In response to industry feedback for deeper insights on the hot
topic of biosimilars or follow-on biologics (FOBs), EBD Group today
added a spotlight panel titled Biosimilars: Risk taking vs. Caution?
BIO-Europe Spring will be held on April 7-9, 2008 at the Palacio
Municipal de Congresos, Madrid.
The biosimilars panel will be led by Dr. Ludger Wess, Managing
Partner, akampion and held on Monday, April 7. Dr. Wess will be
accompanied by a distinguished panel featuring Steve Usdin, Senior
Editor, BioCentury Publications; Dr. Thomas Brennecke, Head Business
Development, BioGeneriX AG; and Cecil Nick, Principal Consultant,
PAREXEL Consulting.
Commenting on the biosimilars spotlight panel, Dr. Wess stated:
"After years of discussions, the consensus view is that an expedited
approval pathway for follow-on biologics (F0Bs) will soon be
established in the United States, following the example of the EU.
Even some of the most steadfast opponents of FOBs have come to the
realization that their ´just say no´ and ´the science isn´t here yet´
arguments are no longer tenable. Against this backdrop industry must
now navigate the shoals of uncertainty as the U.S. Congress, the FDA,
EMEA, and indeed the rest of the world slowly begin to roll out their
own, unique regulatory policies for approval of FOBs.
Dr. Wess added: "In Europe the EMEA appears to be very cautious,
but nevertheless has moved forward on a case-by-case approach for each
biological and each indication. The U.S. approach is still very
uncertain and may be influenced greatly by what happens in the
presidential elections in November. It is clear, however, that the
political tide has shifted in the U.S. and it is no longer a question
of if legislation will be passed, but when. Our panel of experts will
discuss how the different approaches affect their decision making
process and the positioning of their products."
Notes to Editors:
Entry to BIO-Europe Spring(R) 2008 is free to the media, including
full access to the partnering system, sessions, press conferences,
workshops, and pre-arranged partnering meetings. Visit the BIO-Europe
Spring conference website at http://www.ebdgroup.com/bes/press_reg.htm
for detailed information on this year´s conference and online
registration. When you register online, please indicate in the comment
field that you are requesting a complimentary press registration.
Please fax a copy of your press pass to complete your complimentary
media registration to fax number +49 (89) 23 88 756 55.
About BIO-Europe Spring 2008:
The BIO-Europe Spring(R) event brings together international
decision-makers from all sectors of the biotechnology industry, and
features the successful combination of one-to-one meetings, company
presentations, panel discussions and a lively exhibition.
Positioned as the springtime counterpart to EBD Group´s flagship
conference, BIO-Europe, the BIO-Europe Spring event continues the
tradition of providing life science companies with high caliber
partnering opportunities. The event enables biotechnology companies to
identify, meet and network with companies across the life sciences
value-chain from large biotech and pharma companies to financiers and
innovative start-ups.
The local hosts of BIO-Europe Spring 2008 are Madrid Biocluster,
PromoMadrid, Red de Parques y Clusters de la Comunidad de Madrid,
Camara de Madrid, Genoma Espana, INTERES Invest in Spain, Sistema
madri+d and CEIM.
About EBD Group:
EBD Group is the leading partnering firm for the global
biotechnology industry. Since 1993, firms in the life sciences have
leveraged EBD Group´s partnering conferences, technology and services
to identify opportunities and to develop strategic relationships that
drive their business.
EBD Group´s conferences (run in collaboration with leading
industry partners and international trade associations) include
BIO-Europe, the world´s largest stand-alone life science partnering
conference (organized with the support of the Biotechnology Industry
Organization, BIO); BIO-Europe Spring(R); BioPharm America(TM) (EBD´s
new North American partnering event); and BioEquity Europe
(co-organized with BioCentury Publications and BIO).
EBD´s sophisticated web-based partnering service,
partneringONE(TM), is also used at numerous third-party events around
the world. Outside of the conference format, EBD´s consultants can
provide hands-on assistance for firms seeking to in- or out-license
products and technologies. EBD Group has offices in the USA and
Europe.
For more information visit www.ebdgroup.com
