Download 4th Kitasato-Harvard Symposium: Summary and Conclusions

4th Kitasato-Harvard Symposium:
Summary and Conclusions
Stephen Lagakos
Harvard School of Public Health
This year’s goals
• Advance Global Drug Development by
discussion of
– emerging trends
– technology updates
– novel paradigms
Organization of Discussion into 5 Sessions
• Global programs: Is there a Reality?
• Regulatory updates and clinical trends
• Practical use of ICH guidelines for bridging and
global trials
• Use of genomics, preteomics, and metabolomics
to enhance evaluation of drugs
• Other novel technology updates: modeling,
biomarkers, surrogates, and data mining
Speakers and Moderators
• By background
– Academia: 28%
– Government: 26%
– Pharmaceutical Industry: 46%
• By region
– Japan: 65%
– Other Asian country: 10%
– Europe: 8%
– US: 17%
• Quality of presentations has been uniformly excellent—
thank you to speakers !
Sessions 1/2: Global Trials & Regulatory Updates
• Recent changes at MHLW will hopefully lead to
more expedited reviews
• Several important lessons learned from doing
global trials
– Importance of standardization of endpoints, definitions,
protocols
– Need to establish a network among regulatory agencies
to facilitate data sharing and review (common?) and
implementation of results
– Additional complexities but many advantages in terms
of getting more definitive answers and getting results
sooner
Numerous challenges for Japan in doing
clinical trials
– Costs is very high, and appears to be due
mainly to clinical costs
– Lack of availability of enough sites
– Awareness of and desire by public to participate
in clinical research less than in some other
regions
• Reasons unclear: but related to less developed
infrastructure in academia/medical centers compared
to other countries (eg, US), where clinical research
within academia is recognized and rewarded
Global Trials
•
Who has responsibility to increase capacity and
conduct of trials in Japan:
•
•
•
Government?
Industry?
Academia?
 “Yes” to all !
-MHLW, in particular, must do what it can to promote
conduct of more trials in Japan, without lowering
standards of review—a difficult challenge.
-Number of medical and statistical reviewers in MHLW
is still too small. Additional resources needed, and
importance of these positions needs to be better
recognized by scientific community.
Increasing Capacity in Japan
• One approach: large scale CT network
– Ideal if this develops capacity at academic/medical
centers
– Role of Japanese Med. Association a bit unclear (to
me). In US, much responsibility rests within academia
through governmental funding of academic cooperative
groups of academic units. Scientific leadership from
academic researchers, not government
– What is best for Japan overall?
Global versus Bridging Studies
• Global trials will, in general, get answers
sooner and more definitively
• Simultaneous evaluation of a drug in
several regions can avoid ethical dilemmas
– e.g.: if a new drug appears to be very
efficacious in a placebo-controlled trial in the
US, is it still ethical to use a placebo control if
the study is later done in Japan?
Session 3: Practical Use of ICH
Guidelines for Bridging/Global Trials
• ICH advances will further encourage & facilitate
multinational studies and bridging studies
• Increased experience with bridging studies will
likely reduce the need for these (Bob O’Neill)
• Use of surrogate endpoints for bridging very
attractive; use depends on acceptance of the
surrogate by the scientific community. Examples:
– Many vaccines: immune response
– HIV/AIDS:
viral load
– Osteoporosis: bone mineral density
Sessions 4 and 5: How can we use
“omics” and other new technologies?
• Excellent examples of how new technologies can
be useful in all aspects of drug development
• Most believe that future use of genomic
information will increase and offers promise of
eventually developing ‘individualized therapy’
• Use of genetic data also poses new challenges,
both scientific (due to high dimensionality) and
societal (trust by the public; confidentiality).
• Other novel technologies (visual, acoustic,
modeling) offer promise for new and better
endpoints to use in evaluating drugs
Final Comments
• During the 4 years that this symposium has begun,
there has been clear progress in discussing how we
can move to more expedited evaluations of drugs
– clearer notion of how to do bridging studies
– recognition of the great potential of global trials
– also a greater recognition of the challenges in doing
multinational trials
– coordination of regulatory agencies recognized as a
critical step
– Role of ‘omics’ more clearly understood and continues
to offer great promise for future advances; other new
technologies should allow use to refine outcomes and
thereby better measure effects of drugs
• A key challenge for Japan is how to enhance its ability to
conduct large clinical trials
Final Comments
• Goal of this symposium has to bring together
persons with diverse backgrounds to share views
express our differences in opinions in an open
forum where we can learn from one another
• We are reminded that the administrative and
regulatory aspects streamlining drug development
and evaluation are key to advancement of the
science
• Thank you for attending and we hope to see you
next year !