Foreword_edit.qxp 6/6/07 3:37 pm Page 4
Foreword
Embracing New Challenges
Clinical Development – The New Opportunity
a report by
Jonathan Palmer
1
and Nicholas Giannasi, PhD
2
1. Business Development Lead, Clinical Solutions, Europe, Middle East and Africa (EMEA), Oracle, and
2. Senior Business Development Director, Life Sciences, EMEA, Oracle
The clinical development industry is entering a new era of change and across the industry, including by all of the top 20 global pharmaceutical
opportunity. It faces an increasing array of drivers from the commercial, companies and top five clinical research organisations.
regulatory, safety and patient sectors, the like of which have never been
seen before. Billion-dollar development costs are dwarfed by multi-billion- As the world’s leading enterprise software company, Oracle combines
dollar safety withdrawals, such as that of Vioxx by Merck & Co., which leading-edge technologies with domain expertise to build market-leading
erased US$25 billion from the company’s market value overnight. In industry applications. Our Healthcare and Life Sciences Application
parallel, patients are becoming more informed, and are consequently Engineering team is embracing new architectural approaches such as
demanding therapies that can stretch the budgets of their health providers. service-oriented architectures to facilitate integration of ever-flexing
business processes and expanding virtual project teams.
In response to these pressures, the industry is embracing new techniques
and technologies at a rate of change not seen for many years. Clinical With these challenges in mind, we have gathered a collection of experts
trial timelines are under scrutiny, meaning that companies must seek new to provide some thought-provoking commentary and guidance on
technologies and new territories; maturing data standards are changing emerging opportunities:
the way in which data are collected, stored and analysed; realtime clinical
trial adverse event reporting is being considered against rapid electronic • Nicholas Schaltenbrand, Quintiles, illustrates how the industry is finally
data capture (EDC) adoption; and translational medicine is helping to moving from endless EDC pilots into mainstream global deployment.
convert basic research to patient-focused therapies. Across the entire
value chain there is the realisation that those companies that best exploit • Barry Burnstead, i3 Statprobe, considers breaking down the historical
and mine their data as an asset, rather than just collecting and collating boundaries between safety and clinical data management to propose
it, will be the winners in the race to market dominance. more wide-scale usage of EDC as a platform for reporting serious
adverse events during a clinical trial.
Oracle has been involved in providing solutions for the life science and
healthcare markets for more than 20 years. Our suite of six applications • Sharon Marmaras, Boehringer Ingelheim (BI), describes BI’s initiative
for clinical trials and pharmacovigilance is used by more than 300 to optimise clinical integration and reporting through a new
companies globally. The full spectrum of our solutions in discovery, integration platform.
clinical development, supply chain and sales and marketing is widely used
• Pierre-Yves Lastic, sanofi aventis, provides an overview of the latest
data standards initiatives between the Clinical Data Interchange
Jonathan Palmer is Business Development Lead for Oracle’s
Clinical and Pharmacovigilance Solutions across Europe, the
Standards Consortium (CDISC) and Health Level 7 (HL7) to aid
Middle East and Africa. He has 17 years of clinical convergence of clinical trial and healthcare data.
experience. He began his career as a statistical programmer,
then moved through the rapid growth of the contract
research organisation (CRO) industry, ultimately being
• Peter van der Spek, Erasmus University Medical Centre, gives an
responsible for clinical solutions and support at Parexel. He
insight into the architecture of an enterprise platform to enable and
has had numerous roles at Oracle and IBM, helping life
science organisations realise benefits from implementing
exploit translational medicine advances.
new clinical technologies.
• Vladimir Novakovskiy, Congenix, illustrates the growing opportunities
Nicholas Giannasi, PhD, is Senior Business Development
to use broad patient populations and clinical services in Eastern
Director, Life Sciences at Oracle, responsible for the Life
Sciences business in Europe, the Middle East and Africa. Before
Europe.
joining Oracle in 2006, Dr Giannasi was at GE Healthcare, a
US$15 billion unit of General Electric, where he was Head of
We are extremely grateful to our authors for their contributions and
the Informatics Business and Director of Business Development
& Licensing Discovery Systems, as well as being a Member of
insights, and trust you will find their views stimulating and enlightening.
the GE Healthcare Strategic Marketing Executive. He led a
Oracle’s vision is to embrace these emerging approaches and maximise
global team for Sales, Marketing, Support and Research and
Development. His career also includes success at a number of
benefit to all by providing an integrated platform of solutions for life
smaller bioinformatic companies; he was co-founder of a sciences and healthcare organisations to enable collaborative research
start-up biotech company and an advisor to investment
and, ultimately, drive better patient care.
funds. Dr Giannasi holds a PhD in Population Genetics and a
first-class Bachelor degree.
We look forward to your feedback and to working in collaboration soon. ■
4 © TOUCH BRIEFINGS 2007
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