Experience

a pharmaceuticals manufacturer

on national and international standards on interactions with healthcare professionals and healthcare organisations, transparency and disclosure obligations at industry level and under the law

A pharmaceuticals company

specialising in rare diseases on regulatory issues related to the off-label use of medicinal products and right to access to dossiers submitted to the EMA for medicinal product approval

a major global biotech

on pricing and reimbursement issues for some of its key productions, including the application of reimbursement linkage provisions and hospital tender requirements

a major global biotech

on regulatory issues related to requirements for, and the interplay between, different paediatric rewards applicable to one of its key orphan drugs

a global pharmaceuticals company

in relation to the termination of a licence agreement. In particular, on technical and regulatory issues including the impact of data and marketing exclusivity on the interpretation of the agreement

 

Achilles Vaccines

a leading Italian vaccine-developer on various projects, including the creation of a platform for streamlining the research and development of new vaccines (including against COVID-19) and the start of a collaboration with vAMRes Lab at Toscana Life Sciences (TLS) Foundation (based in Siena, Italy) on a research project for the development of human monoclonal antibodies against COVID-19, with the aim of using them for prophylactic/therapeutic purposes and as molecular baits for the discovery of vaccine antigens


Resources

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Key contacts

Laura Orlando photo

Laura Orlando

Managing Partner, Milan Office, Milan

Rebekah Gay photo

Rebekah Gay

Partner, Head of Intellectual Property, Sydney

Sebastian Moore photo

Sebastian Moore

Partner, Head Intellectual Property, London and Milan

Pharmaceuticals and healthcare regulatory