ACCESS SOLUTIONS

Expanded Access Programs

Tanner offers a full range of services to support the design, implementation and execution of Expanded Access Programs in the US.

HOW IT WORKS

Expanding hope

Expanded Access Programs (EAPs) are a pathway created and regulated by the US FDA that allows biopharmaceutical companies to provide investigational new drugs (INDs) to patients with serious diseases or conditions who have exhausted approved therapy and cannot participate in a clinical trial. The FDA has defined specific criteria that determine which part of its program is most appropriate for the medicine in development.

Whether a medication is requested ad hoc for single patients or for a group of patients, Tanner offers a full range of services to support the design, implementation and execution of Expanded Access Programs in the US.

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OUR ACCESS SOLUTIONS

From Early-Access to Compassionate Use, we take a comprehensive approach to access solutions.

  1. Expanded Access Programs

    US FDA regulated pathways that allow provision of investigational new drugs (INDs) to patients with serious diseases or conditions who have exhausted approved therapy and cannot participate in a clinical trial.

  2. Compassionate Use

    The use of a new, unapproved drug to treat a seriously ill patient when no other treatments are available.

  3. Post-trial Supply

    A program to maintain supply of the medicine to patients until it becomes commercially available.

  4. Early Access Programs

    Allow pre-approval access to medicines for certain patients

  5. Donation Programs

    Programs for pharmaceutical companies that are seeking to donate their medicines in low- and middle-income countries where patients do not have the insurance or financial means to pay for them.

  6. Drug Shortages

    A service that sets up the infrastructure to respond to supply chain disruptions that can cause drug shortages and mitigate the impact on patient access to their medicines.

  7. Market Withdrawals

    Providing ways to access a market post-withdrawal where demand from physicians and patients remain, and we can help.

  8. Global Access

    We have the ability to access all products for request internationally – finding access to products in unmet demand of markets of need. We do this through NPP (processed through import).

  9. Clinical Supply Gatekeeper

    We can help you effectively manage inbound requests for comparators and reference listed drugs.

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