Q: What market trend do you think will accelerate single-use manufacturing adoption?
The bioprocessing industry continues to expect better control and connectivity over its single-use devices. Standardization is a broad theme in bioprocessing that will facilitate segment growth through plug and play operations and will reduce worries over getting stuck with a sole supplier. Standardization also will permit sensors and software to effectively monitor, communicate, and automate to optimize the process. This will simplify the regulatory process. Most suppliers are already working on elements of these problems. It will take time to adopt an industrywide, open-architecture format and design process while also facilitating cross-industry agreement. Our research indicates that 44 percent of decision makers are demanding better bags and connectors. Nearly 40 percent want improved sensors for bioprocess monitoring. Sixty-four percent fear getting stuck with a single vendor due to the inability to connect devices. Lack of standards for testing is a key factor holding back adoption.
Eric Langer has over 20 years’ experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies.
Q: What are some pitfalls to avoid when conducting a clinical trial in a developing market, e.g. Africa?
Clinical trials in any country with underdeveloped healthcare delivery systems can require upgrading your lab and clinic infrastructure, training personnel in good clinical practice, and designing creative data management and storage processes. Labs with skilled personnel and expertise in specific clinical-specimen testing protocols are frequently in short supply. Consistent electricity (and backup sources) for clinical study product and specimen storage is a problem in rural sites. Telephone/fax lines and Internet service in many rural areas are often absent or unreliable. Transportation is usually required to bring product in and samples out of field locations, as well as to bring study subjects to the site. Site personnel should have no language barriers with either subjects or study sponsors and should understand the true meaning of “informed consent.” Everyone should be aware of (and respect) local customs and practice.
Carol A. Nacy, Ph.D. is CEO of Sequella, Inc., 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: How will the Supreme Court decision that naturally occurring genes are not patentable impact the development of precision diagnostics?
This decision was seen as good news by many. It may open up new clinical testing options and allow companies that had been precluded from offering tests using patented genes to now step in. The public may benefit with lower-cost products as competition and limiting pricing pressure increase. There are early signals that prices may already be falling. Lower prices may enhance insurance coverage for genetic tests and increase access to important precision diagnostics. However, the court ruling also noted that synthetic cDNA (complementary deoxyribonucleic acid) can be patented (a synthetic version creates something novel), and it cited the importance of “methods patents” in providing protection. How much this will amount to is unclear as many gene patents are set to expire soon anyway.
Mark Pykett, Ph.D. is the president and CEO of Navidea Biopharmaceuticals. Previously, he has held numerous senior executive positions at both public and private companies.