Our service

Implementation of a Managed Access program can be a step into the unknown.

Even with all the best-laid plans, pharmaceutical and biotech companies can’t be sure where demand will come from, for which patients’ access will be requested, and how large the program will be.

Chances are the first request may be for a patient outside the original scope, that demand will be different to what was originally forecasted, and that the program scope will need to adjust alongside the global commercial roll-out.

Pharmaceutical and biotech companies need a partner that can do more than just execute the plan. They need a partner with the capability, experience and resources that can adapt to ensure no eligible patient goes without treatment.

With more than 35 years’ experience across 400+ programs, Clinigen help pharmaceutical and biotech companies navigate this ever-changing global environment.

With the industry’s largest team focused on early access and expertise in regularly supplying 100+ countries, Clinigen will ensure the delivery of a program that means the right medicine gets to the right patient at the right time.

Getting early access right is critical, and that’s why pharmaceutical and biotech companies trust Clinigen.

Global experts

Amanda Shaffer, Program Director

Amanda oversees the US based Managed Access Client Service team. She and members of her team are assigned to manage MAPs on behalf of our clients. Responsibilities include maintaining project budgets and timelines, managing vendors, and recommending distribution strategies to meet the needs of clients. Prior to joining Clinigen her background included protocol implementation at clinical trial sites and pharmaceutical supply chain/distributionAmanda graduated from Drexel University with an MS in Clinical Research Organization and Management.    

Carole Kenyon, Program Director

Carole joined Clinigen in 2018 as a Senior Program Manager, responsible for leading Managed Access Programs principally on behalf of a Top 5 client. She leads all operational aspects from set-up to closure across 9 programs for this client, and therefore has broad oversight of their portfolio. She is supported by dedicated Program Associates and functional teams. Prior to joining Clinigen she held Program Management roles in a niche CRO providing Phase I and IIa clinical trial services and is experienced working with global pharmaceutical and biotech clients. She holds a PhD in Life Sciences, is a member of the Royal Society of Biology and is a Chartered Biologist.  

David De-Keyzer, Project Director

David joined the Clinigen Group in 2012 as a Program Director and is responsible managing a number of programs with pharmaceutical companies in Managed Access. David is also responsible for managing a team of project managers who deliver a variety of programs for our clients. Prior to joining Clinigen, David has spent 20+ years within the pharmaceutical industry fulfilling a range of roles in clinical research (CRA, CRA Manager, CPM) for Genzyme/Sanofi, Medimmune and Altana Pharma. Within this time David also had responsibility for running a number of Managed Access Programs out-sourced to vendors, including Clinigen.    

Katharine Tipper, Client Director

Katharine has worked at Clinigen for 7 years, starting in the role of Senior Programme Manager, managing large scale client programs, moving almost 3 years ago to the role of Client Director for a key clientShe is passionate about ensuring clients receive the best possible service across the account. Prior to working at Clinigen, Katharine held senior level project management and communication roles in a range of different industries, and she has brought the learnings and skills from each of these roles into her work at Clinigen. Katharine holds a BA(Hons) and is a member of the Chartered Institute of Marketing.   

Michael Bois, Program Director

Michael joined Clinigen in 2014 and has a wide breadth of experience across Pharmacovigilance, Medical data, Consulting, Program Management and Director responsibilities, specialising in Managed Access. This follows prior roles at Sanofi, with Michael holding a BSc in Biochemistry. As Program Director at Clinigen, Michael is responsible for program governance and oversight, ensuring we are delivering excellent service to patients and our clients.