2022 SCOPE Summit: What to Expect

Devana Solutions is attending 2022 SCOPE Summit for Clinical Trial Operations Executives

Leaders in the clinical trial industry are set to meet in Orlando, Florida, at the 2022 SCOPE Summit. The event, which takes place February 7-10 at the Rosen Shingle Creek, brings together clinical operations executives to network and become familiar with the latest developments in the clinical trial management industry. If you are attending, you may already know that this event is the “Who’s Who” of clinical operations executives. If you’re unfamiliar with the annual SCOPE Summit or new to the industry, we’ve put together this look at what to expect.

Variety of Participant Programming

The variety of programs this year is unmatched to meet the growing needs of clinical trial management. We are excited to announce that Devana Solutions CEO Barry Lake and Vice President of Operations Linda Parks are attending to observe and discuss the latest technological and data advancements in the clinical trials industry.

12 Program Tracks

This year, there are 11 programs that cater to pharmaceutical and CRO executives, managers, and scientists.

  • FEASIBILITY & STUDY START-UP PROGRAM

    • Protocol Development, Feasibility, and Global Site Selection
    • Improving Study Start-up and Performance in Multi-Center and Decentralized Trials
  • RECRUITMENT & ENGAGEMENT PROGRAM

    • Enrollment Planning and Patient Recruitment
    • Patient Engagement and Retention through Communities and Technology
  • BUDGETING & RESOURCES PROGRAM

    • Clinical Trial Forecasting, Budgeting and Contracting
    • Resource Management and Capacity Planning for Clinical Trials
  • OUTSOURCING PROGRAM

    • Mastering an Outsourcing Strategy
    • Managing Outsourced Clinical Trials
  • CLINICAL SUPPLY PROGRAM

    • Data Technology for End-to-End Clinical Supply Management
    • Clinical Supply Management to Align Process, Products and Patients
  • DATA PROGRAM

    • Clinical Data Strategy and Analytics
    • Artificial Intelligence in Clinical Research
  • TECHNOLOGY PROGRAM

    • Sensors, Wearables and Digital Biomarkers in Clinical Trials
    • Decentralized Trials and Clinical Innovation
  • REAL-WORLD EVIDENCE PROGRAM

    • Accessing and Generating RWD
    • Leveraging Real-World Data for Clinical and Observational Research
  • BIOMARKERS & BIOSPECIMENS PROGRAM

    • Clinical Biomarkers Operations and Innovation
    • Clinical Biospecimens Technology and Outsourcing
  • QUALITY & MONITORING PROGRAM

    • Risk-Based Quality Management
    • Central and Remote Monitoring
  • MEDICAL DEVICE TRIALS PROGRAM

    • Device Trial Regulations, Quality and Data Management
    • Medical Device Clinical Trial Design, and Operations

As Devana Solutions is a technology partner that research sites, pharmaceutical Sponsors, and CROs rely on to reduce drug development costs and streamline operations, our team is interested in the following events:

  • Feasibility & Study Start-Up Program
    • Protocol Development, Feasibility and Global Site Selection
    • Improving Study Start-up and Performance in Multi-Center and Decentralized Trials
  • Budgeting & Resources Program
    • Clinical Trial Forecasting, Budgeting and Contracting
    • Resource Management and Capacity Planning for Clinical Trials
  • Outsourcing Program
    • Mastering an Outsourcing Strategy
  • Technology Program
    • Decentralized Trials and Clinical Innovation

Breakout Sessions

Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions of your interest to discuss some of the key issues presented earlier in the day’s sessions.

Lunch and Learn (or Network)

You can enjoy the learning environment as the morning sessions transition into a luncheon presentation. Others would like to take the lunch break as the time to meet with colleagues at one of the 15 restaurants, lounges and various retail shops located right on Rosen Shingle Creek property, including a mini market and ice cream shop.

UPDATE: SCOPE Summit COVID-19 Safety Protocols

SCOPE Summit organizers at the Cambridge Healthtech Institute (CHI) has implemented the following requirements if you are attending the event in person, including:
Provide proof that you have been fully vaccinated against COVID-19
Take a COVID test within 24 hours prior to arriving at the event
Follow all safety protocols set by event staff, including masking

Are you planning on attending the 2022 SCOPE Summit? We’d love to chat. Devana Solutions CEO and Co-founder Barry Lake and Vice President of Operations Linda Parks will be attending the show and are available to discuss how technology can improve your clinical trial management process. Connect with Barry or Linda on LinkedIn or use the contact form at the bottom of the page to set something up before the big event in Orlando!

IMA Clinical Research Adds Devana Solutions’ PROPEL Clinical Trial Data Platform

Bringing the Clinical Trial Site to the Patient: IMA Clinical Research Adds Devana Solutions’ PROPEL Clinical Trial Data Platform

 

While 2021 certainly had its ups and downs, the Devana Solutions team is delighted to say we were able to end the year with a BANG! This past year we focused on accelerating clinical trials through the power of connectivity and data through our new PROPEL Enterprise technology. With the pandemic accelerating the shift to decentralized clinical trials, the PROPEL platform became an invaluable asset to our larger research organization clients. Devana PROPEL is leveraging the cloud to connect central research operations professionals with site-based clinicians and staff for real-time clinical trial collaboration. In short, Devana Solutions is bringing the clinical trial site to the patient. 

Today, Devana Solutions is pleased to announce IMA Clinical Research has made the commitment to adopt the most innovative site operations and analytics platform in the clinical trials industry, Devana PROPEL. “Partnering with Devana Solutions aligns with IMA Clinical Research’s centralization strategy initiated to improve efficiency within our network and accelerate study startup, supporting our mission of advancing the development of novel treatments to patients in need,” said IMA Group CEO & President, Mark Weinberger, Ph.D., MPH. 

With a rapidly growing network of traditional site locations, over 100 satellite sites and a database of over 300,000 patients, IMA Clinical Research represents the ideal client-profile to adopt Devana PROPEL Enterprise. “We are thrilled to welcome IMA Clinical Research onto our PROPEL platform,” commented Barry Lake, Devana Solutions’ CEO and Co-Founder. “They truly are a perfect fit for our technology which uses the power of the cloud to bring the expertise of clinical trials professionals into the diverse community site locations where IMA Clinical Research excels. Their broadly distributed site network allows millions of genetically, socially and racially diverse patient populations in urban centers and underserved locations to access clinical trials as a care option.” 

Patient access to clinical trials and research professionals leveraging advanced technology shouldn’t be limited by geography. They won’t, thanks to cloud-based platforms like Devana Solutions PROPEL and IMA Clinical Research. Stay tuned for a steady stream of new Devana Solutions client-partnership announcements in 2022! 

 

About Devana Solutions

Decentralized clinical trials and work-from-anywhere is now a reality. Devana Solutions innovative cloud platform supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems. From pipeline administration to rapid study startup automation. From document-sharing through the capture, display, analysis, and exchange of key trial performance metrics data from central research leaders to decentralized trial teams. From investigative site to CRO to trial sponsor, Devana Solutions is the answer. At Devana Solutions, we’re transforming the business of clinical trials. https://devanasolutions.com/ 

About IMA Clinical Research

IMA Clinical Research, a division of The IMA Group, is a physician-founded network of integrated clinical research sites specializing in Phase II-IV clinical trials in multiple therapeutic areas. IMA Clinical Research offers a flexible delivery model for site-based, hybrid and fully decentralized trials through its network of dedicated research clinics, a nationwide array of 100 satellite sites and a rapidly-growing database of over 300,000 patients.  We provide centralized processes for contracting, regulatory, training and patient recruitment ensuring rapid start-up, efficient enrollment and high-quality delivery across our network. For more information visit https://imaresearch.com/ or https://theimagroup.com/

 

Devana Solutions Announces Roxanne Shenefield as New Director, Solutions Services

Roxanne Shenefield

Devana Solutions is excited to announce Roxanne Shenefield as Devana’s Director, Solutions Services.  

Since May of 2019, our partner-clients have benefitted from Roxanne’s technological acumen and customer service during this time.  Roxanne truly lives our motto, Better Data, Better Decisions, Better Outcomes. Analytics are second nature to Roxanne, and her passion for data is unparalleled.

“I’ve always enjoyed the puzzle that surrounds a new technology – learning how it works, putting the pieces together, and continuing to build on it over time,” said Roxanne.

“Roxanne’s programming talent and strong communication skills are well-known to our partner-clients. She’s done an impressive job building out a solid team,” said Devana CEO and Co-founder Barry Lake.

In her new role, Roxanne will serve as the subject matter expert for the Devana Solutions suite of SaaS platform technologies in both customer-facing and internal roles.  

As part technical project manager, part administrator, and part analyst, Roxanne will be the conduit between business and technology. She will lead the development, customization, and integration efforts of solutions for our internal technology requirements.

“Roxanne’s ability to understand the strategic use of our Devana platform makes her the ideal choice to bridge our technological innovation and high growth SaaS business needs as Director, Solutions Services,” Barry added.  

Roxanne will also collaborate with Customer Success and Product Management to develop and implement new optimizations in the Devana Suite of products. She will also play a critical role in partner-client customizations and custom builds, and in future API integrations as Devana’s compatibility with other systems continues to grow.

Roxanne is ready to lead Devana’s future growth.  “I’m excited to be taking on this new challenge, focusing on expanding and scaling our technology solutions both internally and for our valued partner-clients,” she said.

“Roxanne has a history of demonstrating an insatiable curiosity for all things tech and data analytics. She continually demonstrates a mastery of understanding customer pain points and actively developing solutions,” said Devana Vice President of Operations, Linda Parks.

Whether you are a current partner-client or a future one of Devana Solutions, pretty much everything you encounter, from guides to videos and FAQs, will have Roxanne’s fingerprints on them.

 

Devana Solutions Welcomes Kirsten Zagarino as Director, Customer Success

Kirsten ZagarinoDevana Solutions is excited to welcome Kirsten Zagarino to the team as Devana’s Director, Customer Success.  

Kirsten has an accomplished history in the clinical research space with a multi-faceted background that will help lead Devana Solutions and drive partner-client growth and success.  She carries a passion for serving customers and collaborating with innovative teams.  

She said, “I am looking forward to working with the exceptional Devana Solutions team and helping them continue their track record of success with Partner-Clients and speed new therapies to patients.”

Devana Solutions CEO and Co-founder Barry Lake echoed his excitement:

“Kirsten’s hiring to lead our Customer Success Team is a direct reflection of the growth and success of our innovative cloud platform for the clinical trials industry. With most of the leading global site networks and integrated research organizations now partner-clients and major moves into health systems and CROs, sponsors this year, we welcome Kirsten’s expertise in scaling our client-facing staff. 

Kirsten will be responsible for the strategic focus and operational oversight for the Customer Success department, where the priority is optimizing the use and adoption of Devana Solutions platforms.

Kirsten has shown mastery of many of these core responsibilities throughout her career.

In the last decade alone, Kirsten has led client adoption of Life Sciences SaaS products, including the implementation, onboarding and adoption experience. She has held such roles as analyst, software project manager, engagement manager, customer success manager in clinical technologies, and Associate Director Customer Success Shared Data and Profiles for the IQVIA Trial Design Group, where she has spent the last eight years of her career. 

Through her career, Kirsten had working relationships with 17 of the Top 20 Pharmaceutical Companies in the world. 

With Devana, Kirsten will be responsible for delivering an exceptional customer experience and maximizing customer value and retention.  This includes defining and overseeing the partner-client lifecycle process and touchpoints, including the following emphasis with the customer’s leadership team: process reviews, executive business reviews, action plans, roadmaps to drive value against their evolving business objectives. 

Internally, Kirsten will collaborate cross-functionally to advocate for the client-partner and lead the team to ensure that the Voice of the Customer is ingrained in Devana Solutions’ SaaS Suite and support strategies. This leadership centers around building an innate mission to drive value from our platform in support of the customers’ key business objectives.

And while the role is demanding, Barry is confident Kirsten will thrive.  He added, “She’s a perfect fit, and we are thrilled to have her talent.”

 

Data Analytics & Making Decisions for Better Outcomes

At Devana Solutions, our motto is Better Data, Better Decisions, Better Outcomes. But what exactly does that mean to us—and for you? Let’s take a look at how superior data analytics can make a huge impact on the clinical trial industry as a whole—and your organization in particular.

 

Better Data

We believe complete data transparency is absolutely crucial to clinical trial management. Devana’s cloud-based unified platform allows study teams to securely connect remotely and collaborate in real-time—an essential feature in our era of remote work and decentralized or hybrid trials. To optimize execution, you’ll have the ability to standardize and automate study start-up workflows and connect central research operations teams to decentralized clinicians serving patients in diverse community settings. You can even share “up” to CRO and sponsor partners, ensuring everyone has access to the data they need.

One of our key features to generate superior data includes AI-enhanced auto-email capture and attachment, which links relevant information and documentation to each associated trial, streamlining task management and execution follow-through. Devana also captures start-up/timing metrics and enrollment performance data, whether it’s generated on our platform or via API connections to other systems. It can then display this data on the dashboard, providing leadership and study teams with analysis and action items.

 

Better Decisions

We believe data should work for you, giving you the power to make better-informed decisions. Devana’s centralized business intelligence platform provides access for all stakeholders across the entire research footprint. We leverage information from historic and active trial performance by organization, site, and PI/study team/department—across all indications. With digitized trial opportunities, feasibility distribution, collaboration, and more accurate PI/study team selection and trial feasibility, you’ll see more effective feasibility and trial selection. The Devana platform achieves these results through analyses of therapeutic alignment and your organizational, site/study team and investigator capabilities, as well as your bandwidth. And it provides the real-time trial process and enrollment performance insights your leadership needs to correct bottlenecks and improve trial execution overall. 

 

Better Outcomes

We believe that decisions informed by superior data transparency will produce better outcomes for the clinical trial industry and the patients we serve, period. The Devana platform’s pipeline and study start-up automation, along with its inter-organizational trial communication and collaboration capabilities, saves countless hours previously spent on manual data entry and organization—and reduces human error in the process. With process and performance data transparency, you’ll also see improved accountability across functions and between trial stakeholders.

The right data analytics improve the trial process by matching sites and investigators with the clinical trial opportunities that suit them best. When more reliable PIs and study teams are aligned on the right trials with industry sponsors and CROs, you’ll see the results in increasing predictability of trial performance and more trial opportunities. This reduction in trial cycle time and cost means faster delivery of new therapies to patients.

Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes. Book a demo with Devana Solutions today to learn about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.

 

Devana Solutions December 2021 Newsletter

 



Wishing You a Wonderful Holiday and a Happy New Year

 

We’d like to extend a warm holiday greeting to all of our client-partners, friends, and supporters. Our industry has faced unprecedented times in these last two years, and the decentralized clinical trial world has emerged stronger, smarter, and more connected. We value being a part of that connectivity.



Give Back with Greater Gift & Honor Clinical Trial Patients

 

At the core of Devana Solutions’ mission—to connect central research operations teams to decentralized clinicians serving patients in diverse community settings—is the goal of reducing drug development costs and curing disease.

That’s why Devana partners with Greater Gift, a 501 (c)(3) non-profit organization that “honors patient volunteers and research professionals who make clinical trials possible,” by helping the public “understand the powerful role clinical trial volunteers play in the development of new drug therapies, medicines, and vaccines.”

Dedicated to combating the data gaps and inequity resulting from many ethnic, racial, and other demographic groups being underrepresented in clinical research, Greater Gift has donated more than 120,000 vaccines—and meals—to children in need since 2010.

Join Devana this holiday season in honoring clinical trial patients by donating vaccines to children in need through Greater Gift.

Learn More and Join Devana in Donating Vaccines


PROPEL Innovates the Clinical Trial Industry in 2021

 

At Devana Solutions, we are continuously innovating to meet the needs of the clinical trials industry. 2021 was the year of “decentralized trials,” as such, the Devana Solutions’ team developed our PROPEL technology solution to connect centralized research operations teams with decentralized clinicians, bringing the “site” to the patient’s community.

 

In a world in which the swiftness to find cures and treatments is as crucial as ever, the Devana team was very humbled, yet not surprised, by the adoption of this latest innovative platform by leading research organizations and especially salute the earliest adopters, including hyperCORE International, Velocity Clinical Research, Inc. and WCG PharmaSeek.

 

Stayed tuned as we head into 2022 since the Devana team is currently onboarding other major research organizations onto PROPEL in both the site network and IRO space but academic and health systems, as well. We are looking forward to an efficient and well-connected New Year for the clinical trials industry to keep speeding new therapies to patients!

Learn more About PROPEL


Operation Warp Speed – The New Standard for Clinical Trials

 

Operation Warp Speed proved that an accelerated timeline was possible with an unprecedented level of process and performance transparency as well as cooperation between drug developers in the clinical trials industry and government.

 

But what factors enabled this never-before-seen public/private cooperation to achieve the impossible, and how could those factors be standardized for future clinical trials in order to compress development cycle time and achieve faster breakthroughs in our most serious diseases?

 

Devana CEO and Co-Founder Barry Lake shares his thoughts.

Read Barry’s Insights


2022 SCRS Oncology Site Solutions Summit

 

As we head into 2022, one of the first major events taking place in the clinical trial industry is the SCRS Oncology Global Site Solutions Summit.

 

Devana CEO and Co-Founder Barry Lake and Director of Client Partnerships Emily Hardy will be walking the Summit?  If you’ve never been, we break down what to expect.

Learn About the Summit

Learn More About Devana Solutions Clinical Trial Data Platform

How Technology Simplifies Clinical Trial Feasibility Assessments

Ah, the dreaded site assessment and feasibility: pages upon pages of requests for information. From equipment specifications to investigator experience to patient population, the amount of data needed to execute a clinical trial feasibility is onerous. You may have most of this information on hand—across a variety of spreadsheets, emails, documents—and in your head. But there may also be gaps in the information you have access to, leaving you no option but to put down your best guess and muddle through.

See How You Can Easily Close Those Gaps
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Give Back with Greater Gift & Honor Clinical Trial Patients

At the core of Devana Solutions’ mission—to connect central research operations teams to decentralized clinicians serving patients in diverse community settings—is the goal of reducing drug development costs and curing disease. That’s why Devana partners with Greater Gift, a 501 (c)(3) non-profit organization that “honors patient volunteers and research professionals who make clinical trials possible,” by helping the public “understand the powerful role clinical trial volunteers play in the development of new drug therapies, medicines, and vaccines.”

Dedicated to combating the data gaps and inequity resulting from many ethnic, racial, and other demographic groups being underrepresented in clinical research, Greater Gift has donated more than 120,000 vaccines—and meals—to children in need since 2010.

The founder of Greater Gift, Jennifer Byrne, is the CEO of Javara Research. For over 20 years, she has seen thousands of patient volunteers participate in more than 7,500 clinical trials. Whether their motivation was to find treatments for themselves or to help others by contributing to research, the positive impact these volunteers had on future generations cannot be overstated. As a way to honor these patients and their contributions, Jennifer created Greater Gift. In addition to the outreach work that brings vital awareness of clinical research to underrepresented communities, Greater Gift partners with the life science community to provide a vaccine or meal to a child on behalf of each and every clinical trial participant. 

Devana is proud to be both a sponsor and partner of Greater Gift and to help support its mission to advance global health now and for the future. Every year at this time, Devana donates vaccines in the names of each of our clients through Greater Gift. These vaccines go to children in need who are under/uninsured and who might not otherwise have access to life-saving preventative inoculations. 

We hope you will join us in donating to this worthy cause during this holiday season and beyond.

Curious about streamlining your clinical trial data?

Book a demo with Devana Solutions today to learn more about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.

 

Partner Spotlight: Aventiv Research

Aventiv Research Partner Spotlight

Chapel Hill, NC (December 8, 2021) – Devana Solutions is happy to announce a new client-partnership with Aventiv Research, a leading independent, multi-therapeutic clinical research center with seven locations across the greater Columbus, Ohio and Phoenix, Arizona regions. As an alliance partner of hyperCORE International, a super network of highly experienced and awarded clinical research companies, Aventiv’s mission is to enrich the lives of their team members and patients by putting medical research to work. 

Founded in 2007 by Dr. Samir Arora, Aventiv Research has conducted over 475 clinical trials with more than 55 pharmaceutical sponsors and has assisted in the FDA approval of 23 medications available for use today. In addition to their research work and with over 30 years combined experience, Aventiv offers consulting services covering business development, site auditing and operations management, providing proper guidance on SOP implementation, quality assurance, staffing and infrastructure to ensure efficient and streamlined processes.

As a proven leader in the clinical trials industry, Aventiv has chosen to partner with Devana Solutions, the industry’s leading cloud-based technology provider, to help save time through workflow automation, from initial study lead through completion. “In addition to time saved, we now have robust, real-time clinical trial performance metrics to help improve trial execution and better align with our sponsors’ needs,” offered Dr. Samir Arora, President and Medical Director of Aventiv Research. “Devana’s data offerings support our goal to increase clinical trial efficiency.” Devana technology will reduce clinical trial cycle time, costs and ultimately, speed therapies to the market faster.

“I am pleased to have known Samir Arora for several years with Dr. Arora being a longtime leader in the clinical trials industry,” said Devana Solutions CEO, Barry Lake. “It’s humbling that so many of the industry leaders trust our Devana platform for metrics capture and analytics and connecting central teams to decentralized sites, and we’re very honored Dr. Arora and Aventiv Research have also placed their trust in Devana Solutions and our innovative platform.”

With an already excellent reputation for clean and quality data, it comes as no surprise that the Aventiv Research team has chosen to partner with Devana Solutions. “Our access to even more data sets will allow us to help advance our goal of expanding our expertise across vaccine, internal medicine, dermatology, and many other therapeutic areas,” added Rachel Flora, Business Development Manager for Aventiv. “As we gear up for 2022, the partnership with Devana has created a landscape for success for Aventiv. We will continue to work as a collaborative group by sharing insight and achievements to further set our network apart from our competitors.” The Devana team is excited to support this well-respected research organization to advance the clinical trials industry forward.

ABOUT AVENTIV RESEARCH:

Aventiv Research exists to make novel medicines accessible to its patients and deliver industry-best pharmaceutical data to its sponsors. Its mission is to enrich the lives of both its team members and patients by putting medical research to work. Currently operating in two states with seven independent research sites, Aventiv specializes in phase I-IV pharmaceutical, device, and diagnostic clinical trials in various therapeutic areas. Built on the core values of dedication, integrity, resourcefulness, and professionalism, the company embraces a visionary, entrepreneurial spirit that compels its ambassadors to blaze new trails with proprietary systems and processes.

Find out more at www.aventivresearch.com, Facebook, and Instagram.

 

ABOUT DEVANA SOLUTIONS LLC:

Devana Solutions®, LLC is a cloud SaaS provider driven by a core belief that data transparency through technology is critical to the selection of the top-performing research sites to align with pharmaceutical Sponsors and CROs to reduce drug development costs and cure disease.

Devana Solutions® flagship platform, IGNITE, allows integrated site networks and research organizations to standardize workflows, particularly in study startup, across site functions while allowing for the capture and display of performance metrics for dashboarding and analytics beyond site CTMS.  PROPEL extends performance data transparency across Academic Research Institutions or an expanded network of owned and affiliated investigative sites.  IQ allows for the sharing of performance data and documents in real-time between investigative sites and Sponsor or CRO stakeholders. To learn more visit www.devanasolutions.com.

 

 

 

Operation Warp Speed—the New Standard for Clinical Trials

Clinical Trials and Operation Warp Speed

248 days. From the time scientists first sequenced the genome of the COVID-19 virus and published it online, it took just 248 days for the clinical trials industry—working closely with government agencies under “Operation Warp Speed” (OWS)—to develop two emergency-use vaccines to stem the tide of the pandemic. Other vaccines would be developed soon afterward.

 

With 5.2 million deaths and counting attributed to the COVID-19 pandemic worldwide, the loss of life alone has been staggering. Sadly, the Omicron variant will add to this devastating toll. Despite our desperation to put this pandemic behind us and return to “normal,” the clinical trials industry and its regulatory agency partners have a golden opportunity to implement some of the best aspects of OWS as the new industry standard. In so doing, the delivery of new therapies in record speed to patients desperately in need—those with diseases such as Alzheimer’s, Parkinson’s, Cancers—would stand as an enduring tribute to the lives lost to COVID-19.      

 

Formed May 15, 2020, OWS was a partnership between the federal departments of Health and Human Services (HHS), Department of Defense (DOD), and select private sector drug development sponsors. At its outset, the daunting goal of OWS was to accelerate vaccine development through 2020 so that, starting in January 2021, 300 million COVID-19 vaccine doses could be approved by the FDA, manufactured, distributed, and available to the U.S. general public by mid-2021.

 

At the inception of OWS, vaccine clinical trials were already underway with Pfizer, Moderna, Novavax, Sanofi/GSK, Janssen (J&J) and AstraZeneca. However, these trials were in the early stages, with no guarantees regarding timeline or successful outcome. And here was this lofty goal of full vaccine deployment in less than a year. For the nearly 75% of the U.S. adult population who have now been inoculated against COVID-19 and are currently contemplating booster shots, it may be easy to forget the audacity of such a compressed drug development timeline. But for those with experience in the clinical trials industry, this ambitious goal may have seemed flat out impossible!

 

If you look at the pre-pandemic statistics, the clinical trials industry has operated against a backdrop of 153,000 global deaths per day, 7,000 compounds in the drug development pipeline, and almost 12 years in clinical trials before new therapies reach patients—at an average cost of $2.6 billion! Defying the seeming inevitability of decades-long cycle times, OWS proved that an accelerated timeline was possible with an unprecedented level of process and performance transparency as well as cooperation between drug developers in the clinical trials industry and government. But what factors enabled this never-before-seen public/private cooperation to achieve the impossible, and how could those factors be standardized for future clinical trials in order to compress development cycle time and achieve faster breakthroughs in our most serious diseases?   

 

Allow each partner/stakeholder to play to its strengths  

In large part, OWS succeeded because at the outset, there was an understanding and acceptance as to which roles and responsibilities were best suited to private enterprise vs. government. For example, the heads of large government agencies such as HHS, DOD, and the State Department accepted that highly motivated, private drug development enterprises were best left to their own devices to do what they do best: execute on clinical process development and manufacturing plans—assuming successful vaccine creation.

 

For their part, the government agencies working within the OWS partnership deemed that their critical role was to mobilize the full capacity of the U.S. government to clear all roadblocks. Their job was to ensure that no technical, logistical, or financial hurdle would hinder vaccine development or deployment. For example, DOD and HHS collaborated to mitigate supply-chain disruptions of critical manufacturing supplies and equipment. HHS even worked closely with one vaccine company to identify a much-needed additional manufacturing partner. The U.S. Army Corps of Engineers was tasked with overseeing construction projects to expand capacity at some manufacturing plants. Incredibly, DOD even sent 16 public servants to fill quality control positions at two vaccine manufacturing sites until the companies could hire the required private sector replacements!

 

Certainly, promising early-stage clinical trial data should meet an agreed-upon threshold to merit such an all-out mobilization. But shouldn’t we lay down the policy guidelines now if only so drug developers and the public know that enormous public/private support will be there when a breakthrough inevitably comes? There are countless people with devastating diseases such as Alzheimer’s—which many experts caution is a developing tsunami given our aging population and longer life expectancies—waiting for just such a crucial breakthrough in treatment. 

Leverage technology-enabled solutions and data sharing to align stakeholders

Extraordinary cooperation by otherwise fierce competitors in the pharmaceutical industry became standard in the OWS effort to develop the COVID-19 vaccines. BioNTech collaborated with Pfizer for its mRNA-based vaccine. Sanofi worked in tandem with GlaxoSmithKline (GSK) and Merck manufactured J&J’s vaccine. Beneath these high-profile partnerships was one significant factor that helped OWS succeed: data-sharing. Specifically, the competitors developing vaccines on one of the four approved platforms selected by OWS—the mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, or the attenuated replicating live-vector platform—actually relied on data from other vaccines using the same platforms. For as much criticism as the pharmaceutical industry too often receives, this level of sharing and cooperation between fierce rivals to help swiftly combat a deadly virus preying on many of the world’s most vulnerable has, in my humble opinion, not been heralded enough.  

 

As the CEO and Co-Founder of an innovative cloud-based software provider to the clinical trials industry, I have long advocated for more process and performance transparency (as those who know me in the industry can attest). That said, let me be clear: as an entrepreneur and fierce defender of risk taking and free market capitalism, I am not in any way advocating for pharmaceutical industry sponsors and their CRO partners to share the valuable intellectual property behind new therapies they took great risk to develop and advance through clinical trials. Beyond a passion for improving the human condition and eradicating disease, respect for the rule of law and protecting intellectual property are paramount to ensuring therapeutic breakthroughs like we’ve just experienced with the COVID-19 vaccines.

 

However, in the same collaborative spirit of Operation Warp Speed, there are opportunities to use technology to better align—both operationally and clinically—all clinical trial stakeholders, from patients to investigative sites to CROs and sponsors. On the clinical side, for example, technology that uses artificial intelligence to scour EMR data and match eligible patients to clinical trial protocols is beginning to proliferate. In addition, even during the development of clinical trial protocols, predictive analytics are being leveraged to model trial feasibility based on the protocol, thereby allowing for protocol adjustments to ensure a greater degree of success in the clinical trial phase. Operationally, the pandemic has hastened promising technological advances to cut cycle time and, ultimately, costs to deliver new therapies to patients. Remote and risk-based monitoring of clinical trials is poised to become (or already is) the new norm. And of course, at Devana Solutions we provide technology to connect central trial operations teams with decentralized site staff and clinicians or “bring the site into the patient’s own community”. Devana also highly automates clinical trial process workflows and capture site metrics for analysis and improvement in speeding new therapies to patients.

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It is within our power to take from the urgent, can-do, cooperative partner-mindset that was adopted by the clinical trials industry and government agencies during the pandemic—best exemplified by Operation Warp Speed. The industry and regulators should seize the lessons of this moment, and lay down a framework to accelerate the speed of delivery as soon as the next major therapeutic breakthrough against a serious disease is realized. To miss the next opportunity to speed a lifesaving vaccine or cure to those patients by leveraging the collective fighting spirit this pandemic has engendered would be tragic. Rising to meet this challenge would honor the millions of lives cut short by this pandemic.

 

Book a demo with Devana Solutions today to learn more about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.

 

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