Paik Bin, Christine Ng’s Post

Now this is what paternity leaves are meant to be used for when your children are at this tender age...and ofcourse they will outgrow disney stories but such fond memories will stay on generation after generation.. Enjoy the clip and TGIF! https://lnkd.in/g3aUNMqQ

Personal data sharing or transfer is protected by domestic or international privacy laws, security acts and treaties, which are used to mitigate risks, enhance ethical practices and balance the impact of legal implications/exemptions on the requesting country and responding country. It may be worthwhile to examine the exceptions in each act, law and treaty pertaining to personal data and privacy to enable expedited transfer of data in emergency cases and on compassionate basis. You will find this article insightful. https://lnkd.in/gdPVcgqw

While reading how Scrum framework helps in project management, I learnt that it has three pillars: transparency, inspection and adaptation and five values: Courage, Focus, Commitment, Respect, and Openness plus the importance of experimentation, feedback and improvement. The word SCRUM was '...inspired by a scrum in the sport of rugby. In rugby, the team comes together in what they call a scrum to work together to move the ball forward. In this context, Scrum is where the team comes together to move the product forward.' Lets see how I get through to the certification programme. Many thanks to Tian Nee Chai for sharing her SCRUM certification recently. https://lnkd.in/g5qK7Hms

I detected a follow up visit missed out in the Schedule of Visits but listed in the text of the protocol in an IRB approved study protocol for a clinical trial I took over as the CPM. This finding was escalated to the higher management and medical team internally and the lead CRO but no actions were taken to rectify the missing visit which was also not costed, simply because the study protocol had already received IRB approval. To ensure integrity of the study, I proposed to add the visit in the training programs for the clinical sites participating in the study to capture the missing visit and deal with the cost and IRB resubmissions for the amendment at a later date. My proposal is not a one-size-fits-all, so please escalate and discuss issue resolution pathways in similar situation. When I read this article on IRB's merit in assessing trials, I had to share my encounter, that it is right to question the issue on merit, even if it involves IRB review and approval.

First-In-Class and First-In-Human in vivo CAR candidate being developed by Interius Biotherapeutics, 'a leading developer of in vivo cell-specific gene medicine', will enter into phase I clinical trial in Australia by Q4 this year and 'will evaluate the safety of a single INT2104 infusion in adults with refractory/relapsing B cell malignancies. The Phase 1 study is a global, two-part, multicenter, open-label, single dose design with a dose escalation portion designed to inform the dose of INT2104 to be used in the dose confirmation part of the trial and future studies.' If specific endpoints show positive signals, in vivo CAR delivery will certainly set positive precedence over ex vivo delivery system in terms of manufacturing requirements, logistics, transportation, turn around time, temperature control, patient enrolment and preparation before and after infusion, on-site staff training requirements and all other ancillary costs and time, potentially lessening the burdens on clinics with greater number of patients treated and living better quality of life.

This article is packed with statistics, graphs and details on the why, where and when pharma layoffs have taken place or have planned to be executed. In another article I chanced upon, BioSecurity Act and Inflationary Reduction Act were cited as other reasons for strategic shift in staffing, in terms of relocation or reduction. One reason stood out, which is 'merger and acquisition preparation' and this could either mean prospect for re-hiring or further cuts post M&As.

KOLs have voiced out the need to implement better trial design for GLP-1RA and obesity trials by including physical activity and function, in addition to the primary HbA1c and changes in body mass index, as endpoints. "...it is important to point out that with any type of weight loss method, natural or pharmacological, some muscle-wasting effects can be observed, and it is hard to lose only fat mass." Proposed methods to better asses fat loss vs. lean mass: 1. Bioelectrical impedance analysis 2. DEXA scanning Better patient representation will lead to greater access and acceptance by the medical communities and real world patients to approved GLP-1RA related medicinal products, the KOLs further commented. Other details embedded, fyi.

There is no cure and no prior knowledge on the causes of IBD (Inflammatory Bowel Disease) such as Crohn's and colitis which are complex and life-long conditions. "However, genetic susceptibility is still only half the story. It also takes something to trigger the development of IBD, with diet and antibiotic use all implicated." "The group of researchers at the Francis Crick Institute and University College London performed a deep genetic analysis to try to unpick the cause of the IBD. They discovered a section of genetic code – or DNA – that turns out to be the macrophage’s “master regulator” of inflammation. We found not only how and why it goes wrong, but potentially a new way of treating these diseases,” says Dr Lee, who is also a gastroenterologist at the Royal Free Hospital. Yet, there is not going to be an new IBD treatment imminently. The researchers have a head start as drugs already exist, but they need to find a way of targeting just the macrophages so they do not cause side effects throughout the body. The drugs would also need to be precisely calibrated to calm the IBD, but not leave a patient susceptible to infection by switching off the good side of inflammation in fighting disease. Their aim is to start clinical trials within five years." Details as embedded.

It is critical for industry-wide practices or standards to be deliberated, regulated, legislated and complied with, when using regenerated data pulled from sources some established, others may be unknown. In terms of oversight role, where does the role begin and end, as big data is typically pulled in from various sources. Other points include ownerhsip of each data set generated and I believe accountability will be key in cases where adverse or undesirable events occur from utility of regenerated data, even if approvals have been granted to use them. 'Ultimately, while the AI advancements are exciting, the focus needs to remain on how the technology can be used in an optimized and efficient way to ensure the safe and effective provision of healthcare products to global markets.' https://lnkd.in/gp_vjFcq

Was wondering whether to post this article...I went ahead anyway with the intention to help create awareness or reminder on negative health effects caused by low-calorie sweetener used in many reduced-sugar foods and consumer products such as gum, toothpaste, diabetic cookies etc. The chemical name is 'xylitol'. The devil lies in the take up rate in the body of up to 1,000 folds after ingestion. https://lnkd.in/gtfMuvA5