Trish Parry

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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Found this article quite interesting - describing the quest of getting a gene therapy for an ultra rare disease approved in the UK market - not by a pharmaceutical company, but by a hospital! #GeneTherapy #UltraRareDisease #UK #Innovation

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The The Association of the British Pharmaceutical Industry (ABPI) has published its 2024 report on industry clinical trials - a review of the UK's performance and recommendations for the future. We welcome the ABPI’s annual report on the road to recovery for UK industry clinical trials. It is encouraging to see the improvement in the UK’s rankings for phase 2 and phase 3 trials and UKRD wishes to acknowledge, in particular, the hard work of the UK clinical research workforce and NHS organisations that host industry trials. We welcome the clarity in the report around the areas requiring continued focus; the outcomes of our recent UKRD survey of clinical trials set up and delivery (https://lnkd.in/ePzHvSub) also emphasised the need for all system partners to work together to continue to drive systems improvements and we look forward to working together across the industry to drive positive change.

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We're attending the #MHRA complimentary webinar 'Implementing the new UK Clinical Trials regulations' on Tuesday 15th October and there's just 2 days left to reserve your spot, in partnership with Health Research Authority (#HRA) If you sponsor clinical trials or are an interested stakeholder from academia or the pharmaceutical/medical device industry and want to find out more our approach to implementing the regulations, we encourage you to join this webinar The agenda will include: - Updates on the legislative timeframes - High-level details of the plan for developing and sharing draft guidance - Introducing the ‘Implementing the new Clinical Trials regulations’ roadmap You can reserve your spot and find out more about the webinar here: https://lnkd.in/eDfS-mTW #clinicaltrials #pharma #medtech #healthcare #IVDR #MDR #productdevelopment

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📢 **VPAG Agreement: A New Era for Pharmaceutical Manufacturers in the UK?** The new VPAG agreement signals a significant shift in the UK pharmaceutical landscape, promising substantial NHS savings and increased investment in clinical trials. Noteworthy changes from the previous VPAS include innovative rebate structures and payment models, creating both opportunities for new medicines and hurdles for existing products. 🔑 **Key Actions:** - **Adapt Pricing Strategies**: Align pricing models with VPAG's revised rebate structures. - **Invest in Innovation**: Prioritize the development of new medications to leverage favorable terms for fresh products. - **Engage in Policy Dialogue**: Take part in policy discussions to shape forthcoming adjustments. - **Monitor Market Trends**: Stay updated on market shifts and tailor market access strategies accordingly. Exciting times lie ahead for pharmaceutical manufacturers in the UK as they navigate the evolving landscape shaped by the VPAG agreement. Are you ready to seize the opportunities and tackle the challenges this new era presents? #Pharmaceuticals #UKHealthcare #VPAGAgreement #MarketAccess Please note all views and content stated here are my own

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As we have previously posted, the MHRA's issued a new guidance for established medicines licensing. The agency has now released a webinar video that provides even more insights into the updated process. This webinar provides important insights for all teams involved in bringing new therapies to the UK market. To recap, the new guidance aims to help applicants and shorten timeframes for the assessment of established medicines through measures like: ✅ A new "technical completeness check" ✅ Issuing only one Request for Further Information (RFI) per application ✅ Referring incomplete applications or those with potential risks to the Commission on Human Medicines ✅ Requiring a draft lay summary for the UK Public Assessment Report Watch the MHRA webinar now: https://lnkd.in/dT8AZQxE As always, our team at NDA is here to support you with our extensive experience in MHRA procedures. Contact us to discuss how we can help you adhere to the latest guidelines and streamline your product's development for the UK market.

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Join Matthew Hewitt's presentation, “Fast technology coupled with deliberate regulatory: How can the field adapt new guidance to meet therapeutic demand?” CAR-TCR Summit Series As the number of CGT market approvals accelerates, Matt will discuss challenges in manufacturing and address how working collaboratively with partners and regulators aids in tackling the pain points of therapeutic development and clinical trial design. Don't miss this insightful session on regulatory guidance. https://okt.to/KTZMwk #cartcr #cgtdevelopment #celltherapy

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Windsor Framework: Regulatory Manager Neil Prideaux walks you through the knotted history of Brexit. Neil explains how we arrived at our current position, with the Windsor Framework about to come into implementation for human medicines.  The history matters here, as it explains some of the consequences for different types of medicine applications. https://lnkd.in/eCiSUqMm #WindsorFramework #RegulatoryAffairs #Brexit

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Greater ambition is needed to improve patient access to innovative medicines. In this post, Paul Catchpole outlines what needs to change to ensure that NHS patients can access new clinically proven and cost-effective medicines that could benefit them. https://lnkd.in/eGWQSD9y

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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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As a Clinical Trial Manager we are always juggling multiple plates especially when setting up a new Clinical Study/Trial. I am a firm believer in systems and processes and often include them as part of my work ethic. It is really important for sponsors and researchers to be aware of the key differences in the approval and set up process in the UK nations. Therefore I was pleased that the Health Research Authority launched a toolkit to help researchers to navigate the differences between doing study submissions across England, Scotland, Northern Ireland and Wales. The toolkit includes information on: ✔️Approvals processes in the NHS and HSC intrusive research involving adults lacking capacity ✔️General medical devices and in-vitro medical devices ✔️Accessing identifiable data without consent provision of the local information pack to potential participating organisations ✔️Contracting arrangements It is recommend to use the toolkit during the planning and application stages and should be revisited if thinking of making changes to your study or just to keep your knowledge up to date whilst running your research across more than one UK nation. ➡️PDF Offline version of decision tool kit: https://lnkd.in/e5uzCRZR ➡️Direct link to the decision tool kit: https://lnkd.in/eeADkM5W 👇🏽Comment below if you think this will help reduce the timeframe of study set-up in the UK. Reshare this post for visibility. #ClinicalResearch #ClinicalTrialManagement #HealthResearchAuthority #ClinicalInsights #ClinicalResearchMastermind

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In part 2 of 3 Ted Trafford and I continue our discussion with Joel White  about the financial performance of the clinical development space for Q2. We find out what Joel is bullish about and dive into the pre-clinical space to name a few. A couple of the discussion points and insights below... tune in to hear more. 1. 𝗖𝗥𝗢 𝗮𝗻𝗱 𝗦𝗶𝘁𝗲 𝗢𝘄𝗻𝗲𝗿𝘀𝗵𝗶𝗽 𝗧𝗿𝗲𝗻𝗱𝘀     • Private equity and M&A activities are heavily targeting research sites. • Site ownership by CROs could shift supply-demand dynamics, boosting valuations for research sites. 2. 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗳𝗼𝗿 𝗜𝗻𝗱𝗲𝗽𝗲𝗻𝗱𝗲𝗻𝘁 𝗦𝗶𝘁𝗲𝘀     • Independent sites face competition as large CROs integrate more of their own trial sites (e.g. ICON). 3. 𝗣𝗿𝗲𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀     • Preclinical research spending has decreased, particularly in smaller biotech companies. • Inflation Reduction Act has led to reprioritization towards later-phase clinical trials. • Major preclinical companies like Charles River are experiencing shrinking demand. Stay tuned for part 3. Follow Liam Eves, Ted Trafford and Joel White for more insights in the clinical trial space.

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Burden of illness (BOI) and unmet need are key considerations for HTA decision makers, but how do manufacturers assess these when bringing a new medical treatment to market? In the first of our new how-to series Lumanity’s Matthew Woods explores the importance of understanding burden of illness and unmet need, as well as giving an overview of the key considerations when conducting reviews. Want to know more? Follow the link and download the guide. https://buff.ly/3WpGqzn #LumanityPerspectives #UnmetNeed #BOI #HEOR #HTA

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Burden of illness (BOI) and unmet need are key considerations for HTA decision makers, but how do manufacturers assess these when bringing a new medical treatment to market? In the first of our new how-to series Lumanity’s Matthew Woods explores the importance of understanding burden of illness and unmet need, as well as giving an overview of the key considerations when conducting reviews. Want to know more? Follow the link and download the guide. https://buff.ly/3Ah7IRe #LumanityPerspectives #UnmetNeed #BOI #HEOR #HTA

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Read today's thoughtful article on NHS-industry partnerships from Anna Charles at The King's Fund. As she says, effective collaboration between the NHS and industry is not without challenges and requires effort to get right, but "at their best, industry partnerships can be powerful catalysts for improvements in care, bringing the NHS access to resources to pump-prime change, and to a depth and breadth of skills and expertise..." Read more in the Health Service Journal https://lnkd.in/e5GCAibS?

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The Innovative Licensing and Access Pathway (ILAP) is a Medicines and Healthcare products Regulatory Agency (MHRA) initiative designed to provide developers of novel medicines with an optimised route to market. ➡️ https://buff.ly/3WKWTQ0 To help therapy developers to leverage the scheme to support successful adoption of their novel therapy, the Cell and Gene Therapy Catapult has created a guide which provides an overview of the ILAP initiative, how it works, and its benefits. Learn more in the link ☝️ #CellTherapy #GeneTherapy #ATMP #AdvancedTherapies #Innovation

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🚨 Webinar Highlights: MHRA Clinical Trials Update 🚨 We had the pleasure of attending the MHRA Webinar on October 15th, 2024, where the biggest changes in UK clinical trial regulations in over 20 years were discussed. Susan Fitzpatrick, from our team was there, gaining first-hand insights into the revolutionary updates that aim to make the clinical trial approval process faster and more efficient. Here are the key takeaways: ✅ Streamlined approvals: MHRA is working towards a single application process that integrates both regulatory and ethical reviews. In pilots, this has halved approval times. ✅ Faster turnaround: The new regulations will set a target of completing application reviews within a maximum of 30 days. ✅ Enhanced transparency: Clinical trials will need to be registered in a WHO public register, with a requirement to publish results within 12 months. ✅ Layperson summaries: Summaries in plain language will now be required for all trials, making results more accessible to the public. ✅ Updates to Good Clinical Practice (GCP) standards with more focus on transparency and integrity. These changes are expected to be finalized by 2025, with full implementation by January 2026. The new regulations are designed to streamline processes, reduce delays, and foster greater transparency in clinical research. We are excited to help our clients navigate these changes, ensuring compliance while driving innovation in clinical trials. #ClinicalTrials #MHRA #RegulatoryAffairs #PharmaInnovation #DrugSafety #ResearchTransparency #GCP #Biotech

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Interesting presentations and discussions as we wait for ICH E6(R3) Principles and Annex 1 to reach Step 4 adoption and Annex 2 to reach Step 2, prior to public consultation. Watch this space.

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Missed the MHRA/HRA webinar on implementing the new UK Clinical Trials Regulations last week? Here’s a summary of the key takeaways compiled by Shaun H., Director of QA at PHARMExcel: 🖊 Target timelines are as follows: laid before Parliament before end 2024. Engagement activities with key stakeholders will begin (e.g. surveys, webinars, workshops). Final draft Apr-2025, final version Aug-2025, live Jan-2026. Once live, all old versions will be made obsolete on the respective websites. The regulation will cover all countries in the United Kingdom. 🖊MHRA Grey Guide – will not be updated at this time. Updates will be published via the MHRA/HRA websites, and other mediums. 🖊Streamlined approval process – the MHRA/HRA will formalise Combined Review. There will be no change to the process as is, including how EC meetings are managed. 🖊Research transparency – trials to be registered before enrolment of first participant and summary results to be published 12 months after end of trial will also be formalised, layperson summary seems to be optional. The rules regarding WHO compatible database will remain, the MHRA/HRA will not specify which database should be used. 🖊ICH GCP E6 R3 – adoption of the principles and content will be included and language around conditions and principles of GCP will remain. 🖊Manufacturing and assembly – definition of NIMPs will be included. In addition, MAA option will be extended to include radiopharmaceuticals, and there will also be flexibility around labelling of marketing products. 🖊Safety reporting and PV – regulation will remove duplicative requirements and remove the requirement for detailed listings in ASRs, instead replacing with a summary safety report. 🖊Amendment - terminology will be replaced with “Modification”. MHRA/HRA are planning a 3-tier system around substantial/non-substantial modifications. 🖊Transition elements - will be communicated throughout 2025, as the updated guideline progresses, including how changes will be communicated and available to all (e.g. a comparison table was mentioned). Hope you found that useful. Got a question for Shaun? Post in comments below 👇

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