Risk Mitigation
Ben Zeskind, Ph.D., CEO, Immuneering
A: Our company has always prized agility and the ability to work across geographies. We had been operating offices in Boston, New York, and San Diego for some time, making us well-equipped to manage and direct the transition from in-office to in-home easily. Our team was already expert with Zoom meetings and Slack well in advance of COVID-19.
We have also always prioritized hiring highly self-motivated individuals, which enabled continued rapid growth when we all went remote. For example, Immuneering’s dual-RAF/MEK inhibitor is now less than a year from the clinic, and our KRAS modulator is now in hit-to-lead. Immuneering’s neuroscience team also launched a collaboration with Astex during the pandemic.
In addition, we have maintained strong lines of communication with our employees, ensuring them that their safety and comfort comes first. Providing this strong support to an already highly motivated workforce has helped enable us to be productive and successful despite the many changes encountered by the pandemic.
Richard Ettl, CEO and Founder, SkyCell
A: Throughout the pandemic, we have had to contend with flight cancellations and localized lockdowns, the need for emergency shipments of lifesaving vaccines across great distances (one such shipment going from Tokyo to Frankfurt), and misplaced cargo on the tarmac. Despite these mounting challenges, the tracking technology in our smart containers has allowed easier management of cargo and better communication with ground crews across the globe when shipments have been misdirected or lost. The self-charging capabilities of our containers mean that — no matter where they were and no matter the external conditions — they were always at the correct temperature to ensure that products arrive at their destination unspoiled.
The company’s hybrid solution of hardware and software has allowed for smooth operations to continue throughout the crisis, and this should continue in the future. SkyCell’s innovative product design and innovative IoT technology has allowed us to continue to perform at pre-pandemic levels throughout the pandemic — even in March and April when countries were locking down airports and flights were being cancelled at short notice.
Beyond the technology in the actual delivery, we have been successful in remaining efficient while part of our workforce worked from home. As critical suppliers to governments such as the EU and Switzerland, we already had this contingency planning in place, and the transition was smooth. Collaboration, both internally and with external stakeholders, is vital to the work we do, and we were quickly able to move our operations to remote working without any loss of performance. The pandemic has shown all companies in all industries the importance of being able to work remotely, and this will be something that companies will have to look at moving forward.
Amélie Boulais, Marketing Manager within the Vaccine Segment, Sartorius
A: Because we’re a leading supplier for end-to-end bioprocessing products, our sector has been greatly impacted by COVID-19. Our customers developing and producing a SARS-CoV-2 vaccine or therapeutic need the necessary technology immediately, thereby increasing its global demand.
While these changes have caused a significant increase in demand, Sartorius has been able to maintain its performance level thanks to its robust manufacturing strategy and further mitigation actions. Some of these steps include:
- Strengthening safety regulations at the manufacturing sites to keep risk of cross-contamination to a strict minimum in case somebody is infected;
- An established global manufacturing network enabling load balancing across sites, thereby ensuring optimized capacity utilization and limiting risk for site-specific bottlenecks;
- A long-established strategy of a minimum of dual manufacturing capabilities of key product families;
- A fully operational demand-planning structure in close contact with our global customers, including the COVID-19 vaccine developers, to anticipate future demand, which is translated in our routine S&OP process to anticipate future capacity needs.
- A core-carrier program with strong partnerships with our key forwards to ensure a strengthened logistical network, even at times when transportation possibilities are limited;
- Increased manufacturing output through process optimization, additional personnel, production equipment, and production shifts for key technologies;
- Stock review and increase both for finished products as well as raw material; and
- Ensuring that we can maintain our supply chain and product quality outside of COVID-19–related products, so organizations producing other vital products aren’t disrupted.
Dave Freidinger, Vice President, Business Management, BASF Pharma Solutions
A: To me, there’s no such a thing as “crisis-proof” organization. However, there are companies with more capacity to utilize crisis situations as a catalyst for change and a chance to do things differently. At BASF, we were able to build upon our strengths: a diversified and backward integrated portfolio, a global production footprint, the company’s solid financials, and flexible and motivated employees.
BASF’s diversified portfolio offers numerous advantages, especially in difficult times. Not all of our customer industries were and continue to be equally affected by the pandemic, and each showed different degrees of resilience in this environment. The pharma segment, for example, was expected to perform even at levels higher than before the pandemic, as many of our ingredients were utilized in the race for treatment and vaccine options for COVID-19, as well as the countless other essential medicines that patients rely on — quite simply, supply continuity was crucial.
As part of an overarching contingency plan, BASF has had a pandemic preparedness plan for a long time. The company has set up crisis teams in all regions to coordinate and communicate all measures. The crisis teams evaluated current information from external and internal experts and decided on a daily basis which measures are appropriate for BASF at the respective sites and globally. Our objective was and is to secure both the continuity of our business operations and to protect our employees, contractors, visitors, and the communities in which we operate.
We know that many of our products are indispensable for the continued production of essential industries, such as pharma, hygiene, and food. This awareness gives our employees extra motivation to continue strong contributions to their role within the business and the industries that we serve.
Shannon M. Parisotto, Corporate Senior Vice President, Global Safety Assessment, Charles River Laboratories
A: At Charles River, business continuity plans (BCP) are in place to help our sites prepare for a variety of situations and crises. During COVID-19, these plans enabled us to continue operations and exceed client expectations, especially during a time when our services are so critical to clients and the industry. During this time, our BCP enabled us to have 70% of our people, who are considered essential, continue to be on-site in our facilities. It also provided us with the framework to ensure all client meetings, communications, and audits shifted to an entirely virtual model.
Additionally, we have carefully examined our suppliers and know exactly how their process and routing works. Our procurement team has been monitoring changes very closely and helped significantly in sourcing the required supplies to support our businesses. This combination of staying close to our clients and managing our supplies allowed us to continue to deliver for our clients. This coordination would not have been as successful without our well-tested BCP.
As the pandemic evolves or new challenges arise, the key is to remain agile, always monitoring the situation and advising with our internal and external experts on the impact on employee safety and business operations. With proper planning, we can achieve our goals of both protecting our employees while still meeting clients’ needs for research products and services.
Radek Špíšek, Ph.D., Global CEO, Sotio
A: While the advent of the COVID-19 pandemic brought about a tumultuous period across industries, we demonstrated operational resilience and established ourselves as a “crisis-proof” organization. It was a priority to act, rather than react. We seamlessly adjusted operationally by introducing initiatives, such as flexible work-from-home policies, and investing in technology and infrastructure to support remote work and virtual collaboration capabilities. As we embraced adaptability, we were able to continue to achieve important company milestones, such as dosing our first patient in Part B of phase I/Ib study of IL-15 superagonist SO-C101, in combination with PD-1 inhibitor pembrolizumab for the treatment of advanced/metastatic solid tumors, as well as acquiring rights to the BOXR CAR-T platform and products from Unum Therapeutics. Our ability to pivot accordingly allowed us to focus on our mission to develop the next generation of immunotherapies for patients with cancer.
Andrew Badrot, CEO, C2 PHARMA
A: C2 PHARMA is a virtual manufacturing and distribution company specialized in establishing high-quality, redundant supply chains for complex active pharmaceutical ingredients (APIs) from natural and synthetic origins. Our business model is rather unique for this industry, with a focus on building quality, reliability, and sustainability throughout our supply chain.
Rather than pouring money into owned production facilities, our time and money are invested in creating a supply network that manufactures quality APIs from sustainable, reliable sources under contract for us. We also work with affiliates for preferred access to services that further complement our goals.
To ensure that our goals are met, we have implemented a proprietary quality oversight model to fully validate CMO (contract manufacturing organizations) for end-to-end API life cycle management, and all CMO and testing laboratories are under comprehensive QAAs (quality assurance agreements) with audits conducted annually. Our unique approach to doing business requires a level of full transparency on activities that is built on deep partnerships. And this approach has paid off during the pandemic with no delays or gaps in the supply chain.
2020 has been a challenging year mentally, but from a business perspective, our team has stayed committed. We are getting ready to submit more than ten regulatory filings in the United States, Europe, and Asia before the end of 2021, and I am very proud of what we are achieving. We are setting a new standard across the industry.
Nariné Baririan, PharmD, Clinical Pharmacology Expert, SGS
A: With all of the standard protocols that are necessary to maintain the smooth running of clinical trial operations to meet the necessary regulatory requirements, crises such as the COVID-19 pandemic demonstrate the need for organizations to be flexible, responsive, and above-all professional, so that studies can continue.
Obviously, the safety and well-being of trial participants and staff remains the top priority of any organization conducting clinical studies, but it is absolutely imperative that the quality and integrity of data from trials remains at the highest standard.
To this end, we must look to the regulators for guidance in times of crisis, and this pandemic led to the FDA, EMA, and MHRA releasing guidelines to ensure that trial facilities could operate safely, and studies could continue. Alongside this guidance, national and regional instructions and regulations needed to be adhered to, so that we could resume activities in our Clinical Pharmacology Unit (CPU) in Antwerp.
With some adaptions to procedures, and the adoption of new methodologies, as well the commitment and flexibility of staff and investigators, the CPU has continued to run effectively. Visits to the unit are carried out by individually scheduled appointments and are streamlined to reduce the time subjects spend at the facility, minimizing contact with staff and other study participants. Technology has been adopted that allows for data to be collected and reviewed remotely, further reducing staff contact with subjects.
The nature of crises makes events unique, but as a company we learn from them and look to use them to inform future planning.
Antony Fitzpatrick, Executive Vice President Operations, Vectura
A: What we have seen over the last six months is unprecedented and has tested every company’s resilience. At the beginning of the pandemic, Vectura initiated its crisis management procedures, which cover a range of scenarios, and quickly began establishing priority actions to ensure that the safety of employees, business continuity, and delivery of critical products were unaffected.
There are probably two key areas that can be identified as being important to be resilient in this time. First, in our supply chain and our network of logistics operations, we had identified options that minimized risks, both to us being able to manufacture products and ship them to patients throughout the crisis. Second, using technology to its optimal efficiency was crucial to ensure that communications, both internally and externally, throughout the pandemic were swift and decisive. Without face-to-face contact, we have had to adapt our methods of communication, and this has been important both for business needs and to maintain the well-being of employees.
One specific point about resilience should be reserved for the staff and the efforts they have gone through to ensure that business was unaffected. Teamwork has been vital, and the cross-functional teams that were established out of necessity have brought people together. People have also learned new skills because of them, which makes us stronger going forward.
Michael Cannarsa, Ph.D., Director of Business Development, Almac Sciences
A: I’m not sure any organization is completely “crisis-proof” — we never know what is around the corner; however, implementation of the appropriate policies, processes, and structure for communication throughout a crisis can ensure any eventuality can be managed effectively.
With over 5,600 employees operating globally, Almac must act swiftly to assess the situation, agree on the appropriate actions, deploy a strategy to implement agreed measures, and immediately communicate to all key stakeholders across the business. This takes careful planning and decisive action, ensuring preventative measures are implemented where possible, and a flexible approach is adopted to adequately manage all situations, something which we were able to clearly demonstrate throughout the COVID-19 situation.
Jeff Stein, Ph.D., CEO, Cidara
A: While completely “crisis-proof” is a high bar, as an organization, Cidara fosters an adaptive and agile corporate culture, as well as sustaining a strong balance sheet and maintaining continuous dialogue with our employees, board members, and shareholders.
During the pandemic, we actively managed our business operations, while also taking measures to protect the well-being of our employees, their families, and local communities. We transitioned many of our employees to work virtually, and, for positions that required onsite work, we implemented safety measures that aligned with local and state guidelines. Having our own labs in-house also streamlines communication and generates open dialogue. During the COVID-19 crisis, it’s often been our heightened sense of corporate mission to prevent and treat serious infectious diseases, which translates to getting things done no matter what.
Despite the impact of the pandemic, our stock (NASDAQ: CDTX) has gone up 165% over the past year. This is a testament to our experienced management team that not only knows the infectious disease space inside and out, but also has gone through a previous recession together in 2008 and knows how to effectively handle times of uncertainty.
Our team is built around the core values of collaboration, integrity, accountability, urgency, and courage. These values are the basis of our corporate culture and help us to handle adversities. By authentically living out our mission statement, we are equipped to communicate internally and externally in a timely and effective manner, adapt quickly, react purposefully, and work with reliability.
Kay Schmidt, Senior Vice President, Technical Operations, Catalent
A: Like every global organization, Catalent has crisis management plans in place for various scenarios. Surveillance and communication are key and help identify threats quickly to enable timely response.
It is not easy to anticipate everything needed for any crisis. The COVID-19 pandemic is, we hope, a once-in-a-hundred-years crisis. We had no roadmap, but our mission and values provided a compass to guide our actions.
First, we looked to secure the safety of our employees before assessing the impact on 40+ facilities across four continents. Our work is essential in protecting the health and well-being of millions, so we had to ensure reliable supply of medicines to patients and consumers.
It sounds like a cliché, but the strength of our response has undoubtedly been our people. We focused on putting employees and patients first. Above all, we listened to deep expertise from our teams and the needs of our sites. Our facilities remained open, and we are responding to 50+ diagnostic, treatment, antiviral, and vaccine programs against COVID-19.
Effective communication internally and externally has enabled strategic assessment of capacity, equipment, and resource allocation; and, alongside careful planning, proactive investment has been expedited where necessary to ensure that we can deliver on our future commitments. Critical projects were even expedited “at risk,” before contracts were formalized, with a view to saving time.
This ongoing pandemic gives Catalent the opportunity to reflect and re-evaluate the crisis management plans that were in place and refine them for future scenarios.
Sean Kirk, EVP, Manufacturing & Technical Operations, Emergent BioSolutions
A: I don’t believe any organization is crisis proof, because you can’t foresee what the crisis is going to be.
There’s a big difference between an organization dealing with the crisis of a global pandemic versus the crisis of a natural disaster like a tornado, hurricane, or wildfire. A crisis can manifest in many different ways. Speaking specifically in the context of the COVID-19 response, we’ve done an extraordinary job leveraging our historically established business continuity programs that were written years ago and then brought to bear in the COVID-19 emergency in order to protect our employees, solidify our supply chains, and enable our organization to continue to provide a variety of critical products. This has been possible because of the tremendous amount of effort put into proactive planning around business continuity in the past, which has in many ways saved us. We weren’t “creating the will” in the midst of an emergency. Thankfully, it was already created.
Jean Bléhaut, President of the Synthesis Solutions Business Unit, Novasep
A: I wouldn’t go as far as to say that we are crisis-proof, because we never know what can happen in the future. However, we have shown great flexibility and managed to be responsive from the beginning of the COVID-19 pandemic.
We had to adapt and transform our organization to react quickly and minimize the impact of this pandemic on our business. We decided to put in place a dedicated governance, on two different levels:
- A crisis unit with daily calls of the executive committee to make swift decisions, and
- A task force composed of mixed profiles: some people from the top management, as well as employees from various departments within Novasep.
This organization has helped us to take rapid decisions and to set up and disseminate new procedures in the most effective way. We managed to stand by our commitment to customers and patients despite the crisis. It is certainly a best practice that we could duplicate if we face other critical situations in the upcoming years.
Casey Franklin, Senior Manager of Sales & Business Development, Alcami
A: We’ve learned this year to expect the unexpected, and I don’t think any organization can be 100% “crisis-proof.” Still, at Alcami, we work very hard to be proactive and prepared for anything that may come our way. This effort applies beyond natural disasters and force majeure events to anything that may not go as planned. I’m confident anyone working in drug development would agree; unforeseen challenges will inevitably arise somewhere along the way.
At Alcami, our size enables us to adjust quickly and adapt to crises. For instance, this year we have embraced remote working and virtual solutions. Alcami employees have been amazingly creative and persistent in overcoming other challenges like supply chain issues that have come with the pandemic. We’ve maintained operations at all sites and even have a new sterile facility in RTP, North Carolina, on schedule to be operational in October.
A huge part of Alcami’s ability to be “crisis-proof” is the willingness of our employees to go above and beyond to ensure that our work can go on. We are a small cog in the giant machine responsible for providing lifesaving medications, and that is a big responsibility. Across all departments, we keep in mind the patients that our work is benefiting in the end, and that always provides the motivation needed to overcome whatever crisis we may encounter.
Dietrich Stephan, Ph.D., CEO, Neubase Therapeutics
A: The key to overcoming any crisis is robust planning, eliminating single points of failure, adapting quickly, and building a culture of creative problem solving. We spend an enormous amount of focused effort planning our objectives and key results (OKRs) on a quarterly basis, which align with the company’s long-term goals.
Thereafter, we review them from the perspective of risk, so as to deeply understand the fragile points and then shore those up. Many risks fall into the category of single points of failure. In these instances, we build redundancy if possible. In addition to redundancy, we make sure that we monitor potential risks closely and in real time to ensure that we have the earliest visibility into the need to adapt. Adaptation must be done quickly and decisively, and rigorous advance planning allows us to think about how we might adapt should we be required to do so. Early data points indicating a manifesting risk are evaluated unemotionally, followed by a set of diverse inputs from our team and finally decisive decision-making. All failures and resolutions are captured and allow us to keep getting better.
When the pandemic first began, we quickly responded and implemented measures to protect our employees while still pressing ahead with our work. We adjusted schedules, made all of our meetings virtual, and implemented strict safety guidelines. The entire process was surprisingly seamless, and we believe that many of these new practices streamlined our process and will continue well past the pandemic.
Dago Caceres, Global Strategic Marketing Leader for the Pharma Solutions Platform, DuPont Nutrition & Biosciences
A: For the pharmaceutical industry, it’s critical that their strategic suppliers and partners are companies with a robust financial position, a responsible management structure, a long-term view of their business, high ethical standards, a focus on making high-quality and safe ingredients, and redible and up-to-date business continuity plans to ensure a reliable and consistent delivery of the product. DuPont’s alignment with these needs and our decades-long commitment to the industry allow us to maintain and grow our participation in this space even during these difficult times.
