Agenda

  • 8:00 am

  • Registration & Breakfast

  • 8:45 am

  • Conference Chair Opening Remarks

    Christopher Gallen, MD, PhD
    CEO, SK biopharmaceuticals

    Chris Gallen - Welcoming Attendees

    Chair, Dr Christopher Gallen welcoming attendees

  • 9:00 am

  • Global trends in generating clinical evidence for Regulatory approval and Market Access

    • Drivers for change in the way clinical evidence is generated
    • Trends in what regulators are looking for?
    • Trends in what the payers are looking for?
    • Interventional vs non interventional clinical studies
    • Consequences for the pharmaceutical and the CRO industry

    Thomas Lonngren, PhD (hc), MRPharmS, FRCP
    Former Head, EMA

  • 9:20 am

  • Global Regulatory Update

    • Overview on regulatory changes
    • Overcoming regulatory barriers when conducting trials in emerging markets
    • Remote-based monitoring considerations for small, medium and large companies and their affect on global approval
    • Progress for accelerated approval: Breakthrough Designation and Adaptive Licensing

    Moderator:
    Thomas Lonngren, PhD (hc), MRPharmS, FRCP
    Former Head, EMA

    Panelists:
    Debra Barker, MD
    Global Program Head, Oncology Biosimilars, Novartis

    Thomas Haag
    Data Integrity Process Expert, Novartis

    Jonathan Helfgott
    Associate Director for Risk Science (Acting), OSI, CDER, FDA

  • 10:00 am

  • Developing Global Protocols that are Easier to Execute for Patients and Sites

    • Strategies for upfront planning
    • Making protocols less complex and more patient-centric
    • Taking investigator and patient feedback and incorporating this in study design
    • Building quality by design into actual development of protocol and the process itself
    • Tapping into patient insights during the design process
    • Working with patient advocacy groups

    Moderator:
    Christopher Gallen, MD, PhD
    CEO, SK biopharmaceuticals

    Panelists:
    Lori Abrams
    Director, Patient Advocacy, Bristol-Myers Squibb

    Jill Collins
    Senior Director, Clinical Innovation, INC Research

    Daphne Psacharopoulos
    SVP, Client Services & Strategic Initiatives, PatientsLikeMe

    Kate Williams
    Senior Feasibility Strategist, Bayer Healthcare

  • 10:40 am

  • Adaptive Trials and its Uses Globally

    • Communicating the value proposition for adaptive trials
    • Understanding the use of adaptive trials in both exploratory and late phase development
    • Increased use of adaptive design software by regulatory agencies
    • Strategic partnerships to drive portfolio-wide adoption

    Phil Birch
    VP Innovation Strategy, Alliance Partnerships, ICON plc

  • 11:00 am

  • Morning Networking Break

  • 11:30 am

  • Optimizing Patient Enrollment in Global Clinical Trials

    • Overcoming enrollment issues due to changes in country requirements
    • How to create less burdensome global protocols with the patient in mind
    • How to decrease the cost of medicines and care
    • How to incorporate local assessments/reduce travel
    • Mobile technologies used in global enrollment procedures
    • The potential of registries to enhance recruitment

    Moderator:
    Christopher Gallen, MD, PhD
    CEO, SK biopharmaceuticals

    Panelists:
    Alice Donnelly
    Director, Recruitment Strategy & Operations, GR&A, Bristol-Myers Squibb

    Donna Jarlenski, PMP
    Senior Director, Clinical Development Execution & Global Medicines Development & Affairs, Vertex Pharmaceuticals

    Richard Margolin, MD
    VP, Clinical Development, CereSpire, Inc.

    John Reites
    Senior Director, Offer Development, Quintiles

  • 12:05 pm

  • Chiltern, FORUM and Millennium Share Best Practices to Ensure Optimal CRO/Sponsor Global Partnerships

    • What are the challenges of managing multi-national trials?
    • How do you empower CROs to take ownership of a trial?
    • What are the characteristics of the most successful CRO/Sponsor partnerships? What does success look like?

    Moderator:
    Christopher Gallen, MD, PhD
    CEO, SK biopharmaceuticals

    Panelists:
    Carol Lewis-Cullinan
    Senior Director, Clinical Operations, FORUM Pharmaceuticals

    Veronica Ludensky
    Senior Manager, Clinical Outsourcing, Millennium: the Takeda Oncology Company

    Susan Romberg
    VP, Global Clinical Development, NA, Chiltern

  • 12:35 pm

  • Luncheon

  • 1:45 pm

  • 5th Annual Country-Specific Roundtables

    In this very popular section of the conference, global clinical trial leaders with experience on the ground and expertise in different countries will address:

    • Regulatory environment
    • How to work globally with different regulatory agencies
    • Market access
    • Patient recruitment, enrollment and engagement
    • Site selection
    • Government protection of intellectual property
    • Cultural differences and idiosyncrasies
    • Key questions for CROs
    • What does it mean to “have a presence?”

    Attendees may choose one country-specific roundtable in this section. In addition to the discussion points outlined above, you are welcome to bring any additional issues or questions to the table.

    EU Latin America India Japan
    Eastern Europe Middle East/North Africa  Korea

    Roundtable leaders include:

    Debra Barker, MD
    Global Program Head, Oncology Biosimilars, Novartis

    Christopher Gallen, MD, PhD
    CEO, SK biopharmaceuticals

    Mitchell Katz, PhD
    Executive Director, Medical Research Operations, Purdue Pharma

    Simon Li, MD, PhD
    VP of Global Clinical Development, Luye America Pharmaceuticals

    Thomas Lonngren, PhD (hc), MRPharmS, FRCP
    Former Head, EMA

  • 2:20 pm

  • Rethinking How We Partner with Global Investigational Sites

    • How to best target new centers globally
    • Identifying investigator challenges in order to improve training standards
    • Advancements in technology for patients
    • Advancements in technology and training for global sites
    • Non-traditional ways of collecting data globally
    • The emergence of virtual clinical trials

    Moderator:
    Mitchell Katz, PhD
    Executive Director, Medical Research Operations, Purdue Pharma

    Panelists:
    Roberta Duncan
    Senior Director, Clinical Operations, Trevi Therapeutics

    Abraham Gutman
    President & CEO, AG Mednet

    Maria Im Hee Shin, MS, PhD
    Professor, Faculty of Medicine, Multi-Regional Clinical Trials Center at Harvard

    Christine Pierre
    President, Society for Clinical Research Sites (SCRS)

    Shoshana Weiler, MD, MPA
    Chairman, Auditing Board of Clinical Trials, Clalit Health Services

  • 3:00 pm

  • Remote-Based Monitoring Deployments in Global Clinical Trials: Case Study

    This presentation will describe an implementation of risk-based monitoring (RBM) aimed at improving data quality and patient safety, while significantly reducing development costs. The initial focus of cost reduction was to be achieved by reducing the number of on-site visits and implementing a risk-based approach to site management. The speaker will explain how this evolved into a centralized data monitoring solution that optimized resources, while maintaining and/or improving data quality, throughout the study.

    This was a truly collaborative approach, using the client’s systems with Quintiles data management staff driving much of the execution in collaboration with client study teams and global site monitoring providers. The scope included:

    • reducing source document verification (SDV)
    • increasing use of remote monitoring; reducing the number of onsite visits
    • enabling triggered monitoring
    • expanding to centralized medical and clinical data review

    Quintiles Infosario-based applications were used to monitor cleanliness status of the subject and also to perform medical review. Innovative tools were developed and deployed for data readiness, data visualization and project management.

    The outcome of the project has resulted in improved data with metrics far exceeding the targeted industry standard improvement goals. The client has continued to use this approach for more studies.

    Badhri Srinivasan
    SVP & Global Head, Data & Safety Monitoring, Quintiles

  • 3:30 pm

  • Company Spotlight Presentations: Innovative Technologies and Services that Drive Efficiencies in Global Clinical Trials

    • How to use technologies to better plan and design global clinical trials
    • How you can change your business model and manage clinical trials with “e-source”
    • The use of mobile technologies, i.e. remote ECGs and home monitoring
    • Quality data capture and management
    • The use of digital and social media technologies for patient recruitment and engagement

    Introduced by:
    Christopher Gallen, MD, PhD
    CEO, SK biopharmaceuticals

    Presenters:
    Garrett Smith
    Executive Director, Transperfect

    Dan McDonald
    Director of Business Development, DAC Patient Recruitment Services

  • 4:00 pm

  • Networking Break

  • 4:20 pm

  • Global R&D Guest Interview

    In this section of the program, we introduce the head of R&D of Luye America Pharmaceuticals who shares best practices and lessons learned in conducting trials in Asia.

    Simon Li, MD, PhD
    VP of Global Clinical Development, Luye America Pharmaceuticals, Ltd

    with

    Christopher Gallen, MD, PhD
    CEO, SK biopharmaceuticals

  • 5:00 pm

  • Conference Concludes