Marcel Thalen Email & Phone Number

BioLyo Technologies: live bacterial products done right!

Iliad is a clinical stage biotech company, focussed on the eradication of whooping cough by developing a truly improved pertussis vaccine. As General Manager I am responsible for the Company’s International Operations, including process development, GMP manufacturing, and overseeing collaborative research at partner institutions. My role is to: • Create strategy and planning for process development to create stable and manufacturable vaccines• Direct Contract Manufacturing Organizations (CMO’s)• Supervise European R&D activities at partner research institutions• Company Liaison to European clinical research sites• Assist the VP of Development in reporting to the Scientific Advisory Board (SAB), Joint Steering Committee, and Investors on a regular basis• Work with regulatory affairs consultants to create the CMC portion of regulatory filings

After consulting part time for GT Biologics for 4 months, I joined the company full time in November 2013. GT Biologics is a preclinical stage biotech company with a platform technology, that identifies human gut bacteria that have strong immunomodulatory activity with a defined mode of action. The presence or absence of these bacteria have been shown to be important in Crohn's disease as well as a number of autoimmune disorders. As part of the management team my main current role was to identify & select and project manage all CMOs delivering services to GT Biologics such as cell banking, process development and GMP manufacture (fermentation, lyophilization and encapsulation). Other responsibilities included writing the CMC sections for the CTA of GT's lead product Thetanix, meant to treat juvenile Crohn's disease.

Burnaby, British Columbia, Ca

After consulting part time for Qu Biologics for a year, I joined the company full time in May 2012, immigrating from the Netherlands to Vancouver, Canada. Qu Biologics is a clinical stage biotech company with a platform technology, Site Specific Immunomodulators (SSIs), that stimulate the body’s innate immune system to mount a response against various forms of cancer (Lung, Colon, Skin), as well as a number of autoimmune disorders (Crohn’s Disease, Ulcerative Colitis, Arthritis). The unique aspect of Qu Biologics is that a significant amount of data has been gathered in human subject by means of ‘named patient use’ programs in Austria and the Bahamas, i.e. there is a significant amount of data showing the potential of SSI’s to transform the way cancer and auto-immune diseases are treated.As Vice-President Drug Development, reporting to the CEO, I fulfilled a number of different roles:- Oversight and project management of all aspects of manufacturing and testing related to Qu’s drug products for use in clinical trials, including writing CMC sections.- Identification, establishment and management of relationships with CMOs for both non-GMP and GMP manufacturing- Set-up and manage an in-house fermentation laboratory, including purchasing equipment, supervising a qualified fermentation scientist and co-op students- Overseeing all aspects of research and development (R&D) around existing technologies, as well as R&D around optimizing immunological response and new administration technologies to be developed and tested in house.- In addition I contribute to the preclinical research, helping to identify and optimize suitable animal models that will correlate with the effects SSIs have in humans.

Involved in all incoming projects from a scientific and business strategy perspectiveActively pursuiing and managing new and existing customers

Involved in all incoming projects from a scientific perspectiveProject and accountmanagement for a number of clients

Nl

head of process developmentproject manager removal of animal substances from production processes for diphtheria, tetanus and polioproject leader pertussis optimization & scale-up

Bilthoven, Utrecht, Nl

Msc, Molecular Sciences & Biotechnology

Phd, Biotechnology