Start-ups with regulatory and industry- small biotech companies potential to develop treatments - Session 0104

How can idea from academia can be better translated to novel treatment options

Important to give a chance to thesmall companies- they are the ones developing new compounds/drugs that are later bought by Big Pharma.

Small companies challenges (finances and innovation)
New treatments paradigms

Andreas Schmidt CEO AYOXXA Biosystems Germany (35 people)
interest in huge topics
medical decision based on proteomics
company interested in genomics and proteomics
ambition to base clinical trials on proteomics
access to clinical samples
to identify which patients are going to respond (biomarkers)

Sam Wadsworth, Dimension Therapeutic
2013 -company was funded
partnership with big companies (e g. Bayer)
partnership with academics
partnership is bringing money and/or validation
clinical trials- small trials (phase I, II)
gene therapy -challenge for a small companies, few receive positive recommendation by EMA
focus on one topic is better

Melanie Carr, EMA -European Medicine Agency
why is important to support small companies
90% -commercialised by big pharma
no product commercialised by academia
but the true is that less than half health technologies are coming  from big companies
incentives
Innovation Task Force -early guidance how companies can be embarked in development programs
Difficult to comply with EU regulations
Plan Management Risks has to be included in the projects of small companies

Dr. . Kalkbrenner,  Boehringer Ingelheim
Company Bayer -life science companies -pharma component
Grants4Apps, funding and supporting small companies (?)