OBN Digital Webinar: Maximising Your Assets through IP and Regulatory Strategy
During this session, our hosts will share their expert insight on the opportunities available to companies who are seeking ways to maximise their product's assets during early development.
The session will provide a comprehensive strategic focus on up-to-date regulatory and IP matters including;
1) Regulatory Strategy
Engaging with regulators early in development to enhance probability of regulatory success
Incentives offering short term financial gains and long term impact e.g. orphan drug designation; EMA's PRIME scheme and UK's Innovative Licensing and Access Pathway (ILAP including the Innovation Passport) for priority medicines; the UK's Early Access to Medicines Scheme (EAMS) including the Promising Innovative Medicine (PIM) designation.
2) Intellectual Property
An introduction to the supplementary protection certificate system for extending patent protection for pharmaceutical inventions
Tips to make sure your portfolio is in good shape for securing SPCs. Regulatory approval is a lengthy process and often, by the time a pharmaceutical product is approved, the patent which covers it will be well into its 20-year term. Will it be possible to extend your patent, when the time comes? Is your portfolio SPC-ready? There are a number of things that can be done whilst your patent portfolio is at an early stage that can maximise your chances of securing an SPC.
Winner of 2018 Queen's award for Enterprise - International Trade. Carole is an experienced Managing Director with a demonstrated history of working in the pharmaceutical industry for more than 25 years. Leading a highly-proficient and flexible team to assist companies in aspects of European regulatory affairs and pharmacovigilance throughout the development, authorisation and life-cycle management of their medicinal products.
Amanda is a European and UK Patent Attorney and Head of the Chemistry and Pharmaceuticals Group. She works with many start-up companies in the Oxford area and beyond to assist them in developing their IP. Amanda’s work focuses on the pharmaceutical and medtech sectors, including anti-microbials, re-purposed drugs, pharmaceutical formulations, medical sensors and other medical equipment, but she also has experience in a broad range of chemical technologies including sugar chemistry and alloys.