Tower Mains Weekly Newsletter
Company Updates
New Course: Conducting Laboratory Investigations. When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our new ‘Conducting Laboratory Investigations’ course is designed to equip you with the skills and knowledge to conduct a successful investigation. Our next open course date is the 22nd of November 2023 or if you are interested in this training for your organisation at a time of your choosing, please get in touch at training@towermains.com. For further information, click here.
2023 RQA Conference. Delighted to share that we will be attending the 2023 Research Quality Association (RQA) Conference in Belfast, where our Head of Quality Assurance, Shona Ross will also be speaking. Details below:
- Day One, Wednesday 1st November
11am: Exploring the depths of quality – regulator updates and Q&A
Join Shona alongside Chrissy Cochran, FDA, an MHRA representative and other regulators in this update and delegate Q&A session. - Day Two, Thursday 2nd November
1.30pm: Communication of an auditor
While technical expertise and knowledge of the regulatory requirements are essential for auditors, effectively communicating with management and auditees to effect change and improvements is key. Join Shona and the GLP Committee in this interactive workshop to look at developing these skills.
If you’re attending, come visit us at booth 10! Andrew, Shona, Rhona and Lianne will be there to say hi!
Regulatory Updates
Global regulators publish five guiding principles for machine learning-enabled medical devices
On 24th October, the MHRA, FDA and Health Canada announced the publication of five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs aim to remove the regulatory burden for developers of machine-learning-enabled medical devices (MLMDs), enabling the reallocation of resources to improve product performance for patients. Whilst these guiding principles will support PCCP development across the UK, US and Canada, each regulator will have specific national guidance that manufacturers must follow.
MHRA guidance updates
- MHRA phase I accreditation scheme. On 25th October, the Medicines and Healthcare products Regulatory Agency (MHRA) added a list of accredited units to its guidance on joining the phase I accreditation scheme. Click to view source
- Software and Artificial Intelligence (AI) as a Medical Device. On 25th October, the MHRA, US Food and Drug Administration (FDA) and Health Canada’s five guiding principles for the use of PCCPs were added to the guidance on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD). Click to view source
FDA announces 2024 animal drug user fee rates
On 20th October, the FDA announced the 2024 fee rates and payment procedures for animal drugs subject to user fees under the Animal Drug and Animal Generic Drug User Fee Amendments of 2023.
FDA guidance updates
- Topical Dermatologic Corticosteroids: In Vivo Bioequivalence. On 24th October, the FDA published draft guidance intended to assist applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroid products of all potency groups hereinafter referred to as topical corticosteroids. This guidance describes recommendations for in vivo studies to demonstrate the bioequivalence of topical corticosteroids. Click to view source
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Q&A. On 24th October, draft guidance was published, which when finalised, will provide the FDA’s current thinking on common questions regarding certain communications by firms to health care providers (HCPs) of scientific information on unapproved use(s) (SIUU) of approved/cleared medical products. Click to view source
- Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities. On 26th October, draft guidance to describe how we request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities covered under the FDA’s bioresearch monitoring (BIMO) program. Click to view source
Industry Updates
MHRA authorises bispecific antibody therapy as a treatment for diffuse large B-cell lymphoma in adults
On 20th October, the MHRA has today authorised a new medicine called Tepkinly, a treatment for diffuse large B-cell lymphoma in adults. The active ingredient in this treatment, epcoritamab, is a bispecific antibody, which is designed to recognise and attach to a specific target substance in the body, helping a patient’s immune system fight cancer.
FDA expands paediatric indication for entrectinib to include patients from one month
On 20th October, the FDA granted accelerated approval to entrectinib for paediatric patients older than one month with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory standard therapy.
John Hopkins study supports potential for malaria vaccine using atovaquone
On 20th October, it was announced that a study led by researchers from the Johns Hopkins Malaria Research Institute, the Johns Hopkins University School of Medicine, and the University of Liverpool, has provided evidence supporting the potential of an injectable chemical vaccine for malaria. The researchers found that the same genetic mutation that renders malaria parasites resistant to atovaquone in patients also destroys the parasite’s ability to live within mosquito hosts—meaning atovaquone-resistant malaria parasites would not be transmissible. The researchers concluded that atovaquone, despite concerns over resistance, holds promise as a long-acting, injectable “chemical vaccine” that could prevent infection in malaria-endemic areas.
Nanoform grant Global STARMAP® AI License to AstraZeneca
On 23rd October, Nanoform, an innovative nanoparticle medicine-enabling company, announced that it has granted AstraZeneca Plc a global online STARMAP® license. STARMAP® is a digital AI version of the CESS® technology that enables in-silico experiments to determine which molecules should be nanoformed. This comes after several years of early-stage collaboration between Nanoform and AstraZeneca and a successful technology evaluation partnership including STARMAP® which has resulted in clinical candidate feasibility studies.
FDA approves new therapy for rare form of blood cancer called myelodysplastic syndromes
On 24th October, approved Tibsovo for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. This is the first targeted therapy approved for this indication. The agency also approved the Abbott RealTime IDH1 Assay as a companion diagnostic for the selection of R/R MDS patients with an IDH1 mutation.
EMA takes steps to address critical shortages of medicines
On 24th October, the European Medicines Agency published details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). Based on an informal setup during COVID-19, the voluntary mechanism will enable any Member State facing a critical shortage that has been escalated to the MSSG for coordination at European level to request assistance from other Member States in obtaining medicine stocks. This mechanism can only be used under very limited conditions and was developed as a last resort for Member States after they have exhausted all other possibilities.
Issue Number: WN00135
Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Just send an email to info@tower mains.com with the subject “Weekly Newsletter Please.”