Testimonials

Chief investigator

My team have been undertaking a portfolio of clinical trials (mechanistic studies through to phase 3) since 2005 that require significant regulatory IMP input. Since July 2021, this whole process has been much improved as a direct result of working with Yusuf. His knowledge, professionalism, support and dedication is exceptional and I would like to detail some of his input to our studies below.

He has provided regulatory strategies for our trials
He has led with interacting with IMP providers and organising importation and QC
He has supported out team with mechanistic studies
He has led on liaising between IMP providers and department governance

Principle investigator

Yusuf and I have not met in person but have on Zoom many times. He was involved at an early stage when we were asking Company A if they would fund the IMP for our COVID-19 study. Yusuf was exceptionally professional in setting up negotiations and contractual arrangements with Company A and the contracts team. He was also very proactive in discussions relating to drug supply logistics- of which there were many. This IMP is not kept in great supply at the hospital normally and there were concerns about depleting stocks for the standard of care patients. Yusuf also managed the managing pharmacy set up and IMP management at site pharmacy.

Research team

Yusuf has been consistently dedicated to his work. He is extremely knowledgeable and very effective in his role. His responsiveness is a real credit to him and makes a very reliable team member. He understands the importance and passion behind the work we do and it translates into his own work.

We have faced several challenges during the trial set-up and Yusuf has shown tremendous leadership in troubleshooting and navigating these issues.

It has been a pleasure to work with Yusuf and I look forward to future collaborations.

Clinical Trial Unit - QA and Regulatory Manager

Yusuf's work has been of a consistently high standard, he is proactive and has excellent communication skills. Yusuf has been an important asset to the Cancer Trials Centre, ensuring all trials involving investigational medicinal products meet current good manufacturing and distribution practice requirements. He has continually risen to challenges, and of particular note in the past Yusuf has:

Guided the trials unit on actions needed in relation to supplied IMPs in response to regulatory changes following Brexit
Support trials staff in identifying appropriate and proportionate actions regarding IMPs during COVID-19
Continued to deliver training to all trials staff on a variety of GMP areas
Taught on the MSc clinical trials course
Led the review and revision of SOPs and associated templated around IMP sourcing, labelling, recall and quality agreements.

He has supported the ATMP portolio of trials and his guidance has been paramount to the successful set up of ATMP studies

Clinical Trial Unit - Head of Operations

Yusuf’s role at our trials unit is to provide technical advice on the procurement, management and administration of Investigational Medicinal Products, including Advanced Therapies for use in our portfolio of trials. He is incredibly knowledgeable and ensures he remains up to date with the latest legislation and requirements. Yusuf has wide ranging previous experience in GMP manufacturing and hospital pharmacy, expertise that he brings to the varied requirements of the role. He is a driven individual, shown by his dedication to recent courses in ATMPs and Audit. He balances competing priorities well and has made time to ensure trials are well supported as needed. He uses a wide professional network, this has been invaluable in IMP procurement of less traditional products including recombinant proteins, viral vectors and other unlicensed medicines

Specifically, Yusuf has made a step-change in our management of our phase 1 trials where previously we were reliant on external advice. Yusuf has provided extensive review of the IMP Dossier (IMPD) using his technical knowledge of ICH, CMC and GMP requirements to ensure that all elements are covered and liaised with both the external regulatory consultants and the manufacturer to complete this. He had attended meetings with the MHRA and conducted follow up correspondence on behalf of our trials unit. He has a practical approach to challenges, recently working through a delay in timelines to find a pragmatic approach to IMP testing that was approved by the MHRA.

Yusuf has also been providing support on another phase 1 gene therapy study utilising adeno-associated virus and worked closely with the Translational Research Manager and CMC consultant in engineering solutions for complex issues including the recent challenge of the US manufacturer not meeting EU GMP requirements.