06Jun

Green Key Resources is proud to announce that our Director of Pharma, Lindsey Summers, is a co-recipient of the Regulatory Affairs Professional Society (RAPS) 2021 Community Leadership Award

RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics, and nutritional products. As a valued member of the RAPS community, Summers is a regular attendee of RAPS Convergence, the largest and most well-recognized annual gathering of regulatory professionals, scientists, and innovators in the world.

In recognition of this prestigious achievement, we asked Summers to share a bit about her journey with RAPS. Here’s what she had to say:

This is the 5th year in a row that I have attended Convergence and I’ve been incredibly humbled to be a part of the RAPS community.

In 2018, I stumbled into a RAPS Leadership meeting with my colleague, Deloris Jones. That dinner, along with Wesley Carr’s support, helped to kickstart our Colorado RAPS Chapter with Kira Meyer, RAC of Clovis Oncology, and Bryan Ford, RAC now of Seagen.

Deloris Jones (left) and Lindsey Summers (right) at a RAPS Leadership meeting in 2018
Deloris Jones (left) and Lindsey Summers (right) at a RAPS Leadership meeting in 2018

Convergence 2019 in Philadelphia: The Colorado Chapter was officially launched and Susan Carino, MBA, MS, PMP, RAC from the San Francisco Chapter was a guest speaker and came out to Boulder, Colorado the following month for our local launch. 

In 2019 and 2020, Linda Bowen, MS, RAC, FRAPS, Aman Khera, and Oliver Steck invited me to be a panelist at Convergence, where we discussed the digital world and direction for the regulatory profession.

Lindsey Summers as a panelist at RAPS Convergence 2019
Lindsey Summers as a panelist at RAPS Convergence 2019
Lindsey Summers as a panelist at RAPS Convergence 2020
Lindsey Summers as a panelist at RAPS Convergence 2020

All of these events have contributed to the 2021 Community Leadership Award that I am a co-recipient of this year with Pallavi Trivedi, MPH, RAC.

Special recognition to fellow member of the Colorado RAPS Chapter, Michael Morton, FRAPS, RAC who was recognized as a prestigious 2021 Founder’s Award Recipient.

It’s always a pleasure to participate in knowledge sharing, networking, and career development considering the ever-evolving healthcare product regulatory environment.

Convergence offers tracks in multiple disciplines including biopharmaceuticals, medical devices (and IVDs), Business Acumen and incredibly important Health Authority Forums. You can see the events I am participating in this year, below.

Regulatory Needs Now & in the Future Professional PanelPowerful Speed Networking Resulting in Meaningful Information SharingRAPS Volunteers Converge!Meet & Greet: RAPS Colorado Chapter
Sunday, September 12, 2021
10 AM ET
Monday, September 13, 2021
3 – 3:30 PM ET
Tuesday, September 14, 2021
12 – 12:30 PM ET
Wednesday, September 15, 2021
10:15 – 11 AM ET
Moderator: Brian Savoie – Vice President, Education & Professional Development,  RAPS

Lulu Yang – People, Growth & Transformation Leader, Roche/Genentech

Lindsey Summers, MBA – Director, Pharmaceutical Consulting Division, Green Key Resources

Raina Dauria, RAC – Vice President Regulatory Affairs, J&J
Linda Bowen, MS, RAC, FRAPS – Head of Global Regulatory Policy and Intelligence, Seagen Inc.

Lindsey Summers, MBA – Director, Pharmaceutical Consulting Division, Green Key Resources

Susan Carino, MBA, MS, PMP, RAC – Principal Consultant, Integrated Project Management Company, Inc.
Lindsey Summers, MBA – Director, Pharmaceutical Consulting Division, Green Key Resources

Susan Carino, MBA, MS, PMP, RAC – Principal Consultant, Integrated Project Management Company, Inc.
Lindsey Summers, MBA – Director, Pharmaceutical Consulting Division, Green Key Resources

Kira Meyer, RAC – Chapter Incoming Chair

Bryan Ford, RAC – Chapter Chair

Archana Gopalan – Programming Manager
Join Lindsey Summers for Powerful Speed Networking Resulting in Meaningful Information Sharing at RAPS Convergence 2021
Join Lindsey Summers for Powerful Speed Networking Resulting in Meaningful Information Sharing at RAPS Convergence 2021
Join Lindsey Summers for RAPS Volunteers Converge at RAPS Convergence 2021
Join Lindsey Summers for RAPS Volunteers Converge at RAPS Convergence 2021

In 2021, I’m most interested in attending the opening, “Plenary Celebrating the Profession,” because Janet Woodcock, MD, the Acting FDA Commissioner, Jeffrey Shuren, MD, PhD, Director of the Center for Devices and Radiological Health, Peter Marks, MD PhD, Director, Center for Biologics Evaluation and Research, and Alex Nolte, PharmD, PhD, Head of Human Medicines Division of the European Medicines Agency, will be having a future-forward panel discussion.

In addition, AgencyIQ’s discussion, “What’s Next for FDA After COVID-19?” piques my interest because they will be discussing actions taken by the FDA along with lessons learned. I am interested in hearing predictions about ways that the FDA is likely to change in the months and years ahead.

If you’ve never attended Convergence, there is still time to register!

Congratulations, Lindsey!

Green Key Resources is incredibly proud of your commitment to knowledge sharing and career development in the pharmaceuticals industry. We are honored to have you on the Green Key Pharma team.

Interested in working with Lindsey Summers’ team for your pharma job search?

Browse our opportunities below:

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Green Key
Jun 6, 2023

How COVID Is Changing Clinical Trials

Amidst all the uncertainty about a COVID vaccine, at least this one thing is certain: it is changing how clinical trials are conducted.

Instead of taking years to move apotential vaccine from laboratory to trial, the US’s Operation Warp Speed has moved two of six prospective COVID vaccines into Phase 3 recruitment in under six months. Two more are expected to begin Phase 3 recruitment this month.

In the United Kingdom, a different type of clinical trial showed it is possible to enroll 12,000 patients, test several different existing treatment candidates and have the first significant results in fewer than 100 days.

Even given the substantial differences between the government-run health care system of the UK and the private, decentralized US system, there are lessons – “ideas,” Nicole Mather calls them in an article for the journal Nature – researchers here can apply to accelerate trials.

Describing how the UK’s RECOVERY trial went from concept to first, actionable results in such a short time, Mather identifies five differences with traditional trials:

  1. The trial protocol took only 20 pages to detail the design, and data and regulatory requirements. It was flexible enough to allow trial arms to be stopped or added.
  2. It got approvals in 9 days, versus the typical 30-60.
  3. Recruitment paperwork was simplified.
  4. Data collection and processing was accelerated through the UK’s DigiTrials hub, which provides centralized support for clinical trials.
  5. Results were quickly made public.

Though the RECOVERY program has its critics – objections center on releasing results without first being peer-reviewed and structural issues – Mather says it shows how a centralized health data system and a streamlined design and approval process can accelerate the timeline.

“We’ve gone so far towards managing risk that we’ve created layers of bureaucracy that absorb time and money, and, paradoxically, increase the risk that beneficial treatments are not tested,” she writes.

That view is echoed by Martin Landray, deputy chief investigator of RECOVERY, who said the way the National Institute for Health Research cut red tape was “fabulous.” “Many academic and commercial trials have accumulated so much extra baggage over the years, such as long case report forms and 10 page patient consent forms,” he said in an interview with The BMJ.

Digital entry for the RECOVERY trial made consent and subsequent data collection quick and simple, The BMJ article reports.

Leveraging data systems is an important lesson, says Mather, who is life-sciences lead at IBM Services in London, which was a partner in the DigiTrials project. Because of the UK’s National Health System, much information was already available for trial study patients, simplifying the participation process.

That would be a much greater challenge in the US because of its private medical system, although the strong push over the last decade to digitize medical records is making the portability of patient data easier.

The UK RECOVERY program has given momentum to accelerating clinical trial processes. To build on it, says Landray, “We now need to apply the lessons from this approach to other major health challenges such as heart disease, cancer, arthritis, and mental health.”

Photo by JC Gellidon on Unsplash

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