Following a rigorous selection process Aptus Clinical have been appointed as a supplier for Clinical Services by the Cell and Gene Therapy Catapult (CGTC) supporting their in-house Clinical Development team. Aptus Clinical’s role will be to ensure high quality and timely delivery of regulatory clinical trials for the CGTC’s collaborators, primarily through the provision of dedicated site set-up and monitoring of investigational sites within the UK, which will ultimately deliver clinically meaningful benefit to patients through the successful registration of their advanced therapies in the UK and Europe. Aptus has a proven track record of working collaboratively and leveraging their scientific and technical experience in clinical operations to provide innovative solutions, which have successfully optimised the set-up, conduct and reporting of studies. Applying this approach to future work with the CGTC they will contribute to the successful delivery of their Advanced Therapy studies. This collaboration will be led by Dr Ian Thomas, Clinical Development Director at Aptus Clinical. In pursuit of further opportunity to develop partnerships with new clients interested in exploring the benefits of developing advanced therapies in the UK, Aptus CEO, Dr Steve McConchie, will be attending the forthcoming Cell and Gene Meeting on the Mesa from October 3rd to the 5th in La Jolla, California. This conference brings together senior executives and top decision-makers in the industry with the scientific community, to advance cutting-edge research into cures. It attracts one of the biggest audiences in the global Cell and Gene Therapy arena. This follows hot on the heels of the Phacilitate Leaders Europe, Advanced Therapies conference held in London during September where Dr Thomas’ well received presentation on the UK Advanced Therapy Treatment Centres was made during the “Collaboration strategies: constructing a successful partnership with European clinical centres of excellence” workshop, chaired by Dr Jacqueline Barry, Chief Clinical Officer, CGTC. Aptus Clinical CEO Steve McConchie said, “We are delighted to be broadening our collaboration with CGTC which builds on our existing participation in the recently announced Innovate Manchester Advanced Treatment Centre Hub (iMATCH) part of the IUK funded Advanced Therapy Treatment Centre Network. We look forward to collaborating with our colleagues in the CGTC, academia and the NHS to support development and delivery of advanced therapy studies in the UK and beyond.” About Aptus Clinical: Aptus Clinical Limited is a clinical contract research organisation that specialises in the design, conduct and delivery of early phase clinical studies with a focus in oncology, rare diseases and cell & gene therapies. Projects are delivered by a team of highly experienced drug development experts utilising their extensive network of academic links. Aptus aims to partner with clients to help them transform their promising assets into valued medicines. www.aptusclinical.com @aptusclinical About the CGTC: The Cell and Gene Therapy Catapult was established as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With over 180 experts focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. The Cell and Gene Therapy Catapult works with Innovate UK. For more information please visit ct.catapult.org.uk or visit http://www.gov.uk/innovate-uk
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
The State of the Opioid Epidemic
March 26th 2024In part 1 of this video interview, Greg Sturmer, co-founder and CEO of Elysium Therapeutics discusses the current state of opioid usage including how pain treatment is often mismanaged and how the industry can adopt greater safety standards in developing pain therapies.