Data and Artificial Intelligence

As new process validation guidelines emerge, industry needs to reinvent how it releases product.

When validating automated systems from third-party providers, using the V model and failure modes effects and criticality analysis (FMECA) early in the process can help.

Company and People Notes: UCB and Novartis form agreement; AAIPharma appoints VP of regulatory affairs; more...

Also, FDA publishes draft guidances of two ICH Annexes; EMEA sets format for compliance advice; more...

Also, XCELERON and GSK form agreement; Millipore appoints VP of life sciences; more...

Also: DSM's North Carolina facility receives SafeBridge certification; Dynavax CFO to retire; more...

Also, Pfizer forms two research agreements in China; NanoInk appoints John Kubricky to its scientific advisory board; more...

Editors' Picks of Pharmaceutical Science & Technology Innovations

Biotech firms must first close the gaps between science and biology on the path toward QbD.

Individuals and companies at the top seem to have no problem short-circuiting their success.

Researchers working on extending the shelf life of antibody drugs may find help in a computer model developed by a research team at MIT (Cambridge, MA).

Also, Isogen completes sterile facility; Dishman appoints head of generic API business; FDA releases final rule on authorized generic drugs and NDA submissions; more...

Also, Gilead and Tibotec form agreement; FDA approves 2009-2010 flu vaccine; Catalent appoints VP in packaging unit; more...

Also, Lonza and Medarex sign agreement; Covance appoints VP and chief scientific officer of global analytical services; more...

Also, Lundbeck acquired LifeHealth; FDA is seeking a director of its new tobacco regulation branch; Charles River Labs announces personnel changes; more...

Also, Wyeth and Catalyst sign agreement; FDA seeks public opinion about tobacco regulation; Catalent appoints VP of quality and regulatory affairs; more...

REMS to improve the safe use of opioids may lead to controls on other high-risk medicines.

The regulators are doing it. But industry's fear of sharing information may leave them behind.

Editors' Picks of Pharmaceutical Science & Technology Innovations

Is it good policy to pay for bad behavior?

Social media is big news. From Facebook to Twitter, individuals are embracing the opportunity to participate in online publishing at an unprecedented rate. Communities of users interact globally, minutetominute within huge databases of content that they themselves create.

Good information management is essential to help pharmaceutical companies efficiently translate large amounts of data into drug market applications, achieve fast time to market and reduce costs and in Europe, many companies and regulatory agencies are actively assessing the potential of the EMEA's XML-based Product Information Management initiative.

Also, Adimab forms deals with Merck and Roche; Manhattan Pharmaceuticals' CEO and president steps down; more...

Also, FDA debars clinical investigators; Jubilant Organosys forms deal with Endo Pharmaceuticals; AMRI makes changes to its India management team; more...

Also, TorreyPines Therapeutics to liquidate assets and dissolve company; EU's competition services to examine Pfizer/Wyeth merger; Akorn appoints Raj Rai interim CEO; more...