LIFE SCIENCES AND INNOVATION
Moore Law is able to draw upon its legal expertise across a number of commercial and IP disciplines to advise clients in the Life Sciences and Healthcare sectors.
Moore Law acts for a number of clients who are at the forefront of innovation in these sectors and we have developed and refined a contracts management service (on a retained or project to project basis) which delivers timely expertise, personal service and exceptional value.
We are well versed in contractual and commercial issues as well as the legal and regulatory framework and regime relating to life sciences and, in particular, the conduct of Clinical Trials.
Clinical Trials are strictly regulated and governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 implementing EU Directive 2001/20/EC and professional advisors need to keep abreast of regulatory developments.
The interests of a clinical research organisation, a pharmaceutical company and a university clinical trial centre do not always coincide and the expert management and exploitation of the IP generated is crucial to these collaborative arrangements.
- Advice on Clinical Trials Regulations and Clinical Trial Protocols
- Negotiation of contracts with major pharmaceutical companies
- Insurance and Indemnity Arrangements
- Drafting and negotiation of Consortium Agreements and Collaborations
- Complex Sub-contracting arrangements with universities
- IP Audit and advice on protection and exploitation of results
- Licensing, supply and distribution agreements and joint ventures
- Confidentiality agreements
- Consultancy agreements
P1VITAL CASE STUDY
P1vital Limited is a leading clinical research organisation based at Oxford University which coordinates and manages clinical trials for its clients in the area of Central Nervous System (CNS) Experimental Medicine.
Tris Moore has acted for P1vital for more than seven years and has overseen the company’s legal agreements and advised on a number of significant consortiums and collaborations with the major pharmaceutical companies (including Astra Zeneca, GSK, Johnson & Johnson, Lilly, Lundbeck, Merck, Pfizer, Roche, Servier) operating in this area of medicine. These contracts invariably involve regulatory and compliance issues and an IP/IT element due to the creation of results and new IP.
Moore Law also advises P1vital (and its sister products company, P1vital Products Limited) on the complex subcontracting models with its University subcontractors (all clinical trial centres of excellence in their fields of expertise) which underpin its client contracts and in relation to the development of innovative new technologies in support of the studies.
P1vital instructs Moore Law in relation to all significant commercial and IP transactions.
“TRIS HAS ACTED FOR P1VITAL FOR MANY YEARS NOW AND I CONTINUE TO BE IMPRESSED BY HIS WORK ETHIC, DILIGENT ATTENTION TO DETAIL AND COMMERCIAL APPROACH. HE IS REAL ASSET TO US, A VALUED AND TRUSTED ADVISOR AND AN INTEGRAL PART OF THE P1VITAL TEAM.”
Dr Colin Dourish, CEO P1vital Limited
P1vital’s innovative experimental medicine studies enable pharmaceutical company clients to make more rapid and effective decisions in the early development of new compounds to treat disabling disorders such as depression and schizophrenia. Moore Law’s role (which from time to time involves us in direct negotiations with Legal Counsel at various pharmaceutical companies and universities) gives us an insight into developments in this area with regard to IP and IT since these trials are increasingly supported by sophisticated software based cognitive and functional MR imaging test batteries developed by the client.