SCOPE 2021

SCOPE 2021 to take on tough clinical trial challenges

By Jenni Spinner contact

- Last updated on GMT

(LeoWolfert/iStock via Getty Images Plus)
(LeoWolfert/iStock via Getty Images Plus)

Related tags: Clinical trials, Clinical trials software, Patient centricity, Study start-up, Remote monitoring, Decentralized trials, COVID-19

The annual event, moved to the virtual realm thanks to COVID-19, offers content on remote monitoring, drug development technology and other key topics.

For veteran attendees of the Summit for Clinical Ops Executives (SCOPE), it may be hard to believe so much has changed in the year since the event last convened in person. Still, while the clinical research industry has continued despite the obstacles COVID-19 has lobbed in its path, SCOPE also is forging ahead, with dynamic content on a wealth of topics, including emerging technology, patient recruitment and engagement strategies, study planning, and more.

Outsourcing-Pharma (OSP) discussed the online iteration of this year’s event with Micah Lieberman (executive director of the Cambridge Healthtech Institute, a division of Cambridge Innovation Institute) and the entire team from SCOPE. Attendees might be participating virtually, but the event still tackles a wealth of real-world challenges, and opportunities.

OSP: It would be a huge understatement to say COVID-19 has impacted the world—could you share your perspective on the ways it’s impacted the clinical research field?

ML: This is a really big question and I think this is a case where we can focus on the positive. There is a silver lining to this pandemic as it relates to clinical research and drug development more broadly, in that the biopharma industry was forced to accelerate a lot of the more innovative approaches to clinical trials.

There have been many pilots and work beyond pilots in remote/decentralized/hybrid trials and the use of digital tech to enable this transformation. For some, especially those responsible for driving and expanding innovation at their organizations, there was a feeling industry could be moving faster -- and this crisis was the catalyst; I would say that everyone rose to the occasion and the proof is in the record speed at which safe and efficacious vaccines have been developed (all during a global pandemic!).

There is a lot more to talk about here, including diversity and inclusion in clinical trials, how to collaborate across industry, how to better engage regulators and other stakeholders, optimizing our supply chains, etc., but everyone in this industry has learned a lot, worked hard, and pushed to make change.

OSP: Similarly, it’s impacted the SCOPE Summit. Could you please share what looks different about this year’s event, besides the shift from the real world to the virtual space? Feel free to talk about new show features, added tracks or specific sessions, etc.

ML: SCOPE has become something special in industry and we are grateful for all of the support. This year’s SCOPE was going to be at a new venue and was going to feature a charitable golf tournament and many of us were going to bring our families and we can all use a break from our houses… but I don’t want to whine right now. The fact is that there are a lot of people, our team included, that were really excited to have our annual gathering as an in-person event.

Meeting face to face can never be replaced, we know. So, the switch to virtual has been a big pivot and we have done a lot to make sure we maintain quality and create a positive experience. I can say with confidence now that we are really looking forward to it. On the positive side, there are people who can attend this year who may not be able to attend traditionally due to travel and expense.

If you look at the overall agenda, scroll through the web site or read through our 79-page brochure (yes, the PDF is 79 pages) you will see a lot on COVID, of course, on digital tech, remote/decentralize trials, hybrid trials, patient-centricity, utilizing patient insights, diversity and inclusion, use of data and analytics, improved outsourcing/partnering practices, and even a new session on Medical Device trials and partnering w/ China. So, it’s still an ambitious agenda and many issues remain the same despite the pandemic.

OSP: I imagine I’m not the only one looking forward to the Acceleration of Drug Development Due to the Pandemic keynote [Tuesday, March 2, starting at 8 am EST]. Could you share an overview of that session—what are you expecting the presenters to share, and what lessons and advice will attendees gain after sitting in on it?

ML: Yes, this is actually made up of two components: the panel with a big team at Pfizer telling their story from a diverse set of functional backgrounds, and then a broader fireside chat with our editor, Deb Borfitz, and Ken Getz from Tufts/CISCRP and Dr. Leonard Sacks from FDA. These are really good ways to kick off SCOPE and they get right to the bigger questions you asked earlier. We are so lucky to have such great speakers throughout.

Another highlight is Moving Toward Platform Thinking to Transform Pharma [Thursday, March 4, starting at 9 am EST]. This panel with Adama, Hassan, Craig, Mo and Disa will be a highlight for me. It is really trying to look beyond what is right in front of us, as we are all swamped, and trying to continue to solve for the future.

Future proofing is a perfect term and the issues being discussed are not new, but now more than ever biopharma industry is ready. Digitalization is not easy, but we all know we have to get there. How? What does this mean for patients? What does this mean internally? I think Adama poses this key discussion point: How can the biopharma industry work together to have a unified approach to a seamless front-end experience for patients and sites while maintaining their own microservices, competitive advantage and intellectual properties?

OSP: It’s difficult to look through the program and pick highlights, because so much of the content looks worth attending. Do you have any sessions you’d like to spotlight?

M: You are asking me which child I love more. I think it really depends on your interest and your function.

I think the shortcut is to peruse the track names and dive into the ones you find the most compelling. The track names are pretty explicit and we kind of slice things up by function/dept/job. Most people follow a particular track over the three days and the narrative of that agenda matches their interests and their day-to-day job. Some folks really jump around and take the buffet approach…a little of this, a little of that, oh, maybe I will try this.

Either way works, but I think there are two things to consider. One, an attendee may be focused on issues, discussions and presentations that are closely aligned with their work and they choose those at SCOPE. Two, an attendee may choose to attend portions of SCOPE that are well outside of their expertise because they are trying to broaden their understanding or better understand what others in their org are dealing with.

No matter what, I think SCOPE is what you make it and it’s important to take advantage of the networking, the live breakouts, the exhibits, etc. Don’t be shy. Bounce around and participate.

Another timely issue is what are we doing as an industry and what have we learned from COVID to better engage and include underrepresented patient populations. Diversity and inclusion are still big challenges, but there is a lot of good work happing in industry. Here are a few sessions at SCOPE talking about this.

  • Pushing Past Quick Fixes: Lessons Learned from Engaging Diverse Patient Populations in COVID-19 Clinical Trials—Tuesday March 2, 10:55 am EST
  • Advancing Equity in Research and Development—Tuesday, March 2, 1pm CST
  • A Biotech's Journey to Build Diversity into Our Trial Design: Relationships, Technology and Leadership—Tuesday, March 2, 1:20 pm EST
  • Increasing Diversity in Patient Recruitment: a Review of How Race, Gender and Income Impact Trial Enrollment—Tuesday, March 2, 1:40 pm EST
  • Panel: Clinical Trial Diversity for Patient-Focused Drug Development—Tuesday, March 2, 2:50 pm EST

OSP: What can you tell us about the exhibits?

ML: We currently have 90 program sponsors and exhibitors​, all companies worth checking out. Clinical research is a big ecosystem and now more than ever everyone works with everyone. Collaboration is more than a buzzword in this community.

OSP: Could you share why a busy clin-ops professional should take time out of their hectic week to attend this year’s SCOPE Summit?

ML: Whatever your job or role in the clinical research enterprise, you can learn from others. You can and must engage with those facing the same problems as you. You can and should take the risk in moving beyond your own area of expertise to gain exposure to those in a function different than yours.

This community is incredibly gracious, and you will make a year’s worth of connections and walk away with enough content to keep you occupied for a year…all in three days. The format is easy, the platform is smooth, and you can do it all from your own office or home.

Clear your calendar for three days. Your organization, your boss, your colleagues will understand and appreciate it. Jump in.

The SCOPE Summit virtual event takes place March 2-4; for more information or to register, visit scopesummit.com​.

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