Q: What do you see as being the biggest issue for the life sciences industry in 2011?
The biggest issue is helping small companies working on innovative, groundbreaking science access the capital they need to develop life-saving and life-enhancing innovations.
We have seen some recent, hopeful signs. First, the Therapeutic Discovery Project awards announced last fall gave about 3,000 companies a much-needed shot in the arm. Many companies have been able to hire and retain staff, avoid shelving therapies, and keep their operations in the United States as a result.
Second, the mood at investor meetings has been largely optimistic and positive, and a recent survey we did with Ipreo validates these sentiments. The BIO/Ipreo study shows the majority of investors believe biotech is headed in the right direction and this is generally a good time to invest.
Finally, partnering at BIO’s investor meetings has remained strong, and the recent BIO CEO & Investor Conference in New York was one of our strongest partnering conferences to date, which shows there is still strong interest in collaborations and investment in the industry.
Alan Eisenberg serves as executive VP for emerging companies and business development at the Biotechnology Industry Organization (BIO). In this role, he manages and directs BIO’s services and advocacy efforts for BIO’s emerging companies.
Q: When licensing a device in one of the BRIC countries, what beyond the protections in a standard licensing agreement should we consider?
We recently concluded a pharmaceutical licensing deal with a local company in a BRIC country. We spent significant time considering termination clauses to mitigate various country-specific risks, such as the need for protections against government “nationalization” of an industry, not something we encounter in our usual license agreements. Yet some governments have in the past, and could in the future, decide it is in their national interests to control your product or even an entire industry. A second concern was the U.S. Foreign Corrupt Practices Act (FCPA), which prohibits payments to “government officials” to “expedite” the import, registration, marketing, or sales of your product. The definition of “government agent” is actually quite broad, and the U.S. Justice Department is currently very aggressive in pursuing U.S. pharma companies that break the law. So, we preserved our options to avoid these territory-specific issues with carefully crafted performance and termination clauses.
Dr. Carol Nacy
Dr. Carol Nacy is CEO of Sequella, a private company that develops new anti-infective drugs. She was formerly CSO at Anergen and EVP/CSO at EntreMed. Prior to her business experience, Dr. Nacy directed research in tropical infectious diseases at Walter Reed Army Institute of Research.
Q: Is the current enforcement of pre-use/poststerilization integrity testing of sterilizing grade filter by European inspectors a drug safety necessity?
EC (European Commission) Annex 1 included the statement of pre-use/poststerilization integrity testing for a period of years, though the enforcement by European inspectors of such test occurred over the last 12 months. It seems very much that the word “should” is the culprit of confusion, in some regions seen as a recommendation, in others as an obligation. In any case, an enforcement of such test does not enhance drug safety, probably to the contrary as a manipulation of a sterile filtrate side is undesirable in aseptic processing. This causes a major concern within the industry, since process designs would require refitting. Enforcement of such a compromising test may potentially even hinder exports of aseptically filled products into Europe, although the enforcement does not have any beneficial effect on the drug’s quality. The suggestion to the inspectorate is to utilize the word “should’ as a recommendation and leave the decision to the end user, as it has been done so for many years.
Maik Jornitz is founder of BioProcess Resources and senior VP at Sartorius Stedim North America. He has close to 25 years of experience, focusing on biopharmaceutical validation, optimization, and training in sterilizing filtration.
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