ACRES-Greg-Koski-20140426

 
Enhancing
 Safety,
 Quality
 and
 Efficiency
 in
 Medicines
 Development
 
and
 Health
 Research
 through
 Systems
 Solu>ons
 
 

 
 Transla(ng
 Principles
 to
 Performance—
 
Crea(ng
 a
 Global
 System
 to
 Promote
 Responsible
 
Conduct
 of
 Human
 Research
 by
 Physicians
 

 
Greg
 Koski,
 PhD,
 MD
 
President
 and
 Chief
 Execu(ve
 Officer,
 Co-­‐Founder
 
Medicines
 Development:
 
 
 
A
 Complex
 Enterprise
 under
 Intense
 
Environmental
 Pressures
 
In
 a
 rapidly
 
changing
 
environment,
 the
 
ability
 to
 survive
 
is
 determined
 by
 
the
 ability
 to
 
adapt!
 
l  Medicines
 development
 has
 been
 almost
 en(rely
 
proprietary
 and
 conducted
 largely
 in
 corporate
 
silos,
 an
 approach
 fraught
 with
 inefficiency
 
l  Clinical
 trials
 are
 not
 “global”—they
 are
 
interna(onal
 
l  “Harmoniza(on”
 is
 simply
 a
 nice
 way
 to
 say
 
“failure
 to
 standardize”
 
l  Public
 respect
 for
 the
 endeavor
 has
 plummeted
 
and
 par(cipa(on
 is
 low
 
l  One
 cannot
 keep
 doing
 things
 the
 same
 way
 and
 
expect
 different
 results
 
Current
 Situa(on
 in
 a
 Nutshell
 
l  Medical
 research
 involving
 human
 subjects
 must
 
be
 conducted
 only
 by
 individuals
 with
 the
 
appropriate
 ethics
 and
 scien(fic
 educa(on,
 
training
 and
 qualifica(ons.
 
 
l  Research
 on
 pa(ents
 or
 healthy
 volunteers
 
requires
 the
 supervision
 of
 a
 competent
 and
 
appropriately
 qualified
 physician
 or
 other
 health
 
care
 professional.
 

 Principles
 for
 Physicians
 
Engaged
 in
 Clinical
 Research
 
Declaration of: Helsinki, 2013
l  There
 are
 minimal
 formal
 professional
 training
 
requirements
 for
 physician
 inves(gators.
 
l  Most
 “physician
 inves(gators”
 do
 only
 one
 
clinical
 trial
 during
 their
 career.
 
l  Ethical
 lapses
 and
 scandals
 have
 tarnished
 
respect
 for
 and
 confidence
 in
 the
 research
 
enterprise
 at
 all
 levels.
 
l  The
 stage
 is
 set
 and
 the
 (me
 is
 right
 for
 
fundamental
 systemic
 change!
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 But,
 in
 reality….
 
“For
 too
 long,
 the
 industry
 has
 failed
 to
 recognize
 the
 
importance
 and
 value
 of
 well-­‐established,
 sustainable,
 high-­‐
performing
 research
 sites.
 
 They
 are
 a
 resource
 that
 we
 
have
 undervalued.
 Now
 is
 the
 (me
 for
 us
 to
 take
 a
 more
 
systemic
 approach
 that
 promotes
 site
 produc(vity
 and
 
sustainability…”
 

 
 
 
 
 
 
 
 
 
 
 -­‐-­‐Briggs
 Morrison,
 MD
 
 

 
 
 
 
 
 
 
 
 Vice-­‐President
 for
 Global
 Medicines
 Development
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 and
 Chief
 Medical
 Officer,
 AstraZeneca
 

 
 
 
 Member
 of
 the
 ACRES
 Board
 of
 Directors
 
 

 
Sites
 MaZer!
 
Change
 Management—
 
It
 takes
 a
 crisis!
 
“The
 current
 approach
 to
 drug
 
development
 is
 inefficient,
 
ineffec(ve
 and
 unsustainable.”
 

 Consensus
 DIA
 Europe,
 2010
 
A
 mul(-­‐sector
 alliance
 of
 like-­‐minded
 
organiza(ons
 working
 collabora(vely
 
to
 build
 a
 shared
 
Global
 System
 for
 Clinical
 Research
 
What
 is
 ACRES?
 
 
 

 An
 Integra(ve
 System

 
 
–  Examples
 of
 an
 integra(ve
 system
 are
 charitable
 
organiza(ons
 or
 business
 endeavors
 where
 
individuals
 ban
 together
 to
 accomplish
 some
 
common
 desired
 objec(ve
 or
 goal.
 
 
–  “Where
 you
 and
 I
 do
 something
 together
 because
 
of
 what
 we
 both
 want
 to
 accomplish.”
 
 
–  The
 greatest
 leverage
 is
 found
 in
 integra(ve
 
systems,
 where
 all
 the
 individuals
 are
 mo(vated
 
by
 what
 they
 are
 endeavoring
 to
 create.
 
 

 
hZp://www.systemswiki.org/index.php?(tle=Systems_Classifica(ons
 
What
 is
 ACRES?
 
 
 
A
 neutral,
 not-­‐for-­‐profit
 organiza3on
 opera3ng
 in
 the
 
public
 interest
 
–  a
 “home”
 for
 collabora(on
 among
 Stakeholder
 
Alliances
 
 
–  an
 “incubator”
 for
 innova(on
 
–  an
 “adapter”
 of
 successful
 models
 and
 prac(ces
 
from
 other
 highly-­‐regulated
 and
 complex
 
research-­‐focused
 industries
 
–  a
 “coordinator”
 for
 mul(-­‐stakeholder
 ac(vi(es
 
–  an
 “integrator”
 for
 complex
 cross-­‐cuang
 
ini(a(ves
 
 
A
 Transforma(ve
 
 
Mul(-­‐Sector
 Alliance
 
ACRES—through
 and
 with
 its
 allies—is
 working
 to
 build
 an
 
shared
 global
 system
 that:
 
–  Leverages
 stakeholder
 collabora(on,
 innova(on
 and
 
investment
 to
 implement
 change
 
–  Promotes
 and
 improves
 the
 use
 of
 exis(ng
 tools,
 
policies
 and
 processes
 rather
 than
 re-­‐inven(ng
 ,
 
–  Facilitates
 and
 streamlines
 clinical
 research
 
 while
 
improving
 safety
 and
 quality
 
–  Reduces
 waste,
 redundancy
 and
 inefficiency
 in
 the
 
clinical
 trials
 process
 
–  Responds
 fairly
 to
 the
 world’s
 health
 needs
 
 
What
 are
 ACRES
 goals?
 
 
•  The
 Alliance
 for
 Clinical
 Research
 Excellence
 &
 
Safety
 is
 working
 to:
 
–  posi(vely
 align
 ethics,
 scien(fic
 integrity
 and
 good
 
business
 prac(ces
 
 
–  provide
 appropriate
 opportuni(es
 
 and
 incen(ves
 
to
 further
 the
 mission
 of
 medicines
 and
 device
 
development
 globally
 
–  to
 ensure
 that
 clinical
 trials
 are
 conducted
 in
 a
 
safer,
 scien(fically
 sound,
 socially
 responsible
 and
 
ethical
 manner
 that
 rewards
 all
 par(cipants
 and
 
stakeholders,
 including
 pa(ents,
 everywhere
 
 
Ini(al
 projects
 are
 underway
 in
 each
 of
 four
 opera(onal
 domains
 where
 
cri(cal
 processes
 for
 research
 sites,
 sponsors,
 CROs,
 regulatory
 authori(es,
 
ethics
 commiZees,
 and
 research
 subjects
 intersect
 to
 achieve
 “clean
 data”
 
with
 greater
 efficiency,
 safety
 and
 interoperability
 -­‐-­‐
 at
 the
 points
 where
 
change
 is
 most
 needed.
 

 
ACRES
 Founda(on
 Ini(a(ves
 
Execu(ve
 
 
Office
 
Ongoing
 Global
 Ini(a(ves
 
l  Promoting professionalism, performance and
sustainability through compentency-based education,
training, and accreditation.
l  Driving creation and adoption of standards and
metrics through effective implementation of a shared
technology infrastructure and informatics
l  Fostering more effective and efficient ethical and
regulatory oversight through standardization,
innovation, collaboration, and stakeholder
engagement
l  Building an enterprise-wide culture that embraces
safety as its highest priority and most valued asset

 
Each
 
 ACRES
 ini(a(ve
 is
 intended
 to
 leverage
 
investments
 for
 the
 mutual
 benefits
 of
 all
 
stakeholders
 –
 like-­‐minded
 organiza(ons
 and
 
individuals
 driven
 by
 principles
 of
 inclusivity,
 
integra(on,
 integrity
 and
 innova(on
 to
 achieve
 
effec(ve
 implementa(on
 with
 close
 aZen(on
 to
 
elimina(ng
 waste,
 mi(ga(ng
 risk
 and
 learning
 from
 
varia(on,
 
 while
 enhancing
 responsible
 ethical
 
conduct
 
 of
 research
 and
 professionalism.
 
ACRES
 Alliance
 Approach
 
to
 Ini(a(ves
 
Opportunities for Collaboration
l  The WMA and ACRES share common beliefs that clinical
research is highly-valuable and that it must be done in a
responsible manner by well-trained, qualified investigators
and research teams within an ethical framework and with
effective oversight:
u  Competency-based guidelines for education and
training for physician investigators during graduate and
post-graduate medical education.
u  Pathways to professionalism for clinical investigators
through professional certification as part of a program
for global accreditation to recognize and reward
excellence in clinical research.
Fundamental
 Elements
 
of
 an
 Enterprise
 
System
 
 
“A
 system
 is
 an
 en>ty
 
that
 maintains
 its
 
existence
 through
 the
 
mutual
 interac>on
 of
 
its
 parts
 to
 achieve
 a
 
specific
 goal
 or
 goals.”
 
 

 
 
 
 Richard
 Wright
 
Drug
 development
 is
 far
 
behind
 other
 industries
 in
 the
 
applica>on
 of
 a
 system
 
approach
 to
 standardize
 and
 
integrate
 mission
 cri>cal
 
processes.
 
Systems
 Thinking!
 
Current
 Drug
 Development
 Process
 
from
 a
 Systems
 Perspec(ve
 
In
 it’s
 (me,
 it
 
performed
 
adequately…
 

 
The
 (mes
 and
 
the
 environment
 
have
 changed
 !
 
Other
 industries
 can
 help
 us
 envision
 a
 
beZer
 future
 for
 Drug
 Development:
 
– Informa(on
 Technology
 
– Transporta(on
 
– Communica(ons
 
– Shipping
 
Successful
 Systems
 
Models
 Do
 Exist
 
The
 Systems-­‐Focused
 
Intelligent
 Organiza(on
 
Systems
 Thinking:
 

 The
 Global
 Air
 Transport
 System
 
Current
 Drug
 Development
 Process
 
from
 a
 Systems
 Perspec(ve
 
No
 maZer
 how
 
much
 we
 (nker
 
with
 the
 parts,
 
what
 we
 are
 leg
 
with
 has
 limited
 
ability
 to
 perform
 
adequately
 in
 
today’s
 demanding
 
environment!
 

 
Systemic
 change
 is
 
necessary….
 
 
How
 do
 we
 get
 there…?
 
 
 
Systems
 Thinking!
 
“For
 too
 long,
 the
 industry
 has
 failed
 to
 recognize
 the
 
importance
 and
 value
 of
 well-­‐established,
 sustainable,
 high-­‐
performing
 research
 sites.
 
 They
 are
 a
 resource
 that
 we
 
have
 undervalued.
 Now
 is
 the
 (me
 for
 us
 to
 take
 a
 more
 
systemic
 approach
 that
 promotes
 site
 produc(vity
 and
 
sustainability…”
 

 
 
 
 
 
 
 
 
 
 
 -­‐-­‐Briggs
 Morrison,
 MD
 
 

 
 
 
 
 
 
 
 
 Vice-­‐President
 for
 Global
 Medicines
 Development
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 and
 Chief
 Medical
 Officer,
 AstraZeneca
 

 
 
 
 Member
 of
 the
 ACRES
 Board
 of
 Directors
 
 

 
Sites
 MaZer!
 
We
 cannot
 achieve
 
effec(ve
 solu(ons
 using
 
the
 same
 tools,
 processes
 
and
 thinking
 that
 created
 
the
 current
 ineffec(ve
 
approach…
 
Benefits
 of
 a
 Systems
 
Approach
 
 
•  Drive
 and
 reward
 standardiza(on
 
•  Drive
 regulatory
 simplifica(on
 and
 compliance
 
•  Promote
 and
 value
 professionalism
 
•  Enhances
 performance
 
–  Increase
 efficiency
 
–  Reduce
 redundancy
 
•  Promote
 and
 enhance
 safety
 
•  Reduce
 costs
 and
 (me-­‐to-­‐approval
 
•  Promote
 investment
 in
 sustainable
 clinical
 research
 
capacity
 in
 emerging
 na(ons
 and
 markets
 
•  Align
 ethics
 and
 good
 business
 prac(ces
 
•  Increase
 transparency
 and
 improve
 public
 trust
 
All
 stakeholders
 across
 all
 
sectors
 of
 the
 enterprise
 
must
 embrace
 systems
 
thinking
 and
 collaborate
 
for
 their
 mutual
 benefit…
 
Network
 Systems
 
Architectures
 
ACRES
 Collabora(ve
 Informa(on
 
Technology
 Infrastructure
 
l  Web-­‐enabled,
 “cloud-­‐based”
 integrated
 
informa(on
 system
 with
 a
 shared
 virtual
 data
 
warehouse
 and
 knowledge
 engines
 
l  System
 support/facilita(on
 of
 all
 opera(ons
 
–  Point-­‐of-­‐entry
 EDC
 
 and
 CTMS,
 including
 AE
 repor(ng
 and
 
performance
 dashboard/metrics
 
 
–  SOP
 driven
 con(nuous
 compliance/quality
 control
 
–  Shared
 data-­‐base
 for
 trial
 ini(a(on
 and
 support
 
–  Remote
 risk-­‐based
 quality
 management,
 safety
 and
 
performance
 monitoring—
 “site
 op(cs”
 
 
 

 
Asia
Latin America
Europe
North America Africa and
Middle East
ACRES
Executive
Office
ACRES Global Headquarters and
Regional Coordinating Centers
ACRES
 National
 
 
Co-­‐Development
 Affiliates
 
Research Sites, Investigators
and Ethics Committees
Professional Organizations
and Academia
National Government Offices
and Oversight Agencies
ACRES
National
Affiliate

 
An
 Integrated
 Global
 Network
 
ACRES
 Value
 Proposi(on
 

 
 Urgent
 Challenges
 
–  Educa(on
 and
 training
 
–  Trial
 complexity
 
–  Site
 selec(on
 
–  Performance
 
–  Monitoring
 
–  Data
 management
 
–  Pharmacovigilance
 
–  Regulatory
 compliance
 
–  Delays
 and
 redundancy
 
–  Time
 to
 market
 
–  Ethical
 review
 
–  Misconduct
 
–  Public
 confidence
 
–  Economic
 pressures
 
–  Global
 dispari(es
 

 
More
 effec>ve
 applica>on
 
(redirec>on)
 of
 exis>ng
 resources
 to
 
build
 a
 sustainable,
 shared
 “system
 
infrastructure”
 will
 provide
 a
 
handsome
 return
 on
 investment,
 
economically
 and
 socially.
 
Current
 es3mates
 of
 
waste
 due
 to
 inefficiency
 
and
 redundancy
 in
 the
 
clinical
 trials
 process
 is
 
approximately
 30%
 

 
An
 effec3ve
 system
 could
 
realize
 annual
 savings
 in
 
excess
 of
 
 
10
 Billion
 Euro
 
Why
 ACRES?
 
 
 
•  “Construc(ve
 transforma(on”
 
•  Unique
 global
 integrated
 systems
 approach
 
–  Comprehensive
 
–  Inclusive
 
•  Solu(on
 oriented-­‐-­‐implementa(on
 focused
 
–  Established
 plan
 
–  Coherent
 strategy
 
•  Mul(-­‐sector
 exper(se,
 credibility
 and
 collabora(on
 
–  Experience
 
–  Capability
 
–  Leadership
 

 
hZp://www.acresglobal.net
 
-­‐-­‐building
 a
 global
 collabora>ve
 ecosystem
 for
 
clinical
 research,
 together!