Durbin Expanded Access is now Uniphar
Our heritage and experience remain in facilitating multi-region access to innovative therapies and we continue to be uniquely equipped to handle the complexity of diverse country-specific EAP regulations and supply chain networks.
Choosing Uniphar as your trusted access partner replaces risk with certainty and control.
Access programs are optimized to meet your commercialization and development objectives, to make a positive impact for your product and patients, and to provide the best level of service and care.
Expanded and Global Access
An Expanded Access Program, or EAP, gives patients with high unmet medical needs access to therapies that are not yet commercially available including innovative therapies such as cell and gene therapy. Such programs are also known as named patient, post-trial access, early access, managed access or compassionate use programs depending on the regulatory framework in different regions.
Often, patients with serious or life-threatening conditions, for which there are no other suitable treatments, are not eligible or able to participate in the clinical study for investigational drugs being developed for their condition.
Uniphar enables pharma and biotech companies to offer patients access to life changing therapies via Global Access Programs. Uniphar have experience in investigational and unlicensed medicines to cell and gene therapies.
Global reach
Uniphar’s experts harness the capabilities, infrastructure and expertise of a diversified pharmaceutical service provider with more than 55 years’ building success stories with 200+ multinational clients.
Our understanding of the shifting market dynamics allow us to deliver tailored specialist services and solutions for our clients’ changing needs. We streamline EAP processes, capturing Real-World Data (RWD) and generate powerful reporting and data insights.
Working from clinical development to commercialisation, our end to end services remove barriers to launch, increase access and optimise brands.
workforce worldwide
pharmacomedical manufacturers
revenue
delivering to 160 countries
Meet our team
Global expertise
Dan Piggott
Managing Director Exclusive Access
Uniphar | Access
Wendy Hope
Global Head of Regulatory Affairs
Eileen Carroll
Quality Lead and Responsible Person
Maurice Leonard
Medical Director | Uniphar Pharma
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Tom Smith
Strategic Director, Cell and Gene Therapies
Wayne McGarry
Strategic Operations Director
Palvi Sharma Bains
Interim HR Director
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Ruth Rostron
Director of Program Management
Harriet Coupland
Program Director
Annemarie Langsteiner-Hatem
Associate Medical Director
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Dan Piggott
Managing Director Exclusive Access
Uniphar | Access
Tom Smith
Strategic Director, Cell and Gene Therapies
Wendy Hope
Global Head of Regulatory Affairs
Eileen Carroll
Quality Lead and Responsible Person
Ruth Rostron
Director of Program Management
Harriet Coupland
Program Director
Quality Lead and Responsible Person
Eileen has 14 years’ experience working in quality assurance across GDP, GMP and TE regulated environments. Since joining Uniphar in 2015, she has been responsible for the compliant management of unlicensed medicines across the Group’s businesses.
Strategic Partnerships Director
Tharshan’s skills extend to global expanded access programs, clinical trial services and identifying in-licensing opportunities for rare diseases, haematology and oncology across Europe.
HR Director
Finance Director
Program Director EAP
Harriet’s role is to lead the program design and implementation of your program, working closely with your team on a weekly basis. Harriet is supported by an assigned program manager.
Director Global Operations
Wayne is a trained engineer, solutions driven operational leader with heavy focus on “right first time”. He is responsible for designing, developing and implementing Uniphar Global operational infrastructure and capabilities.
Global Head of Regulatory Affairs
Wendy has over 15 years’ experience in pre-approval access, supporting 100+ programs across a variety of therapeutic areas.
Wendy is responsible for providing regulatory strategy and ensuring ongoing compliance throughout each program.
Program Delivery Director
With over 14 years’ experience in life science, Damien is focused on the evolution of delivery models and service innovation within the Pre-Approval Access Unit. He is responsible for developing processes and operating structures that are suitable to deliver client programs.
Prior to joining in 2021, Damien worked in both pharmaceutical and medical device sales, marketing, and business development across specialist and primary care settings and multiple therapeutic areas.
Director of Program Management
Ruth has been leading teams in the delivery of more than 100 EAP programs over the past seven years. Prior to specialising in this area Ruth spent over 15 years in the pharmaceutical industry with roles spanning marketing, market access, market intelligence and sales.
Strategic Director, Cell and Gene Therapies
Tom’s role is focused on the delivery of strategic projects, collaborating with partners on their EAP strategy and Uniphar’s cell and gene capabilities.
Managing Director Exclusive Access
Uniphar | Access
Dan has over 25 years pharmaceutical experience and worked in outsourced healthcare services for the majority of his time in industry.
Dan has held a variety of international leadership roles, working for UDG Healthcare, where he was General Manager for their US Commercial & Clinical operation. Dan was on the leadership team at AbbVie UK, where he led the launch of their Oncology franchise. Dan joined Uniphar in 2017 to lead their Product Access business, which specialises in the supply of unlicensed/pre-commercialisation medicine around the world.
A successful access program is, at its core, about collaboration. Partnering to provide patients with access to emerging and critical therapies, connecting all stakeholders in the access ecosystem. Working together we gather real-world data that assists product development and planning.