Track Update Track #: 1 Clinical Trials Track

slide1. Track UpdateTrack #: 1 Clinical Trials<br>
slide2. 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 Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 2<br>
slide3. 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) What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 3<br>
slide4. 28 total Sessions
3 workshops (Metrics, Risk-based monitoring and Investigator site management)
10 symposia
11 sessions
4 forums
1 poster Provide additional details of planned content Drug Information Association www.diahome.org 4<br>
slide5. TMF (Track 7)
Protocol Design (Track 2)
Impact of outsourcing in clinical trial execution (governance, quality)
FDA site inspections (Track 11) Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 5<br>
slide6. Managing clinical studies during mergers and acquisitions
Partnership (CRO/Sponsor) governance impact on study execution/project teams Where are the gaps? If any? Drug Information Association www.diahome.org 6<br>
slide7. Study subjects
Patient advocacy group
Other industries Potential speakers to invite Drug Information Association www.diahome.org 7<br>
slide8. Track UpdateTrack 2: Project/Portfolio Management and Strategic Planning<br>
slide9. 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<br>
slide10. What is the focus and flow of this track for 2012? Stay with hot topics for protocol and project-level topics:
PM skills and techniques
Protocol design topics
Bring more focus to program- and portfolio-level topics:
Program-level strategic planning
Portfolio Management topics Drug Information Association www.diahome.org 10<br>
slide11. Provide additional details of planned content Drug Information Association www.diahome.org 11 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<br>
slide12. 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<br>
slide13. 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<br>
slide14. 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<br>
slide15. Track UpdateTrack 3: Innovative PartneringModels and Outsourcing Strategies<br>
slide16. 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, co-development 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<br>
slide17. 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<br>
slide18. Provide additional details of planned content CRO Industry
ACRO Executive Roundtable
Avoca Industry Survey with reactions from sponsors and CROs
Hidden costs and consequences of Sponsor CRO partnerships
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
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<br>
slide19. 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<br>
slide20. 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<br>
slide21. 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<br>
slide22. Track UpdateTrack #: 4 Nonclinical and Translational Development / Early Phase Clinical Development<br>
slide23. 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 Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 23<br>
slide24. 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<br>
slide25. Provide additional details of planned content Listed below are the primary topics announced in the Call for Proposals.

Innovative approaches to nonclinical and early clinical safety

Challenges in the early development of novel and advanced therapies

New methods that reduce reliance on animal testing

Translational biomarkers in drug development (preclinical, clinical, safety, and efficacy)

Clinical pharmacology and experimental medicine

Interactions with regulatory agencies

Exploring drug development failures Drug Information Association www.diahome.org 25<br>
slide26. Current possible sessions and the primary topics to which they relate indicated by letter (see previous page):

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)
Drug Transporters: Regulatory and Clinical Relevance (A, D, E, F)
Regulatory and Biosafety Challenges of Live Human Attenuated Vaccines (A, B, F)
Juvenile Animal Studies and Pediatric Drug Development (A, F)
Skin Drug Biotransformation and Stevens Johnson Syndrome (A, F, G) Provide additional details, page 2 Drug Information Association www.diahome.org 26<br>
slide27. 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<br>
slide28. 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<br>
slide29. 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<br>
slide30. Track UpdateTrack 5: Product Advertising and Marketing<br>
slide31. Discuss the current regulatory landscape related to drug advertising and promotion. Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 31<br>
slide32. 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. What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 32<br>
slide33. 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. Provide additional details of planned content Drug Information Association www.diahome.org 33<br>
slide34. Joint compliance program with the medical communications track – looking at MSLs, publications, CME grants, investigator initiated trials, etc. Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 34<br>
slide35. Abstracts submitted did not include the requested topics for the track. We will be developing the four offerings for the track. Where are the gaps? If any? Drug Information Association www.diahome.org 35<br>
slide36. Tom Abrams and Kate Gray from the Office of Prescription Drug Promotion, CDER Potential speakers to invite Drug Information Association www.diahome.org 36<br>
slide37. Track Update: Medical Writing and Medical CommunicationsTrack #: 6<br>
slide38. 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) Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 38<br>
slide39. What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 39<br>
slide40. Provide additional details of planned content: MC+MW Drug Information Association www.diahome.org 40<br>
slide41. Provide additional details of planned content: MC www.diahome.org 41<br>
slide42. Provide additional details of planned content: MW Drug Information Association www.diahome.org 42<br>
slide43. Provide additional details of planned content: MW Drug Information Association www.diahome.org 43<br>
slide44. Explored adaptive clinical trials and leveraging social media and leveraging technology in safety reporting.
All landed in track 6, no overlap with other tracks Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 44<br>
slide45. REMs, CER/EBM may be opportunity to get Medical Communications perspective
PROs may be opportunity to get Medical writing perspective Where are the gaps? If any? Drug Information Association www.diahome.org 45<br>
slide46. To invite Justina Molzon for 43506 (global subs)
Invite FDA speaker for 43050 (adaptive trial)
Dr Chew FDA 43347 invite Gregory Busse Potential speakers to invite Drug Information Association www.diahome.org 46<br>
slide47. What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 47<br>
slide48. Track UpdateTrack #: 7Processes and Technologiesfor Clinical Research<br>
slide49. 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 Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 49<br>
slide50. 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 What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 50<br>
slide51. 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 Provide additional details of planned content www.diahome.org 51<br>
slide52. 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….. Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 52<br>
slide53. Still need to address:
Automated understanding of data (statistics)
Sponsor perspective
Still need to map abstracts to defined topics Where are the gaps? If any? Drug Information Association www.diahome.org 53<br>
slide54. Todd Park - HHS Potential speakers to invite Drug Information Association www.diahome.org 54<br>
slide55. Track Update: Regulatory Affairs and SubmissionsTrack #: 8<br>
slide56. Discuss latest global regulatory trends and developments that impact the industry
Target audience: regulatory affairs, regulatory policy, operations/e-submission specialists Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 56<br>
slide57. 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 What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 57<br>
slide58. Global development strategies
Emerging markets
Biosimilars
Therapeutics/diagnostics co-development
Transparency
Benefit-Risk
Vaccines Orphan/rare disease
Pediatrics
Rx-OTC switch
PDUFA V
Drug Shortages
IND safety reporting requirements
Patient advocacy Provide additional details of planned content Drug Information Association www.diahome.org 58<br>
slide59. 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) Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 59<br>
slide60. 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) Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 60<br>
slide61. Drug shortage – need to expand – possible forum? Where are the gaps? If any? Drug Information Association www.diahome.org 61<br>
slide62. Combining speakers for consolidated topics Potential speakers to invite Drug Information Association www.diahome.org 62<br>
slide63. Track UpdateTrack # 9: Medical Diagnostics and Devices<br>
slide64. Track Learning Objective:
Identify opportunities for drug companies to address changing regulations in the area of medical devices, diagnostics, and drug/device combination products. Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 64<br>
slide65. 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 What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 65<br>
slide66. Collaborating with Public Policy (Track 10) on “Litigation Management Strategies: The Role of “Human Factors” Experts in Medical Device Litigation” Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 66<br>
slide67. Heather Rosecrans and Daniel Schultz of Green Leaf Health llc Potential speakers to invite Drug Information Association www.diahome.org 67<br>
slide68. Track UpdateTrack 10: Public Policy, Healthcare Compliance and Regulatory Law<br>
slide69. 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 Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 69<br>
slide70. 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 What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 70<br>
slide71. 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 Provide additional details of planned content Drug Information Association www.diahome.org 71<br>
slide72. 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 Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 72<br>
slide73. 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 Where are the gaps? Additional topics? Drug Information Association www.diahome.org 73<br>
slide74. Potential speakers to invite Drug Information Association www.diahome.org 74<br>
slide75. Track UpdateTrack #: 11 Compliance to GCP, GLP and QA<br>
slide76. 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<br>
slide77. 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 www.diahome.org 77<br>
slide78. 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
Compliance
Vendor Quality
Quality in Clinical Trials
Quality by Design
Lessons Learned from Warning letters Drug Information Association www.diahome.org 78<br>
slide79. Possible topics for collaboration with other Tracks Additional topics submitted for consideration:
Clinical Operations
Outsourcing
Process and Technologies Drug Information Association www.diahome.org 79<br>
slide80. Where are the gaps? If any? Quality metrics
Joint regulatory inspections
eSource and compliance implications Drug Information Association www.diahome.org 80<br>
slide81. Potential speakers to invite TBD Drug Information Association www.diahome.org 81<br>
slide82. Track UpdateTrack #: 12 Pharmaceutical Quality<br>
slide83. Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 83 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<br>
slide84. What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 84 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.<br>
slide85. Provide additional details of planned content Drug Information Association www.diahome.org 85 8 Total Sessions (6), Forums (1), Workshops (1)
ICH Update on Pharmaceutical Quality – Forum (Abstract # 43983)
Preparing for CMC-only meetings with FDA – Session (Abstract # 43497)
Current Trends in Drug Quality and Manufacturing – Session (Abstract # 43926)
Post Approval Change Pathways in EU and US – Challenges & opportunities for Harmonization – Session (Abstract # 43990)<br>
slide86. Provide additional details of planned content Drug Information Association www.diahome.org 86 8 Sessions, Forums, Workshops (continued)
Auditing Pharmaceutical Quality Systems – Session (Abstract # 43598)
Practical Implementation of Knowledge Management for QbD Applications – Session (Abstract # 43334)
Opportunity for Global Harmonization of Audits and Inspection Paradigm – Session (not submitted)
Quality Risk Management – Workshop (Abstract # 43227)<br>
slide87. Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 87 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<br>
slide88. Where are the gaps? If any? Drug Information Association www.diahome.org 88 No gaps identified at this time.<br>
slide89. Potential speakers to invite Drug Information Association www.diahome.org 89 Not all the potential speakers have been identified at this time.
It is expected that speakers for this track will include speakers from: FDA (particularly CDER/ONDQA and CDER/OC),
EU,
ICH,
Pharmaceutical firms, and
perhaps a consulting firm<br>
slide90. Track UpdateTrack 13: HEO/CER/HTA<br>
slide91. 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 Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 91<br>
slide92. 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 What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 92<br>
slide93. Registries-Emerging areas of controversies
Applying quality of evidence tools in pharmacoepi. studies
Demystifying epidemiology in observational CER studies
Role of meta-analysis in drug safety: methodological considerations Provide additional details of planned content Drug Information Association www.diahome.org 93<br>
slide94. CER-a tool for driving health care decisions
Advancements of HTA and its impact on healthcare reform + product lifecycle management in Asia-Pacific
HTA appraisals in Italy, Taiwan
Cross-border HTA- how decisions in 1 country affect another
If room, Innovative tools for CER: super datasets, EMR and other databases Provide additional details of planned content Drug Information Association www.diahome.org 94<br>
slide95. 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 Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 95<br>
slide96. No gaps identified Where are the gaps? If any? Drug Information Association www.diahome.org 96<br>
slide97. 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 Potential speakers to invite Drug Information Association www.diahome.org 97<br>
slide98. Track UpdateTrack 14: Clinical Safety  & PVG<br>
slide99. 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. Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 99<br>
slide100. Chose abstracts that speak to:
Novel approaches - Collaboration
Want to be provocative, challenge old ideas!
Themes include:
Signal detection - Social Media
REMS - Collaborations (PACeR, Mini-Sentinel)
EHRs in safety - IRBs & minimizing risk
Observational Studies - PVG organz’l structure
Pediatric safety - Role/s of epidemiologists x life cycle
Outsourcing - Biologics
Combination products - MedDRA
DMCs - ‘Doping’ (Patients behaving badly) What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 100<br>
slide101. 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) Provide additional details of planned content Drug Information Association www.diahome.org 101<br>
slide102. 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.) Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 102<br>
slide103. We don’t have any real gaps …
We got at least one abstract for each solicited. topic! Where are the gaps? If any? Drug Information Association www.diahome.org 103<br>
slide104. 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 Potential speakers to invite Drug Information Association www.diahome.org 104<br>
slide105. Track UpdateTrack #: 15Statistical Science and Quantitative Thinking<br>
slide106. 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
Statisticians
Clinical Trialists
Epidemiologists
Health Economists Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 106<br>
slide107. 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. What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 107<br>
slide108. Topics will include
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) Provide additional details of planned content Drug Information Association www.diahome.org 108<br>
slide109. Comparative Effectiveness Research with Track 13 Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 109<br>
slide110. Less number of abstract proposals submitted
Less quality
Created sessions to fill the gaps Where are the gaps? If any? Drug Information Association www.diahome.org 110<br>
slide111. 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 Potential speakers to invite Drug Information Association www.diahome.org 111<br>
slide112. Track UpdateTrack #: 16Professional Development<br>
slide113. Track Learning Objective and Targeted Audience Drug Information Association www.diahome.org 113 Foster collaborative innovation through professional development and education<br>
slide114. What is the focus and flow of this track for 2012? Drug Information Association www.diahome.org 114 Professional Development! Industry-related Academia! Training!<br>
slide115. Provide additional details of planned content Drug Information Association www.diahome.org 115<br>
slide116. Possible topics for collaboration with other Tracks Drug Information Association www.diahome.org 116<br>
slide117. Where are the gaps? If any? Drug Information Association www.diahome.org 117<br>
slide118. Drug Information Association www.diahome.org 118<br>