Andreas Schneider, VP Life Science Alliances, Roche
1. Can you please give a brief overview of your key research interests?
Key interests are technologies that improve Life Science Research, Biological Drug Development, Biological Drug Manufacturing and patient diagnosis / biomarker
Out of that, my additional interest is the challenge of establishing information and knowledge management concepts in a global complex environment.
2. What can industry gain from this?
Safer and more efficient drugs for patients Increasing efficacy and productivity of Development and Manufacturing
3. And what work will you be presenting at the 2012 BioProduction conference?
I will present an assessment done by the global Data Management Team of ISPE PAT Community of Practice, which assessed the “readiness” of the biopharmaceutical industry to implement knowledge management in QbD environment. The team setup was a collection of big pharma companies, Academia, Suppliers and Consultants.
4. What will delegates gain by attending your presentation and session? What is the message you would like them to leave with?
Since the drug discovery, development and manufacturing process is very complex, involves a lot of unit operations and takes multiple years, people underestimate the impact of state of the art data- and information management to successfully implement Knowledge management in a QbD environment. The talk will present a concept to evaluate the own company status of readiness.
5. What is the No 1 challenge facing the bioprocessing industry at the moment?
Applying knowledge from different unit operations, because of the fast evolving environment in terms of healthcare systems, personalized medicine, regulatory bodies and analytical technology. If one would know what other people know a lot of problems would just disappear!
6. What was the last “breakthrough” technology you either bought or used?
Technology that reduced the analytical noise within the bioprocess in order to generate more useful data for our in silicon models.
7. How will the industry look in 2-3 years? What challenges will still remain/ would have been overcome?
Scientific risk based approach in QbD environment will be common standard within the large biotech company segment but small biotech and CMOs need to adopt. However, the availability of useful tools for Scientists to gain knowledge will still be a segment for significant improvement.
8. What other sessions/ talks are you interested in attending at this year’s BioProduction 2012?
I will pick individual talks from all sessions since the program is so exciting that I won’t set a general limit.
9. Are there any articles that you would recommend the audience follow that relates to your area?
The A-mAB Case Study of CMC working group (www.ispe.org) and FDA websites which discuss QbD.
10. What did you want to be when you were young?
I had no specific preference but I wanted to be in a business in which new thing can be discovered any single day. Here I am!