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European Drug Development: A Masterclass

  • Havana, 5th Floor, CIC Cambridge One Broadway Cambridge, MA 02142 (map)

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Discount Code: "CIC"

Join Alacrita at the CIC on January 29th, 2019, for an educational session on European drug development and commercialization. You will learn about valuable insight into most challenging aspects of the European drug development process. 

Ex-US markets can be lucrative, but the complexity and shifting dynamics in Europe can make the path complex to navigate, causing many emerging pharmaceutical companies to focus their development resources on the US. The result is often a protracted delay that diminishes a drug's global potential. In this seminar we will shed light on some of the most common issues. 

We will be joined by Anna Casse-Sumeray, Managing Partner, Alacrita, who has launched more than 13 products in Europe in oncology and rare diseases. She will speak on topics such as partnering strategies, positioning, typical organizational structures, typical budgets, and benchmarks. 

Julie Warner, senior consultant of regulatory affairs, will provide an update on the EU regulatory affairs landscape, including: 
- How to obtain scientific advice (and from whom) 
- Clinical trials 
- Fast track approval routes such as PIM and PRIME 

Lastly, Tim Clackson, previously President of R&D & Chief Scientific Officer, ARIAD, will share his first-hand experience from ARIAD and their launch of ponatinib into the European market. 

After the presentations, the speakers will participate in a panel-discussion where they will take questions from the audience. 

Event Agenda 

11:30PM - 12:00PM 
Arrival and Networking | Lunch 

12:00PM 12:45PM 
Julie Warner, Senior Consultant of Regulatory Affairs | Topic: European Regulatory Affairs: A Changing Landscape 

12:45PM - 1.30PM 
Tim Clackson, Previous President of R&D & Chief Science Office, ARIAD | Case Study: EU Launch of Ponatinib 

1:30PM - 2.15PM 
Anna Casse-Sumeray, Managing Partner, Alacrita Switzerland | Topic: EU Partnering Strategies and Timelines 

2:15PM - 2.45PM 
Panel Discussion 

This Alacrita event is being planned in collaboration with the Cambridge Innovation Center. We look forward to seeing you there!