Nordic Life Science 1
Pär Gellerfors and Lars Lannfelt, Founders of Bio
Arctic She advises other companies pursuing FDA approval to ensure they have access to the right resources to bring forward a well-worked, thorough and high-quality package supporting the IND application. “Take advantage of a pre-IND process with the U.S. FDA to get answers to your important questions beforehand,” she adds. Another highlight at the end of 2018 was U.S. Federal Trade Commission (FTC) clearance to license BioArctic’s alpha-synuclein antibody portfolio for Parkinson’s Disease and other potential indications to AbbVie. “The collaboration with AbbVie has a deal value totaling a potential $755 million in upfront and milestone payments, plus royalties on any products, making this an extremely meaningful transaction,” says Osswald. “The FTC clearance process is required in the U.S. for significant transactions and takes time, so companies should factor this into their project plans.” Just as important as developing successful drugs is creating the means to detect and monitor central nervous system diseases. “For disease modifying treatments to be effective, it is crucial to start treatment before neurodegeneration becomes too advanced,” explains Osswald. BioArctic is working with Uppsala University to develop an improved imaging diagnostic tool to measure the accumulation of the toxic forms of proteins that currently are too small to be measured accurately. “Together with scientists at Gothenburg University, we are developing more sensitive biochemical diagnostics to diagnose central nervous system disorders with blood and cerebrospinal fluid samples.” Also in conjunction with Uppsala University, BioArctic is working on technology to help antibodies cross the blood-brain barrier to improve the effectiveness of immunotherapy for diseases such as Alzheimer’s and Parkinson’s. Meeting patient needs through disease-modifying treatments for Alzheimer’s and Parkinson’s diseases could translate into large commercial potential for BioArctic, Osswald adds. Ensuring that BioArctic is an appealing workplace for potential and current employees is also a priority for her. “By focusing on meaningful work and developing our employees, we also strive to be an attractive employer. Leadership is something I am passionate about. I believe in leadership that makes individuals grow in their respective roles.” NLS 35