The industry shaping agenda



Keynote: Reimagine the clinical trial: Your post-COVID-19 opportunity

00:00am - 00:00am (ZONE)

Panel: Embrace the stakeholder: why collaboration is the key to unlock clinical innovation

  • Discover how pre-competitive, interdisciplinary, and interdepartmental collaboration is re-shaping the way you can develop and operationalise clinical trials
  • From 5-year to 6-month planning - implement and scale innovations effectively through change management principles, overcoming increased visibility and timeline pressure
  • Reshape clinical trial design around patient needs with increased process flexibility and opportunity for patient led decision-making

00:00am - 00:00am (ZONE)

Case study: Calling all clinical innovators: your new marketplace for novel collaboration and partnership

  • Discover how Janssen’s new “Marketplace for Digital Measurements” is propelling start-up to industry partnerships
  • Why increased cross-industry collaboration is the key to unlocking the next stage of clinical capability and how Janssen’s marketplace is helping overcome challenges in approval, integration and implementation
  • How patients and doctors are already benefiting, key factors that have driven platform adoption, and how you can get involved

00:00am - 00:00am (ZONE)

Drive trial success through digital and cultural innovation

  • Understand how to assess and categorise your strategic agility
  • Day 1 > Stasis > Irrelevance and decline. Understand how to apply the “Day-1” innovation mentality in your organisation and ensure a responsive patient engagement programme. How to build a digital framework that can withstand fast-paced cultural change

00:00am - 00:00am (ZONE)

Case study: Drug discovery without borders: Uncover the world’s first global trial

  • How AstraZeneca drove patient diversity and improved outcomes by designing and operationalising the world’s first global clinical trial
  • Scale your own trial ambitions with new insight on how to overcome e-consent, regulatory pathway and cross-border data capture and storage challenges

Speakers include:

Lionel Bascles - Headshot
Sanofi - Logo

Lionel Bascles Global Head, Clinical Sciences & Operation Sanofi

Stephane Orssaud - Headshot
Ipsen - Logo

Stephane Orssaud Director, Biometry Innovation Ipsen


Kai Langel - Headshot
Janssen Clinical Innovation - Logo

Kai Langel Director, R&D Operations Innovation Janssen Clinical Innovation

Section 1: Transformational design: The next step in decentralised trials

00:00am - 00:00am (ZONE)

Panel: Trial decentralisation in practice

  • A practical guide to how data consensus, intelligent process design, and talent optimisation can be used in DCTs to drive operational efficiency, reduce trial costs and ensure successful and coherent external vendor strategies
  • Discover how integration with pre-existing health networks can streamline trial operations and increase flexibility
  • Identify the practical barriers to operational decentralisation and how technological solutions to e-consent, telemedicine, ECON and devices can be employed to mitigate these challenges

00:00am - 00:00am (ZONE)

Presentation: Grow your post COVID DCT capabilities through capacity building with key stakeholders

  • How to build and define remote data capture processes with local sites to ensure consistency in reporting
  • Align your stakeholders to scale study assessment capabilities and drive greater opportunities for decentralization

00:00am - 00:00am (ZONE)

Presentation: Navigate the complexities of direct to patient shipping

  • Understand challenges round storage and shipping to ensure drug quality
  • Build reporting networks that meet regulation requirements and ensure patient safety
  • Protect patient data safety with 3rd party partners including couriers

00:00am - 00:00am (ZONE)

Presentation: Partner with and train DCT sites to ensure consistent data quality

  • Understand the 5 core components of data quality: accuracy, relevancy, completeness, timeliness and consistency
  • Assess DCT site data profiling capabilities and ensure consistency in control of incoming data
  • Discover how to build cross-site data pipelines to avoid duplicate data

Speakers include:

Craig Lipset - Headshot

Craig Lipset Advisor and Founder Clinical Innovation Partners

Munther Baara - Headshot

Munther Baara VP Product Strategy and innovation EDTEK Inc.


Grace Cordovano, PhD, BCPA - Headshot

Grace Cordovano, PhD, BCPA Board-Certified Patient Advocate & Founder Enlightening Results

Section 2: Align on data to fuel your digital transformation

00:00am - 00:00am (ZONE)

Panel: Employ cross-platform data standardisation to drive novel endpoints

  • Understand the key pre-trial measures needed to enable interoperability between digital tools, sites and data capture measures
  • Utilise big data, AI and ML to prioritise data outputs, identify novel endpoints and build endpoint flexibility into trial design
  • Discover the tools and projects currently driving the future of agile, data driven trial design

00:00am - 00:00am (ZONE)

Presentation: How to align diverse data sources to drive trial diversity

  • Make your trials more accessible by using patient-generated health data to better identify target trial populations and facilitate participation from otherwise unrepresented patient populations
  • Understand the biases in patient-generated data and discover how to overcome difficulties in analysis and data storage

00:00am - 00:00am (ZONE)

Presentation: Widen participant pools with big data and advanced analytics in clinical trials

  • Understand how to assess, cleanse and harmonize your big data and analytics strategy
  • Investigate and select promising therapeutic targets by incorporating Natural Language Processing and other AI technologies to build a computer vision strategy

00:00am - 00:00am (ZONE)

Case study: Use RWE to streamline trial design

  • Discover an Amgen cancer therapy gained regulatory approval based on a single-armed Phase 2 study supported by EHRs
  • Understand how employing novel digital endpoints in your own trials can reduce time and cost requirements

Speakers include:

Irfan Khan - Headshot
Circuit Clinical - Logo

Irfan Khan CEO Circuit Clinical

Section 3: Patients as navigators: Ensure new clinical innovation is patient-preferred

00:00am - 00:00am (ZONE)

Presentation: Ensure patient centricity drives digital development

  • Achieve sustainable progress towards a more patient-centric reality as health care research becomes increasingly decentralized and digitized
  • Learn which steps you can take to center digital transformation on the patient experience and deliver meaningful value to the individual, their family, caregivers, and broader society

00:00am - 00:00am (ZONE)

Panel: Identify, recruit and retain diverse patient populations with a patient-driven digital transformation strategy

  • Discover how patient-centric priorities such as patient data return and early co-creation are driving innovation in DCT design
  • Connect the disconnected: Novel digital channels that drive novel patient group collaboration and raise awareness of trial opportunities in under-represented patient populations
  • Employ digital tools to train and implement best practices for diverse recruitment
  • Discover how to overcome patient digital fatigue and encourage trial retention

00:00am - 00:00am (ZONE)

Maintain trial populations: The blueprint for a patient-preferred user experience

  • Improve the patient experience by integrating learning and support on a single platform
  • Understand how to assess and implement an intelligent workflow programme to ensure patient receive the support they need, when they need it
  • Assess the value of an omnichannel platform and understand the key priorities for successful development

00:00am - 00:00am (ZONE)

Fireside Chat: Diversity

  • More information coming soon…

00:00am - 00:00am (ZONE)

Case Study: Employ TransCelerate’s Modernizing Clinical Trial Conduct Initiative to reduce conduct burdens

  • See the progress of clinical trial modernization since COVID-19, key remaining challenges, and how to drive sustainable change in the future
  • Learn how TransCelerate’s Modernizing Clinical Trial Conduct Initiative has led to improved patient centricity through reduced clinical trial conduct burdens

00:00am - 00:00am (ZONE)

Direct from the FDA: Guidance on diversity, implementation and RWD integration with extended Q&A

  • Sneak peak of detail from the new RCT Diversity Guidance releasing in 2021
  • Gain advice on implementation issues specific to the US, including alternative submissions
  • Discover the possibilities for RWD integration within existing models and discuss upcoming regulatory updates

Speakers include:

Jessica Federer - Headshot
Huma - Logo

Jessica Federer Managing Director Huma

Jen Horonjeff - Headshot

Jen Horonjeff Founder Savvy Cooperative


Anne Marie L. Inglis, PhD - Headshot
Mallinckrodt Pharmaceuticals - Logo

Anne Marie L. Inglis, PhD Senior Director, Clinical Operations Mallinckrodt Pharmaceuticals


Joy Bhosai - Headshot

Joy Bhosai Co-Director, Digital Health Solutions Duke Clinical Research Institute


Charlotte Burton - Headshot

Charlotte Burton Vice President Otsuka

Melissa Suprin - Headshot
Pfizer - Logo

Melissa Suprin Head of Quality Risk Management Pfizer


Dr. Amy Abernethy - Headshot
FDA - Logo

Dr. Amy Abernethy CIO FDA

Roundtables

00:00am - 00:00am (ZONE)

Day 1: Ensure intelligent process optimisation in trial design

00:00am - 00:00am (ZONE)

Day 1: Integrate with pre-existing community health networks for greater trial efficiency

00:00am - 00:00am (ZONE)

Day 1: Overcome barriers in home sampling

00:00am - 00:00am (ZONE)

Day 1: Build, assess and implement effective digital companion tools

00:00am - 00:00am (ZONE)

Day 1: Break down barriers to data standardisation and flow

00:00am - 00:00am (ZONE)

Day 2: Overcome digital fatigue in patient support

00:00am - 00:00am (ZONE)

Day 2: How to assess and choose digital tools

00:00am - 00:00am (ZONE)

Day 2: Build data transparency for patients in clinical trials

00:00am - 00:00am (ZONE)

Day 2: Underwrite patient safety in decentralised trials

00:00am - 00:00am (ZONE)

Day 2: Leverage and manage the online narrative before during and after a clinical trial

00:00am - 00:00am (ZONE)

Day 2: Work with patient groups to identify patient needs

Facilitators include:

Julia Walsh - Headshot

Julia Walsh CEO Brand Medicine International

Vicky DiBiaso - Headshot
Sanofi - Logo

Vicky DiBiaso Global Head Patient Informed Development & Health Value Translation Sanofi