7th - 10th June 2011 - Granada Spain
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Industry Day

Translating research and innovation into the clinics

Date: June 9th, 2011

Location: Granada Congress and Exhibition Centre

Fees: €150 for day attendee only

Co-organizer: Yves Bayon, Covidien

Supported by: Covidien and Granada Parque Tecnol'ogico de Ciencias de la Salud. Other companies and societies will join soon.

Overview:

Yves Bayon1, Miguel Alaminos2, Antonio Campos2

1Covidien - Sofradim Production, 116 Avenue du Formans - BP132, F-01600 Trevoux, France
2 University of Granada, Dept of Histology, Avda de Madrid 11, E-18012 Granada, Spain

After the successful experience during the last TERMIS-EU2010 meeting held in Galway, Ireland, an Industry Day session will again be held at the TERMIS-EU2011 meeting in Granada, Spain. The main goal of the Industry Day is to reach a common language and perspectives among different partners in the objective of translating research and innovation into the clinics for the advancement of the practice of medicine and for better patient outcomes, for the most challenging clinical indications.

Key-note speakers from a variety of areas, including academia, regulatory agencies, health systems, etc. will participate in the forum. Several companies will also share their experience and points of view on topical issues.

In addition, high level panel sessions will focus on topics which will be very useful for both the academic and entrepreneurial communities, shedding light on critical issues for the successful development and commercialization of regenerative medicine products:

1) "Translating academic research into commercial products" with experts sharing their experience on the management of an academic concept to a clinical stage company, the potential of academic / industry research collaborations, interactions with patient advocacy groups / associations, the management of intellectual property issues, the manufacturing of cells therapy products;

2) "Regulation of advanced therapies: Overcoming regulatory hurdles" with US and European representatives;

3) "Regulatory issues and Clinical trial Management of cell based products" with companies sharing their experience on cell products, tissue-engineered products and on cell delivered gene therapy.

This forum will give without any doubt high level information and answers to critical questions around the development of commercial regenerative medicine products. It may further nurture entrepreneurial initiatives from academics, wishing to translate smart and promising regenerative medicine projects into clinical products, raising new hopes for disease patients waiting for effective treatments.

Abstracts presented at the Industry Day will be published in the Journal "Histology and Histopathology" (impact factor 2.404), the official organ of the Spanish Society of Histology and Tissue Engineering.

Please note that attendance at the Industry day is included for all full paying delegates.

Agenda

Chairs: Geoff MacKay & Rui Reis

9:30 am - 10:00 am
James Yoo - Institute for Regenerative Medicine, Wake Forest University
Regenerative Medicine: academic perspective on translational research

10:00 am - 10:30 am
Chris Mason - University College London
Regenerative Medicine - Translating research into commercially successful therapeutics - From bench to bedside

10:30 am - 11:00 am
Simon Ellison - National Health Service (NHS)
Translating cellular therapies into viable clinical treatments
Case study: The NHS partnership experience for the delivery of cell therapies

11:00 am - 11:15 am
Morning Break

Chairs: Chris Mason and Heinz Redl

11:15 am - 11:45 pm
Maarten de Château - Swedish Orphan Biovitrum (SOBI)
Growth factors & Regenerative Medicine
Palifermin (Kepivance/KGF) is a growth factor with many potential uses, but still only approved for treatment of oral mucositis in a small subset of patients. Why?

11:45 pm - 12:15 pm
Paul Stroemer - ReNeuron
Stem cells for neuroindications
Case study: ReN001 stem cell therapy for the treatment of patients left disabled by the effects of a stroke

12:15 pm - 12:45 pm
Michael Fehlings - University of Toronto
Clinical evaluation of Regenerative Medicine therapies
Case study: Regenerative medicines for spinal cord injured patients - The experience of a principal clinical investigator

12:45 pm - 13:45 pm
Lunch Break

Chairs: Nicolas L'Heureux and Yves Bayon

13:45 pm - 14:15 pm
Regulation of advanced therapies: Overcoming regulatory hurdles
20 min-presentation followed by a 10 min Q&A session

14:15 pm - 15:45 pm
Panel: Translating academic research into commercial products
Brief presentations (10 - 12 min), followed by a Q & A panel session

Panellists: Robert Mays, Rahul Aras, Thomas Stelzer, Roke Iñaki Oruezabal, Matthieu Egloff, Sol Ruiz

15:45 pm - 16:00 pm
Afternoon Break

Chair: Robert Mays and Brian Newsom

16:00 pm - 16:30 pm
Frédéric Chéreau - Pervasis Therapeutics
Regulatory & Financing issues of the clinical development of Regenerative Medicine products
Case Study

16:30 pm - 17:00 pm
Natividad Cuende - Andalusian Initiative for Advanced Therapies, Regional Ministry of Health
Regenerative Medicine translation centre, a partner for the translation into commercial breakthrough therapeutics. The Andalusian Experience

17:00 pm - 18:00 pm
Panel: Regulatory issues and Clinical trial management of cell based products
Brief presentations (5 - 10 min), followed by Q & A sessions