A roundup of some of the more unusual items that crossed our desk recently.
Whether they are big or small, collaboration is the new trend for life sciences companies looking to do business in NJ.
There was a time when the preferred mode for life sciences companies was to be the strong, silent type: self-reliant, independent, secretive.
With that approach, companies didn't have to share the glory - or the profits - that came with conquering industry frontiers.
These days, those cowboy corporations are actively seeking - well, pardners. Small and big companies are collaborating with each other and with educational institutions, joining forces across the boundaries of the pharmaceutical, biotechnology and medical device fields.
It's a national trend, with New Jersey companies setting the pace, as befits a state that's seeking to evolve after spending decades as a global leader in pharmaceutical and biotechnology industries.
"Partnering is really the way the industry has grown in recent years," said Debbie Hart, president and CEO of BioNJ, a nonprofit dedicated to the advancement of biotechnology in the state. "Everyone is looking to do more with less, and collaborations have be- come a really successful, strategic way of going about that."
PROS OF PAIRING UP
"Companies seek partnerships for specific reasons," said Francois Nader, the chief executive of NPS Pharmaceuticals in Bedminster. "There is the need to access capital, or expertise, or technology or facilities. Depending on the evolution of a company, it will be involved in partnerships for one of these four areas."
Life sciences companies are increasingly rejecting diversification in favor of consolidation around a core business, Nader said, resulting in the need to outsource key functions. Those can include anything from a portion of research and development - such as discovery - to the entire R&D function, marketing and sales or manufacturing.
In 2007, Nader and his team at NPS, then a company on the brink of insolvency, decided to let go of anything not core to the business. They narrowed their focus to this definition: developing and commercializing products for rare diseases for which there are no other treatments. It was a gutsy strategy that involved extensive layoffs and the closing of facilities, he said, but ultimately led to success with the development of drugs for rare gastrointestinal and endocrine disorders.
"With this mission, we made a deliberate decision not to be in manufacturing," Nader said. "That meant we had to strike partnerships with a number of manufacturers, some in Europe and some in the U.S. It's a very intimate collaboration. It's really like a marriage - you can't just change partners every other year."
In order to be sure it selects appropriate partners, NPS has developed a list it calls "the 10 C's" - such as cultural fit, clarity of controls and credibility - to use as a filter.
Across the life sciences sector, technology is not only driving collaborations but making them possible through the new ease of sharing data. In fact, many cutting-edge products virtually mandate the creation of a partnership between a pharmaceutical and a medical device company - for example, self-injectable syringes that are preloaded with a precise amount of a drug.
"There's been such a rapid pace of change in life sciences that things are getting mixed and matched in different ways," said Walter Greenblatt, managing director of Walter Greenblatt & Associates, a life sciences-focused investment bank in Princeton. "Just think, not long ago, a word like 'theragnostics' didn't even exist."
Now it does, and the combination of "therapeutics" and "diagnostics" describes the hot new field of personalized medicine, in which diagnostic testing at the molecular level determines which patients will benefit from a given treatment. In this space, Camden-based Coriell life Sciences has partnered with IBM to, among other things, curate vast amounts of medical literature and deliver personalized medicine via "the cloud."
THE COST FACTOR
A main driver of the collaboration trend is, not surprisingly, the need to conserve funds.
"Life sciences companies are engaged in very high-risk, high-reward endeavors," said David Sorin, managing partner of East Brunswick-based Sorin Rand, LLP, whose practice focus is technology and life sciences companies. "Taking a new product from discovery to commercialization can cost a billion and a half dollars and 12,13,14 years because the industry is very capital-intensive and highly regulated."
It's easy to see the benefits for a smaller company that joins forces with a larger company: It gains access to a depth and quality of resources it would not otherwise have. For example, Signum Biosciences of South Brunswick has developed a broad R&D collaboration with global giant GlaxoSmithKline to develop new therapies for Alzheimer's and other neurodegenerative diseases. Through careful partner choices, big companies reap benefits as well.
"What's happened is that big companies are getting away from doing all their own R&D; they're looking to acquire or collaborate with smaller companies who have already done the work around efficacy and risks of toxicity and are ready - or nearly ready - to go to the FDA for Phase III trials," said Michael Daley, the founder of OrthogenRx and a board member of the Life Sciences Collaborative, an advocacy and networking group for mid-Atlantic companies.
For example, last June, New Brunswick-based Johnson & Johnson purchased Aragon Pharmaceuticals, a San Diego-based company, in order to acquire its ARN-590 product for the treatment of prostate cancer. And Swiss company Roche has entered a $30 million licensing deal with South Plainfield-based PTC Therapeutics for the smaller company's in-development drug Ataluren, a treatment for spinal muscular atrophy.
Successful strategic partnering Lessons Learned:
Following is a list NPS Phamaceuticals has developed, and follows, when selecting appropriate partners:
The 10 C's
CULTURE The Cultural Fit between your two organization is of paramount importance.
CREDIBILITY Always select a partner with the highest degree of Credibility.
CAPABILITY Assess the partner's Capabilities based on today's and tomorrow's specifically defined needs.
CAPACITY A key determinant, especially in the supply chain.
COMPLIANCE The Achilles' heel of any partnership, as the accountability always resides with you.
CLARITY of controls as expressed in governance, quality assurance and audits is critical.
CONTRACTING Terms should always generate a win-win for both partners.
CONVENIENCE Often underestimated.
CONFIDENTIALITY If not considered, could trigger a significant negative impact.
COST While cash is king, it is not fortuitous that it is in position 10 rather than in position 1.
Meet the matchmakers
When it comes to potential for company collaborations, the Garden State is fertile ground, indeed. Home to 17 of the world's 20 largest pharmaceutical companies, at last count it also boasts 360 biotechnology companies - up from a total of 80 in 1998.
Organizations such as BioNJ and the Life Sciences Collaborative (LSC) are doing their best to inspire new matches. In March, the LSC had its first event, "From Startup to Exit: Lessons for Success," bringing together a range of life sciences advisors and entrepreneurs from mid-Atlantic states.
"We're here to help entrepreneurs get connected with capital and to be mentored and to network with successful people," said Steven Kantor, LSC co-chair and executive vice president of KEH Insurance Agency in Cherry Hill, which provides risk management and insurance for companies in the life sciences sector. "The need is great."
Meanwhile, the state officials are doing their part with New Jersey's Technology Business Tax Certificate Transfer Program, which allows small and midsized biotechnology firms to sell net-operating-loss credits to profitable companies for cash.
- Lee Lusardi Connor
LeeLusardi Connor is a freelance writer based in Morris Plains.