FIERCEBIOTECH PRESENTS:

Virtual Series: Clinical Trials

JUNE 22–24, 2020 | FREE VIRTUAL EVENT

 

Register Today Group

FierceBiotech’s upcoming series will cover technology’s role in clinical trials. Panel discussions include: the use of sensors, wearables and other remote monitoring devices for tracking patient statistics, real-world data and patient-centric technology, and the role manufacturing plays in clinical trials.   

June 22

MONDAY, JUNE 22

 

11:00AM ET

The Future of Clinical Trials: Reimagine the Way Technology and Data Support Clinical Research

 

1:00PM ET

Necessity and Invention: Accelerating Innovations in Clinical Trials

 

3:00PM ET

Up to the Challenge: Manufacturing’s Central Role in the Cell- and Gene-Therapy Revolution

June 23

TUESDAY, JUNE 23

 

11:00AM ET

eISF Remote Monitoring and Site Access Strategies

 

1:00PM ET

Real-World Evidence: Another "Gold Standard" for Drugmakers?

 

3:00PM ET

Let the Right Ones in: Using AI to Break the Trial Enrollment Bottleneck

June 24

WEDNESDAY, JUNE 24

 

11:00AM ET

Minimize the Impact of Trial Disruptions with RWD Driven Digital Recruitment and Operational Scenario Simulations

 

1:00PM ET

The Complete Patient’s Journey and the Impact of Virtualization Technologies

 

Register for this free event Group

AGENDA
MONDAY, JUNE 22

11:00AM ET
The Future of Clinical Trials: Reimagine the Way Technology and Data Support Clinical Research

oracle

Sponsored by:

Oracle Health Sciences

AGENDA
MONDAY, JUNE 22

1:00PM ET
Necessity and Invention: Accelerating Innovations in Clinical Trials
The COVID-19 outbreak sent pharmaceutical companies scrambling to find new ways to monitor patients in clinical trials. Above all, the pandemic required drug developers to increase their use of telehealth technologies, so patients could update clinical trial investigators on their symptoms without having to risk traveling to a medical facility.

This willingness among drug companies and contract research organizations to embrace new methods of running clinical trials during the pandemic could actually benefit the industry over the long run. Companies can improve the efficiency of their clinical trials by implementing not just remote patient monitoring, but a host of other emerging technologies like wearables and electronic patient diaries.

This Fierce webinar will bring together executives with expertise in clinical trial design, telehealth technologies and regulatory affairs to discuss strategies for incorporating technology innovations into clinical trials. It will include representatives from pharma companies who implemented some of these tools into their clinical trials during the COVID-19 lockdowns and can pass along advice about what does and does not work.

Arlene

MODERATOR
Arlene Weintraub
Editor
FierceBiotech Research

Kowalski

Rob Kowalski
Executive Vice President, Global Head of Regulatory Affairs and US Head of Development
Novartis

AGENDA
MONDAY, JUNE 22

3:00PM ET
Up to the Challenge: Manufacturing’s Central Role in the Cell- and Gene-Therapy Revolution
Pharma took a huge leap from small-molecule drugs to biologics, and now it’s taking another one as the industry beefs up in cell and gene therapies. Some 800 such therapies are moving through the biopharma pipeline, and former FDA commissioner Scott Gottlieb expects 10 to 20 to be approved annually by 2025.

Drugmakers, CDMOs, and even hospitals are investing big money in production capacity and the complicated supply-chain infrastructure necessary to make all that happen. The upfront investment is daunting, and the complexity of the production processes themselves are unmatched in the rest of the pharma world.

In this session, our experts will describe the state of play in cell and gene therapy manufacturing today, and outline the growth and changes necessary to keep up with demand as the next-generation therapies make their way through pipelines, past regulators and to patients themselves.

Vancott

Opening Remarks
Thomas VanCott, PhD
Chief Technology & Strategy Officer
Catalent Cell & Gene Therapy

Kyle

MODERATOR
Kyle Blankenship
Editor
FiercePharma

Steffan

Steffen Lang
Global Head - Technical Operations
Novartis

Holles

Natalie Holles
President and Chief Executive Officer
Audentes, an Astellas Company

Sponsored by:

Catalent

AGENDA
TUESDAY, JUNE 23

11:00AM ET
eISF Remote Monitoring and Site Access Strategies
COVID-19 drives clinical operations leaders to evaluate their remote site access capabilities for start-up, monitoring, and SDV. The implications of this assessment extend well beyond 2020, however— this is the start of a fundamental transformation to remote work for research operations. In this session learn how leading sponsors and CROs are actively future-proofing business continuity by harnessing existing site infrastructure—and securing site access fast as a result.

You’ll hear how sponsors and CROs are using eISF (electronic Investigator Site Files) to avoid compliance mistakes, ensure site adoption, and create site access when remote work is required.. In addition, you’ll understand the business implications of remote monitoring by exploring new monitoring models that work for sites and sponsors.

Tips and strategies will be shared from real-world case studies powered by Florence, the largest site and sponsor connectivity platform in the world active at over 7,200 study sites across 27 countries.

Florence

Sponsored by:

Florence Healthcare

AGENDA
TUESDAY, JUNE 23

1:00PM ET
Real-World Evidence: Another "Gold Standard" for Drugmakers?
In their hunt for new approvals, biopharma companies spend billions of dollars every year on clinical trials. In recent years, though, real-world studies as sources of practice-informing data––and even as the basis for new indications––have multiplied. but clinical trials remain the gold standard.

In a post-pandemic future, will clinical trials ever look the same again? Could real-world data help fill in the gaps? In this session, we will discuss the role real-world evidence now plays in informing clinical guidelines and securing new indications for approved medicines. We will also consider the novel coronavirus’ effect on the traditional clinical trial model and how real-world evidence could evolve as an important tool for drugmakers and regulators as research adapts to a new reality.

Kyle

MODERATOR
Kyle Blankenship
Editor
FiercePharma

AGENDA
TUESDAY, JUNE 23

3:00PM ET
Let the Right Ones in: Using AI to Break the Trial Enrollment Bottleneck
Recruiting participants for clinical studies has always been one of the most arduous tasks in biomedical research, with a host of delays and expenses—and sometimes trial failures—stemming from this particular bottleneck. Reaching the right people is paramount, and many have tried to use real-world data to tailor outreach such as physician referrals and media advertisements.

Now, artificial intelligence is just beginning to make good on its long-promised abilities to advance nearly every aspect of science and drug development, including trial recruitment. This can include sifting through electronic health records for eligible patients and matching them directly with open studies, or expanding access to care by casting a wider net to underserved populations.

But more than a few obstacles remain. Privacy policies must be maintained, adoption can be slow and fragmented, and not all AI tools are created equal. In this session, we’ll tackle the key challenges ahead for using AI to recruit patients—and keep them engaged once they’ve enrolled.

Conor

MODERATOR
Conor Hale
Editor
FierceBiotech

Ritesh

Ritesh Patel
Chief Digital Officer
Ogilvy Health

AGENDA
WEDNESDAY, JUNE 24

11:00AM ET
Minimize the Impact of Trial Disruptions with RWD Driven Digital Recruitment and Operational Scenario Simulations
With the COVID-19 pandemic, many ongoing clinical trials have been delayed for a number of reasons: redistribution of health care resources, travel restrictions and stay-at-home directives. These disruptions delay time to market and delivery of drugs and vaccines to the patients that need them. To minimize these effects, advanced data science techniques, real-world data (RWD) and technology, coupled with a personalized service to match and engage patients in clinical trials, can deliver predictable, value-based outcomes for patients, investigators and sponsors. The quality of study data, to ensure regulatory validity, can be considerably enhanced via cloud-based technology platforms that digitizes the entire study flow, streamlining patient recruitment and supporting overall patient retention and compliance. Furthermore, computer based modeling and clinical trial simulation in the study planning stage and during implementation can identify uncertainties and enable timely mitigating actions to deliver a study within agreed timelines and cost.

trialbee

Sponsored by:

trialbee

AGENDA
WEDNESDAY, JUNE 24

1:00PM ET
The Complete Patient’s Journey and the Impact of Virtualization Technologies

medidata

Sponsored by:

medidata

SPONSORS