Tower Mains Weekly Newsletter
Company Updates
? Attention clinical researchers and trial sponsors! ?
With the increased use of computerised systems in clinical trials, it is crucial that data integrity and patient safety are a top priority, and that the requirements for compliant data management are understood. Do you need assistance in assuring the integrity of data and compliance with regulatory guidelines? Are you confident that your vendors are meeting requirements?
Don’t leave it to chance – our experienced team are on hand to provide you with comprehensive support and expert advice, and we currently have availability in Q3 and Q4 for computerised system vendor audits.
For further information on how we can assist you, or if you have any questions, don’t hesitate to contact us at info@towermains.com.
Regulatory Updates
MHRA launches public consultation on ICH Good Clinical Practice Guideline
On 26th May, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a three-month public consultation on the Good Clinical Practice (GCP) guideline revised by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The consultation is seeking views on whether the resolutions set out in the ICH reflection and concept papers have been achieved, in addition to requesting detailed comments on the text. As the ICH Principles of GCP (in section II of the guidance) will form part of the revised UK legislation, the consultation will inform the UK Clinical Trials Regulations. The consultation closes at 11:59pm on the 31st August 2023.
MHRA Inspectorate Blog: ICH E6 (R3) Good Clinical Practice
On 26th May, the MHRA Inspectorate published a blog highlighting the changes to the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) guideline now that the updated version R3 has reached Step 2b and is available for public consultation.
FDA guidance updates
- Diabetes Mellitus: Efficacy endpoints for clinical trials investigating antidiabetic drugs and biological products. On 24th May, the US Food and Drug Administration (FDA) published draft guidance to help sponsors develop antidiabetic drugs for adults and children with type 1 diabetes mellitus (T1D) and/or type 2 diabetes mellitus (T2D). In this guidance, antidiabetic drugs refer to drugs intended to improve glycemic control, including drugs intended to reduce diabetes-related hyperglycemia and drugs intended to mitigate iatrogenic hypoglycemia associated with diabetes management. Click to view source
- Adjusting for Covariates in Randomised Clinical Trials for Drugs and Biological Products. On 25th May, the FDA published final guidance providing recommendations on non-clinical performance testing to support premarket submissions for gynecologic and general laparoscopic power morcellation containment systems and may also help manufacturers comply with the special controls related to non-clinical performance data for these devices. The recommendations are intended to promote consistency and facilitate efficient review of gynecologic and general laparoscopic power morcellation containment systems submissions. Click to view source
- Non-clinical performance assessment of tissue containment systems used during power morcellation procedures. On 26th May, the FDA published final guidance to describe current recommendations regarding adjusting for covariates in the statistical analysis of randomised clinical trials in drug development programs. The main focus of the guidance is on the use of prognostic baseline covariates to improve statistical efficiency for estimating and testing treatment effects. Click to view source
ICH M7(R2) Introductory Training Presentations now available on the ICH website
Following the ICH M7(R2) guideline on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” reaching Step 4 of the ICH Process in April 2023, a Step 4 Introductory Training Presentation has been developed by the M7(R2) Expert Working Group and is available on the website. In addition to this, a Step 4 Introductory Training Presentation has been developed by the group for the ICH M7(R2) Questions and Answers, which reached Step 4 of the ICH Process in May 2022.
Industry Updates
FDA announces FY2024 grant funding application period for animal drugs for minor uses and minor species
On 24th May, the FDA announced a new period for applications for grants to support the development and potential approval or conditional approval of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species (MUMS drugs).
Chancellor reveals life sciences growth package
On 25th May, the Chancellor of the Exchequer unveiled a £650 million package to fire up the UK’s life sciences sector. The ‘Life Sci for Growth’ package brings together 10 different policies including £121 million to improve commercial clinical trials to bring new medicines to patients faster, up to £48 million of new money for scientific innovation to prepare for any future health emergencies, £154 million to increase the capacity of the UK’s biological data bank further aiding scientific discoveries that help human health, and up to £250 million to incentivise pension schemes to invest in our most promising science and tech firms.
Centre for Genomic Regulation and Almirall collaborate to identify skin cancer treatments
On 25th May, Almirall, a biopharmaceutical company focused on medical dermatology, announced it has entered into a research partnership with the Centre for Genomic Regulation (CRG), an international biomedical research institute of excellence. The collaboration aims to develop novel preclinical models to identify new treatments for non-melanoma skin cancer (NMSC).
MHRA and Genomics launch genetic research resource
On 25th May, the MHRA announced it will pilot a new genetic research resource with Genomics England to better understand how a patient’s genetic makeup can impact the safety of their medicines. The ‘biobank’ will contain genetic data and patient samples and will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices. It forms part of a long-term vision for more personalised medicine approaches, as scientists will use the repository of genetic information in the biobank to determine whether a side effect from a medicine was caused by a specific genetic trait.
MHRA patient safety alert: Updated advice for the treatment of patients with a history of major cardiovascular disease
On 25th May, the MHRA issued updated advice for the treatment of patients with a history of major cardiovascular disease. The agency warned caution is required if prescribing febuxostat in patients with pre-existing major cardiovascular disease, particularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy.
MHRA Drug Safety Update
On 25th May, the MHRA published the May edition of the Drug Safety Update newsletter compiled by the agency and its independent advisor, the Commission on Human Medicines
First oral antiviral for the treatment of COVID-19 in adults approved in the US
On 25th May, the FDA approved the oral antiviral Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalisation or death. Paxlovid, manufactured and packaged under the emergency use authorisation (EUA) and distributed by the U.S. Department of Health and Human Services, will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by this approval.
Global AI challenge launched to investigate veterans’ cardiovascular health
On 25th May, the Veterans Cardiac Health and AI Model Predictions (V-CHAMPs) Challenge was launched by regulators and healthcare organisations in the UK and the US to better understand the cardiovascular risks and specific health outcomes in veterans. Using entirely synthetic datasets based on real US veteran health records, participants will explore a range of potential outcomes following heart failure, including the prediction of cardiovascular outcomes, hospital readmission rates and mortality.
New recognition routes to facilitate safe access to new medicines announced in the UK
On 26th May, the MHRA announced new recognition routes to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners. The new routes will be established using approvals from Australia, Canada, the EU, Japan, Switzerland, Singapore and the US, and will sit alongside the MHRA’s unique innovation pathway for medicines which integrates early regulatory advice with health technology assessment advice.
SKYCovion COVID-19 vaccine authorised by MHRA
On 26th May, the MHRA authorised SKYCovion, the COVID-19 vaccine developed by SK Chemicals. The vaccine combines a part of the SARS-CoV-2 virus spike protein with an ‘adjuvant’ – an additional ingredient designed to trigger a stronger immune response – and is given as two injections, four weeks apart.
Meeting highlights from the latest EMA CHMP
On 26th May, the European Medicines Agency (EMA) issued highlights from the Committee for Medicinal Products for Human Use (CHMP), held on the 22nd-25th May 2023.
Issue Number: WN00114
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