Arena International most recently held its 5th Annual Clinical Trial Supply New England conference in early March, and it really did prove to be a fantastic success. With the New England region providing a steady flow of rising biotechs, as well as the long standing presence of large pharmaceutical companies, we were privileged to welcome esteemed individuals from various pharmaceutical and biotech companies from the region.
The 2016 event brought together clinical supply experts to share experiences and provide key practical learnings to help create an efficient and targeted approach towards clinical supply. The vast array of topics being discussed allowed for an exciting event and one particularly captivating presentation came from Gelesis's Chief Technology Officer, Eyal Ron. The vastly experienced Dr. Ron succinctly showcased manufacturing management strategies and examined selection processes to help provide the ideal manufacturing partner for your company.
For any pharma or biotech, one of the underlying crucial factors in ensuring clinical supply success is selecting a reliable manufacturing partner to allow for efficient and timely clinical supply. Dr. Ron took no exception to this rule and outlined the ideal manufacturing strategy along with an in depth analysis of the critical factors within the RFP process.
A manufacturing strategy can consist of many steps and require a lot of consideration to help find the right formula that fits your company. Dr. Ron highlighted the importance of considering your business strategy and manufacturing strategy as a combined component, and went on further to pinpoint two particular aspects of a manufacturing strategy. These are competitive priorities and decision categories. Competitive priorities are considerations, such as cost and quality, whereas decision categories are components, such as performance, reliability and resources.
In order to find a partner who meets the needs of your company, one must carry out a Request for Proposal (RFP). An RFP, as mentioned by Dr. Ron, can establish accountability throughout, as well give the opportunity to "bridge the gap between vague aspirations that launch a product, and concrete, measurable requirements that guide it to a successful conclusion".
As already outlined, RFP's are an important factor in selecting the right partner for your company. However, with it holding so much significance, it is essential to know exactly what must be included in a standard RFP. Dr. Ron provided the audience with a clear checklist to ensure all future RFPs contain the necessary questions and considerations to guide you in making the right choice. In particular, Dr. Ron analysed the "killer criteria" - quesions designed to highlight previous experiences, fee structures or product specifics (physical properties).
Timelines is also a crucial factor in every RFP, largely because in order to meet your supply needs the company must set reasonable and achievable timelines. This can be done by proposing specific deadlines and milestones.
Another component of an RFP, often overlooked by Dr. Ron, is including your own contact information and deadline for submissions. By providing a submission deadline, you can get an understanding of who the really interested parties are and also reduce the possibility of time being wasted to audit potential partners who are perhaps not as invested in achieving your goals.
Whilst Dr. Ron did provide a checklist to understand what must be included in an RFP, it does not minimize the challenges that do occur during an RFP. The most common challenges faced during an RFP are forecasting uncertainties, establishing a key point of communication through product changes, and ensuring the product quality falls in line with the competitive priorities and decision categories.
However it is worth pointing out that with the correct partner these challenges can be reduced. The only way to ensure you have the best partner for your company is to carry out thorough evaluations from the RFP vendor feedbacks. According to Dr. Ron, in order to completely evaluate each vendor proposal, it is important to consider the level of quality provided, timelines proposed, and crucially, cost. Quite intriguingly, Dr. Ron broke down cost into three key categories in order to determine the "true cost". These are: Quality (number of failures/defects), Delivery (lead time) and Innovation (ideas or improvement suggestions from the vendor). This unique approach to help identify the true cost of the services provided by the vendor and allows your company to gain a better understanding of the reliability, flexibility, and lastly, its willingness to provide solutions to situations.