Global Named Patient
Programmes
Mawdsleys Specialty Pharma offers
Medical Affairs &
Pharmacovigilance
Distribution and logistics
aligned with GDP
Full product registration and
regulatory affairs support to
license and commercialise
products in Brazil, Israel and the UK
In country Marketing and Sales teams
specialising in rare disease, speciality
pharma, oncology, haematology,
critical care and orphan products
Global Named Patient Programmes
A Named Patient Programme (NPP) provides a safe, legal and ethical route for physicians and patients to access medications that have not yet been licensed or made commercially available in their home country. It is also often called an Early Access Programme.
Examples of why patients may not have a licensed treatment option include when a medicine is new and has not yet been approved in their country because a clinical trial in which they have been enrolled is finishing, or because a previously licensed medicine has been discontinued.
Mawdsleys Specialty Pharma has a track record of successfully launching such programmes by partnering with small and mid-size companies to advise them on suitable programme design, regulatory compliance and successful implementation.
In all these cases, Mawdsleys can provide a bespoke, turnkey solution which will provide patients with quick and ethical access to the medicines they need.
By centralising access for patients through Mawdsleys, the pharmaceutical company will gain visibility of demand, as well as control of the information which passes to and from the healthcare provider. This access will be fully controlled by Mawdsleys in accordance with the particular commercial and clinical parameters agreed with the pharmaceutical company.
Managed
Access
Compassionate
Supply
Expanded
Access
Early
Access
Find out more about the licensing service
Mawdsleys provide:
-
Clinical Trials Services
-
Named Patient Supply
-
Rapid Licensing
-
Accelerated Reimbursement
-
Marketing and Sales
-
Regulatory Affairs and PV
-
Sale Growth
-
Distribution
Clinical Trials Services
- Support with supply, logistics and management during clinical trials
- Coordination and distribution of investigational drugs, comparators and placebos
- Full project management
Named Patient Supply
The Pharma Partner
- Manages early demand via a reliable partner
- Secures early sales in new territories without jeopardising future pricing
- Increases company and product awareness in local territory
- Establishes and enhances KOL network and patient advocacy groups
The Patient
- Gains access to innovative therapies prior to launch in their country
Rapid Licensing
- Complete turn-key regulatory service covering on all aspects of licensing
- Strong contacts with local regulatory bodies
- Access to advice from local regulatory bodies regarding the best approach in each individual case
- Our experience in named patient supply can increase the possibility for accelerated registration
Accelerated Reimbursement
- Extensive experience with national players and reimbursement bodies
- Identification of the most appropriate reimbursement route depending on the product designation and unique characteristics
- Access to specialist advisors to support our market access team in optimising the reimbursement case for each opportunity
Marketing and Sales
- Highly targeted approach to building a market access strategy tailored to each individual project
- Marketing activities led by MSL’s engaging with key clinicians involved in the targeted disease area
- Unique access to historic market data and payors
Regulatory Affairs and PV
- Experienced in-country regulatory specialists
- Specialists covering registration, license maintenance, QA/QC and PV
- Advice on most appropriate licensing routes according to the product designation
- Extensive knowledge and experience of the regulations governing named patient supply
Sale Growth
- Effective and thorough identification and analysis of the current and potential patient population
- Networking with patient advocacy groups
- Identifying early sales opportunities via named patient supply
- Facilitating early reimbursement via named patient supply
- Highly professional sales teams comprising of experienced representatives and sales managers
- Advanced targeting capabilities to enable focused efforts to drive growth
Distribution
- Established end-to-end distribution service into our core territories
- Fully audited and approved by the UK MHRA, ANVISA in Brazil and the Israeli MoH
- Supporting regular audits by our partners
- Validation processes of all computerised systems, cold-rooms and warehouses to be positively assured of compliance
- All procedures are subjected to a defined system of SOPs which are managed by the QA department
Why launch a
Named Patient Programme?
- Helps to satisfy unmet patient needs in a local territory
- Increases company/product awareness in a local territory
- Establishes & enhances KOL (Key Opinion Leaders) networks and Patient Advocacy Groups
- Commercial insight to aid in launch decision
- Captures pharmacovigilance data while complying with regulations
- Gather physician feedback on, for example, ease of use
Product Licensing
For pharmaceutical companies who want to get their products licensed in new territories, Mawdsleys Specialty Pharma has the expertise to manage this process on your behalf. Using the skills and extensive experience within the Mawdsleys Group, we can manage submissions to regulatory bodies on behalf of pharmaceutical companies, navigating the process to ensure a smooth pathway to commercialisation.
Mawdsleys Specialty Pharma is dedicated to seeking breakthrough medical innovations for the healthcare community through in-licensing and long term partnerships with small and mid-size specialty pharmaceutical companies. We are particularly focused on high added value products that require a well-established partner with a track record of success stories.
Find out more about the licensing service
Mawdsleys provides:
-
Prelaunch
Clinical Trials Services
- Support with supply, logistics and management during clinical trials
- Coordination and distribution of investigational drugs, comparators and placebos
- Full project and budget management
Named Patient Supply
The Pharma Partner
- Manages early demand via a reliable partner
- Secures early sales in new territories, taking into account future pricing plans
- Increased company and product awareness in local territory
- Established and enhance KOL (Key Opinion Leaders) network and patient advocacy groups
The Patient
- Gains access to innovative therapies prior to launch in their country
-
Rapid Registration & Reimbursement
Marketing and Sales
- Highly targeted approach to building a market access strategy tailored to each
individual project - Marketing activities led by MSL’s (Major Science Liaisons) engaging with key clinicians involved in the targeted
disease area - Unique access to historic market data and payors
Regulatory Affairs and PV
- Experienced in-country regulatory specialists
- Specialists covering registration, license maintenance, QA/QC and PV
- Advice on most appropriate licensing routes according to the product designation
- Extensive knowledge and experience of the regulations governing named patient supply
Sale Growth
- Effective and thorough identification and analysis of the current and potential patient population
- Networking with patient advocacy groups
- Identifying early sales opportunities via named patient supply
- Facilitating early reimbursement via named patient supply
- Highly professional sales teams comprising of experienced representatives and sales managers
- Advanced targeting capabilities to enable focused efforts to drive growth
- Highly targeted approach to building a market access strategy tailored to each
-
License / Commercialise
Rapid Licensing
- Complete turn-key regulatory service covering on all aspects of licensing
- Strong contacts with local regulatory bodies
- Access to advice from local regulatory bodies regarding the best approach in each individual case
- Our experience in named patient supply can increase the possibility for accelerated registration
Accelerated Reimbursement
- Extensive experience with national players and reimbursement bodies
- Identification of the most appropriate reimbursement route depending on the product designation and unique characteristics
- Access to specialist advisors to support our market access team in optimising the reimbursement case for each opportunity
Our Location
Salford – International House
International House
4 Houston Park, Montford Street
Salford
M50 2RP
Contact us
