Track Update
Track #: 1 Clinical Trials
Track Learning Objective and Targeted Audience
• Track Learning Objectives:
– Identify current issues and challenges in clinical trial management
and execution
– Reduce clinical trial costs by using innovate practices and
technologies
– Ensure ethical treatment of clinical trial participants globally
• Targeted Audience
–
–
–
–
Clinical operation staff
Investigator site personnel
CROs
Budget managers
Drug Information Association
www.diahome.org
2
What is the focus and flow of this track for 2012?
•
•
•
•
•
•
Development of cost effective site budgets
Patient enrollment including use of social media
Protocol design optimization
Approaches to risk based monitoring
Supply chain management
Ethical consideration in clinical studies
– Special populations
• Global study execution (emerging markets)
• Disruptive innovation to clinical study execution
(Pfizer study)
Drug Information Association
www.diahome.org
3
Provide additional details of planned content
• 28 total Sessions
– 3 workshops (Metrics, Risk-based monitoring
and Investigator site management)
– 10 symposia
– 11 sessions
– 4 forums
– 1 poster
Drug Information Association
www.diahome.org
4
Possible topics for collaboration with other Tracks
• TMF (Track 7)
• Protocol Design (Track 2)
• Impact of outsourcing in clinical trial
execution (governance, quality)
• FDA site inspections (Track 11)
Drug Information Association
www.diahome.org
5
Where are the gaps? If any?
• Managing clinical studies during mergers
and acquisitions
• Partnership (CRO/Sponsor) governance
impact on study execution/project teams
Drug Information Association
www.diahome.org
6
Potential speakers to invite
• Study subjects
• Patient advocacy group
• Other industries
Drug Information Association
www.diahome.org
7
Track Update
Track 2: Project/Portfolio
Management and Strategic
Planning
Track Learning Objective and Targeted Audience
•
Project Management
– Discuss product development/project management practices and
budget/forecasting/financing practices used in the industry
– Identify PM practices, systems, and current trends used in global product
development
•
Portfolio Management
– Identify product development portfolio management practices and portfolio assess
strategy decision making methods and tools
– Discuss portfolio asset strategy decision making, management, portfolio/product
prioritization and optimization practices
•
Strategic Planning
– Describe quality design of clinical trials, complexity of study development, and
building quality risk management in clinical trials
– Identify project and portfolio management practices for strategic planning
•
Targeted audience:
– Project Managers, Project Leaders, Portfolio Managers
– Clinical Development Leaders
– Finance
Drug Information Association
www.diahome.org
9
What is the focus and flow of this track for 2012?
• Stay with hot topics for protocol and projectlevel topics:
– PM skills and techniques
– Protocol design topics
• Bring more focus to program- and portfoliolevel topics:
– Program-level strategic planning
– Portfolio Management topics
Drug Information Association
www.diahome.org
10
Provide additional details of planned content
• PM skills and techniques
– Critical chain, Pharma PM competencies, risk mgmt
• Protocol design topics
– QbD in clinical dev’t, adaptive design, improving
protocol design
• Program-level strategic planning
– Working with Asia, pharmacogenomics/ companion
diagnostics in dev’t planning, case studies on planning/
execution of global programs, achieving alignment, keys
from going from R to D
• Portfolio Management topics
– Tools, techniques, and approaches
Drug Information Association
www.diahome.org
11
Possible topics for collaboration with other Tracks
• Pharmacogenomics and Companion
Diagnostics
• Development in Asia, including leveraging
CROs
• Execution of protocols
Drug Information Association
www.diahome.org
12
Where are the gaps? If any?
• Abstracts (in general) were not as high
quality as anticipated
– Tended to be CRO and clin ops focused
– Not enough high-quality abstracts to be as
selective as we would have liked
• General immaturity (across industry?) in
portfolio management and strategic planning
Drug Information Association
www.diahome.org
13
Potential speakers to invite
• Peter Ray, BMS (Portfolio Mgmt) – has accepted
• NOTES:
• Potential approach to scheduling of sessions should take
into account the opportunity of day registrations, given the
proximity of Philadelphia to many major pharma and CROs
– Preference to put all PM topics or portfolio topics on a single day to
encourage day registrations for those interested in that topic?
• Will discuss further suggesting some of the B abstracts for
posters and whether/how to give feedback to abstract
authors whose abstracts were not selected
Drug Information Association
www.diahome.org
14
Track Update
Track 3: Innovative Partnering
Models and Outsourcing
Strategies
Track Learning Objective and Target Audience
• Learning Objective
– Identify innovative partnering models and unique
outsourcing strategies that are shaping the way in which
pharmaceutical and biotechnology companies work with
CROs and other service providers academia, codevelopment partners and other organizations.
• Target Audience
– Pharma/Biotech R&D leaders involved in partnering and
outsourcing with service providers
– CRO leaders involved in partnering with sponsors
– Leaders from academia, non-profits, etc.
Drug Information Association
www.diahome.org
16
What is the focus and flow of this track for 2012?
• Focus
– CRO / Sponsor collaboration
– Other types of collaboration
• Flow
– CRO Industry
– Sponsor / CRO Collaborations
– Other Collaborations
– CRO Consortium
Drug Information Association
www.diahome.org
17
Provide additional details of planned content
•
CRO Industry
–
–
–
•
Sponsor / CRO Collaborations
–
–
–
–
–
–
–
–
•
Preferred provider partnerships
Virtual pharma partnerships
Multi-discipline long term partnership
Balanced scorecard
Pharma / CRO Risk sharing
Vaccine development partnership
Using technology to build successful partnerships
Functional Service Provider partnerships
Other Collaborations
–
–
–
–
–
•
ACRO Executive Roundtable
Avoca Industry Survey with reactions from sponsors and CROs
Hidden costs and consequences of Sponsor CRO partnerships
Gates Foundation – Not for Profit Development Collaboration
Patient Advocacy Programs
Sites, Sponsors, and CROs
Academia
Public/Private Partnerships
CRO Consortium
–
–
Small CRO Consortium
Asian Contract Research Consortium
Drug Information Association
www.diahome.org
18
Possible topics for collaboration with other Tracks
• Outsourcing of specific disciplines
– Regulatory, statistics, etc.
• Quality and oversight of service providers
– QA
– Sent to SIAC
• IT systems for collaborations
Drug Information Association
www.diahome.org
19
Where are the gaps? If any?
• Full Development Partnering Models
(including outsourcing and integration of
nonclinical development, CMC, regulatory,
clinical development, and
commercialization)
Drug Information Association
www.diahome.org
20
Potential speakers to invite
• ACRO Executive Roundtable
– Doug Peddicord (Executive Director)
– CRO Executives
– Rob Wright (Editor, Life Science Leader)
Drug Information Association
www.diahome.org
21
Track Update
Track #: 4 Nonclinical and
Translational Development /
Early Phase Clinical
Development
Track Learning Objective and Targeted Audience
• Explain some of the latest nonclinical technologies and approaches for
assessing the safety of pharmaceutical products
• Discuss recent advances in coping with particularly challenging issues
that arise in the early phases of novel pharmaceutical development
• Present current strategies for designing successful early clinical
pharmacology and experimental medicine trials
• Provide information to facilitate successful early interactions
between regulatory agencies and other stakeholders
• Targeted Audience: academic, government and industry scientists,
study directors and managers working in the nonclinical and early
clinical phases of drug development
Drug Information Association
www.diahome.org
23
What is the focus and flow of this track for 2012?
• Track 4 continues to focus on nonclinical
and translational issues in drug development
and, in 2012, will have an enhanced
emphasis on other aspects of early phases
of clinical development.
Drug Information Association
www.diahome.org
24
Provide additional details of planned content
Listed below are the primary topics announced in the Call for Proposals.
A. Innovative approaches to nonclinical and early clinical safety
B. Challenges in the early development of novel and advanced therapies
C. New methods that reduce reliance on animal testing
D. Translational biomarkers in drug development (preclinical, clinical,
safety, and efficacy)
E. Clinical pharmacology and experimental medicine
F. Interactions with regulatory agencies
G. Exploring drug development failures
Drug Information Association
www.diahome.org
25
Provide additional details, page 2
Current possible sessions and the primary topics to which they relate indicated by
letter (see previous page):
1.
2.
3.
4.
5.
6.
7.
8.
Microdosing in translational medicine (E)
Integrated Early Phase Decision-making (E)
Drug QT Derisking (A)
First in Human Challenges of Biologics and Biosimilars (A, B, F)
Clinical Renal Impairment Studies (A, E)
Assessment of Carcinogenic Risk (A, D)
Dried Blood Spot Technology (A, C, E)
Novel Imaging Techniques (A, B, D, E)
– Microtracer/Macrotracer Doses in Human AME (E)
– F-18 PET imaging (E)
9. Drug Transporters: Regulatory and Clinical Relevance (A, D, E, F)
10. Regulatory and Biosafety Challenges of Live Human Attenuated Vaccines (A,
B, F)
11. Juvenile Animal Studies and Pediatric Drug Development (A, F)
12. Skin Drug Biotransformation and Stevens Johnson Syndrome (A, F, G)
Drug Information Association
www.diahome.org
26
Possible topics for collaboration with other Tracks
• Nonclinical and Clinical Strategies in the
Development of Therapeutic Vaccines [Maybe
used in SIAC Showcase]
• Can Animal Models of Disease Be Used to
Support Drug Development for Rare Diseases?
Roadblock or Highway to Drug Approval? [Maybe
used in special session on rare diseases]
• The Impact of Volunteers on Early Drug
Development: A Cross-Sectional Panel
Discussion. [Potentially interesting topic. Uncertain
where appropriate.]
Drug Information Association
www.diahome.org
27
Where are the gaps? If any?
• Overall the balance seems acceptable.
• Not a lot of direct exploration of drug
development failures although some topics
may have that as an underlying impetus.
• Not many new nonclinical models although
some of the topics may touch on these (e.g.,
assessment of carcinogenicity).
Drug Information Association
www.diahome.org
28
Potential speakers to invite
• To help address first in human challenges
with high risk products such as some
biologic therapeutics – Dr. Howard Uderman
(Pfizer)
• To help address clinical applicability of dried
blood spot technology – Dr. Christopher
Evans (GSK)
Drug Information Association
www.diahome.org
29
Track Update
Track 5: Product Advertising
and Marketing
Track Learning Objective and Targeted Audience
Discuss the current regulatory landscape
related to drug advertising and promotion.
Drug Information Association
www.diahome.org
31
What is the focus and flow of this track for 2012?
The Product Advertising and Marketing Track will
focus on the advertising, promotion, and marketing
of pharmaceuticals, and other medical products.
Topics will include how advertising/promotion
materials and programs are regulated, the political
and legislative issues that affect marketing at both
the federal, state and international levels, and
innovations that are changing the marketing
landscape.
Drug Information Association
www.diahome.org
32
Provide additional details of planned content
1. Marketing Primer
2. FDA Enforcement Update
Other topics we are considering at this point:
- International session consisting of panelists from US, EU, Asia and New
Zealand
- Social media/DTC update session
-Drug development utilizing a strong Targeted Product Profile – developing
a drug for maximum commercialization. Development
backwards/forwards. When should this be developed? Who should
help in the development? Strategic thinking. Involvement of the
Ad/Promo regulatory professional. Creating a strategic development
plan with the end in mind. Maximizing the end of phase 2 meeting with
this strategy in mind. How to involve the important FDA professional.
This will have a strong emphasis on ad/promo regulatory professionals
involvement in this process. This will have FDA, industry and perhaps
consultant participation.
Drug Information Association
www.diahome.org
33
Possible topics for collaboration with other Tracks
• Joint compliance program with the medical
communications track – looking at MSLs,
publications, CME grants, investigator
initiated trials, etc.
Drug Information Association
www.diahome.org
34
Where are the gaps? If any?
• Abstracts submitted did not include the
requested topics for the track. We will be
developing the four offerings for the track.
Drug Information Association
www.diahome.org
35
Potential speakers to invite
• Tom Abrams and Kate Gray from the Office
of Prescription Drug Promotion, CDER
Drug Information Association
www.diahome.org
36
Track Update: Medical Writing and
Medical Communications
Track #: 6
Track Learning Objective and Targeted Audience
• Identify opportunities to collaborate and
meet the expectations of multiple, global
regulatory authorities, patients, payers, and
other customers
• Medical Communicators (ie, call center,
medical information, MSL) and Medical
Writers (clinical regulatory writing,
publications writing and strategies/plans for
scientific message management)
Drug Information Association
www.diahome.org
38
What is the focus and flow of this track for 2012?
Monday
Tuesday
Wednesday
Thursday
Benefit Risk
Visualization
(MC+MW)
Publish or perish
(MC+MW)
Structured
Authoring/DITA
(MC+MW)
Adaptive Clinical
Trial Design (MW)
Social Media & Drug
Safety (MC)
Promotional tactics
(MC)
Global submissions
(MW)
Building global
capabilities (MW)
Wrangling Safety
Docs (MW)
Design to Disclosure
(MW)
Building global
capabilities (MC)
Back up: leveraging
technology in safety
reporting (MW)
SIAC showcase
Technology (MC)
Global practice &
collab (MW)
MSL (MC)
Drug Information Association
www.diahome.org
39
Provide additional details of planned content: MC+MW
Author
#
type
Title
level
Co
comments
Rebecca
Noel
43582
Session
Advancing benefitrisk visualization &
communication
Beg needs to
change to
Advanced
Lilly
Need focus
both MC +
MW;
consider
adding
43389; add
focus from
EMA & FDA
Art
Gertel
43201
Forum
Publish or Perishretracted scientific
literature
Beg. please
change to Int
Beardsw Need focus
orth
both MC +
MW
Michael
Brennan
43390
Worksho
p
Implementing SA:
understanding the
DITA model & its
applicability for
content & metadata
management
www.diahome.org
Beginner
J&J
Drug Information Association
Need focus
both MC +
MW
40
Provide additional details of planned content: MC
Author
#
type
Title
level
MSL
Advanced
Co
comments
Maureen
put
placeholder
Dr. Chew.
Gregory
Busse,
FDA
43347
Forum
Communicating Drug
Safety Information
using Social Media:
FDA & Industry
perspectives
Beginner –
should it be
intermediate
FDA
Send 43523
& 43853 to
Dr Chew.
Natalie to
reach out
David
Clemow
(Lucy
Rose)
43732
Session
Medical
contributions to
promotional tactics
(review last years’
feedback)
Beginner –
should it be
int?
Lilly
Consider as
joint with
Adv/Promo
tion/Compli
ance
Natalie to
find chair
43279
44011
Symposi
um
Building Global
Medical
Communications
capability
Beginner
tbd
Call center,
med info,
new service
delivery
41
models
www.diahome.org
Provide additional details of planned content: MW
Author
#
Purcell
Maxemow
McLean
level
Co
comments
42499 Symposiu MW Competencies
43305 m
and best practice in
43009
the Global Env
Beginner
Urtech
INC Res
MMS
holdings
Ask Purcell to
chair
Getz (chair)
Swaminatha
n
Gawrylewski
43072 Session
From Design to
43807 or
Disclosure pleasing
43994 symposiu multiple masters
m
Intermediat
e
Tufts
GSK
J&J
Need to ensure
focus on
solutions,
implementation
Van Etten
43217 Session
Wrangling the bestiary of safety
documents: coordination &
integration across multiple
requirements
Intermediat
e
Amgen
He’s proposed
Hecker (?) and
Hoffman
Hecker
43506 Session
Efficient Regulatory
Advanced
medical writing for
global submissions
including “ICH outlier”
authorities
Drug Information Association
type
Title
www.diahome.org
Hecker & Request for
assoc,
FDA speaker
Justina Molzon
42
Provide additional details of planned content: MW
Author
#
Mozzicato
Guld
Zink
Sietsema
Co
comments
42874 symposiu Leveraging technology Beg
43153 m
in safety writing and
43379
reporting
MEDRA
MSSO
BMS
SAS
Back up.
Who to chair?
43050 Session
INC
research
Need to make
it relevant to
writing.
Speaker wants
FDA speaker
Drug Information Association
type
Title
level
Recent advances in
adaptive clinical trial
designs for medical
writers
www.diahome.org
Intermediat
e
43
Possible topics for collaboration with other Tracks
• Explored adaptive clinical trials and
leveraging social media and leveraging
technology in safety reporting.
• All landed in track 6, no overlap with other
tracks
Drug Information Association
www.diahome.org
44
Where are the gaps? If any?
• REMs, CER/EBM may be opportunity to get
Medical Communications perspective
• PROs may be opportunity to get Medical
writing perspective
Drug Information Association
www.diahome.org
45
Potential speakers to invite
• To invite Justina Molzon for 43506 (global
subs)
• Invite FDA speaker for 43050 (adaptive trial)
• Dr Chew FDA 43347 invite Gregory Busse
Drug Information Association
www.diahome.org
46
What is the focus and flow of this track for 2012?
Monday
Tuesday
Wednesday
Thursday
Benefit Risk
Visualization
(MC+MW) Mary or
Janet
Publish or perish
(MC+MW) Mary or
Janet
Structured
Authoring/DITA
(MC+MW) Mary or
Janet
Adaptive Clinical
Trial Design (MW)
Mary or Janet
Social Media & Drug
Safety (MC) Natalie
Promotional tactics
(MC) Natalie
Global submissions
Building global
(MW) Mary or Janet capabilities (MW)
Mary or Janet
Wrangling Safety
Docs (MW) Mary or
Janet
Design to Disclosure
(MW)
Building global
capabilities (MC)
Natalie
Drug Information Association
SIAC showcase
MSL (MC) Natalie
Technology (MC)
Global practice &
www.diahome.org
collab (MW)
Back up: leveraging
technology in safety
reporting (MW)
Mary or Janet
47
Track Update
Track #: 7
Processes and Technologies
for Clinical Research
Track Learning Objective and Targeted Audience
• Objectives:
– Describe how innovative and collaborative
technologies and processes have been or could
be used in clinical research to yield measurable
benefit
– Describe how processes and technologies in
clinical research bring progress in medicine and
assist in the delivery of health care
• Targeted audience:
– Those who select/lead/use new processes and
technologies
Drug Information Association
www.diahome.org
49
What is the focus and flow of this track for 2012?
• Focus:
– Educate and solicit ideas from those who
conduct clinical trials, by offering sessions that
are new and different, incorporate case studies,
reflect a global perspective, and demonstrate
measurable benefit
• Flow:
– Continuum from tried-and-true through
innovative case studies to emerging, but not yet
proven, future possibilities
Drug Information Association
www.diahome.org
50
Provide additional details of planned content
•
•
•
•
•
•
•
•
Economics
Adaptive trials
eProtocol thru eTMF
Patient engagement
strategies
Patient benefit
Standards
Security
Cloud
•
•
•
•
•
•
•
•
•
Validation (Workshop?)
Social media
EHR
Telemedicine
CDM
Endpoints (including labeling)
Post approval
Data warehousing/data mining
Workshop: PRO Instrument
Development
www.diahome.org
51
Possible topics for collaboration with other Tracks
• Telemedicine: mobile health within
clinical research (Medical Devices,
HEO/CER, Clin Ops Tracks)
• EHR (Clin Ops Track)
• Measuring effectiveness/efficiencies of
technologies (Outsourcing Track)
• Education challenges and opportunities
(Professional Development Track)
• eTMF (Clin Ops Track)
• More to come…..
Drug Information Association
www.diahome.org
52
Where are the gaps? If any?
• Still need to address:
– Automated understanding of data (statistics)
– Sponsor perspective
• Still need to map abstracts to defined topics
Drug Information Association
www.diahome.org
53
Potential speakers to invite
• Todd Park - HHS
Drug Information Association
www.diahome.org
54
Track Update: Regulatory Affairs and
Submissions
Track #: 8
Track Learning Objective and Targeted Audience
• Discuss latest global regulatory trends and
developments that impact the industry
• Target audience: regulatory affairs,
regulatory policy, operations/e-submission
specialists
Drug Information Association
www.diahome.org
56
What is the focus and flow of this track for 2012?
• Local and global topics pertaining to
development, submission, approval and
beyond.
• Emphasizes regulatory trends, strategic
regulatory issues and practices, and tactical
issues that affect the regulatory process
Drug Information Association
www.diahome.org
57
Provide additional details of planned content
• Global development
strategies
• Emerging markets
• Biosimilars
• Therapeutics/diagnostics
co-development
• Transparency
• Benefit-Risk
• Vaccines
Drug Information Association
•
•
•
•
•
•
Orphan/rare disease
Pediatrics
Rx-OTC switch
PDUFA V
Drug Shortages
IND safety reporting
requirements
• Patient advocacy
www.diahome.org
58
Possible topics for collaboration with other Tracks
• Potential for multi-track sessions:
– Benefit-Risk (Statistics)
– Drug Shortages (Quality)
– Patient Perspective (Clinical)
– REMS/Safety (PV)
– Vaccines (Outsourcing)
– E-submissions collaborative outsourcing
(Outsourcing)
– Emerging Mkts Reg Intelligence (multiple)
Drug Information Association
www.diahome.org
59
Possible topics for collaboration with other Tracks
• Pediatrics (Public Policy)
• FDA/EMA/PMDA (Global Health Authorities)
• Potential Poster Sessions (clinical topics)
– QT study heart rate correction
– Medical imaging repository
– Alzheimer biomarkers
– Nuclear cardiology scans
• Nanotechnology (Devices)
Drug Information Association
www.diahome.org
60
Where are the gaps? If any?
• Drug shortage – need to expand – possible
forum?
Drug Information Association
www.diahome.org
61
Potential speakers to invite
• Combining speakers for consolidated topics
Drug Information Association
www.diahome.org
62
Track Update
Track # 9: Medical Diagnostics
and Devices
Track Learning Objective and Targeted Audience
Track Learning Objective:
• Identify opportunities for drug companies to
address changing regulations in the area of
medical devices, diagnostics, and
drug/device combination products.
Drug Information Association
www.diahome.org
64
What is the focus and flow of this track for 2012?
• Topics we plan to cover
– Venture Capitalists fund opportunities in the
drug device combo area
– CDRH PLENARY with past CDRH Directors
– Changes in the 510 (k)
– Companion Diagnostic
– IVD
– Combination products
– Device reform (Asia Pacific)
– Device reform and recast (EU)
– OTC and Home Use
Drug Information Association
www.diahome.org
65
Possible topics for collaboration with other Tracks
• Collaborating with Public Policy (Track 10)
on “Litigation Management Strategies: The
Role of “Human Factors” Experts in Medical
Device Litigation”
Drug Information Association
www.diahome.org
66
Potential speakers to invite
• Heather Rosecrans and Daniel Schultz of
Green Leaf Health llc
Drug Information Association
www.diahome.org
67
Track Update
Track 10: Public Policy,
Healthcare Compliance
and Regulatory Law
Track Learning Objective and Targeted Audience
• Track 10 will feature discussions, panels and forums on
topics pulled from headline industry news which impacts
the way industry conducts business, interacts with health
authorities, and is perceived by the public
• Track 10 audience demographics in 2011 demonstrate that
more than 50% of attendees:
– Have > 11 years of experience in industry
– Are at least at an executive level of industry
• Therefore, Track 10 needs to go beyond training on
regulatory and legal fundamentals, and focus on
Intermediate and Advanced sessions raising the level of
dialogue
Drug Information Association
www.diahome.org
69
What is the focus and flow of this track for 2012?
• Highlight and discuss current compliance
and policy topics and implications among
multiple stakeholders
• Include topics large enough to gain cross
regional perspective
• Focus and expand discussion on globally
impactful regional topics
Drug Information Association
www.diahome.org
70
Provide additional details of planned content
• New theories of legal liability or trends in industry behavior that
increase the risk of product liability lawsuits
– Symposium: legal aspects of clinical trial compliance, creating a non-conflicts policy;
inspection readiness
– Product liability in EU and US
– Civil and criminal liability from clinical trials
– Mock trial: clinical trials on trial
– Off label use: practical and legal considerations
• Review global regulatory changes and requirements impacting industry
strategy, operations and compliance
– International cooperation among regulatory agencies
– Biosimilars legislation & requirements in contrast to small molecule generics
• New theories of government enforcement
–
–
–
–
Policy and enforcement trends
EU Compliance trends and impact
Mock trial: marketing practices on trial
Regulatory compliance driving business advantages
Drug Information Association
www.diahome.org
71
Possible topics for collaboration with other Tracks
• Clinical Operations: compliance topics
• Product Advertising and Communications:
Mock trial on Marketing Practices:
• Global Agency: International Cooperation
Among Agencies
• Executive: Emerging development and
policy trends in the economics of the
biopharmaceutical industry
Drug Information Association
www.diahome.org
72
Where are the gaps? Additional topics?
Gaps: Did not receive abstracts regarding:
• Industry-physician payment relationships
• Current conflict of interest policy for FDA Advisory Committee process
• Pediatric drug development and global compliance from industry perspective
• U.S. patent cliff & Innovation drought-how do industry and regulators need to
evolve?
• FDA/CMS parallel review – what are we learning from pilots? What do we need
to do differently?
• PDUFA V – how to prepare in order to optimize the “enhanced agency
communication”?
Additional Topics (from submitted Abstracts):
• Drug discovery as an innovative tool to meet unmet medical needs
• Regulatory capacity building
• Meeting the needs of older patients
• Emerging development and policy trends in the economics of the
biopharmaceutical industry
Drug Information Association
www.diahome.org
73
Potential speakers to invite
Drug Information Association
www.diahome.org
74
Track Update
Track #: 11 Compliance to GCP, GLP and QA
Track Learning Objective and Targeted Audience
• Learning Objective
– Describe how to avoid GCP / GLP non compliance
through innovation and collaboration in a period of
increasing complexity and globalization
• Focus on best practices, quality systems and
plans, CAPA and metrics
• Audience
– Compliance
– Quality Management
– Clinical professionals
Drug Information Association
www.diahome.org
76
What is the focus and flow of this track for 2012?
• 10 Sessions
• Focus on:
–
–
–
–
–
–
–
–
–
–
CAPA
GLP
Compliance
Quality and Vendors
Good Documentation Practice (GDP)
Quality by Design
Global GCP
Regulatory Collaborations in GCP
Quality in Clinical Trials
Risk Based Compliance
Drug Information Association
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Provide additional details of planned content
• Workshop - 2
– CAPA
– GDP
• Symposium - 3
– GLP: Focused on design and inspection readiness
– Compliance: Changing face of clinical compliance
– Global GCP
• Session - 5
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Compliance
Vendor Quality
Quality in Clinical Trials
Quality by Design
Lessons Learned from Warning letters
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Possible topics for collaboration with other Tracks
• Additional topics submitted for
consideration:
– Clinical Operations
– Outsourcing
– Process and Technologies
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Where are the gaps? If any?
• Quality metrics
• Joint regulatory inspections
• eSource and compliance implications
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Potential speakers to invite
• TBD
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Track Update
Track #: 12
Pharmaceutical Quality
Track Learning Objective and Targeted Audience
Discuss application of fundamental and
advanced scientific and regulatory
approaches to current and emerging
pharmaceutical quality issues, including a
strong emphasis on global harmonization
efforts within and outside ICH.
Target audience:
CMC & Regulatory Professionals
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What is the focus and flow of this track for 2012?
• The Pharmaceutical Quality Track includes basic
and advanced information to aid scientist and
regulatory professionals in understanding
approaches to successful CMC aspects in
application in today’s regulatory environment.
• The track will have a strong emphasis on
international harmonization and on emerging
topics, such as Quality by Design and Real-time
release testing.
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Provide additional details of planned content
8 Total Sessions (6), Forums (1), Workshops (1)
1. ICH Update on Pharmaceutical Quality – Forum
(Abstract # 43983)
2. Preparing for CMC-only meetings with FDA – Session
(Abstract # 43497)
3. Current Trends in Drug Quality and Manufacturing –
Session (Abstract # 43926)
4. Post Approval Change Pathways in EU and US –
Challenges & opportunities for Harmonization –
Session (Abstract # 43990)
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Provide additional details of planned content
8 Sessions, Forums, Workshops (continued)
5. Auditing Pharmaceutical Quality Systems – Session
(Abstract # 43598)
6. Practical Implementation of Knowledge Management for
QbD Applications – Session (Abstract # 43334)
7. Opportunity for Global Harmonization of Audits and
Inspection Paradigm – Session (not submitted)
8. Quality Risk Management – Workshop (Abstract # 43227)
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Possible topics for collaboration with other Tracks
•EMA- FDA Parallel Assessment Pilot Update
(Abstract # 43988)
• Propose for Track 8: Regulatory Affairs and
Submissions under global development.
•Special Regulatory Considerations in the
Development of Injectable Drug Delivery Devices
(Abstract # 43967)
• Propose for Track 9: Medical Diagnostic and
Devices
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Where are the gaps? If any?
No gaps identified at this time.
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Potential speakers to invite
• Not all the potential speakers have been identified at this
time.
• It is expected that speakers for this track will include
speakers from:
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•
Drug Information Association
FDA (particularly CDER/ONDQA and CDER/OC),
EU,
ICH,
Pharmaceutical firms, and
perhaps a consulting firm
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Track Update
Track 13: HEO/CER/HTA
Track Learning Objective and Targeted Audience
LEARNING OBJECTIVES:
• Real-world use of Pharmacoeconomics & Outcomes
Research (PEOR) and Comparative Effectiveness
data/research techniques
• Use of Health Technology Assessments by payers,
government agencies, and pharmaceutical manufacturers
• Use of registry data in effectiveness or comparative
effectiveness studies
• Legislation (current and future) regarding pricing and
reimbursement as they relate to comparative effectiveness
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What is the focus and flow of this track for 2012?
• Attendees will build the scientific capability
to measure and communicate the medical
need, health impact, and economic value
associated with medical products.
• Focus:
– Comparative Effectiveness
– Health Technology Assessment
– Pharmacoeconomics
– Outcomes Research
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Provide additional details of planned content
1. Registries-Emerging areas of controversies
2. Applying quality of evidence tools in
pharmacoepi. studies
3. Demystifying epidemiology in observational
CER studies
4. Role of meta-analysis in drug safety:
methodological considerations
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Provide additional details of planned content
5. CER-a tool for driving health care decisions
6. Advancements of HTA and its impact on
healthcare reform + product lifecycle
management in Asia-Pacific
7. HTA appraisals in Italy, Taiwan
8. Cross-border HTA- how decisions in 1
country affect another
If room, Innovative tools for CER: super
datasets, EMR and other databases
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Possible topics for collaboration with other Tracks
• Track 14 (Safety): The Role of Meta-analyses in Drug
Safety: Methodological Considerations
• Track 8 (Regulatory): How the Same Licensing Data Are
Differently Evaluated by Payers / The Effects of NICE
Technology Assessments on Prescribing and Cost-sharing
Behavior in the US
• Track 8 (Regulatory): The Impact of CER/HTA and the
Changing Regulatory Environment on Drug Development
• Track 15 (Stats): Extending Methods of Bias Reduction
From Pharmacoepidemiology to Comparative Effectiveness
Research
• Track 15 (Stats): Challenges in Global Observational
Studies: Managing Study Design, Regional Diversity and
Multiple Needs
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Where are the gaps? If any?
• No gaps identified
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Potential speakers to invite
Presenters on the Track 14 Approval “Short List” that
may be of interest to other tracks:
• Dr. George Neyarapally, FDA
• Dr. Simone P Pinheiro, FDA
• Dr. Chih-Hwa Wallace Lin, CDER
• Dr. Luca De Nigro, Italian Medicines Agency
• Dr. Pietro Folino Gallo, Italian Medicines Agency
• EMA representative
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Track Update
Track 14: Clinical Safety
& PVG
Track Learning Objective and Targeted Audience
Objective:
Discuss a broad array of concepts and tools (traditional
and new) that support participants’ pursuit of excellence
in patient safety, for both investigational and marketed
products.
Target Audience:
Individuals working on - or interested in - product safety.
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What is the focus and flow of this track for 2012?
• Chose abstracts that speak to:
– Novel approaches
- Collaboration
• Want to be provocative, challenge old ideas!
• Themes include:
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Signal detection
REMS
EHRs in safety
Observational Studies
Pediatric safety
Outsourcing
Combination products
DMCs
Drug Information Association
- Social Media
- Collaborations (PACeR, Mini-Sentinel)
- IRBs & minimizing risk
- PVG organz’l structure
- Role/s of epidemiologists x life cycle
- Biologics
- MedDRA
- ‘Doping’ (Patients behaving badly)
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Provide additional details of planned content
• Will cover 16 different ‘themes’
• Social Media and REMS will be allowed two
sessions each for a total of 18 sessions
• Aimed for a nice balance of academic,
industry, CRO and regulatory speakers
• Don’t have to force anyone to change format
(from forum to topic, for example)
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Possible topics for collaboration with other Tracks
•
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Social Media (w/ Advertising, Med Comm)
Outsourcing (w/ Outsourcing)
IT ‘Clouds’ (w/ IT)
Benefit-Risk (w/ Stats, HEO-HTA)
Patients behaving badly (w/ Clin. Ops)
Role/s of Epidemiologists (w/ Prof. Dvlpmt.)
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Where are the gaps? If any?
• We don’t have any real gaps …
• We got at least one abstract for each
solicited. topic!
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Potential speakers to invite
• Need
– Industry speaker for Social Media
– DHHS (OHRP or FDA) speakers on IRBs
– Industry or CRO speakers for Organizational
Structure, Role/s of Epidemiologists
– Speakers engaged in successful collaborations
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Track Update
Track #: 15
Statistical Science and
Quantitative Thinking
Track Learning Objective and Targeted Audience
• Track Learning Objectives
– Identify innovative statistical solutions to issues associated with the
evidence and regulatory review of drugs, diagnostics/devices, and
biologics
– Describe relevant application of statistical science and quantitative
thinking to the development of new therapeutic biologics, drugs,
and diagnostics/devices
• Targeted Audience
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Statisticians
Clinical Trialists
Epidemiologists
Health Economists
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What is the focus and flow of this track for 2012?
• This track will focus on the contributions
arising from statistical science and
quantitative thinking across the entire
spectrum of clinical product development.
• The track will cover a wide range of
statistical topics relevant to clinical trial
design and analysis.
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Provide additional details of planned content
• Topics will include
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Hot Topics in Statistics
Data Standards
Modeling and Simulation
Data safety analysis and labeling issues
DIA Working Group: highlights on Bayesian and Adaptive Designs
Open Source Software Validation
Comparative Effectiveness Research (Multi-track)
Benefit-Risk
Guidance Development Topics
• Non-inferiority
• Multiplicity
• Subgroups
• Enrichment Design (possible)
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Possible topics for collaboration with other Tracks
• Comparative Effectiveness Research with
Track 13
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Where are the gaps? If any?
• Less number of abstract proposals submitted
• Less quality
• Created sessions to fill the gaps
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Potential speakers to invite
• Academic
– Susan Ellenberg (UPenn – will contact)
– Temple U (will contact)
• Industry
– Christy Chuang-Stein
– Matt Rotelli
– Alex Dmitrienko
• FDA
– Bob O’Neill
– Bob Temple
– Sue Jane Wang
– Ram Tiwari
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Track Update
Track #: 16
Professional Development
Track Learning Objective and Targeted Audience
Drug Information Association
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What is the focus and flow of this track for 2012?
Professional
Development!
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Provide additional details of planned content
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Possible topics for collaboration with other Tracks
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Where are the gaps? If any?
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