Clinical development challenges faced by advanced therapies for rare disease
Advanced therapies are a class of products based on genes, tissues or cells used to treat or deliver treatment to patients.
Advanced therapies for rare disease - a regulatory roadmap
Navigating advanced therapy development for rare diseases is challenging from many perspectives and requires a customised development strategy.
Diarmaid Cunningham, Chief Administrative Officer and General Counsel, reflects on the publication of ICON’s 2021 ESG report
ICON has published our 2021 ESG report, which shows the strong progress we have made against our ESG priorities and commitments.
Clinical trials through a child’s eyes: Writing lay summaries for paediatric trial results
Patient centricity and transparency are increasingly important topics in the area of clinical trials. How can sponsors create a PLS that is better understandable to paediatric audiences?
Using Bayesian-based, model-assisted designs to improve dose selection in early phase oncology trials
As oncology therapeutics and early phase design models evolve, sponsors will benefit from working with a partner experienced in innovative adaptive designs for phase 1 and 2 oncology trials.
Interviews with patients in clinical trials
Interviewing patients in clinical trials is a valid approach to understanding the patient perspective of a disease or treatment and provides context for interpreting quantitative clinical data.
Cell and Gene Therapy: Specific Market Authorisation Guidances
Therapeutic developers may benefit from working with a partner whose regulatory expertise with CGTs will help ensure that development programmes are optimal and compliant.
Why ICON is celebrating its first Inclusion Day
Inclusion Day is an opportunity for us to come together in ICON as an organisation to think about the choices we make to further inclusion and diversity.
Irritable Bowel Disease (IBD): A patient’s perspective
Finding appreciation in the experience and treatment of IBD as a life-changing condition.
My Clinical Research story – Jeslyne Margrette Isaac
ICON's Jeslyne Margrette Isaac shares their personal experience with clinical trials.
My Clinical Research story – Lisa Linn
ICON's Lisa Linn shares their personal experience with clinical trials.
My Clinical Research story – Jill Doherty
ICON's Jill Doherty shares their personal experience with clinical trials.
My Clinical Research story – Ellen Dalbo
ICON's Ellen Dalbo shares their personal experience with clinical trials.
How joint venture models can boost Japan’s pharmaceutical industry
Japan is the third-largest consumer of ethical drugs and the world’s third-largest economy; therefore, it is an important development centre for new medicines. However, there are various cultural and economic challenges in Japan that make it difficult to manage a fixed workforce against a variable portfolio of clinical research.
NICE guidance on real-world evidence to usher innovative treatments
NICE published new guidance to give patients early access to innovative treatments by allowing greater flexibility considering a broader evidence base, making it easier for innovative and promising treatments to reach the patient incorporating the usage of real-world evidence.
Sharing my Down syndrome story - Beverly Romero
Beverly Romero tells the story of her son Oliver.
Progressive IVDR rollout made official
In the fall of 2020, the European Commission issued a proposal to modify the implementation timeline for the new In Vitro Diagnostic Medical Devices Regulation (IVDR). Now, as of 15 December 2021, the European Parliament and the European Council have adopted this proposal, making the suggested progressive IVDR rollout timeline official.
Combatting AMR with new tools to diagnose and treat infectious disease
The employment of antimicrobials to fight previously devastating microbial diseases, such as tuberculosis, meningitis and pneumonia has been a transformative medical achievement.
Camaraderie and collaboration – what sets ICON apart
ICON was recently named one of the World’s Best Employers for 2021 by global media company Forbes. This recognition is solely the result of employees’ on-the-job experiences and firsthand feedback.
EC proposes extended transition period for IVDR compliance
The European Commission has issued a proposal for a modified rollout of the new In Vitro Diagnostic Regulation (IVDR).