Company Updates
From Trainee to Trainer
We are excited to share a milestone in the journey of our Senior Associate Rosemary Ichaba, recently she joined our Co-Founder Dr. Andrew Waddell as a course tutor for the Research Quality Association (RQA) Auditing Course.
What makes this special is that for Rosemary the journey has come full circle. Back in 2021, she was a delegate undergoing the same training that she now delivers!
Vacancy: Senior or Principal Clinical Auditor
Are you a clinical auditor looking for a new role? We are looking for someone with experience in clinical trials, quality systems and audits to join our dynamic team.
We’re looking for someone who can:
- Deliver GCP training to all roles and experience levels in clinical trials from startups and biotech to investigators and CRAs in pharma.
- Support QMS development for our clients, from those just starting out who know and have nothing, to those looking to update, streamline or review their processes against the regulatory landscape.
- Conduct audits independently throughout Europe and potentially globally.
Please note: You should have the right to work in the UK and hold a full driving licence.
Interested in working for us?
Tower Mains Limited is proud of our reputation as a high-quality international provider of Quality Assurance and Clinical / Quality Management consultancy services, if you’re interested in working for us, please don’t hesitate to contact us in confidence at careers@towermains.com with a copy of your CV.
What can we offer you?
We offer ample opportunities for career growth and development, and offer full-time, part-time, and flexible contracts so that you can build your job around family and other commitments. Maintaining a healthy work-life balance is important to us, and taking time away from work for rest and relaxation is essential, and we encourage our team to make use of personal improvement time or ‘PIT’ days – in addition to their annual leave entitlement – to switch off and recharge. This equates to, on average, an additional day off each month.
Regulatory Updates
MHRA Updates
MHRA Pharmacovigilance Symposium 2024 On 12th February, the MHRA issued a new blog post regarding the one-day Pharmacovigilance Symposium taking place on 28th February 2024, topics covered will include insights on artificial intelligence, latest inspection metrics and upcoming regulatory changes. Registration is available on the GPvP Symposium website for in-person attendance in West London and virtual attendance.
Manufacturing and Wholesale Dealer Licences On 13th February, the Medicines and Healthcare products Regulatory Agency (MHRA) issued an updated list of sites granted a manufacturer or wholesale dealer licence.
FDA guidance updates
Advanced Manufacturing Technologies Designation Program On 12th February, the US Food & Drug Administration (FDA) issued draft guidance related to recommendations to individuals and organisations interested in participating in the FDA’s Advanced Manufacturing Technologies (AMT) Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT, the eligibility criteria for AMT designation, the submission and assessment process.
Use of Data Monitoring Committees in Clinical Trials On 13th February, the FDA published draft guidance concerning data monitoring in clinical trials. The guidance includes recommendations to help sponsors of clinical trials determine when a data monitoring committee (DMC), a data and safety monitoring committee (DSMC) or an independent data monitoring committee (IDMC)) would be useful for trial monitoring and what procedures should be implemented to set up their operation. Comments on the draft guidance can be submitted online until the 15th of April.
Charging for Investigational Drugs Under an IND: Questions and Answers On 14th February, the FDA issued final guidance specifying circumstances when sponsors can charge for an investigational drug in a clinical trial or for expanded access use. The regulation under 21 CFR 312.8 allows sponsors in certain circumstances, to charge patients for investigational drugs under an investigational new drug application (IND) or for receiving expanded access treatment. The guidance, which is in a question-and-answer format, is aimed at industry, researchers, physicians, institutional review boards and patients.
WHO Issues 10th Edition of Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials
The World Health Organisation (WHO) has issued the new edition of the Good Manufacturing Practices (GMP) Compendium for Medical Products. This publication provides guidance on the manufacturing and quality control of pharmaceuticals, vaccines and other biologicals, and other medical products to ensure their quality, safety, and efficacy.
The new edition includes forty-five (45) guidelines covering topics related to GMP and the inspection of pharmaceutical manufacturers and distribution channels.
Meeting Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024
On 9th February, the European Medicines Agency (EMA) issued an alert reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) which is used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. There is a risk of severe adverse reactions when used in combination with certain immunosuppressants that have a narrow safe dosage range (calcineurin inhibitors and mTOR inhibitors) which reduce the activity of the immune system.
They are used for treating certain autoimmune disorders or for preventing the body from rejecting transplanted organs.
Industry Updates
FDA Approval for Once-snubbed Takeda’s Eohilia
On 12th February, Takeda announced that the FDA approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). Eohilia, an oral suspension formulation of the corticosteroid budesonide, has surprisingly won over the FDA even after the drug’s developer, Takeda, had at one point abandoned the program following FDA rejection.
Vertex’s CRISPR Drug Casgevy™ Picks up Conditional Approval in Europe
On 13th February, Vertex Pharmaceuticals announced that the European Commission (EC) granted conditional marketing authorization to Casgevy™, a CRISPR/Cas9 gene-edited therapy. Casgevy™ is approved for the treatment of patients who are 12 years of age and older with severe sickle cell disease characterized by recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia, for whom hematopoietic stem cell transplantation is appropriate and a human leukocyte antigen matched related donor is not available. Between the two indications, about 8,000 patients in Europe could be eligible for treatment, the company estimates.
Phesi’s AI-driven Trial Reached Critical Milestone
On 13th February, Phesi, a provider of patient-centric data analytics, announced that its artificial intelligence (AI)-driven Trial Accelerator™ Platform has reached a critical milestone of now containing global data from more than 100 million patients. The volume will allow sponsors to access data on patients with over 4000 indications, plan more successful trials and simulate clinical development activity more accurately.
Thermo Fisher Launches New Ion Chromatography Instrument to Improve Reliability, Efficiency and Functional Adaptability for Labs
On 14th February, Thermo Fisher Scientific launched the Thermo Scientific™ Dionex™ Inuvion™ Ion Chromatography (IC) system, helping to make ion analysis simpler and more intuitive for laboratories of all sizes. The new analytical instrument is designed to be easily reconfigurable, providing those who require the determination of ionic and small polar compounds with a one-stop for consistent, reliable ion analysis.
Osivax Announces Vaccination of First Participant in Phase I Trial Evaluating Sarbecovirus Vaccine Candidate
On 15th February, Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, announced vaccination of first subject in First-in-Human trial evaluating Sarbecovirus vaccine candidate OVX033.
The single-center trial is a randomised, double-blind, placebo-controlled Phase I clinical study evaluating the safety and immunogenicity of OVX033 at three dose levels (100 µg, 250 µg, and 500 µg). One single dose of OVX033 vaccine or of placebo will be administered intramuscularly in 48 healthy subjects aged 18-49 years.
Issue Number: WN00149
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