National Health and Medical Research Council

Lisata Therapeutics Announces Outcome of Interim Futility Analysis for its Phase 2b ASCEND Trial of LSTA1 in Metastatic Pancreatic Ductal Adenocarcinoma

Retrieved on: 
Wednesday, September 6, 2023

Based on the results of the interim futility analysis, which was reviewed by the study’s Independent Data Safety Monitoring Committee (“IDSMC”), the ASCEND trial will continue as planned without modification.

Key Points: 
  • Based on the results of the interim futility analysis, which was reviewed by the study’s Independent Data Safety Monitoring Committee (“IDSMC”), the ASCEND trial will continue as planned without modification.
  • The trial is fully funded by Lisata through an unrestricted research support agreement.
  • The trial is approved by the Sydney Local Health District (SLHD) Ethics Review Committee (Royal Prince Alfred Hospital Zone) (2021/ETH00985).
  • Trial enrollment completion is projected for the first half of 2024; however, current enrollment already exceeds 80% of the target, so earlier enrollment completion may be achieved.

We are finally moving towards a national strategy on concussions in sport. Will the government and sports bodies now act?

Retrieved on: 
Wednesday, September 6, 2023

Senator Janet Rice, the committee chair, urged the government to take the report very seriously and quickly move to implement the recommendations.

Key Points: 
  • Senator Janet Rice, the committee chair, urged the government to take the report very seriously and quickly move to implement the recommendations.
  • Our sports leagues have begun paying greater attention to the risks associated with concussions and mild traumatic brain injuries.
  • However, governments have been slow to act on repeated calls for a national strategy to what is fundamentally a public health concern.

Conflicting approaches to concussions

    • Two conflicting narratives emerged from the evidence.
    • On the one hand, athletes, families, health care professionals and other public interest groups expressed concern that the current approach on concussions and player safety was inadequate.
    • They argued there are too many gaps in the system and, in some cases, that sports organisations are putting self interest above player health.

Lack of reliable data on head injuries

    • One of the main concerns in the report was the lack of reliable and accurate data on the prevalence of concussions in sport and our general level of understanding on the health risks.
    • To address the data issue, the inquiry recommended the government establish a national sports injury database as a matter of urgency.
    • There is clear evidence of a causal link between repeated head trauma and
      concussions and subsequent neurodegenerative diseases such as CTE.

‘High level of confusion’ on return-to-play rules

    • Other recommendations focus on how sporting codes should change their rules or policies to mitigate the risks of head injuries.
    • Read more:
      New study highlights the brain trauma risks for young athletes

      This is an important point.

    • The report cited concern over the “high level of confusion” over how much time a player should sit out, which comes from the disparate rules across sporting codes.

Inadequate support for athletes


    The final sections of the report deal with the current lack of financial support for players who suffer concussions, including:
    • The report made clear much more could be done by sporting organisations to improve their duty of care to athletes.
    • As a baseline, it “encourages” professional sports organisations to ensure their athletes have insurance coverage for head trauma and the removal of the exclusion of athletes from workers’ compensation regimes.
    • The goal here is to address the inequities in access to adequate support for professional athletes.

Medical Research Future Fund has $20 billion to spend. Here’s how we prioritise who gets what

Retrieved on: 
Thursday, July 20, 2023

The Medical Research Future Fund (MRFF) is a A$20 billion fund to support Australian health and medical research.

Key Points: 
  • The Medical Research Future Fund (MRFF) is a A$20 billion fund to support Australian health and medical research.
  • It was set up in 2015 to deliver practical benefits from medical research and innovation to as many Australians as possible.
  • Unlike the other research funding agencies, such the National Health and Medical Research Council (NHMRC), most of the MRFF funding is priority-driven.

Assess gaps in evidence

    • However, most researchers and institutions will simply argue more funding is needed for their own research.
    • If the board seeks to satisfy such lobbying, it will produce fragmented funding that aligns poorly with the health needs of Australians.
    • A better approach would be to systematically assemble evidence about what is known and the key evidence gaps.

Seek public input

    • A structured framework for engaging with the public is also missing in Australia.
    • The public’s perspective on research prioritisation has often been overlooked, but as the ultimate consumers of research, they need to be heard.
    • Research is a highly complex and specialised endeavour, so we can’t expect the public to create sensible priorities alone.

Consider our comparative advantages

    • A single research grant, even if it involves a few million dollars of funding, is unlikely to lead to a medical breakthrough.
    • Instead, the MRFF should prioritise areas where Australia has a comparative advantage.
    • However, there is an area where Australian researchers have an absolute advantage: using research to improve our own health system.
    • Now that is something the MRFF should consider as a funding priority.

Should GPs bring up a patient’s weight in consultations about other matters? We asked 5 experts

Retrieved on: 
Thursday, July 13, 2023

A 15-minute consultation isn’t long enough to provide support to change behaviours, Brumfitt says, and GPs don’t have enough training and expertise to have these complex discussions.

Key Points: 
  • A 15-minute consultation isn’t long enough to provide support to change behaviours, Brumfitt says, and GPs don’t have enough training and expertise to have these complex discussions.
  • By raising the issue of weight, Brumfitt says, GPs also risk turning patients off seeking care for other health concerns.
  • So should GPs bring up a patient’s weight in consultations about other matters?
  • He does not have a specific interest in obesity, but like almost all GPs, he treats many patients who are overweight or obese.

Lupus Research Alliance Honors Carola Vinuesa, MD, PhD, for Discovering a Specific Gene Variant that Causes Lupus in Some Patients

Retrieved on: 
Thursday, June 22, 2023

The Lupus Research Alliance awarded its 2023 Lupus Insight Prize to Carola Vinuesa, MD, PhD, of The Francis Crick Institute.

Key Points: 
  • The Lupus Research Alliance awarded its 2023 Lupus Insight Prize to Carola Vinuesa, MD, PhD, of The Francis Crick Institute.
  • Many lupus patients display increased TLR7 activity; however, disease-causing mutations in the TLR7 gene had not been identified.
  • "I am honored to receive this most prestigious award from the Lupus Research Alliance in recognition of our discovery of a genetic cause of lupus.
  • To determine whether the TLR7 mutation identified causes lupus, Dr. Vinuesa's team used a gene-editing tool, CRISPR/Cas9, to introduce the specific variant into mice.

The first sleep health program for First Nations adolescents could change lives

Retrieved on: 
Sunday, June 18, 2023

In teenagers, irregular bedtimes, short sleep duration and poor sleep quality are commonly reported sleep issues.

Key Points: 
  • In teenagers, irregular bedtimes, short sleep duration and poor sleep quality are commonly reported sleep issues.
  • In the longer term, poor sleep can lead to obesity, health conditions (including diabetes), mental health problems, and risk taking behaviour.

Sleep vulnerability

    • The ongoing effects of colonisation, intergenerational trauma, and other social determinants of health increase the vulnerability of Aboriginal and Torres Strait Islander teenagers to poor sleep.
    • While some poor sleep issues are transient, continued exposure to racism, discrimination, household overcrowding and lack of safe sleeping spaces lead to chronic sleep issues.
    • This could be because although the need for healthy sleep is universal, the meaning of sleep health is shaped by cultural and societal factors.

A co-designed approach

    • Community yarns also identified the need to strengthen local sleep health service delivery and train Aboriginal and Torres Strait Islander people as “sleep coaches”.
    • Read more:
      Drinking fountains in every town won't fix all our water issues – but it's a healthy start

What the program involves

    • The program empowers young people to identify their sleep health goals and work with coaches to achieve them.
    • At the beginning of the program, participants identify a group and an individual goal they would like to attain.
    • The program has also led to the training of two Aboriginal and Torres Strait Islander people as Australia’s first Indigenous sleep coaches.

What happened as a result of improved sleep

    • The program data shows the majority of the program participants were staying up until very late at the night.
    • However, participants achieved their self-identified goals and believe this program gave them tools to improve their sleep.
    • The project team and community members are working to co-design a sleep health program for adults and extend the youth sleep program to other communities.
    • Yaqoot Fatima is supported by funding from the NHMRC Partnership Grant, MRFF Indigenous Health Research Grant, MRFF-EMCR grant, and Beyond Blue for sleep health research.

Lisata Therapeutics Announces Enhancements to Ongoing Phase 2b ASCEND Trial of LSTA1

Retrieved on: 
Wednesday, May 24, 2023

BASKING RIDGE, N.J., May 24, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced protocol changes to the ongoing ASCEND trial, a Phase 2b trial evaluating LSTA1, Lisata’s lead investigational drug, in combination with standard-of-care (“SOC”) gemcitabine/nab-paclitaxel in patients with first-line, metastatic pancreatic ductal adenocarcinoma (“mPDAC”). The objective of the original ASCEND trial was to confirm, in a rigorous, controlled, double-blind study, the positive results of the Phase 1b/2a open label study evaluating LSTA1 in mPDAC patients receiving one dose of LSTA1 plus SOC. The amended protocol retains this objective while adding the goals of optimizing the dose of LSTA1 in this indication and establishing effect size for a possible Phase 3 study. The protocol amendment includes an additional cohort (Cohort B) to assess whether a second dose solely of LSTA1, administered 4 hours after the original dose of LSTA1 plus SOC, will further improve efficacy and patient outcomes.

Key Points: 
  • The objective of the original ASCEND trial was to confirm, in a rigorous, controlled, double-blind study, the positive results of the Phase 1b/2a open label study evaluating LSTA1 in mPDAC patients receiving one dose of LSTA1 plus SOC.
  • The amended protocol retains this objective while adding the goals of optimizing the dose of LSTA1 in this indication and establishing effect size for a possible Phase 3 study.
  • The trial is fully funded by Lisata through an unrestricted research support agreement.
  • “We are excited to announce the enhancements to the ASCEND trial design, including the addition of a second cohort for the evaluation of a second dose of LSTA1 in patients with mPDAC.

Surescripts to Present New Data on Opportunities to Expand Access & Fill Gaps in Primary Care and More at NCPDP 2023 Annual Technology & Business Conference

Retrieved on: 
Friday, April 28, 2023

Shannon Reidt , Director of Medication Research and Analytics at Surescripts, will present new data and analysis that supports the opportunity for evolving care teams, including pharmacists, to help fill gaps in primary care so patients will continue to have access to essential services.

Key Points: 
  • Shannon Reidt , Director of Medication Research and Analytics at Surescripts, will present new data and analysis that supports the opportunity for evolving care teams, including pharmacists, to help fill gaps in primary care so patients will continue to have access to essential services.
  • Nearly half of all counties in the United States have relative shortages of primary care providers (PCPs), with just one PCP for every 1,500 people.
  • Surescripts is a member and sponsor of NCPDP , supporting dozens of workgroups that inform leading pharmacy industry standards.
  • Where to Find Surescripts at NCPDP:
    Speaking session: Opportunities to Expand Access & Fill Gaps in Primary Care, Tuesday, May 9, 3:10—3:30 p.m., in the Innovation Theater
    Under intense pressure, today’s care team is evolving—and new data shows that pharmacies have a unique opportunity to improve access to primary care.

Nobel laureate Brian Schmidt's big ideas for how Australia funds and uses research

Retrieved on: 
Tuesday, April 25, 2023

The federal government is calling for ideas to “reshape and reimagine higher education, and set it up for the next decade and beyond”.

Key Points: 
  • The federal government is calling for ideas to “reshape and reimagine higher education, and set it up for the next decade and beyond”.
  • In my personal submission to the accord process, I outline three big ideas to help reset higher education to deliver the system Australians need and deserve.
  • In this piece I want to focus on my other two big ideas – improving the way we fund and then translate research.

Australia’s research ecosystem

    • Australia’s research ecosystem has become highly reliant on funding via cross-subsidies from international student fees.
    • Instead, universities now spend more on research (using international student fees) than the government.
    • Research funding is also not fully integrated with workforce and major equipment needs, and this all leads to shortfalls in key areas of national research need.

We need to identify and properly fund sovereign research

    • Sovereign research capability is about Australia being able to fund and undertake the research it deems vital to its national interests.
    • We must identify the core set of sovereign research capabilities necessary for the future security and prosperity of the Australian people.
    • A large fraction of the sovereign curiosity research money should be competitively allocated via existing bodies, the Australian Research Council and National Health and Medical Research Council grant system.

We need to make it easier to translate research

    • In addition to fully funding sovereign research capabilities, we must also rethink how we fund research translation for the public good.
    • This is the process whereby we move research from labs or journals out into the real world.
    • When we fund applied research, we need to be strongly focused on outcomes.
    • This includes the government directing funding for specific missions in areas of national need.

Blue-sky thinking

    • This is the research universities do that leads to new products, jobs and industries never envisaged when the research cycle begins.
    • These are hard to measure, and emerge with a considerable lag, but our best estimates are that they are large.
    • Government has a special role in funding this activity, as firms cannot typically capture the benefits of this work.
    • Alternatively, new types of future higher education institutions could have research dropped from their mission entirely.

Making our own luck

    • The government’s accord process gives us the chance to make sure our universities can continue to deliver on this promise for our future generations.
    • If we fail to value and fund university research in the way that we need, and should, the so-called Lucky Country might just run out of luck.

BioCina Awarded Grant to Develop Enabling Technologies for Manufacturing Precision mRNA Vaccines

Retrieved on: 
Tuesday, March 28, 2023

SAN DIEGO and ADELAIDE, Australia, March 28, 2023 /PRNewswire/ -- BioCina , a leading contract development and manufacturing organization (CDMO), has been awarded a $5 million AUD grant under the Federal Government's Medical Research Future Fund (MRFF) Grants scheme to fund work with its industry partners to develop enabling technologies for manufacturing precision mRNA vaccines.

Key Points: 
  • SAN DIEGO and ADELAIDE, Australia, March 28, 2023 /PRNewswire/ -- BioCina , a leading contract development and manufacturing organization (CDMO), has been awarded a $5 million AUD grant under the Federal Government's Medical Research Future Fund (MRFF) Grants scheme to fund work with its industry partners to develop enabling technologies for manufacturing precision mRNA vaccines.
  • The project will help BioCina address the post-pandemic mRNA demand for specific and essential attributes of new personalized RNA products.
  • The project will help BioCina address the post-pandemic mRNA demand for specific and essential attributes of new personalized RNA products.
  • The first is an increase in mRNA manufacturing and associated analytical capability at BioCina, and the second is a microfluidics-based device for parallel manufacturing at the small scales required for the personalized therapeutic vaccines market.