March 11, 2022 PAO-03-022-RT-02
A: Perspective and agility. Being agile can mean flexible, but in a modern business setting it has more to do with a mindset that is adaptable through feedback. Perspective, for me, means removing the blinkers that we naturally acquire when we think it is necessary to focus. A leader must have priorities, but the pharma industry is providing many new inputs at this time. Balancing the absolute need to preserve the highest quality for actives, inactive ingredients, and solutions with a need to remove — or make more transparent — the blinkers we use to focus on development channels is an evolving skill. A specific example of this blinkered thought relates to my experiences with quality by design (QbD). I have often made a statement that excipient innovation has been held back. Why? Because many formulators and material scientists felt that the variances that could exist with excipients should be processed out. But oftentimes we needed this “variance” to make a particular formulation effective. If we processed the variance out, an essential medicine could not be produced. This could lead to normalizing excipient performance yet completely squandering opportunities to utilize natural performance. Not only that, but QbD in other industries strived to make great, efficient, and long-lasting design, and it also searched for the innovative new materials to make their completed products better. Leaders in drug discovery, drug delivery, biopharma, and ingredient/excipient technology should find more time to understand each other in practice, not just on paper. This will also come as AI enters a new phase of value.
We are going through some of the fastest-paced change I have seen in my 20+ years in the pharmaceutical industry. The recent U.S. FDA (CDER) directive to allow “novel” excipient review prior to use in drug formulations means that leaders in the industry need to assemble and develop diverse teams. We have seen the global pandemic bring unprecedented speed to development of therapy. These “waves” are not common in our industry, and we should have effective and agile leadership to sort out the value and benefits for innovation across the product inputs and processes.
A: Alcami leads within the CDMO sector through convenience of offerings and reduction of complexity in processes offered to customers. True beneficiaries of such an approach are smaller-scale companies, which are the innovation engines of the pharmaceutical industry responsible for an increasing rate of new drug approvals.
In a time of uncertainty fueled by resource constraints and supply chain issues, Alcami embraces change by being dexterous and adapting to client needs by utilizing new technologies and empowering our frontline team. Strong organizational culture and robust quality systems, supported by compliant but lean processes, are at the core of Alcami.
Alcami delivers high-standard work with realistic expectations based on self-awareness, strong communication, integrity, and transparency. The partnership between Alcami and customers begins at the early stages of drug development, from understanding client needs through the development of customized solutions that ensure success at the commercialization stage.
The strategic and operational changes at Alcami — combined with the highly talented business development team and intellectual horsepower of phenomenal operational teams — have resulted in significant growth for the company based on customer intimacy and a focus on finding solutions.
In summary, what makes Alcami the true north of CDMOs is a high-quality cGMP operation supported by versatile development teams and a robust regulatory approach, technical competence, customer-centric culture, and a meaningful partnership approach to business. With our advantageous locations in the Carolinas and Missouri next to innovative pharmaceutical and biotech hubs, Alcami is perfectly positioned to support U.S.-based customers.
A: It’s about always being there for our customers. We help them with the answers that they need, using our unparalleled portfolio of solutions and unrivaled technical service in critical application areas, such as immediate and controlled release. Our strong and timely regulatory and quality support, a global manufacturing footprint, and an outstanding team of resilient people with vast experience support our customers’ every need.
In our long and rich history as the leading supplier of excipients and ingredients for the pharmaceutical industry, there have been challenges — small and large — but our customers know that they can always count on us to be with them through change and support their needs.
A: At BASF, we believe that true leadership involves more than innovation or a healthy bottom line. It involves building diverse teams and fostering an inclusive culture where everyone has a true sense of belonging and can contribute to the business in meaningful ways.
In our experience, prioritizing diversity and inclusion (D&I) has taken collaboration and innovation to a whole new level. When people feel included, valued, and recognized, they tend to also feel empowered to bring their ideas forward, take risks, and challenge the status quo. They bring a deeper understanding of our customers and their needs from both a global and local perspective, allowing us to provide more personalized service and solutions. This ensures that strategic initiatives are driven forward in the most productive, efficient, and profitable way, while creating a high level of employee engagement and satisfaction. We regularly gather feedback from our employees to keep an open dialogue and put actions in place when needed.
A: We are in an industry that is being transformed and transforming — and leadership is defined by how we respond, the new approaches we can provide, and the generation of evidence that the new approaches are working. Some of this industry transformation has occurred as a result of the COVID-19 pandemic and the new care management and clinical delivery approaches that were initiated as a result. Traditional ways of interacting with patients and conducting clinical trials have been challenged. As industry leaders, we are similarly transforming ourselves out of a deep and profound responsibility to patients.
Leaders know that beneficial disruption does not reflect a disdain for past approaches, but rather how that knowledge is applied to changing what data, technologies, and people can achieve comparable or superior outcomes with greater productivity, lower cost, and more rapidly. The transformation of RWD into RWE for regulatory decisions is a perfect example of this — once deemed inferior to RCT studies, they’re now all part of a single, integrated “System of Evidence.” So, key to being a leader is (1) being guided by this imperative of accelerating and assuring new, innovative, medicines to patients; (2) operating with the highest ethics and independence in an industry where foundational trust is hard-won and easy to lose; (3) staying committed to concepts of health equity and elimination of research disparities; and (4) challenging all legacy notions for how research should be conducted while providing higher precision, confidence, and generalizability to the new research approaches we advance.
A: Many factors contribute to strong leadership in the pharmaceutical and biotech industries, but two absolutely vital elements are authentically embodying and exemplifying integrity and grit. Being an effective and successful leader requires being well trusted, as we are entrusted with the health and lives of patients; this often results from a culmination of several factors, including transparency, knowledge, and operating with a truly people- and patient-first approach. And perseverance and determination are also essential, particularly in today’s healthcare landscape, as, given the enormous complexity of our industry, there are many obstacles and issues that inevitably arise and must be worked through. Science is not easy — but, when done right, the benefits are tremendous.
A: The key to being a leader in any industry is being strategic, developing unique ideas and approaches, and, importantly, doing the hard, hard work of pressure testing current best standards, pushing them to a new level, and then championing adoption.
It’s about identifying the tough challenges and being willing to work with the people who are trying to solve them day in and day out and to partner with them. Once you’ve found how to start moving the needle, and proven it, it’s about sharing the good word and bringing more along.
In our industry, and for us, it’s about the many interrelated things necessary to unlock clinical research, access to scientific breakthroughs beyond the confines of academic centers, and engagement with real-world studies — and continuing to improve. How can we take what makes America’s top institutions so successful, and bring more cancer centers serving more of America into that process?
A: Leadership today requires strategic innovation, which comes with a keen focus on what physicians need in order to practice precision medicine. That also means having deliberate focus on how the economics of medicine can be simplified through Prior Authorization automation. The Spesana Platform serves clinical, operational, and financial needs.
If we improve the user experience — of physicians, nurse navigators, administrators, and patients — with an elegant, data-driven workflow and highly sensitive molecular diagnostics to improve patients’ outcomes, then we can significantly improve upon the unnecessarily complicated processes that exist now.
Leaders will increase the velocity of patients moving to the right specialists. Beyond that, clinical collaborations to allow physicians, patients, and insurance teams to come together around the best available therapies are paramount.
A: The biopharma industry is changing relentlessly, requiring biopharma leaders to quickly navigate through fast-moving market dynamics while overcoming complex challenges. Biopharma leaders must consider four factors in order to succeed in advancing biologics to the market, especially considering the shifting market dynamics: agility, capacity, innovations in technologies, and end-to-end capabilities.
In order to successfully meet the urgent need of new projects, a company must find ways to demonstrate a high degree of responsiveness to react to the changing requirements for product demand, particularly during the pandemic crisis.
This demand will need to be supported by available manufacturing capacity at multiple scales to accommodate both clinical and commercial supply of products in order to provide speed to market for the supply of critical medical treatments. We currently have several projects underway to maximize our manufacturing capacity footprint, including the ongoing construction and validation of Plant 4 and more.
A biopharma company must be able to balance and accommodate the needs of rapidly changing projects involving novel technologies, and this can be done by implementing continuous innovation with new modalities to supply next-generation therapeutics. In addition to launching the supply of mRNA drug substance in 2022, our planned expansion of Plant 5 is expected to begin construction within this year and will offer multimodal products, including cell and gene therapies and next-gen vaccines utilizing mRNA, pDNA, and viral vectors, all at a single site.
Last but not least, a biopharma company must strategically plan out resources to get a molecule across to the finish line from one location, minimizing time loss due to shipping, tech transfer, et cetera. A company should be well-equipped with end-to-end capabilities or outsource to a CDMO with such service offerings across all areas of product development, clinical and commercial manufacturing, and fill/finish of drug product for speedy delivery to market.
A: In recent years, and in light of the global pandemic, the biopharmaceutical industry has faced many challenges and undergone significant change. The binary-choice model of in- versus outsourcing has been replaced by close and flexible collaboration models, where Lonza is a leader with solutions such as Ibex. In addition, the customer base for CDMOs has diversified, as emerging and small biotechs now make up approximately 80% of the total development pipeline.
A key offering component of a leading CDMO is being able to develop and manufacture complete offerings at different scales, as this allows companies to manage market variability, project economy, product life cycle, and unexpected needs for more product.
As an industry leader, Lonza creates a customer-centric offering by ensuring quality and increasing flexibility to customers of all sizes. The wide range of modalities and technologies we support, along with locations and asset size, continue to evolve with evolving customer needs. We invest in multipurpose, large-scale manufacturing capacity, as well as dedicated suites. Our end-to-end offering spans the entire life cycle of a molecule across late discovery, preclinical and clinical testing, and commercial supply. Our teams provide additional value through their extensive expertise and regulatory experience.
A: It is a very exciting time to be in the healthcare business. New technologies are emerging rapidly to tackle diseases that we were previously unable to treat. However, we are working in a complex landscape, and there are key qualities and capabilities required to navigate and maximize the benefits of emerging technologies.
A customer-centric approach is essential, so being a leader necessarily means being fully integrated along the value chain. By putting the customer and ultimately the patient first, we can think beyond simply solving a problem to create solutions that are really needed.
Strong core competencies must be complemented by versatility and flexibility when it comes to choosing the best technical solution. A partner must be able to select the perfect technology to match a specific drug, formulation, and application requirement. Parenteral CDMO services and solutions that can add value at any product development stage, including clinical phase–appropriate support, are crucial for success going forward.
A: One key is to anticipate, identify, and cater to clients’ needs. For example, with WuXi Biologics' "follow and win-the-molecule" strategy, we have seized many opportunities in the growing market of biologics start-ups, recognizing that small biotech companies usually need to use external technologies regarding new modalities, such as ADCs or bispecifics. Foreseeing their demand for end-to-end services, we built a comprehensive, open-access platform so that they can focus on their R&D efforts instead of infrastructure investments. With this strategy, we have been enabling 480 programs for global clients — 156 of them in 2021 — and have one of the largest portfolios of complex biologics, including mAbs, bispecifics, ADCs, and fusion proteins. Now, we are proud to see nine commercial manufacturing projects as successful results of this strategy.
At the same time, it is important to stay flexible and be able to address the evolving demands of diverse clients. A great portion of the small business clients WuXi Biologics serves in the development phase then become bigger companies and stay with us as they enter the manufacturing phase. As we empower clients to grow and be successful, we become their long-term partners.
Continual innovation is another key. After a successful first decade, WuXi Biologics is now entering a new era of our “CRDMO” business model. We define WuXi Biologics as a contract research development and manufacturing organization because, as opposed to traditional CMO or CRO companies, our core expertise is in discovery and development services, as well as large-scale manufacturing. We are pioneers in adopting disposable manufacturing technologies in large-scale commercial manufacturing, too, which gives us more flexibility and better efficiency by allowing us to combine multiple disposable bioreactors. In this way, we can better cater to diversified needs and fuel up client innovation.
A: All great leaders, regardless of industry, must actively listen to their customers and employees to completely understand their needs. To offer a customer-leading experience means providing specialized solutions for every client. For example, in the restaurant industry, they cater and design meals to each diner’s needs. It’s not that different in the pharmaceutical supply chain business. If a client requests a product manufactured and packaged specific to their unique demands, companies must deliver quality, science, and expertise to their liking. This is how you gain repeat clients, and your reputation develops as a leader.
Listening to the needs and concerns of your employees is also vital. There must be two-way communication, allowing all members of your organization to voice their opinions and beliefs so that employers can address issues and prevent conflicts. This creates an inclusive, trustworthy culture and generates a more productive work environment.
At PCI, we understand that we cannot properly execute our vision without listening to the needs of our clients and employees.
A: To be a successful leader, you must be team focused and open minded and maintain perseverance. There are several challenges that come from starting a company from the ground up, and I’ve always strived to create a culture where we can learn from our successes and failures and continuously improve. A few key traits that have been core to my success are ambition, transparency, and obsession. Ambition is probably the most significant one that led to our early success. SOPHiA GENETICS was founded in Switzerland, and there are not many Swiss companies that have the ambition to lead the way in a very competitive industry. I knew this when I started the company, and it’s something that has driven me since day one. It’s also imperative to be transparent, even when the message is constructive — otherwise, we can never improve. This doesn’t just apply to my colleagues, but to our customers as well and the data insights we provide them. This is the reason why we want to break down data silos and share knowledge globally. The final trait that has served me well, despite perhaps its negative connotation, is my tendency to obsess over things. I’ve always known where I wanted to be, and because I remain committed to that vision, that sometimes means that I’m my own toughest critic. When I chart a course, I keep moving in that direction until I’ve achieved my objective.
A: The industry SOCMA represents is very specialized, making high-grade, value-add products that go into almost everything people use daily, as well as active pharmaceutical ingredients (APIs) that are critical to pharma health care. The contract development manufacturing organizations (CDMOs, which are tollers) and their design teams play an integral part in ongoing pandemic recovery. The ability to deliver customized solutions to each of our members is vital to their pursuit of innovation and is the foundation of SOCMA’s mission to provide such unique solutions and services. Bringing the industry together to share best practices, connect with new partners, and provide personalized regulatory assistance is key to the success of our members. What underpins SOCMA’s ability to deliver these critical tools and resources to our members is our ability to be agile, adapting to the ever-changing needs of the companies we represent — and we will continue to lead our members into the future, always in the name of safety and innovation.
A: Leaders in this industry are only as good as the team behind them. The key to being a successful leader lies in bringing together a diverse group of employees who have a wide variety of work and life experiences, who share the same vision of reaching an aspirational goal and who are not afraid to ask hard questions. Everyone has strengths and weaknesses. But when you find people who can fill each other’s gaps and fortify each other’s strengths, you can make big strides toward the company’s ultimate objective.
In the life sciences, a leader needs to be able to see the bigger picture in order to be fearlessly audacious when it comes to executing a company’s greater plan. But leading needs to be balanced with listening intently to the team, so that the finer nuances of the day-to-day challenges are not missed. At Skye, the team makes it easy for me to lead. We all work tirelessly to make our goal of bringing a potentially life-changing drug for glaucoma patients to market. Their steadfast dedication and true accountability give me the confidence to take Skye to new heights.
A: As a provider of solutions, we view leadership as dependent on the value your customers and suppliers find in your services and offerings. Our goal is to be the most valued ingredient distributor on the planet by exceeding expectations, building trust, and treating our customers’ challenges and obstacles as if they were our own.
Our customers value our ability to navigate the present challenges while looking ahead and helping them plan and prepare for what’s coming. Given our scale and line of sight across the entire raw material supply chain, we look to identify shifts and potential disruptions before others and use those insights to help our customers make better decisions.
Customers also value our reliability for the what-ifs and our flexibility to pivot and course-correct quickly and efficiently. Whether it’s a natural disaster impacting supply or a new regulation forcing a consideration of a different ingredient, we have the expertise, global material accessibility, and distribution footprint to help our customers mitigate risk and costly business disruptions.
Most importantly, serving the biopharmaceutical and pharmaceutical industries requires an all-in commitment starting with the executive level and continuing down to the drivers delivering the product to our customers’ docks. Our organizational leaders at Univar Solutions recognize the importance of our role in this industry with the willingness to continuously invest and strengthen the value that we provide our customers and suppliers. In total, every individual — our field, corporate, and warehouse staff — contributes to a team fully dedicated to serving this crucial industry with ethics, integrity, and the service excellence it takes to lead.
A: Collaboration is the catalyst for scientific innovation. As such, leaders need to be focused on how they can make the world a better place, together. Think about what your products, solutions, and research bring to the table, as well as what other players in the industry can bring. You may have a gap that another company’s product or research can fill, and vice versa. Each of us have different strengths and weaknesses, and to identify those within ourselves and others will result in strategic partnerships that highlight our strong suits and solve important problems. By promoting industry-wide collaboration, we can all focus on the overall mission of making the world a better place.
A: Be nimble. COVID-19 and its variant waves, remote employees, supply chain demands, market volatility — all these issues have shown us that we need to be perceptive and to react quickly to multiple headwinds. Being nimble is critical for business continuity. I’ll also add that a leader needs to be more employee-centric. There’s a massive change taking place in the workforce today, with many people demanding fulfilling work and personal lives and switching jobs — or opting out of the workforce — if their needs aren’t being met. We all want the best talent and the best people to grow our companies. We need to listen more and ensure our teams are engaged, to build a more vibrant culture.
A: Clinical trials tend to be so large and complex that it can be difficult to know whether the innovation you are pursuing is really moving the needle. It is possible to draw a conclusion of causation when really what you are seeing is correlation.
At Reify Health, we have chosen to innovate in areas where we can clearly tie results to value, and we have tried to create a culture of looking objectively at the results we are seeing. Did we really achieve the result we set out to achieve? And are we actually making a significant difference here?
To create change in any industry, you have to focus on answering those questions, but I think a relentless focus on creating and demonstrating real value is especially important for leading change in clinical trials.
A: The key to being a successful leader in the life sciences industry is never losing focus on why your company exists — “What is the challenge that you’re directly fixing” and “Who are the people you’re looking to help” are always top of mind. For eClinical Solutions, our mission is to make the clinical data acquisition and analysis process easier and faster for pharmaceutical companies with modern technology and digital capabilities. We are constantly asking ourselves how we can transform the way we do business in order to make the work of our team members and clients more rewarding and to deliver faster results to the patients waiting for treatments.
As a leader in the industry, it’s critical to always be looking ahead to what’s next for both the industry and your company’s products and services. At eClinical Solutions, we’re focused on anticipating the future as much as possible and solving emerging problems to ensure that the company evolves constantly with market changes and customer needs. By being able to quickly pivot and, when possible, get ahead of industry trends, companies will be able to better support the growing needs of all stakeholders in the clinical development process.
A: I think the key to being a leader in the industry is staying focused on who the customer is and how to be most impactful for that customer. While it can be tempting to get distracted by what competitors are doing or novel technologies, true industry leaders define their vision and direction from their customers’ needs, which stems from a deep understanding of customers. At epocrates, we are laser-focused on clinicians. We know that our commercial clients turn to us because we have a highly engaged audience of clinicians who use epocrates every day to make decisions about how to treat patients. Everything at epocrates originates from that clinician customer obsession. For example, we constantly think about: “What industry trends are likely to affect clinicians and how?”, “What technology is best suited to solving the challenges of clinicians?”, “How are clinicians attempting to solve challenges that they have now and how can we help?”, and “What new policies are developing that could impact how clinicians work?” We are always coming back to that “true north” of customer needs, which is crucial for industry leadership.
A: To be a true leader in the industry, it’s important to be driven by a genuine focus and dedication to provide treatment options that can better the lives of patients — significantly, not just incrementally. At 9 Meters, we have a highly experienced leadership team with complementary backgrounds who share the common goal of improving the treatment landscape for those suffering from rare and debilitating gastrointestinal conditions. We approach the objective of leadership in the gastrointestinal (GI) arena through building a diversified pipeline of products that address profoundly unmet medical needs and by working closely with healthcare providers and patient advocates supporting those with serious GI disorders.
A: A key facet of being a leader in the biotech industry is building a team of the best and brightest talent that share a mission of developing something truly transformative in the industry. Basing our company in Pittsburgh, one of the United States’ top emerging health technology hubs, has positioned us to form a truly remarkable team. A good leader knows that the “ship” is only as good as the crew and that our crew shares our passion for developing personalized immuno-oncology therapies.
However, the work doesn’t stop there, as it’s imperative that we push beyond conventional boundaries and develop strong, lasting working relationships. A leader must be open to change and home in on maintaining strong relationships with their staff. I believe this is what has made our company so successful in a world with COVID-19 when our work dynamic has completely shifted. Our core values of respect, innovation, collaboration, and executional excellence have enabled us to continue pushing the envelope no matter the circumstances. I’m honored to be CEO of this incredible company and look forward to continuing the fantastic work we are doing at BlueSphere Bio for years to come.
A: Developing and communicating a vision, common goals, and values are essential to being a leader. In the biotech industry, the common goals are to bring new potential drugs to the patients to positively impact their lives. These are powerful and highly rewarding motivations to align a team that is multidisciplinary by nature and often multicultural. In a biotech experiencing rapid growth, the long-term vision to build a fully integrated, sustainable organization with a social impact based on shared values is another set of motivations that serves as a common guide of the organization.
Being able to adapt and be reactive while keeping the high-level objectives and the long-term vision in mind is another core characteristic that leaders in the industry must demonstrate. The ability to pivot in real time is especially valuable, since biopharma can present many twists and turns along the way. We have all seen how COVID-19 abruptly required us to change our ways of working, recruiting, and adapting drug development plans, as the majority of the world shifted to the virtual setting.
Finally, cultivating a mindset of optimism, resilience, and empathy, even when things are not going as planned, and encouraging others through challenging times are other vital characteristics of a leader. It is highly unlikely that any leader in this space will face a road that has no obstacles or setbacks. During these times, maneuvering around and executing alternate plans to achieve the same outcome while motivating others around you will be tremendously important.
A: There are several qualities that are needed to be successful as a leader in this industry: scientific and business knowledge, passion, tenacity, and ingenuity, among others. To be a good leader, you must surround yourself with the right people who share in the company’s vision and be open to their input. No accomplishment is a result of one person’s work, and I know that firsthand from holding leadership positions at several companies over the last 30+ years. At Elicio, I'm privileged to work with a team of brilliant scientists who, like myself, have been impacted by cancer and are driven to find solutions to combat it. As we advance our pipeline of lymph node–targeted therapies through the clinic, I rely on their counsel to make informed decisions.
Having a genuine passion for what your company is working on is also key. There will be long days and setbacks along the way. Truly loving what you do doesn’t necessarily make any of that easier, but it does give you a sense of purpose that can carry you through those rough times. It also makes the exciting moments, like clinical and regulatory milestones, feel that much more meaningful. I continue to find inspiration in the progress that our team is making toward treating these challenging diseases.
A: To be a leader in this industry, it’s critical to have a meaningful and impactful pipeline with the potential to transform the lives of patients. At Araris, our novel antibody–drug conjugate (ADC) linker technology allows for the production of a wide range of potentially safer and more efficacious ADC therapies for various cancer indications. However, the team behind the pipeline is just as important. A strong management team, stable investor base, and external validation through partnerships also solidifies a company’s place in the industry. Our company is backed by an expert leadership team, a scientifically diverse group of advisors, and sound biotech investment firms, giving us the support to advance our therapies forward. Lastly, communication is key. A strong leader clearly communicates key data and discoveries within their industry to drive innovation forward and move one step closer to bringing effective treatments to patients.
A: As someone with more than 20 years of leadership experience across multiple industries, two key areas come to mind. The first is to combine a deep understanding of the particular scientific niche that you’re focused on with the tools to explain it without jargon to a layperson. For example, if you work on cancer treatments (which is part of what my company, Anixa Biosciences, does), you can probably easily talk about all of the nuances of different therapeutic modalities, which is great. But arguably more important is knowing how to explain your differentiators to someone with no scientific background. Part of our job as leaders in this industry is learning how to pull back the curtain on the work we’re doing and make it digestible for all audiences, rather than leaning into the complexity. Ultimately, if our work is successful, our products will be used by patients, and we want them to understand what we do and trust the efforts we made to make our treatments as safe as possible.
Another key to being a leader in this space is building a strong team of experts to surround you in order to provide counsel and help you navigate through this rapidly evolving industry. Whether it’s strategizing on clinical trial design, discussing how to go about your next financing, or initiating conversations about a new partnership or collaboration, a strong leader knows the limits of their own expertise and has a network of people that they can engage with when needed.
A: As a leader, one must think big picture in addition to keeping end goals top of mind in order to drive a company forward and execute decisions at the right time. It’s important to think about overall strategy and the benefits from all angles to determine value for project management, identifying what to pursue and what to abandon, in addition to having agility in the decision process. For me, two important aspects for effective industry leadership are prioritization and focus, crucial for applying the right amount of time and energy in order to get a product to market faster and deliver medicines to patients in need.
While some of these aspects require experience and natural intuition, a leader is only as good as the team and must have clear communication with personnel in order to bounce off ideas to eventually reach sound consensus. The ability to build and maintain a strong collaborative team and a trustworthy relationship allows the company as a whole to function better, to solve problems, and ultimately to be successful in our goals.
A: I believe there are three critical components to being a successful leader in this industry: vision, authenticity, and enabling the success of others.
Vision: The path to creating a new drug that will change a patient’s life, from the starting point of an idea in a laboratory to the approved treatment, is a long and perilous path through the woods with many twists and turns. To lead the team and not get lost, one has to be able to see and communicate the vision of that destination, of bringing forward a drug that can fundamentally improve the life of oneliving with a disease.
Authenticity: A leader is more than just actions. People will join a leader who is committed, who cares, and who is authentic. This authenticity will carry one through the challenges that a company faces over time, bringing the community together to help advance the effort and give confidence to the investors who join us on the voyage.
Enable success: What we are trying to do requires the efforts of many people working together as a team. To achieve team success,leaders must enable the success of everyone on their team. This includes providing clear direction and supporting intellectual, technical,and financial endeavors to create an environment where every individual feels that they are appreciated and can grow. This is a continuous effort that a company’s leader has to be committed to and nurture.
A: To be a leader in the industry, we believe that your philosophy must be patient-centered. The entire field is driven by the opportunity to offer patients hope for more effective therapeutics through innovation. True innovation requires leaders to relentlessly push the boundaries of what is possible and be comfortable with the uncertainty that comes with every calculated risk.
As leaders, we are often pioneering uncharted territory. Quickly recognizing the underpinnings of a problem and remaining flexible will allow you to pivot when needed to create the best chance for success. The biopharma industry is rapidly evolving, and, as leaders, we must be able to adapt. Being agile allows you to make smart decisions that maximize future success for both the company and patients.
The final key to impactful leadership in this industry is flawless execution. As research progresses, businesses develop, and clinical trials are carried out, it is important to execute on each aspect over which you have control. To be successful, you need to build an experienced team with diverse perspectives that is comfortable with the challenges of drug development. While anyone can set goals, only the right team can make all the difference in executing on them seamlessly for patient benefit.
A: There are several important factors that contribute to leadership in this industry — building a great team, prosecuting great science, and keeping the end goal top of mind — developing life-changing medicines for patients.
Drug development is a team endeavor, and it is critical to build a multidisciplinary team of individuals who bring different experiences and backgrounds and can work collaboratively toward a shared goal. This is what we have worked to build throughout the organization at Nurix.
At Nurix, prosecuting great science means always striving to push the frontiers of molecular biology and genetics while combining such approaches with the latest in structural, computational, and medicinal chemistry. Based on a great scientific foundation, we have developed our proprietary DELigase platform, which combines our deep knowledge of the E3 ligase class of proteins with the powerful technology of DNA-encoded libraries (DEL). We are leaders in the field in this exciting new application of massive combinatorial DEL chemistry. Our DEL collection now includes over five billion compounds and fuels our pipeline, enabling us to rapidly build and screen drugs that can address therapeutic targets that were once thought to be undruggable. We advanced four wholly owned programs to clinical studies in the last year, as well as making progress in significant strategic partnerships with both Sanofi and Gilead Sciences.
Great science and a great team are what power Nurix as we work toward our goal of bringing novel, first-in-class, life-changing medicines to patients.
A: To be a leader in this industry, you must genuinely care and have empathy for the people you are intending to help. With over 50 million American adults suffering from mental illness and 250 dying per day due to substance abuse disorders, we are all impacted directly or indirectly by this.
Leadership takes courage and an ability to persuade others to believe in an alternative approach. Amid a renewed interest in psychedelic-assisted therapy for mental health, MindMed is leading with science, conducting clinical trials, and building on the extensive existing data to prove the therapeutic potential of psychedelics while changing the surrounding narrative.
Building a team with expertise in areas beyond your own with a shared goal and with people you can trust is key. We’re expanding our team with not only psychedelic and mental health experts but scientists in other areas of drug development who believe in the potential of psychedelic-inspired medicines and experiential therapies to provide patients sustained mental healing.
Being open to strategic collaborations is also critical. I believe that, in our industry, a rising tide will lift all boats, so our ethos is to cheer on others making genuine, lasting innovations in this space. With many psychedelic compounds and derivatives being studied for a range of indications, collaboration is the way forward. This will not be a winner-take-all market. We are taking a collaborative approach to advancing our pipeline through partnerships with all who share our mission to revolutionize the treatment of brain health disorders.
A: In this industry, we believe that the key element to being a leader is placing patients and their quality of life at the center of your strategy. We are committed to pushing the boundaries of our immunotherapeutic platform to offer potentially better treatments for hematologic and solid cancers. Current therapy options for many cancers are inadequate, and some can cause devastating side effects and can be difficult to administer, and, over time, many patients become resistant to treatment or relapse. We are keeping patients’ quality of life at the forefront of our work, and we are motivated every day by providing new therapeutic options to fulfill unmet medical needs.
Continuous innovation is necessary in this entire industry, but a vital driver in the oncology landscape in creating novel therapies for patients with limited treatment options and changing the current standard of care. At IMV, we are working to develop partnerships to build on the expertise of all stakeholders in the industry (institutes, researchers, biotechs, and pharmaceutical companies) and creating new and better immunotherapies to fight cancer. Through our science, the passion of our team, and continued collaborations, we look to move drugs to market, but most importantly to make a difference in the lives of patients.
A: Two factors that stand out as differentiators for leaders (and their companies) are being proactive and innovative. Staying in tune with the continued development of trending therapies in the space is essential to making progress and continuing to develop cutting-edge treatments. Take my company, Immunome, as an example. Our goal is to become a leader in redefining drug discovery by leveraging the information provided by the most educated components of the human immune system (memory B cells) to develop new therapeutics, beginning with oncology and infectious diseases. Guided by that innovative mindset and ambitious strategy, we quickly adapted after the start of the COVID-19 pandemic to develop an antibody cocktail against SARS-CoV-2, which we believe could provide a novel and powerful approach to combat the virus, despite its rapid mutational drift. We have been proactive in testing our cocktail’s efficacy against new variants as they emerge, and the rapid response nature of our platform allows us to introduce new therapeutics should the need arise.
This innovation and proactivity is important not only for Immunome as a company, but for the patient communities that could benefit from our treatments. We have seen with immune checkpoint inhibitors how powerful harnessing the PD-L1 pathway can be in treating cancer. We believe the immune system can be a tremendous source of new innovation in new drugs, and we intend to lead this effort.
A: As an executive in the emerging life sciences space, it’s critical that we stay ahead of the ever-changing landscape to anticipate potential risks and opportunities and take actions to mitigate them or be in a position to create options for the company. As a retired military veteran, I was trained to identify potential threats and then plan contingencies and alternate actions around those issues. By applying these principles, I have found that our team has been able to remain highly flexible and to maintain progress, often thinking creatively and differently to overcome the obstacles we’ve faced and quickly pivoting to potential solutions.
In addition to remaining agile, it’s also critical to identify the right talent to help your company achieve its overarching objectives. In small companies, each person and position is critical. After hiring the right individuals in terms of experience and disposition for small companies, putting in place a culture of collaboration and joint accountability leverages the strengths of your team. By encouraging them to be empowered in their respective areas of expertise, I have found that people truly feel themselves becoming a part of something much bigger. That is the environment we have seen generate the best results. At Windtree, I am very proud of the team we’ve assembled, which has demonstrated an overwhelming passion for helping advance the multiple programs in our pipeline, despite significant headwinds associated with the pandemic and executing complex programs. Through our work, we hope to bring transformative solutions for significantly underserved patient populations that face critical health situations.
A: A leader is only as strong as their team. At TFF Pharma, we rely on the expertise and dedication of our management, our advisory boards, and our many collaborators who impart a wealth of invaluable scientific, medical, and technical knowledge to propel our programs from early-stage development to advanced clinical testing. This level of integrated and consistent collaboration requires transparency and communication with all of TFF’s partners and stakeholders. In an industry where timelines are consistently shifting, especially during the ongoing COVID-19 pandemic, we prioritize maintaining consistent discussions with our collaborators on progress to ensure alignment and ability to shift or reassess if challenges arise.
With so many moving parts involved — including in TFF’s partnerships and our in-house programs — it’s also my responsibility as a leader to remind my team to remain steadfast in our focus, which is to use our Thin Film Freezing technology to improve efficacy and administration of medicines and improve health outcomes for patients. This synergy of maintaining communication and awareness across ongoing projects while still staying focused on your company’s core goal is essential to successful leadership in the biotech industry.
A: To be a leader, you must have a mission — a driving force. For me personally, and for SCYNEXIS, our primary mission as a leader in the antifungal space is to positively impact patients by bringing truly innovative medicines to market. With this in mind, our scientists are developing the company’s lead asset, ibrexafungerp, as a broad-spectrum, systemic antifungal for multiple indications in both the community and hospital settings. Years of dedicated work led to the development and commercialization of our first product, which is in the area of women’s health and which represents the first new antifungal class approved in more than 20 years.
Tenacity, commitment, and purposeful collaboration are key components that lead us to be successful. With this ongoing work and collaboration, we can align ways not only to best diagnose, contain, and treat infected patients, but to appropriately support and fund the development of specific and targeted antifungals. Encouraging a sense of collaboration and teamwork is important. We can accomplish a lot more together than individually with our “never give up” attitude in the fight against serious and often deadly infectious diseases. Ultimately, SCYNEXIS has a robust pipeline that speaks for itself, but having a clear and distinct mission with open ears as a leader is what makes the real difference.
A: The key to being a leader in the biotech industry is relationships both externally and internally. Building a complementary team with individuals from different backgrounds leads to an invigorating work environment that allows individuals to think beyond conventional boundaries and take what they learned from their own unique experiences and challenges to efficiently solve problems. Utilizing these various perspectives from different walks of life allows our team to develop creative and innovative ideas that can better serve patients and the organization. As a CEO, this pushes me to think outside of the box and continuously look through a different lens that ultimately strengthens the company’s vision and approach in a fast-paced, constantly evolving industry. Additionally, cultivating relationships within your team and professional network is an essential part of the learning process for any leader that helps to identify opportunities for growth. Maintaining these relationships is even more important as your company grows and you are challenged to navigate the industry. Being open to different ways of thinking and gaining insight from external perspectives has allowed me to build a strong foundation for long-term success and growth.
A: Over the past ten years, we have witnessed the unprecedented evolution of the life sciences, exploding to a $190 billion market. At MilliporeSigma, through an innovative and customer-first mindset, we have catalyzed this change in what continues to be a highly competitive and dynamic industry. Today, we are a top-tier player with a broad portfolio of products and a complementary range of services, including CDMO and contract testing, supporting our customers’ ambitions to deliver traditional and novel therapies. Several key factors contribute to our strong position.
First, we can serve our customers’ full spectrum of needs with solutions rather than stand-alone products. For example, we are moving beyond specific products for the R&D and Quality Control labs to complete workflow solutions, including digital data capture and management. Another example is leveraging synergies between our best-in-class products for our bioprocessing customers with service offerings and collaborating with our customers on designing robust, efficient processes to enable them to get therapies to patients faster.
Second, we constantly scan for emerging trends — scientific, customer, and societal expectations — and proactively invest to capture the key ones to stay ahead of the curve. We aim to ensure that we have the right technologies mature enough to serve rising demand as the market evolves. For example, our capabilities in lipids for nonviral delivery positioned us at the right time and place to support the delivery of the breakthrough mRNA vaccine. We have since augmented this by building capabilities in services to provide our customers with a unique end-to-end offering to support the pipeline of future mRNA vaccines and therapeutics, ultimately bringing them to patients.
Third, we define leadership not just in terms of products or services but also in societal impact. The ability to holistically address sustainability, environmentally and socially, whether it is helping customers understand the CO2 footprint with a transparent, data-driven approach, having a clear roadmap to decarbonizing your business, or proactively engaging the supply chain to be prepared for the new green economy, is now a key decision-making criterion. While we have much to do here, it is central to our plan going forward.
A: For contract development and manufacturing organizations (CDMOs), customer service excellence is crucial to forging successful long-term partnerships and collaborations. At the core of this is investment in technology, capabilities, capacity, and people. At Sterling, we have strategic plans to ensure that we look forward and stay ahead of the competition by constantly evaluating the market and industry in order to better understand existing and future needs. This allows us to identify opportunities to continuously improve and invest, both in manufacturing assets and in our employees’ skills and training.
Every manufacturing process involves on-time delivery of product, in full, and to the correct specification. For the manufacturer, this means that the process must be optimized and executed with all safety and quality compliances adhered to. Behind every process are countless hours of development, in both the chemistry and analysis, as well as investments in, and qualification of, laboratory and production equipment. There are also the crucial systems such as maintenance, as well as secure data capture and handling.
Customer audits now look beyond whether a company can simply make a product and include assessments on environmental and employment procedures, as well as long-term security of supply chains and overall business practices. Evaluation of processes and capabilities — and investments made where necessary — are crucial to maintaining a leadership position and meeting customers’ demands.
A: Experience. Future orientation. Customer focus. Extensive know-how with numerous technologies — that doesn't happen overnight. Syntegon has built this up over 160 years. It is important not only to face market trends like digitalization, efficiency, and flexibility, but to actively shape them. Sustainability is also becoming increasingly important for the pharma industry. We can use our broad experience from the food business to support our customers in achieving their sustainability goals. An industry leader also works closely with its customer. Besides a global presence, this means knowing customer needs and being able to offer complete solutions: from consulting and services to machines and systems.
A: To be a successful leader in the bioreagents and CRO services industry, one must have a broad depth of understanding regarding client needs in basic research, as well as vaccine, therapeutic, and diagnostic platform development. Forward vision as to what clients in industry and academia will desire, both in the short and long term, is critical. In addition, a leader must always surround him or herself with talented and driven individuals and not be afraid to aggressively draw on those talents and that ambition to grow the company at every level.
A: When I think about being a leader in our industry, I think about being a role model — one that inspires others to focus on the greater purpose that we serve and one who drives positive change. Developing new medicines with the potential to improve the quality of life for patients in need is an incredibly rewarding purpose and an important responsibility. This is why Quotient’s manifesto is focused on exactly that: “Molecule to Cure. FAST.”
The leaders that I admire have consistently had this focus at the front and center of their vision as their North Star. I’m fortunate to be surrounded every day by great leaders in Quotient and at our customers. Importantly, such leaders are not dictated by their position in an organizational hierarchy. They are colleagues that come from anywhere in the business and have the vision to deliver a real positive impact that is so powerful that it inspires those around them to mobilize and support. Strong leaders maintain that passion when things don’t always work out, which, unfortunately, we know happens all too frequently in drug development. But when it does work out, it’s an incredibly fulfilling experience.
A: I think one of the things that has kept Corning Life Sciences relevant over time is our ability to innovate — while working closely with our customers on these innovations. Each recent innovation we have launched has one thing in common: we worked closely with customers to understand their research or bioproduction processing challenges, and we worked to address and alleviate these constraints. Staying in touch with the pulse of where industry trends are going and what it will take to drive widespread adoption and cost-effective solutions for these trends is another key factor.
A: A key trait for any leader is offering the best service to customers possible, and I am no exception. This means that customer centricity is essential — treating your customers’ products like they are your products. It also means making yourself easily accessible as a leader and providing counsel to customers that need it. My goal is always to work with them to find solutions, define clear timelines, and create fair pricing policies that bring their products to market and ensure the supply of drug substances for the patients who need them.
Customer centricity is also important for our most important stakeholders — our employees. A service provider is only as good as their staff enables them to be, and that’s why being a leader starts at home. It starts with treating employees respectfully, enabling them to bring new ideas to the table for consideration, and providing them with the training and support they need. It also means investing in your employees.
We are proud to be developing new training opportunities for our teams across the globe this year that will allow them to advance their careers and better serve our customers.
Dr. Alen Guy is the Technical Director in the Pharmaceutical Business Group of IMCD. He has previously held senior positions in excipient manufacturers and drug delivery companies. He holds a Ph.D. in analytical chemistry. At IMCD, he leads a team of more than 25 specialists and scientists and five Technical Centers. Dr. Guy has presented at numerous Drug Delivery and Pharmaceutical conferences on topics such as co-processing of active ingredients and excipients, excipient innovation, orally disintegrating tablet technology, taste-masking, and solid dose development. In recent years, Dr. Guy has particularly focused on the development challenges for products in pediatric, aging population, and long-term care patient groups.
Many of the change agents I have seen in 2019 are derived from changes in regulatory law, commercial downscaling, and impact from patent expiry strategies. The largest external regulatory change came from the issuance of the long-awaited EMEA Annex I, clarifying which technologies are required and acceptable, when and why.
The change in operational focus, from clinical scale-up to commercial scale-down, is enabling use of smaller, modular, flexible fillers with self-contained isolators. In parallel with the approval of biosimilars and biobetters, there is strong industry focus on individualized micro-batches, for CAR-T solutions and gene therapy products. The use of process automation and robotics have increased in all fill-finish unit operations. Widespread implementation of ready-to-use/ready-to-sterilize components and single-use (SUT) in upstream and downstream (SUS) through final fill designs have changed how facilities are planned, reducing plant size and changing warehouse space to accommodate densely packaged plastics goods.
Filling modalities have also been changing; bags that can be mated to lock-luer fittings with pre-sterilized needles and blow-fill-seal/form-fill-seal are re-emerging as processes that offer potential unit cost reduction. Traditional vial and syringe container designs are also changing as suppliers improve standardize offerings while having options including clear plastics.
The most exciting technological or scientific advancement that has influenced our business strategy in 2019 is our novel epigenetic regulator program. Unlike gene therapies, which target and modify DNA directly by inserting specific genes into patient’s cells, epigenetic regulators control or modify gene expression through processes that do not alter the sequence of DNA directly. Our lead asset DUR-928 is a small endogenous molecule that plays an important role in regulating cellular functions such as lipid homeostasis, inflammation and cell survival, crucial pathways involved in many acute and chronic diseases. DUR-928 has shown positive results in a phase IIa trial for the treatment of alcoholic hepatitis, a devastating acute condition with high mortality rates and limited therapeutic options. We are also advancing programs in other indications that could benefit from DUR-928, such as non-alcoholic steatohepatitis (NASH) or psoriasis. We believe that epigenetic regulation is a powerful and untapped treatment approach for many challenging diseases.