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From trial design for patients to trial design with patients: a key topic at DIA ’22

At the 2022 Drug Information Association (DIA) annual meeting last week, it was inspiring to connect with fellow
The post From trial design for patients…

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At the 2022 Drug Information Association (DIA) annual meeting last week, it was inspiring to connect with fellow research and development (R&D) stakeholders, regulators, health and digital data partners and more to navigate challenges in drug development that impact patients globally. As an industry, we recognise patients as partners in the development process, but if we aim to enhance the patient experience in clinical trials and ultimately, improve patients’ lives, we need to continue to consider how we keep the patient front and centre in drug development. This discussion was top of mind at DIA, especially as we looked ahead to patient-centred drug development in a post-pandemic era. In fact, DIA 2022 was officially designated as a “Patients Included” conference, emphasizing its commitment to inclusivity and integrating patients into discussions as experts in their conditions and experiences.

Tearing down information silos and talking through concrete ideas to help shift from drug development for patients to drug development with patients, I shared several actionable steps with DIA attendees.

Patient journey

Patients are at the heart of drug development, so this is where planning is key. Considering the patients’ voice, preferences, burdens/barriers, social determinants, etc., and fully engaging and informing them before, during, and after trials is critical to successful patient-centric trials. Gaining insights from patient and caregiver surveys, patient advocacy groups and others can help us secure perspectives. Active social listening, using the breadth of real-world data insights available to us, including patient journey by country, helps us better understand disease landscapes and patient behaviours and expectations to inform engagement strategies. Importantly, patients are taking a front row seat in their clinical care decision making and demanding (rightfully) more personalized medicine. We must meet patients where they are and ensure implementation of agile trial methodologies.

Patient centricity also means designing protocols that recruit and retain the right patients for individual trials. This means designing or evaluating protocols for elements that impact enrolment, including reducing patient burden, patient-site friction, and competitive trials.

Patient access

When designing trials, sponsors, and clinical research organization (CRO) partners need to focus on increasing diversity in trials. Our industry has a long-standing commitment to expanding trial access and participation, especially among traditionally underrepresented populations. However, with COVID-19 re-emphasizing gaps in trial diversity and inclusion, there is a renewed focus on doing more, especially as we can leverage deep expertise and transformative technologies to knock down long-standing barriers.

To increase patient engagement, we should consider:

  • Culture and trust: We need to secure an understanding of what individual patient populations need to participate and stay engaged. Local community partnerships and real-world insights can help.
  • Site selection: Factoring in diversity when determining target sites helps strengthen awareness and engagement among key patient populations. Using machine learning, we can extract trial protocol details, site features, previous performance, claims data and patient demographics at trial sites to produce a ranked list of ideal trial sites that serve diverse patients. Sponsors and CROs can also support and upskill research-naïve sites where target patient populations receive care and train minority physicians to participate in research too.
  • Socioeconomic variables: Transportation, general trial awareness, health literacy levels, preferred language, access to healthcare and more is important to gauge per population.
  • Site and patient needs: Keeping individual needs in mind throughout the entire trial process can help sites meet their goals. Direct-to-patient advertising, referral networks and validated recruitment strategies help with engagement. After trials, culturally-informed communications and understanding burdens and barriers can ensure participants maintain a thoughtful connection to the trial.

Delivery models

It’s vital we know what’s necessary to interest patients and sites in trial participation. At DIA, we presented findings from a 2021 global survey of patients and study investigators conducted by IQVIA, which showed that both groups are interested in decentralized trials (DCTs). Approximately 95% of surveyed investigators indicated interest in hybrid DCTs, trials enabling participants to perform some tasks away from trial sites. Most patients appreciated the flexibility offered by DCT options like telehealth and in-home care. More than 80% of patients were comfortable using apps to report symptoms and other relevant information.

Engagement, retention, and follow-up

Creating a consistent experience throughout the trial partnership helps personalize engagement for participants. Sponsors and study teams can initiate engagement by using an analytics-driven strategy to target and create awareness among the right patients. Hyper-customized communications through social media, pharmacies, and more can increase the likelihood that patients will respond.

Upon enrolment, intuitive online patient portal solutions give patients access to their full trial journey and data, heightening collaboration as patients are provided information on trial updates, visit reminders, their disease, and more. Sponsors can also offer concierge services to guide patients through the trial process, providing a human touch to further personalise their experience and reduce burdens, including helping them navigate DCT platforms, coordinating provider visits and encouraging them to share input.

As patients want to be informed about trial outcomes and post-trial activities, maintaining a patient relationship during and after their trial journey is key for continued engagement. This connected approach empowers patients, keeping communication front and centre.

What the future holds

Looking at the future of patient centricity from an operational perspective, there are three core elements to consider:

  • Trial design that incorporates patient feedback and removes burdens.
  • Consistent and ongoing engagement with patients that emphasises the value of trial participation, allows them access to their health data and trial results, and highlights their contributions to future drug development.
  • Various uses of interoperable technology that connect patients to clinical care and offers other DCT solutions.

As we continue to work to integrate DCT and other solutions and better connect with sites and communities to engage patients, we left DIA thinking about how to broaden our patient centricity focus. For example, how can we integrate caregiver perspectives more meaningfully, and how can we strengthen collaborations across the global healthcare ecosystem to improve patient outcomes?

Equipped with the expertise, innovative solutions and collaborative spirit, our industry has never been better positioned to empower the patient, elevate their experience and personalise healthcare to drive better outcomes for all. We can’t wait to share additional learnings with colleagues and patients at DIA 2023.

About the Author

Dr. Cynthia Verst is president, Design and Delivery Innovation, Research & Development Solutions at IQVIA and chair-elect of the DIA Board of Directors.

In this role, Dr. Verst is responsible for driving innovation and transformation throughout the trial lifecycle. Having previously served as president of both clinical operations and real world and late phase research for IQVIA, Dr. Verst brings a holistic and comprehensive view of clinical research and champions the advanced use of real-world data, analytics, and technology to advance therapies for patients.

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Moderna To Commence Construction Of World’s First mRNA Factory On Australian College Campus

Moderna To Commence Construction Of World’s First mRNA Factory On Australian College Campus

Authored by Jessie Zhang via The Epoch Times…

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Moderna To Commence Construction Of World’s First mRNA Factory On Australian College Campus

Authored by Jessie Zhang via The Epoch Times (emphasis ours),

The U.S. pharmaceutical giant Moderna has finalised arrangements with the Australian and Victorian governments to build the world’s first mRNA production facility located on a university campus.

An aerial view of Monash University in Melbourne, Australia on Oct. 21, 2002. (Getty Images)

The construction at Melbourne’s Monash University is expected to commence at the end of 2022, with production anticipated to begin by the end of 2024.

The company said that the facility is expected to produce up to 100 million mRNA respiratory vaccine doses annually, targeting respiratory viruses, including COVID-19, seasonal influenza, respiratory syncytial virus, “and other potential respiratory viruses, pending licensure.”

Moderna CEO Stephane Bancel speaks at the World Economic Forum annual meeting in Davos on May 23, 2022. (Fabrice Coffrini/Getty Images)

“We look forward to being a part of the Monash Clayton precinct and contributing to the R&D ecosystem in Melbourne and across Australia,” Moderna General Manager Michael Azrak said in a statement on Aug. 15.

The prime minister of Australia and the premier of Victoria said that the plan for the ten-year partnership to create a “homegrown” mRNA ecosystem has been completed.

It is designed to reduce Australia’s dependence on imported mRNA vaccines, vulnerability to supply disruptions, and delays, according to the Australian ministers.

Premier of Victoria Daniel Andrews said that this agreement means that Australia will be home to Moderna’s only mRNA manufacturing centre in the Southern Hemisphere.

“We’re not wasting a second in making sure we have access to the vaccines we need to keep Victorians safe,” Andrews said.

Vaccine Development Rushed

However, a professor of medicine at Australia’s Flinders University has said that, in his opinion, the mRNA development was rushed, and that this may have contributed to issues with adverse reactions.

“I think there was early leadership by Oxford University [AstraZeneca] with the adenovirus viral vector being put into human trials very quickly, you saw that similarly with Moderna and its mRNA approach,” Nikolai Petrovsky told The Epoch Times previously.

“This created a ‘follow the leader’-type mentality with (manufacturers) Sputnik and Johnson and Johnson copying the Oxford approach and Pfizer following Moderna with the mRNA approach.”

Last year, the Victorian government made a significant $50 million (US$35 million) investment to establish “mRNA Victoria,” an initiative responsible for leading the mRNA vaccine industry for future generations.

As part of this initiative, they granted Monash University $5.4 million to create the mRNA production facility on its campus.

Tyler Durden Wed, 08/17/2022 - 22:15

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Las Vegas Strip Gets a Brand New Technology

It’s not just Caesars and MGM innovating on the Strip. A number of other companies are trying big idea.

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It's not just Caesars and MGM innovating on the Strip. A number of other companies are trying big idea.

Las Vegas has quietly become a hotbed for innovation. Some of that has been driven by the major casino operators -- Caesars Entertainment (CZR) - Get Caesars Entertainment Inc. Report, MGM Resorts International (MGM) - Get MGM Resorts International Report, Resorts World Las Vegas, and Wynn Resorts (WYNN) - Get Wynn Resorts Limited Report -- trying to outdo each other to win over customers.

Some innovations are ostentatious and hard to miss, like the MSG (MSGE) - Get Madison Square Garden Entertainment Corp. Class A Report Sphere being built at the Venetian. That first-of-its-kind concert venue looks as if it dropped to Earth from a technologically advanced civilization, and it has raised the bar for performance venues.

Many innovations, however, aren't as obvious. Caesars, for example, uses an artificial intelligence text-based concierge that's surprisingly effective. "Ivy," as it goes by, can answer questions, help with mundane tasks like getting clean towels delivered, or advance your issue to a human where needed.

Innovations big and small are happening up, down, and under the Las Vegas Strip. Elon Musk's Boring Co. has been building a network of tunnels under the city that will eventually use driverless Tesla  (TSLA) - Get Tesla Inc. Report electric vehicles to ferry people all over the city. 

That's a revolutionary idea -- but now a rival has emerged.  

Image source: Daniel Kline/TheStreet

Musk Goes Low, Lyft Goes High?

Musk's Boring Co. has a bold plan for more than 50 stations connecting the Las Vegas Strip to the airport, the Convention Center, Allegiant Stadium, and Fremont Street using driverless Teslas. 

Currently, only a small portion of that network has been built -- a section connecting the two halves of the Las Vegas Convention Center (and one connecting Resorts World Las Vegas to that same location.

For Musk and Boring Co., it's all about taking traffic off the city's busy streets and bringing it underground.

"During typical peak hours, driving from the Las Vegas Convention Center to Mandalay Bay, for example, can take up to 30 minutes. The same trip on Vegas Loop will take approximately 3 minutes," the company says on its website.

If Musk's plan is fully built, it'll effectively give Las Vegas a modern subway, helping alleviate road congestion. It will not, however, stop tourists from using ride-share and taxi cabs.

Now, ride-share company Lyft  (LYFT) - Get Lyft Inc. Report has brought a solution to Sin City that may ultimately help it solve another problem: a shortage of taxi and ride-share drivers. 

Lyft Brings Driverless Cars (Sort of) to Las Vegas

Labor in Las Vegas has been in short supply since the pandemic hit. Some people left the city and others found work outside the service-industry jobs that fuel the Las Vegas economy. At times, that has made the wait for a cab, or a ride-share from Uber (UBER) - Get Uber Technologies Inc. Report and Lyft, longer than usual.

Lyft plans to fix that by partnering with Motional to bring Motional's "Ioniq-5-based robotaxi, an autonomous vehicle designed for fully driverless ride-hail operation, to the Lyft network in Las Vegas," the ride-share company shared in a news release.

The Ioniq 5 is Hyundai's  (HYMTF)  prominent EV. Motional is the Boston joint venture between Hyundai and automotive-technology specialist Aptiv.  (APTV) - Get Aptiv PLC Report

"Launching Motional’s all-electric Ioniq 5 on Lyft’s network in Las Vegas represents tremendous progress in our vision to make an electric, autonomous, and shared future a reality for people everywhere," said  Lyft CEO Logan Green.

It's Self-Driving Lyfts, But...

There is, however, a pretty big catch.

"Each vehicle arrives with not one but two backup drivers standing by to take control of the car should anything go wrong" Casino.org's Corey Levitan reported.

Lyft has promised a truly driverless system at some point in 2023, but current laws and the state of driverless technology make the backups necessary.

Motional and Lyft have quietly been testing driverless vehicles in Las Vegas since 2018. In the news release, Lyft explained how the system works.

"This means riders are able to easily control their ride without assistance from a driver. The enhanced experience includes unlocking the doors through the Lyft app and starting the ride or contacting customer support from the new in-car Lyft AV app, an intuitive in-ride display tailored to autonomous ride-sharing," the company said.

Lyft and Boring Co. are not working together. But if Musk's plan takes vehicles off Las Vegas's streets, the new program makes the experience better for any that remain. 

Ride sharing and taxis will continue to cost significantly more than using Boring Co's subway-like system, so it's easy to see how the two options will work well together.   .

 

  

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Elon Musk’s Las Vegas Strip Plan Has Some Competition

It’s not just Caesars and MGM innovating on the Strip. Elon Musk has been tunneling under Las Vegas to solve a big problem, and now he has a rival.

Published

on

It's not just Caesars and MGM innovating on the Strip. Elon Musk has been tunneling under Las Vegas to solve a big problem, and now he has a rival.

Las Vegas has quietly become a hotbed for innovation. Some of that has been driven by the major casino operators -- Caesars Entertainment (CZR) - Get Caesars Entertainment Inc. Report, MGM Resorts International (MGM) - Get MGM Resorts International Report, Resorts World Las Vegas, and Wynn Resorts (WYNN) - Get Wynn Resorts Limited Report -- trying to outdo each other to win over customers.

Some innovations are ostentatious and hard to miss, like the MSG (MSGE) - Get Madison Square Garden Entertainment Corp. Class A Report Sphere being built at the Venetian. That first-of-its-kind concert venue looks as if it dropped to Earth from a technologically advanced civilization, and it has raised the bar for performance venues.

Many innovations, however, aren't as obvious. Caesars, for example, uses an artificial intelligence text-based concierge that's surprisingly effective. "Ivy," as it goes by, can answer questions, help with mundane tasks like getting clean towels delivered, or advance your issue to a human where needed.

Innovations big and small are happening up, down, and under the Las Vegas Strip. Elon Musk's Boring Co. has been building a network of tunnels under the city that will eventually use driverless Tesla  (TSLA) - Get Tesla Inc. Report electric vehicles to ferry people all over the city. 

That's a revolutionary idea -- but now a rival has emerged.  

Image source: Daniel Kline/TheStreet

Musk Goes Low, Lyft Goes High?

Musk's Boring Co. has a bold plan for more than 50 stations connecting the Las Vegas Strip to the airport, the Convention Center, Allegiant Stadium, and Fremont Street using driverless Teslas. 

Currently, only a small portion of that network has been built -- a section connecting the two halves of the Las Vegas Convention Center (and one connecting Resorts World Las Vegas to that same location.

For Musk and Boring Co., it's all about taking traffic off the city's busy streets and bringing it underground.

"During typical peak hours, driving from the Las Vegas Convention Center to Mandalay Bay, for example, can take up to 30 minutes. The same trip on Vegas Loop will take approximately 3 minutes," the company says on its website.

If Musk's plan is fully built, it'll effectively give Las Vegas a modern subway, helping alleviate road congestion. It will not, however, stop tourists from using ride-share and taxi cabs.

Now, ride-share company Lyft  (LYFT) - Get Lyft Inc. Report has brought a solution to Sin City that may ultimately help it solve another problem: a shortage of taxi and ride-share drivers. 

Lyft Brings Driverless Cars (Sort of) to Las Vegas

Labor in Las Vegas has been in short supply since the pandemic hit. Some people left the city and others found work outside the service-industry jobs that fuel the Las Vegas economy. At times, that has made the wait for a cab, or a ride-share from Uber (UBER) - Get Uber Technologies Inc. Report and Lyft, longer than usual.

Lyft plans to fix that by partnering with Motional to bring Motional's "Ioniq-5-based robotaxi, an autonomous vehicle designed for fully driverless ride-hail operation, to the Lyft network in Las Vegas," the ride-share company shared in a news release.

The Ioniq 5 is Hyundai's  (HYMTF)  prominent EV. Motional is the Boston joint venture between Hyundai and automotive-technology specialist Aptiv.  (APTV) - Get Aptiv PLC Report

"Launching Motional’s all-electric Ioniq 5 on Lyft’s network in Las Vegas represents tremendous progress in our vision to make an electric, autonomous, and shared future a reality for people everywhere," said  Lyft CEO Logan Green.

An Important Caveat

There is, however, a pretty big catch.

"Each vehicle arrives with not one but two backup drivers standing by to take control of the car should anything go wrong" Casino.org's Corey Levitan reported.

Lyft has promised a truly driverless system at some point in 2023, but current laws and the state of driverless technology make the backups necessary.

Motional and Lyft have quietly been testing driverless vehicles in Las Vegas since 2018. In the news release, Lyft explained how the system works.

"This means riders are able to easily control their ride without assistance from a driver. The enhanced experience includes unlocking the doors through the Lyft app and starting the ride or contacting customer support from the new in-car Lyft AV app, an intuitive in-ride display tailored to autonomous ride-sharing," the company said.

Lyft and Boring Co. are not working together. But if Musk's plan takes vehicles off Las Vegas's streets, the new program makes the experience better for any that remain. 

Ride sharing and taxis will continue to cost significantly more than using Boring Co's subway-like system, so it's easy to see how the two options will work well together.   .

 

  

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