Biotechnology

Biotechnology is unfolding in our sector to genomics, gene techniques, applied immunology, development of highly innovative therapies and diagnostic tests.

Biotechnology companies ‘Biotechs’ are usually small structures with specific needs in terms of funding, regulatory & market access advice.

Whilst the financial markets are proving more receptive to biotechs than in the past few years, access to capital is still limited, emphasising the need for a strong business case and development pipeline. Consolidation is seen as one solution, however, there is also a noticeable increase in early stage licensing deals to secure much needed funding for the sector. Grants and subsidies from public authorities, including European grants (H2020 and IMI2 programmes) are also a significant source of funding.

As far as regulatory constrains are concerned, strict legislation applies to research and development including clinical trials where the GDPR has also an important role to play.

In-depth understanding of the rules governing advanced therapy medicinal products as well as of the rules applicable to biomarkers and personalised medicine is also key.

Our international corporate, regulatory and market access teams work closely with our commercial, employment and IP colleagues and are able to provide a tailored one-stop-shop package for biotechs.

From the firm’s financing to the product’s early stages of development until its (inter)national launch, with full compliance on production & distribution channels, product liability and pharmacovigilance, we can help you on all fronts, including with:

• Funding
• R&D contracts
• Clinical trials
• Manufacturing agreements
• Product classification
• Market access and CE marking
• Pricing and reimbursement
• Supply chain and distribution
• Employment
• Advertising and promotional activities
• IP/patents (life cycle strategies)
• Data and regulatory exclusivity
• Regulatory enforcement and (criminal) sanctions/compliance
• Industry codes of conduct/self-regulation
• Transparency – data and relationships with healthcare professionals
• Administrative/public law
• Public/private partnerships with healthcare institutions
• Product recall and liability
• Business development and partnerships.