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Case Studies

Case Study #1

A subsidiary of a global pharmaceutical company approached MWB Consulting for advice in respect of Article 20 and Article 31 procedures commenced by the EMA’s CHMP for two of their products.
We assisted the subsidiary with regulatory interactions and proposed risk minimization measures to be adopted. We worked with a team, including an external medical expert, developed a key message communication strategy, and responded to CHMP. We attended as safety experts at an Oral Examination and helped negotiate follow-up leading to a new Risk Management Plan and successful retention of products on the market.
Because of this success, we were asked to provide the QPPV and Deputy and have continued to provide this service for the past 12 years.

Case Study #2

A US pharma company had developed a new strength/concentration of a marketed injectable oncology medicine. They had run into objections from the CHMP in respect of potential confusion with the reference product leading to medication errors. They approached MWB Consulting for advice.
We proposed risk minimization measures based around design elements of the product vial, labelling, and ancillary risk minimization activities. We acted as the safety expert at an Oral Examination with the CHMP and successfully overcame the objections leading to the product being granted a Marketing Authorisation.

Case Study #3

A US development company wanted to submit for Orphan Designation for an an innovative immunological therapy. The company approached MWB Consulting to prepare a submission to EMA COMP.
Due to only a handful of paediatric subjects worldwide with the disease and the difficulty in estimating prevalence across a number of organs where the disease might manifest, a novel triangulation method was designed to estimate prevalence involving transposition of Japanese data to the European setting, prevalence of analog diseases using a physician survey, and a ‘sum of organ manifestations’.
COMP accepted the method and Orphan Designation was obtained.
The company subsequently asked MWB Consulting to assist with SAWP meetings, successful submission of the Paediatric Investigation Plan, and project management for early clinical trials for the same product. The product was acquired by a global pharmaceutical company at the end of Phase 2a.
The company has continued to use a wide range of MWB Consulting’s services for the past 8 years.

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