Avid Bioservices Inc (CDMO): IND Submission – Drugs and Biologics Reg...

Reply Private New

Replies (1) Next 10 Prev Next

Send PM Follow Ignore

Followers	85
Posts	12714
Boards Moderated	0
Alias Born	10/12/2010

biopharm

Re: None

Saturday, 10/03/2015 10:00:45 PM

Saturday, October 03, 2015 10:00:45 PM

IND Submission – Drugs and Biologics Regulations Project
March 2014

Drafted a FDA submission ready investigator IND for Bavituximab for the indication of metastatic cancer as a 2nd line treatment
Authored Investigational Brochure and Informed Consent forms for global multisite Phase 2 clinical trials along with study protocol plan

Planned appropriate Pharmacology and Toxicology studies and outlined inclusion and exclusion criteria for subject recruitment and retention

Submitted a final report and a presentation summarizing a brief introductory statement, a short summary of previous human experience, a overall plan of investigating the drug product, labeling, toxicology and pharmacology studies

https://www.linkedin.com/pub/sheetal-khanna/3b/157/335

"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical
pipeline." -- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!