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Real world project management

Access programmes are complex and each will have its own individual considerations to balance
Global access programmes represent an important option for patients and physicians who need an alternative therapeutic for an unmet medical need. Through these programmes, pharmaceutical and biotech companies can respond in a fully compliant, ethical manner to requests for access to medicines that are in clinical development, are unlicensed in a specific market but licensed elsewhere, or are in the marketing authorisation application (MAA) process.

With patients located around the world, regulations that vary from country to country, and supply chains needing careful monitoring, proper planning for a global access programme is essential. Here we explore in greater detail the practical aspects of setting up and effectively managing a global access programme to ensure regulatory compliance, minimising exposure to risk and ensuring the appropriate level of support and advice is available.

Getting started
If your organisation is considering a global access programme, a number of topics should be addressed at the outset by a cross-functional team including representatives from regulatory, clinical, medical affairs, commercial, quality, procurement, legal and finance.

When developing a programme, initial discussions with internal stakeholders should focus on how the company wants to allow access and include the following aspects:

  • Geographies in which the programme will operate
  • Patient eligibility requirements
  • Pharmacovigilance and safety reporting requirements and processes
  • Processes by which physicians will request access and the documentation they will need
  • Training that will be needed for local affiliates, medical directors, and others
  • Timing and exit strategy for completion of the programme.
The set-up phase is also the time to identify decision makers, routes of communication, and what the escalation process will be should an unexpected event take place. This phase is a very intense period of time for the team involved and typically requires four to six months – in exceptional circumstances, this length of time can be compressed but in order to ensure a successful result will have different resource and support implications.

A critical element of the set-up phase is establishing a robust training programme that is delivered to all internal stakeholders. In practice, with the global nature and disparate locations of the teams involved, web-based sessions are an effective and inexpensive solution. The training programme is a fundamental step in the process of ensuring clarity and buy-in with everyone and the content includes the basics of a description of the programme, outlines policies and procedures, and defines roles and responsibilities.

An often overlooked element, which should always be included as a standard element with the set-up phase and training programme, is the proper procedures for communicating about the programme and appropriate handling of requests. The basic premise of a global access programme for an investigational drug is that access is requested by the physician to treat a patient with unmet medical need; there can be no promotion of the product as part of this process. In addition, once launched, programmes can generate a great deal of interest among patients and physicians – with easy access to global social media networks, word of a global access programme will spread rapidly. The sponsoring company should be aware that this will happen and have protocols in place to deal with all scenarios, including responding to requests that come from geographies not covered by the programme or from patients who do not meet eligibility requirements. Well-defined programme parameters will ensure fair and equitable access.

In order to provide the appropriate level of support and advice for physicians, educational materials about the access
programme are also developed at this time for the sponsoring company to provide to physicians once a request for access has been made.

Once a programme launches, it is likely to evolve, especially for drugs that are early in the development cycle and not yet licensed. The programme thus needs to have processes in place to ensure regular and timely review of all relevant information and materials. As new safety information becomes available, documentation used as part of the programme will need to be updated. Similarly, as approvals are obtained, patients in those countries will be transitioned from the unlicensed supply to commercial packs.

A project we are currently managing provides a good example of this in practice. The programme is for a cystic fibrosis drug with patients in Latin America and Europe. Patients eligible for the programme include those who had been in the clinical trial which ended and those who were not able to enter a trial. Over the course of the programme, the drug transitioned from being unlicensed to licensed in the EU and therefore as countries in the EU launched the drug - all at different times - patients were transitioned from clinical material to the commercial supply enabling them to continue treatment. The ex-trial patients were allowed to continue access free of charge until the product was commercially available in their country.

In contrast to this is a programme we are managing to support the global withdrawal of an oncology product. The drug had already been commercially available; the challenge of rolling approvals and the need to transition patients to commercial supply was therefore not present. The programme has been in place for a year and reaches approximately 4,000 patients in fifty countries. Without the global access programme, these patients would not have been able to continue on the medication.

Interest in global access programmes is increasing both from patients and their physicians as well as drug developers. These programmes offer a well-regulated, ethical way of responding to demand across many geographies to satisfy areas of unmet medical need. From a practical perspective, any company considering whether a global access programme is relevant for their products should consider partnering with a specialist to develop and manage these programmes. As we have highlighted above, each programme has its own individual considerations and is a complex project to manage, balancing the needs, requirements and expectations of a wide range of stakeholders. A specialist partner can help the company plan effectively, minimise exposure to risk, facilitate the navigation of complex and at times, vague regulations, and ensure its objectives are met.

The Author

Debra Ainge is Head of Project Management at Clinigen GAP. She can be reached at

5th November 2013



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Real world project management
Access programmes are complex and each will have its own individual considerations to balance