Medicines Access

We are experts in the strategy, design, and implementation
of global pre-approval and unlicensed medicines access programs

Pre-approval and unlicensed medicines 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 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 pre-approval and unlicensed medicines access programs.

‘Pre-approval access’ is an umbrella terminology that is becoming more commonly used to describe the process of making a medicine available to a patient (or group of patients), when it is unlicensed in the country of intended use. A number of other terms for this process are in use, including: ‘expanded access’, ‘early access’, ‘compassionate use’, ‘named patient supply’, and ‘managed access’. These terms are used interchangeably, which can cause confusion, so Inceptua prefer the use of the ‘pre-approval access’ terminology

Consulting and delivery

The Inceptua Medicines Access management team pioneered many of the support services which are now standard across the industry, including:

  • Corporate pre-approval access strategy development, and associated policy development (strategies developed for many Top 10 Pharma companies, through to small, niche biotechs)
  • Pre-approval Access Viability Assessments – a high-level assessment to determine whether to move forward with planning for a pre-approval access program for a particular asset
  • Product-specific Feasibility Analysis, a global, detailed analysis to determine whether a program is suited to your asset, and how and where to implement a program to ensure success
  • Pre-approval access-specific real-world data (RWD) collection, to easily obtain robust outcomes data from patients on your pre-approval access program
  • Physicians Perceptions Analysis – understand prescribers views of your product (likelihood of prescribing commercially, thoughts on price, dosing, administration, adherence etc.) prior to commercial launch

At Inceptua we constantly strive to deliver value for our clients. We continually refine our offerings, based on client feedback, to ensure we maintain our position as the thought leader within this industry. Inceptua can support you whatever your need is, and we can create customized services to address your specific requirements.

If you are at the early stages of considering pre-approval access to one of your medicines, but aren’t quite ready to move ahead and engage with a vendor, then please take a look at our Ask Inceptua service, through which we commit to answering up to 10 questions you may have about pre-approval access, in a no-obligation setting.

We help patients get access to treatment
  • Pre-approval programs
  • Unlicensed medicines access programs
  • Un-met medical need
  • Regulatory support
  • Healthcare professional support
We run access programs
  • Designed to meet the needs of medicine, company, and patients
  • Fully outsourced or in collaboration
  • Navigation of regulations and customs requirements
  • Personal service and project management
  • Global infrastructure and capabilities
Consulting services to biotechs and pharma
  • Strategies and policies
  • Education and insights
  • Feasibility and implementation
  • Real-World Data collection
  • Compliant communications
Supporting HCPs
  • Specialist Medicines Access Advisor support
  • Pre-approval and unlicensed medicines supply
  • Providing access globally
  • Supporting local regulatory and logistics requirements
  • Imap online access portal
  • Rapid, bespoke service

If you would like to discuss how Inceptua can support you with pre-approval access to your medicines, please either call Inceptua on: +44 203 910 7670, or email at: access@inceptua.com

Our expert team have implemented over 200 access programs across all stages of the drug lifecycle, and supported healthcare professionals across the globe in accessing critical treatments for patients in need

We work with pharmaceutical and biotech companies of all sizes to design programs which meet global requirements.  As a team of leading experts in pre-approval and unlicensed access to medicines, we design strategies and programs to meet your objectives, the requirements for each specific product and the needs of the patients who are to be treated.

Our programs are powered by an understanding of specific need and delivered with compassion for patients. We understand the importance of your clinical development program, and ensure that any access program implemented delivers for both patients and physicians.

We have experience in the implementation of pre-approval access programs for medicines still in clinical development, as well as unlicensed medicines access programs providing access to medicines post first approval in countries where they are not commercially available.

Our Experts

We are here to help you

About

Mark has specialized in access programs for over 12 years and leads Medicines Access.

Mark Corbett

EXECUTIVE VICE PRESIDENT,
MEDICINES ACCESS

About

With over 20 years of industry experience, Stuart leads the consulting arm of our Medicines Access team.

Stuart Bell

Vice President Consulting,
Medicines Access

About

With 20 years experience in the pharmaceutical industry, Ruth leads the implementation of our pre-approval access programs.

Ruth Rostron

Vice President Project Management,
Medicines Access

About

Kelly has 25 experience in regulatory affairs and quality assurance, 10 of which specializing in Medicines Access regulations

Kelly Fearn

Senior Director,
Head of Regulatory

We are here to help by providing vital advisory and practical support for the biopharmaceutical industry, healthcare professionals, and patient advocacy groups.

Clinical Trial Services

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Commercial Products

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If you would like to discuss how Inceptua can support you with pre-approval access to your medicines, please either call Inceptua on: +44 203 910 7670, or email at: access@inceptua.com