Clearly, supply chain has been one of the most impacted functions at all these life science firms. But BSMA leaders have demonstrated a willingness and ability to respond quickly and effectively.
For example, many biopharmaceutical firms tap other groups for scenario planning and forecasting. MIT is one such group that has held regular webinars to discuss potential outcomes that companies can use to baseline the next batch of forecasts.
Companies have also explained that forecast transparency throughout the supply chain is critically important. Having all stakeholders work from a single forecast which is updated in real time is a powerful tool for maintaining a robust system from incoming raw materials to outgoing finished goods.
If a supplier understands on a daily basis where its product stands in a manufacturer’s inventory levels, it can do a far better job of maintaining appropriate volume.
Another way BSMA supply chain leaders have responded to COVID-19 relates to shipping lanes. Most companies have adjusted shipping lanes, especially those which rely on commercial air carriers. Cancellations of scheduled flights have increased cost and lengthened shipment time. So, in many cases, supply chain professionals have turned to cargo flights and have, in some cases, even chartered their own aircraft.
Clinical study supply is especially challenging to predict in the best of times, with enrollment cycling up and down. Companies have had to work far more closely with clinical sites in order to maintain sufficient supply, ensure data integrity, and protect study teams.
In those instances where a manufacturer interacts directly with trial participants, remote study visits have been combined with telemedicine, home health care, and other techniques to ensure continuity of care and data integrity.
For both commercial and clinical situations, companies have ramped up inventories to enable them to respond to unexpected fluctuations.
This, of course, has led to increased communication with contract providers. Interaction with CROs and CMOs has moved from “regular” to “critical”. As one member explained, Paul Seaback, Senior Vice President, Technical Operations, Dermavant Sciences: “We took the initiative to stay close to FDA guidance, to deal with emerging logistical challenges as well, to ensure the supply of product to patients.”
Communicate, communicate, communicate. Companies have upped their communication internally as well as externally. Cross-functional response teams have been created at many BSMA member firms. These typically bring together operations, research, IT, HR, safety, finance, commercial to decide on overall response. Then, functionally-oriented subgroups focus on implementation.
Companies have added daily communications summary on COVID-19 and hold frequent all staff meetings.
Their workplaces transformed, most staff now function from home offices, which brings both opportunities and challenges.
“We’ve evolved,” Seaback of Dermavant Sciences, commented, “… doing everything everyone else is doing in terms of cross-functional teams and communication … while remaining flexible in the midst of cats, dogs, and kids … while advancing the business.”
Staff responsible for essential functions such as manufacturing and testing continue to visit their facilities.
Mitigation measures for these essential function workers are in place at most organizations. Use of personal protective equipment, social distancing, split shifts, and non-interacting teams are common. Temperature is usually taken for all entering employees, as well.
Prior to discarding incoming material packaging, the company sanitizes all boxes, packing, etc.