Posted on January 29, 2018 by Pete Kissinger
Since reengaging with BASi in 2017, I've seen positive trends that matter for 2018. We've had four consecutive quarters with positive earnings after a rough decade with both a slowly recovering economy and ongoing restructuring of the biopharma industry. Investing in growth is a priority. It is well recognized that life science innovation is very healthy, with new initiatives taking hold in editing out genetic abnormalities and marshaling the immune system to help root out a variety of cancers. The FDA approved many new therapies in 2017 and now promises to ease the way to more.
Neuroscience has continued to see late stage clinical disappointments with degenerative diseases. On the other hand, the new tools for study of the brain and new animal models are at an early stage and will enhance approaches to the clinic down the road, perhaps modifying these devastating diseases earlier in their progression. Optogenetics, multiple new imaging modalities, and higher resolution electrophysiology are particularly encouraging.
After a long hiatus, I attended the Society for Neuroscience (SfN) this past November in Washington D.C. with BASi. Spirits were high with presentations and on the exhibit floor. When BASi started in 1974, we were all about neurochemistry, specifically biogenic amines. This year we introduced new open flow microperfusion (OFM) technology with our Austria-based partner, Joanneum Research. These sampling probes enable collecting high molecular weight materials from animal models, for both brain and dermal applications. Such substances are not easily accessible with conventional microdialysis probes, which we first introduced at SfN in 1985. Joanneum has also done excellent clinical work using their new probes to study transdermal delivery in human research subjects. You can find more information on OFM at our website. No doubt this topic will be discussed at the Monitoring Molecules in Neuroscience (MMIN) meeting BASi will be attending in Oxford, UK, in late March.
With respect to our own in-house research capabilities, neuroscientist Dr. Srinivasan "Srini" Jayaraman has extended the viability of our in vivo blood sampling models to over 30 days, enabling a rat to be sampled periodically throughout that time and returned to a home cage between experiments. This enables more comparative data from individual animals, with respect to both comparing NMEs and dosing. Fewer animals, better samples, better controls, delivers better data. The West Lafayette vivarium has been upgraded with new automation and software. Visitors are welcome. New staff have been added along with the return of two familiar leaders of our pharmacology team, Candace Rohde Johnson and Jim Burleigh. In 2017, the FDA's Standard for Exchange of Nonclinical Data (SEND) was validated in partnership with PDS Life Sciences using their TranSEND product. Every year drug development becomes more of an IT activity as the amount of data increases, and paper-based files disappear. A great deal of time is saved as data entry, management, reporting and auditing are facilitated.
We continue to be proud of our exceptional regulatory record following a number of audits and inspections in 2017. These visits have been very helpful in keeping us alert to anticipated regulatory changes and best practices throughout the industry. With new leadership at the FDA, we can be sure the regs will continue to evolve to best assure that drugs will be as safe and effective as new science and measurement tools become available.
Besides the vivarium in West Lafayette, a major expansion of the Evansville toxicology site is underway to reduce current capacity constraints, particularly with more protein-based therapies requiring safety studies in non-human primates. In addition, new assets are being added to the West Lafayette site to meet current guidance for in vitro bioequivalence studies.
Board of Directors and other Management
Philip Downing was promoted to Senior Vice President of Preclinical Services last spring. He will soon begin his third decade at our Evansville laboratory. Mr. Larry Boulet retired as Chairman of the Board and Dr. Greg Davis has taken on that role, while Mr. Matthew Neff, J.D., has joined the board and assumed the chair of the audit committee. After retiring in 2012 from a long career in senior positions at Eli Lilly and Co., Dr. Davis has consulted and taken on entrepreneurial assignments, especially with regard to regulatory compliance. Mr. Neff has recently served as Chairman, President, and CEO of AIT Laboratories, following an assignment as President and CEO of the venture capital subsidiary of Indiana University Health. Click for more complete biosketches for both Dr. Davis and Mr. Neff.
The year is off to a good (but rather white and cold) start. We look forward to seeing many of you at upcoming conferences on analytical chemistry, electrochemistry, pharmaceutical science, and toxicology. Genotype guides, phenotype decides.
Written by Pete Kissinger
Dr. Peter T. Kissinger is the founder and former Executive Chairman and CEO of BASi and now serves as scientific adviser. Pete has published more than 250 scientific papers and is a fellow of the American Association of Pharmaceutical Scientists and the American Association for the Advancement of Science. He is a regular columnist for the trade publication Drug Discovery News and serves on the boards of Chembio Diagnostic Systems Inc., a NASDAQ-listed company; the Indiana Health Industry Forum; and Tymora, a recent Purdue-based startup company. In 2007 Peter Kissinger and Candice Kissinger founded Phlebotics Inc., a development-stage medical device company focused on diagnostic information for intensive-care medicine. In 2005 he became chairman and interim CEO of Prosolia, which markets new mass spectrometry innovations for life science applications. Pete was a founder of the first Purdue University new business incubator, INventure, in the late 1980s and has a bachelor's degree in chemistry from Union College in Schenectady, N.Y., and a doctorate in analytical chemistry from the University of North Carolina.