Dr. Christian B. Fulda, Partner, Jones Day

1. Please can you tell me a little bit more about the talk that you will give at the conference?

Companion diagnostics are not only a possibility from a technology perspective, they have become a must in many cases from a market perspective, to demonstrate value added / additional benefit and to secure reimbursement. However, the regulatory pathway is ill-defined, and in particular in cooperation between pharma and IVD companies, awareness of the different pathways and timelines is critical for project success.

 

2. Who will be most interested in the subject matter of your presentation?

Attendees from the regulatory functions in both pharma and diagnostic, from business development functions, and from research and development as well as IP.

3. What do you expect delegates to “take away” with them from your talk?

Awareness of the different regulatory pathways, the resulting pitfalls and challenges – and an understanding how to overcome them.

4. Which presentations are you most looking forward to attending?

The opening panel on “transparency” (read: mandatory disclosure of confidential commercial information) is covering the most disturbing development we currently see in the industry, and which will require fundamental repositioning of the regulatory, IP, R&D and business development functions.


5. What is the most challenging part of your job?

Managing client expectations to the end that complex matters should be duly reviewed, instead of answered with shots from the hip – not a sustainable approach in this industry.

 

6. How long have you been working at your current company/association/organisation?

I am now with Jones Day for more than seven years; before I worked at another international law firm, totalling more than 10 years of experience in the industry.

7. Why did you first get involved in this field?

For a lawyer, it is a fascinating combination: to work at the forefront of medical-scientific research, and at the same time to be involved in one of the big topics of our time, public healthcare. And between sciences and society, lawyers provide structured solutions.