article thumbnail

Increasing patient engagement with UK clinical trials

pharmaphorum

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Having worked for CROs since graduating, Sophie joined Pfizer in 2011 and has had various roles within the UK and now global groups.

article thumbnail

Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

11 have recently conducted an analysis of international HTA submissions from 2011-2019 to determine the acceptability of single arm clinical studies and ECs as part of the drug reimbursement process. 2011 May; 46(3): 399–424. Patel et al. FDA presentation. Available at: [link]. Multivariate Behav Res. doi: 1080/00273171.2011.568786.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Sharing experiences to level the healthcare playing field

pharmaphorum

In 2011, Alfred was a fit and healthy 54-year-old providing security for music’s A-listers on global tours. He also sits on a patient consultation panel for pharmaceutical company Parexel. I think pharmaceutical companies are cottoning on to that now, but there’s still a lot of mistrust.

article thumbnail

The role of outsourcing in antibody drug manufacture

European Pharmaceutical Review

A study investigating the trend for existing pharmaceutical companies to outsource to contracted development and manufacturing organisations (CDMOs), analysing the position of companies manufacturing monoclonal antibody drugs (mAbs). Yoshiura et al. Yoshiura et al.

article thumbnail

Amendments Set to Clear Ambiguity

Pharmaceutical Technology

Pharmaceutical companies dealing with the US will be closely watching the debate surrounding a proposed revision by the Senate which could see the watering down of some requirements, and an increase in others, under its Physician Payments Sunshine Act (S.2029). Over the years, the company has had time to oversee these changes.

article thumbnail

The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

There was bipartisan support for the program at the hearing and support for measures such as requiring pharmaceutical companies to publish their prices in a password protected site on HRSA's website. Also, in 2011, the U.S. 2006: Congress passed, and President George W.

article thumbnail

Advanced Therapy and Advanced Manufacturing for Unmet Medical Needs

ISPE

1 Peter Densen, “Challenges and Opportunities Facing Medical Education,” Transactions of the American Clinical and Climatological Association, 2011, [link] 2 Unclassified DELSA/HEA/WD/HWP(2017)5. Accessed September 7, 2023. Advanced Technology to deliver medicines faster, cheaper, and with enhanced quality. The combination of the two above.