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Initiative Updates

2020

Project Data Sphere
April 29, 2020
Updated Project Data Sphere platform, website to debut
Project Data Sphere

More than 2,400 researchers are using the Project Data Sphere® platform to answer important questions about cancer. Many of them have offered feedback on how we can make the platform even easier to use.  We are delighted to announce that we expect an updated platform to be available early in 2Q 2020.

A new PDS website will be launched at the same time, offering more information on our programs, introductions to new program managers and easier ways to communicate with us.

The website will be a place that you can register for important events like the PDS Symposium IX on rare cancer registries that we are planning for Oct. 7, 2020, in the Washington DC area. 

This annual symposia series has consistently elevated the conversation about research areas that are ripe for fresh attention in the realm of cancer clinical trials, often deriving major new thrusts from academia, industry as well as from our FDA.

Rare cancer registries hold potential to solve some of the most difficult challenges to advancing treatment of these rare cancers, which account for more than 25% of the cancers reported worldwide.

The symposium attempts to bring together multiple stakeholders representing all sides of this challenge: Practice in the clinic, Pharmaceutical research, Policy and regulatory science, and Patient advocacy to brainstorm the operational dynamics between the groups.

Registries can impact these four areas in the following ways:

  • Refine clinical decision making and more effectively manage patient therapy.
  • Assist pharma in designing comparator arms efficiently, thus accelerating the drug development process.
  • Inform regulators who must decide whether to approve new medicines and how to use them in rare cancers.
  • Provide relief for the suffering patients with better treatment strategies.

Symposium IX will consider how registries for rare tumors might address these existing shortcomings and drive improvements in patient care. More information will be coming soon.

MaryLisabeth Rich

MaryLisabeth Rich

April 29, 2020
Task Force looks to 'Go for the Gold'
Gold Standard: Task Force

More than 200 employers are covering 7 million lives through CEO Cancer Gold Standard accreditation, an impressive population benefitting from increased cancer awareness, prevention and treatment. But the CEO Roundtable on Cancer Gold Standard Task Force is asking whether that’s enough.

“Can we do more as employers to be a catalyst for better health in our communities?” said MaryLisabeth Rich, President of the Gold Standard and Member Services. “Enormous health disparities exist so we need to ask ourselves whether we can bridge the gap in clinical trial diversity through corporate well-being? Healthy communities are good for our business, good for recruiting and retaining employees and it’s the right thing to do.”

MaryLisabeth is exploring the topic with leadership from the Task Force and in preparation for this year’s CEO Roundtable on Cancer Annual Meeting and Conference, where there will be more presentations and discussion of how companies can “Go for the Gold” and reach a higher level of health for their community. One aspect to be explored is a potential partnership between corporate partners and historically black colleges and universities.

New Member Logos
April 29, 2020
Welcome to new members
CEO Roundtable on Cancer: In the News

BeiGene and John V. Oyler, Chairman, Co-Founder and CEO. BeiGene started in Beijing and has expanded to be a global company. Its focus is discovery, development, and commercialization of innovative, molecularly-targeted, and immuno-oncology drugs for the treatment of cancer.

Daiichi Sankyo Inc. and Ken Keller, President and CEO. Daiichi Sankyo is a global pharmaceutical company with corporate origins in Japan. It provides innovative products and services in more than 20 countries around the world. With more than 100 years of scientific expertise, the company draws upon a rich legacy of innovation and a robust pipeline of promising new medicines to help patients.

Foundation Medicine Inc. and Brian Alexander, Chief Medical Officer. Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.

The Menarini Group and CEO Elcin Barker Ergun. Menarini Group, the leading Italian pharmaceutical company in the world, has 17,640 employees in 136 countries, including the US in San Diego and Philadelphia.

All the Best Podcast
April 29, 2020
Bush Foundation Podcast Features CEO Cancer Gold Standard
Gold Standard

At the CEO Roundtable on Cancer, we've come a long way in the 20 years since President George H.W. Bush urged us to do everything we could to defeat cancer.  One of the Bushes’ grandsons, Sam LeBlond, recently asked Dr. Martin Murphy to recall the start of the Roundtable and how it has expanded into China.

LeBlond hosts All the Best, a weekly podcast for the George & Barbara Bush Foundation. All the Best features interviews with the Bushes’ family, friends, former colleagues and fellow Points of Light with a special emphasis on service to others.

We hope you’ll take a listen to Episode 15, “The Gold Standard.” The podcast is on Apple podcasts or can be found here: http://allthebestbush.libsyn.com/15-the-gold-standard

Anne Arundel Medical Center

Anne Arundel Medical Center

April 13, 2020
Anne Arundel Medical Center Earns CEO Cancer Gold Standard Accreditation
Gold Standard

The CEO Roundtable on Cancer has accredited Anne Arundel Medical Center with the CEO Cancer Gold StandardTM recognizing its efforts to reduce the risk of cancer for its employees and covered family members.

“Anne Arundel Medical Center is honored to be among the leading organizations to achieve the CEO Cancer Gold Standard Accreditation,” said Sherry B. Perkins, president of Anne Arundel Medical Center. “We strive to provide the highest quality of care for our patients and are equally committed to promoting the wellbeing of our employees and their families. We offer the latest technology in diagnostics and treatments with access to innovative research and clinical trials to deliver care and support that comes with compassion. Cancer is not only treating a disease; it’s caring for each person throughout his or her journey.”

Employers from many industries are keenly aware of the positive impact they can have on health and controlling healthcare costs when they take steps to address cancer and other chronic diseases.

COVID-19

COVID-19

April 09, 2020
Roundtable online event focuses on clinical trial solutions during COVID-19
CEO Roundtable on Cancer

COVID-19 immediately affected the conduct of ongoing clinical trials but it equally changed the way they will be conducted in the future, said speakers at the CEO Roundtable on Cancer online conference April 24 on “Maintaining Oncology Clinical Trial Integrity during the Covid-19 Pandemic.”

“Oncology trials represent an important subset of clinical trials,” said Dr. Mace Rothenberg, panel moderator and Chief Medical Officer, Pfizer. “There is the serious and life-threatening nature of the disease; the fact that a clinical trial may represent the best or only option for some patients with few or no other therapeutic options; they require special expertise in administration, monitoring, and management of acute adverse events or hypersensitivity reactions; and the use of advanced technology processing samples that cannot be easily performed outside of trial sites.”

There were three primary areas of discussion about trials amid the pandemic: managing patients in studies, managing data from studies, and interpreting trials with missing data and other challenges.

Speakers included clinical trial experts from industry, academia, and the US Food and Drug Administration who shared recent experiences. The audience was invited to pose questions and more than a dozen FDA staff attended the 90-minute panel to gather input and learn more about what’s happening on the front lines of research.

Within the US there have been wide geographic disparities in severity of COVID-19 and response to the virus, which makes trial operations challenging. But many shared accounts of positive results with telemedicine that will become a standard trial feature going forward.

“If there is a silver lining, it is that we are running a grand experiment concerning decentralized trials,” said Dr. Paul Kluetz, Deputy Director, Oncology Center of Excellence, FDA. “We have been interested in this for a long time, because they can show us efficiencies and can be quite patient friendly.”

Other speakers expressed frustration that regulatory agencies around the world do not agree on what trial modifications are permitted.  

“Most of our recommendations at the moment have been based on internally coordinating across centers and within FDA and less of a coordination externally with the other regulatory bodies,” said Dr. Patricia Keegan, Associate Director for Policy, Oncology Center for Excellence, FDA. “That’s why I was particularly interested in comments about differences across regulatory agencies that are posing particular problems.”

Panelists agreed that some of the most pressing questions that remain include:

  • How should missing trial data be handled? What statistical techniques should be used to address this?
  • How do we assess the impact of geographic disparities because of the varying intensity and duration of the pandemic?
  • How will we share information about tools and technologies that have been effective for remote monitoring and data collection?
  • How should we view the so-called “period” effect related to the time before, during and after COVID?
  • What should be site-level protocol deviations versus protocol amendments? Safety measures are being implemented without approval leading to compliance concerns.
  • How do we always keep in mind the benefit to patients as well as their safety?

“We are in the middle of a grand experiment. What we don’t know yet is the result of that experiment,” Dr. Dave Reese, Executive Vice President, R&D, Amgen, said in summing up the conference. “What are the conclusions of the experiment? I believe it’s incumbent on all of us to really ask fundamental deep questions of what do we change permanently? There are many things that we must learn from this experiment.”

Most of the attendees represented pharma and biotech industries but government agencies, academia and others, including non-profits, also made up a substantial part of the audience.

Post-event surveys reflected that participants found the content important and they would likely attend a future virtual meeting hosted by the CEO Roundtable on Cancer. Discussion is ongoing about future topics for similar events.

2019

BHAC 2019

Meeting health and wellness champions from around the country. Learning and sharing evidence-based best practices.

April 29, 2019
The Gold Standard is for U
Gold Standard: Community

Therese Martin represented the CEO Roundtable on Cancer at the 2019 Building Healthy Academic Communities (BHAC) Summit held on the campus of the first BIG Ten University to earn Gold Standard accreditation, The Ohio State University in Columbus, Ohio. BHAC connects health and wellness professionals from US academic institutions in pursuit of healthier campuses. 

Recognizing leaders in academia are uniquely suited to influence their own institutions workforce as well as the leaders for tomorrow, Ms. Martin encouraged those in attendance to lead by example by earning Gold Standard accreditation. The message that leadership drives culture and prevention saves lives was well recieved.

April 17, 2019
FDA-PDS Symposium VII
Project Data Sphere: FDA Symposium

More than 90 experts in the oncology community were convened on April 17, 2019, in Bethesda, Md., to focus on immune-related adverse events (irAEs) that can occur with the use of combination checkpoint blockade therapies. Co-sponsored by Project Data Sphere, LLC (PDS) and the U.S. Food and Drug Administration (FDA), this symposium focused on ways to strengthen irAE and toxicity reporting and data collection so as to better understand which patients are more likely to suffer these often-devastating adverse events. As attendees learned from a patient advocate who spoke, it is not unheard of for a patient who succumbs to an irAE to be tumor-free at the time of death. 

Thought leaders organized presentations and panels on the clinical presentation of irAEs and toxicity during combination therapy, preliminary findings from immune checkpoint inhibitor (ICI) clinical trial data submitted to the FDA and post-marketing surveillance data, and current initiatives to accelerate knowledge with biorepositories and patient registries. The Symposium was distinguished by the FDA presentations of selected clinical trial data on ICIs and the post-market surveillance (FAERS) data on adverse events associated with ICIs; neither of these rich FDA data sources had ever been presented.

January 24, 2019
PDS Highlighted in In Vivo Feature
Project Data Sphere: In the News

Now that Project Data Sphere has established itself as a world-class data-sharing platform, the group's leadership is planning for its next phase of the struggle against cancer. In this In Vivo piece, PDS President Bill Louv talks about how the organization has "raised the bar on what is possible to achieve in cancer research."

2018

Photo from FDA-PDS Symposium VI
August 08, 2018
FDA-PDS Symposium VI
Project Data Sphere

More than 60 oncologists, data scientists, pharma/biotech industry leaders, patient advocates, health science research investigators, and regulators representing myriad esteemed institutions convened in Bethesda, Md., on August 8 for Project Data Sphere, LLC’s (PDS) sixth symposium co-sponsored with the U.S. Food and Drug Administration (FDA). With the goal of accelerating new options for small cell lung cancer patients (SCLC) in a stagnant treatment landscape, PDS is collaborating with the FDA on the development of an external control arm for SCLC clinical trials. This would enable patients to be enrolled directly into a trial’s new drug investigational arm, which ultimately would reduce the number of patients per trial as well as the cost and time of discovery for new treatment options. The daylong event featured a combination of individual and panel presentations and lively discussions 

Shanghai Tobacco Control Workshop on Law Enforcement, Aug. 8, 2018

August 08, 2018
Tobacco Control Workshop held in Shanghai under the auspices of CEO Roundtable on Cancer-China
CEO Roundtable on Cancer - China

On August 8, 2018, the CEO Roundtable on Cancer-China (上海拓新健康促进中心) organized and co-hosted an all-day Tobacco Control Workshop with the Shanghai Association on Tobacco Control (SATC) under the auspices of the Office of Shanghai Health Promotion Committee.  The committee were guests of the China Financial Information Center located in the world’s second tallest building, The Shanghai Tower, in the Financial District of Lujiazui.

This was the  first time that all of Shanghai’s different law enforcement agencies jointly attended an open discussion on tobacco control law enforcement. Representatives from virtually every different law enforcement agency participated to including those responsible for tobacco control at Shanghai’s airports, buses and trains as well as those who oversee and conduct cultural and athletic events in this huge metropolis.  It is worth noting that only rarely do municipal government  and legislative officers meet  together with the media. 

 

Dave Shepperly & Ann Skye at ORCHSE Meeting, August 8, 2018 in Washington, DC.

August 07, 2018
Gold Standard Framework Shared at Corporate Health Directors Network Meeting
Gold Standard

David Shepperly, MD, MHS, FACOEM, Head of Employee Health and Fitness at Bristol-Myers Squibb, invited fellow Gold Standard Task Force Member Ann Skye, BSN, MPH, Associate Director, Employee Health Management for IQVIA, to present an overview of the Gold Standard to the ORCHSE Strategies summer meeting of the Corporate Health Directors Network in Washington, DC.

Ann's overview of the unique global approach to wellness in the workplace using the framework of the CEO Cancer Gold Standard was well received. The presentation prompted a productive discussion and garnered interest in the program from meeting participants. We thank Ann and Dave for their efforts to expand the reach and impact of the Gold Standard!

ORC HSE is a membership based global HSE (Health, Safety, and Environment) networking and service firm that has been connecting HSE thought leaders across the globe for more than 45 years. The Corporate Health Directors Network serves corporate leaders with primary responsibility for occupational health program management, drawing members from the most innovative multinational Fortune 500 companies. 

Student Photo

Students from Nonglinlu Primary School in Handan city in Hebei province look at an anti-smoking exhibit on May 30.

June 21, 2018
CEOs Pledge to Stub Out Smoking
CEO Roundtable on Cancer - China

Senior executives of companies in Shanghai’s Lujiazui district, known as the “Wall Street of China”, pledged to create a smoke-free working environment last Wednesday. Initiated by NGO the CEO Roundtable on Cancer-China and supported by the World Health Organization, the national campaign aims to encourage as many enterprises as possible in the country to say no to smoking not only inside their offices, but also in factories, on campuses and other open spaces.

“We hope to help more employers in China to create 100 percent smoke-free workplaces, where employees are encouraged to give up smoking,” said Ray Wang, senior director of the CEO Roundtable on Cancer-China in Shanghai.

Ann Skye, RN, MPH

Ann Skye, BSN, MPH, Associate Director, Employee Health Management, IQVIA

June 14, 2018
Global Workplace Wellness through the CEO Cancer Gold Standard Frame: Focus on China
Gold Standard: Global

Employers can play a pivotal role in reducing cancer incidence and premature death. Healthier employees and healthier bottom lines can be achieved by providing evidence-based prevention and early detection services and encouraging employee engagement. By providing access and encouraging participation, more lives – and more money-be saved. The Gold Standard's employer-led work-place wellness model is now being shared in China and across the globe. 

Ann Skye, BSN, MPH, Associate Director, Employee Health Management, IQVIA, and Global Gold Standard Subcommittee Chair, was invited by the International Association of Worksite Health Promotion (IAWHP) and the Global Center for Healthy Workplaces (GCHW) to discuss how the Gold Standard's evidence-based wellness framework can be adopted by corporations with a presence in the US, China and globally. Ann was joined by representatives from Gold Standard employers, Bristol-Myers Squibb, GlaxoSmithKline and Novartis who also shared their unique insights and perspectives.

The informative presentation and subsequent discussion focused on the challenges associated with adapting the Gold Standard requirements to a global workforce with particular emphasis on China. A recording of the webinar is available here.

Meeting the Gold Standard’s comprehensive requirements is a notable achievement. To meet the complex challenges of adopting this standard of health and wellness globally and in China takes exceptional leadership.

Elisabet de los Pinos, PhD, CEO, Aura Biosciences

June 12, 2018
Aura Biosciences Earns CEO Cancer Gold Standard Accreditation
Gold Standard

The CEO Roundtable on Cancer has accredited Aura Biosciences of Cambridge, MA — a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells — with the CEO Cancer Gold StandardTM recognizing its efforts to reduce the risk of cancer for its employees and covered family members.

“Our passion at Aura Biosciences is to improve treatment options for a wide range of cancers that are poorly managed today — so this recognition is very meaningful to us,” said Aura Chief Executive Officer Elisabet de los Pinos, Ph.D. “We are dedicated to creating a healthy workplace where employees have access to the highest quality medical care.”

Employers from many industries are keenly aware of the positive impact they can have on health and controlling healthcare costs when they take steps to address cancer and other chronic diseases.

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