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Cancer Policy Related News from Washington DC and New NCI Appointments

Reportor: Stephen J. Williams, PhD.

Biden to announce appointees to Cancer Panel, part of initiative to cut death rate

The president first launched the initiative in 2016 as vice president.

By Mary Kekatos

July 13, 2022, 3:00 PM

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President Joe Biden will announce Wednesday his appointees to the President’s Cancer Panel, ABC News can exclusively reveal.

The Cancer Panel is part of Biden’s Cancer Moonshot Initiative, which was relaunched in February, with a goal of slashing the national cancer death rate by 50% over the next 25 years.MORE: Biden relaunches cancer ‘moonshot’ initiative to help cut death rate

Biden will appoint Dr. Elizabeth Jaffee, Dr. Mitchel Berger and Dr. Carol Brown to the panel, which will advise him and the White House on how to use resources of the federal government to advance cancer research and reduce the burden of cancer in the United States.

Jaffee, who will serve as chair of the panel, is an expert in cancer immunology and pancreatic cancer, according to the White House. She is currently the deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University and previously led the American Association for Cancer Research.

PHOTO: In this Sept. 8, 2016, file photo, Dr. Elizabeth M. Jaffee of the Pancreatic Dream Team attends Stand Up To Cancer (SU2C), a program of the Entertainment Industry Foundation (EIF), in Hollywood, Calif.
In this Sept. 8, 2016, file photo, Dr. Elizabeth M. Jaffee of the Pancreatic Dream Team attends Stand Up To Cancer (SU2C), a program of the Entertainment Industry Foundation (EIF), in Hollywood, Calif.ABC Handout via Getty Images, FILE

Berger, a neurological surgeon, directs the University of California, San Francisco Brain Tumor Center and previously spent 23 years at the school as a professor of neurological surgery.

Brown, a gynecologic oncologist, is the senior vice president and chief health equity officer at Memorial Sloan Kettering Cancer Center in New York City. According to the White House, much of her career has been focused on eliminating cancer care disparities due to racial, ethnic, cultural or socioeconomic factors.

Additionally, First Lady Jill Biden, members of the Cabinet and other administration officials are holding a meeting Wednesday of the Cancer Cabinet, made up of officials across several governmental departments and agencies, the White House said.

The Cabinet will introduce new members and discuss priorities in the battle against cancer including closing the screening gap, addressing potential environmental exposures, reducing the number of preventable cancer and expanding access to cancer research.MORE: Long Island school district found to have higher rates of cancer cases: Study

It is the second meeting of the cabinet since Biden relaunched the initiative in February, which he originally began in 2016 when he was vice president.

Both Jaffee and Berger were members of the Blue Ribbon Panel for the Cancer Moonshot Initiative led by Biden.

The initiative has personal meaning for Biden, whose son, Beau, died of glioblastoma — one of the most aggressive forms of brain cancer — in 2015.

“I committed to this fight when I was vice president,” Biden said at the time, during an event at the White House announcing the relaunch. “It’s one of the reasons why, quite frankly, I ran for president. Let there be no doubt, now that I am president, this is a presidential, White House priority. Period.”

The initiative has several priority actions including diagnosing cancer sooner; preventing cancer; addressing inequities; and supporting patients, caregivers and survivors.

PHOTO: In this June 14, 2016, file photo, Dr. Carol Brown, physician at Memorial Sloan Kettering Cancer Center, gives a presentation, at The White House Summit on The United State of Women, in Washington, D.C.
In this June 14, 2016, file photo, Dr. Carol Brown, physician at Memorial Sloan Kettering Cancer Center, gives a presentation, at The White House Summit on The United State of Women, in Washington, D.C.NurPhoto via Getty Images, FILE

The White House has also issued a call to action to get cancer screenings back to pre-pandemic levels.

More than 9.5 million cancer screenings that would have taken place in 2020 were missed due to the COVID-19 pandemic, according to the National Institutes of Health.MORE: Louisiana’s ‘Cancer Alley’ residents in clean air fight

“We have to get cancer screenings back on track and make sure they’re accessible to all Americans,” Biden said at the time.

Since the first meeting of the Cancer Cabinet, the Centers for Disease Control and Prevention has issued more than $200 million in grants to cancer prevention programs, the Centers for Medicaid & Medicare Services implemented a new model to reduce the cost of cancer care, and the U.S. Patent and Trademark Office said it will fast-track applications for cancer immunotherapies.

ABC News’ Sasha Pezenik contributed to this report.

Biden to tap prominent Harvard cancer surgeon to head National Cancer Institute

Monica Bertagnolli brings leadership experience in cancer clinical trials funded by the $7 billion research agency

headshot of Monica Bertagnolli
Monica BertagnolliASCO; GLENN DAVENPORT

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President Joe Biden is expected to pick cancer surgeon Monica Bertagnolli as the next director of the National Cancer Institute (NCI). Bertagnolli, a physician-scientist at Brigham and Women’s Hospital, the Dana-Farber Cancer Center, and Harvard Medical School, specializes in gastrointestinal cancers and is well known for her expertise in clinical trials. She will replace Ned Sharpless, who stepped down as NCI director in April after nearly 5 years.

The White House has not yet announced the selection, first reported by STAT, but several cancer research organizations closely watching for the nomination have issued statements supporting Bertagnolli’s expected selection. She is “a national leader” in clinical cancer research and “a great person to take the job,” Sharpless told ScienceInsider.

With a budget of $7 billion, NCI is the largest component of the National Institutes of Health (NIH) and the world’s largest funder of cancer research. Its director is the only NIH institute director selected by the president. Bertagnolli’s expected appointment, which does not require Senate confirmation, drew applause from the cancer research community

Margaret Foti, CEO of the American Association for Cancer Research, praised Bertagnolli’s “appreciation for … basic research” and “commitment to ensuring that such treatment innovations reach patients … across the United States.” Ellen Sigal, chair and founder of Friends of Cancer Research, says Bertagnolli “brings expertise the agency needs at a true inflection point for cancer research.”

Bertagnolli, 63, will be the first woman to lead NCI. Her lab research on tumor immunology and the role of a gene called APC in colorectal cancer led to a landmark trial she headed showing that an anti-inflammatory drug can help prevent this cancer. In 2007, she became the chief of surgery at the Dana-Farber Brigham Cancer Center.

She served as president of the American Society of Clinical Oncology in 2018 and currently chairs the Alliance for Clinical Trials in Oncology, which is funded by NCI’s National Clinical Trials Network. The network is a “complicated” program, and “Monica will have a lot of good ideas on how to make it work better,” Sharpless says.

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One of Bertagnolli’s first tasks will be to shape NCI’s role in Biden’s reignited Cancer Moonshot, which aims to slash the U.S. cancer death rate in half within 25 years. NCI’s new leader also needs to sort out how the agency will mesh with a new NIH component that will fund high-risk, goal-driven research, the Advanced Research Projects Agency for Health (ARPA-H).

Bertagnolli will also head NCI efforts already underway to boost grant funding rates, diversify the cancer research workplace, and reduce higher death rates for Black people with cancer.

The White House recently nominated applied physicist Arati Prabhakar to fill another high-level science position, director of the White House Office of Science and Technology Policy (OSTP). But still vacant is the NIH director slot, which Francis Collins, acting science adviser to the president, left in December 2021. And the administration hasn’t yet selected the inaugural director of ARPA-H.

Correction, 22 July, 9 a.m.: This story has been updated to reflect that Francis Collins is acting science adviser to the president, not acting director of the White House Office of Science and Technology Policy.

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National Cancer Institute Director Neil Sharpless says mortality from delays in cancer screenings due to COVID19 pandemic could result in tens of thousands of extra deaths in next decade

Reporter: Stephen J Williams, PhD

UPDATED: 08/14/2023

A Cross Sectional Study Reveals What Oncologists Had Feared: Cancer Screenings During Pandemic Has Decreased, leading to Decreased Early Detection

As discussed in many articles here on COVID-19 and cancer, during the pandemic many oncologists were worried that people slowed getting their cancer screenings due to health risks due to the COVID-19 outbreak.  Governmental agencies went as far to project upticks in future cancer rates, as preventative screening rates were down due to closed hospitals, shuttered services, or patient trepidation during the height of the pandemic.  As many oncologists voiced, a decrease in cancer screenings might lead to missing out on the early stages of the disease, when most treatable. Now, reported in a Lancet cross-sectional analysis by investigators at ACS and University of Texas Southwest (1), we have the first indication of the effects of this decrease in preventative screening, namely decreased early detection and diagnosis.

The authors used data from the US National Cancer Database, a nationwide hospital-based cancer registry, to perform a cross sectional nationwide assessment of the prevalence of new cancer diagnosis before, during, and after the height of the pandemic (March 1 2020 to December 31, 2020).  Newly diagnosed cases of first primary malignant cancer between Jan1, 2018 to Dec 31, 2020 were identified and monthly and annual counts and stage distributions were caluculated andpresented as adjusted odds ratios (aORs).  They also used the period from 2018 to Jan 2020 as a baseline or prepandemic level of newly diagnosed cancer.

Results of this analysis identified 2,404,050 adults with newly diagnosed cancer during study period 2018 to 2020.  The monthly number of new cancer diagnoses (all stages) decreased significantly after the start of the COVID-19 pandemic in March 2020.  However new cancer diagnosis returned to pre-pandemic levels by end of 2020.  The decrease in diagnosis was largest for stage I diseases however the odds of being diagnosed with late stage IV disease were higher in 2020 than in 2019.  When the authors stratified the cohorts based on sociodemographic groups, interestingly those most affected (with lowest diagnosis rates during the pandemic) were those living in socioeconomic deprived areas, hispanics, asian americans, pacific Islanders, and uninsured individuals.

The authors’ interpretations are a warning: Substantial cancer underdiagnosis and decreases in the proportion of early stage diagnoses occurred during 2020 in the USA, particularly among medically underserved individuals. Monitoring the long-term effects of the pandemic on morbidity, survival, and mortality is warranted.

 

 

Evidence before this study

We searched PubMed using the terms “COVID”, “pandemic”, and “cancer” for studies published in English between

March 1, 2020, and Nov 30, 2022. Health care was disrupted during the emergence of the COVID-19 pandemic. In the USA, rapid decreases in screening were reported for nearly all types of cancer screening services after the declaration of the COVID-19 national emergency. Decreased screening, and delayed and forgone routine check-ups or health-care visits, can lead to underdiagnosis of cancer, especially for early stage disease for which treatment is most effective. Several studies have identified reduced use of diagnostic procedures and decreases in the number of newly diagnosed patients during 2020 in the USA. However, these studies were done in selected populations, in specific geographical areas, or for only a single cancer type, limiting understanding of the COVID-19 pandemic on cancer burden nationally.

Added value of this study

Using a recently released nationwide cancer registry dataset, we comprehensively evaluated changes in cancer diagnoses and stage distribution during the first year of the COVID-19 pandemic by cancer type and key sociodemographic factors in the USA.

Implications of all the available evidence

Along with existing evidence, our findings should help to inform future policy and cancer care delivery interventions to improve access to care for underserved populations. Research is warranted to monitor the long-term effects of the underdiagnosis of early stage cancer identified in this study on morbidity, mortality, and disparities in health outcomes.

Results

The main results from the paper are summarized below:

 

Between 2020 and 2019, annual stage I diagnoses decreased by 17·2% (95% CI 16·8–17·6), and annual stage IV diagnoses decreased 9·8% (9·2–10·5). Notably, by race and ethnicity, the largest percentage reduction in stage I diagnoses was among Hispanic individuals and Asian American and Pacific Islander individuals, and the largest percentage reduction in stage IV diagnoses was among non-Hispanic Black and non-Hispanic White individuals. Diagnoses of lung cancer, colorectal cancer, melanoma, and non-Hodgkin lymphoma had the largest percentage reduction among both stage I (>18%) and stage IV (>10%) diagnoses; cancers of the prostate, cervix, liver, oesophagus, stomach, and thyroid also had large percentage reductions in stage I diagnoses (>20).

After adjusting for sociodemographic and clinical factors, the stage distribution of new diagnoses changed in 2020 compared with 2019 (table 3). Specifically, the aOR for being diagnosed with stage I disease versus stage II–IV disease in 2020 compared with 2019 was 0·946 (95% CI 0·939–0·952), and the aOR for being diagnosed with stage IV disease versus stage I–III disease in 2020 compared with 2019 was 1·074 (1·066–1·083).

These results also confirmed results seen in other studies coming from Europe (2,3, 4).

References

  1. Han X, Yang NN, Nogueira L, Jiang C, Wagle NS, Zhao J, Shi KS, Fan Q, Schafer E, Yabroff KR, Jemal A. Changes in cancer diagnoses and stage distribution during the first year of the COVID-19 pandemic in the USA: a cross-sectional nationwide assessment. Lancet Oncol. 2023 Aug;24(8):855-867. doi: 10.1016/S1470-2045(23)00293-0. PMID: 37541271.
  2. Kuzuu K, Misawa N, Ashikari K, et al. Gastrointestinal cancer stage at diagnosis before and during the COVID-19 pandemic in Japan. JAMA Netw Open 2021; 4: e2126334. DOI: 10.1001/jamanetworkopen.2021.26334
  3. Linck PA, Garnier C, Depetiteville MP, et al. Impact of the COVID-19 lockdown in France on the diagnosis and staging of breast cancers in a tertiary cancer centre. Eur Radiol 2022; 32: 1644–51. DOI: 10.1007/s00330-021-08264-3
  4. Mynard N, Saxena A, Mavracick A, et al. Lung cancer stage shift as a result of COVID-19 lockdowns in New York City, a brief report. Clin Lung Cancer 2022; 23: e238–42.  DOI: 10.1016/j.cllc.2021.08.010

 

 

UPDATED: 10/11/2021

Source: https://cancerletter.com/articles/20200619_1/

NCI Director’s Report

Sharpless: COVID-19 expected to increase mortality by at least 10,000 deaths from breast and colorectal cancers over 10 years

By Matthew Bin Han Ong

This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.

The COVID-19 pandemic will likely cause at least 10,000 excess deaths from breast cancer and colorectal cancer over the next 10 years in the United States.

Scenarios run by NCI and affiliated modeling groups predict that delays in screening for and diagnosis of breast and colorectal cancers will lead to a 1% increase in deaths through 2030. This translates into 10,000 additional deaths, on top of the expected one million deaths resulting from these two cancers.

“For both these cancer types, we believe the pandemic will influence cancer deaths for at least a decade,” NCI Director Ned Sharpless said in a virtual joint meeting of the Board of Scientific Advisors and the National Cancer Advisory Board June 15. “I find this worrisome as cancer mortality is common. Even a 1% increase every decade is a lot of cancer suffering.

“And this analysis, frankly, is pretty conservative. We do not consider cancers other than those of breast and colon, but there is every reason to believe the pandemic will affect other types of cancer, too. We did not account for the additional non-lethal morbidity from upstaging, but this could also be significant and burdensome.”

An editorial by Sharpless on this subject appears in the journal Science.

The early analyses, conducted by the institute’s Cancer Intervention and Surveillance Modeling Network, focused on breast and colorectal cancers, because these are common, with relatively high screening rates.

CISNET modelers created four scenarios to assess long-term increases in cancer mortality rates for these two diseases:

  1. The pandemic has no effect on cancer mortality
  1. Delayed screening—with 75% reduction in mammography and, colorectal screening and adenoma surveillance for six months
  1. Delayed diagnosis—with one-third of people delaying follow-up after a positive screening or diagnostic mammogram, positive FIT or clinical symptoms for six months during a six-month period
  1. Combination of scenarios two and three

Treatment scenarios after diagnosis were not included in the model. These would be: delays in treatment, cancellation of treatment, or modified treatment.

“What we did is show the impact of the number of excess deaths per year for 10 years for each year starting in 2020 for scenario four versus scenario one,” Eric “Rocky” Feuer, chief of the NCI’s Statistical Research and Applications Branch in the Surveillance Research Program, said to The Cancer Letter.

Feuer is the overall project scientist for CISNET, a collaborative group of investigators who use simulation modeling to guide public health research and priorities.

“The results for breast cancer were somewhat larger than for colorectal,” Feuer said. “And that’s because breast cancer has a longer preclinical natural history relative to colorectal cancer.”

Modelers in oncology are creating a global modeling consortium, COVID-19 and Cancer Taskforce, to “support decision-making in cancer control both during and after the crisis.” The consortium is supported by the Union for International Cancer Control, The International Agency for Research on Cancer, The International Cancer Screening Network, the Canadian Partnership Against Cancer, and Cancer Council NSW, Australia.

A spike in cancer mortality rates threatens to reverse or slow down—at least in the medium term—the steady trend of reduction of cancer deaths. On Jan. 8, the American Cancer Society published its annual estimates of new cancer cases and deaths, declaring that the latest data—from 2016 to 2017—show the “largest ever single-year drop in overall cancer mortality of 2.2%.” Experts say that innovation in lung cancer treatment and the success of smoking cessation programs are driving the sharp decrease (The Cancer LetterFeb. 7, 2020).

The pandemic is expected to have broader impact, including increases in mortality rates for other cancer types. Also, variations in severity of COVID-19 in different regions in the U.S. will influence mortality metrics.

“There’s some other cancers that might have delays in screening—for example cervical, prostate, and lung cancer, although lung cancer screening rates are still quite low and prostate cancer screening should only be conducted on those who determine that the benefits outweigh the harms,” Feuer said. “So, those are the major screening cancers, but impacts of delays in treatment, canceling treatment or alternative treatments—could impact a larger range of cancer sites.

“This model assumes a moderate disruption which resolves after six months, and doesn’t consider non-lethal morbidities associated with the delay. One thing I think probably is occurring is regional variation in these impacts,” Feuer said. “If you’re living in New York City where things were ground zero for some of the worst impact early on, probably delays were larger than other areas of the country. But now, as we’re seeing upticks in other areas of the country, there may be in impact in these areas as well”

How can health care providers mitigate some of these harms? For example, for people who delayed screening and diagnosis, are providers able to perform triage, so that those at highest risk are prioritized?

“From a strictly cancer control point of view, let’s get those people who delayed screening, or followup to a positive test, or treatment back on schedule as soon as possible,” Feuer said. “But it’s not a simple calculus, because in every situation, we have to weigh the harms and benefits. As we come out of the pandemic, it tips more and more to, ‘Let’s get back to business with respect to cancer control.’

“Telemedicine doesn’t completely substitute for seeing patients in person, but at least people could get the advice they need, and then are triaged through their health care providers to indicate if they really should prioritize coming in. That helps the individual and the health care provider  weigh the harms and benefits, and try to strategize about what’s best for any individual.”

If the pandemic continues to disrupt routine care, cancer-related mortality rates would rise beyond the predictions in this model.

“I think this analysis begins to help us understand the costs with regard to cancer outcomes of the pandemic,” Sharpless said. “Let’s all agree we will do everything in our power to minimize these adverse effects, to protect our patients from cancer suffering.”

UPDATED: 10/11/2021

Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak

Source:

Mengyuan DaiDianbo LiuMiao LiuFuxiang ZhouGuiling LiZhen ChenZhian ZhangHua YouMeng WuQichao ZhengYong XiongHuihua XiongChun WangChangchun ChenFei XiongYan ZhangYaqin PengSiping GeBo ZhenTingting YuLing WangHua WangYu LiuYeshan ChenJunhua MeiXiaojia GaoZhuyan LiLijuan GanCan HeZhen LiYuying ShiYuwen QiJing YangDaniel G. TenenLi ChaiLorelei A. MucciMauricio Santillana and Hongbing Cai. Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak

Abstract

The novel COVID-19 outbreak has affected more than 200 countries and territories as of March 2020. Given that patients with cancer are generally more vulnerable to infections, systematic analysis of diverse cohorts of patients with cancer affected by COVID-19 is needed. We performed a multicenter study including 105 patients with cancer and 536 age-matched noncancer patients confirmed with COVID-19. Our results showed COVID-19 patients with cancer had higher risks in all severe outcomes. Patients with hematologic cancer, lung cancer, or with metastatic cancer (stage IV) had the highest frequency of severe events. Patients with nonmetastatic cancer experienced similar frequencies of severe conditions to those observed in patients without cancer. Patients who received surgery had higher risks of having severe events, whereas patients who underwent only radiotherapy did not demonstrate significant differences in severe events when compared with patients without cancer. These findings indicate that patients with cancer appear more vulnerable to SARS-CoV-2 outbreak.

Significance: Because this is the first large cohort study on this topic, our report will provide much-needed information that will benefit patients with cancer globally. As such, we believe it is extremely important that our study be disseminated widely to alert clinicians and patients.

Introduction

A new acute respiratory syndrome coronavirus, named SARS-CoV-2 by the World Health Organization (WHO), has rapidly spread around the world since its first reported case in late December 2019 from Wuhan, China (1). As of March 2020, this virus has affected more than 200 countries and territories, infecting more than 800,000 individuals and causing more than 40,000 deaths (2).

With more than 18 million new cases per year globally, cancer affects a significant portion of the population. Individuals affected by cancer are more susceptible to infections due to coexisting chronic diseases, overall poor health status, and systemic immunosuppressive states caused by both cancer and anticancer treatments (3). As a consequence, patients with cancer who are infected by the SARS-CoV-2 coronavirus may experience more difficult outcomes than other populations. Until now, there is still no systematic evaluation of the effects that the SARS-CoV-2 coronavirus has of patients with cancer in a representative population. A recent study reported a higher risk of severe events in patients with cancer when compared with patients without cancer (4); however, the small sample size of SARS-CoV-2 patients with cancer used in the study limited how representative it was of the whole population and made it difficult to conduct more insightful analyses, such as comparing clinical characteristics of patients with different types of cancer, as well as anticancer treatments (5, 6).

Using patient information collected from 14 hospitals in Hubei Province, China, the epicenter of the 2019–2020 COVID-19 outbreak, we describe the clinical characteristics and outcomes [death, intensive care unit (ICU) admission, development of severe/critical symptoms, and utilization of invasive mechanical ventilation] of patients affected by the SARS-CoV-2 coronavirus for 105 hospitalized patients with cancer and 536 patients without cancer. We document our findings for different cancer types and stages, as well as different types of cancer treatments. We believe the information and insights provided in this study will help improve our understanding of the effects of SARS-CoV-2 in patients with cancer.

Results

Patients Characteristics

In total, 105 COVID-19 patients with cancer were enrolled in our study for the time period January 1, 2020, to February 24, 2020, from 14 hospitals in Wuhan, China. COVID-19 patients without cancer matched by the same hospital, hospitalization time, and age were randomly selected as our control group. Our patient population included 339 females and 302 males. Patients with cancer [median = 64.00, interquartile range (IQR) = 14.00], when compared with those without cancer (median = 63.50, IQR = 14.00) had similar age distributions (by design), experienced more in-hospital infections [20 (19.04%) of 105 patients vs. 8 (1.49%) of 536 patients;P < 0.01], and had more smoking history [36 (34.28%) of 105 patients vs. 46 (8.58%) of 536 patients; P < 0.01], but had no significant differences in sex, other baseline symptoms, and other comorbidities (Table 1). With respect to signs and symptoms upon admission, COVID-19 patients with cancer were similar to those without cancer except for a higher prevalence of chest distress [15 (14.29%) of 105 patients vs. 36 (6.16%) of 536 patients; P = 0.02].

Table 1.

Characteristics of COVID-19 patients with and without cancer

Clinical Outcomes

Compared with COVID-19 patients without cancer, patients with cancer had higher observed death rates [OR, 2.34; 95% confidence interval (CI), (1.15–4.77); P = 0.03], higher rates of ICU admission [OR, 2.84; 95% CI (1.59–5.08); P < 0.01], higher rates of having at least one severe or critical symptom [OR, 2.79; 95% CI, (1.74–4.41); P < 0.01], and higher chances of needing invasive mechanical ventilation (Fig. 1A). We also conducted survival analysis on occurrence of any severe condition which included death, ICU admission, having severe symptoms, and utilization of invasive mechanical ventilation (see cumulative incidence curves in Fig. 1B). In general, patients with cancer deteriorated more rapidly than those without cancer. These observations are consistent with logistic regression results (Supplementary Fig. S1), after adjusting for age, sex, smoking, and comorbidities including diabetes, hypertension, and chronic obstructive pulmonary disease (COPD). According to our multivariate logistic regression results, patients with cancer still had an excess OR of 2.17 (P = 0.06) for death (Supplementary Fig. S1A), 1.99 (P < 0.01) for experiencing any severe symptoms (Supplementary Fig. S1B), 3.13 (P < 0.01) for ICU admission (Supplementary Fig. S1C), and 2.71 (P = 0.04) for utilization of invasive mechanical ventilation (Supplementary Fig. S1D; Supplementary Table S1). The consistency of observed ORs between the multivariate regression model and unadjusted calculation reassures the association between cancer and severe events even in the presence of other factors such as age differences.

Figure 1.

Severe conditions in patients with and without cancer, and patients with different types, stages, and treatments of cancer. Severe conditions include death, ICU admission, having severe/critical symptoms, and usage of invasive mechanical ventilation. Incidence and survival analysis of severe conditions among COVID-19 patients with cancer and without cancer (A and B), among patients with different types of cancer (C and D), among patients with metastatic and nonmetastatic cancers (E and F), among patients with lung cancer, other cancers than lung with lung metastasis, and other cancers than lung without lung metastasis (G and H), and patients receiving different types of cancer treatments (I and J). P values indicate differences between cancer subgroups versus patients without cancer. For ACEGI, *, P < 0.05; **, P < 0.01. OR, 95% CI, and P values between different subgroups are listed in Supplementary Table S2. For BDFHJ, HR, 95% CI, and P values are listed in Supplementary Table S3.

Cancer Types

Information regarding potential risks of severe conditions in SARS-CoV-2 associated with each type of cancer was calculated. We compared different conditions among cancer types (Table 2). Lung cancer was the most frequent cancer type [22 (20.95%) of 105 patients], followed by gastrointestinal cancer [13 (12.38%) of 105 patients], breast cancer [11 (10.48%) of 105 patients], thyroid cancer [11 (10.48%) of 105 patients], and hematologic cancer [9 (8.57%) of 105 patients]. As shown in Fig. 1C and D and Supplementary Table S2, patients with hematologic cancer including leukemia, lymphoma, and myeloma have a relatively high death rate [3 (33.33%) of 9 patients], high ICU admission rate [4 (44.44%) of 9 patients], high risks of severe/critical symptoms [6 (66.67%) of 9 patients], and high chance of utilization of invasive mechanical ventilation [2 (22.22%) of 9 patients]. Patients with lung cancer had the second-highest risk levels, with death rate [4 (18.18%) of 22 patients], ICU admission rate [6 (27.27%) of 22 patients], risks of severe/critical symptoms [11 (50.00%) of 22 patients], and the chance of utilization of invasive mechanical ventilation [4 (18.18%) of 22 patients; Table 2].

Table 2.

Severe events in 105 patients with cancer for each type of cancer

Cancer Stage

We found that patients with metastatic cancer (stage IV) had even higher risks of death [OR, 5.58; 95% CI (1.71–18.23); P = 0.01], ICU admission [OR, 6.59; 95% CI (2.32–18.72); P < 0.01], having severe conditions [OR, 5.97; 95% CI (2.24–15.91); P < 0.01], and use of invasive mechanical ventilation [OR, 55.42; 95% CI (13.21–232.47); P < 0.01]. In contrast, patients with nonmetastatic cancer did not demonstrate statistically significant differences compared with patients without cancer, with all P > 0.05 (Fig. 1E and F; Supplementary Tables S2 and S3). In addition, when compared with patients without cancer, patients with lung cancer or other cancers with lung metastasis also showed higher risks of death, ICU admission rates, higher critical symptoms, and use of invasive mechanical ventilation, with all P values below 0.01, but other cancers without lung metastasis had no statistically significant differences (all P values > 0.05; Fig. 1G and H; Supplementary Table S3) when compared with patients without cancer.

Cancer Treatments

Among the 105 COVID-19 patients with cancer in our study, 13 (12.26%) had radiotherapy, 17 (14.15%) received chemotherapy, 8 (7.62%) received surgery, 4 (3.81%) had targeted therapy, and 6 (5.71%) had immunotherapy within 40 days before the onset of COVID-19 symptoms. All of the targeted therapeutic drugs were EGFR–tyrosine kinase inhibitors for treatment of lung cancer, and all of the immunotherapy drugs were PD-1 inhibitors for the treatment of lung cancer. A patient with cancer may have more than one type of therapy. Our observation suggested that patients who received immunotherapy tended to have high rates of death [2 (33.33%) of 6 patients] and high chances of developing critical symptoms [4 (66.67%) of 6 patients]. Patients who received surgery demonstrated higher rates of death [2 (25.00%) of 8 patients], higher chances of ICU admission [3 (37.50%) of 8 patients], higher chances of having severe or critical symptoms [5 (62.50%) of 8 patients], and higher use of invasive ventilation [2 (25.00%) of 8 patients] than other treatments excluding immunotherapy. However, patients with cancer who received radiotherapy did not show statistically significant differences in having any severe events when compared with patients without cancer, with all P values > 0.10 (Fig. 1I and J). Clinical details on the cancer diagnoses and cancer treatments are summarized in Supplementary Table S4.

Timeline of Severe Events

To evaluate the time-dependent evolution of the disease, we conducted the timeline of different events for COVID-19 patients with cancer (Fig. 2A) and COVID-19 patients without cancer (Fig. 2B) with death and other severe events marked in the figure. COVID-19 patients with cancer had a mean length of stay of 27.01 days (SD 9.52) and patients without cancer had a mean length of stay of 17.75 days (SD 8.64); the difference is significant (Wilcoxon test, P < 0.01). To better clarify the contributing factors that might influence outcomes, we also included logistic regression of COVID-19 patients with cancer adjusted by immunosuppression levels in Supplementary Table S5. However, no significant association between immunosuppression and severe outcomes was observed from the analysis (with all P > 0.05).

Figure 2.

Timeline of events for COVID-19 patients. A, Timeline of events in COVID-19 patients with cancer. B, Timeline of events in COVID-19 patients without cancer. For visualization purposes, patients without timeline information are excluded and only 105 COVID-19 patients without cancer are shown.

Discussion

The findings in this study suggest that patients with cancer infected with SARS-CoV-2 tend to have more severe outcomes when compared with patients without cancer. Patients with hematologic cancer, lung cancer, and cancers in metastatic stages demonstrated higher rates of severe events compared with patients without cancer. In addition, patients who underwent cancer surgery showed higher death rates and higher chances of having critical symptoms.

The SARS-CoV-2 virus has spread rapidly globally; thus, many countries have not been ready to handle the large volume of people affected by this outbreak due to a lack of knowledge about how this coronavirus affects the general population. To date, reports on the general population infected with SARS-CoV-2 suggest elderly males have a higher incidence and death rate (7, 8). Limited information is known about the outcome of patients with cancer who contract this highly communicable disease. Cancer is among the top causes of death. Asia, Europe, and North America have the highest incidence of cancer in the world (9), and at the moment of the writing of this study the SARS-CoV-2 virus is mainly spreading in these three areas (referred from https://www.cdc.gov/media/releases/2020/s0226-Covid-19-spread.htmlhttps://www.nytimes.com/2020/02/27/world/coronavirusnews.html). Although COVID-19 patients with cancer may share some epidemiologic features with the general population with this disease, they may also have additional clinical characteristics. Therefore, we conducted this study on patients with cancer with coexisting COVID-19 disease to evaluate the potential effect of COVID-19 on patients with cancer.

On the basis of our analysis, COVID-19 patients with cancer tend to have more severe outcomes when compared with the noncancer population. Although COVID-19 is reported to have a relatively low death rate of 2% to 3% in the general population (10), patients with cancer and COVID-19 not only have a nearly 3-fold increase in the death rate than that of COVID-19 patients without cancer, but also tend to have much higher severity of their illness. Altogether, these findings suggest that patients with cancer are a much more vulnerable population in the current COVID-19 outbreak. Our findings are consistent with those presented in a previous study based on 18 patients with cancer (4). Because of the limited number of patients with cancer in the previous study, the authors concluded that among patients with cancer, age is the only risk factor for the severity of the illness. On the basis of our data on 105 patients with cancer, we have discovered additional risk factors, including cancer types, cancer stage, and cancer treatments, which may contribute to the severity of the disease among patients with cancer.

Our data demonstrate that the severity of SARS-CoV-2 infection in patients is significantly affected by the types of tumors. From our analysis, patients with hematologic cancer have the highest severity and death rates among all patients with cancer, and lung cancer follows second. Patients with hematologic cancer in our study include patients with leukemia, myeloma, and lymphoma, who have a more compromised immune system than patients with solid tumors (11). These patients all had a rapidly deteriorating clinical course once infected with COVID-19. Because malignant or dysfunctional plasma cells, lymphocytes, or white blood cells in general in hematologic malignancies have decreased immunologic function (12–14), this could be the main reason why patients with hematologic cancer have very high severity and death rates. All patients with hematologic cancer are prone to the complications of serious infection (12–14), which can exacerbate the condition which could have worsened in patients with COVID-19. In our study, 55.56% of patients with hematologic cancer had severe immunosuppression, which may be the main reason for deteriorated outcomes. Although the small sample size limits representativity of the observation, we believe our finding can serve as an informative starting point for further investigation when a larger cohort from a wide range of healthcare providers becomes available. Among solid tumors, lung cancer is the highest risk category disease in patients with SARS-CoV-2 infection (Fig. 1C). Decreased lung function and severe infection in patients with lung cancer could contribute to the worse outcome in this subpopulation (15, 16).

In our analysis, we classified the SARS-CoV-2 infection–related high risk factors based on death, severe or critical illness, ICU admission, and the utilization of invasive mechanical ventilation. Using these parameters, we detected a multi-fold increase in risk in the cancer population, in contrast to the noncancer population. If there were primary or metastatic tumors in the lungs, patients were more prone to a deteriorated course in a short time. Intriguingly, when patients with cancer had only early-stage disease without metastasis, we did not observe any difference between the cancer and noncancer population in terms of COVID-19–related death rate or severity (Fig. 1E). The stage of cancer diagnosis seemed to play a significant role in the severity and death rate of COVID-19.

Patients with cancer received a wide range of treatments, and we also found that different types of treatments had different influences on severity and death when these patients contracted COVID-19. Recently, immunotherapy has assumed a very important role in treating tumors, which aids in treatment of cancer by blocking the immune escape of cancer cells. But in our study, in contrast to patients with cancer with other treatments, patients with immunotherapy had the highest death rate and the highest severity of illness, a very puzzling finding. According to pathologic studies on the patients with COVID-19, there were desquamation of pneumocytes and hyaline membrane formation, implying that these patients had acute respiratory distress syndrome (ARDS; ref. 17). ARDS induced by cytokine storm is reported to be the main reason for death of SARS-CoV-2–infected patients (18). It is possible that in this setting, immunotherapy induces the release of a large amount of cytokines, which can be toxic to normal cells, including lung epithelial cells (19–21), and therefore lead to a more severe illness. However, in this study the number of patients with immunotherapy was too small; further research with a large case population needs to be conducted in the future.

In addition, COVID-19 patients with cancer who are under active treatment or not under active treatment do not show differences in their outcomes, and there is a significant difference between COVID-19 patients with cancer but not with active treatment and patients without cancer (Supplementary Table S2). These results indicate that COVID-19 patients with both active treatment and just cancer history have a higher risk of developing severe events than noncancer COVID-19 patients. The possible reasons could be due to some known cancer-related complications, for example, anemia, hypoproteinaemia, or dyspnea in early phase of COVID-19 (22). We considered that cancer had a lifetime effect on patients and that cancer survivors always need routine follow-up after primary resection. Therefore, in clinical COVID-19 patient management, equivalent attention needs to be paid to those with cancer whether they are under active therapeutics or not during the outbreak of COVID-19.

This study has several limitations. Although the cohort of COVID-19 patients with cancer is one of the largest in Hubei province, China, the epicenter of the initial outbreak, a larger cohort from the whole country or even from multiple countries will be more representative. Large-scale national and international research collaboration will be necessary to achieve this. At the initial stage of the outbreak, data collection and research activities were not a priority of the hospitals. Therefore, it was not possible to record and collect some data that are potentially informative for our analysis in a timely manner. In addition, due to the urgency of clinical treatment, medical data used in this study were largely disconnected from the patients’ historical electronic medical records, which are mostly stored with a different healthcare provider than the medical center providing COVID-19 care. This left us with limited information about each patient.

Our study is the midsize cohort study on this topic and will provide much-needed information on risk factors of this population. We hope that our findings will help countries better protect patients with cancer affected by the ongoing COVID-19 pandemic.

Methods

Study Design and Patients

We conducted a multicenter study focusing on the clinical characteristics of confirmed cases of COVID-19 patients with cancer in 14 hospitals in Hubei province, China; all of the 14 hospitals served as government-designated hospitals for patients diagnosed with COVID-19. SARS-CoV-2–infected patients without cancer matched by the same hospital and hospitalization time were randomly selected as our control group. In addition, as age is one of the major predictors of severity of respiratory diseases like COVID-19 (4), we excluded from our analysis 117 younger COVID-19 patients without cancer so that median ages of patients with cancer (median = 64.0, IRQ = 14.00) and patients without cancers (median = 63.5, IQR = 14.00) would be comparable.

End Points and Assessments

There were four primary outcomes analyzed in this study: death, admission into the ICU, development of severe or critical symptoms, and utilization of invasive mechanical ventilation. The clinical definition of severe/critical symptoms follows the 5th edition of the 2019Novel Coronavirus Disease (COVID-19) Diagnostic Criteria published by the National Health Commission in China, including septic shock, ARDS, acute kidney injury, disseminated intravascular coagulation, and rhabdomyolysis.

Case Fatality Rate of Cancer Patients with COVID-19 in a New York Hospital System

Source:

Vikas MehtaSanjay GoelRafi KabarritiDaniel ColeMendel GoldfingerAna Acuna-VillaordunaKith PradhanRaja ThotaStan ReissmanJoseph A. SparanoBenjamin A. GartrellRichard V. SmithNitin OhriMadhur GargAndrew D. RacineShalom KalnickiRoman Perez-SolerBalazs Halmos and Amit Verma. Case Fatality Rate of Cancer Patients with COVID-19 in a New York Hospital System

Abstract

Patients with cancer are presumed to be at increased risk from COVID-19 infection–related fatality due to underlying malignancy, treatment-related immunosuppression, or increased comorbidities. A total of 218 COVID-19–positive patients from March 18, 2020, to April 8, 2020, with a malignant diagnosis were identified. A total of 61 (28%) patients with cancer died from COVID-19 with a case fatality rate (CFR) of 37% (20/54) for hematologic malignancies and 25% (41/164) for solid malignancies. Six of 11 (55%) patients with lung cancer died from COVID-19 disease. Increased mortality was significantly associated with older age, multiple comorbidities, need for ICU support, and elevated levels of D-dimer, lactate dehydrogenase, and lactate in multivariate analysis. Age-adjusted CFRs in patients with cancer compared with noncancer patients at our institution and New York City reported a significant increase in case fatality for patients with cancer. These data suggest the need for proactive strategies to reduce likelihood of infection and improve early identification in this vulnerable patient population.

Significance: COVID-19 in patients with cancer is associated with a significantly increased risk of case fatality, suggesting the need for proactive strategies to reduce likelihood of infection and improve early identification in this vulnerable patient population.

Introduction

The novel coronavirus COVID-19, or severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has spread rapidly throughout the world since its emergence in December 2019 (1). The virus has infected approximately 2.9 million people in more than 200 countries with more than 200,000 deaths at the time of writing (2). Most recently, the United States has become the epicenter of this pandemic, reporting an estimated 956,000 cases of COVID-19 infection, with the largest concentration in New York City (NYC) and its surrounding areas (approximately >203,000 cases or 35% of all U.S. infections; ref. 3).

Early data suggests that 14% to 19% of infected patients will develop significant sequelae with acute respiratory distress syndrome, septic shock, and/or multiorgan failure (1, 4, 5), and approximately 1% to 4% will die from the disease (2). Recent meta-analyses have demonstrated an almost 6-fold increase in the odds of mortality for patients with chronic obstructive pulmonary disease (COPD) and a 2.5-fold increase for those with diabetes, possibly due to the underlying pulmonary and immune dysfunction (6, 7). Given these findings, patients with cancer would ostensibly be at a higher risk of developing and succumbing to COVID-19 due to immunosuppression, increased coexisting medical conditions, and, in cases of lung malignancy, underlying pulmonary compromise. Patients with hematologic cancer, or those who are receiving active chemotherapy or immunotherapy, may be particularly susceptible because of increased immunosuppression and/or dysfunction.

According the NCI, there were approximately 15.5 million cancer survivors and an estimated 1,762,450 new cases of cancer diagnosed in the United States in 2019 (8). Early case series from China and Italy have suggested that patients with malignancy are more susceptible to severe infection and mortality from COVID-19 (9–12), a phenomenon that has been noted in other pandemics (13). Many of these descriptive studies have included small patient cohorts and have lacked cancer site–specific mortality data or information regarding active cancer treatment. As New York has emerged as the current epicenter of the pandemic, we sought to investigate the risk posed by COVID-19 to our cancer population with more granular data regarding cancer type and active treatment, and identify factors that placed patients with cancer at highest risk of fatality from COVID-19.

Results

Outcomes of 218 Cancer Patients with COVID-19 Show High Overall Mortality with Tumor-Specific Patterns

A total of 218 patients with cancer and COVID-19 were treated in Montefiore Health System (New York, NY) from March 18, 2020, to April 8, 2020. These included 164 (75%) patients with solid tumors and 54 (25%) with hematologic malignancies. This cohort included 127 (58%) males and 91 (42%) females. The cohort was predominantly composed of adult patients (215/218, 98.6%) with a median age of 69 years (range 10–92 years).

Sixty-one (28%) patients expired as a result of COVID-19disease at the time of analysis (Table 1). The mortality was 25% among all patients with solid tumors and was seen to occur at higher rates in patients with lung cancers (55%), gastrointestinal (GI) cancers [colorectal (38%), pancreatic (67%), upper GI (38%)], and gynecologic malignancies (38%). Genitourinary (15%) and breast (14%) cancers were associated with relatively lower mortality with COVID-19 infection.

Table 1.

Outcomes in patients with cancer and COVID-19

Hematologic malignancies were associated with higher rate of mortality with COVID-19 (37%). Myeloid malignancies [myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML)/myeloproliferative neoplasm (MPN)] showed a trend for higher mortality compared with lymphoid neoplasms [non-Hodgkin lymphoma (NHL)/chronic lymphoid leukemia (CLL)/acute lymphoblastic leukemia (ALL)/multiple myeloma (MM)/Hodgkin lymphoma; Table 1]. Rates of ICU admission and ventilator use were slightly higher for hematologic malignancies than solid tumors (26% vs. 19% and 11% vs. 10%, respectively), but this did not achieve statistical significance.

Disease Characteristics of Cancer Patients with COVID-19 Demonstrate the Effect of Age, Comorbidities, and Laboratory Biomarkers on Mortality

Analysis of patient characteristics with mortality did not show any gender bias (Table 2). Older age was significantly associated with increased mortality, with median age of deceased cohort at 76 years when compared with 66 years for the nondeceased group (P = 0.0006; Cochran-Armitage test). No significant associations between race and mortality were seen.

Table 2.

Disease characteristics of patients with cancer with COVID-19 and association with mortality

COVID-19 disease severity, as evident from patients who needed ICU care and ventilator support, was significantly associated with increased mortality. Interestingly, active disease (<1 year) and advanced metastatic disease showed a trend for increased mortality, but the association did not achieve statistical significance (P = 0.09 and 0.06, respectively). Active chemotherapy and radiotherapy treatment were not associated with increased case fatality. Very few patients in this cohort were on immunotherapy, and this did not show any associations with mortality.

Analysis of comorbidities demonstrated increased risk of dying from COVID-19 in patients with cancer with concomitant heart disease [hypertension (HTN), coronary artery disease (CAD), and congestive heart failure (CHF)] and chronic lung disease (Table 2). Diabetes and chronic kidney disease were not associated with increased mortality in univariate analysis (Table 2).

We also analyzed laboratory values obtained prior to diagnosis of COVID-19 and during the time of nadir after COVID-19 positivity in our cancer cohort. Relative anemia pre–COVID-19 was associated with increased mortality, whereas pre-COVID platelet and lymphocyte counts were not (Table 3).Post–COVID-19 infection, lower hemoglobin levels, higher total white blood cell (WBC) counts, and higher absolute neutrophil counts were associated with increased mortality (Table 3). Analysis of other serologic biomarkers demonstrated that elevated D-dimer, lactate, and lactate dehydrogenase (LDH) in patients were significantly correlated with dying (Table 3).

Table 3.

Laboratory values of cancer patients with COVID-19 and association with mortality

Next, we conducted multivariate analyses and used variables that showed a significant association with mortality in univariate analysis (P < 0.05 in univariate was seen with age, ICU admission, hypertension, chronic lung disease, CAD, CHF, baseline hemoglobin, nadir hemoglobin, WBC counts, D-dimer, lactate, and LDH). Gender was forced in the model and we used a composite score of comorbidities from the sum of indicators for diabetes mellitus (DM), HTN, chronic lung disease, chronic kidney disease, CAD, and CHF capped at a maximum of 3. In the multivariate model (Supplementary Table S1), we observed that older age [age < 65; OR, 0.23; 95% confidence interval (CI), 0.07–0.6], higher composite comorbidity score (OR, 1.52; 95% CI, 1.02–2.33), ICU admission (OR, 4.83; 95% CI, 1.46–17.15), and elevated inflammatory markers (D-dimer, lactate, and LDH) were significantly associated with mortality after multivariate comparison in patients with cancer and COVID-19.

Interaction with the Healthcare Environment was a Prominent Source of Exposure for Patients with Cancer

A detailed analysis of deceased patients (N = 61; Supplementary Table S2) demonstrated that many were either nursing-home or shelter (n = 22) residents, and/or admitted as an inpatient or presented to the emergency room within the 30 days prior to their COVID-19 positive test (21/61). Altogether, 37/61 (61%) of the deceased cohort were exposed to the healthcare environment at the outset of the COVID-19 epidemic. Few of the patients in the cohort were on active oncologic therapy. The vast majority had a poor Eastern Cooperative Oncology Group performance status (ECOG PS; 51/61 with an ECOG PS of 2 or higher) and carried multiple comorbidities.

Patients with Cancer Demonstrate a Markedly Increased COVID-19 Mortality Rate Compared with Noncancer and All NYC COVID-19 Patients

An age- and sex-matched cohort of 1,090 patients at a 5:1 ratio of noncancer to cancer COVID-19 patients from the same time period and from the same hospital system was also obtained after propensity matching and used as control to estimate the increased risk posed to our cancer population (Table 4). We observed case fatality rates (CFR) were elevated in all age cohorts in patients with cancer and achieved statistical significance in the age groups 45–64 and in patients older than 75 years of age.

Table 4.

Comparison of cancer and COVID-19 mortality with all NYC cases (official NYC numbers up to 5 p.m., April 12, 2020) and a control group from the same healthcare facility

To also compare our CFRs with a larger dataset from the greater NYC region, we obtained official case numbers from New York State (current up to April 12, 2020; ref. 3). In all cohorts, the percentage of deceased patients was found to rise sharply with increasing age (Table 4). Strikingly, CFRs in cancer patients with COVID-19 were significantly, many-fold higher in all age groups when compared with all NYC cases (Table 4).

Discussion

To our knowledge, this is the first large report of COVID-19 CFRs among patients with cancer in the United States. The overall case fatality among COVID-19–infected patients with cancer in an academic center located within the current epicenter of the global pandemic exceeded 25%. In addition, striking tumor-specific discrepancies were seen, with marked increased susceptibility for those with hematologic malignancies and lung cancer. CFRs were 2 to 3 times the age-specific percentages seen in our noncancer population and the greater NYC area for all COVID-19 patients.

Our results seem to mirror the typical prognosis of the various cancer types. Among the most common malignancies within the U.S. population (lung, breast, prostate, and colorectal), there was 55% mortality among patients with lung cancer, 14% for breast cancer, 20% for prostate cancer, and 38% for colorectal cancer. This pattern reflects the overall known lethality of these cancers. The percent annual mortality (ratio of annual deaths/new diagnosis) is 59.3% for lung cancer, 15.2% for breast cancer, 17.4% for prostate cancer, and 36% for colorectal cancer (8). This suggests that COVID-19 infection amplifies the risk of death regardless of the cancer type.

Patients with hematologic malignancies demonstrate a higher mortality than those with solid tumors. These patients tend to be treated with more myelosuppressive therapy, and are often severely immunocompromised because of underlying disease. There is accumulating evidence that one major mechanism of injury may be a cytokine-storm syndrome secondary to hyperinflammation, which results in pulmonary damage. Patients with hematologic malignancy may potentially be more susceptible to cytokine-mediated inflammation due to perturbations in myeloid and lymphocyte cell compartments (14).

Many of the predictive risk factors for mortality in our cancer cohort were similar to published data among all COVID-19 patients. A recent meta-analysis highlighted the association of chronic diseases including hypertension (OR, 2.29), diabetes (OR, 2.47), COPD (OR, 5.97), cardiovascular disease (OR, 2.93), and cerebrovascular disease (OR, 3.89) with a risk for developing severe COVID-19 infection among all patients (15). In our cancer patient dataset, a large proportion of patients had at least one of these concurrent risk factors. In a univariate model, we observed significant associations of death from COVID-19 infection in patients with hypertension, chronic lung disease, coronary heart disease, and congestive heart failure. Serologic predictors in our dataset predictive for mortality included anemia at time of infection, and elevated LDH, D-dimer, and lactic acid, which correlate with available data from all COVID-19 patients.

Rapidly accumulating reports suggest that age and race may play a role in the severity of COVID-19 infection. In our cancer cohort, the median age of the patients succumbing to COVID-19 was 76 years, which was 10 years older than patients who have remained alive. The CDC has reported a disproportionate number of African Americans are affected by COVID-19 in the United States, accounting for 33% of all hospitalized patients while constituting only 13% of the U.S. population (15). However, the racial breakdown of our patients was proportional to the Bronx population as a whole, and race was not a significant predictor of mortality in our univariate or multivariate models. Our data might argue that the increased mortality noted in the larger NYC populations might also likely be driven by socioeconomic and health disparities in addition to underlying biological factors. Overall mortality with COVID-19 has been higher in the Bronx, which is a socioeconomically disadvantaged community with a mean per capita income of $19,721 (16, 17). Our patients with cancer were predominantly from the Bronx and potentially had increased mortality in part due to socioeconomic factors and comorbidities. Even after accounting for the increased mortality seen in COVID-19 in the Bronx, the many-fold magnitude increase in death rates within our cancer cohort can potentially be attributed to the vulnerability of oncology patients. This was evident in the comparison with a control group from the same hospital system that demonstrated a significant association of cancer with mortality in patients between 45 and 64 years of age and older than 75 years of age.

Interaction with the healthcare environment prior to widespread knowledge of the epidemic within NYC was a prominent source of exposure for our patients with cancer. Many of those who succumbed to COVID-19 infection were older and frail with significant impairment of pulmonary and/or immunologic function. These findings could be utilized to risk-stratify patients with cancer during this pandemic, or in future viral airborne outbreaks, and inform mitigation practices for high-risk individuals. These strategies could include early and aggressive social distancing, resource allocation toward more outpatient-based care and telemedicine, testing of asymptomatic high-risk patients, and institution of strict infection-control measures. Indeed, such strategies were implemented early in the pandemic at our center, possibly explaining the relatively low number of infected patients on active therapy.

There were several limitations to our study. Data regarding do not resuscitate or intubate orders were not included in the analysis and could have significantly affected the decision-making and mortality surrounding these patients. Although an attempt was made to control for those receiving active cancer treatment or with additional comorbidities, we could not fully account for the patients’ preexisting health conditions prior to COVID-19 infection. Differential treatment paradigms for COVID-19 infection and sequelae were not controlled for in our analysis. Because of the limited follow-up, the full clinical course of these patients may not be included. Future comparative studies to noncancer patients will be needed to fully ascertain the risk posed to oncology patients. Finally, though our data does include those who were tested and discharged within our health system, we cannot fully account for those who were tested in nonaffiliated outpatient settings, which may potentially bias our study to more severe cases. We also acknowledge that the mortality rate is highly dependent on the breadth of testing, and therefore understand that more widespread detection of viral infection would likely alter the results.

Our data suggest significant risk posed to patients with cancer infected with COVID-19, with an observed significant increase in mortality. The highest susceptibility appears to be in hematologic or lung malignancies, suggesting that proactive strategies to reduce likelihood of infection and improve early identification of COVID-19 positivity in the cancer patient population are clearly warranted. Overall, we hope and expect that our data from the current epicenter of the COVID-19 epidemic will help inform other healthcare systems, patients with cancer, and the public about the particular vulnerability of patients with cancer to this disease.

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The Sylvester Comprehensive Cancer Center of the University of Miami named 71st NCI designated Cancer Center

 

Reporter: Stephen J. Williams, PhD

As seen in the Cancer Letter at https://cancerletter.com/articles/20190729_1/

Conversation with The Cancer Letter

Sylvester becomes 71st NCI-designated cancer center

Stephen Nimer

Director,

Sylvester Comprehensive Cancer Center

 

After six years of  aggressively recruiting and spending more than $250 million to build up its programs, Sylvester Comprehensive Cancer Center has become the 71st NCI-designated cancer center in the US and the only such institution in South Florida.

The designation was announced July 29.

Sylvester, which is a part of the University of Miami Leonard M. Miller School of Medicine, is one of 64 cancer centers with the NCI Cancer Center designation in the nation. Fifty of these centers hold the Comprehensive Cancer Center designation. Seven more are designated as Basic Laboratory Cancer Centers.

“There are over 21 million people who live in the state of Florida. In 2014, Florida became the third largest state in the United States, surpassing New York—yet New York has seven NCI designated cancer centers and Florida had had only one,” Stephen D. Nimer, director of Sylvester, said to The Cancer Letter.

“There are over six million people in our catchment area, South Florida, and if they wanted to go to an NCI-designated cancer center they’d have to either get on a plane or drive nearly 300 miles—to Tampa.”

Public health programs that helped Sylvester secure the NCI designation include the Game Changer vehicle, which brings evidence-based interventions to underserved communities in the cancer center’s catchment area (The Cancer Letter, April 27, 2018). The center’s cancer control program also includes the Firefighter Cancer Initiative, a long-term study of exposures to carcinogens and ways to reduce and prevent cancer risks for Florida firefighters.

 

 

The cancer center is working on deploying another Game Changer vehicle. Recently, Peter Tunney, a New York and Miami-based artist and gallerist who donated a painting for the first Game Changer van, donated another painting that Sylvester can sell to raise money for its programs (The Cancer Letter, April 27, 2018).

 

“When they got that designation, they were walking on sunshine,” Tunney said to The Cancer Letter. “I think it’s a universal idea. I think that’s the goal for all of us—for all of mankind, for sick and healthy—to have that feeling that is so rare today: I am walking on sunshine. It’s almost like a thing of the past. Who can walk on sunshine today, in this crazy world filled with suffering and illness? And I just feel like we can, we can, it’s possible to be grateful for the things we have.

The intense yellow wallpaper motif reminds Tunney of the wallpaper in his grandmother’s house in the 1960s and 1970s, the time when American astronauts walked on the moon. “It’s somebody’s grandmother’s wallpaper from the sixties. We look back at that time, we look back at landing on the moon, and everyone is aflutter, ‘Oh, those were the good old days.’ No, these are the good old days.”

The word “comprehensive” in Sylvester’s name doesn’t refer to its level of NCI designation. When it was founded in 1973, the institution was known as the Comprehensive Cancer Center for the State of Florida. In 1992, after receiving a $27.5 million gift from the philanthropist Harcourt Sylvester Jr., it was renamed Sylvester Comprehensive Cancer Center.

 

Sylvester director Nimer spoke with Paul Goldberg, editor and publisher of The Cancer Letter.

 

Paul Goldberg:

First of all, congratulations.

Stephen Nimer: 

Thank you; it’s a big deal.

 

PG:

How long did it take to get this done?

SN:

I’d say, six years. I arrived in 2012, seven years ago, and the first year started by assessing what’s going on at Sylvester. We then developed our first five-year strategic plan, which ran from 2014 to 2018, and we submitted our [Cancer Center Support Grant] application in September 2018. We’re now in the midst of our second five-year plan.

 

PG:

And how much money did it require?

SN:

I’d have to add it all up. One of the most important things for us was that the state, in 2014, started giving us a bit over $16 million a year so that we could become NCI-designated. The health system, over a five-to-six-year period, probably gave us somewhere between $90 and $100 million. And then we’ve raised philanthropy. The philanthropy over five to six years, is maybe close to $100 million. So, it’s probably $250 -$270 million.

 

PG:

How many people did you have to recruit?

SN:

We went in [to NCI] with 124 members on our CCSG application, but over the last seven years we’ve recruited nearly 150 people. In addition to recruiting researchers I’ve been given the opportunity to build the clinical programs also.

Many of the clinical people are not included on the grant, because the grant has very specific requirements to be a member. For example, we’ve hired a couple of breast cancer surgeons, and they are not listed on the grant, because they are not yet doing significant research.

The NCI doesn’t want to know about people who don’t have grants or aren’t running clinical trials. So, out of the 124, which is what we went in with, I believe nearly 50 of our members were new.

 

PG:

How is your cancer center different from all others?

SN:

One of the things that we got the highest marks on is our community outreach and engagement efforts and how relevant the research we’re doing is to our catchment area.

A couple of examples:

We have a West Indies population, so we have an endemic HTLV-1-infected population, and thus a significant number of HTLV-1-related adult T-cell leukemia patients. So, one of our physician scientists has an R01 studying ATL. And we have a number of clinical trials for people with adult T-cell leukemia.

We also have a large burden of advanced cervical cancer patients in our region, especially in Little Haiti. And so, we have a lot of efforts on early detection of high-risk HPV, prevention and clinical treatment trials for women with cervical cancer.

Another thing that distinguishes us from many centers is the diversity of our faculty, our students, and the patients we put on clinical trials. In our CCSG application, roughly 30% of the patients on interventional trials were black and 40% were Hispanic—so both racial and ethnic diversity. We also have incredible socio-economic diversity.

What’s unique among the black population in our catchment area is that it is Afro-Caribbean more than African American—different genetics, different cultures.

The Hispanic population is unique as well. MD Anderson is probably largely Mexican Americans. New York is probably mostly Dominican and Puerto Rican. We have significant populations of Cuban Americans, Venezuelans, Brazilians, Argentinians, Colombians—an incredibly diverse group.

One example of how this plays out is in our prostate cancer research. The watch-and-wait approach is an appropriate strategy for many people. We found that our black population has more anterior prostate cancer lesions, so when you do blind biopsies, you’re more likely to miss lesions.

And then we’ve looked among the Hispanic populations as to who has a better or worse prognosis and we’ve identified subgroups within the Hispanic population that have different genetics and a different biology. So, we are tailoring our approach. Based on genetic ancestry as well as other factors.

The other thing is, we have a very strong cancer epigenetics programs, a very strong program on infections and cancer, including H. Pylori, HPV, and hepatitis viruses B and C.

We are very focused on developing programs that meet the needs of the people in this six-million-plus community.

Our catchment area is four counties, somewhat famous, because of the election news nearly every cycle: Broward, Palm Beach County, Miami Dade and Monroe County.

 

PG:

New York, where you come from, has an NCI-designated cancer center on every street corner. And Miami—make that South Florida—has just one now. How is Florida different? You would have thought that there would be multiple NCI-designated cancer centers in South Florida.

SN:

Your point is very well taken. There are over 21 million people who live in the state of Florida. In 2014, Florida became the third largest state in the United States, surpassing New York—yet New York has seven NCI designated cancer centers and Florida had had only one.

Moffitt had gotten a huge investment from the state in the past, and that enabled them to become NCI-designated. And upon designation, they could recruit more researchers, attract more patients, and get more philanthropy, and get all the positives from that. And for the longest time, Florida has only had one.

There are over six million people in our catchment area, South Florida, and if they wanted to go to an NCI-designated cancer center they’d have to either get on a plane or drive nearly 300 miles—to Tampa.

Now, one problem that we face in our region, which is very splintered in terms of market share, etc. is that there’s a lot of community hospitals here that have cancer centers, but they are not necessarily conducting cancer research in any way.

I’ve been reading Joe Simone’s Journal of Clinical Oncology paper from 2002, where he talks about the fact that there are no criteria to call yourself a cancer center. And because people may feel like you can get great care anywhere, they may not seek out the experts.

Probably, in many markets throughout the US, there’s still an ongoing process of trying to educate people as to what’s the difference between an NCI-designated cancer center and one that’s not. And, obviously, the designation is given, because of the research that’s going on. And so, people wonder: “What is the connection between the research and me being a patient there?”

A big part of educating our community is to tell people that oftentimes the doctors who are doing research on a specific cancer have a deeper knowledge about its management. Also, experts more often make the correct diagnosis and come up with more exact multidisciplinary treatment approaches for many cancers.

NCI-designated cancer centers have more clinical trials and more investigator-initiated clinical trials. Now, with NCI designation, we’ll have access to the [NCI Cancer Therapy Evaluation Program] drugs and treatments. Already, we have a very robust phase I clinical trials program, having put 161 patients on phase I trials last year.

This means that we are doing more innovative things, not accepting the status quo, which is what you often get in community hospitals.

I get asked all the time: “Don’t only complicated cancers need to get seen in Sylvester?” and I usually say, “Any cancer that you have is complicated.”

There are other things we need to stress:  Sometimes patients spend more time figuring out which flat screen TV they’re going to buy than they do figuring out who should be taking care of them. And so, we tell patients to ask: “How sure are you that you have made the correct diagnosis?”

So many people are misdiagnosed in the US each year, and sometimes people are treated who don’t need to be treated and vice-versa.

For instance, we are working with Moffitt and the University of Florida on pancreas cancer. We’re hoping to look at how many patients in our state are told that with radiation, chemotherapy, and surgery there’s a potential for cure, as opposed to being told that pancreatic cancer is terrible, and you better get your affairs in order.

While the NCI designation, of course, relates to multidisciplinary and collaborative research efforts, we have—given the diversity of our catchment area and community—an important task to educate people in culturally appropriate ways.

 

PG:

Well, there’s a lot happening that actually very good. Having the University of Florida on the path to designation is also wonderful for the state. There’s so much room in there for growth.

SN:

Absolutely. Absolutely.

 

PG:

Since we are talking about Joe Simone’s paper, the word “comprehensive” is in the name of your cancer center. Yet, you don’t—yet—have the NCI-koshered comprehensive designation. Can you change the name? Do you need to?

SN:

The University of Miami’s cancer center started in 1973 shortly after Nixon signed the National Cancer Act. Later, with a naming gift from the Sylvester family, we opened our doors as the Sylvester Comprehensive Cancer Center in 1992. The comprehensive in our name does not refer to an NCI designation. It’s been our name because we have always delivered comprehensive cancer care.

 

PG:

Let’s talk about the Game Changer. That’s such a cool thing. That was one of your center’s great ideas.

SN:

The Game Changer vehicle has been really incredible, already in its impact on our cancer education and early detection programs (The Cancer Letter, April 27, 2018). We’re accruing people for research, and we’re already following some of their health habits.

We’re in the process of delivering HPV vaccines. We have been working with our AIDS group, so you can get PrEP. And we go into communities, like Little Havana, Liberty City, Little Haiti. We are also going into areas to provide education on HIV. As you know, the incidence of HIV in the Miami Dade area is the highest in the nation. So, the vehicle is already having an impact in so many ways.

We’ve just gotten the second Game Changer!

Peter Tunney, the artist, is going to wrap this one also. And this one’s going to focus primarily on Monroe County, which has been hit hard by hurricanes, and also has very poor medical infrastructure.

If you travel to Miami, for business or pleasure, you don’t realize that it’s not that far to get to an extraordinarily rural area. The density of population in Monroe county is very low and access to health care is limited.

The areas that we’re trying to reach have so much socioeconomic gap and disparities. And the Game Changer vehicles are going to help us reach people who otherwise do not access traditional medical systems.

You asked me about the Game Changer vehicle as an idea, and I wanted to shout out the leadership team that we’ve been able to put together at Sylvester. They have been incredible. Our people have worked together in amazing ways. And so, when you say, “That’s a great idea of yours,” yours is the whole team, of course.

 

PG:

Of course.

SN:

It’s remarkable how much work it takes to build the research programs that allow us to even have a competitive application. There were so, so many people who spent so much time for the benefit of the cancer center, and not for their own research.

 

PG:

Can we talk about hurricanes? They have an impact on your mission.

SN:

It’s interesting, because the Sylvester Comprehensive Cancer Center opened its doors in 1992, which is just when Hurricane Andrew hit. I’ve looked through our archives: There are some great articles in the Miami newspaper, because we remained open and provided care right after Hurricane Andrew, which has been the most devastating hurricane here in, I don’t know exactly how many years, maybe 30 or 50 or whatever.

But even following the more recent hurricanes, we’ve been able to provide care for our patients. After Hurricane Irma, in one of our satellites we were open the next day, and we treated 30 patients with chemotherapy who needed it, even though many folks were without electricity.

It’s a unique challenge. We have hurricane preparedness for our laboratories. We have drills for the hospital. And we have a command center.

During Irma, because I live on Miami Beach, in a mandatory evacuation zone, I had to leave my home for a few days. And so, my wife and I slept in the hospital for three nights. There’s food, water, and air conditioning in the hospital. It’s not a bad place to be!

 

PG:

You’re driving now to one of the clinics, even as we speak; right? One of the satellite clinics?

SN:

Yes.

 

PG:

Can you tell me about that?

SN:

We have seven sites where we deliver clinical care. The main site in downtown Miami, and then we have three quite large facilities, one in Coral Gables, one in Plantation, one in Deerfield Beach. And we have three other satellites that are smaller, in Coral Springs, Hollywood, and Kendall.

And this allows us to deliver regional care. We’re all on the same EPIC electronic medical record. And we have patients enrolled on clinical trials in the satellites. Not all the satellites at the moment can have a research pharmacy. But the plan is we’re going to continue our expansion of facilities and services and increase the number of accruals and the sophistication of the trials that are available here. Everybody working in these satellites is a University of Miami employee.

The doctors are all part of our site disease groups, and they teleconference in to meetings and lectures. And many of them spend a day in Miami at the main satellite for education and clinical and other purposes.

Many of the doctors in the satellites are principal investigators on the clinical trials. And it’s important because people don’t want to travel necessarily on the freeways here to get to downtown Miami. And so, we can deliver academic care out in the community, which is always important and a challenging thing to do.

 

PG:

Is there anything we’ve forgotten, anything we need to address?

SN:

Maybe I can talk briefly about the state money for a minute. When Sen. [Rick] Scott [(R-FL)] was the governor, he got us together in his office, the University of Florida, Moffitt, and the University of Miami, and asked us what we needed to become major cancer centers and attain NCI designation so we could have three such facilities in the state.

The next year, the state gave us $10. 5 million to split three ways. So, we each got $3.5 million to bring in somebody from outside the state of Florida, a world-class scientist, and provide them with $500,000 a year for seven years.

We brought Ramin Shiekhattar from the Wistar Institute. He’s one of the leaders of our Cancer Epigenetics Program and a year and a half ago, Ramin won one of the highly prestigious NIH Director’s Pioneer Awards. I believe they give 10 out a year.

Next, the state set up a pool of $60 million to be shared between the three institutions each year for five and now six years. These funds are being used so that all three institutions can attain NCI designation. The directors of these cancer centers get along extremely well, and, in a pretty unique model, we created something called the Florida Academic Cancer Center Alliance.

It exists to promote collaborations across our institutions to conduct important cancer research and bring more federal research dollars to the state.

There are one or two other points I’d like to make: Another person we brought in, Gilberto Lopes, is the head of our Global Oncology Program and the editor of the Journal of Global Oncology for ASCO.

He just gave a plenary talk at 2018 ASCO, showing that immunotherapy is better than chemotherapy for the upfront treatment of certain subsets of lung cancer. His talk was one of four plenary talks we’ve recently given at important national cancer meetings.

I think the other message is just the level at which we’re operating on now. We are demonstrating to our community that we have people who are national leaders, and programs that are among the very best in the country. For this, I must thank the incredible team of researchers who work at Sylvester.

I think that, as we recruit more and more people, this designation is going to help us. I’m very pleased that when we submit NIH grants, the reviewers comment upon the environment in Miami, we now get the high scores for the research environment.

 

PG:

This brings up a problem that held back Sylvester for years, which was the lack of independence of the cancer center, or at least it was perceived to be that. Do you have the independence you need now?

SN:

First of all, I would never have left Sloan Kettering without the authority I needed from the leadership of the University of Miami, the health system and the Miller School of Medicine…

 

PG:

Yeah, that’s a good point.

SN:

I should point out, that I am the head of the cancer center, but I’m also the head of the oncology service line for UHealth health system. This arrangement allows me to align the clinical and the research missions in a way that many cancer center directors cannot.

It’s a real privilege, and I have great leadership and great people working on the service line to make our patient care and patient-related activities superb.

 

PG:

Well, that’s hugely important.

Copyright (c) 2018 The Cancer Letter Inc.

More on NCI Designated Cancer Centers can be found here: https://www.cancer.gov/research/nci-role/cancer-centers

Other articles on NCI Cancer Centers on the Open Access Online Journal include:

Salivary Gland Cancer – Adenoid Cystic Carcinoma: Mutation Patterns: Exome- and Genome-Sequencing @ Memorial Sloan-Kettering Cancer Center

Engineered Bacteria used as Trojan Horse for Cancer Immunotherapy

First Cost-Effectiveness Study of Multi-Gene Panel Sequencing in Advanced Non-Small Cell Lung Cancer Shows Moderate Cost-Effectiveness, Exposes Crucial Practice Gap

 

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NIH SBIR Funding Early Ventures: September 26, 2018 sponsored by Pennovation

Stephen J. Williams PhD, Reporter

Penn Center for Innovation (Pennovation) sponsored a “Meet with NCI SBIR” program directors at University of Pennsylvania Medicine Smilow Center for Translational Research with a presentation on advice on preparing a successful SBIR/STTR application to the NCI as well as discussion of NCI SBIR current funding opportunities.   Time was allotted in the afternoon for one-on-one discussions with NCI SBIR program directors.

To find similar presentations and one-on-one discussions with NCI/SBIR program directors in an area nearest to you please go to their page at:

https://sbir.cancer.gov/newsevents/events

For more complete information on the NCI SBIR and STTR programs please go to their web page at: https://sbir.cancer.gov/about

A few notes from the meeting are given below:

  • In 2016 the SBIR/STTR 2016 funded $2.5 billion (US) of early stage companies; this is compared to the $6.6 billion invested in early  stage ventures by venture capital firms so the NCI program is very competitive with alternate sources of funding
  • It was stressed that the SBIR programs are flexible as far as ownership of a company; SBIR allows now that >50% of the sponsoring company can be owned by other ventures;  In addition they are looking more favorably on using outside contractors and giving leeway on budgetary constraints so AS THEY SUGGEST ALWAYS talk to the program director about any questions you may have well before (at least 1 month) you submit. More on eligibility criteria is found at: https://sbir.cancer.gov/about/eligibilitycriteria
  • STTR should have strong preliminary data since more competitive; if don’t have enough go for  an R21 emerging technologies grant which usually does not require preliminary data
  • For entities outside the US need a STRONG reason for needing to do work outside the US

Budget levels were discussed as well as  the waiver program, which allows for additional funds to be requested based on criteria set by NCI (usually for work that is deemed high priority or of a specialized nature which could not be covered sufficiently under the standard funding limits) as below:

Phase I: 150K standard but you can get waivers for certain work up to 300K

Phase II: 1M with waiver up to 2M

Phase IIB waiver up to 4M

You don’t need to apply for the waiver but grant offices may suggest citing a statement requesting a waiver as review panels will ask for this information

Fast Track was not discussed in the presentation but for more information of the Fast Track program please visit the website  

NCI is working hard to cut review times to 7 months between initial review to funding however at beginning of the year they set pay lines and hope to fund 50% of the well scored grants

NCI SBIR is a Centralized system with center director and then program director with specific areas of expertise: Reach out to them

IMAT Program and Low-Resource Setting new programs more suitable for initial studies and also can have non US entities

Phase IIB Bridge funding to cross “valley of death” providing up to 4M for 2-3 years: most were for drug/biological but good amount for device and diagnostics

 

Also they have announced administrative supplements for promoting diversity within a project: can add to the budget

FY18 Contracts Areas

3 on biotherapies

2 imaging related

2 on health IT

4 on radiation therapy related: NOTE They spent alot of time discussing the contracts centered on radiation therapy and seems to be an area of emphasis of the NCI SBIR program this year

4 other varied topics

 

Breakdown of funding

>70% of NCI SBIR budget went to grants (for instance Omnibus grants); about 20-30% for contracts; 16% for phase I and 34 % for phase II ;

ALSO the success rate considerably higher for companies that talk to the program director BEFORE applying than not talking to them; also contracts more successful than Omnibus applications

Take Advantage of these useful Assistance Programs through the NIH SBIR Program (Available to all SBIR grantees)

NICHE ASSESSMENT Program

From the NCI SBIR website:

The Niche Assessment Program is designed to help small businesses “jump start” their commercialization efforts. All active HHS (NIH, CDC, FDA) SBIR/STTR Phase I awardees and Phase I Fast-Track awardees (by grant or contract) are eligible to apply. Registration is on a first-come, first-serve basis!

The Niche Assessment Program provides market insight and data that can be used to help small businesses strategically position their technology in the marketplace. The results of this program can help small businesses develop their commercialization plans for their Phase II application, and be exposed to potential partners. Services are provided by Foresight Science & Technology of Providence, RI.

Technology Niche Analyses® (TNA®) are provided by Foresight, for one hundred and seventy-five (175), HHS SBIR/STTR Phase I awardees. These analyses assess potential applications for a technology and then for one viable application, it provides an assessment of the:

  1. Needs and concerns of end-users;
  2. Competing technologies and competing products;
  3. Competitive advantage of the SBIR/STTR-developed technology;
  4. Market size and potential market share (may include national and/or global markets);
  5. Barriers to market entry (may include but is not limited to pricing, competition, government regulations, manufacturing challenges, capital requirements, etc.);
  6. Market drivers;
  7. Status of market and industry trends;
  8. Potential customers, licensees, investors, or other commercialization partners; and,
  9. The price customers are likely to pay.

Commercialization Acceleration Program  (CAP)

From the NIH SBIR website:

NIH CAP is a 9-month program that is well-regarded for its combination of deep domain expertise and access to industry connections, which have resulted in measurable gains and accomplishments by participating companies. Offered since 2004 to address the commercialization objectives of companies across the spectrum of experience and stage, 1000+ companies have participated in the CAP. It is open only to HHS/NIH SBIR/STTR Phase II awardees, and 80 slots are available each year. The program enables participants to establish market and customer relevance, build commercial relationships, and focus on revenue opportunities available to them.

I-Corps Program

The I-Corps program provides funding, mentoring, and networking opportunities to help commercialize your promising biomedical technology. During this 8-week, hands-on program, you’ll learn how to focus your business plan and get the tools to bring your treatment to the patients who need it most.

Program benefits include:

  • Funding up to $50,000 to cover direct program costs
  • Training from biotech sector experts
  • Expanding your professional network
  • Building the confidence and skills to create a comprehensive business model
  • Gaining years of entrepreneurial skills in only weeks.

 

ICORPS is an Entrepreneurial Program (8 week course) to go out talk to customers, get assistance with business models, useful resource which can guide the new company where they should focus on for the commercialization aspect

THE NCI Applicant Assistance Program (AAP)

The SBIR/STTR Applicant Assistance Program (AAP) is aimed at helping eligible small R&D businesses and individuals successfully apply for Phase I SBIR/STTR funding from the National Cancer Institute (NCI), National Institute for Neurological Disorders and Stroke (NINDS), National Heart, Lung and Blood Institute (NHLBI). Participation in the AAP will be funded by the NCI, NINDS, and NHLBI with NO COST TO PARTICIPANTS. The program will include the following services:

  • Needs Assessment/Small Business Mentoring
  • Phase I Application Preparation Support
  • Application Review
  • Team/Facilities Development
  • Market Research
  • Intellectual Property Consultation

For more details about the program, please refer to NIH Notice NOT-CA-18-072.

 

These programs are free for first time grant applicants and must not have been awarded previous SBIR

Peer Learning Webinar Series goal to improve peer learning .Also they are starting to provide Regulatory Assistance (see below)

NIH also provides Mentoring programs for CEOS and C level

Application tips

  1. Start early: and obtain letters of collaboration
  2. Build a great team: PI multi PI, consider other partners to fill gaps (academic, consultants, seasoned entrepreneurs (don’t need to be paid)
  3. They will pre review 1 month before due date, use NIH Project Reporter to view previous funded grants
  4. Specify study section in SF to specify areas of expertise for review
  5. Specific aims are very important; some of the 20 reviewers focus on this page (describes goals and milestones as well; spend as much time on this page as the rest of the application
  6. Letters of support from KOLs are important to have; necessary from consultants and collaborators; helpful from clinicians
  7. Have a phase II commercialization plan
  8. Note for non US clinical trials:  They will not fund nonUS clinical trials; the company must have a FWA
  9. SBIR budgets defined by direct costs; can request a 7% fee as an indirect cost; and they have a 5,000 $ technical assistance program like regulatory consultants but if requested can’t participate in NIH technical assistance programs so most people don’t apply for TAP

 

  • They are trying to change the definition of innovation as also using innovative methods (previously reviewers liked tried and true methodology)

10.  before you submit solicit independent readers

NCI SBIR can be found on Twitter @NCIsbir ‏

Discussion with Monique Pond, Ph.D. on Establishment of a Regulatory Assistance Program for NCI SBIR

I was able to sit down with Dr. Monique Pond,  AAAS Science & Technology Policy Fellow, Health Scientist within the NCI SBIR Development Center to discuss the new assistance program in regulatory affairs she is developing for the NCI SBIR program.  Dr Pond had received her PhD in chemistry from the Pennsylvania State University, completed a postdoctoral fellow at NIST and then spent many years as a regulatory writer and consultant in the private sector.  She applied through the AAAS for this fellowship and will bring her experience and expertise in regulatory affairs from the private sector to the SBIR program. Dr. Pond discussed the difficulties that new ventures have in formulating regulatory procedures for their companies, the difficulties in getting face time with FDA regulators and helping young companies start thinking about regulatory issues such as pharmacovigilence, oversight, compliance, and navigating the complex regulatory landscape.

In addition Dr. Pond discussed the AAAS fellowship program and alternative career paths for PhD scientists.

 

A formal interview will follow on this same post.

 

Other articles on this OPEN ACCESS JOURNAL on Funding for Startups and Early Ventures are given below:

 

Mapping Medical Device Startups Across The Globe per Funding Criteria

Funding Oncorus’s Immunotherapy Platform: Next-generation Oncolytic Herpes Simplex Virus (oHSV) for Brain Cancer, Glioblastoma Multiforme (GBM)

 

Funding Opportunities for Cancer Research

 

Team Profile: DrugDiscovery @LPBI Group – A BioTech Start Up submitted for Funding Competition to MassChallenge Boston 2016 Accelerator

 

A Message from Faculty Director Lee Fleming on Latest Issue of Crowdfunding; From the Fung Institute at Berkeley

 

PROTOCOL for Drug Screening of 3rd Party Intellectual Property Presented for Funding Representation

 

Foundations as a Funding Source

 

The Bioscience Crowdfunding Environment: The Bigger Better VC?

 

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Live Notes From AACR TownHall on Precision Medicine January 21, 2016 in Philadelphia, PA: Background Information on Speakers

Reporter: Stephen J. Williams, Ph.D.

The Speakers:

Margaret Foti, PhD, MD (hc)

Chief Executive Officer
Margaret Foti, PhD, MD (hc)
​American Association for Cancer Research
Philadelphia, Pennsylvania

Margaret Foti, PhD, MD (hc), is the chief executive officer of the American Association for Cancer Research (AACR), the oldest cancer research organization in the world. Under her visionary leadership, membership has grown from about 3,000 members to 35,000 in 101 countries and the AACR’s portfolio of peer-reviewed scientific journals has increased from one to eight.

Chi Van Dang, MD, PhD

faculty photo

John H. Glick, M.D. Abramson Cancer Center Director’s Professor
Director, Abramson Cancer Center, University of Pennsylvania

 

Selected Publications:

Koppenol WH, Bounds PL, Dang CV: Otto Warburg’s contributions to current concepts of cancer metabolism. Nature Reviews Cancer 11 (5): 325-337,2011.

Dang CV, Hamaker M, Sun P, Le A, Gao P: Therapeutic targeting of cancer cell metabolism Journal of Molecular Medicine 89 (3): 205-212,2011.

Seltzer MJ, Bennett BD, Joshi AD, Gao P, Thomas AG, Ferraris DV, Tsukamoto T, Rojas C, Slusher BS, Rabinowitz JD, Dang CV, Riggins GJ: Inhibition of Glutaminase Preferentially Slows Growth of Glioma Cells with Mutant IDH1. Cancer Research 70 (22): 8981-8987,2010.

Wang, JB, Erickson, JW, Fuji, R, Ramachandran, S, Gao, P, Dinavahi, R, Wilson, KF, Ambrosio, ALB, Dias, SMG, Dang, CV, Cerione, RA: Targeting Mitochondrial Glutaminase Activity Inhibits Oncogenic Transformation (vol 18, pg 207, 2010) Cancer Cell 18 (4): 397,2010.

Otto AE, Hurd TW, Airik R, Chaki M, Zhou W, Stoetzel C, Patil SB, Levy S, Ghosh A K, Murga-Zamalloa CA, van Reeuwijk J, Letteboer SJF, Sang L, Giles RH, Liu Q, Coene KLM, Estrada-CuzcanA, Collin RWJ, McLaughlin HM, Held S, Kasanuki JM, Ramaswami G, Conte J, Lopez I, Washburn J, MacDonald J, Hu J, Yamashita Y, Maher ER, Guay-Woodford L, Neumann HPH, Obermüller N, Koenekoop RK, Bergmann C, Bei X, Lewis RA, Katsanis N, Lopes V, Williams DS, Lyons RH, Dang CV, Brito DA, Zhang X, Dias MB, Nürnberg G, Nürnberg P: Candidate exome capture identifies mutation of SDCCAG8 as the cause of a retinal-renal ciliopathy. Nature Genetics 42 (10): 840-50,2010.

Dang CV: Glutaminolysis Supplying carbon or nitrogen or both for cancer cells? Cell Cycle 9 (19): 3884-3886,2010.

Wang JB, Erickson JW, Fuji R, Ramachandran S, Gao P, Dinavahi R, Wilson KF, Ambrosio ALB, Dias SMG, Dang CV, Cerione RA: Targeting Mitochondrial Glutaminase Activity Inhibits Oncogenic Transformation. Cancer Cell 18 (3): 207-219,2010.

Koh, CM, Bierberich CJ, Dang CV, Nelson WG, Yegnaubramanian S, De Marzo A: Myc and prostate cancer. Genes & Cancer 1 (6): 617-628,2010.

Fan J, Zeller K, Chen YC, Watkins T, Barnes KC, Becker KG, Dang CV, Cheadle C: Time-Dependent c-Myc Transactomes Mapped by Array-Based Nuclear Run-On Reveal Transcriptional Modules in Human B Cells. Plos One 5 (3): e9691,2010.

Dang CV: p32 (C1QBP) and Cancer Cell Metabolism: Is the Warburg Effect a Lot of Hot Air? Molecular And Cellular Biology 30 (6): 1300-1302,2010.

Nancy E. Davidson, MD

photo

Director, University of Pittsburgh Cancer Institute

Hillman Professor of Oncology

Associate Vice Chancellor for Cancer Research

Distinguished Professor of Medicine

Richard I. Fisher, MD,

President and CEO

Cancer Center Director

Senior Associate Dean, Lewis Katz School of Medicine, Temple University

Robert C. Young, MD, Chair in Cancer Research

Richard Fisher, MD

Stephan A. Grupp, MD, PhD,director of the Cancer Immunotherapy Frontier Program, director of Translational Research for the Center for Childhood Cancer Research at CHOP and medical director of the Stem Cell Laboratory

Stephan A. Grupp, MD, PhD, is director of the Cancer Immunotherapy Frontier Program, director of Translational Research for the Center for Childhood Cancer Research at CHOP and medical director of the Stem Cell Laboratory.

Areas of Expertise: Development of engineered T cell therapies such as CTL019, Novel leukemia therapy, Stem cell transplants, Treatment of high-risk neuroblastoma

Working with our colleagues at the University of Pennsylvania, we have recently opened a phase I clinical trial called CART19. We’re using genetically modified T cells in this trial to treat patients with B cell cancers such as ALL, B cell non-Hodgkin lymphoma (NHL), the adult disease chronic lymphocytic leukemia and other B cell malignancies. T cells have the potential to kill cancer cells, but in patients with cancer, they’re not doing their job. By modifying them we can make the cells behave differently so they’ll attack cancer cells, using an engineered targeting protein called a chimeric antigen receptor (CAR). Initial results show that this could be an effective therapy for patients with B cell cancers. Indeed, our initial results show some of the most powerful activity against cancer of any clinical trial testing engineered cell therapy to date. This has received international attention, and some of this work has been published recently in Science Translational Medicine and the New England Journal of Medicine.

Expertise & Research Interests

Prostate cancer is the most commonly diagnosed malignancy in the Unites States and the second leading cause of cancer death in men. Early prostate cancers require androgen to survive and proliferate; this dependence is exploited in treatment for disseminated disease. Wherein androgen ablation in the first line of therapeutic intervention. Although these regimens are initially effective, tumors ultimately recur due to reactivation of androgen receptor (AR) signaling, causing treatment failure and patient morbidity.

Despite the importance of understanding androgen action in the prostate, little is understood about the mechanisms underlying androgen dependence, and the means by which the androgen requirement is bypassed in relapsed tumors. My lab is dedicated to delineating the molecular mechanisms that govern these events. We currently have four main projects in the lab:

1. Regulation of AR dependent gene expression and cellular proliferation by cell cycle crosstalk in prostate cancer

2. Impact of SWI/SNF chromatin remodeling factors on AR function and prostate tumorigenesis

3. Impact of cell cycle deregulation on therapeutic efficacy

4. Role of endocrine disrupting compounds in circumventing the androgen requirement

George C. Prendergast, PhD, President and CEO, Lankenau Institute for Medical Research

Photo of George Prendergast

By studying disease modifier genes we seek to develop new principles to treat cancer, diabetes, autoimmune disorders and cardiovascular disease. Currently most biomedical research focuses on understanding disease pathways. We seek to understand general disease modifier pathways that determine disease severity, an understudied area from which many useful drugs such as NSAIDs and statins are based. A major thrust of our present work focuses on modifiers of inflammatory processes which contribute significantly to the severity of many age-associated diseases. In our main project, we have developed a new class of drugs that recruit the immune system to eradicate a broad spectrum of advanced cancers, including breast, lung, skin, and pancreas tumors that are often refractory to chemotherapy. These drugs, called IDO inhibitors, are presently in Phase II clinical trials. In other projects, with our Lankenau colleagues we are developing new agents to treat autoimmune disorders, reduce risks of cardiovascular disease, and ameliorate diabetes.

Scientific Description

Our laboratory is interested primarily in cancer genes, cancer immunology and molecular therapeutics. We use transgenic mouse models and preclinical drug strategies to learn new ways to suppress cancer, focusing on long-term goals of improving strategies for cancer prognosis and treatment.

Localized tumors are often curable if they are detected before progression to invasive status, but many patients diagnosed with cancer already have invasive disease. What factors dictate malignant progression and how might they be therapeutically exploited? Molecular therapeutics that target key oncogene and tumor suppressor pathways show some clinical promise, but they have shown limited efficacy to date. Cancer modifier pathways that influence the immune microenvironment of tumor cells may strongly influence clinical course. Accordingly, new therapies we are developing are based on blocking enzymes that limit the ability of immune cells to destroy cancer cells or drive disease.

RhoB studies derive from our long-standing research on this member of the Ras/Rho superfamily in cancer cell signaling. Recent work in collaboration with Drs. Lisa Laury-Kleintop and Laura Mandik-Nayak at Lankenau has opened exciting new directions in studies of the role of RhoB in autoimmune and cardiovascular disease. A start-up company has been created to fund and advance the preclinical and clinical work needed to explore a provocative new therapy emerging from these novel directions, which in principle may be useful to treat one or more diseases in important areas of medicine.

Bin1 studies originating in cancer cell studies led us to discover that it regulates the immune modulatory enzyme indoleamine 2,3-dioxygenase (IDO). Bin1 modifies inflammation in a variety of settings including cancer. Recently, in preclinical studies we found that its genetic blockade can limit the development of inflammatory bowel disease (colitis). Based on this finding, we are now investigating the use of Bin1 antibodies we have developed to treat this disorder.

IDO is a tryptophan catabolic enzyme that blocks T cell activation in physiological settings such as pregnancy and in many pathophysiological settings like cancer. IDO is very widely activated as a mechanism of immune escape by cancer cells. Genetic studies reveal that IDO is essential for inflammation-driven cancers, not only supporting immune escape but also angiogenesis and metastasis. We pioneered preclinical studies of IDO inhibitory drugs that can arrest tumor growth and enhance chemotherapeutic efficacy. Mechanistic studies of one clinical lead inhibitor, D-1MT (indoximod), will greatly assist ongoing Phase II studies of this drug. Translational studies including on an IDO-related gene called IDO2 discovered at Lankenau are currently a major focus of the laboratory.

 

 

Please Follow on Twitter @pharma_BI and @AACR using meeting #cbi16

 

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AACR and Philly New Media Present a Town Hall Discussion on Precision Medicine

Reporter: Stephen J. Williams, PhD

Cancer Precision Medicine: Big Ideas in Research, Treatment, and Prevention

A Town Hall Forum will discuss the latest findings with regard to precision medicine, its impact currently in cancer treatment, and future directions, discussed by some of the preeminent cancer researchers and oncologists in the country. This unprecedented event is being hosted by the American Association for Cancer Research (AACR) and Philadelphia Media Network – publisher of The Philadelphia Inquirer, Daily News, and Philly.com.

Given the following speakers, this event will have a large focus on use of cancer immunotherapy as well as new targets in the precision medicine arena.

Register today: Philly.com/CancerEvent – Use the promo code “AACR” for discounted $45 tickets.

When: Thursday, January 21, 2016 • Program: 2 pm • Networking reception: 5:30 pm.

Where:  The College of Physicians of Philadelphia • 19 South 22nd Street, Philadelphia, Pa.

The event will be held in Philadelphia at the College of Physicians of Philadelphia, home of the famous Mutter Museum.

Please follow the meeting coverage on @pharma_BI and using the following @ handle and # hastags of Twitter:

@AACR

@pharma_BI

@PhillyInquirer

#cbi16

#precisionmedicine

#endcancer

 

From Penn Medicine News Blog: Archives (please click on link below)

Penn’s Center for Personalized Diagnostics (CPD), which recently named Kojo S.J. Elenitoba-Johnson, MD, as its founding director, is diving deeper into cancer patients’ tumors with next generation DNA sequencing.

The genetic tests help refine diagnoses with greater precision than standard imaging tests and blood work by spotting known mutations that can inform the treatment plan. Since it launched in February 2013, the CPD has performed more than 4,000 advanced diagnostics, representing a wide range of cancers.  It’s also producing actionable findings: Of those tests, 75 percent found disease-associated mutations, revealing possible new treatment pathways.

This new CPD video helps breakdown how the process works, but a patient story can really help connect the dots. We’ve written about several people who benefited from the CPD, including one acute myeloid leukemia patient with an FLT3 mutation that made her a candidate for a targeted therapy, and another whose cholangiocarcinoma was successfully treated with a BRAF-targeted therapy after the mutation—typically associated with melanoma—was spotted.

ACC’s role as a national leader in personalized cancer care was also reinforced with the opening of the Center for Rare Cancers and Personalized Therapy in 2015.

Directed by Marcia Brose, MD, PhD, this virtual center enrolls patients into clinical trials based on genetic markers rather than tumor origin.  Patients with the same mutation, BRAF for instance, but different cancers, are part of the same clinical study investigating a targeted therapy.  A story, set to air on TV news affiliates across the country in the upcoming weeks, will feature a patient with a rare salivary tumor who ran out of treatment options, until a HRAS mutation identified through the CPD put him back on track, after switching to the drug tipifarnib. The patient responded well, and a recent scan revealed that his disease has stabilized.

“Philadelphia is a hotbed for healthcare innovation and groundbreaking scientific research—which becomes even more apparent as the ACC continues to move the needle in the precision medicine world,”Abramson Cancer Center (ACC) director Chi Van Dang, MD, PhD, said.  “Quickly evolving diagnostics and genetic tests, cancer vaccines, and powerful personalized therapies that use the body’s own immune system to fight off cancer: These are just a few of the medical advances being utilized today that are giving patients the greatest chance.”

For Media Inquiries see the following AACR contact information:

Julia Gunther
Assistant Director, Media and Public Relations
215-446-6896
Cell: 267-250-5441
Fax: 215-861-5937
julia.gunther@aacr.org
Gunther promotes the AACR’s meetings, journals, and initiatives to the media and the public.

Lauren Walens
Senior Manager, Media and Public Relations
215-446-7163
Fax: 267-765-1050
lauren.walens@aacr.org
Walens promotes the AACR’s meetings, journals, and initiatives to the media and the public. She also manages the AACR’s blog, Cancer Research Catalyst.

Lauren Riley
Senior Coordinator, Media and Public Relations
215-446-7155
Fax: 215-446-7291
lauren.riley@aacr.org
Riley is responsible for media relations promotion and support, conference newsroom logistics, writing and proofreading, website and news release copy, as well as office support for the Communications and Public Relations Department staff.

 

 

 

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Will President Obama’ s Cancer Immunotherapy Colloquium (dubbed Moonshot) mean Government is Fully Behind the War on Cancer or have we heard this before?

 

UPDATED on 12/13/2016

Greg Simon, White House Cancer Moonshot Task Force: Interview Q&A

Dec 12, 2016 | AnnouncementsQ&ASpeaker spotlights |

The following is an interview recently conducted by PMWC with Greg Simon, Executive Director at the White House Cancer Moonshot Task Force. The discussion focused on the future of the Cancer Moonshot with the upcoming change of administration.

A status update on the Cancer Moonshot will be presented at the upcoming Precision Medicine World Conference (PMWC) 2017 Silicon Valley. To registerclick here.

http://www.pmwcintl.com/greg-simon-qa/

 

SOURCE:

From: Tal Behar <talb=pmwcintl.com@mail61.atl161.mcsv.net> on behalf of Tal Behar <talb@pmwcintl.com>

Reply-To: Tal Behar <talb@pmwcintl.com>

Date: Tuesday, December 13, 2016 at 1:40 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: PMWC News – Late Breaking Interview – The White House Cancer Moonshot in Limbo

 

 

Reporter: Stephen J. Williams, Ph.D

potusmoonshotannouncementsotus

President Obama announces a “Moonshot” Program to create collaborations aimed at developing immunotherapies to cure cancer by 2020 at his last State of the Union Address. Vice President Biden will lead the effort.

 

From Cancer Letters

  • Obama Announces Moonshot to Cure Cancer
  • When Moonshots Collide
  • Soon-Shiong Says FDA & NCI are Onboard For His Moonshot; Feds Deny Involvement

Obama Announces Moonshot to Cure Cancer

President Barack Obama announced a moonshot aimed at curing cancer, a project to be led by Vice President Joe Biden.

The United States can do “so much more,” Obama said in his seventh and final State of the Union address Jan. 12. “Last year, Vice President Biden said that with a new moonshot, America can cure cancer. Last month, he worked with this Congress to give scientists at the National Institutes of Health the strongest resources they’ve had over a decade.

“Tonight, I’m announcing a new national effort to get it done. And because he’s gone to the mat for all of us, on so many issues over the past 40 years, I’m putting Joe in charge of mission control. For the loved ones we’ve all lost, for the family we can still save—let’s make America the country that cures cancer once and for all.”

  When Moonshots Collide

Did Patrick Soon-Shiong attempt to scoop President Barack Obama’s State of the Union address?

Several days before Obama announced the federal government’s moonshot to cure cancer, Soon-Shiong put out a draft press release, claiming that the White House, NIH, FDA and pharmaceutical companies have united in “Cancer MoonShot 2020,” an immunotherapy clinical trials program he devised.

Soon-Shiong, founder and CEO of NantWorks and the Chan Soon-Shiong Institute of Molecular Medicine, ultimately announced his moonshot on Jan. 11, a day before Obama announced his.

Conversation with The Cancer Letter

Soon-Shiong Says FDA & NCI are Onboard For His Moonshot; Feds Deny Involvement

Government agencies said the biotechnology billionaire Patrick Soon-Shiong had overstated the extent of their involvement in “Cancer MoonShot 2020,” the immunotherapy clinical trials program he put together.

In an in-depth conversation with Matthew Bin Han Ong, a reporter with The Cancer Letter, Soon-Shiong said that while his program doesn’t seek federal funds, it has the support of NCI and FDA officials.

Soon-Shiong said he and Vice President Joe Biden met to discuss their interlocking missions and are now pursuing them.

 

From the AACR website

AACR Thanks President Obama and Vice President Biden for Their Strong Commitment to Cancer Research and Biomedical Science in State of the Union Address

1/12/2016

PHILADELPHIA — The American Association for Cancer Research (AACR) applauds and commends President Obama and Vice President Biden for their dedication in the fight against cancer discussed during tonight’s State of the Union address.

The AACR looks forward to working with the administration and Congress to make faster progress against cancer so that we might achieve the goal that Vice President Biden outlined during his speech in the Rose Garden Oct. 21, 2015, specifically that now is the time to make an “absolute national commitment to end cancer as we know it today.”

“We have indeed reached an inflection point, where the number of discoveries that are being made at such an accelerated pace are saving lives and bringing enormous hope for cancer patients, even those with advanced disease,” said AACR President José Baselga, MD, PhD, physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center. “Now is the time for a major new initiative in cancer science that supports and builds upon our basic science foundation while translating these exciting scientific discoveries into improved treatments for cancer patients, such as in the areas of genomics, precision medicine, and immuno-oncology. Tonight’s State of the Union address underscores the importance of collaborations if we are to achieve the vision that President Obama has outlined.”

To that end, on Jan. 8, a group of 15 AACR members, led by Baselga and comprising a number of AACR Board Members, and other AACR leaders from nine states and 10 of the top cancer centers and medical institutions in the U.S., met with Vice President Biden’s senior staff to discuss the state of cancer research, as well as Vice President Biden’s commitment to leading in this important issue.

From Philly.com

Biden to open effort to fight cancer Friday at Penn

 

011316_Biden-SOTU

US Vice President Biden will meet with University of Pennsylvania researchers to discuss the new Moonshot program to eliminate cancer. Photo from http://www.philly.com

 

Jonathan Tamari

Posted: Wednesday, January 13, 2016, 4:14 PM

image: http://media.philly.com/designimages/partnerIcon-Inquirer-2014.jpg

WASHINGTON – Vice President Biden will launch his effort to find a cure for cancer Friday in Philadelphia, with a visit to Penn’s Abramson Cancer Center at the school’s Perelman School of Medicine.

Biden announced the visit in an online post Tuesday night, when the call to cure the disease was one of the highlights of President Obama’s State of the Union speech.

“It’s personal for me. But it’s also personal for nearly every American, and millions of people around the world,” said Biden’s post on Medium. The vice president’s son Beau died of brain cancer at the age of 46 last year.

Biden compared the effort to President Kennedy’s call to go to the moon.

“From my own personal experience, I’ve learned that research and therapies are on the cusp of incredible breakthroughs,” Biden wrote. “The goal of this initiative — this “Moonshot” — is to seize this moment.”
Read more at http://www.philly.com/philly/blogs/capitolinq/Biden-to-open-effort-to-fight-cancer-Friday-at-Penn.html#sQFbeebwSDM17S0d.99

 

Biden to tour labs, meet cancer researchers at Penn

 

Vice President Biden is scheduled to spend part of Friday afternoon at the University of Pennsylvania’s Abramson Cancer Center, the first stop on his quest for the United States to cure cancer. President Obama announced the new “Moon Shot” mission during his State of the Union address Tuesday night, comparing it with John F. Kennedy’s 1961 declaration to Congress that the nation would land a man on the moon by the end of the decade.Biden’s 3 p.m. visit includes a tour of laboratories and a roundtable discussion with researchers at the Smilow Center for Translational Research and the Perelman Center for Advanced Medicine, both 3400 Civic Center Blvd. The events are not open to the public but are likely to cause some disruption.

In an internal e-mail Thursday afternoon, Garry Scheib, CEO of the Hospital of the University of Pennsylvania, told employees that parts of the building would be emptied for security reasons from 11 a.m. through evening. “In addition, the Secret Service will temporarily close roadways near our campus to allow for secure transport of the Vice President,” Scheib wrote.

– Don Sapatkin
Read more at http://www.philly.com/philly/health/20160115_Biden_to_visit_Penn_cancer_center_Friday_afternoon.html#vCpr4Hfu2AGYLSoX.99

 

Billionaire pulls together drugmakers, IBX for cancer collaboration

A billionaire medical entrepreneur has pulled together several drugmakers and Philadelphia-based Independence Blue Cross to speed development of what researchers hope could be a powerful weapon against cancers – potent combinations of new drugs that harness the body’s immune system.

So-called immunotherapies help disease-fighting cells attack tumors. Yet researchers believe they may work best when two, three, or more of the drugs are used together – overwhelming a tumor’s cellular defenses with attacks from all sides.

The group – called the National Immunotherapy Coalition – brought together by Patrick Soon-Shiong calls itself Moon Shot 2020. The name spun out of conversations Soon-Shiong had last year with Vice President Biden, whose son Beau died of cancer in May. In his October announcement that he was not running for president, Biden suggested a project of moon-shot proportions would be needed to defeat cancer.

A controversial figure in oncology research circles because of his self-promotion, Soon-Shiong made his fortune by inventing the cancer drug Abraxane in the early 1990s. California-based Amgen and New Jersey-based Celgene have joined the effort. Early reports suggested Pfizer, Merck, and GlaxoSmithKline might participate, but other reports indicated they had not as of Monday.

Independence Blue Cross said in a statement Monday that it entered into an agreement with NantHealth, one of Soon-Shiong’s companies, to cover next-generation whole genome sequencing, which is a test designed to detect gene mutations that may serve as markers to help doctors choose cancer treatment.

Independence said its agreement with NantHealth involves a “very specific and complex lab study” related to certain types of cancer. The test will be covered for members with “specific conditions including rare cancers, tumors in children, metastatic cancer of unknown primary, primary brain cancer, triple negative breast cancer, and metastatic cancer where conventional therapies have been exhausted and patients remain candidates for further therapy. Coverage for the testing will be available to eligible members of Independence commercial plans in March 2016.”

As for the National Immunotherapy Coalition, Independence said members referred by their oncologist for participation in one of the approved Moon Shot 2020 clinical trials will be eligible for coverage for the routine patient care costs related to the trial. The coverage includes all routine services required for the patient – such as blood tests, supportive medications, and surgical interventions.

“Independence Blue Cross is committed to bringing state-of-the-art advances in oncology to our members and making care accessible and affordable,” Daniel J. Hilferty, president and CEO, Independence Blue Cross, said in the statement. “Decisions around cancer care are complex and personal. We’re focused on supporting Independence members and their oncologists by offering coverage for this innovative approach to treating cancer. Whole genome sequencing is one more option to help inform a personalized, effective treatment plan.”
Read more at http://www.philly.com/philly/business/20160112_Billionaire_pulls_together_drugmakers__IBX_for_cancer_collaboration.html#XuXeFCydClgRsX0W.99

 

This is a Great Announcement But What is the History of the Government and THE WAR on CANCER? (Have we heard this before?)

 

The War on Cancer (launced by US President Nixon in the early 1970’s) has been discussed on this site from a historical perspective

2013 Perspective on “War on Cancer” on December 23, 1971

 

as well as the further needs the cancer field needs from this governmental effort

War on Cancer Needs to Refocus to Stay Ahead of Disease Says Cancer Expert

World facing cancer ‘tidal wave’, warns WHO

 

A summation of these efforts would say we have achieved great results in reducing the burden of cancer (through smoking cessation, early screening programs, better education, as well as therapeutic advances) however as the worldwide populace ages we are, and will see, a “rising tidal wave” of cancer incidence across the globe, and cancer researchers are feeling we are at an important precipice on this war, one which could be lost.

And the program which both President Obama and Vice President Biden are suggesting, the power would be a massive collaboration between government, academia, industry, and patient advocacy will certainly produce positive results.

However these efforts have been ongoing as with the University of Pennsylvania-Novartis deal to work together on CAR-T therapies for leukemias as well as other cancers

New Facility Poised to Accelerate the Research and Development of Personalized Cellular Cancer Therapies

 

as well as other academic-industry partnerships in immuno-oncology.

There have been other such announcements in recent years (mainly to draw in research $ or assist in forming academia-industry partnerships) such as:

NCI sets goal of eliminating suffering and death due to cancer by 2015.

 

In 2003 then NCI president Dr. Andrew C. von Eschenbach announced, after discussions with leaders in the field, that

“I have proposed a challenge goal for the field of cancer research- to eliminate suffering and death due to cancer by 2015. I issued this challenge because I believe we are at a ‘strategic inflection’ in oncology…”

Later in early decade of 2010 another program began to help make a push to recoup some of the government research $ lost to budgetary constraints on the NIH

STAND UP TO CANCER

stand-up-2-cancer

This program has met much success in raising money, awareness, and clinical trial enrollment (following shows current stats from the organization site)

Founded: May 28, 2008
Funds Pledged since inception: Over $370 Million
Number of scientists participating in SU2C-funded research: Over 1000
Clinical Trails funded by SU2C planned, initiated or completed: Over 160
Patients enrolled in SU2C supported Clinical Trials: Over 6,000 patients
Number of institutions joining in SU2C’s collaborative mission: 129

However, although it has grown the cancer research world encompasses a greater number than they can provide for.

 

In short, there has been no government effort much like Nixon’s War on Cancer, which took an obscure disease at the time and not only put it in the limelight but probably the most powerful result was the creation of the National Cancer Institute, thereby developing a framework to promote cancer research for the next century. President Obama should be applauded for this effort yet the real test for the Moonshot program will be to create, much like the NCI did, a self-perpetuating system by which continued further advancement can be made.

 

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Multiple factors related to initial trial design may predict low patient accrual for cancer clinical trials

Reporter: Stephen J. Williams, Ph.D.

UPDATED 5/15/2019

A recently published paper in JCNI highlights results determining factors which may affect cancer trial patient accrual and the development of a predictive model of accrual issues based on those factors.

To hear a JCNI podcast on the paper click here

but below is a good posting from scienmag.com which describes their findings:

Factors predicting low patient accrual in cancer clinical trials

source: http://scienmag.com/factors-predicting-low-patient-accrual-in-cancer-clinical-trials/

Nearly one in four publicly sponsored cancer clinical trials fail to enroll enough participants to draw valid conclusions about treatments or techniques. Such trials represent a waste of scarce human and economic resources and contribute little to medical knowledge. Although many studies have investigated the perceived barriers to accrual from the patient or provider perspective, very few have taken a trial-level view and asked why certain trials are able to accrue patients faster than expected while others fail to attract even a fraction of the intended number of participants. According to a study published December 29 in the JNCI: Journal of the National Cancer Institute, a number of measurable trial characteristics are predictive of low patient accrual.

Caroline S. Bennette, M.P.H., Ph.D., of the Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle, and colleagues from the University of Washington and the Fred Hutchinson Cancer Research Center analyzed information on 787 phase II/III clinical trials sponsored by the National Clinical Trials Network (NCTN; formerly the Cooperative Group Program) launched between 2000 and 2011. After excluding trials that closed because of toxicity or interim results, Bennette et al. found that 145 (18%) of NCTN trials closed with low accrual or were accruing at less than 50% of target accrual 3 years or more after opening.

The authors identified potential risk factors from the literature and interviews with clinical trial experts and found multiple trial-level factors that were associated with poor accrual to NCTN trials, such as increased competition for patients from currently ongoing trials, planning to enroll a higher proportion of the available patient population, and not evaluating a new investigational agent or targeted therapy. Bennette et al. then developed a multivariable prediction model of low accrual using 12 trial-level risk factors, which they reported had good agreement between predicted and observed risks of low accrual in a preliminary validation using 46 trials opened between 2012 and 2013.

The researchers conclude that “Systematically considering the overall influence of these factors could aid in the design and prioritization of future clinical trials…” and that this research provides a response to the recent directive from the Institute of Medicine to “improve selection, support, and completion of publicly funded cancer clinical trials.”

In an accompanying editorial, Derek Raghavan, M.D., Levine Cancer Institute, writes that the focus needs to be on getting more patients involved in trials, saying, “we should strive to improve trial enrollment, giving the associated potential for improved results. Whether the basis is incidental, because of case selection bias, or reflects the support available to trial patients has not been determined, but the fact remains that outcomes are better.”

###

Contact info:

Article: Caroline S. Bennette, M.P.H., Ph.D., cb11@u.washington.edu

Editorial: Derek Raghavan, M.D., derek.raghavan@carolinashealthcare.org

Other investigators also feel that initial trial design is of UTMOST importance for other reasons, especially in the era of “precision” or “personalized” medicine and why the “basket trial” or one size fits all trial strategy is not always feasible.

In Why the Cancer Research Paradigm Must Transition to “N-of-1” Approach

Dr. Maurie Markman, MD gives insight into why the inital setup of a trial and the multi-center basket type of  accrual can be a problematic factor in obtaining meaningful cohorts of patients with the correct mutational spectrum.

The anticancer clinical research paradigm has rapidly evolved so that subject selection is increasingly based on the presence or absence of a particular molecular biomarker in the individual patient’s malignancy. Even where eligibility does not mandate the presence of specific biological features, tumor samples are commonly collected and an attempt is subsequently made to relate a particular outcome (eg, complete or partial objective response rate; progression-free or overall survival) to the individual cancer’s molecular characteristics.

One important result of this effort has been the recognition that there are an increasing number of patient subsets within what was previously—and incorrectly—considered a much larger homogenous patient population; for example, non–small cell lung cancer (NSCLC) versus EGFR-mutation–positive NSCLC. And, while it may still be possible to conduct phase III randomized trials involving a relatively limited percentage of patients within a large malignant entity, extensive and quite expensive effort may be required to complete this task. For example, the industry-sponsored phase III trial comparing first-line crizotinib with chemotherapy (pemetrexed plus either carboplatin or cisplatin) in ALK-rearrangement–positive NSCLC, which constitutes 3% to 5% of NSCLCs, required an international multicenter effort lasting 2.5 years to accrue the required number of research subjects.1

But what if an investigator, research team, or biotech company desired to examine the clinical utility of an antineoplastic in a patient population representing an even smaller proportion of patients with NSCLC such as in the 1% of the patient population with ROS1 abnormalities,2 or in a larger percentage of patients representing 4%-6% of patients with a less common tumor type such as ovarian cancer? How realistic is it that such a randomized trial could ever be conducted?

Further, considering the resources required to initiate and successfully conduct a multicenter international phase III registration study, it is more than likely that in the near future only the largest pharmaceutical companies will be in a position to definitively test the clinical utility of an antineoplastic in a given clinical situation.

One proposal to begin to explore the benefits of targeted antineoplastics in the setting of specific molecular abnormalities has been to develop a socalled “basket trial” where patients with different types of cancers with varying treatment histories may be permitted entry, assuming a well-defined molecular target is present within their cancer. Of interest, several pharmaceutical companies have initiated such clinical research efforts.

Yet although basket trials represent an important research advance, they may not provide the answer to the molecular complexities of cancer that many investigators believe they will. The research establishment will have to take another step toward innovation to “N-of-1” designs that truly explore the unique nature of each individual’s cancer.

Trial Illustrates Weaknesses

A recent report of the results of one multicenter basket trial focused on thoracic cancers demonstrates both the strengths but also a major fundamental weakness of the basket trial approach.3

However, the investigators were forced to conclude that despite accrual of more than 600 patients onto a study conducted at two centers over a period of approximately 2 years, “this basket trial design was not feasible for many of the arms with rare mutations.”3

They concluded that they needed a larger number of participating institutions and the ability to adapt the design for different drugs and mutations. So the question to be asked is as follows: Is the basket-type approach the only alternative to evaluate the clinical relevance of a targeted antineoplastic in the presence of a specific molecular abnormality?

Of course, the correct answer to this question is surely: No!

– See more at: http://www.onclive.com/publications/Oncology-live/2015/July-2015/Why-the-Cancer-Research-Paradigm-Must-Transition-to-N-of-1-Approach#sthash.kLGwNzi3.dpuf

The following is a video on the website ClinicalTrials.gov which is a one-stop service called EveryClinicalTrial to easily register new clinical trials and streamline the process:

 

UPDATED 5/15/2019

Another possible roadblock to patient accrual has always been the fragmentation of information concerning the availability of clinical trails and coordinating access among the various trial centers, as well as performing analytics on trial data to direct new therapeutic directions.  The NIH has attempted to circumvent this problem with the cancer trials webpage trials.gov however going through the vast number of trials, patient accrual requirements, and finding contact information is a daunting task.  However certain clinical trial marketplaces are now being developed which may ease access problems to clinical trials as well as data analytic issues, as highlighted by the Scientist.com article below:

Scientist.com Launches Trial Insights, A Transformative Clinical Trials Data Analytics Solution

The world’s largest online marketplace rolls out first original service, empowering researchers with on demand insights into clinical trials to help drive therapeutic decisions

SAN DIEGO–(BUSINESS WIRE)–Scientist.com, the online marketplace for outsourced research, announced today the launch of Trial Insights, a digital reporting solution that simplifies data produced through clinical trial, biomarker and medical diagnostic studies into an intuitive and user-friendly dashboard. The first of its kind, Trial Insights curates publicly available data nightly from information hubs such as clinicaltrials.gov and customizes it to fit a researcher or research organization’s specific project needs.

Trial Insights, new clinical trial reporting solution, allows researchers to keep track of the evolving landscape of drugs, diseases, sponsors, investigators and medical devices important to their work.

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“Trial Insights offers researchers an easy way to navigate the complexity of clinical trials information,” said Ron Ranauro, Founder of Incite Advisors. “Since Trial Insights’ content is digitally curated, researchers can continuously keep track of the evolving landscape of drugs, diseases, sponsors, investigators and medical devices important to their work.”

As the velocity, variety and veracity of data available on sites like clinicaltrials.gov continues to increase, the ability to curate it becomes more valuable to different audiences. With the advancement of personalized medicine, it is important to make the data accessible to the health care and patient communities. Information found on the Trial Insights platform can help guide decision making across the pharmaceutical, biotechnology and contract research organization industries as clinical trial data is a primary information source for competitive intelligence, research planning and clinical study planning.

“We are extremely excited to launch the first Scientist.com exclusive, original service offering to our clients in the life sciences,” said Mark Herbert, Scientist.com Chief Business Officer. “Our goal at Scientist.com is to help cure all diseases by 2050, and we believe solutions like Trial Insights, which greatly simplifies access to and reporting of clinical trial data, will get us one step closer to reaching that goal.”

source: https://www.businesswire.com/news/home/20190416005362/en/Scientist.com-Launches-Trial-Insights-Transformative-Clinical-Trials?utm_source=TrialIO+List

 

Other article on this Open Access Journal on Cancer Clinical Trial Design include:

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Early Diagnosis

Reporter: Stephen J. Williams, Ph.D.

This post contains a curation of all Early Diagnosis posts on this site as well as a curation of the Early Detection Research Network.

Early Research Detection Network (EDRN)

Welcome to EDRN

The Early Detection Research Network (EDRN), an initiative of the National Cancer Institute (NCI), brings together dozens of institutions to help accelerate the translation of biomarker information into clinical applications and to evaluate new ways of testing cancer in its earliest stages and for cancer risk.

Getting Started…

Check out the EDRN Highlights — a listing of our accomplishments and milestones.

 

► Scientific Components ► For Public, Patients, Advocates
► Collaborative Opportunities (how to join EDRN) ► For Researchers

Highlights

Highlights of the accomplishments of the Early Detection Research Network.

A brief list of major EDRN-developed assays that have been adapted for clinical use is described in the table below:

Detection/Biomarker Assay Discovery Refine/Adapt for Clin Use Clinical Validation Clinical Translation
Blood proPSA FDA approved
Urine PCA3 FDA approved
OVA1™ for Ovarian Cancer FDA approved
ROMA Algorithm for CA125 and HE4 Tests for Pelvic Mass Malignancies FDA approved
Blood/DCP and AFP-L3 for Hepatocellular Carcinoma FDA approved
Blood GP73 Together with AFP-L3 used  for monitoring cirrhotic patients for HCC in China
MiPS (Mi Prostate Score Urine test), Multiplex analysis of T2-ERG gene fusion, PCA3 and serum PSA In CLIA Lab
FISH to detect T2S:Erg fusion for Prostate Cancer In CLIA Lab
GSTP1 methylation for repeat biopsies in prostate cancer In CLIA Lab
Mitochondrial deletion for detection of prostate cancer In CLIA Lab
Somalogic 12-marker panel for Lung Cancer In CLIA Lab
80-gene panel for Lung Cancer In CLIA Lab
Vimentin Methylation Marker for Colon Cancer In CLIA Lab
Galectin-3 ligand for detection of adenomas and colon cancer In CLIA Lab
8-gene panel for Barrett’s Esophagus In CLIA Lab
SOPs for Blood (Serum, Plasma), Urine, Stool Frequently used by biomarker research community
EDRN Pre/Validation Specimen Reference Sets (specimens from well characterized and matched cases and controls from specific disease spectra) Frequently used by biomarker research community

Since its inception in 1999 EDRN has achieved several key milestones, summarized below:

1998 through 2000: Inception and Inauguration of EDRN

2001 to 2003: Meeting the Challenges to Harness and Share Emerging Scientific Knowledge

  • EDRN Second Report, Translational Research to Identify Early Cancer and Cancer Risk, October 2002, http://edrn.nci.nih.gov/docs.) published.
  • EDRN joined the Gordon Research Conferences to co-host the New Frontiers in Cancer detection and Diagnosis in 2002.

 

  • Guidelines Set for Studies Measuring Biomarker Predictive Power Journal of National Cancer Institute (Vol. 93, No. 14, July 18, 2001).
  • EDRN Associate Membership Program Initiated: This novel approach to make EDRN inclusive has been extremely successful. EDRN has now more than 120 Associate Members who are significantly contributing to EDRN efforts in biomarker discovery, development and validation.

2003 to 2004: Network Surges Ahead in Real-time

  • Collaborative Discovery and Validation Projects:  More than 100 collaborative projects spanned the various organ sites. These projects are monitored through the EDRN’s electronic System Information System (eSIS).
  • EDRN Virtual Specimen Bank and Validation Management System Launched: The EDRN Virtual Specimen Bank, also known as ERNE knowledge system, was deployed to 10 institutions in early 2003, allowing a common web-based query to search for available specimens across the EDRN Clinical Epidemiology and Validation Centers https://ginger.fhcrc.org/edrn/imp/GateServlet?pwd. VSIMS was created to allow multiple studies to be administered efficiently by minimizing development time with standardization of information and data management across multiple activities and research sites. This system encompasses all the security features of Food and Drug Administration (FDA)-required auditing systems.
  • Partnership on the Plasma Proteome Project (PPP) Initiative of the Human Proteome Organization (HUPO): PPP project was initiated to evaluate multiple technology platforms, develop bioinformatic tools and standards for protein identification, and create a database of the plasma proteome. The entire study was published in the August issue of the journal Proteomics August 2005, Volume 4 (4), pp 1045-1450.

2005 to 2008: An Investment in Prevention

  • In late 2006, EDRN’s Program for Rapid, Independent Diagnostic Evaluation (PRIDE), was established (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-07-003.html ) as an administrative means to assist extramural investigators in successfully conducting cross-laboratory validation of biomarkers. Ten applications have been reviewed and five are being supported.
  • EDRN underwent external reviews in 2007 and 2008.
  • The Canary Foundation, Palo Alto, CA signed a Memorandum of Understanding with EDRN, NCI on supporting prostate cancer surveillance network of investigators from seven institutions. The tissue and serum will be collected during a three-year period and will be made available to extramural scientists for discovery and validation research.
  • The Lustgarten Foundation, N.Y., funded 6 institutions to generate monoclonal antibodies and associated hybridoma cell lines for pancreatic cancer antigens (biomarkers) identified by EDRN and non-EDRN investigators. These resources will be stored at the NCI-Frederick Facility for distribution to extramural investigators.

2009 to 2011: Realizing Investment for Clinical Use

  • Two biomarker tests approved by FDA and two IVDs pending FDA review.
  • Six biomarker tests offered by CLIA labs.
  • One biomarker test approved for clinical use outside the USA

A Curation of Posts on Early Detection of Cancer and Other Early Detection Networks is Included Below

 

BRCA 1 and 2 and Early Detection of Cancer

Early Detection of Prostate Cancer: American Urological Association (AUA) Guideline

Mechanism involved in Breast Cancer Cell Growth: Function in Early Detection & Treatment

Warning signs may lead to better early detection of ovarian cancer

Cancer Detection

Biomarker tool development for Early Diagnosis of Pancreatic Cancer: Van Andel Institute and Emory University

China, India, and Russia account for 46% of all new cancer cases globally, as well as 52% of cancer-related mortality per 4/2014 Lancet Oncology article

 

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Heroes in Medical Research: Dr. Robert Ting, Ph.D. and Retrovirus in AIDS and Cancer

Curator and Reporter: Stephen J. Williams, PhD

This is the second posting in this series in which I highlight the basic research which led to seminal breakthroughs in the medical field, brought on by the result of basic inquiry, thorough and detailed investigation, meticulously following the scientific method, and eventually leading to development of important medical therapies.

In his autobiography, Virus Hunting: AIDS, Cancer & the Human Retrovirus: A Story of Scientific Discovery, Dr. Robert Gallo, M.D. describes a wonderful story of the history behind, scientific biographies, and chronology of the discoveries which led he and his colleagues (including co-discoverer Dr. Luke Montagnier) to recognize retroviruses (in particular HIV) as the leading culprit for the cause of AIDS and in the etiology of Kaposi’s sarcoma.   For anyone who appreciates the history behind scientific discoveries and appreciates learning about the multitude of individual efforts which are the crux of seminal research, this book is a must read.

Recommendations from the back cover include:

Virus Hunting will be read and reread, for years to come.” —New York Newsday

“Provides a human, revealing look into the arcane, usually secret confines of laboratory science.”

Martin Delany, Project Inform

..as well as others.

While a fascinating aspect of this book is the description, like fitting pieces of a puzzle, of the important discoveries throughout history which are the necessary foundations for further investigations and discoveries, more important is a telling, personal narrative of the people involved in those initial and subsequent discoveries.  In fact, the book has over 396 colleagues, mentors, technicians, students, and even critiques who are given credit, in one form or another, for the ultimate discovery of HIV as a causative agent for the development of AIDS. The book is a literal Who’s Who in Science and shows how important personal collaboration and friendships are in the process of scientific discovery.

In 1972, Dr. Seymour Perry had appointed the young Dr. Robert Gallo as head of a new department, the Human Tumor Cell Biology Branch, renamed the Laboratory of Tumor Cell Biology.  The lab was carrying on the work on tRNA that Dr. Gallo had performed in Dr. Sid Perska’s group at NIH.  However, with the help of new lab members Dr. David Gillespie, Dr. Flossie Wong-Staal, and Dr. Marjorie Robert-Guroff the lab focused on the search for disease-causing retroviruses, especially in human leukemias.  This was, in part, due to conversations with Dr. Robert Huebner and Todaro, who insisted that

“within the genetic makeup of this endogenous retroviral material was, they suggested, a special gene, the oncogene, that was the parent of the cancer-causing protein”

which may explain some of the early work by Rous concerning the Rous sarcoma virus.

Enter in Gallo’s good friend Dr. Bob Ting.  Dr. Gallo had known Dr. Ting socially since 1966, shortly after Gallo had arrived at NIH.  Dr. Bob Ting was a well-established NCI investigator, who was doing work on DNA and RNA oncogenic viruses of animals.  Originally from a large and wealthy family in Hong Kong, Dr. Ting had worked with Nobel Prize winners Salvatore Luria (who worked on phages) and Renato Dulbecco, who, along with his well-known cell culture media, had made the seminal discoveries that led to our knowledge how some DNA viruses can transform normal animal cells into neoplastic-like cells in culture.

Bob Ting gave a talk on these oncogenic viruses and Gallo was very interested in his observations that oncogenic viruses like Rous and Maloney, could transform cells in vitro in a matter of days.

A friendship developed between the two over tennis matches and Chinese food.  During this time, Dr. Ting made the important suggestion that they both collaborate and use the viral systems developed by Dulbecco.  Ting also introduced him to RNA viruses, Dr. Robert Huebner, and Dr. Howard Temin.  It was, in part, due to these associations that Gallo started looking, in earnest, at the possibility of RNA retroviruses in leukemias. Thus, just like the internet today, connections and networking provided new insights into current research, and helped lead the advent of new discoveries, therapies, and scientific disciplines.

Therefore, “after some late-night discussion with Bob Ting, I decided to enter the fray. My own laboratory, … would immediately be set up to compare the properties of reverse transcriptase enzymes from many different animal retroviruses”.

Although the rest is more history, this early friendship, collaboration, and mentoring by Bob Ting had “transformed” Gallo’s research efforts to set him up to make some of the important discoveries eventually leading to the discovery of the role of HIV in AIDS.

A video interviewing Dr. Gallo can be found here:

VIEW VIDEO

https://www.youtube.com/watch?v=ELRlXLGWu4I

A very nice writeup/obituary for Dr. Ting was written by Patricia Sullivan of the Washington Post and is included below.

Robert Ting, 77; Biotech Pioneer

ME/Ting-ob

Dr. Robert Ting’s biotech company in Rockville developed the first FDA-approved diagnostic test kits to test for HIV antibodies. (By Gerald Martineau — The Washington Post)

 

By Patricia Sullivan

Washington Post Staff Writer
Friday, September 22, 2006

Robert C.Y. Ting, 77, a research scientist who started one of the early biotechnology companies in the Washington area, died Sept. 11 of complications after cardiac surgery at the Cleveland Clinic in Cleveland.

Dr. Ting founded Biotech Research Laboratories Inc. in Rockville in 1973, producing cells for government scientists to use in research. Eleven years later, his firm obtained a federal license to develop and produce the first FDA-approved diagnostic test kits for HIV antibody confirmation.

Robert C. Gallo, who co-discovered the HIV virus as the cause of AIDS, called Dr. Ting a pioneer in the field who popularized the term “biotechnology” when he moved from research to entrepreneurship.

“He introduced me to virology, and he did it twice,” said Gallo, director of the Institute of Human Virology in Baltimore. The men had known each other since the 1960s, and while playing tennis one day, Dr. Ting advised the cancer researcher to look at new research in viruses. Later, when Gallo was studying leukemia, Dr. Ting directed him to animal research in leukemia. “First he showed me how viruses change cells. Then he introduced me to retrovirology. . . . I went into retrovirology solely because of those discussions with Bob Ting on tennis courts,” Gallo said.

Dr. Ting, whom Gallo described as a quiet, modest man, was born in Shanghai, the son of a physician to Gen. Chiang Kai-Shek. His family fled the country during the Japanese invasion of China during World War II and moved to Hong Kong. Soon after, he moved to the United States, where he received a bachelor’s degree and in 1956 a master’s degree in genetics from Amherst College.

He received a doctoral degree in microbiology and biochemistry from the University of Illinois in 1960 under Salvador E. Luria, who later won the 1969 Nobel Prize in Medicine and Physiology. Dr. Ting spent the next two years on a postdoctoral fellowship at the California Institute of Technology, working with Renato Dulbecco, who later won the 1975 Nobel Prize in Medicine and Physiology. Their work focused on how viruses cause tumors.

“A lot of molecular biology developed from this,” Dr. Ting told The Washington Post in 1984 from his Rockville office, cluttered with scientific journals, awards and a large blackboard. “There was so much evidence in animal systems [that viruses cause tumors], that the next question was obvious — can you find the equivalent in humans.”

Dr. Ting joined the National Institutes of Health in 1962 as a visiting fellow and then a senior research scientist at the National Cancer Institute. From 1966 to 1968, he was an associate editor for the Journal of the National Cancer Institute.

In 1969, he joined Litton Bionetics Inc. in Rockville as director of experimental oncology, leading a project funded by the institute to search for viruses in human leukemia patients. He became scientific director of the cancer research branch the next year.

With academic, government and private business experience under his belt, Dr. Ting decided to go into business on his own and in 1973 started Biotech Research Laboratories in Rockville. It was a profitable supplier of research services and supplies until 1981, when it went public and produced the HIV diagnostic test kits. It became one of the most successful public biotech companies in the area in the mid-1980s.

The Economic Development Board of Singapore invited him to return to Asia to start a biotech company, which he did in 1985, forming Diagnostic Biotechnology Ltd. He also joined the Institute of Molecular and Cell Biology at the National University of Singapore, which Gallo called “the most prominent Asian academic biotechnology center.”

He returned to the United States in 1998 to join the board of Cell Works Inc. in Baltimore, and became chair and chief executive of a joint venture, Cell Works Asia Limited, in 2000.

Most recently, Dr. Ting was the founding president and chief executive of Profectus Biosciences Inc. of Baltimore, previously known as Maryland BioTherapeutics Inc.

Dr. Ting was past chairman of the F.F. Fraternity, one of the oldest Chinese fraternities in the United States. He was also a member of the Organization of Chinese Americans in the D.C. area since its inception in the early 1970s. He enjoyed tennis, golf, ballroom dancing and international travel. He also was a wine connoisseur.

Survivors include his wife of 44 years, Sylvia Han Ting of Potomac; three children, Anthony Ting of Shaker Heights, Ohio, Andrew Ting of Beverly, Mass., and Jennifer Chow of Potomac; seven sisters; and seven grandchildren.

An obituary written from his son Anthony can be found here:

https://www.amherst.edu/aboutamherst/magazine/in_memory/1953/robertting

Sources:

http://www.amazon.com/Virus-Hunting-Retrovirus-Scientific-Discovery/dp/0465098150

http://www.washingtonpost.com/wp-dyn/content/article/2006/09/21/AR2006092101936.html

Other articles/postings related to this topic and HIV on this site includes:

Heroes in Medical Research: Barnett Rosenberg and the Discovery of Cisplatin

History of medicine, science, and society: 200 Years of the New England Journal of Medicine

Why did Pauling Lose the “Race” to James Watson and Francis Crick? How Crick Describes his Discovery in a Letter to his Son

John Randall’s MRC Research Unit and Rosalind Franklin’s role at Kings College

Interview with the co-discoverer of the structure of DNA: Watson on The Double Helix and his changing view of Rosalind Franklin

Otto Warburg, A Giant of Modern Cellular Biology

Inspiration From Dr. Maureen Cronin’s Achievements in Applying Genomic Sequencing to Cancer Diagnostics

Nanotechnology and HIV/AIDS treatment

HIV vaccine: Caltech puts us One step further

Getting Better: Documentary Videos on Medical Progress — in Surgery, Leukemia, and HIV/AIDS.

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