This month in Philadelphia at the BIO International Convention, BIO will be partnering with the National Science Foundation (NSF) and the National Institutes of Health (NIH) to host the 2nd annual, newly-expanded BIO Innovation Zone. The Zone will feature Small Business Innovation Research (SBIR) funded early-stage biotech companies.
The SBIR/STTR program provides U.S. federal funding to small businesses engaged in research with the potential for commercialization. Each of the companies has been rigorously vetted through the SBIR/STTR review process prior to receiving the non-dilutive funding to engage in R&D that has the potential for commercialization. The NIH and NSF invest a combined $940 million annually in the programs.
What is your company’s lead product or technology?
Protein Dynamic Solutions, LLC (PDS) brings to market a novel, accurate, and reproducible high throughput platform for the determination of protein aggregation. PDS’ solution advances biologics candidates assessment through a Quality by Design (QbD) and Design of Experiment (DoE) approach. The technology is a label free assessment of: the size and identity of the aggregate, the stability of the protein therapeutic, while providing the mechanism and extent of protein aggregation. Our patented method can discern all of these attributes and the mechanism of aggregation with minimal protein sample requirements in just one experiment.
PDS’ technology will transform R&D productivity by deciphering the protein aggregation process as never before. Novartis-MIT have disclosed that 70% of average biologics R&D costs come from analytical characterization and development, process development and formulation functions. These are precisely the areas PDS technology will reengineer. Biologics groups conduct 90% of these activities in-house.
Currently PDS has three products in different stages of development:
- We have developed a prototype of a Dual Cell Holder (DCH) for single sample assessment. DCH is a unique and simple solution for the characterization of proteins. A patent for this device has been issued.
- Kaskade allows for biopharma industry develop ability assessment under varying formulation conditions of several protein therapeutic candidates in an accurate and reproducible manner. Initial proof of concept has been highly successful. The device is an accessory that meets industry needs. It can be used both with any microscope for imaging and spectral data acquisition.
- Correlation Dynamics software determines the mechanism and extent of aggregation along with an application programming interface (API) and a commercial statistical analysis software.
How has the NSF SBIR program helped your company grow?
First and foremost the NSF award has provided credibility to PDS’s goals and benchmarks. Furthermore, NSF support has been invaluable to the development of this startup company, from training workshops in entrepreneurship to funding access to the 2015 Bio Innovation Conference, while providing non-dilutive funds to generate initial prototype and proof of concept. These are crucial in the development to any company.
What are the upcoming milestones and long-term priorities for your company?
- Sublicense the Dual Cell Holder (DCH)
- Complete the Kaskade™ HT device with solution partners
- Launch of high throughput solution to developability assessment of protein therapeutic candidates
- Development of the Correlation Dynamics software and the automated liquid handling system
Our long term priority is to avoid protein aggregates in biologics and biosimilars with our transformative technology so protein therapeutics act as intended, avoid immune response, increase approval rates, lower R&D costs (which on average are $1B and up to $4B when including failed drugs) and reduce product recalls. There is an urgent need for accurate, easily reproducible analytical methods.
What do you hope to gain out of your participation at the 2015 BIO International Convention?
Market our company, products and technology
Meet with potential industry partners
Meet with angel and venture capitalist
Network with complimentary companies
Sublicense products to LST
Attend workshops of interest
Tell us something about your company that investors might not know.
Besides our licensed patents, PDS is committed towards continued IP development, currently has an active collaboration agreement with the Center for Cancer Research, NCI, Bethesda, MD. Our advisers include a former director for Research and the Cancer Center at Mayo Clinic and who is an Eli Lilly consultant; the Procter & Gamble scientist who developed 2D correlation spectroscopy and a global regulatory and validation expert.