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 early access (pre-approval, managed access program, compassionate use program, expanded access program) or unlicensed medicines.
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 early access (pre-approval, managed access program, compassionate use program, expanded access program) or unlicensed medicines.
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 an early access program and unlicensed medicines 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 needs, your physicians’ needs and your patients’ needs are taken into account, and ultimately helping you achieve your product launch objectives.
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 requirements 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.
Whether it is detailed, real-time metrics on your program, robust outcomes and real-world data, or market access-relevant insights, Inceptua Early Access is set up to maximize the data from 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 jeopardizes 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 non-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.
Wherever patients are, we can reach them
- Inceptua Early Access has provided much-needed medicines to patients across Europe, North America, Latin America, AsiaPacific, the Middle East and Africa. Wherever your patients are, Inceptua can reach them. 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 ATU, 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 asset 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
Vice President, Early Access
Telephone: +44 20 39107 645
E-mail: stuart.bell@inceptua.com
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