Stuart Bell, Author at Inceptua Group

Is there a role for Ethics Committees in Pre-approval Access?

Stuart Bell, Vice President, Consulting, Inceptua Medicines Access In discussions with our clients over recent months the topic of ethics committee involvement in pre-approval access programs (expanded access, compassionate use,…

Stuart BellJanuary 14, 2021

Medicines Access

Inceptua Q&A: What is Pre-Approval Access?

Typically, there are three ways in which patients can get access to a medicine; through a clinical trial, when it is commercially available, or via a pre-approval / unlicensed medicines…

Stuart BellDecember 10, 2020

Featured Medicines Access

Pre-approval Access

Regulatory Update 2020 Stuart Bell, Vice President, Consulting, Inceptua Medicines Access The regulations governing pre-approval access (early access, expanded access, compassionate use, named patient supply etc.) are constantly being updated…

Stuart BellNovember 6, 2020

Featured Inceptua Pharma Update

Helping get orphan drugs to patients quicker

Across Europe there is disparity in the average time for new drugs to be approved and accessible to patients. There are a number of factors delaying these processes. Stuart Bell,…

Stuart BellOctober 7, 2020

Featured Medicines Access

Industry Trends in Pre-approval Access to Medicines

Expanded Access as a Key Component in the Development and Launch Process On February 20, 2020, Inceptua hosted a webinar on industry trends in pre-approval access to medicines. You…

Stuart BellMarch 3, 2020

Medicines Access White Paper

The 21st Century Cures Act: Turn your obligations into an advantage

The 21st Century Cures Act (21CCA), which came into effect in February 2017, is intended to help accelerate the development of medicines and bring those medicines to patients more quickly.…

Stuart BellOctober 29, 2019

Update

Pre-Approval Access Policy

Policies on pre-approval access (‘early access’, ‘expanded access’ etc.) have come into focus since the enactment of the US 21st Century Cures Act. Driven by the requirements of the Act,…

Stuart BellAugust 17, 2019

Update

Small Data for a Big Benefit

Underlining the tendency, a poll in one of the DIA sessions revealed that 30% of the industry delegates attending the meeting believe that RWD may actually be more relevant than…

Stuart BellJune 28, 2019

Update

Pre-Approval Access – the Theory and the Practicality

With the raised profile of pre-approval access (thanks in part to Right-to-Try and the 21st Century Cures Act) there has been a noticeable increase in the number of companies and…

Stuart BellSeptember 26, 2018

Update

Time for clarity on RWD in Early Access Programs

The US is the most straight forward of all countries for collecting data within an Early Access Program (EAP), due to clear guidelines, requirement for a protocol and site contracting.…

Stuart BellMay 1, 2018