ACCESS SOLUTIONS
Early Access
Depending on the country, it can take months or years before the medicine is commercially available, especially when a pharmaceutical company receives its first regulatory approval. Tanner can help manage this process until they are commercially available in the market.
HOW IT WORKS
Reducing the gap in access and meeting the demand
When a pharmaceutical company receives its first regulatory approval for an innovative medicine, physicians, distributors, patients or ministries of health in other countries often begin requesting access to it.
Depending on the country, it can take months or years before the medicine is commercially available. Similarly, a company may choose not to commercialize the medicine in some countries for various reasons. In most countries, there is an established named patient supply process for fulfilling the demand if the medicine is not commercially available. While some pharmaceutical companies have the means to fulfill requests free of charge, companies may be able to charge for the medicine. Tanner works with pharmaceutical companies to manage all requests for such medicines and satisfy the demand until they are commercially available in the market.
OUR ACCESS SOLUTIONS
From Early-Access to Compassionate Use, we take a comprehensive approach to access solutions.
-
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.
-
Compassionate Use
The use of a new, unapproved drug to treat a seriously ill patient when no other treatments are available.
-
Post-trial Supply
A program to maintain supply of the medicine to patients until it becomes commercially available.
-
Early Access Programs
Allow pre-approval access to medicines for certain patients
-
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.
-
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.
-
Market Withdrawals
Providing ways to access a market post-withdrawal where demand from physicians and patients remain, and we can help.
-
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).
-
Clinical Supply Gatekeeper
We can help you effectively manage inbound requests for comparators and reference listed drugs.