Early Access Programs

We are experts in the strategy, design, and implementation
of global early access programs

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.

“Solution-finder mindset, customized approach, and highly customer-oriented. I strongly believe this has made the difference in the implementation of our EAP, and I particularly appreciate the customer service team engagement and their approach to supporting physicians in our programs.”

Executive Director

Strategy & Business Operations EUMEA, US Rare Disease Biotech

"When you work with Inceptua you truly get a partner working with you as an extended part of your team. They provide you with deep regulatory, supply chain and customer service expertise as well as work with a great sense of urgency and passion. The Inceptua team helped us to develop our global early access strategy and then supported us on a daily basis in its diligent implementation. If I had to select such a partner again I would go for Inceptua without hesitation!"

Vice President

General Manager EUMEA, US Rare Disease Biotech

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:

Early Access Program Transition Specialists

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

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

Any questions?

Ask our experts

About

Mark has specialized in access programs for over 12 years and leads Medicines Access.
EXECUTIVE VICE PRESIDENT
MEDICINES ACCESS

Mark Corbett

About

With over 20 years of industry experience, Stuart leads the consulting arm of our Medicines Access team.
VICE PRESIDENT CONSULTING
MEDICINES ACCESS

Stuart Bell

About

With 20 years experience in the pharmaceutical industry, Ruth leads the implementation of our pre-approval access programs.
VICE PRESIDENT PROJECT MANAGEMENT
MEDICINES ACCESS

Ruth Rostron

About

Kelly has 25 experience in regulatory affairs and quality assurance, 10 of which specializing in Medicines Access regulations
SENIOR DIRECTOR
HEAD OF REGULATORY

Kelly Fearn

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Early Access News and Insights

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