Whether the ultimate goal is securing a partnership, selling your asset to a large biopharmaceutical company, or successfully navigating your way through the clinical drug development process on your way to achieving commercial success, this symposium is for you.
Since 2006, close to 10 percent of the new drug approvals granted by the FDA have been via the Accelerated Approval pathway. In 2015, the FDA granted a record 45 drug approvals, with 6 granted approved under the Accelerated Approval program. In 2015, EMA granted 39 authorizations, with 5, or 13 percent, under conditional authorization.
This symposium provides local biotechnology innovators direct access to industry leaders with experience in preparing companies for the scientific, logistical, regulatory and commercial challenges of taking a promising asset from lab to life.
Hosted by inVentiv Health, a global, top-tier professional services company that helps accelerate the clinical and commercial success of biopharmaceutical companies worldwide, this symposium features clinical drug development and commercial industry experts that are available to answer your questions and help you anticipate your needs.
Date: May 18th 2016
Time: 13:30 – 17:30 Followed by networking reception
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S – Ground Floor
Cost: FREE
PROGRAM
| 13:30 | Registration |
| 14:00 | Welcome and introductions |
| 14:10 | The clinical development stage: considerations for strategic advantages; what is accelerated development and what are the advantages/disadvantages? |
| 14:45 | Overview of the transition from clinical development to commercial planning – what are the big considerations and available options? |
| 15:30 | Coffee Break |
| 15:45 | A case study for accelerated approval for the first-in-class Bruton-tyrosine-kinase inhibitor ibrutinib for Lymphomas |
| 16:15 | Perspective of a large pharmaceutical company in the development of relationships and fostering innovative partnerships |
| 17:00 | Closing |
| 17:10 | Q&A |
| 17:30 | Networking reception |
SPEAKERS:
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David J. Hewitt, MD |
Robert Millham, MS, MSc |
Thomas Moehler, MD, PhD |
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Mark Archer |
Anna Gran, PhD MBA |
Louise Jopling |
Participation
For members: Free of charge (late cancellation*/no-show fee DKK 500 ex VAT)
For non-members: The fee is DKK 500 excl. VAT, please see our event policy for non-members participation (late cancellation* /no-show fee DKK 500 excl. VAT).
Registration ends on May 17th, 2016.
* If you cancel after the registration ends, it is considered late cancellation.
In Collaboration with:
