December 2023
The UK government has published its full response to Lord O’Shaughnessy’s independent review into commercial clinical trials in the UK. All the recommendations will be implemented:
An article on how high-quality clinical trial monitoring oversight ensures the success of clinical trials by avoiding the serious consequences arising from protocol deviations, poor data quality, and regulatory issues:
The NHS-Galleri Trial investigating a new blood test to see if it can help the NHS detect cancer early when used alongside existing cancer screening has recruited the target of 140,000 participants. Interim results are expected in spring or summer 2024:
AstraZeneca has launched a new separate health-technology business, Evinova, to accelerate innovation across the life sciences sector and the delivery of clinical trials and better health outcomes:
astrazeneca.com
Cambridge, UK, continues to be a mecca for developers of new laboratories. The latest is the demolition of the existing 3-storey 4,000 m2 R&D Vitrum Building at St John’s Innovation Park in Cowley Road to make way for a 5-storey 44,196 m2 monstrosity:
And this is just a taster of other proposals:
The Wellcome Genome Campus at Hinxton will undergo a massive expansion costing hundreds of millions of pounds: businessweekly.co.uk
The University plans to redevelop the Forvie Site on the Cambridge Biomedical Campus: cambridge-news.co.uk
TWI Limited will rebuild – much larger – R&D buildings at Granta Park: cambridge-news.co.uk
Developers Mission Street plan to create a “globally significant science destination” on an old landfill site off Coldhams Lane: cambridge-news.co.uk
The Grafton shopping centre will be largely changed into new laboratory space: cambridge-news.co.uk
If approved, the Beehive shopping centre would also become laboratory and office space: cambridge-news.co.uk
The justification? Creating the UK as a scientific superpower: radical.bidwells.co.uk
The Medicines and Healthcare products Regulatory Agency (MHRA) has extended the validity of GMP and GDP certificates until the end of 2023. This is because not all on-site GMP and GDP inspections, restarted after being postponed or carried out remotely during the COVID pandemic, have been completed:
Mission Therapeutics, based at the Babraham Research Campus in Cambridge, is to undertake human trials in early 2024 of a potential new drug that it is hoped could slow the progression of Parkinson’s disease by inhibiting an enzyme called USP30:
In two clinical trials with 200+ children aged 4 to 11, a VR device called the Smileyscope reduced self-reported pain levels by up to 60% and anxiety levels by up to 40%. The article also looks at RelieVRx which in 2021 became the first VR therapy authorised by the FDA for chronic pain, and which can be used in a domestic setting:
November 2023
Vision Research Reports project the global clinical trials market size will surpass c. $95bn by 2030 from $51.78bn in 2022, expanding growth at a CAGR of 7.07%. This will be driven by increases in chronic diseases and the rise in R&D activities in biotechnology & pharmaceuticals industries:
Another report, from DataM Intelligence, predicts the global clinical trials market will have a CAGR of 7.4% between 2023 and 2030: up from $56,64bn in 2022 to $99.2bn. This is largely driven by increased R&D investment by key biopharmaceutical firms:
According to DataHorizzon Research, the clinical trials management market size was estimated to be valued at $1.4bn in 2022 and projected to arrive at $4.8bn by 2032 with a CAGR of 13.0%. North America dominates the market due to its advanced medical infrastructure, favourable regulatory policies, and quick adoption of new technologies and medicines:
Alzheimer’s Research UK, the Alzheimer’s Society and the National Institute of Health and Care Research have announced a £5m-funded Blood Biomarker Challenge project to make blood tests for Alzheimer’s disease available on the NHS within five years:
Radicle Science, which conducts clinical trials that are 100% remote, is on a mission to make clinical trials truly diverse, inclusive and accessible to all including the historically underrepresented such as women, pregnant, older adults, rural residents and people of colour:
A study conducted by the British Medical Journal (BMJ) on retaining potential patients for mental health clinical trials saw a 637% jump in contactable patients within 12 months. The “Count Me In Approach” used electronic health record (EHR) searches and dramatically increased both the amount and diversity of recruits:
Johnson & Johnson is using artificial intelligence (AI) to make clinical trials more diverse. For example, identifying clinics frequented by black people has helped increase the participation of black cancer patients in clinical trials by 5.2%:
UK patients, the healthcare system and the life sciences sector are set to benefit from a new scheme that will see the time taken by the Medicines and Healthcare products Regulatory Agency (MHRA) to approve the lowest-risk clinical trials reduced by more than 50%:
The US Food and Drug Administration has approved Eli Lilly's appetite-suppressing / weight loss drug tirzepatide (Mounjaro). Clinical trials have shown it can help patients lose 21% of their body weight when combined with a healthy lifestyle. It will be administered as a weekly injectable:
Wearing a face mask really does work to reduce the spread of COVID-19 and the risk of being infected, according to a comprehensive review of over 40 studies conducted with seven different methodologies:
October 2023
This year’s Nobel Prize in Physiology or Medicine has been awarded to Katalin Karikó and Drew Weissman for their discoveries that enabled the development of effective messenger ribonucleic acid (mRNA) vaccines against COVID-19:
DexCom, Inc., the global leader in real-time continuous glucose monitoring (CGM) for people with diabetes, has announced that its COMISAIR study, the longest prospective real-world CGM study ever conducted, demonstrates significant and continued HbA1c reduction for patients using real-time CGM over seven years:
According to a market report, the global RNA therapy clinical trials market is anticipated to reach $3.5 billion by 2030 and grow at a CAGR of 3.84 percent from 2023 to 2030. Expansion in emerging markets is attributed to the rising success rate of RNA-based COVID-19 vaccines, regulatory approval, and demand for personalised medicines:
The world’s most advanced genetic database in the form of the UK Biobank, which has sequenced the genomes of half a million Britons, is suffering from the inertia and conservatism of the NHS which, in a host of ways, is imperilling the UK’s lead in life sciences claims Camilla Cavendish in the FT:
Sanofi and Teva Pharmaceuticals are to jointly develop and commercialise Teva’s TEV’574, an anti-TL1A therapy. It is currently being evaluated in phase 2b clinical trials as a treatment for ulcerative colitis and Crohn's disease which are thought to affect ten million people worldwide:
New patient enrollment in the Phase II TELLOMAK trial in cutaneous T-cell lymphoma (CTCL) and the Phase Ib trial in peripheral T-cell lymphoma (PTCL) has been halted following a participant’s death due to haemophagocytic lymphohistiocytosis (HLH):
The serious global problem of emerging resistance to antibiotics is exacerbated by the lack of discovery and development of new ones. In 2021, there were only 27 antibiotics in clinical development against priority pathogens, down from 31 in 2017. Between 2017 and 2021, only 12 new antibiotics entered the market:
According to Transparency Market Research the global clinical laboratory services industry was valued at $313.3bn in 2021. It is projected to grow at a CAGR of 5.9% from 2022 to 2031, reaching a value of $561.1bn:
www.transparencymarketresearch.com
According to Transparency Market Research the global toxicology drug testing market was valued at $34.7bn in 2022. It is projected to increase at a CAGR of 5.5% from 2023 to 2031 and reach $55.9bn by 2031:
www.transparencymarketresearch.com
August 2023
The global clinical trials market size reached USD 48,680 million in 2022 and is estimated to hit around USD 83,550 million by 2032, expanding at a CAGR of 5.6% from 2023 to 2032. This growth is significantly influenced by the increasing trend of outsourcing and collaborative partnerships between pharmaceutical companies and Contract Research Organizations (CROs):
Stricter serialisation practices – requiring identification down to the individual dose of a pharmaceutical product – could help to mitigate unsafe medication practices and medication errors and offer improved patient protection. However, there are challenges for product coding and marking:
factoryandhandlingsolutions.co.uk
The International Accrediting Organization for Clinical Research (IAOCR) and the UK NHS’s Research and Development (R&D) Forum have announced a collaboration launching the UK Clinical Trials Talent Taskforce to attract, develop and retain people in the clinical research sector:
The SAFE CT project, funded under the EU4Health Programme (EU4H), runs until 29 April 2025 in order to build the competence and expertise needed to implement the concepts of safety cooperation and work-sharing among member states that were introduced with the new clinical trial regulation (CTR):
The Christie NHS Foundation Trust in Manchester, which has in progress around 30 clinical trials of new immunotherapy drugs for blood cancer including myeloma, said it is seeing the vast majority of patients responding to treatment. There are around 6,000 new myeloma cases in the UK every year:
A debate about missing clinical trial results in Germany has taken a fresh turn, with two powerful patient groups demanding the mandatory disclosure of all clinical trial results after a study revealed that the results of nearly a third of 1,700 clinical trials run by universities in the country have never been made public:
The UK government has announced a £210m investment from the Aid Budget to support the global fight against antimicrobial resistance (AMR) in 25 countries across Asia and Africa. The investment is the largest ever by a country in AMR surveillance, and will incentivise drug companies to develop new antibiotics:
The rising success rate of RNA-based COVID-19 vaccines and demand for personalised medicines is driving the global RNA therapy clinical trials market, which is predicted to reach $3.5 billion by 2030:
europeanpharmaceuticalreview.com
Boehringer Ingelheim has advanced its survodutide weight loss drug to Phase III trials. The weight loss market worldwide is expected to reach $37.1bn by 2031:
The National Institute for Health and Care Excellence (NICE) has recommended the use of MSD’s Keytruda (pembrolizumab), a tumour therapy. It is the first verdict based on data from a wider immunotherapy basket study, rather than a traditional clinical trial:
Over 4,000 clinical trials violate U.S. law. The FDA sent only one warning letter:
Greg Plunkett, founder and CEO of Melbourne-based contract research organisation (CRO) Accelagen, shares his company’s perspective on the importance of diversity in clinical trials and why the science of inclusion matters:
July 2023
The European Commission has published updated guidance on the transition of clinical trials from the Clinical Trials Directive (2001/20/EC) to the Clinical Trials Regulation ((EU) 536/2014):
The UK Government has signed a long-term partnership agreement with the German company BioNTech to support clinical trials for personalised mRNA cancer immunotherapies. To help deliver this research, BioNTech plans to set up new laboratories in Cambridge for over 70 scientists:
www.gov.uk & www.cambridgeindependent.co.uk
On 17 May 2023, the UK Government introduced a licensing ban on animal testing of chemicals exclusively intended as ingredients in cosmetics. There are currently three live licences that authorise animal testing of chemicals used as ingredients in cosmetics:
questions-statements.parliament.uk
A research team at the Medical Research Institute Kitano Hospital in Osaka, Japan is making progress on the development of a groundbreaking medication that may allow people who lack a full set of adult teeth due to congenital factors to grow new ones. Clinical trials are set to begin in July 2024:
According to research by The Insight Partners, the clinical trials market size is expected to grow to $76.02 billion by 2028 from $55.05 billion in 2022; it is estimated to grow with a CAGR of 5.5% from 2022 to 2028, with strong drivers from the Oncology segment:
Another report by The Insight Partners estimates the Pre Clinical CROs market size will grow from $4.28 billion in 2018 to $8.41 billion by 2027; it is estimated to grow at a CAGR of 8.1% from 2019 to 2027. The growth is influenced by rising biosimilars and biologics markets, and the higher cost of drug development process in developed countries:
NK:IO, a spin out from Imperial College and a leader in Natural Killer (NK) cell biology applied to the development of off-the-shelf cell therapies targeting solid ovarian tumours, has been awarded £1.6M in grant funding from Innovate UK’s New Cancer Therapeutics program:
www.pharmaceutical-technology.com
The Biden administration has suspended US funding for the Wuhan Institute of Virology after it failed to answer safety and security questions. This would impose a 10-year ban on funding. The institute had been granted $1.4 million since 2014, though it has not received U.S. funds since 2020:
Led by Addenbrooke's Hospital in Cambridge, a study of 3,500 first time mothers aims to explain why some women develop pre-eclampsia and other placental complications and how they can impact women's long-term health:
A breast cancer vaccine has shown promise in a phase 1 trial spearheaded by researchers at University of Washington's Cancer Vaccine Institute and is preparing to move to phase 2. The trial was conducted with 66 patients with advanced-stage ERBB2-positive breast cancer:
Professor Sir Andrew Pollard, chief investigator of the Oxford Covid-19 vaccine trials and director of the Oxford Vaccine Group, gives his views on why Britain’s once-leading role in clinical research has fallen off a cliff:
Labcorp has completed the spin-off of Fortrea, to create the newly formed CRO that will give pharmaceutical and biotechnology organisations access to global Phase I-IV clinical trial management, patient access and technology solutions:
www.pharmaceutical-technology.com
In late May Elon Musk’s brain-implant company Neuralink received regulatory approval from the US Food and Drug Administration (FDA) to conduct the first clinical trial of its experimental device in humans. There are many reasons for caution:
Hyderabad-based Bharat Biotech has applied to the Drugs Controller General of India to initiate phase 1 and 2 clinical trials of India’s first indigenous tuberculosis vaccine. India has over 2 million TB patients and aims to eliminate the disease by 2025:
A look at how to reduce participant drop-out in digital clinical trials (DCTs) and maintain participant engagement throughout their entire duration:
www.pharmaceutical-technology.com
Moderna has filed a regulatory application seeking approval from the European Medicines Agency (EMA) for its modified Covid-19 vaccine that encodes the spike protein of the SARS-CoV-2 virus’s XBB.1.5 sub-variant:
www.pharmaceutical-technology.com
A new Corporate Plan covering 2023 to 2026, setting out how the Medicines and Healthcare products Regulatory Agency (MHRA) plans to keep patients safe by enabling access to innovative, safe and effective medical products over the coming three years, was published on 4 July:
Roctavian, a gene therapy from BioMarin Pharmaceutical Inc., is the first to be approved by the US Food and Drug Administration (FDA) for adults with severe haemophilia A. This news follows the European Commission’s approval of the first gene therapy for haemophilia B in February:
www.europeanpharmaceuticalreview.com
The NHS's Health Research Authority’s response to the findings of Lord O’Shaughnessy independent review into the UK’s commercial clinical trials landscape and the UK government's response to those findings:
A look at technology trends that are set to further revolutionize the design, conduct, and analysis of trials, including decentralised trials, wearable devices, machine learning, and Risk-Based Quality Management (RBQM):
An article on clinical trials in Ukraine, investigating how Oximio - despite all the challenges and disruption - successfully manages clinical supply chains during the ongoing war with Russia:
www.pharmaceutical-technology.com
Massive Bio, a leading oncology artificial intelligence analytics company, has been selected by the Precision Cancer Consortium, a collaboration of global biopharmaceutical companies AstraZeneca, Bayer, Eli Lilly & Company, GSK, Johnson & Johnson/Janssen, Novartis, and Roche, to optimise clinical trial matching:
The “Global Contract Research Organization (CRO) Industry Market Report 2023-2029” report claims the market reached $20,720mn in 2022 and will grow at a CAGR of 10.9% to a value of $138,070 million by 2029:
India has emerged as a key destination for clinical trials in the wake of the pandemic with the numbers registering a 10-fold increase in the past three years, according to Parexel, India’s largest clinical trial firm:
And another article looks at growth potential in Indian CROs and CDMOs such as Syngene, Suven, and Divis:
A searchable database of thousands of UK-based clinical trials:
beta.clinicaltrials.gov/search
In an Opinion Piece, Patrick King of Reform claims that “clinical trials can be our turning point to turbocharge life sciences here in the UK”, but that they first need to be freed from bureaucracy:
Lord James O’Shaughnessy’s independent review has been published, offering recommendations on how to resolve key challenges in conducting commercial clinical trials in the UK and transform the UK commercial clinical trial environment:
One of the O’Shaughnessy review recommendations is that doctors, nurses, and NHS organisations should be offered financial incentives to take part in clinical research:
The DIOSynVax needle-free vaccine, described as a “breakthrough”, which can be manufactured as a powder and delivered by air-jet technology, has been developed by researchers at the National Institute for Health and Care Research’s clinical research facility in Cambridge. First-stage clinical trials have now been launched:
www.researchprofessionalnews.com
Dr. Jennifer Dahne from Hollings Cancer Center in South Carolina calls for rigorous randomised controlled trials comparing traditional in-person clinical trial methods to decentralised trial methods to determine which has the most positive outcome for trial enrolment across various patient demographic groups:
The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking views from the public and other stakeholders in a 3-month long consultation on the Good Clinical Practice (GCP) guideline revised by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):
June 2023
On 20th May the global clinical trials community celebrated Clinical Trials Day. Organised by the Association of Clinical Research Professionals (ACRP), the day commemorates the date in 1774 when James Lind, a British Royal Navy ship’s surgeon, started the first randomised clinical trial (studying different treatments for scurvy):
In the latest report from Zion Market Research, “Clinical Trials Market By Phase… And By Region - Global And Regional Industry Overview, Market Intelligence, Comprehensive Analysis, Historical Data, And Forecasts 2023 – 2030”, the Global Clinical Trials Market size was valued at $53.92bn in 2022 and is estimated to grow to $85.01bn by 2030, at a CAGR of 5.93% between 2023 and 2030:
On Thursday 1st June (10am EDT (NA); 3pm BST (UK); 4pm CEST (EU-Central)) a free 1-hour Webinar will examine the new EU Clinical Trials Regulation (CTR), outline the EU CTR process, and offer insights into where efficiencies can be gained, pitfalls avoided, and working with CROs:
Bruntwood SciTech, a joint venture partnership between Bruntwood and Legal & General, has unveiled Birmingham innovation cluster. It has previously redeveloped a life science lab in Macclesfield, a £21m tech hub at Manchester Science Park and is working on offices in Glasgow:
Recommendations on the conduct of remote clinical trial visits are included in new US Food and Drug Administration (FDA) draft guidance:
europeanpharmaceuticalreview.com
A new report, “DCT Strategies to Enhance Patient Satisfaction and Future Participation - 2022” examines perceptions of 360 clinical trial participants and 440 respondents from the general population that have not participated in a clinical trial:
The first patient has been dosed in the phase 1 element of CureVac’s wider research into modified mRNA seasonal flu vaccine candidates. The multivalent vaccine therapies – which address the four World Health Organisation-recommended flu types for research – have been developed in collaboration with GSK:
The European Medicines Agency (EMA) has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Responses are required online by 28th June:
India is emerging as a favourable destination for conducting clinical trials according to a joint report by PwC India and US-India Chamber of Commerce (USAIC) entitled “Clinical Trial opportunities in India”:
On Tuesday 6th June (11am EDT (NA); 4pm BST (UK); 5pm CEST (EU-Central)) a free 1-hour Webinar will examine Diversity and Inclusivity in Clinical Trials: Effective Strategies and Best Practices for Patient Recruitment and Engagement:
In a French nationwide study, ICU-admitted COVID-19 patients, especially older adults (≥65 years), have been shown to have a consistently higher mortality risk than ICU-admitted influenza patients independent of invasive ventilation or vaccination status:
journalofinfection.com
April 2023
Innovate UK has awarded the Cambridge biotech firm Maxion Therapeutics a £2mn grant from its Biomedical Catalyst fund. The grant will go towards developing its antibodies for autoimmune diseases and chronic pain, and for running clinical trials:
From 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) will move to a new model which will allow rapid, often near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the United States, Europe and Japan:
The Global Clinical Trials Connect Conference 2023: A Platform to Discuss Futuristic Advancements in Clinical Trials and Clinical Research will take place at the Holiday Inn Kensington High St., London, from 1 - 11 May. It is aimed at “Pharmaceutical, Bio-Tech, Bio-Pharma, CROs, Investigative Sites, Solution providers and Government institutions”:
www.researchandmarkets.com
Failure to report clinical trial results is a longstanding problem in medical research, but funders are starting to take action against laggard investigators. Only one funder worldwide, the UK’s National Institute of Health Research, has adopted all 11 research waste safeguards recommended by the World Health Organisation:
RBW Consulting, a UK-based recruitment and search consultancy specialising in the life science sector, and The International Longevity Centre (ILC), have released a new report on the lack of age inclusivity in clinical trials including recommendations to ensure improvements are made:
The “Global Clinical Trials Market (2023-2028) by Study Phases, Study Designs, Indication of Disease and Geography, Impact of Covid-19 with Ansoff Analysis” report estimates the Global Clinical Trials Market as $3.07 Bn in 2023 and projects growth at a compound annual growth rate (CAGR) of 8.20% to reach $4.56 Bn by 2028:
According to the “Contract Research Organization Market Information By Segment, Clinical Trial Phase, End Users - Forecast till 2030” report by Market Research Future, the market size was valued at $39.69 Bn in 2021. It is projected to grow from $45.53 Bn in 2022 to $115.19 Bn by 2030, a CAGR of 12.01% during the forecast period (2023 - 2030):
Almirall, S.A., a global biopharmaceutical company focused on skin health, has published its POSITIVE study protocol in the British Medical Journal. This is the first clinical study in dermatology to assess patients’ wellbeing in a real-world setting and uses the 5 item World Health Organization Wellbeing Index, WHO-5:
An article by Fi Forrest, Senior writer at VMS, GlobalData, on Digital clinical trials: Trends to watch in 2023:
www.pharmaceutical-technology.com
In March, the Medicines and Healthcare products Regulatory Agency (MHRA) introduced several new measures to make it easier to run clinical trials in the UK:
Global clinical trial activity remained resilient in 2022 despite the continued pandemic, says the IQVIA Institute for Human Data Science. The 15 largest pharmaceutical companies together spent a record $138Bn on R&D in 2022, up 1.7% from 2021:
Despite clinical trials being heavily impacted by the war in both Ukraine and Russia, this assessment shows they may face a different future for their clinical industry:
The leading American medical journal, the Journal of the National American Association, read regularly by doctors of all specialties, has been found to systematically omit Black research, reinforcing a legacy of racism in medical knowledge:
Abstract Securities has unveiled a blueprint for the new South Cambridge Science Centre on a c. 5-acre brownfield site in Sawston owned by Peterhouse. The two-phase development will provide 180,000 sq ft of CL2 science & lab facilities. Phase 1 already has planning permission:
In March, Kadans Science Partner submitted plans for a new, purpose-built laboratory and office building at Merlin Place, Cambridge, on the site of the existing Taylor Vinters office opposite the Science Park and next to the Innovation Centre in the Cambridge North Cluster:
Scientist.com, the leading R&D marketplace for the biopharmaceutical industry, has expanded its AI-based Disease Model Platform in collaboration with top CROs.
Researchers can now access over 8,000 patient-derived xenografts (PDX), cell-derived xenografts (CDX), organoids and cell lines:
MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions: www.gov.uk
International Women's Day interview: Addressing the balance of women in medicine, research and clinical trials. The first of a two-part interview with Medable’s chief growth officer, Sanskriti Thakur:
Interview: Women's health and access to clinical trials is 'severely underinvested in - and the facts don't lie'. The second part of an interview with Medable’s chief growth officer, Sanskriti Thakur, discusses ways to ensure the importance of women’s roles in clinical trials is recognised, how decentralised trials will become the norm and accessible to all - regardless of sex, race, colour, or creed:
Property developers Bruntwood SciTech are investing £60m into Manchester Science Park and supporting the creation of over 2,500 jobs with its plans for an additional 131,000 sq ft of highly specialist lab space. The development will expand the life sciences campus to 1m sq ft.:
