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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

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Track Update Track #: 1 Clinical Trials


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    1. Track UpdateTrack #: 1 Clinical Trials

    2. 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 www.diahome.org

    3. 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) www.diahome.org

    4. 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 www.diahome.org

    5. 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) www.diahome.org

    6. Where are the gaps? If any? • Managing clinical studies during mergers and acquisitions • Partnership (CRO/Sponsor) governance impact on study execution/project teams www.diahome.org

    7. Potential speakers to invite • Study subjects • Patient advocacy group • Other industries www.diahome.org

    8. Track UpdateTrack 2: Project/Portfolio Management and Strategic Planning

    9. 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 Track Learning Objective and Targeted Audience www.diahome.org

    10. 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 What is the focus and flow of this track for 2012? www.diahome.org

    11. Provide additional details of planned content • PM skills and techniques • Critical chain, Pharma PM competencies, risk mgmt • Protocol design topics • QbD in clinical dev’t, adaptive design, improving protocol design • Program-level strategic planning • Working with Asia, pharmacogenomics/ companion diagnostics in dev’t planning, case studies on planning/ execution of global programs, achieving alignment, keys from going from R to D • Portfolio Management topics • Tools, techniques, and approaches www.diahome.org

    12. Pharmacogenomics and Companion Diagnostics Development in Asia, including leveraging CROs Execution of protocols Possible topics for collaboration with other Tracks www.diahome.org

    13. 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 Where are the gaps? If any? www.diahome.org

    14. 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 Potential speakers to invite www.diahome.org

    15. Track UpdateTrack 3: Innovative PartneringModels and Outsourcing Strategies

    16. 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. Track Learning Objective and Target Audience www.diahome.org

    17. Focus CRO / Sponsor collaboration Other types of collaboration Flow CRO Industry Sponsor / CRO Collaborations Other Collaborations CRO Consortium What is the focus and flow of this track for 2012? www.diahome.org

    18. 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 Provide additional details of planned content www.diahome.org

    19. Outsourcing of specific disciplines Regulatory, statistics, etc. Quality and oversight of service providers QA Sent to SIAC IT systems for collaborations Possible topics for collaboration with other Tracks www.diahome.org

    20. Full Development Partnering Models (including outsourcing and integration of nonclinical development, CMC, regulatory, clinical development, and commercialization) Where are the gaps? If any? www.diahome.org

    21. ACRO Executive Roundtable Doug Peddicord (Executive Director) CRO Executives Rob Wright (Editor, Life Science Leader) Potential speakers to invite www.diahome.org

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

    23. 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 www.diahome.org

    24. 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. What is the focus and flow of this track for 2012? www.diahome.org

    25. 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 Provide additional details of planned content www.diahome.org

    26. Provide additional details, page 2 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) www.diahome.org

    27. 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.] Possible topics for collaboration with other Tracks www.diahome.org

    28. 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). Where are the gaps? If any? www.diahome.org

    29. 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) Potential speakers to invite www.diahome.org

    30. Track UpdateTrack 5: Product Advertising and Marketing

    31. Track Learning Objective and Targeted Audience Discuss the current regulatory landscape related to drug advertising and promotion. www.diahome.org

    32. 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. www.diahome.org

    33. 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. www.diahome.org

    34. 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. www.diahome.org

    35. 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. www.diahome.org

    36. Potential speakers to invite • Tom Abrams and Kate Gray from the Office of Prescription Drug Promotion, CDER www.diahome.org

    37. Track Update: Medical Writing and Medical CommunicationsTrack #: 6

    38. 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) www.diahome.org

    39. What is the focus and flow of this track for 2012? www.diahome.org

    40. Provide additional details of planned content: MC+MW www.diahome.org

    41. Provide additional details of planned content: MC www.diahome.org

    42. Provide additional details of planned content: MW www.diahome.org

    43. Provide additional details of planned content: MW www.diahome.org

    44. 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 www.diahome.org

    45. 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 www.diahome.org

    46. 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 www.diahome.org

    47. What is the focus and flow of this track for 2012? www.diahome.org

    48. Track UpdateTrack #: 7Processes and Technologiesfor Clinical Research

    49. 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 www.diahome.org

    50. 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 www.diahome.org