Susan Langley Email & Phone Number

I am resposible for managing all of our activities at major industry congresses and conventions nationwide. Additionally, I plan and execute all meetings for the Commercial and Clinical departments, including KOL meetings, advisory board meetings, investigator meetings, etc. Additionally, I am the Publication Manager. It is my responsibility to plan the publication strategy, manage the development of abstracts, manuscripts, poster and slide presentations and I assist with the development of all educational material displayed in our tradeshow booth and on our investigator and patient internet portals. Another aspect of my position is that of Patient Liaison /Outreach Representative. In this role I am the conduit between the company and the advocacy groups as well as any of our patients who may wish to become an advocate for our lead candidate product during its upcoming approval.

In this role, I was responsible for all of the study start up activities for each of Favrille's clinical trials, including site qualifications and selection, all regulatory paperwork through IRB approval, and all contract and budget negotiatios for each of our clinical sites. Of particular note was our accomplishment of enrolling a 350+ patient oncology study in less than 18 months.

BioQ was a company developing software to support the lifesciences/biotechnology industry. My responsibility was to identify content available on the internet that people within these industries would be interested in receiving each day, delivered directly to their desktop without searching for it. It was important to be famliar with CFR part 21 and other regulatory guidelines.

Managed more than 20 employees in the process of starting up large studies for a multitude of sponsor pharmaceutical and biotechnology companies. Wrote Master Investigator Agreements and Informed Consents for each study. Negotiated investigator site contracts and routinely negotiated budgets in excdess of $500,000.

Managed eight employees in the production of all clinical documentation for the Medical and Regulatory Affairs Division. Prepared and administered departmental budget. Provided customer service interface between Clinical Documentation and Regulatory Affairs, Biometrics, and Clinical Trials. Ensured quality, accuracy, and uniformity of all documents submitted to the FDA. Electronic Submission Committee member.