Clinical trial professionals and in-house counsel from many emerging drug development companies in the Bay Area received valuable advice when they attended a seminar on “Optimizing Clinical Trial Agreements for Effective Trial Management” on May 9, 2018, sponsored by Faber Daeufer & Itrato PC and hosted by the California Life Sciences Association (CLSA). The half-day event in South San Francisco, designed to assist biotech professionals efficiently manage the clinical trial process and avoid common challenges, provided a rare opportunity for skilled advice and counsel, as well as highly useful peer involvement and information sharing.
Event speakers from Faber included Isabelle DeBear (the Founding Director of Faber’s unique Contracts Specialists team), Jon Linden (a Principal at Faber who helps supervise the firm’s large team of lawyers and Contracts Specialists handling clinical trial agreements and related clinical development matters), and Greg Ikonen (a Principal at Faber who leads the firm’s new San Francisco office and helps lead the firm’s complex transactional practice). They led discussions about creating clinical trial agreements that address study priorities while appropriately addressing liability allocation, IP rights and other essential contract terms. They additionally provided advice on leveraging the capability of a CRO by establishing an efficient contracting process and special considerations for ex-U.S. studies, including complying with the EU’s new General Data Protection Regulation (GDPR). ”
Attendees also got a unique opportunity to hear from Ian Nisbet, Ph.D., a partner with Afandin, who is an expert on clinical trials in Australia. He revealed the advantages and disadvantages of conducting studies in Australia, including opportunities for biotech companies to access R&D tax rebates that subsidize this work. He also graciously made himself available for one-on-one conversations with attendees.
“I think they enjoyed the information in general,” said Linden, speaking about the professionals in attendance, “and they particularly appreciated the whole approach—there are things you can do to smooth the implementation of a clinical trial by thinking ahead, knowing how to leverage your CRO’s best qualities and planning the contract process. Most of our team have worked in-house in pharma or biotech supporting ClinOps teams, and we have a lot of practical experience that helps us better counsel our clients about contracting approaches and makes the process work more efficiently.”
Linden thought the interaction among the attendees was a high point of the program. “Some of the best moments at the event were when the attendees shared their own war stories. We had some really interesting discussions about real-world experiences where I think everybody learned something.”