Q: What game-changing technology/technique is not being utilized within the clinical space, and what can be done to change this?
A: There are three that come to mind: 1. Business intelligence tools geared at giving insight to key performance indicators and compliance; 2. Central statistical monitoring (CSM) software used to target sites that can be identified “at risk” (By identifying discrepancies early we can implement timely corrective actions to ensure the quality and integrity of the data. Industry groups need to collaborate on testing these systems to gain insight into the pros and cons of these systems.); 3. Electronic monitoring devices to capture subject information (e.g., vital signs, ECGs) wirelessly and seamlessly to the vendor and sponsor EDC systems. This technology, to some extent, can reduce or eliminate redundant data entry and reconciliation time while also improving quality and timeliness of data. In addition, it would make centralized remote monitoring a reality, reducing costs and improving detection of adverse events.
DR. MITCHELL KATZ
Dr. Mitchell Katz has 26 years’ experience in the pharmaceutical and biotech industries, including preclinical research, pharmaceutical operations, and regulatory affairs. In his position at Purdue Pharma L.P., he is the executive director of medical research operations.
Q: What’s the most valuable insight gained from working with local government officials during expansion projects, and how would you suggest to prepare for these types of interactions?
A: I learned that there are as many interests at play as there are government agencies and officials. You shouldn’t expect that it is a simple bilateral interaction. As with most interactions with government officials, you need to be familiar with the remit and perspective of the various agencies and political bodies. There are a lot of local nuances in how these groups interact with businesses and each other, and you should spend time getting good intelligence from people who have experience in dealing with them on projects of similar scope. It helps to understand the constituencies and “hot” issues for the various groups so that when negotiating on particular points you know who are the likely allies and who are likely to be in opposition.
William Ciambrone is the executive VP of global technical operations at Shire. He has more than 20 years of experience in the pharmaceutical, device, and biopharmaceutical industry.
Q: What supply chain practices need to be updated, and how would you do so?
A: Supply chains are typically modeled around the core processes of plan, source, make, and deliver. Upstream in the supply chain are forecasting processes that have inherent variability and lead to (amongst other things) high inventory levels, wrong product mix, and product shortages. More progressive companies see their supply chains as an integrated, collaborative, end-to-end process that delivers a competitive advantage and enhances total value. Shifting from being a reactive, forecast-driven supply chain to a demand-sensing one allows for better alignment between functions. A pull-replenishment model receives demand value and service. All of this drives an enhanced customer experience.
Anu Hans is the VP and chief procurement officer, enterprise supply chain at Johnson & Johnson. She also serves as a board member for the Drug, Chemical, and Associated Technology Association (DCAT).