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:

Jun 6, 2023

Diabetes and Weight Loss Is a High Risk for Cancer

A just published study says adults with recent-onset diabetes who have lost weight – even as little as 1 pound – are at higher risk of developing pancreatic cancer. The greater the weight loss, the higher the risk.

Published online at JAMA Oncology, the study found that individuals with recent-onset diabetes who lost between 1 and 4 pounds had a 25% higher risk of pancreatic cancer, while those whose weight loss was more than 8 pounds had a 92% higher risk than those who had no weight loss.

When compared to those without diabetes, the risk of developing cancer was almost 7 times higher for those with the biggest weight loss.

That there’s an association between diabetes and pancreatic cancer is well known. Previous studies have shown that recent-onset diabetes and unintentional weight loss could lead to developing pancreatic cancer.

“The more novel finding here is that when both risk factors are combined, the risk is even greater,” said Peter Campbell, PhD, scientific director of epidemiology research at the American Cancer Society.

The significance of these findings, according to the researchers, is that individuals with recent-onset diabetes accompanied by weight loss “may be a group for whom early detection strategies would be advantageous.”

“Pancreatic cancer is the third-leading cause of cancer-related death in the United States, with a 5-year survival rate of less than 10%,” wrote Chen Yuan, ScD, with the Harvard Medical School and Dana-Farber Cancer Institute, and his research colleagues.

“This low survival rate is largely associated with the diagnosis occurring at an advanced stage when the cancer is no longer curable.”

By monitoring high risk individuals, as is done with those having a family history of pancreatic cancer, the chance of detecting it early improves markedly and substantially increases the survival rate.

How aggressively this should be done for those with recent-onset diabetes and weight loss requires additional study, the researchers said.

However, “The coexistence of these symptoms should be recognized by clinicians given that both the relative and absolute risks for pancreatic cancer are high, particularly in individuals with healthy weight before weight loss or those who are not trying to lose weight through changes in physical activity or diet.”

Photo by Samuel Ramos on Unsplash

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