STRATEGY
What are the current supply chain challenges still facing the clinical landscape, and what suggestions would you recommend to resolve them?
The top three supply chain challenges I see still facing the clinical landscape are: 1. Demand: We need more accurate demand forecasts, in order to help us plan our supply chains accordingly. The lack of accurate forecasts has mainly impacted small clinical- stage companies, which haven’t yet acquired the knowledge/expertise. It’s important for sponsors to work closely with their opinion leaders and contract research organisation (CRO) to discuss, determine, and provide recurrent updates on what’s the latest realistic enrolment rate for supply planning purposes. 2. Supply: Not surprisingly, most contract packaging organisations (CPOs) are still focusing their resources on COVID-19-related trials – which is understandable because we are still in the pandemic. I suggest that sponsors make strategic partnerships with vendors that relatively match their own size, therefore the sponsor priority is an urgency for the vendor. 3. Communication: Timely and transparent communication is critical to daily supply chain operations, both horizontally and vertically. It’s also important to be able to to articulate your message in a way that others can easily understand. That’s easier said than done.
How will trial designs shift, and how will supply chain strategies change as a result? Sponsors will explore opportunities to conduct their trials in countries that are more compliant to public health during their 1st Tier study- country launch phase, which will involve a lot of upfront planning, especially around manufacturing, regulatory compliance, and supply chains. Strategic partnerships will be highly important for supply chains in setting up depots, couriers, and packaging capability in those countries.
What kinds of models are there for supply- planning processes and how will these look post-pandemic? As I’ve mentioned, we need more accurate demand forecasts from both internal clinical science and development, and external opinion leaders, and contract research organisation
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expertise. Plus, I think there will be more collaborative work between chemical manufacturing control (CMC), quality control, and regulatory control to determine supply availability due to resource constraints in all levels of operations caused by COVID. Lastly, I foresee that we will see more performance-based service contracts moving forward post-COVID.
How can trial sponsors ensure vendor capabilities match their production needs, and what they need to consider when choosing a facility? A good way to assess vendor capabilities is through a thorough vendor selection process with detailed questionnaires and request-for- proposal (RFP) assessments with cross- functional group inputs. In addition, the core consideration criteria should include but not be limited to: capability and capacity; quality system compliance; and pricing. I would also highly suggest including customer engagement, agility and flexibility, and reference checks. Ideally, you should select a partner who has interchangeable equipment/facilities across the globe, so that the sponsor can easily mitigate risks in case of any geographical impacts. For ongoing vendor management, it’s important to agree on performance criteria, and conduct quarterly performance reviews with vendors to assess areas of improvement, but also celebrate achievements.
Shell Lee has more than 20 years of experience in the pharma/biotech industry, with diverse experience across all phases of development, commercial, contract manufacturing organisation, and management consulting. He has managed supply chains across multiple therapeutic areas including antibacterial, ADHD, cardiovascular, HIV/AIDS, and oncology. Shell received his
B.Sc. in ceramic engineering, and his
B.Sc. in applied sciences in engineering (packaging engineering) from Rutgers University; an MBA from the University of San Francisco; and completed his lean six sigma certification from Rutgers School of Business. Shell currently serves as a member of the Board of Directors of Extreme Kids & Crew in New York; a member of the Board of Health; and a volunteer firefighter in Chatham New Jersey.
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