David Simpson

The recent ABPI report published last week, highlights the crucial role of the MHRA and a robust UK regulatory framework in the success of life sciences in the UK. Beyond its implications for clinical trials and licensing, there’s a deeper takeaway for those of us in healthcare comms, significant change is on the horizon, and how we prepare now will shape our ability to support clients talk about their therapies in the UK effectively in the future. The ABPI’s call for enhanced communication, transparency, and accountability in regulation carries key lessons for communicators: 1. Simplifying Complex Narratives: With new reliance models and pathways shaping product approvals, we must break down this complexity into clear, stakeholder-specific messaging. Regulatory reliance agreements and early-access pathways, for instance, will need careful communication to healthcare professionals, payers, advocacy groups and patients to inspire trust. 2. Scenario-Based Planning: The call for horizon scanning and resourcing points to a more dynamic regulatory landscape. Comms plans should now include scenario-based messaging that accounts for possible changes in regulatory processes and timelines. Predictability will be key in launch planning and product positioning. 3. Restoring Confidence: The report highlights a decline in the MHRA’s global standing in recent years. The current push to rebuild its reputation presents an opportunity for healthcare communications professionals to position the UK as a leader in regulatory science. Strong messaging from our clients can reinforce this narrative, showing how a revitalised MHRA benefits patients globally. What Can We Do Now? 💡 Collaborate Early: Work closely with regulatory teams from the outset to understand how these changes might affect communications. 💡 Educate Stakeholders: Provide accessible, targeted information on regulatory shifts, positioning clients as leaders in regulatory excellence. 💡 Advocate for Support: Help clients articulate the need for robust regulatory investment, ensuring a smooth path to approvals, particularly in the UK. The ABPI’s ambition for the UK to be the “best place in the world” for life sciences is bold—and achieving it will require bold, strategic communications. Let’s take the lead in shaping this story. https://lnkd.in/esCuZpbe

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Our recent industry meeting inspired me to share my experience with the clinical trials budget and contract process. As always I try to provide some recommendations on how we can improve the process. At the end of the day our patients will be the winners if we can set up clinical trials much quicker. It is always good to have that in mind! #clinicaltrials #budget #contract #UK

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This an interesting read. Of particular relevance to me - skills shortages continue to be a concern for the industry, and so it's more important than ever that organisations consider not just their talent acquisitions strategies, but also talent retention and succession planning

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So... Lots going on re EMR analysis / AI for patient recruitment, but we still know that building relationships with potentially eligible patients / onboarding the right way is so important (shout out to the great study coordinators and PIs out there!). Is EMR analysis the main game? Is better patient onboarding the main game? Please check out (and like/promote) my latest column in Applied Clinical Trials that focuses on challenges / debates in clinical trial recruitment. Special thanks to Brett Kleger and Elisa Cascade for their contributions!

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Milestones can be challenging to accomplish, but with the MHRA metric for the average CTA assessment within their statutory timeframe, by acting now you could have your FiH data for Q1, 2025.

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Milestones can be challenging to accomplish, but with the MHRA metric for the average CTA assessment within their statutory timeframe, by acting now you could have your FiH data for Q1, 2025. 

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💡 Our wonderful Oncology Therapeutic Experts at ICON Biotech collaborated with Citeline and industry specialist to uncover how new wave technology-driven therapeutics are reshaping oncology development! Have a read through the insightful discussion and feel free to reach out if you would like to connect with Andreas Dreps and Muaiad Kittaneh for a chat! #oncologydevelopment #emergingtechnologies #clinicalresearch

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VS&M Tops ClinOps Investment Landscape Our recent Clinical Operations Strategy Meeting revealed that Vendor Selection and Management is the top priority for trial stakeholders. 27.5% of delegates identified VS&M as a crucial investment area. Not too far behind is Patient Recruitment with just 2 decimal places a miss ClinOps' Rank 1. These Top 2 Priority Investment Areas highlight a unique opportunity for investors to support groundbreaking innovations in meticulously forging clinical trial partnerships while also ensuring a streamlined patient recruitment approach. Discover the top investment areas shaping the clinical operations landscape and position yourself at the forefront of innovation.

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A significant increase in Scientific Advisor roles has been observed in Q1 of this year. If this trend continues, there will be a 118% rise compared to last year. 📈 Discover more data-driven insights in the latest report by Cpl Life Sciences and Vacancysoft: https://zurl.co/3AhQ #lifesciences #datainsights

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Following Endpoint's Women in Biopharma 2024 event has been a reminder of just how vital diverse leadership is to this industry’s progress. Although the full event recap isn’t out yet (and I'm looking forward to when it is), what’s already clear is how these women are driving meaningful change. From Marsha Henderson's work advancing women’s health research at the FDA, to Angie You (Architect Thearpeutics) and Katherine Bowdish, PhD (PIC Therapeutics) reshaping the landscape for biotech investors, these leaders are not just breaking barriers — they’re setting new standards for innovation and resilience. Despite the persistent challenges in this field, these women continue to lead with clarity, purpose, and a vision that benefits all of us. Their contributions go far beyond gender; they’re advancing science and improving lives, building a path for the next generation of innovators. Looking forward to seeing what’s next, but for now, let’s celebrate the incredible impact they’ve already made. Register to watch the full panel on demand... #WomenInBiopharma #Leadership #BiotechInnovation #DiversityMatters

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🚨 miDiagnostics Secures €30M Series D Funding to Advance Sterility Testing for Biopharma! 🧬💡 Belgium-based MiDiagnostics has raised €30M in its Series D funding round, led by Thermo Fisher Scientific and supported by existing investors like Alychlo, VMF Invest, and Pamica. With this new funding, MiDiagnostics will: 🔬 Accelerate development of a revolutionary sterility test for batch release in biopharma using its cutting-edge qPCR technology. 🌍 Leverage Thermo Fisher’s expertise to bring innovative solutions to market. 💻 MiDiagnostics’ tech combines: ✔️ A nanofluidic processor on a silicon chip ✔️ A compact reader for rapid analyte measurement MiDiagnostics CEO Katleen Verleysen stated: "This funding will enable us to expedite our development efforts and revolutionize sterility testing in the biopharma sector.” Notably, MiDiagnostics is also behind a SARS-CoV-2 breath test developed in 2021, showcasing its commitment to pushing boundaries in diagnostics. 🔗 Collaborations with imec and The Johns Hopkins University highlight the firm’s strong foundation in innovation. #Diagnostics #Biopharma #FundingNews #Innovation #ThermoFisher #LifeSciences #MiDiagnostics #PCRTechnology

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🚨 Leadership Update at PharmaEssentia! 🚨 🌟 Joe Horvat joins PharmaEssentia as the Global Chief Commercial Officer, bringing nearly 30 years of industry expertise to strengthen the company’s commercial operations. 💼 Horvat's journey so far: 🔹 Former GM at MorphoSys US. 🔹 Leadership roles at Oncopeptides, EMD Serono, and Bristol Myers Squibb. 🔹 Extensive track record in business development and product commercialization across pipeline stages. 🔬 PharmaEssentia's focus: ✅ Boosting Besremi: Its first FDA-approved drug for polycythemia vera, a rare blood disorder. ✅ Expanding Besremi’s reach and exploring new indications. ✅ Advancing a pipeline tackling blood cancers, blood diseases, solid tumors, and neutropenia. 🌍 Horvat's impact: CEO Ko-Chung Lin, Ph.D., shares, “Joe's leadership will align global commercial strategies, focusing heavily on PharmaEssentia USA as the key driver for our next phase of growth.” 📈 With Horvat at the helm, PharmaEssentia is poised to elevate its U.S. operations and bring transformative therapies to patients worldwide. #LeadershipUpdate #PharmaEssentia #Biotech #CommercialStrategy #PharmaNews #RareDiseases #Innovation #BloodDisorders #HealthcareLeadership

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In this interview with Triangle Business Journal, CEO Peyton Howell shares her vision for how Parexel will tackle global challenges and leverage cutting-edge technology to reach more patients where they are. Read it: https://lnkd.in/gqS-FRmJ #PatientsFirst

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Interesting read on the future of radiopharma, especially with BMS backing Ratio and Eli Lilly backing Point Biopharma.

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Interesting article from earlier this year about sponsor preference when looking into CROs. Curious to see what the #CRO, #Biotech and #Pharma leadership think and if the size of the CRO is a major factor in the decision process. #contractresearch #biotech #clinicalresearch #executivesearch #recruiting #therapeutics #lifesciences #contractresearchorganizations

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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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5 Cell & Gene Therapy Decisions to watch as 2024 shapes up to be landmark year for the CGT space. The FDA has already approved 3 CGT's this year with an additional 7 products expecting approval by year's end. Pfizer's Beqvez: An in vivo gene therapy for hemophilia B, with an FDA action date of April 27, 2024. Abeona Therapeutics' pz-cel: A gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa, with an FDA action date of May 25, 2024. Rocket Pharmaceuticals' Kresladi: An ex-vivo vector gene therapy for leukocyte adhesion deficiency-1, with an FDA action date of June 30, 2024. Adaptimmune's afami-cel: A T cell receptor therapy for advanced synovial sarcoma, with an FDA action date of August 4, 2024. Autolus Therapeutics' obe-cel: A CAR-T cell therapy for B cell acute lymphoblastic leukemia, with an FDA action date of November 16, 2024. #CGT #GeneTherapy #Celltherapy https://lnkd.in/eJ6y_9y4

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Latest blog on approaches to participant recruitment in #RWE! Patients are at the heart of our real-world evidence research. But what to do if you craft a fabulous study design, in collaboration with patients and KOLs, and then start to look at the part of the design concerning the recruitment pathways?! ❓ How to do it? ❓ What are the options? ❓ What do you need to think about? Have a read to see the possible approaches to participant recruitment in real-world evidence research. #patientcenteredresearch #patientrecruitment

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In this episode of the podcast I am discussing diversity plans (no, it has nothing to do with politics!) and what to consider when developing your diversity plans. We need to reach out to more patients and make sure all patients have equal access to clinical trials but before we get to this point there are some steps that we all have to take (the industry, the patient groups and the regulators). #clinicaltrials #diversityplan #podcast #patientrecruitment

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