track update track #: 1 clinical trials. track learning objectives: –identify current issues and...

Track Update

Track #: 1 Clinical Trials

• 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

• 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?


• 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


• 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


• Managing clinical studies during mergers and acquisitions

• Partnership (CRO/Sponsor) governance impact on study execution/project teams

Where are the gaps? If any?


• Study subjects • Patient advocacy group• Other industries

Potential speakers to invite


Track Update

Track 2: Project/Portfolio Management and Strategic Planning


• 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



• 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




• 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


• Pharmacogenomics and Companion Diagnostics

• Development in Asia, including leveraging CROs

• Execution of protocols



• 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



• 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


Track Update

Track 3: Innovative PartneringModels 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, 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.



• Focus– CRO / Sponsor collaboration – Other types of collaboration

• Flow – CRO Industry– Sponsor / CRO Collaborations – Other Collaborations– CRO Consortium



• 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



• Outsourcing of specific disciplines– Regulatory, statistics, etc.

• Quality and oversight of service providers– QA– Sent to SIAC

• IT systems for collaborations



• Full Development Partnering Models (including outsourcing and integration of nonclinical development, CMC, regulatory, clinical development, and commercialization)



• ACRO Executive Roundtable– Doug Peddicord (Executive Director)– CRO Executives– Rob Wright (Editor, Life Science Leader)


Track Update

Track #: 4 Nonclinical and Translational Development / Early Phase Clinical Development

• 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 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.



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


Current possible sessions and the primary topics to which they relate indicated by letter (see previous page):

1. Microdosing in translational medicine (E)2. Integrated Early Phase Decision-making (E)3. Drug QT Derisking (A) 4. First in Human Challenges of Biologics and Biosimilars (A, B, F)5. Clinical Renal Impairment Studies (A, E)6. Assessment of Carcinogenic Risk (A, D)7. Dried Blood Spot Technology (A, C, E)8. 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)

Provide additional details, page 2



• 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.]



• 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).



• 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)


Track Update

Track 5: Product Advertising and Marketing

Discuss the current regulatory landscape related to drug advertising and promotion.



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.



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.



• Joint compliance program with the medical communications track – looking at MSLs, publications, CME grants, investigator initiated trials, etc.



• Abstracts submitted did not include the requested topics for the track. We will be developing the four offerings for the track.



• Tom Abrams and Kate Gray from the Office of Prescription Drug Promotion, CDER



Track Update: Medical Writing and Medical Communications

Track #: 6

• 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)



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 showcaseTechnology (MC)Global practice & collab (MW)

MSL (MC)



Author # type Title level Co comments

Rebecca Noel

43582 Session Advancing benefit-risk 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 Perish-retracted scientific literature

Beg. please change to Int

Beardsworth

Need focus both MC + MW

Michael Brennan

43390 Workshop

Implementing SA: understanding the DITA model & its applicability for content & metadata management

Beginner J&J Need focus both MC + MW

Provide additional details of planned content: MC+MW



MSL Advanced 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/Promotion/Compliance

Natalie to find chair

4327944011

Symposium

Building Global Medical Communications capability

Beginner tbd Call center, med info, new service delivery models

Provide additional details of planned content: MC

www.diahome.org 41


PurcellMaxemowMcLean

424994330543009

Symposium

MW Competencies and best practice in the Global Env

Beginner UrtechINC ResMMS holdings

Ask Purcell to chair

Getz (chair)SwaminathanGawrylewski

430724380743994

Session or symposium

From Design to Disclosure pleasing multiple masters

Intermediate

TuftsGSKJ&J

Need to ensure focus on solutions, implementation

Van Etten 43217 Session Wrangling the bestiary of safety documents: coordination & integration across multiple requirements

Intermediate

Amgen He’s proposed Hecker (?) and Hoffman

Hecker 43506 Session Efficient Regulatory medical writing for global submissions including “ICH outlier” authorities

Advanced Hecker & assoc,

Request for FDA speaker Justina Molzon

Provide additional details of planned content: MW



MozzicatoGuldZink

428744315343379

symposium

Leveraging technology in safety writing and reporting

Beg MEDRA MSSOBMSSAS

Back up.Who to chair?

Sietsema 43050 Session Recent advances in adaptive clinical trial designs for medical writers

Intermediate

INC research

Need to make it relevant to writing. Speaker wants FDA speaker

Provide additional details of planned content: MW


• Explored adaptive clinical trials and leveraging social media and leveraging technology in safety reporting.

• All landed in track 6, no overlap with other tracks



• REMs, CER/EBM may be opportunity to get Medical Communications perspective

• PROs may be opportunity to get Medical writing perspective



• To invite Justina Molzon for 43506 (global subs)

• Invite FDA speaker for 43050 (adaptive trial)• Dr Chew FDA 43347 invite Gregory Busse



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 (MW) Mary or Janet

Building global capabilities (MW) Mary or Janet

Wrangling Safety Docs (MW) Mary or Janet

Design to Disclosure (MW)

Building global capabilities (MC) Natalie

Back up: leveraging technology in safety reporting (MW) Mary or Janet

SIAC showcaseTechnology (MC)Global practice & collab (MW)

MSL (MC) Natalie



Track Update

Track #: 7Processes and Technologiesfor Clinical Research

• 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



• 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



• 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

• 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…..



• Still need to address:– Automated understanding of data (statistics)– Sponsor perspective

• Still need to map abstracts to defined topics



• Todd Park - HHS



Track Update: Regulatory Affairs and Submissions

Track #: 8

• Discuss latest global regulatory trends and developments that impact the industry

• Target audience: regulatory affairs, regulatory policy, operations/e-submission specialists



• 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



• 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



• 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)



• 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 shortage – need to expand – possible forum?



• Combining speakers for consolidated topics



Track Update

Track # 9: Medical Diagnostics and Devices

Track Learning Objective: • Identify opportunities for drug companies to

address changing regulations in the area of medical devices, diagnostics, and drug/device combination products.



• 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



• Collaborating with Public Policy (Track 10) on “Litigation Management Strategies: The Role of “Human Factors” Experts in Medical Device Litigation”



• Heather Rosecrans and Daniel Schultz of Green Leaf Health llc



Track Update

Track 10: Public Policy, Healthcare Compliance and Regulatory Law

• 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



• 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



• 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



• 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



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?


Track Update

Track #: 11 Compliance to GCP, GLP and QA


• 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



• 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



• 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



• Additional topics submitted for consideration:– Clinical Operations– Outsourcing– Process and Technologies



• Quality metrics• Joint regulatory inspections• eSource and compliance implications



• TBD


Track Update

Track #: 12 Pharmaceutical Quality



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



• 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.



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)



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)



• 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



No gaps identified at this time.



• 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

Track Update

Track 13: HEO/CER/HTA

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



• 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



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



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



• 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



• No gaps identified



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



Track Update

Track 14: Clinical Safety & PVG

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.



• 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)



• 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)



• 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.)



• We don’t have any real gaps …• We got at least one abstract for each

solicited. topic!



• 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



Track Update

Track #: 15Statistical Science and Quantitative Thinking

• 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



• 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.



• 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)



• Comparative Effectiveness Research with Track 13



• Less number of abstract proposals submitted • Less quality• Created sessions to fill the gaps



• 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



Track Update

Track #: 16Professional Development



Foster collaborative innovation through

professional development and education



Professional Development!

Industry-related Academia!

Training!

track update track #: 1 clinical trials. track learning objectives: –identify current issues and...

Documents

clinical trial management

track update track

protocol design track

projectportfolio management

tmf track

strategic planning slide

investigator site management

quality risk management