January 2021
The UK rollout plan for the Oxford/AstraZeneca vaccine has been changed, but Pfizer/BioNTech say their vaccine was not designed to be used in two shots 12 weeks apart:
Three more coronavirus vaccines are expected early this year, from Novavax, AstraZeneca and Johnson & Johnson:
A novel computational drug screening strategy developed in China has determined that pralatrexate outperforms remdesivir in inhibiting the Covid-19 virus:
The pharmaceutical industry sifts through the details of the EU trade deal:
What the UK-EU Trade and Cooperation Agreement means for pharma and medical device companies:
According to the report “Contract Research Organization (CRO) Market” the global contract research organisation market size is expected to surge at 11.48% CAGR through to 2023:
The Europe contract research organization (CRO) market is expected to grow with a CAGR of 7.7% from 2018-2025:
Moderna has announced the Phase 3 study of its COVID-19 vaccine candidate, mRNA-1273, has demonstrated efficacy of 94.5%:
Sunderland-based CRO Onyx Scientific has announced a multi-million pound investment in its facility which will be used for non-GMP & GMP Phase I – III and commercial API manufacturing:
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a guidance document for clinical trial sponsors and research organisations dealing with the submission of Suspected Unexpected Serious Adverse Drug Reactions and Development Safety Update Reports following the end of the Brexit transition period (requires free trial registration):
uk.practicallaw.thomsonreuters.com
February 2021
The UK’s National Institute for Health Research (NIHR) Clinical Research Network Virtual Event for the Life Sciences Industry is now open for registration. It will take place on 3 March from 09:15 to 12:30:
Computer scientists from Ohio State University have used a new deep-learning model that can predict how human genes and medicines will interact to identify at least 10 compounds that may hold promise as treatments for COVID-19:
Sponsored by the Institute of Biomedical Science (IBMS), nominations for the next Biomedical Scientist of the Year are now underway, with entries closing on 15th March:
Sanofi Will Make Pfizer’s Covid-19 Vaccine. Are More Manufacturing Partnerships Coming?
Novavax’s experimental vaccine is highly effective against the variant identified in Britain — but saw a worrying drop in efficacy against a lineage detected in South Africa:
Will the UK government's COVID-19 dosing regime gamble pay off?
The “Global Laboratory Information Management Systems (LIMS) Market Analysis 2020” report predicts the global LIMS market will reach $2.21 billion by 2026 growing at a CAGR of 14.1% during 2019 to 2026:
Big Pharma has been one of the most-hated sectors globally for a long time now, but could the global pandemic be a key opportunity for the sector to salvage its reputation?
GSK has sold its GCLP-certified clinical bioanalytical laboratory located in Marburg, Germany to Canadian clinical research organization (CRO), Nexelis:
March 2021
For almost a year, the journal Nature has been looking at the literature on the coronavirus and summarising key papers as they appear. To track the remarkable progress on understanding the virus and on vaccine developments see:
The Pfizer and AstraZeneca vaccines are more than 80 per cent effective at preventing hospitalisations from COVID-19 in those over 80 after one dose of either shot, Public Health England has said, citing a pre-print study:
The European Commission has released an updated version of its draft Q&A guidance document dealing with the application of the Clinical Trials Regulation ((EU) 536/2014) - (requires free trial registration):
uk.practicallaw.thomsonreuters.com
It is becoming increasingly apparent that a large number of children with symptomatic and asymptomatic COVID-19 are experiencing long-term effects, many months after the initial infection. Up to 100 symptoms have been reported by support groups and researchers:
longcovidkids.org/long-covid-research-on-children
The Institute of Biomedical Science (IBMS) has rescheduled its 2021 Congress to Monday 14th - Thursday 17th March 2022 in Birmingham, UK, with the theme of “Linking learning to the Laboratory”. Booking is now open, with early bird discounts:
AstraZeneca sold its 7.7% stake in rival COVID-19 vaccine maker Moderna for over $1 billion in late 2020:
A cross-sectional study of 230 US-based clinical trials, Black or African American, American Indian or Alaska Native, Hispanic or Latino, and older adults were underrepresented and women were overrepresented compared with the US population, suggesting diversity enrolment targets are needed for vaccine trials:
The global virtual clinical trials market size is expected to reach USD 13.78 billion by 2027. They have several advantages over traditional trials including lower costs, lower drop-out rates, higher recruitment rates, better compliance, and faster completion rates:
The European Medicines Agency (EMA) has published guidance outlining the requirements for manufacturers planning to modify their approved COVID-19 vaccines to combat emerging SARS-CoV-2 variants:
europeanpharmaceuticalreview.com
American biotech firm Vaxess Technologies has moved to the forefront in developing a refrigeration-free, virtually painless single-dose skin vaccine patch that can be applied by patients in their own homes:
The UK’s National Institute for Health Research (NIHR) has developed a new approach to engage with patients in the design of clinical trials, thereby improving the sustainability and quality of research while remaining aligned with ethics guidelines and codes of conduct:
April 2021
The Institute of Biomedical Science (IBMS) pays tribute to the biomedical scientists and laboratory staff who have made, and will continue to make, a vital contribution in tackling COVID-19 while maintaining high-quality healthcare services:
A run-down of clinical trials news for the week ending 2nd April, courtesy of BioSpace.com:
A team of researchers from Stanford University working with biotechnology corporation Genentech, has developed an artificial-intelligence based system that can safely add clinical trial participants that may have previously been excluded:
The eClinical & Clinical Data Management Innovation Conference 2021 will be held online on 2nd June. It is free to Pharma, Biotech and Medical Devices companies and all attendees will receive a free copy of ‘The Covid-19 Pandemic Impact on Clinical Trials’ report:
By deploying surface testing, the Eurofins Steins Laboratory in Vejen, Denmark, was able to detect the presence of SARS-CoV-2 one week before infected occupants even experienced symptoms, ensuring no interruption to operations:
internationalairportreview.com
The Outsourcing in Clinical Trials Europe 2021 conference will take place online on Wednesday 5th and Thursday 6th May. It is free to Pharma, Biotech and Medical Devices companies and offers a free Clinical Trial Assessment and a free copy of ‘State of the Biopharmaceutical Industry 2021’ report:
The Pistoia Alliance, a global, not-for-profit alliance advocating for greater collaboration in life sciences R&D, has launched its Data Governance Community of Interest (CoI) to develop best practices and advance digital transformation in the pharma/life sciences industry:
europeanpharmaceuticalreview.com
An artificial-intelligence tool called Trial Pathfinder can run clinical-trial emulations using health-care data from people with cancer, and can learn how to optimize trial-inclusion eligibility criteria, while maintaining patient safety:
The LIMS market is expected to grow at a CAGR of around 12% during the period 2020−2026 from $1.1bn to over $2bn according to the latest report from Arizton Advisory and Intelligence:
Sharp declines in US biotech stock indices gave equity investors a nervous start to 2021, but start-up drug developers raised a phenomenal $7.1bn in venture cash:
American coronavirus tracking can't keep up with concerning variants. The USA has an enormous virus-sequencing capacity, but funding and coordination roadblocks are holding it back:
Important material on the six key areas where the UK must increase research scale to maintain resilience against Covid-19 - the National Core Studies:
Of these, the Clinical Trials Infrastructure programme builds on established National Institute for Health Research (NIHR) infrastructure (and equivalent in Devolved Administrations) to accelerate delivery of large scale Covid trials for drugs and vaccines:
May 2021
The Global Clinical Trials Market is predicted to reach $77.20 billion by 2026, driven by the outbreak of tropical and infectious diseases and digitisation:
The first part of a two-part blog for Clinical Trials Day 2021, looking back at a year of COVID-19 studies registered at the ISRCTN registry, starting with the platform and repurposed drug treatment trials:
The second part of a two-part blog for Clinical Trials Day 2021, looking back at a year of COVID-19 studies registered at the ISRCTN registry, focusing on vaccine trials, testing and impacts on other conditions:
The safety and efficacy of both the Pfizer and AstraZeneca COVID-19 vaccines in a real-world community setting in the UK have proved to be even better than clinical trials predicted:
The European Medicines Agency (EMA) has announced that the clinical trial EU portal and database is now fully functional and on track to go live by 31 January 2022. The portal and database are one of the main deliverables of the 2014 Clinical Trial Regulation (Regulation (EU) No 536/2014), which was enforced to harmonise the assessment and supervision processes for clinical trials throughout the EU:
europeanpharmaceuticalreview.com
There are worrying sociodemographic disparities in cancer clinical trials, according to a new study from the University of Missouri School of Medicine, with people of colour, those with a higher income and younger individuals more likely to participate:
Drug trials need more participants. Research shows the potential benefits of changing the criteria used to determine who can enrol:
A FREE Webinar “Keeping standards high” about maintaining completion rates during vaccination rollout for COVID-19 is being held on 27 May at P.M. London/3M CET time. Sponsored by Nucleus Network, it will present strategies for ensuring reliable data while also maintaining the health and safety of trial participants:
The Q2/Matrix-M has become only the second malaria vaccine candidate ever to start a Phase III trial. It is the first malaria vaccine to reach the 75% efficacy target set by the WHO:
Seven trends and market changes affecting clinical trials in 2021: vaccine trials on the rise; Brexit; disruptions from the pandemic; increase in remote trials; personalised medicines; expanded access and post-trial monitoring; and digital transformation:
June 2021
The Cambridge Biomedical Campus will double in size in the next 20 years if the new vision published by its occupiers - including Cambridge University, AstraZeneca, and Addenbrooke's - is realised:
With India battling a shortage of Liposomal Amphotericin B to treat Mucormycosis (black fungus), Hyderabad-based specialty biopharma player Celon Laboratories has developed an alternative emulsion-based Amphotericin B injection:
Wide ethnic and gender representation in clinical trials are extremely important, leading directly to better data and hence advice given by regulators, trust in health authorities, and uptake in vaccinations:
Reportlinker.com announces the release of the report "Post-COVID-19 Trends Disrupt the Global Contract Research Organization (CRO) Market". The study highlights key growth drivers and restraints, identifies initiatives by major global CROs, and estimates growth patterns for the next five years:
America’s National Institutes of Health has started a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens:
In this resource, you can track COVID-19 vaccines advancing through clinical trials, including efficacy data and side effects of approved vaccines, as well as progress on new candidates entering human studies:
US lawmakers are proposing a bill to jumpstart Covid-disrupted clinical trials. The Loans for Biomedical Research Act would provide funding to clinical trials researching treatments for unmet medical needs:
The world’s first Alzheimer’s disease (AD)) drug candidate designed by artificial intelligence will soon enter a first-in-human Phase I clinical trial in the US. The study will assess whether DSP-0038 has improved antipsychotic effects in patients with AD psychosis:
europeanpharmaceuticalreview.com
The potential of repurposed drugs targeting COVID-19 - The Montreal Heart Institute’s COLCORONA Study results published in The Lancet reveal promise with the gout drug Colchicine:
Consideration has to be given to extending Covid vaccine shelf-life as African nations including Malawi and the DRC have been given doses without enough time to complete distribution before expiry dates kick in:
July 2021
Multiple research reports have been published in the last month on the global CRO market:
3. https://www.businesswire.com/news/home/20210616005393/en
How the COVID-19 pandemic has brought about explosive change in adoption of digital technologies, and its lasting effect on life sciences:
Contract research organizations were hit last year as the COVID-19 pandemic disrupted clinical trials, but they are now seeing a resurgence in demand as drugmakers and governments invest in newer treatments:
Scientists are on the hunt for a universal vaccine that will protect against not only SARS-CoV-2, but other members of its family that may emerge in the future. One candidate is already in a Phase 1 clinical trial:
Nearly 6,000 clinical trial results are currently missing from the European trial registry, despite transparency rules requiring countries to upload results within 12 months of trial completion:
Medical researchers are beginning to shift their focus away from COVID-19 — but the pandemic could continue to affect clinical trials focused on other diseases:
A new study suggests that significant variation in the amount of virus from person to person may be a contributing factor to inconsistent findings reported in clinical trials for antiviral COVID-19 drugs:
COVID-19 affects men and women differently. So why don’t clinical trials report gender data?
AstraZeneca’s proposed $39billion acquisition of Alexion Pharmaceuticals has cleared its European Commission review. It follows competition clearances in the United States, Japan and a number of other countries around the world, but regulatory clearance in the UK is pending:
Practical actions for consideration to increase diversity in clinical trials - by Dr Esther Mukuka, National Institute for Health Research (NIHR) Head of Equality, Diversity and Inclusion:
August 2021
On 4 August, the Good Clinical Trials Collaborative launched a 6-week consultation on new guidance for the conduct and regulation of randomised controlled trials (RCTs). Please HAVE YOUR SAY:
Scientists are scratching their heads over the precipitous decline in daily COVID-19 infections in the UK. Officially recorded new cases more than halved in 2 weeks from a high of 54,674 on 17 July to 22,287 on 2 August:
Cambridge-headquartered AstraZeneca has completed its $39billion acquisition of Alexion Pharmaceuticals. It will prompt the creation of a rare diseases group called ‘Alexion, AstraZeneca Rare Disease’, headquartered in Boston, USA:
www.cambridgeindependent.co.uk
The U.S. Food and Drug Administration has sent a “Notice of Noncompliance” to pharma company Accuitis over its failure to make a clinical trial result public as required by law. This is only the second such notice the FDA has issued:
Solidarity, a global study led by the World Health Organization (WHO), will test three new drugs in hospitalized COVID-19 patients: the cancer drug imatinib, the antibody infliximab, and the antimalarial artesunate:
Research and Markets are offering the report “Hybrid/Virtual/Decentralized Clinical Trials Market Outlook” which surveyed 109 respondents at sponsors and CROs regarding their experiences with hybrid trials and their providers:
Phase I study data has shown CanSino Biologic’s inhaled COVID-19 vaccine stimulated neutralising antibodies against SARS-CoV-2 at a dose well below that required with intramuscular administration:
A recent check-in with several biopharma and CRO companies, conducted by Life Science Strategy Group, indicates adjustment to pandemic-related challenges:
Cambridge Clinical Laboratories, which is UKAS-accredited to ISO 15189, has launched a new partnership with C-19 Direct to provide Covid-19 travel tests directly to consumers:
www.cambridgeindependent.co.uk
Research published by Ipsos MORI and the ABPI provides new insight into perceptions of the pharmaceutical sector by UK healthcare professionals, the public and Members of Parliament, and how these have been shaped by the pandemic:
September 2021
The global market for Contract Research Outsourcing is expected to slump by -1.9% in the year 2020 and thereafter recover to reach US$ 72.1 billion by the year 2027 according to the “Contract Research Outsourcing - Global Market Trajectory & Analytics” report.
Moderna Inc. has announced its number one priority as a company is to bring to market an annual single-dose vaccine combining a booster dose against both COVID-19 and flu, which it will always customize and upgrade:
India’s contract research firms have big ambitions and they are beginning to pay off in the global market:
The world's first COVID-19 drug based on human immunoglobulin developed from plasma recovered from COVID-19 patients will enter clinical trials in China:
Over the last 18 months, decentralized clinical trials have been proven to boost enrollment and increase patient diversity, and should be increased:
prweb.com. And this FREE live webinar by AliveCor on Wednesday, September 22, 2021 at 6pm BST | 1pm EDT will cover new ways to capture medical-grade data remotely and securely during decentralized clinical trials.
“Clinical Trials In Crisis: Building on COVID-19’s Lessons Toward A Better Future”: part of the Health Affairs Blog short series, “Envisioning A Transformed Clinical Trials Enterprise For 2030” looking at the US health care system:
The Bill & Melinda Gates Foundation is making a $35m equity investment in Oxford-based privately owned Exscientia Ltd to fund the development of antiviral drugs against SARS-CoV-2 and its variants. Exscientia is making a matching contribution:
The European Medicines Agency (EMA) has published a new handbook to guide trial sponsors in using Europe’s new CTIS trial registry, which will launch at the end of January 2022:
COVID-19 vaccine makers ought to make their approved vaccines available as comparators for clinical trials or risk hobbling the development of more vaccines, say the Coalition for Epidemic Preparedness Innovations (CEPI):
FREE Webinar “Vaccines - Lessons Learnt From The Pandemic” Associate Professor Teresa Lambe, The Jenner Institute, University of Oxford, Co-Developer of Oxford AstraZeneca COVID-19 Vaccine will describe the development, testing and immune readout after vaccination with ChAdOx1 nCOV-19/AZD1222. September 15, 4PM BST |11AM EDT:
October 2021
If authorised, Merck & Co’s molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19. It could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19:
Birmingham is set to vastly expand its life science and digital healthcare capabilities over the next decade with the construction of its vast Health Innovation Campus (BHIC) in Selly Oak - a partnership between Bruntwood SciTech and the University of Birmingham:
Topline results from the phase 3 Cov-Compare trial comparing Valneva’s VLA2001 COVID-19 vaccine candidate against the AstraZeneca AZD1222 (ChAdOx1-S) vaccine showed that VLA2001 generated a stronger immune response:
Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, and known for decades to be “hormone disruptors,” affecting the endocrine system, may lead to approximately 100,000 deaths in older Americans annually:
Metrion Biosciences, a specialist ion channel contract research and drug discovery company, has moved into new headquarters on Granta Park, Cambridge, which more than doubles its laboratory space:
An international consortium of collaborators facilitated by an alliance between the Icahn School of Medicine at Mount Sinai in New York, University of Texas at Austin (UT Austin), and PATH are developing a new egg-based vaccine to tackle COVID-19, inspired by influenza vaccines:
Medical research and practice have long assumed a narrow definition of the ‘default’ human, badly compromising the care of anyone outside that category. How can this be fixed?
David Frost, Brexit Minister, has promised a “review of the inherited approach to genetically modified organisms”, which include insects and soil bacteria used in farming, along with reform of “outdated EU legislation” around medical devices and clinical trials. This, he suggested, would help British research and development and speed up access to lifesaving medicines for patients:
Cambridge will see further facilities built for its booming life sciences sector following BioMed Realty’s acquisition of two new future laboratory sites at Cambridge International Technology Park on Fulbourn Road, and at Granta Park:
A new industry-academic partnership between the University of Oxford and biopharmaceutical company NuCana as found in a Phase 1 clinical trial that a chemotherapy drug NUC-7738, derived from a Himalayan fungus Cordyceps sinensis, has 40 times greater potency for killing cancer cells than its parent compound:
November 2021
As demands for diversity and equity increase across the globe, a new analysis by the Tufts Center for the Study of Drug Development in Boston, USA, finds nearly 75% of patients who are enrolled in industry-sponsored clinical trials in academic medical centres and community hospitals are white:
csdd.tufts.edu/impact-reports (navigate to press release)
To meet the need for increased output, pharmaceutical companies are embracing an entirely new approach, using the Internet to access instruments and run experiments in a remote lab facility called a “cloud lab” instead of operating physical laboratories of their own:
Researchers from the University of Toronto Faculty of Applied Science & Engineering have developed a polymer coating enabling low surface tension liquids to be transported over distances 15 times longer than currently possible. One of the many potential applications is to miniaturise the standard analytical tests currently preformed in chemical laboratories:
In the UK, the Good Law Project has begun legal proceedings against the Secretary of State for Health and Social Care, Sajid Javid, over the Immensa private laboratory testing scandal in Wolverhampton, in which 43,000 people were given false negative Covid test results:
According to a recent survey from Oracle Health Sciences, 97% of trial professionals say newly adopted approaches (hybrid and decentralised models) will stay in use as we move beyond COVID-19, giving patients more choice in how they participate in trials:
Wellcome Leap, a charity funded by the UK research funder Wellcome, has launched a three-year, US$60-million drive to help researchers develop standardized manufacturing of mRNA in the hope of jumpstarting an entire mRNA industry:
Alva market intelligence group has used the Sustainability Accounting Standards Board (SASB) framework to analyse 20 pharma companies from January 1 to April 30 2021 and produced The top 10 Environmental, Social and Governance (ESG) pharma companies in 2021. Boehringer Ingelheim scored highest:
Britain on 4 November became the first country in the world to approve a potentially game-changing COVID-19 antiviral pill jointly developed by US-based Merck & Co Inc and Ridgeback Biotherapeutics. The pill will be branded as Lagevrio in Britain and is designed to introduce errors into the genetic code of the coronavirus that causes COVID-19:
The inexpensive, generic antidepressant and obsessive-compulsive disorder treatment Fluvoxamine has been shown in clinical trials to significantly reduce the risk of severe illness and death from COVID-19 when prescribed early:
A free one hour online event is on offer from Outsourcing-Pharma on 17th November with a group of experts offering insights, advice, and examples of solutions that put patients at the centre of clinical trials, starting with trial design:
December 2021
Fujifilm Diosynth Biotechnologies, a world leading contract development and manufacturing organisation (CDMO) for biologics, viral vaccines and viral vectors, has confirmed a £400 million planned investment package at its UK facility in Billingham, Teesside:
GSK has announced that its antibody-based COVID-19 therapy with U.S. partner Vir Biotechnology is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies:
Prof Dame Sarah Gilbert, whose University of Oxford team developed the Covid vaccine, says “Just as we invest in armed forces and intelligence and diplomacy to defend against wars, we must invest in people, research, manufacturing and institutions to defend against [future] pandemics.”
Fifty subjects have been enrolled in Helixmith Co., Ltd.’s double-blind placebo controlled COVID-19 clinical trial in India involving 100 subjects. The investigational product is called TADIOS, a proprietary botanical treatment:
The rising importance of the patient’s voice: how closed patient groups and other vehicles for empowering patients can contribute to improved understanding of their needs by pharma companies at all stages of the development pathway – from initial research and development to clinical trials:
Increasing use of AI in the life science sector has implications for the demand for laboratory real estate, with pharma companies and CROs establishing contractual wet labs that operate autonomously:
Despite the future predictions of shrinking demand for actual laboratory space as AI makes incursions into life sciences, the US is currently seeing explosive demand for laboratory space, and Biotech job openings are growing at their fastest pace on record:
AstraZeneca has announced for the first time it will seek to make modest profit from sales of the Covid jab in order to fund the development of a new Covid-19 treatment. It will also supply the vaccine at cost to developing nations:
A biochemist and a pioneer in the development of mRNA technology - used in both the Pfizer and Moderna vaccines - Hungarian-born Dr Katalin Karikó is the recipient of the 2021 Professor Hawking Fellowship:
Leslie Galloway, chairman of the Ethical Medicines Industry Group (EMIG) and an Expert Advisor within NICE, presents a brief review of the UK life sciences sector in 2021 with a quick look forward to next year:
Finally, we wish all our customers and website visitors a very happy and safe Christmas and New Year.
