Qi GUAN

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

8

Episode 2 - The Market Access @ HEOR Podcast is released with Andrew Xia and the excellent Marcus Metcalfe! Full episode see the link below or go to my profile page. I placed Andrew at Mundipharma about 8 years ago and we've stayed in touch. One of the bits i remember is he had a more complex business setup with interests in China and the US - so for him working as an HEOR/Access Interim made perfect sense. In this short taster we touch on the perception of Interims from a Client perspective - they kind of operate in this unclear/middle space space between an FTE and a fixed project consultant. Which is exactly why it can work very well, because there is a lot to get done in between! I hope you enjoy the podcast, it's been great fun. I'm looking to include some truly global perspectives, so get in touch if you'd like to have a chat? Putting yourself out there on camera is daunting, but what's the worst that can happen.. https://lnkd.in/esrTJ3f3

9

5 Comments

Great heads up from Virginia Acha. This study reports impressive numbers regarding the contribution of pharmaceutical companies. One among many worth highlighting is that "Investment in health innovation could add $12 trillion to global GDP by 2040."

19

1 Comment

All eyes are often on big pharma, investing hundreds of millions of dollars in clinical trials. While they are indeed the driving force behind the drug developpement and clinical trial industry, the most significant innovations in the past decade have emerged from small biotech. These organizations must be creative with limited budgets to develop their pipelines. Small biotech firms are more strategic in their investments and need to work with service providers that understand their constraint and can adapt on their evolving company strategy. Despite representing only 30% of total clinical trials, small pharmaceutical companies make invaluable contributions to innovation and medicine. It is crucial that they receive support not only from the government but also from their partners, service providers, and investors. #biotech #clinicaltrials #WithEveryPatient

2

Exciting news in the world of oncology as BeiGene, transitioning to BeOne Medicines, secures global licensing rights for SYH2039, a cutting-edge MAT2A inhibitor, from CSPC. This innovative drug targets the MTAP gene deletion found in approximately 15% of all cancers, including challenging types like glioblastoma, pancreatic cancer, and non-small cell lung cancer. The agreement involves a substantial upfront payment and milestone-based structure amounting to $150 million, along with royalties for CSPC. This strategic move by BeiGene addresses a crucial medical gap within oncology. The MTAP deletion is a prevalent factor in many hard-to-treat cancers, presenting a valuable target for therapeutic solutions. The potential synergy between SYH2039 and BeiGene’s in-house PRMT5 inhibitor, BGB-58067, opens doors to a potent combination therapy for these cancers, potentially enhancing treatment outcomes for numerous patients across different cancer forms. Moreover, this agreement marks BeiGene’s expansion into targeted therapies for solid tumors, showcasing a shift from its existing focus on immune-oncology with tislelizumab. Financially, the deal structure minimizes risk for BeiGene by linking a significant portion of payments to developmental and commercial milestones, enabling strategic investments while safeguarding capital in case of underperformance. With comprehensive global rights to SYH2039, covering development, manufacturing, and commercialization, BeiGene is poised to streamline operations and maximize potential returns. This acquisition aligns perfectly with BeiGene’s mission to fortify its portfolio with top-tier therapies, particularly in lung, breast, and gastrointestinal cancers, reinforcing its dedication to solid tumor treatments. The upcoming clinical trial for BGB-58067, anticipated by year-end, coupled with the SYH2039 acquisition, underscores BeiGene’s commitment to diversifying its treatment offerings. 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞:https://lnkd.in/dN4A2x9A Naisargee Shah (Parikh), Ph.D. Fredrik Schuurink

1

An interesting piece on how patient advocacy has evolved significantly over the past two years. Patient advocates are now recognised as important stakeholders who bring valuable insights and perspectives to clinical research. Moreover, there is a growing acknowledgement within pharmaceutical companies and regulatory bodies about the critical role of patient advocacy in ensuring the accessibility, and ethical conduct of clinical studies. As it is being highlighted in the interview, it is important to distinguish patients from patient advocacy, both of which need seats at the table, because patient advocacy represents the greater voice of patients as a collective while a patient represents the individual. Patients are also important drivers for innovation in clinical research by providing their opinions and feedback. #PatientCentricity #ClinicalTrials #Research

25

3 Comments

I agree with the following piece from Ken Getz, in the Reuters white paper, Pharma and Future: Powered by Partnership and Patient Experience, addressing the challenges of measuring impact and demonstrating value of patient engagement.  “Currently, not every function is as committed to supporting patient engaged drug development.” There are two clear challenges. One is the validity of current measurements and whether organizations are fully to committed to implementing and executing truly patient engaged activity. Two is the extent to which there is broad-based organizational preparedness and readiness to fully embrace patient-first approaches. “When you look at any transformative innovation, we do not do a good job of change management,” he says. Among the limitations are a lack of training and transparent, visible support for senior management. --- As I have stated earlier, I believe that in order to truly succeed with patient engagement in the pharmaceutical industry, the next challenges will be to develop standard processes for patient engagement, ensuring these processes are integrated into as many divisions and departments within the organisation as possible, and ensuring to collect and present the ROI data on the patient engagement activities. #clinicaltrials #patientengagement

7

1 Comment

❔Why is Oncology the most invested in therapeutic research area? 💰R&D investment figure estimates vary considerably, but Oncology generally accounts for ~40% of drug development spending. 🩺Despite continued investment, cancer remains a leading cause of disease burden globally with more than 19.3 billion cases and 10 million deaths recorded in 2020. 🏦With this comes significant economic burden: A 2021 study estimated that between 2020 and 2050, cancers will cost the world economy $25.2 trillion in international dollars, which is equivalent to an annual tax of 0.55% on GDP. China and the US face the largest economic costs of cancers, accounting for 24.1% and 20.8% of the total global burden. ⛓This doesn’t take into consideration the wider impact of disease burden such as productivity levels, care costs and wider social consequences. 📈Over the next 10 years it is estimated that cancer cases will grow by around 40%. 👵Whilst the main reason is our increasing life span (exacerbated by generally decreasing rates of other causes of death such as cardiovascular and infectious disease, and estimated at about 2/3 of the reason), other factors such as lifestyle, genetics, family history, where you live, exposure to viruses and environmental pollutants and even the job we do, are having an impact too. 🚬Note: Smoking remains the largest preventable area of cancer deaths globally, currently contributing to more than 1 in 4 UK cancer deaths alone and 15% of all cancer cases in the UK. 💲The economic burden is clear. 🏥Cancer research and resultant improved treatment not only saves and improves lives, but plays a vital role in boosting economic growth. 💱Investment creates jobs and ultimately relieves healthcare budget pressures. 🤑Return on investment: it’s got to be talked about. Whilst the ultimate aim of clinical research is to improve and extend patient lives, it cannot be ignored that this is a multi-billion dollar industry driven by profit-seeking businesses. It’s hard for investors not to be attracted to the success seen in late stage oncology pipelines! 💡There is so much more I could go into.. country disparities, funding sources.. and I’ve not even touched on the emotional, mental and whole-life strains for disease sufferers and their communities. It’s not uncommon to hear of Biotech founders having had a personal confrontation with cancer. 🦸‍♀️I wanted to finish with some positives.. 🧪Cancer screening programmes are increasing early diagnosis. 📉The rates of certain cancers such as stomach cancer are reducing, with improvements in food preparation methods. ✨ Outcomes of cancers of the pancreas and upper gastrointestinal tract have been greatly improved. 🥼Technical expansions such as in surgery and radiotherapy are improving dramatically, as well as in imaging for diagnosis. 🏄‍♂️Cancer survival rates are improving, with breakthroughs in treatment methods (survival rates have doubled since the 1970s!) #cancer #oncologyresearch

19

2 Comments

Are adaptive trials the answer to more personalised clinical trials? 💊   Personalised medicine is a well-established approach to patient management, but is it time it became the gold standard for clinical trials as well? Adaptive trials may hold the answer.   Whereas traditional clinical trials follow fixed, predetermined protocols, adaptive clinical trials use the data generated from participants to inform decisions made throughout the trial - such as dropping poorly performing arms. Combined with additional insights from machine learning, adaptive designs could lead to trials that yield better and more useful data and directly benefit patients.   Several trials have already used this innovative approach including: 🔹 The I-SPY 2 Trial for women with newly diagnosed, high-risk breast cancer. 🔹 The PREVAIL II trial evaluating the effectiveness of ZMapp for Ebola virus disease.   Although more complex than traditional trials, their advantages include faster access to new therapies, reduced exposure to less effective treatments and enhanced patient safety.   #healthcare #drugdevelopment #clinicaltrials #pharma

10

Balancing a sustainable healthcare system whilst enabling a healthy and supportive environment for healthcare innovations as a launchpad for the region is a delicate balancing act. Innovators need to have a solid problem statement, a functioning innovation (to address said problem at least as well as the next best comparator), a forward looking and capable team, as well as financial sense. In most other industries, that'd probably be good enough (with a healthy dose of joss sticks, incense, rain dances and/or luck). Healthcare innovation is a different animal though. An evolved and flexible payer landscape to address affordability, an efficient and robust regulatory mechanism to establish safety and effectiveness, as well as respected and skilled champions of the technology in the local setting (to well...use the innovations), are required to enable innovations to establish proof-of-concept or gain critical mass (in later stages). It's clear that markets which enable these will generally lead the way in becoming innovation hubs for healthcare. Suppliers and innovators are the same parties in healthcare. It is therefore imperative that the wrong pocket problem, where realization of outcomes for one aspect of the economy are not translated into material wins for another aspect of it, does not permeate Asian healthcare ecosystems and lead to a zero-sum game, in the pursuit of both sustainable healthcare systems and highly innovative ones. Glad to have had Saumick Pal Fadhli A. Cairan He Morris L. share their candid thoughts on the evolving healthcare ecosystems locally and in the region at MSD's Makan Talks series (our 10th milestone session -and what a session!) Jaga-Me Mobile Medical & Home Care EDBI Pte LtdVentureBlick

21

1 Comment

The NHS as a driver of economic growth—that is the vision of Wes Streeting, the Secretary of State for Health and Social Care in the new Labour government in the UK. He also sees a need to shift care increasingly out of the hospital setting, boost prevention and embrace digital healthcare.   Speaking of the role of the NHS, Streeting said: “This is no longer simply a public services department—this is an economic growth department, and the health of the nation and the health of the economy are inextricably linked.”   Streeting believes “if we can marry our health and social care system with the incredible life sciences and medtech ecosystem we have in this country, we can be a powerhouse for the life sciences and medtech revolution here in this country … and in the world. And that is an economic growth mission.”   The NHS has one of the largest workforces in the world, and Streeting thinks that “as anchor institutions, the NHS, the social care system, we can be drivers of economic growth in every part of the country.” He added: “It also means ending the begging bowl culture, where the only interaction the Treasury has with the Department of Health and Social Care is: ‘We need more money for X, Y and Z.’”   On reform of the NHS, he said: “Conservative politicians are now conceding publicly what many have been saying privately for a long time, which is, just as only Nixon could go to China, only Labour can reform the National Health Service.” In his view, reform will require some “tough love,” but he does not envisage major changes to the organisational structure of the NHS. Rather, he identifies three overarching priorities:   • “A shift in the centre of gravity—out of hospital into the community, primary care, community services, mental health, social care.”   • “A shift from a service that's hopefully focused on treating sickness to a cross-government, cross-society focus on preventing illness in the first place.”   • “A shift from an analogue system that still has too many pagers and fax machines to one that is not only benefiting from, but drives, the life sciences and medtech revolution here and internationally.”   Responding to the interview, the ABPI set out its priorities for the first 100 days of the new administration, including the following actions:   • Pass outstanding UK clinical trials legislation to enhance the UK’s attractiveness for inward investment. • Increase commercial flexibility in the NHS England Commercial Framework for New Medicines to remove barriers for companies to launch new drugs and indications.   • Support NICE’s rapid review of its disease severity modifier.   Given that Streeting has described the #NHS as “broken” at present, it will be no easy task to make it “an economic #growth department,” but the new Secretary of State has at least set out his stall.   I recently delivered a webinar on what the new #UK government may mean for the NHS and pharma. Get in touch if you would like a copy of my slides.

62

2 Comments

“Interventions to help patients adhere to cancer treatment can also be beneficial, as shown in the prospective, randomised, controlled IMPACT study evaluating a standardised teaching tool designed especially to educate and coach patients receiving oral treatments (the Multinational Association of Supportive Care in Cancer [MASCC] oral agent teaching tool, or MOATT) and local routine patient coaching (Abstract 378O). The probability of patients with advanced breast cancer permanently discontinuing oral abemaciclib plus endocrine therapy in the first 6 months of treatment was reduced by approximately 40% by following the MOATT education and coaching tool compared with routine patient coaching. This study shows that when we add an educational component to a coaching component – as included in MOATT – we really empower patients and help them to remain on treatment. As non-adherence to oral therapy is often multifactorial (Support Care Cancer. 2020;28:4043–4050), I think this study reinforces the idea that a multifactorial problem requires a multifactorial intervention.”

2

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.

1

The Lancet September 2024! Early findings from the NHS Type 2 Diabetes Path to Remission Programme: a prospective evaluation of real-world implementation!

12

Dear Market Access Leaders, Imagine you're on the cusp of launching a ground-breaking drug —a product that could transform patient outcomes and revolutionise treatment paradigms. Your team has meticulously crafted value propositions. Honed messages.  And prepared robust evidence for Health Technology Assessment (HTA) submissions. But here's the catch . . . What if I told you that despite your best efforts, a crucial ingredient that could make or break your market access strategy is slipping through the cracks — left untapped and unused? As Market Access Leaders, we pride ourselves on our strategic skills and our ability to navigate the complexities of HTA processes. Yet, in our mission to secure reimbursement and market access, we often overlook this fundamental ingredient that could make Reimbursement & Access quicker — faster — and easier. 🙋🏼‍♀️❓❓❓ Question: Can you guess what the missing ingredient is? Please share your answers in the comments below. 👇 👇👇 #MarketAccess #CustomerInsights #Payers #HTA #MarketResearch

10

6 Comments

Do you need robust clinical and economic evidence for the US market? What are payers really looking for? Bob Nordyke (Senior Advisor in US Evidence and HEOR – Petauri) sheds light on this critical question. Whilst US commercial payers don't specify clinical and economic evidence comparisons in the systemic way HTA markets do, strong head-to-head studies can still significantly boost your market access success. Beyond that, Bob emphasises how evidence types that are often overlooked in HTA markets can be used to effect in the US, such as: ✅ Patient-reported outcomes ✅ Patient preference information 🎥 Catch the full webinar (first broadcast in October 2024) to learn how to align your evidence portfolio with US payer expectations: https://lnkd.in/eyFVQpMb 💬 Have questions or need support with your US evidence strategy? Contact our experts at [email protected] #GlobalWhispers #USpayerevidence #marketaccess #pharma #medtech #clinicalevidence #patientoutcomes #patientpreferences #patientchoice

3

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

6