Author: Sven Versmissen

Our colleagues Ann Meulemans (CEO & Managing Partner) and Leen Thielemans (Managing Partner) are attending the Vlerick Healthcare Conference in Brussels on Oct 27, 2016.

We are very excited to announce that within the past 1,5 year, 2 Bridge has welcomed 4 new team members:

An Rykx (clinical project leader)
Leni Vandekerckhove (scientific project manager)
Fiona Cilli (clinical program leader)
Inge Verachtert (CMC project manager)

2 Bridge is certified to organise training activities on drug development and product purity management for the next 5 years. More specific information can be found on the Training tab in our main menu. If you have any questions or needs on training, please feel free to contact us.

In the context of Janssen’s 11th Entrepreneurial Innovation Boot Camp, 7 promising ventures will present their business plan on the Open Life Sciences Campus in Beerse, at December, 5th.

These ventures, a mix of university spin-offs, a Janssen spin-off and young companies, focus on assistive technology development, research platforms or drug discovery and development platforms.

Free webinar in cooperation with Analytical Services – “Threshold concepts and best practice recommendations for toxicological assessment”, presented by Dr. Koen Van Deun (European Registered Toxicologist). Scientifically justified safety thresholds for Leachables & Extractables were developed for Orally Inhaled and Nasal Drug products (OINDPs) and Parenteral and Ophthalmic Drug Products (PODP). These thresholds allow to do a step-wise analysis and assessment of Leachables & Extractables according to their hazard potential.

FlandersBio is the networking organisation for the Life Sciences sector in Flanders, a dynamic non-profit, fee-based organisation with currently more than 270 members.
We are pleased to announce that 2 Bridge has become part of FlandersBio’s membership list.

2Bridge is planning to organise training activities on drug development and product purity management in cooperation with Partner organisations. More specific information will follow soon. If you have any questions or needs on training, please feel free to contact us.

ICH M7 Step 4 implemented: ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK. What is up? Which products are affected? What is new? What is the timeline? Further reading? How can 2 Bridge help you?

Updates are being expected for following Guidance documents on risk management of pharmaceuticals: ICH Q3 (Elemental impurities), ICH M7 (DNA reactive impurities in pharmaceuticals) and EMA (health based exposure limits in manufacture). More information on impact on the business and possible support by 2 Bridge is provided in attached Newsletter.

We are happy to announce that Eva Vets has joined 2Bridge on June 16th! Eva strengthens the Team with her medical expertise and strategic insights in different therapeutic areas. She is valued for her enthusiasm and her analytical though pragmatic approach.