The industry shaping agenda

For most up to date live agenda please check Swapcard platform


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

9:00am – 10:00am (ET)

Embrace the stakeholder: why collaboration is the key for clinical innovation

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

Lionel Bascles Global Head, Clinical Sciences & Operation Sanofi

Rachel Edwards Exec Director Global Development Operations Amgen

Mo Ali VP Digital Analytics and Performance GSK

Kendal Whitlock Metasite Strategic Engagement Lead Boehringer Ingelheim

Moderator:: Marie Lamont President and Chief Operating Officer Inteliquet

10:00am – 10:15am (ET)

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

  • Learn about DEEP – Digital Endpoints Ecosystem and Protocols framework initiated by Janssen Clinical Innovation
  • Discover how the new DEEP “Marketplace for Digital Measurements” is propelling start-up to industry tech, services and industry partnerships
  • Why increased cross-industry collaboration is the key to unlocking the next stage of clinical smart measurement capability and how DEEP Janssen’s marketplace is helping overcome the many challenges with digital measurements in approval, integration and implementation
  • What does it mean to doctors and patients and how you can get involved

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

10:15am – 10:30am (ET)

In partnership with:
Science 37

Enable patient-centric clinical research with The Decentralized Clinical Trial Operating System: A requisite, technology-first system.

  • Ease the burden on investigators and patients by integrating DCT components at trial onset
  • Discover a network-based clinical research ecosystem that empowers increased utilization of decentralized clinical trial tools and methods
  • Understand how to build an Operating System agile enough to integrate into traditional, site-based studies, and scalable enough to empower clinical trials entirely virtually—unbound by geographic limitations.

David Coman Chief Executive Officer Science 37

10:30am – 10:45am (ET)

Fireside chat: The Digital Responsibility

  • Discover the impact of out-of-industry approaches to digital innovation on the future of pharma’s innovation, access, and business strategy
  • Explore multi-stakeholder indicators of a successful digital integration in the biopharma enterprise.
  • Define the responsibility of the industry for setting and achieving standards for digital leadership, access and innovation.

Cindy Hoots Chief Digital Officer & CIO AstraZeneca

Jessica Federer Managing Director Huma

10:45am – 11:00am (ET)

Live Q&A

11:00am – 11:10am (ET)

BREAK (10 Minutes)

Transformational design: The next step in decentralised trials

11:10am – 12:00pm (ET)

In partnership with:
PRA Life Sciences

Trial decentralisation in practice

  • A practical guide to how data consensus, intelligent process design, and talent optimisation can be used 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

Craig Lipset Advisor and Founder Clinical Innovation Partners

Munther Baara VP Product Strategy and innovation EDETEK

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

Sam Hariry Global Head, Clinical Innovation Novartis

Moderator: Kent Thoelke EVP & Chief Scientific Officer PRA Health Sciences

12:00pm – 12:15pm (ET)

Grow your post COVID DCT capabilities

  • 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.

Rachel Soon Innovation Project Manager Novartis

12:15pm – 12:30pm (ET)

In partnership with:
Obvio Health

Bringing clinical trials home: How virtual research can reduce patient burden & improve outcomes

  • Discover the RedHill BioPharma interventional trial to evaluate the safety/efficacy of an oral investigational drug for the treatment of COVID-19
  • See how to effectively recruit patients rapidly and early in the course of their illness and enable to participate from home
  • Learn how virtual teams and user-friendly technology can work seamlessly to remotely capture vitals and monitor adverse events

Dr. Terry Plasse Medical Director RedHill Biopharma

Matty Culbreth-Notaro SVP Global Operations ObvioHealth

12:30pm – 12:45pm (ET)

From patient visits to patient study tasks

  • Understand the benefit of remote asynchronous visits for the HCP and patient
  • Understand the benefit of remote asynchronous visits for the HCP and patient
  • Discover the impact of remote patient study tasks substituting in-clinic visits on patient retention and study drop-out rates
  • Learn how to involve patients in protocol writing and the effect this has on study design

John Zibert CEO Studies and me

12:45pm – 1:00pm (ET)

Live Q&A

Transformational design: The next step in decentralised trials

9:00am – 9:15am (ET)

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

Catharina Östberg Head Clinical Operations Sweden GSK

9:15am – 9:30am (ET)

In partnership with:
THREAD

Best Practices to Scale Your Global Hybrid Decentralized Studies

  • Learn how to identify and plan the initial studies for DCT approaches to scale
  • Understand how to evaluate country-specific regulatory requirements and feature specific limitations
  • Assess DCT providers for optimal capabilities related to integrations, technical helpdesk, device provisioning and multi-lingual support availability

John Reites CEO THREAD

9:30am – 9:45am (ET)

New Strategies to Balance Protocol Complexity, Customization and Executional Feasibility

  • Understand the developments in protocol design practices across 2020 and the pandemic
  • Assess the impact of decentralization and other approaches on clinical trial performance and efficiency
  • Discuss solutions and strategies to optimize protocol designs including patient advisory board input and organization-wide data governance and coordination mechanisms

Ken Getz Director and Professor Tufts University School of Medicine

9:45am – 10:00am (ET)

Live Q&A

Data: Fuelling the future of clinical’s digital transformation

10:00am – 10:15am (ET)

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

Irfan Khan CEO Circuit Clinical

10:15am – 10:30am (ET)

In partnership with:
MEDIDATA

14. Longitudinal Patient Insights - Linking Clinical Trial and Real World Data to Create an End-to-End Patient Record

  • Understand how to break down data silos across clinical trial and real world data to ensure greater understanding of drug efficacy and post-launch patient outcomes.
  • Employ proper patient consent, data linking, tokenization and patient identification technologies to fix the broken feedback loop and enable a wide variety of use cases, including patient safety monitoring, trial design and long-term therapeutic efficacy beyond the duration of clinical trials
  • Discover the rewards and risks associated with data linkage that facilitates merging information from clinical trial and real world data

Arnaub Chatterjee Senior Vice President - Product, Acorn AI Medidata, a Dassault Systèmes company

10:30am – 10:45am (ET)

Advanced Analytical Approaches to Enrollment Forecasting and Screening Impacts during the Pandemic

  • Discover a modern stacked approach to enrollment forecasting that leverages historical data as well as within-time-series predictive modeling
  • Understand the Impacts of the pandemic on enrollment and screening across Therapy Area and region
  • Discuss future applications for these capabilities across other clinical operations use cases"

Rohit Nambisan President Lokavant

10:45am – 11:00am (ET)

Live Q&A

11:00am – 11:10am (ET)

Break (10 Minutes)

11:10am – 12:00pm (ET)

In partnership with:
Halloran Consulting

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

John Zibert CEO Studies and me

Ralph A. DeMasi, Ph.D. VP, Head of Biostatistics and Data Management ViiV Healthcare

Haider Alleg Global Head Of Digital Excellence Ferring

Mimi Huizinga VP and Head, US Oncology Medical Novartis

Chair: Todd Johnson, MPH, MBA Principal Consultant, Organizational Solutions Halloran Consulting

12:00pm – 12:15pm (ET)

Direct from the FDA: guidance on diversity, implementation and RWD integration

  • Discover details on the new Diversity Guidance, releasing 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 updates

Dr. Amy Abernethy CIO FDA

12:15pm – 12:30pm (ET)

Extended FDA Q&A

Dr. Amy Abernethy CIO FDA

Patients as navigators: Driving clinical innovation towards a patient-preferred destination

9:00am – 10:00am (ET)

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

Jen Horonjeff Founder Savvy Cooperative

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

Satasuk "Joy" Bhosai, MD MPH Founder Pluto Health Entrepreneur-in-Residence Duke

Charlotte Jones-Burton, MD, MS VP of Clinical Development, Nephrology Otsuka Pharmaceutical

Rosamund Round Vice President, Patient Innovation Center Parexel

10:00am – 10:15am (ET)

Fireside Chat: A Call for the Democratization of Clinical Trials

  • Discover how diversity is coming to prominence in the age of the democratization of clinical trials
  • Learn how technology is transforming the future of clinical trials and facilitating patient support programs for commercially approved products
  • Understand how Otsuka are forming clinical trial strategy based on recent industry guidelines

Charlotte Jones-Burton, MD, MS VP of Clinical Development, Nephrology Otsuka Pharmaceutical

10:15am – 10:30am (ET)

Putting patients first in COVID-19 research: Improving the experience and health outcomes for study participants

  • Treatments: Discover strategies to identify, enroll and equip COVID-19 positive (+) patients to participate remotely from their home, including novel approaches to reach patients with critical supplies and IMP
  • Vaccines: Learn how to reduce on-site visits for COVID-19 negative (-) patients through the utilization of mobile sites to protect vulnerable patient populations from potential exposure
  • Long COVID: Understand which post-pandemic research modalities should be considered as new variants emerge and long-term follow-up is needed for patients working towards recovery

Niklas Morton Senior Vice President, PPD® Digital PPD

10:30am – 10:45am (ET)

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

Melissa Suprin Head of Quality Risk Management Pfizer

10:45am – 11:00am (ET)

Live Q&A

11:00am – 11:15am (ET)

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

Jessica Federer Managing Director Huma

11:15am – 11:30am (ET)

Generate new insights with digital health platforms to put patients at the center and drive clinical innovation

  • Learn how a connected ecosystem model across the clinical development and pharmaceutical product lifecycle can drive efficiency and ensure a patient centric strategy across the clinical and commercial continuum
  • Learn how to utilize an interoperable end to end digital health platform that utilizes real time patient data in clinical trial design and improves outcomes
  • How to create an intuitive user experience within virtual trials including applying AI and ML

Amy Apostoleris, MAT, MBA Global Head, Digital Clinical Trials Solutions Medocity Inc

11:30am – 11:45am (ET)

Fireside chat International Vaccines and the USA

  • HOLD

Jessica Federer Managing Director Huma

Céline Gounder Infectious Disease Specialist, Former member Biden-Harris Transition COVID Advisory Board and CEO Just Human Productions

11:45am – 12:00pm (ET)

Sanofi case study: Building digital clinical assessments to measure what matters most

  • How Sanofi’s ground-breaking Parkinson’s digital biomarker programme incorporated patient and clinician perspectives, in detail and at scale
  • Discover how to engage regulators early, often, and globally when building a ‘minimum viable product’
  • Put patient centricity hypotheses to the test in the lab and at home

Andrew Pearlmutter Digital Innovation Leader – Sanofi North American Digital Innovation Hub Sanofi

12:00pm – 12:30pm (ET)

Live Q&A

Roundtables

Roundtable · Date & Time (TBC)

Digital Resilience: How can we keep our clinical data safe?

  • Understand the challenges, ideas and practical solutions for protecting your clients, patients and business strategy amidst the escalating cyber threat landscape.
  • Develop a data and technology strategy to maximize business the opportunities presented by accelerated digitalisation and online collaboration.
  • Questions you should be asking the business - so that you can collectively protect your crown jewels from threat actors.

Robert Hannigan Chairman BlueVoyant International

Dr. Amy Williams Director of Proactive Services BlueVoyant

Roundtable · Date & Time (TBC)

Patient Activation and Behavioural Science to raise Patient Engagement in Clinical Trials

  • How to combine patient insights and behavioral sciences with data and analytics, to personalize the connection with patients in clinical trials.
  • How can behavioral science be implemented across the clinical trial lifecycle.
  • How to apply patient activation in clinical trials and predict patient’s willingness to participate.

Ying Jiang SVP of Customer Engagement Hū Clinical Solutions

Roundtable · Date & Time (TBC)

Break down barriers to data standardisation and flow

Stephanie Lee Chief Business Officer Lokavant.

Roundtable · Date & Time (TBC)

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

Julia Walsh CEO Brand Medicine International

Roundtable · Date & Time (TBC)

Work with patient groups to identify patient needs

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

Roundtable · Date & Time (TBC)

Implement patient experience in post-pandemic early phase R&D

  • Identify your primary objectives of implementing PE experience in post-pandemic early phase R&D
  • Build partnerships by selecting the most appropriate approaches to engaging with your patients during early phase R&D
  • Develop condition profiles using PE experience in early phase R&D
  • Introduce PE experience to R&D design of methodology & TVP/TPP in early phase R&D

Carole Scrafton Patient Advocate Fibroflutters

Dr. Oleksandr Gorbenko, MD, PhD, BCMAS Global Patient Centricity Director Ipsen

Roundtable · Date & Time (TBC)

Role of Decentralized Clinical Trials and Clinical Research as a Care Option to Modernize Trial Design and Enhance Patient Experience

  • Discuss the multiple strategic and operational dimensions involved in Decentralized Clinical Trials (DCTs)
  • Understand the concept and principles of Clinical Research as a Care Option (CRAACO)
  • Explore synergies that exist between Decentralized Clinical Trials (DCTs) and CRAACO
  • Adopt and adapt fit-for-purpose technology for DCTs applying CRAACO
  • Appraise enhancing patient experience and including diversity in DCTs applying CRAACO compared to traditional trials

Isaac Rodriguez-Chavez SVP Scientific and Clinical Affairs, Global Center of Excellence for DCTs PRA Health Sciences

Louisa Roberts VP Corporate Development and Partnerships PRA Health Sciences

Workshops

Workshop · Thursday 8th April · 10:00am (GMT)

Welcome to the content cloud: One secure platform for Clinical collaboration and remote site monitoring

Due to Covid-19, life sciences organisations are pressured to accelerate collaboration across their clinical researchers, clinicians, sponsors, and external alliances like CROs and Labs. Traditional in-person clinical site workflows, like document verifications or clinical site monitoring digital are challenged without an easy way to share and collaborate on clinical site documents, analyse it, and then drive it through the value chain quickly.

Join Manu Vohra, Managing Director, Life Sciences, Katherine Davidson, Large Enterprise Account Executive, Marco Rohr, Large Enterprise Account Executive, Jan Husemeier, Large Enterprise Account Executive, Box to discuss:

  • Why in-person or paper-based clinical workflows like, reporting, auditing, monitoring or verification are no longer viable
  • Clinical data is stuck in silos because CROs, Hospitals, and Clinics have many different technologies in place
  • Getting clinicians trained on multiple systems in order to access trial info is time consuming and slows down clinical operations
  • Purpose built solutions are incredibly costly and do not allow custom integrations
  • Lack of control and visibility into how data is being shared creates data leak risk
  • Compliance violations are costly and can hurt brand reputation especially when patient data (PII) is concerned

Accelerate clinical R&D processes across the value chain, maintain GxP compliance and reduce your overall IT footprint. Designed with content at the center, Box is the content cloud: one secure platform for managing your clinical and patient records in the cloud.

Workshop · Tuesday 13th April · 9:00am (ET) / 2:00pm (GMT)

Protecting the crown jewels from cyber threats.

Discuss the challenges, ideas and practical solutions for protecting the Life Sciences sector amidst the escalating cyber threat landscape. 

They will kick off the discussion and share their experiences and perspectives on keeping data safe.

Join Abel Archundia, MD Life Sciences, Istari, & Advisor to BlueVoyant, formerly the Global Pharma CIO and Digital Transformation at Bayer, Robert Hannigan CMG a cybersecurity specialist and International Chairman, BlueVoyant and Dr. Amy Williams, Director of Proactive Services, BlueVoyant as they explore the following questions:

  • Developing a data and technology strategy to maximize business the opportunities presented by accelerated digitalisation and online collaboration.
  • Third-party and supply chain cyber risk has the attention of the Board - the inherent risks that COVID-19 presented has accelerated this visibility. What are the lessons learnt from other industry sectors? 
  • Questions you should be asking the business - so that you can collectively protect your crown jewels from threat actors.
  • Board members are now paying attention, and want to know what their teams are doing about it, now. What can be done to answer this?

Workshop · Tuesday 13th April 11:00am (ET) / 4:00pm (GMT)

Wearables and Remote Monitoring in Clinical Trials: Patient and Human Factors

With hybrid and decentralized clinical trials becoming the new normal, the use of sensor-based wearables, monitoring devices and clinical trial apps intended to regularly collect PRO and experience data are critically important to the success of the trial.  Choosing, testing, modifying, and then validating devices and solutions for trials can be complex, yet it needs to be done quickly and effectively. The answers and validation are often, "outside the building" with the patients, caregivers, and investigators who will use these devices and tools. This will be a highly engaging conversation about the real-world concerns and factors about preparing for success. 

Join Todd Greenwood PH.D, Director of Client Solutions, Medullan, Vasundhara Sridharan, Principle user experience researcher, Medullan and Adriano Garcez, Director, Digital Health Strategy & Implementation, Medullan as they discuss:

  • Standardize and accelerate the process of choosing clinical trial devices
  • Ensure that devices provide endpoints that are both fit-for-purpose and exploratory
  • Improve the consistency of wearables and devices used across the clinical research program
  • Develop repeatable processes for future device selection

Workshop · Thursday 15th April 11:00am (ET) / 4:00pm (GMT)

Crisis as a Catalyst: Clinical Trial Decentralization Perspectives on Patient, Clinical Sites and Sponsors

Join Matthew McCarty, Integrated Customer Solutions, ERT, Elisa Cascade, EVP, eCOA, ERT and Matt Johnson, Vice President, Wearables & Digital Biomarkers, ERT as they discuss the key learning objectives:

  • Understand current environment and implications of moving towards a decentralized trial framework
  • Understand the difference in Stakeholder perspective and addressing practical needs across the start-up, conduct, and close-out phases of trial operations
  • Understand the opportunity for trial enhancement by leveraging connected devices and digital endpoints capture into trials
  •  Understand considerations for data capture, analysis and clinical workflow in a decentralized model, including trial oversight implications