Q: If you could implement a change at the FDA, what would it be?
The criteria for PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Amendments) provide the framework for a change I’d like to see implemented — an enhanced communication strategy developed by the FDA that includes all stakeholders. Why? As innovation in the industry has accelerated, so have the submissions for approval. For a number of reasons, the FDA has been challenged in meeting PDUFA timelines, leading to delays to the market. By executing a consistent, clearly defined communication plan, many of the obstacles along the path to drug approval can be overcome and ultimately, patient needs are served.
Ann Willmoth, M.Ed., is the general manager of Blue Standard Consulting, a healthcare management consultancy, advising companies on business strategy and commercial approaches to the market.
Q: What’s the future for a global harmonized regulatory approach to reduce supply chain costs?
In a word? Distant. Companies have accepted that meeting splintered regulatory requirements and reducing supply chain costs are often mutually exclusive undertakings. A global regulatory approach or standard to reduce supply chain costs, in my view, is a long way off because protecting patient safety trumps expense for implementation and practicability, and too often these considerations are not given enough weight. Many countries with specific requirements — and the need for national autonomy — have made harmonization under one overarching, harmonized standard seem an improbable and distant hope. Product and service suppliers to the industry have recognized this and have strategized to improve the “value-add” to their offerings as a means of leverage and gaining competitive advantage. Likewise, 3PL and 4PL service providers continue to expand the breadth and scope of their global operations and fulfillment options, all in an effort to compensate for this regulatory incongruity.
Kevin O’Donnell is senior partner at Exelsius Cold Chain Management Consultancy US, an international provider of consultative, research, and training services to manufacturers, airlines, forwarders, and other stakeholders in the life sciences logistics sector.
Q: As a CEO/founder of a life sciences company, what is the biggest obstacle you struggle with, and how do you overcome it?
As a founder of an early-stage virtual start-up, one of the major challenges is balancing the scientific and business priorities of the company within the limited resources that are available. Essentially, a lot of it comes down to funding. Accomplishing company goals and staying on track with limited funding means tapping into every available resource and seeking out as much “free” help when necessary. It also means “wearing many hats” and learning how to do as many things as is possible yourself. Of course, success is not possible without good consultants and advisors. Finding the best consultants and managing them well is another challenge. Success comes from having a wide but valuable network to tap into when necessary. Staying well-organized, with daily prioritization, is the only way to stay in the game.
Dr. Laura Hales has more than a decade of experience in biologics discovery research and is currently a founder of Extend Biosciences and The Isis Group.
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