ARENSIA Innovative Spotlight Session, November 5th, Boston, MA

We are pleased to announce ARENSIA Innovative Spotlight Session "Practical Insights and Future Visions to maximize Efficiency in Proof-Of-Concept Patient Trials", which will take place on November 5th, 2018 in Boston, MA.

In today's fast-changing world, to stay competitive means to be innovative and open to embrace new approaches. Industry is facing time-pressing competition when fast movement through exploratory clinical phase is posing great challenges. Early go/no-go decisions have become critical. This is in contrast to dropping efficiency of clinical operations, constantly increasing complexity of study protocols and skyrocketing costs.

Industry thought leaders will gather for a one-day series of round table discussions to exchange their vision of paradigm shifts in early clinical development that are already underway and yet to happen. The focus will be on practical aspects of implementation of innovative approaches to achieve Proof of Concept results in record time. We will share best practices and real-life case studies, exploring them from different perspectives – regulatory, sponsor, clinical site and patient.

Attendees will be able to address these issues and leave the day better informed on how to:

• Develop an efficient strategy to Proof of Concept (First-in-Man -> First-in-Patient): classical approach vs. "umbrella" protocols
• Overcome challenges in execution of exploratory protocols: from feasibility stage to successful patient enrolment in Phase 1b/2a studies. Case studies from oncology, immunology and infectious diseases.
• Balance scientific/business interests & regulatory requirements
• Navigate in the new EMA legislation on Phase 1 clinical trials following the incident in France

We are happy to invite you to join us in Boston. For registartion, agenda and any other detail, please contact us at daria.marian@arensia-em.com.

05.11.2018