Alexander Russell-Smith

A Holistic Approach to Patient Engagement Clinical trial efficiency and patient-centric approaches are spoken about a great deal within our sector as numerous clinical trials face recruitment and retention hurdles. Invariably this leads to costly delays and missed milestones. In these discussions I often find that one critical component is overlooked: the patient's support system. Engaging not only the patient but also their family or guardian can support ✅ Improved engagement, recruitment and retention rates ✅ Promote a positive sense of community Aiding compound development through ✅ Timely recruitment ✅ Enhanced data quality Ultimately reducing costs with the focus on delivering new therapies to more patients faster. In the spirit of building on what is already a collaborative community I have shared my perspective on engaging families in clinical trials. Share your thoughts and together let’s continue to promote collaboration in our sector. #clinicaltrials #patientengagement #familycenteredcare #clinicalresearch #biotech #pharma

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Do you want to hear more of Vincent Keunen’s thoughts on patient centricity? Watch the 1st part of his interview with Applied Clinical Trials where he discusses the current challenges of patient centricity: https://lnkd.in/es-DC5Uj

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Interesting to see the various hybrid working models deployed in the healthcare and life science industry and how this will continue to evolve with the help of technology. GSK is certainly one of many life science companies leading the way toward more efficient and collaborative work spaces, but proving once again that office isn't going away, the demand and utilization is of this asset class is just changing to be more efficient and amenitized.

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At AstraZeneca, we're continuously innovating to advance care for complex immune-mediated diseases like cutaneous lupus erythematosus (CLE) and idiopathic inflammatory myopathies (IIM). By targeting the underlying drivers of the disease we’re working to optimise care, moving beyond symptom management to disease modification, remission and one day, even cure in immune-mediated diseases. Learn more: https://lnkd.in/ecaZvedr.

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ASCO Day 4 GlobalData’s top 10 late-breaking abstracts for #ASCO24 with updated results. Sunday (Phase III ADRIATIC): AstraZeneca's Imfinzi (durvalumab) is set to conquer the post-chemoradiation inoperable population of LS-SCLC after achieving the same a few years ago in NSCLC. There was a clear OS improvement, mOS= 55.9 months for Imfinzi vs 33.4 months for the control (HR: 0.73). Grade 3/4 AEs were very balanced at around 24% but as expected Imfinzi had a higher discontinuation rate at 16.3% vs 10.6%. Sunday (Phase III LAURA): In another post-CRT inoperable setting, AstraZeneca's Tagrisso (osimertinib) is seeking to displace its own Imfinzi as the SOC for EGFR-mutant unresectable Stage III patients. Tagrisso resulted in mPFS of 39.1 months vs 5.6 months for the control (HR: 0.16). OS data were immature however currently there is not a strong trend towards Tagrisso benefit. Serious AEs were reported in 38% vs 15% of patients and Tagrisso's discontinuation rate was 13% vs 5%. The main concerns for these data will be that the control arm was placebo, and not Imfinzi, and that it is not clear whether receiving Tagrisso early vs late has any OS benefit. Sunday (Phase III DREAMM-8): GSK's anti-BCMA ADC Blenrep (belantamab mafodotin) was evaluated in combination with pomalidomide and dexamethasone in 2L+ R/R multiple myeloma versus the control of pomalidomide/bortezomib/dexamethasone. The mPFS was not reached for Blenrep vs 12.7 months for the control (HR: 0.52). OS trend is positive so far at HR of 0.77 but there will be a future analysis. Ocular toxicity, the main concern for Blenrep treatment was as previously reported at 89% vs 30% for the control, and the discontinuation rate was 15% vs 12%. Along with the recent results of the DREAMM-7 trial, these data place Blenrep back on the treatment algorithm for R/R multiple myeloma. Monday (Phase III CodeBreaK 300): Updated OS data from the CodeBreaK 300 trial for Amgen's Lumakras (sotorasib) in combination with Vectibix (panitumumab) for 2L+ KRAS-G12C-mutant CRC sparked interest. Previously, the trial had met its primary endpoint of mPFS versus investigator's choice, albeit with a meager OS advantage. Despite the trial not being powered for OS, the new ~14-month follow-up showed an improvement in mOS. The mOS for Lumakras + Vectibix was not estimated, vs 10.3 months for investigator's choice (HR: 0.7). However the combination's regulatory status with the FDA remains uncertain. Monday (Phase III KEYNOTE-942): Sustained benefit for Moderna/Merck's mRNA vaccine mRNA-4157 in combination with Keytruda in the adjuvant melanoma setting. At 3 years of follow-up, the 2.5yr-RFS was 74.8% for mRNA-4157 + Keytruda vs 55.6% for Keytruda alone (HR: 0.51). The 2.5yr-OS was 96% vs 90.2% (HR: 0.42). Safety was consistent with previous analysis where mRNA-4157 was shown to be very well tolerated. https://lnkd.in/e7U6NeTz

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The practice-changing drugs that will land in 2025. -69 noteworthy approvals across 66 discrete drugs. Click the below link in the post to read the article- https://ow.ly/V10q50TKMxG

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The Innovative Licensing and Access Pathway (ILAP) was introduced in the UK in 2021 to accelerate patient access to transformative medicines, with 166 “innovation passports” awarded to date. ILAP has an upcoming relaunch in March 2025, which will address feedback regarding its overly permissive entry criteria and the lack of NHS involvement. Key updates will include: •More selective entry criteria to focus on transformative medicines. •Inclusion of drug-device combinations. •Enhanced NHS involvement, with NHS as core partner focusing on operational planning. •Simplified Target Development Profile (TDP) for clearer guidance. Additionally, the MHRA will continue to provide crucial regulatory support, ensuring that the pathway remains robust and efficient. If you want to assess how new ILAP might impact your business, please do not hesitate to reach out to us for further discussion. Source: Gov.uk

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Is a focus on "Cost-efficiency" the reason your trial is not performing as planned... We all love a good deal (especially in this economy 😉). But when it comes to keeping patients engaged and participating in your trials, penny-pinching can seriously backfire. Think of it like this: Cost-efficiency is like having a state-of-the-art research facility but neglecting to train your staff on the latest techniques and technologies. 👨‍🔬👩‍🔬 What a waste of potential! Cost-EFFECTIVENESS, on the other hand, is like investing in your people, giving them the knowledge and tools they need to excel. That's where the real magic happens! ✨ The same goes for your trials! Instead of always choosing the cheapest options, focus on using your budget wisely to create a positive patient experience. Think easy-to-use platforms, personalized communication, and genuine support. Why is this so important? 🤔 ➡️ Engaged patients are more likely to stick around, saving you the cost of recruiting replacements. ➡️ Happy patients provide better data, leading to faster and more successful trials. ➡️ Positive experiences mean patients are more likely to recommend your trials to others. So, ditch the "skimping" mentality and start thinking about how to maximize your budget to create a truly patient-centric experience. It's not about spending more, it's about spending smarter.   Speaking of spending smarter, who else is attending the Osborne Clarke networking evening on November 19th during London Life Sciences Week? I'm keen to hear your perspectives on this. Let's connect and chat! 💬 #ClinicalTrials #PatientEngagement #PatientRetention #CostEffectiveness #Innovation #JefferiesHealthcare #OsborneClarke #LondonLifeSciencesWeek

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📈 Ready to take your next #pharma congress to the next level? We have a phenomenal congress capability in Emota, part of Inizio Engage. We've conducted some research into how to maximise your #ROI and our latest research report is now live. This report identifies: 1️⃣ Challenges faced by congress planners in pharma 2️⃣ What is required to mitigate these challenges 3️⃣ How to improve the execution of future congress events 👉 Download your copy today: https://lnkd.in/e4ePx2k3 #ConnectedCapabilities #ReimagineHealth #EventPlanning #Congress #Inizio

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tapping into the expertise that will decide and use pharma and medtech products and services is real world evidence!

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And yet more EU HTA news! Yesterday the ‘Enhanced Procedural Guidance for JCAs for medicinal products’ was published. Here are my key learnings: - The scoping process duration has been REDUCED by 38 days with ‘administrative efficiency’ improving overall timelines - There is an increase in stakeholder involvement. Patients and experts provide critical input throughout the JCA lifecycle - EXTENDED TIME for PICO surveys (3 weeks rather than 2 weeks) to allow stakeholder insights. HTDs are then informed of the consolidated scope with a virtual explanation meeting held during fixed monthly slots - Scope explanation meetings held for 60 mins max and will only clarify (not modify) the scope - All HTD submissions are accessible to the entire JCA subgroup. All factual accuracy check comments and responses are to be published online - There will be NO CLOCK STOPS (even for indication changes during regulatory approval from EMA) backing the emphasis on procedural continuity - Roles: - Assessor and co-assessor roles will be on a case-by-case basis with work split between and overall responsibility for accuracy - JCA SG are responsible for methodological aspects by review of the assessment scope and draft JCA report - (NEW - Optional) watcher role has been introduced to add an educational aspect to the subgroup, enhancing capacity-building. Watchers will be invited to all meetings between the assessor and co-assessor Full guidance is available here: https://lnkd.in/eRsdiG5q

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I'm really keen to see how 3D genomics is used by academics for biological disease insights with ENHANC3D GENOMICS. The non-coding genome holds the key to regulation of genes in different cell types and dysregulation in disease, all important associations to understand for drug discovery. It a pleasure to welcome Christina Stankey from The Francis Crick Institute, who will present: "Decoding Disease Genetics: Translating GWAS Associations into Therapeutic Insights" #GenomicsResearch #GWAS #TherapeuticDiscovery #GeneRegulation #BioinformaticsResearch #VirtualSeminar

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Great case study in one of our popular categories!

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