The ramarketing review offers vital industry knowledge to keep you in the know, featuring a different ramarketing expert each month to deliver headline highlights. If you’d like to receive updates straight to your inbox, sign up here.
Introducing October’s sector expert…
Laura Child, Strategic Brand Consultant
Laura is an integral member of our agency’s Research and Strategy team, contributing valuable insights that consistently drive enhanced results for our clients worldwide. With an impressive career as a Program Director within leading multinational CROs, Laura has successfully managed and delivered numerous high-value and highly complex global trials, ranging from Phase 1 to Phase 3.
As an accomplished leader, Laura has adeptly guided large, multicultural teams while ensuring the highest quality in project delivery. Her extensive experience in collaborating with CDMOs and third-party vendors across all facets of clinical trials makes her an invaluable asset to our organization. With her expertise and proficiency, Laura consistently elevates our business and enhances our ability to meet the needs of our clients.
Soaring congenital syphilis rates in US risk lives of thousands of babies
Syphilis is a sexually transmitted disease (STD) spread through direct person-to-person contact, capable of causing serious health effects without treatment. However, it is not widely known that pregnant people with syphilis can transmit the infection to fetuses in utero, resulting in congenital syphilis, with stark consequences.
Many babies who contract congenital syphilis are born with severe birth defects, including sight and hearing loss, bone deformities and severe anemia. It is further reported that up to 40% of babies born to mothers who have not received syphilis treatment will be stillborn or die. When we take a second to pause, this statistic weighs heavily — two out of five babies affected will be stillborn or die from a disease that is treatable with between one and three shots of medication.
Disruptions to healthcare services during the COVID-19 pandemic have resulted in a 30.5% increase in congenital syphilis cases in the U.S., with rates of the disease reaching a nearly 30-year high. Health advocates are requesting that the Biden administration take action. The spike in disease rates has put the Bicillin L-A treatment in short supply. As the sole supplier of the product (a penicillin G benzathine injectable suspension), Pfizer has prioritized manufacturing capacity to address the shortage, with an anticipated release date of April 2024. However, the implications of this for patient care are significant. As Bicillin L-A is the only approved product that safely treats syphilis during pregnancy, the remaining available doses are being almost exclusively directed to pregnant patients.
Short supply is not the only factor contributing to rising cases. People who are infected with syphilis don’t always know they have it — and although detection tests are available, lack of funding has impacted public health clinics that typically address sexually transmitted infections. This is further complicated by social stigmas around sexual health and STDs in populations with elevated risk of contracting syphilis, as well as by socioeconomic factors.
Speaking to the criticality of a robust supply chain, a White House spokesperson told the Guardian, “This work to strengthen pharmaceutical supply chains is a continuation of the work that began on day one of President Biden’s administration to ensure Americans can access the medicine they need when they need it.”
MHRA pledges two-week review for low-risk clinical trials
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has taken a big step toward shortening review timelines for low-risk studies, cutting the review period from 30 days down to 14 days. Certain factors would mean a study is not eligible for a two-week review: first-in-human, phase 1 and phase 2 trials do not qualify, and neither do amendments to existing protocols. It is estimated that 20% of UK initial clinical trial applications could be eligible for a two-week review.
Dr. June Raine, Chief Executive of the MHRA, stated, “Clinical trial regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents.”
The UK saw a 41% reduction in new industry clinical trial starts per year between 2017 and 2021, in part due to the time required for clinical study setup and approval. Implementing the two-week review time frame is an important step to improve the attractiveness and ability of the UK to be a key player in the global clinical research sector.
UK launches national full-body scan platform to accelerate drug discovery
Also in the UK, as part of the government’s efforts to bolster the life science sector, a new screening program has been launched to support drug discovery and asset development. The National PET Imaging Platform (NPIP) has been created in partnership with Medicines Discovery Catapult, the Medical Research Council and Innovate UK, with funding from the UK Research and Innovation (UKRI) Infrastructure Fund. NPIP will see PET/CT scanners being supplied to two major research hospitals in the UK — the Royal Infirmary of Edinburgh and St Thomas’ Hospital in London.
Positron emission tomography (PET) scans produce 3D imagery of the inside of the body after it has been injected with small amounts of radioactive material. PET is a powerful yet expensive imaging technique that is even more costly when used to image the entire body rather than a localized area. Unfortunately, this creates a barrier to diagnosis for many complex diseases, such as cancer and Alzheimer’s disease.
The key advantages of PET scans are the speed, patient comfort and clarity of findings. More patients can be scanned and more information can be collected than with less advanced techniques, which results in larger available datasets that can help experts understand disease mechanisms and treatment responses better. The connected data from the new PET scanners provided by NPIP will undoubtedly fuel the therapeutic decisions of tomorrow.
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