Track Update Track #: 1 Clinical Trials Track

Track Update Track #: 1 Clinical Trials Track

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 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 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 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 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 6 Potential speakers to invite

Study subjects Patient advocacy group Other industries Drug Information Association 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 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 10 Provide additional details of planned content PM skills and techniques Critical chain, Pharma PM competencies, risk mgmt Protocol design topics QbD in clinical devt, adaptive design, improving protocol

design Program-level strategic planning Working with Asia, pharmacogenomics/ companion diagnostics in devt 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 11 Possible topics for collaboration with other Tracks Pharmacogenomics and Companion Diagnostics

Development in Asia, including leveraging CROs Execution of protocols Drug Information Association 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 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 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 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 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 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 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 20 Potential speakers to invite ACRO Executive Roundtable Doug Peddicord (Executive Director) CRO Executives Rob Wright (Editor, Life Science Leader) Drug Information Association 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 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 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 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 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 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 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

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 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 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 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 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 35 Potential speakers to invite Tom Abrams and Kate Gray from the Office of Prescription Drug Promotion, CDER Drug Information Association 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 38 What is the focus and flow of this track for 2012? Monday

Benefit Risk Visualization (MC+MW) Tuesday Publish or perish (MC+MW) Wednesday Structured Authoring/DITA (MC+MW) Thursday Adaptive Clinical Trial Design (MW) Social Media & Drug Safety (MC) Wrangling Safety

Docs (MW) Promotional tactics (MC) Design to Disclosure (MW) Global submissions (MW) Building global capabilities (MC) Building global capabilities (MW) Back up: leveraging technology in safety reporting (MW) SIAC showcase Technology (MC)

Global practice & collab (MW) MSL (MC) Drug Information Association 39 Provide additional details of planned content: MC+MW Author # type Title

level Co Rebecca Noel 43582 Session Advancing benefitrisk visualization & communication Beg needs to change to Advanced Lilly

Art Gertel 43201 Forum Publish or Perishretracted scientific literature Beg. please change to Int Michael Brennan 43390 Worksho p

Implementing SA: understanding the DITA model & its applicability for content & metadata management Beginner Drug Information Association comments Need focus both MC + MW; consider

adding 43389; add focus from EMA & FDA Beardsw Need focus orth both MC + MW J&J 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 Beginner should it be int? Lilly

Natalie to find chair 43279 44011 Symposi um Medical contributions to promotional tactics (review last years feedback) Building Global Medical Communications capability Beginner

tbd Consider as joint with Adv/Promo tion/Compli ance Call center, med info, new service delivery models 41 Provide additional details of planned content: MW Author

Purcell Maxemow McLean # type 42499 Symposiu 43305 m 43009 Getz (chair) Swaminatha n Gawrylewski 43072 Session From Design to 43807 or Disclosure pleasing 43994 symposiu multiple masters

m Van Etten 43217 Session Wrangling the bestiary of safety documents: coordination & integration across multiple requirements Hecker 43506 Session Efficient Regulatory Advanced medical writing for global submissions including ICH outlier

authorities Drug Information Association Title MW Competencies and best practice in the Global Env level Beginner Intermediat e Intermediat e

Co Urtech INC Res MMS holdings Tufts GSK J&J comments Ask Purcell to chair Need to ensure focus on solutions, implementation Amgen Hes proposed

Hecker (?) and Hoffman 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 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

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 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 46 What is the focus and flow of this track for 2012? Monday Benefit Risk Visualization (MC+MW) Mary or Janet Tuesday Publish or perish (MC+MW) Mary or Janet

Wednesday Structured Authoring/DITA (MC+MW) Mary or Janet Social Media & Drug Safety (MC) Natalie Promotional tactics (MC) Natalie Wrangling Safety Docs (MW) Mary or Janet Design to Disclosure (MW)

Global submissions Building global (MW) Mary or Janet capabilities (MW) Mary or Janet Building global Back up: leveraging capabilities (MC) technology in safety Natalie reporting (MW) Mary or Janet MSL (MC) Natalie SIAC showcase Technology (MC) Global practice & collab (MW) Drug Information Association

Thursday Adaptive Clinical Trial Design (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 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 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 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 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 53 Potential speakers to invite Todd Park - HHS Drug Information Association 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 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 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 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 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 60

Where are the gaps? If any? Drug shortage need to expand possible forum? Drug Information Association 61 Potential speakers to invite Combining speakers for consolidated topics Drug Information Association

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 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 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 66 Potential speakers to invite Heather Rosecrans and Daniel Schultz of Green Leaf Health llc Drug Information Association 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 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 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 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 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 73 Potential speakers to invite Drug Information Association 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 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 77 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 78 Possible topics for collaboration with other Tracks

Additional topics submitted for consideration: Clinical Operations Outsourcing Process and Technologies Drug Information Association 79 Where are the gaps? If any? Quality metrics Joint regulatory inspections eSource and compliance implications Drug Information Association 80 Potential speakers to invite TBD Drug Information Association 81 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 Drug Information Association 83 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 todays 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. Drug Information Association 84 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) Drug Information Association 85 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) Drug Information Association 86 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 Drug Information Association 87 Where are the gaps? If any? No gaps identified at this time. Drug Information Association 88 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: FDA (particularly CDER/ONDQA and CDER/OC), EU, ICH, Pharmaceutical firms, and perhaps a consulting firm Drug Information Association 89 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 Drug Information Association 91 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 Drug Information Association 92 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 Drug Information Association 93 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 Drug Information Association 94 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 Drug Information Association 95 Where are the gaps? If any? No gaps identified Drug Information Association 96

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 Drug Information Association 97 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. Drug Information Association 99

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: Signal detection - Social Media

REMS - Collaborations (PACeR, Mini-Sentinel) EHRs in safety - IRBs & minimizing risk Observational Studies- PVG organzl structure Pediatric safety - Role/s of epidemiologists x life cycle Outsourcing - Biologics Combination products- MedDRA DMCs - Doping (Patients behaving badly) Drug Information Association 100 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 Dont have to force anyone to change format (from forum to topic, for example) Drug Information Association 101 Possible topics for collaboration with other Tracks

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.) Drug Information Association 102 Where are the gaps? If any? We dont have any real gaps

We got at least one abstract for each solicited. topic! Drug Information Association 103 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 Drug Information Association 104 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 Statisticians Clinical Trialists Epidemiologists Health Economists Drug Information Association 106 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. Drug Information Association 107 Provide additional details of planned content 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)

Drug Information Association 108 Possible topics for collaboration with other Tracks Comparative Effectiveness Research with Track 13 Drug Information Association 109 Where are the gaps? If any?

Less number of abstract proposals submitted Less quality Created sessions to fill the gaps Drug Information Association 110 Potential speakers to invite Academic Susan Ellenberg (UPenn will contact) Temple U (will contact)

Industry Christy Chuang-Stein Matt Rotelli Alex Dmitrienko FDA Bob ONeill Bob Temple Sue Jane Wang Ram Tiwari Drug Information Association 111 Track Update

Track #: 16 Professional Development Track Learning Objective and Targeted Audience Foster collaborative innovation through professional development and education Drug Information Association 113 What is the focus and flow of this track for 2012? Professional Development! Industr

y-relate d Academ ia ! ! g n i n i a r T Drug Information Association 114

Provide additional details of planned content Drug Information Association 115 Possible topics for collaboration with other Tracks Drug Information Association 116 Where are the gaps? If any? Drug Information Association 117 Drug Information Association 118

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