“Effectively Collect Real World Evidence for Early Access Programs”. We have asked Stuart a few questions to reflect on the topic …
We are experts in the strategy, design, and implementation
of global early access programs
When patients have a life threatening or debilitating illness, their physicians have exhausted current treatment options or there simply aren’t any treatment options available or they are unable to enter a clinical trial, mechanisms exist across the globe to enable access to (pre-approval access, managed access , compassionate use , expanded access ) to medicines where they are not approved in the country of intended use.
Healthcare professionals often seek to access these medicines for their patients, and biopharmaceutical companies developing innovative medicines are increasingly making these medicines available to patients through early access programs.
Successful Early Access Programs Depend on Detailed Strategic Planning
Early Access is not a ‘box-shifting’ exercise – it is a complex route of medicine provision which dovetails between your clinical development and commercial launch.
In addition to our collective experience in over 200 early access programs, Inceptua pioneered the pre-program consulting services such as global strategy development and Early Access Feasibility Assessments.
These services, and our extensive in-house pharma commercial experience, mean that Inceptua has the breadth of knowledge and detailed operational experience to devise the most appropriate early access strategy for your asset, ensuring your
Broad-Spectrum Early Access Data
Inceptua can support your Early Access data requirements, whatever they might be. Inceptua Early Access can manage all aspects of your data collection, whether it is detailed outcomes data (collecting real-world evidence from the first patient population outside of your clinical trials), patient-reported outcomes, physician perception data to feed into your commercial launch (perception of product, likelihood of prescribing, issues with dosing, administration or adherence), or real-time access to detailed program metrics, Inceptua can maximize the data returns on your program.
Data generated during your Early Access Program can support:
- Program modifications
- Program expansion
- HTA submissions
- Market access
- Publications
A misfiring Early Access Program is more than just a drain on your resources – it can result in physician frustration, a negative perception of your company amongst your key prescriber base, a loss of goodwill, and ultimately can jeopardize your commercial launch.
Transferring an ongoing Early Access Program to a new vendor can be a daunting prospect – so much so that sometimes the decision may be that it’s better to persist with a sub-optimal program rather than risk any potential disruption, but transferring vendors is relatively straight forward, if managed correctly.
Inceptua utilizes its ‘Program Transfer Toolkit’ which capitalizes on its experience in this area to provide a seamless, cost-effective transfer, ensuring minimal disruption for your physicians and uninterrupted supply of medicines to your patients.
Wherever your patients are, we can reach them
- Wherever patients are, we can reach them. Inceptua Early Access has provided much-needed medicines to patients across Europe, North America, Latin America, Asia Pacific, the Middle East and Africa. In addition, Inceptua Early Access is also a specialist in the more complex group program approaches.
- Whether it is a US Expanded Access Program (EAP), a French AC/AP, German Compassionate Use Program (CUP) or a UK EAMS program, Inceptua can manage all of your end-to-end requirements, from protocol development, submissions and interactions with the national agencies, through site set up, monitoring, close-out, data capture and drug supply.
Recognized Industry Thought Leaders
The Inceptua team pioneered now industry-standard services for Early Access (e.g. Corporate Early Access Strategies, Early Access Feasibility Analysis, Compliant Early Access Communications and Early Access-specific RWD collection).
We strive every day to bring new solutions to our clients to support their objectives, and ensure their Early Access Program exceeds their expectations, and seamlessly transitions their assets from pre-approval to launch.
Get in contact with Inceptua Early Access
Contact Inceptua Early Access to discuss partnering opportunities.
If you are interested in learning more, please contact:
Stuart Bell
Senior Vice President, Early Access
Telephone: +44 20 39107 645
E-mail: stuart.bell@inceptua.com
Ask our experts
About
Mark has specialized in access programs for over 12 years and leads Medicines Access.
About
With over 20 years of industry experience, Stuart leads the consulting arm of our Medicines Access team.
About
With 20 years experience in the pharmaceutical industry, Ruth leads the implementation of our pre-approval access programs.
About
Kelly has 25 experience in regulatory affairs and quality assurance, 10 of which specializing in Medicines Access regulations
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
The regulations governing earlyl access (expanded access, compassionate use, named patient supply etc.) are constantly being
As an agile, global, and robust provider of medicines access programs for the biopharmaceutical industry, Inceptua is uniquely positioned to safely
