February 2020
A study on the disclosure of the results of clinical trials found that a majority did not meet the publication deadline, with non-industry most likely to fail to publish:
Leveraging Eurofins’ pharmacology, in-vitro models and ADME capabilities, PharmaResources aims to accelerate drug discovery for its clients in small molecule drug R&D:
SCORR Marketing, a global health science communications firm, has released a life sciences industry salary and employee satisfaction survey report:
The UK is experiencing a boom in the number of cell and gene therapy clinical trials:
Acquisition of Clindata’s human health biometrics division is expected to increase Synteract’s geographical footprint along with the adaptability of its biometrics services solutions.
March 2020
DIA Direct’s first Coronavirus webinar in a new series is COVID-19: Experts from China Speak on Conducting Clinical Trials During the Pandemic. It will be a live, interactive session on Thursday, March 26, 8:30 AM ET / 12:30 pm GMT. Details & booking here: http://engage.diaglobal.org/20220-COVID-19-Webinar.html
April 2020
Our response to the COVID-19 pandemic has been to ensure all our staff in the UK, USA and India are equipped for home-working and are fully aware of the need to comply with all their national government restrictions on social distancing, travel etc. We foresee no interruption to services and ask our customers to continue logging support requests via our Customer Login.
The World Health Organization (WHO) has published interim guidance to laboratories and stakeholders involved in COVID-19 virus laboratory testing of patients. It is based in part on the interim guidance on laboratory testing for Middle East respiratory syndrome (MERS) coronavirus. Download available: https://apps.who.int/iris/handle/10665/331501
Due to the COVID-19 pandemic, many of our industry’s exhibitions and conferences have been cancelled or postponed. Our Events list has been updated and we will continue to post any changes on this list as they are announced.
In response to the COVID-19 pandemic, Eli Lilly and Company has delayed most new study starts and paused enrollment in most ongoing studies. However, it is continuing ongoing clinical trials for patients who are already enrolled: https://investor.lilly.com/news-releases/news-release-details/lilly-provides-update-clinical-trial-activities-during-covid-19
May 2020
The Health & Safety Executive (HSE) has issued comprehensive guidance to employers about working with COVID-19:
The HSE and the Police are considering prosecution of employers who have failed to provide proper protection for key workers, including corporate manslaughter prosecutions:
Researchers at Royal Melbourne Hospital in Australia have launched the AustralaSian Covid-19 trial (ASCOT) to assess the safety and effectiveness of lopinavir/ritonavir and hydroxychloroquine in hospitals:
The May 2020 updated COVID-19 pipeline report from VPA Research presents the most recent updates on drug candidates and vaccine candidates that will potentially reach the market in the next 2 years:
Leading Asia Pacific CRO Novotech is producing a series of free Whitepapers on how Australian and Asia-Pacific clinical trial companies are responding to the need for their vital work during the COVID-19 pandemic:
novotech-cro.comGlobalData is offering a free COVID-19 Executive Briefing report to explain the COVID-19 outbreak, its economic impact, and implications for specific sectors:
DIA Europe 2020 will take place on 29 June - 3 July in a Virtual Format:
The 5-day Excellence in Pharmacovigilance Training Course, organised jointly by the Medicines Evaluation Board and DIA, will continue as planned on 15-19 June, but in a Live Virtual format:
The World Health Organization (WHO) has issued multiple technical guidance documents on Laboratory testing for 2019-nCoV in humans: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance
America’s Centers for Disease Control and Prevention (CDC) have produced a comprehensive Q&A on COVID-19 Testing and Reporting by Laboratories: https://www.cdc.gov/coronavirus/2019-ncov/lab/testing-laboratories.html
Cambridge University has established a new laboratory to help meet the UK government’s 100,000-a-day target. The facility at the Anne McLaren Lab is the result of a collaborative effort between Cambridge University, AstraZeneca and GlaxoSmithKline: https://thetab.com/uk/cambridge/2020/04/08/cambridge-university-opens-new-laboratory-in-attempt-to-meet-uks-ambitious-covid-19-testing-goals-135317
AstraZeneca and Oxford University are partnering to scale a coronavirus vaccine that has already entered Phase 1 trials: https://www.biopharma-reporter.com/Article/2020/04/30/AZ-and-Oxford-University-partner-on-COVID-19-vaccine?utm_source=newsletter_daily&utm_medium=email&utm_campaign=30-Apr-2020
Clinical supply chain and logistics company Marken evaluate how COVID-19 is shaking up the clinical trial supply chain: https://www.outsourcing-pharma.com/Article/2020/04/02/COVID-19-disrupts-clinical-trial-supply-chain?utm_source=newsletter_daily&utm_medium=email&utm_campaign=21-Apr-2020
Arena International Events Group is running a Virtual Experience "Outsourcing in Clinical Trials 2020" at 10 a.m. BST on 27th May. Registration and Agenda here: https://arena-international.com/octvirtual/ plus download "Outsourcing in Clinical Trials Handbook 2020" on the same link.
Transperfect Lifesciences’ three Clinical Trials and COVID-19 Webinars, held in April, are now available to watch online. Part 1: Clinical Trials and COVID-19: Situation now, its challenges, and the future; Part 2: Converting to Remote Trial Management – How to Get Started; and Part 3: Adapting to Rapid Change: https://lifesciences.transperfect.com/webinar?utm_term=View%20more%20webinars&utm_campaign=Webinar%20Series%20-%20Part%201%3A%20Clinical%20Trials%20and%20COVID-19&utm_content=landing+page&utm_source=Act-On+Software&utm_medium=landing+page
Covid-19 makes the future of UK clinical research uncertain: https://www.bmj.com/content/369/bmj.m1619?utm_source=twitter&utm_medium=social&utm_term=hootsuite&utm_content=sme&utm_campaign=usage
June 2020
The UK government’s Department for Business, Energy and Industrial Strategy has published a guide to help England-based laboratory and research facilities understand how to work safely during the coronavirus pandemic:
REGISTER VERY SOON for InformaConnect’s free-to-attend Clinical Trials Digital Week from 1-4 June. This global series of live educational webcasts and downloadable resources provides the latest insights for operational challenges and responding to a pandemic, partnerships, outsourcing and operations, technology in clinical trials, and clinical innovation:
“Lessons from the crucible of crisis”, a timely article from Marcia McNutt, president of the U.S. National Academy of Sciences in Washington, DC, USA:
Clinical trials of the Russian-made coronavirus drug favipiravir enter final stage. It is being tested by Russian pharmaceutical investment firm ChemRar with the support of the Russian Direct Investment Fund (RDIF):
According to a report from Reportlinker.com, the global Clinical Laboratory Services market is projected to grow by US$39.9 Billion by 2025, driven by a compounded growth of 5.3%. Hospital-based Laboratories have the potential to grow at over 5%:
Britain should consider deliberately infecting volunteers involved in vaccine-testing projects, which is in line with World Health Organization proposals to set up such human challenge trials. Earlier this month, the WHO issued a 19-page set of guidelines on how these trials might operate:
July 2020
The clinical trial site network company LMC Manna Research shares insights gained from a survey of clinical trial participants’ COVID-19 views that could shed light on ways to improve recruitment and retention: outsourcing-pharma.com
Drug development firm Covance has introduced COVID-19 Clinical Trial Connect, a site designed to help potential patients match with research studies: outsourcing-pharma.com
A study of the contract research organisation field by Life Science Strategy Group (LSSG) offers a glimpse into how the virus has affected firms, and what the future might hold: outsourcing-pharma.com
As of 22 June, there were over 140 Covid-19 vaccines in various stages of development and, of these, 13 are now in human clinical trials: technologynetworks.com
Preliminary data from BioNTech and Pfizer’s Covid-19 vaccine trial show ‘significantly elevated’ antibodies among US clinical study participants: ft.com
In Cambridge, UK, Chesterford Research Park-based biotech company NodThera has raised £44m to develop a new class of medicines to fight inflammatory diseases: cambridgeindependent.co.uk
The Scottish Government has issued guidance for laboratories and research facilities, including those on university campuses, on safer working during the coronavirus pandemic. It came into effect on 29 June 2020 and extends until further notice: gov.scot
Private and government laboratories in Puna, Maharashtra, India could face action for slow reporting of COVID-19 test results that have led to a delay in contact-tracing and treatment: indiatimes.com
The DIA Medical Information and Communications Conference will be held entirely virtually from 12:50 PM on 3 Nov 2020 to 7:00 PM on 5 Nov 2020. They are calling now for posters and presentation abstracts, and registration is open: diaglobal.org
August 2020
After the end of the Brexit transition period, EU rules on clinical trials will no longer, by default, apply to the UK. This article from law firm Mishcon de Reya LLP analyses the effect of Brexit on the life sciences industry, not least the changes that will occur to the conduct of clinical trials both in the EU and UK: mishcon.com/news/clinical-trials-after-the-end-of-the-brexit-transition-period. USA registration will also be affected: fda.gov/about-fda/office-global-operations/europe-office
The Global Analytical Laboratory Services Market is expected to grow from USD 652.14 Million in 2019 to USD 1,281.00 Million by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 11.90%:
Globally, clinical trials have rebounded after the COVID-19 crash, but - asks Eli Cahan, an intern on the News staff of the journal Science - can enrollment gains continue?
The UK government is streaming an additional £100 million into ensuring that any COVID-19 vaccine making it to the finish line can be produced at scale in the UK. The investment will fund a state-of-the-art Cell and Gene Therapy Catapult Manufacturing Innovation Centre in Braintree, Essex:
Entries are invited for the 2020 Clinical Trials Arena Excellence Awards, celebrating and recognising the achievements of the individuals and companies in clinical trials. Entries are free and the deadline for submissions is Friday 4 September 2020. Winners will be announced on Thursday 3 December 2020:
Testing the quality of vaccines by using laboratory animals has to change, according to researchers from Leiden University and the vaccinological institute Intravacc:
Scientific testing on animals has fallen to its lowest level in England, Scotland and Wales since 2007, Home Office official figures show. 3.4 million scientific testing procedures were carried out on live animals in Britain in 2019r, a fall of 3% from 2018:
annual-statistics-scientific-procedures-living-animals-2019.pdf
In the United States the Department of Energy’s (DOE) 17 national laboratories are mobilising on a national scale to combat the COVID-19 pandemic, launching the National Virtual Biotechnology Laboratory (NVBL): newswise.com
The University of Pennsylvania Perelman School of Medicine is running two clinical trials to test infusing blood plasma from recovered/convalescent patients into sick patients as a treatment for COVID-19, and will - unusually - include pregnant women:
Novartis has launched a not-for-profit portfolio of COVID-19 treatments. The company’s Sandoz division is offering 15 generic and OTC medicines to be sold at zero profit to low-and middle-income countries to treat the virus until a vaccine or curative treatment is available:
September 2020
The COVID-19 pandemic has disrupted thousands of clinical trials worldwide. At the same time, the pandemic has seen an unprecedented reorientation in clinical trials research towards COVID-19. Both of those aspects ensure that the effects of the COVID-19 pandemic will be felt in clinical trials research long after the initial effects have faded:
The biggest supply chain challenge is how to vaccinate the entire world safely, efficiently and fairly. How do we get from formulating, to planning, to manufacturing and finally distributing billions of doses of vaccine:
New PowerPoint report ‹Coronavirus Disease 2019 (COVID-19) Pandemic Impact on Clinical Trials› and the challenges arising from the move toward decentralized clinical trials:
On 27th August, Russia became the first country to register a COVID-19 vaccine, but without publishing clinical data that would prove the vaccine's efficacy. Scientists see downsides to this vaccine, and to other COVID-19 vaccines from China:
So far in the COVID-19 pandemic, surveillance systems are not monitoring ill health and long-term implications of COVID-19, only deaths are reported. Most are also not tracking all cases, only positive tests are counted:
More than 150 coronavirus vaccines are in development. Here are the vaccine prospects that have made it to phase three trials and beyond:
The ‹AI-based Clinical Trial Solution Providers Market, 2020-2030› report studies companies offering AI-based platforms for clinical trial applications, the current market landscape and their future potential:
Now online from DIA, an on-Demand Training Course to learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy:
American Gene Technologies has received the FDA’s approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC.
Events organiser Arena International is hosting the ‹Outsourcing in Clinical Trials USA – Virtual Conference› on 30th September - 1st October. Complimentary passes are available for Pharma, Biotech and Medical Devices Companies. For non-biotech, vendor, CRO and service providers the fee is $600 per pass:
arena-international.com/octusavirtual
News on the impact of Brexit on the healthcare sector has taken a back seat to the COVID pandemic. However, preparations still need to be made for post-Brexit regulations. The Medicines & Healthcare Products Regulatory Agency (MHRA) website on gov.uk lists documents chronologically, making it extremely hard to search. We suggest taking a look at the TOPRA site, the membership organisation for individuals working in healthcare regulatory affairs. It has guidance, some available for non-members, on areas such as clinical trials, GLP, and medicine safety:
October 2020
Novartis CEO Vas Narasimhan says a vaccine will not magically save us from COVID-19, but that we will learn to live with it by using a combination of vaccines, therapeutics, and other technologies:
The global pharmaceutical industry is expected to witness positive growth as the top pharma companies are at the forefront of the fight against COVID-19. Here are the top ten pharmaceutical companies in 2020 by revenue:
www.pharmaceutical-technology.com
172 economies are now engaged in discussions to potentially participate in COVID-19 Vaccines Global Access Facility, or COVAX, a global initiative aimed at working with vaccine manufacturers to provide countries worldwide equitable access to safe and effective vaccines, once they are licensed and approved:
According to a report from GlobalData, more than 100 COVID-19 vaccines are in preclinical testing and 23 companies have moved their candidates into clinical trials. There are, broadly, eight different vaccine technologies: mRNA, DNA plasmid, protein subunit, adenovirus-vectored, measles-vectored, vesicular stomatitis virus-vectored, adenovirus associated-vectored and inactivated virus vaccines:
Healthcare software provider eResearchTechnology has been the subject of a ransomware attack, with IQVIA (a research firm managing AstraZeneca’s COVID-19 vaccine work) and Bristol Myers Squibb (the leader of an alliance developing a fast COVID-19 test) being two of the largest targets:
The 2020 Outsourcing in Clinical Trials USA event will be held virtually on 30th September & 1st October, bringing together experts from across the USA to discuss the latest innovations and providing network opportunities with 2,000 delegates, all senior members of the Clinical Trial industry:
Registration is open for DIA Europe 2021, Europe's largest healthcare conference which will take place in Basel 17th - 19th March 2021. Register before 22 October to benefit from Early Bird Rates:
A new report from Roots Analysis, ‹AI-based Clinical Trial Solution Providers Market, 2020-2030›, features an extensive study of the companies offering AI-based platforms for clinical trial applications, in addition to the current market landscape and their future potential:
When will COVID-19 vaccine be ready in the UK? Latest updates from around the world:
A comprehensive study by the Center for Cancer and Aging at City of Hope, a world-renowned independent research and treatment centre for cancer, diabetes and other life-threatening diseases based in Duarte, California, has led to strategies to address barriers keeping older adults out of clinical trials:
November 2020
The World Health Organization (WHO) and the Wikimedia Foundation, the non-profit that administers Wikipedia, have announced a collaboration to expand the public’s access to the latest and most reliable information about COVID-19:
From Johnson & Johnson to Shanghai Pharmaceuticals, Pharmaceutical Technology lists the top ten global pharmaceutical companies in 2020, based on revenues:
Scientists offering to help the UK Government scale up coronavirus testing were snubbed by Health Secretary Matt Hancock after he apparently mistook the professional body representing almost 20,000 lab workers for a private firm:
A look inside the 40,300 sq. ft. Bio-Innovation Centre, the first bio-incubator on the Cambridge Science Park:
www.cambridgeindependent.co.uk
The Business Research Company has released its report on the Analytical Laboratory Instruments Global Market Opportunities and Strategies to 2030:
A new visualisation created by graphics journalist Mariano Zafra shows how COVID-19 can spread through a room where someone has the virus:
The U.S. Food and Drug Administration (FDA) has alerted clinical laboratory staff and health care providers that false positive results can occur with antigen tests for the rapid detection of SARS-CoV-2:
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has initiated the accelerated rolling review of AstraZeneca’s potential vaccine to treat COVID-19 which is being developed in collaboration with the University of Oxford:
www.pharmaceutical-technology.com
The 5th edition of Arena International’s Clinical Trial Supply Handbook 2020 is now available. This is a valuable reference guide for clinical trial supply chain professionals across the globe:
The Health Industry Distributors Association (HIDA) has released its 2020 Laboratory Market Report, which reviews the current landscape of U.S. clinical diagnostics and provides data on the biggest trends shaping laboratory testing:
December 2020
IBM has uncovered a global phishing campaign targeting the COVID-19 vaccine cold chain. Attacks seem focused on companies and organisations associated with Gavi, the Vaccine Alliance’s Cold Chain Equipment Optimization Platform:
The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has granted a temporary authorisation for emergency use to Pfizer and its German partner BioNTech’s mRNA vaccine, BNT162b2, for Covid-19:
UK GPs will be prioritised for Covid vaccination based on their personal risk level, exposure and amount of contact with vulnerable people, says the UK Joint Committee on Vaccination and Immunisation:
The Institute of Biomedical Science (IBMS), with members in 73 countries, rightly recognises the key contribution laboratory staff have made, and will continue to make, in tackling COVID-19 while maintaining high-quality healthcare services:
Moderna has announced that the primary efficacy analysis data from the Phase III COVE study of mRNA-1273 indicated 100% vaccine efficacy against severe Covid-19:
A new report, "Phase I Study Trends and Market Outlook (2020-2024)" is designed to provide readers with a high-level view of the Phase I clinical development space to illustrate current market dynamics and inform strategic planning:
Queensland, Australia, has emerged as “the Hollywood of the global clinical trial industry.” Now there is a new online portal that links global organisations wanting to conduct clinical trials with research groups, public and private health care providers, universities, and manufacturers across the state:
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a guidance document on managing access to electronic personal health data processed during clinical trials. The document is specifically aimed at sponsors, contract research organisations (CROs) and investigator sites:
uk.practicallaw.thomsonreuters.com
The latest announcements from the U.S. Food and Drug Administration on actions taken in its ongoing response effort to the COVID-19 pandemic:
José Baselga, executive vice president, oncology research and development at AstraZeneca, says Covid-19 could accelerate cancer clinical trials
Increasing prevalence of chronic diseases and infections will drive the clinical laboratory service market according to new research by Transparency Market Research:
Research technology company uMed has raised £3.7m in venture capital to help healthcare providers in the UK and US, including GPs, hospitals and health specialists, run patient research more efficiently and safely.
