppey from 1972 -75. He
holds a Masters degree in Chemistry from the University
of Kerala. He has also won the Young Scientist award
from Charing Cross and Westminster Medical School, UK
for 3 times, for the work in the role of membrane
pathology in schizophrenia and the development of EPA as
a therapy for schizophrenia. He has extensive experience
in basic research activities, having handled prestigious
projects in the US & UK, both Universities and in
the Pharma Industry. He has over 25 years of rich
experience in the areas of teaching, basic research,
Drug discovery programme and disease mechanisms, guiding
M Sc. / Ph D. students and setting up Research facility.
Dr Ramchand has closely
worked on several molecules and many of these molecules
are at different stages of Clinical trials. He has also
held the position of Joint coordinator and Head,
Laboratory research program at biomedical sciences,
University of Sheffield and Northern General Hospital
Sheffield, UK (1994-1999), a prestigious University
Position. Prior to this he was the Sr. Scientist and
Project Head at the Institute of Biological Psychiatry
at University of Wales, Bangor UK (1990-1994). He has
also worked as Senior Research Officer at the
Biochemistry Department, University of North Wales,
Bangor, UK (1987-1990). Prior to this he was also
a postdoctoral fellow at University of South Carolina,
USA (1984-1987)
Dr. Ramchand has
published over 70 peer-reviewed papers in international
journals, edited 5 books, has 3 patented products and
has applied for over 15 patents.
Dr. Ramchand is the
Advisor of Biochemical sciences, ICAR, Delhi
–Agricultural Research Recruitment Board and an Advisor,
Visiting Professor and PhD guide at Swinburne University
of Technology, Australia, Charotar University of Science
& Technology, Gujarat and Sumandeep Vidhyapeeth
University, Baroda.
Lothar
Roessig, MD
Global Clinical Leader CV
Bayer Pharma AG
Lothar Roessig received
his MD from the Hannover Medical School, Germany. He is
board certified in Cardiology and in Internal Medicine,
and serves as a Lecturer in Medicine at the Goethe
University of Frankfurt, Germany. A senior cardiologist
and member of the faculty at the University Hospital
Frankfurt, he participated as clinical investigator in
numerous cardiovascular trials, including ENABLE
(Endothelin Antagonist Bosentan for Lowering Cardiac
Events in Heart Failure) and the European Heart Survey
until 2007, when he moved into clinical research
industry. In
October 2009 he joined Bayer HealthCare as Global
Clinical Leader for the development program of a soluble
guanylate cyclase stimulator in left heart failure.
Lothar Roessig authored more than 30 international
scientific publications, peer reviews for various
cardiovascular journals including Circulation, and was
finalist of the American Heart Association Samuel A.
Levine Young Clinical Investigator Awards.
Dr.
Boaz Mendzelevski
Consultant Cardiologist, Cardiac Safety Consultants Ltd.
Member of FDA, EMEA, MHLW/PMDA ICH-E14 Expert Advisory
Panel
Boaz Mendzelevski, MD, is a
board certified expert in Internal Medicine and
Cardiology with subspecialties in interventional
cardiology and electrophysiology.
Dr. Mendzelevski has extensive clinical experience in
internal medicine, cardiology and cardiac
electrophysiology and drug development and
pharmaceutical research. He has been consulting for the
pharmaceutical industry since 1995. He co-founded the
first European core ECG laboratory, which was later
acquired by Quintiles Transnational and rebranded as
QECG. Dr Mendzelevski served as Vice President of
Cardiology and Chief Medical Officer for the Quintiles
Cardiac Safety Division (1995-2003), as Director of
Cardiology for Covance Cardiac Safety Services
(2003-2007) and since 2008 is serving as Vice President
of cardiology for CoreLab Partners Inc. He is also
consulting independently with Cardiac Safety Consultants
Ltd, a consulting group he launched in 2008.
His primary research interests involve cardiac
repolarization, drug induced pro-arrhythmia and
cardiotoxicity and CV safety of new drugs. He has
authored approximately 250 cardiology expert reports,
many of which supported regulatory submissions. Dr.
Mendzelevski served on multiple pharmaceutical advisory
boards and Data Safety Monitoring Boards. He represented
pharmaceutical sponsors before the US and EU regulatory
authorities and attended multiple regulatory meetings in
Japan.
Dr Mendzelevski was also directly involved in the
evolution of the regulatory environment for
cardiovascular safety assessments of new drugs and set
on the ICH-E14 expert advisory panel (ICH Step 3).
Dr Mendzelevski is a frequent chair and a regular
speaker at CV Safety scientific and industry meetings.
He has been the co-chair of the Annual European DIA
Cardiac Safety Conferences since 2006 and is also the
chairperson of the Annual Japanese DIA/PMDA Cardiac
Safety Workshops since 2010. He also chaired the US
DIA/FDA Diabetes CV Safety conference in 2009 and
presented in the 2010 follow-up conference. In 2011 he
co-chaired the European DIA Cardio-Metabolic and
Cardio-Oncology Conferences.
Dr. Mendzelevski received his degree in Medicine and
Board Certification in Internal Medicine from the
Ben-Gurion University Medical School and Hospital in
Beer-Sheva, Israel. He then trained in cardiology and
received his board certification in Cardiology from the
Shaare-Zedek Medical Centre and the Hebrew University in
Jerusalem, Israel. He was appointed Attending
Cardiologist at the Shaare-Zedek Medical Center
Cardiology Department and a Faculty Member at the Hebrew
University in Jerusalem. He completed a further
postgraduate training in Interventional Cardiology and
Electrophysiology at the Royal Brompton, National Heart
and Lung Hospital in London, UK and performed
cardiovascular interventional procedures in private
clinics in London.
Jurij
Petrin, M.D. President and Founder Pharmaceutical
Regulatory Services
He spent 10 years with Bristol-Myers Squibb in Europe
and the US, first as Medical Director for Eastern Europe
and later as Executive Director and finally Vice
President for Intercontinental Regulatory Science.
Before leaving BMS to start his own company in 2001, he
was responsible for Bristol-Myers Squibb’s regulatory
affairs in markets outside of the US and Europe. He
organized and supervised international filings and
approvals of new and supplemental submissions of (among
others): paclitaxel (Taxol), stavudine (Zerit),
cefprozil (Cefzil), cefepime (Maxipime), didanosine
(Videx), pravastatin (Pravachol), irbesartan (Aprovel),
butorphanol (Stadol), nefazodone (Serzone), fosinopril
(Monopril), gatifloxacin (Tequin), eflornithine
(Vaniqa), etc.
During his ten years of consulting, he worked on
numerous projects for pharmaceutical and biotech
companies, ranging from developing regulatory strategies
for new drugs to providing worldwide regulatory support
and services of all phases of drug development in
various therapeutic areas. The two companies he founded,
Pharmaceutical Regulatory Services, Inc. and PRS
Clinical Ltd, together with their extensive network of
local drug development experts provide drug development
consulting and services in around 90 countries on all
continents. He serves as a consultant to the Thai FDA
and numerous pharmaceutical companies, was member of
PhRMA’s Asia Pacific Technical Committee, and
represented PhRMA at EFPIA and IFPMA.
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.
J. Rick Turner, PhD
Senior Scientific Director, Cardiac Safety Services
Quintiles
Dr Rick Turner obtained
his Bachelor of Science degree in Psychology from the
University of Sheffield. His doctoral degree was
awarded by the University of Birmingham following his
innovative genetic research in the field of
Cardiovascular Behavioral Medicine. He has
published 50 peer-reviewed papers and five books in this
field, and received two international research awards.
For the last 14 years
Dr Turner has worked in the pharmaceutical field, as a
Clinical Submissions Scientist at GlaxoSmithKline,
Chairman of the Department of Clinical Research at
Campbell University School of Pharmacy, and President
and Chief Scientific Officer at Turner Medical
Communications LLC. He has published many papers
and three books on drug development and drug safety: New
Drug Development: Design, Methodology and Analysis
(2007), a second edition of which will be published in
2010; Introduction to Statistics in Pharmaceutical
Clinical Trials (2008), and Integrated Cardiac Safety:
Assessment Methodologies for Noncardiac Drugs in
Discovery, Development, and Postmarketing Surveillance
(2009).
Dr Turner is now Senior
Scientific Director, Cardiac Safety Services, at
Quintiles. He leads their Interdisciplinary
Cardiac Safety Team, providing Sponsors with strategic
insight and operational support during clinical
development programs.
He spoke before two FDA
Advisory Committees in July 2007 concerning the
cardiovascular safety of the thiazolidinedione drug
rosiglitazone, and has published many papers addressing
the cardiac and cardiovascular safety of noncardiac
drugs. He has a special interest in the
centralized adjudication of events during cardiovascular
outcomes trials, has given numerous invited
presentations at international conferences, and is an
active participant in the Cardiac Safety Research
Consortium.
Dr Turner is also
Senior Fellow, Center for Medicine in the Public
Interest, New York, and Affiliate Clinical Associate
Professor, University of Florida College of Pharmacy.
Fiona Waddell Managing Director
3D CLINICAL RESEARCH LTD
(Formerly Tower Mains Clinical)
Fiona Waddell has been involved in clinical research for
the last 30 years, well before the days of GCP when ethics
committees wouldn’t even review trial documentation if the
patient information sheet was longer than one A4 page
(apparently, no subject would ever want to read past page
1).
Her experience includes academic, pharmaceutical and
medical device trials as a research sister, CRA, project
manager and trials manager in all phases and all types of
trials in a wide variety of therapeutic areas. As a
result, she has gained expertise in ‘thinking outside the
box’ and has become a notable trouble-shooter and problem
solver. These skills are now invaluable in light of
the advent of risk-management in clinical trials.
Fiona currently heads up her own contract research
consultancy (3D Clinical Research Ltd) and training
organization in Edinburgh, Scotland.
Fiona conducts pragmatic training in the practical use of
clinical trial regulations throughout Europe. In
addition, she offers courses in many role-specific (eg
monitor, investigator) or department-specific (eg drug
safety,) clinical trial topics. For the last five
years Fiona and her husband, Dr Andrew Waddell have joined
forces to offer practical advice and training in how to
prepare for and survive a regulatory inspection.
These courses give participants advice on how to prepare
for inspection. They also give them realistic
experience of audit and interview under mock inspection
conditions.
Fiona has been a guest presenter at many conferences and
seminars and offers realistic insight into the world of
clinical trials.
Fiona is also trained and experienced in ‘soft skills’ and
the development of people. She brings these skills
to personal development training courses (eg influencing
skills, team working, people management etc) which are a
valuable adjunct to monitors and QA professionals.
More profiles to be added as we receive them.....
For
further information please contact;
Steve Hambrook Conference Director
Jerry
Buysse
Dr
David Kallend
Lothar
Roessig, MD
Dr.
Boaz Mendzelevski
J. Rick Turner, PhD
Fiona Waddell 