Q: What is your biggest concern with the U.S. life sciences industry, and what should be done to address it?
There are real threats to the U.S. life sciences industry, including increasing pressures on reimbursement for innovative new medicines, a scaling back of investment in early-stage biopharmaceutical companies, and a drain of scientific and entrepreneurial talent to rising powers such as China. To address these threats, we need to first educate political leadership and the public that continued medical innovation is worth the price, as innovative medicines actually reduce net healthcare costs over time. Second, we need to use the tax code more effectively, enacting laws that allow start-ups to appropriately retain and use nonoperating losses (NOLs) while providing other tax incentives. Third, we need an immigration policy that allows the brightest scientific minds to remain in the U.S., offering green cards to foreign nationals who receive an advanced U.S. degree.
Ron Cohen, M.D. is president, CEO, and founder of Acorda Therapeutics, Inc., a public biotechnology company developing therapies for spinal cord injury, multiple sclerosis, and other nervous system disorders.
Q: What are the top 3 challenges (and possible solutions) faced by U.S. companies outsourcing to India/China?
Ensuring product quality and consistency is, of course, an overriding objective. This requires effective technology transfer but is equally dependent on securing a reliable supply chain. It is important to recognize that there are significant differences between India and China, which will impact outsourcing decisions. The maturity of the pharma industry is quite different in each. Issues such as infrastructure and language may also play an important part in the success of an outsourcing exercise, and there will need to be work with local regulators and a focus to ensure the quality systems employed meet the high standards required. Finally, it is important to recognize that any equipment used may well be sourced locally so its suitability, integrity, and reliability all need to be considered.
Tim Freeman is managing director for powder characterization company Freeman Technology. He has 10 years of experience in understanding and characterizing powder behavior and works closely with the pharmaceutical and powder processing industries.
Q: Why does it seem the pharmaceutical industry is slow to adopt new technologies?
The pharmaceutical and biotechnology industries are dominated by scientists, even on the commercial side of the business. Scientists become uniquely excited and personally engaged by new technologies. Yet, the regulated nature of the industry means that scientists’ personal desire to adopt better, more effective and efficient technologies are seriously hobbled by the need to consider how they will affect regulatory submissions, reviews, and ultimately revenue flow for their areas of responsibility. The hurdles to adoption are as varied as the innovations themselves, times the number of regulators potentially involved. Though scientists are attracted to new technologies, the industry is very risk-averse, and thus why you have a significant difference between what bio/pharma decision makers say they want and need and what actually gets implemented. If you want to speed up adoption, be sure to address their regulatory concerns about your new technological innovation proactively.
Eric Langer has more than 20 years of experience in biotech and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies.