Ben Franklin

INVESTING IN PENNSYLVANIA’S FUTURE

Saladax: Providing Biomedical Opportunities in Pennsylvania

Chris Spedaliere was so bullish on working for Saladax Biomedical that he moved his entire family from New Jersey to the Lehigh Valley, Pennsylvania—and has never regretted the big decision. But his path could easily have taken him in a different direction.

Chris Spedaliere, Principal Scientist, Saladax

Spedaliere received his Ph.D. in biochemistry from the University of Delaware in 2005. After his post-doctoral work, he began living in New Jersey, commuting to a contract position at BioNanomatrix, a Ben Franklin Technology Partners (BFTP) client company in Philadelphia. His experience with BFTP led him to apply for a permanent position at Saladax, also a BFTP client company, this one located in the Lehigh Valley.

“As larger corporations increasingly rely on outsourcing,” says Spedaliere, “smaller companies will play an increasingly prominent role in scientific, pharmaceutical, and healthcare industries. Startups also create an environment where it is possible to gain a more broad experience compared to a larger, well-established company.”

Today, Spedaliere is principal scientist at Saladax and lives in Allentown. He is a key team member of a leading-edge company that develops new diagnostic tools for the practical delivery of personalized medicine and companion diagnostics.

Pennsylvania’s Support for Entrepreneurs

Saladax’s founders originally launched the company in New Jersey, where they had previously worked in a multinational diagnostic company. But New Jersey did not offer the start-up support they were seeking, so they moved it to Bethlehem. Today Saladax is located in Ben Franklin TechVentures®, a high-tech incubator/post-incubator facility located on the campus of Lehigh University.

“BFTP offers tremendous opportunities to early-stage companies,” says Spedaliere. “It is a great system for getting companies off the ground. So many parties benefit from BFTP. I am glad to be employed thanks to this innovative program.”

BFTP of Northeastern PA invested $800,000 in Saladax and also helped refine its investor presentation and advised company principals on many start-up issues. Since joining the Ben Franklin portfolio, Saladax has received nine patents with an additional 16 patents pending on a portfolio of 15 tests, and raised more than $20.3 million in follow-on funding including investments from the Life Sciences Greenhouse of Central Pennsylvania, Golden Seeds, Delaware Crossing and other angels and venture capitalists.

The company has increased employment from the two original founders to 26 people, and launched its first product, My5-FU, which is used primarily in the treatment of colorectal cancer. It is available on the US market through a license to Myriad Genetics, in Japan through an exclusive distribution agreement with FALCO Laboratories, and in Europe through direct sales channels.

“Success requires a broad understanding that not only includes scientific knowledge, but knowledge of business and regulatory affairs as well.”—Chris Spedaliere, Principal Scientist, Saladax

Because No Two Patients Are Alike

Saladax developed the MyCare™ line of chemotherapy monitoring tests to aid oncologists in adjusting chemotherapy drug dosing by measuring their concentration in the blood of cancer patients—because, as the company slogan says, “No two patients are alike.” Saladax also works with pharmaceutical companies to develop companion diagnostics to achieve optimal patient benefit for drugs in the development pipeline.

While Saladax’s technology platform can address a variety of therapeutic areas, its initial focus is oncology. By addressing dose optimization, Saladax can objectively assess whether patients are receiving the optimal dose of their prescribed medications. MyCare ensures the optimum level of medication to maximize therapeutic efficacy while minimizing debilitating and potentially life-threatening side effects. The Saladax MyCare portfolio also extends beyond oncology, with two central nervous system disorder drug management tests.

Saladax achieved ISO 13485:2003 certification for the design, manufacture, and distribution of in vitro diagnostic medical devices in the area of clinical chemistry. Recently, Saladax also entered into a multi-year development and commercialization agreement with Bristol-Myers Squibb Company. Under the terms of the agreement, both the partners will collaborate globally on development and regulatory approvals. Saladax received exclusive global rights to commercialize the assays it develops.

Freedom to Innovate

In the end, the freedom to innovate is perhaps Spedaliere’s favorite part of working in an early-stage company.

“Working at a startup gives me the opportunity to start a project and take it from R&D all the way to market. I also like the sense of community and the fact that I know everyone at the company personally.” And the experience has helped him grow professionally as well. “Success requires a broad understanding that not only includes scientific knowledge, but knowledge of business and regulatory affairs as well,” he adds.

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This article was featured in
Keynotes October, 2010
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