The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.
Issue link: https://lifescienceleadermag.epubxp.com/i/183291
EDITORIAL ADVISORY BOARD John Baldoni Chair, Leadership Development Practice N2growth Heather Erickson President and CEO Life Sciences Foundation Rafik Bishara, Ph.D. Chair, Pharmaceutical Cold Chain Interest Group, PDA Norman Klein Principal, Core Results Jeffrey Evans, Ph.D. Life Science Entrepreneur Jerold Martin Chairman Bio-Process Systems Alliance (BPSA) Timothy Krupa President, TSK Clinical Development John LaMattina, Ph.D. Tim Freeman Senior Partner, PureTech Ventures Director of Operations at Freeman G. Steven Burrill Technology and Past Chair of the Process Eric Langer CEO & Founder, Burrill & Company Analytical Technology Focus Group of AAPS President and Managing Partner BioPlan Associates Ron Cohen, M.D. Laura Hales, Ph.D. President and CEO Founder, The Isis Group Lynn Johnson Langer, Ph.D. Acorda Therapeutics , Inc. Director, Enterprise and Fred Hassan Regulatory Affairs Program Laurie Cooke Chairman of the Board Center for Biotechnology Education CEO Johns Hopkins University Healthcare Businesswomen's Association (HBA) Bausch + Lomb John Hubbard, Ph.D. Alan Eisenberg Senior VP & Worldwide Head Executive VP, Emerging of Development Operations, Pfizer Companies and Bus. Dev. Biotechnology Industry Organization (BIO) Maik Jornitz Founder, BioProcess Resources, LLC Barry Eisenstein, M.D. Immediate Past Chair PDA Senior VP, Scientific Affairs Cubist Pharmaceuticals Mitchell Katz, Ph.D. Exec. Dir. of Medical Research Operations Purdue Pharma, L.P. Craig Lipset Head of Clinical Innovation, Worldwide Research & Development Pfizer Greg MacMichael, Ph.D. Global Head of Biologics Process R&D; Novartis CHIEF EDITOR'S BLOG Mark Pykett, Ph.D. President and CEO Navidea Biopharmaceuticals Bernard Munos Founder, InnoThink Center for Research in Biomedical Innovation John Reynders, Ph.D. Chief Information Officer Moderna Therapeutics Mike Myatt Leadership Adviser, N2growth James Robinson VP, Vaccine & Biologics Technical Operations, Merck Carol Nacy, Ph.D. CEO, Sequella, Inc. Mark Snyder, Ph.D. Former Associate Director, Purification Process Development Bayer HealthCare Sesha Neervannan, Ph.D. VP Pharmaceutical Development Allergan Kenneth Newman, M.D. CMO, Exec. VP, Clinical Dev. and Medical Affairs, Acton Pharmaceuticals Kevin O'Donnell Senior Partner, Exelsius Cold Chain Mgt. Consultancy U.S., Chair Int. Air Transport Assoc. Time & Temp. Task Force Leslie Williams Founder, President, and CEO ImmusanT Ann Willmoth General Manager Blue Standard Consulting Find more original content in (or submit your own to) any of the other Life Science Connect websites, such as BioresearchOnline.com, ClinicalLeader.com, OutsourcedPharma.com, and PharmaceuticalOnline.com. Outsourced Pharma sourced Have a response to our experts' answers or a question of your own? Send us an email to atb@lifescienceconnect.com. 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 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. 8 Tina Morris, Ph.D. VP, Biologics and Biotechnology USP Division of Documentary Standards MORE ONLINE CONTENT Want to find out what's on the mind of our chief editor, Rob Wright? Check out his blog on our website where he writes about a variety of topics such as recent shows attended, conversations with industry experts, and irritating business buzzwords. ASK THE BOARD John Orloff, M.D. Senior VP, CMO, Global Development Novartis Pharma AG LifeScienceLeader.com 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. Nacy 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. October 2013 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. Pykett, is the president and CEO of Navidea Biopharmaceuticals. Previously, he has held numerous senior executive positions at both public and private companies.