We thank Leslie Orne, the President and CEO of Trinity Life Sciences, for sharing her insights with us in this exclusive interview. Trinity Life Sciences is a company at the forefront of providing strategic solutions in the life sciences industry. With her extensive experience in the sector, Leslie sheds light on the latest technological innovations, the critical role of data-driven strategies, and the impact of AI in pharmaceutical development. She also delves into the nuances of leadership and strategic decision-making in high-stakes transactions, along with the intricacies of brand planning. Furthermore, Leslie offers insights into maintaining work-life balance while steering a leading organization.
- Innovations and Challenges in Life Sciences
- Strategic Integration and Data-Driven Insights at Trinity
- Strategic Insights in Transactions, Launch Planning, and the Influence of a Scientific Background
- The Transformative Role of AI and Effective Leadership
- Navigating High-Level Executive Roles and Personal Balance
Innovations and Challenges in Life Sciences
Q: With over 20 years of experience in the life sciences sector, you’ve seen numerous changes. What do you consider to be the most significant technological advancement in life sciences so far?
- As someone who has always been interested in science, I’ve been particularly excited by the translation of innovative science into novel therapeutics. This is especially notable in the areas of gene and cell therapy and the use of advanced nucleic acid technologies, such as gene editing approaches, antisense oligonucleotides, and inhibitory RNA-based therapies. These approaches are enabling personalized therapies that address the fundamental basis of disease and provide hope to patients who have no or suboptimal treatment options.
- A key challenge for the industry is that these exciting scientific advances have not been matched with innovation in the commercial arena. Several of these new treatment modalities are expensive – costing hundreds of thousands to even millions of dollars. Traditional pricing models simply don’t work for a therapy with a high upfront cost that offers the potential for lifelong benefit. Similarly, as therapies become increasingly personalized, the patient population for which they are appropriate usually gets smaller. Companies need new approaches to finding these patients — both to enable clinical development and to realize the full commercial potential of approved products.
- One of the most exciting aspects of bringing AI into the pharmaceutical arena is that it has the potential to transform every aspect of how drugs are discovered, developed, and commercialized. It is already transforming how we work internally at Trinity and enabling us to develop highly effective tools and strategies for our clients.
One of the most exciting aspects of bringing AI into the pharmaceutical arena is that it has the potential to transform every aspect of how drugs are discovered, developed, and commercialized.Leslie Orne
Q: Your expertise includes licensing and acquisition due diligence, as well as new product planning. Can you share some critical factors that life sciences companies should consider in these areas?
- Stakeholders’ expectations have been influenced for years by the common wisdom that the overall success of a new drug launch is determined in the six months following approval. Trinity Life Sciences’ analysis of actual sales rebuts this. A growing percentage of pharmaceutical launches—62% of those that were launched between September 2019 and December 2021, including a staggering 24 out of 28 non-rare, non-oncology products—performed below Wall Street forecasts. Several factors play into this, including failure to adapt payer access and engagement strategies, the use of unrealistic prelaunch forecasts for rate and peak uptake, and failure to understand the profile of healthcare providers who will prescribe the drug.
- The remedy to this is adopting a next-generation commercialization approach that can work with our evolving healthcare landscape. Companies and their investors need to adopt a new mindset that has a longer-term focus and accept that return on investment will likely take longer than it used to. This is going to be the case for acquisitions and for new products. It doesn’t mean that the peak return will necessarily be less, but it likely means it will take longer to get there. This needs to be considered when determining when and where to invest in products and companies.
Strategic Integration and Data-Driven Insights at Trinity
Q: As you lead Client Services at Trinity, how do you ensure the integration of strategic advisory, primary market research, and advanced analytics to deliver comprehensive solutions?
- The best way to integrate our services is to ensure that every team and service group is accountable for the success of the firm as a whole. We achieve this by having a single P&L and aligning our incentives in a manner that allows every one of our team members to focus on what is best for each of our clients rather than competing against each other. Organizations can talk all they want to about integration, but if their internal teams live in separate financial solos or need to compete against each other for resources they are creating environments in which true integration is challenging, if not impossible. Trinity thrives when we help our clients achieve their goals and objectives, and that happens when each employee is empowered to find creative ways to deploy our products and services regardless of where they sit within the firm.
Q: Trinity boasts data-driven insights as one of its pillars. Can you discuss a project in which these insights made a crucial difference in the client’s strategic direction?
- We worked on an amazing project with a global rare disease company that was looking to improve targeting precision and support the field team’s effectiveness for patient finding. Before working with Trinity, they had a previous analytics partner attempt and fail to identify new patients for their small patient population with a complex disease recognition and diagnosis, and restrictive therapy eligibility criteria.
- The previous partner had used rule-based alerts for two years with no luck – so we approached things differently. At Trinity, we did the following:
- Created an artificial intelligence and machine learning (AIML) model that identified clinically on-label patients, instead of general patients with the disease
- Used key learnings from on-therapy patients to identify how patients presented prior to starting therapy and implemented AIML models to flag patients based on the probability that they were the right candidates for treatment
- Deployed bifurcated push alerts within the client’s CRM to both inside and field-based reps and enabled ‘pull’ solutions to support call planning
- As a result of these efforts, we successfully designed and deployed AIML models for three indications in eight weeks and identified 100 high probability targets within the first two months of launch, which led to at least five patients confirmed to be clinically on-label for therapy within the first two months, and a first new patient enrolled within 5 weeks of initiating alerts.
- Additionally, we believe in a phased commercialization approach based on analytics – which allows strategies to be refined, expanded, or eliminated based on real-world evidence of success at each step of deployment. Rather than the traditional “go for broke” approach to product launch, we start with smaller, data-driven initiatives. Then we assess what is or isn’t’ working and refine the strategy as we go. This phased approach allows our clients to invest as they go, which makes it easier and more cost-effective to course-correct if data suggest a different approach. Ultimately, this allows them to maximize launch success while minimizing spending on efforts and tactics that aren’t meeting their goals.
Strategic Insights in Transactions, Launch Planning, and the Influence of a Scientific Background
Q: You’ve been an advisor on billions of dollars in strategic transactions. Can you share some general strategies or approaches you employ when navigating particularly challenging strategic transactions in the life sciences field?
- Costly failures across the drug development and commercialization continuum are a major issue in the healthcare industry. While clinical failure can be difficult to predict, commercial failure should be avoidable and have a more prominent role in decision-making with respect to both organic and inorganic new product development.
- Companies need to adopt a commercial mentality early in the pre-commercial period by viewing strategies and marketing plans from the perspective of commercial reality. This means that companies need to ask themselves basic but essential questions: What will the market landscape resemble when a product is introduced? Do costly, time-consuming studies or market research need to be conducted given the anticipated market opportunity? How do we fairly price a product to reflect the clinical value it provides, and does that price provide sufficient return on investment to warrant moving forward? Companies also need to revisit these questions as the competitive, regulatory, and reimbursement landscapes evolve.
- To achieve this, businesses need to develop and implement systems that enable them to access and utilize relevant information in real time. Through advanced analytics, we carefully evaluate specific product or corporate acquisition transactions with an eye toward evolving factors that will determine long-term success rather than looking solely at clinical data or other pre-approval metrics.
Q: Your LinkedIn profile mentions that you specialize in launch and brand planning. What common mistakes do companies make in this aspect, and how can they be avoided?
- Oftentimes, companies and brands fail to meaningfully differentiate themselves from the competition. This can result from failed marketing campaigns or because they are actually bringing the “wrong” drugs to market — meaning drugs that don’t offer a tangible and significant benefit that is valued by patients and payors, such as improved safety, efficacy, tolerability, ease of use or cost. As a company, you really need to find what sets you apart from the rest and commit to a stringent and rigorous approach to developing drugs that have a clear value proposition. This demands a strategic and data-driven process for understanding unmet needs from the patient, physician and payer perspective and then determining how a product can address those needs in a manner that is meaningful to these audiences. Meaningful enough for a payer to cover it, a physician to prescribe it, and a patient to fill and adhere to that prescription. In the long run, it’s more effective to invest in developing a drug that truly fills a treatment gap than investing in costly marketing campaigns designed to promote a drug that offers little advantage over competitors.
- At Trinity, we’re committed to supporting clients in the process of creating effective corporate strategy development, insightful pre-commercial planning, launch excellence and ongoing commercial execution – allowing them to rise above the rest. As market watchers, we are constantly documenting what makes products successful (or not), as we catalog in our annual Drug Index white paper. With this lens, we help our clients make better decisions on which drugs to develop and eventually how to optimally market them to get to the right patients.
Q: Given your educational background in Biology, how has your scientific education influenced your approach to strategic consulting within the life sciences?
- I’ve loved science since my first biology teacher ignited my passion for the complexities within the subject. This ultimately led me to pursue my bachelor’s degree in biology at Dartmouth College, where I later spent a lot of time in the lab working on an honors thesis at Woods Hole Biological Laboratory under the guidance of Professor George Langford. While working tireless hours at the lab, I concluded that while I do love science, being in the lab was not going to be a long-term career for me. I was even considering medicine but realized being in the clinic wasn’t going to be right for me either.
- While still in college and not yet immersed in my career search, I was completely unaware of how many jobs were out there that focused on the business of science. I reached this revolutionary discovery when I began consulting at Trinity, where I was able to combine my interest in science with my newfound interest in business. While I eventually came to realize that I appreciate the vigor and dynamism of consulting and the variety of perspectives it offers, Trinity was also an excellent place for me to learn about alternative career opportunities in the life sciences.
- As CEO of Trinity, I have the privilege of collaborating with a variety of businesses in the life sciences industry. I find it to be immensely fulfilling to stay in touch with the wonders of science but support the industry in other ways – helping to improve the commercial delivery of these important innovations to patients. Someday, we or someone we love will be patients – this notion fuels my commitment to the urgent pursuit of progress so that we are able to help our clients by providing patients with life-changing treatments more quickly and effectively.
The Transformative Role of AI and Effective Leadership
Q: The role of AI in healthcare is one of your key topics of interest. How do you envision AI reshaping pharmaceutical commercialization in the next five years?
- AI has the capability to revolutionize the way we develop and commercialize medicines globally. If deployed effectively, it can improve commercial operation activities such as optimizing launch and marketing strategies. I’m particularly excited about its role in enabling development of drugs that meet specific patient need and helping to find those patients, and its potential to change how we make decisions across the entire drug lifecycle.
- One of the most transformative aspects of AI and machine learning (ML) technologies is their ability to upend how we acquire knowledge. For centuries scientists have posed questions based on what we know and then generated data in the hope of answering them. AIML enables the opposite approach – looking at thousands if not millions of data points that are already known and telling us what they mean. This is incredibly powerful in any field that can be improved by data-driven decision making, including pharmaceutical commercialization.
- Patient finding is one of the most exciting applications of AIML in the commercialization arena. At Trinity, we see four essential components of patient identification:
- Identifying, gathering, and integrating the appropriate data
- Defining an optimal test population
- Building the appropriate model attributes
- After locating the right patients, planning and implementing the necessary actions
- Beyond patient finding, AI also has the potential to improve HCP engagement in a plethora of ways. This includes finding, classifying and targeting HCPs based on their propensity to adopt, switch, increase or decrease prescribing of a product or therapeutic class; optimizing message content based on prior interactions; and creating new HCP-targeted content and messaging based on prior responses and using systems trained to create content that complies with regulatory requirements.
Q: As an All-American and captain of Dartmouth’s National Championship varsity sailing team, do you find any parallels between sports leadership and organizational leadership?
- Absolutely! Being a captain of a sports team is very similar to being a leader in any sort of work environment, and the same values come into play. Being your team’s biggest cheerleader and encouraging teamwork to facilitate an environment in which we can all win is the goal in both scenarios.
- Some tips I’ve found to be helpful for leadership in any shape or form are taking charge, stepping up, offering solutions and maintaining resilience and a little bit of grit. Last but not least is passion. If you’re passionate about what you’re doing, whether it be work or a sport, and are surrounded by teammates who are just as passionate as you – you’re already on track towards success.
Navigating High-Level Executive Roles and Personal Balance
Q: As the leader of an organization with more than 1,000 employees, how do you manage work-life balance, especially with a family and interests like skiing and horseback riding?
- I try to remind myself that despite being a CEO, I’m still the same person I always was and that I need quality time with friends and family and a healthy work-life balance. I like to remember to relax and have fun, and always say “Work, work out (keep yourself healthy and take care of you!) and go out (have fun!).”
- At the end of the day, I’m first and foremost the mom of my two girls and a wife. I spend my off time doing mom things, whether it’s sitting on the sidelines at soccer games, snowboarding with my family or hanging at the horse barn. My transition into CEO has been a continuum of what I’ve always done, and you just keep pushing forward because you’re truly never done making progress.
Q: What are some of the top books that have significantly helped you in your career, and what key takeaways from them have you applied in your executive roles?
- Lean in by Sheryl Sandberg helped me appreciate the power that comes from sitting at the table and getting out of your comfort zone; Good to Great by Jim Collins showed me the value of getting the right people on the bus and then figuring out where they sit.
Q: Who are some of the individuals who have significantly influenced your leadership approach or whom you follow for fresh perspectives?
- I would not be where I am today without Dave Fitzhenry, my predecessor and 20+ year mentor. Not only did Dave convince me to start my career journey at Trinity in 2001, but he also helped me see why staying at Trinity for the long haul was worthwhile. When it then came time to fill his shoes as CEO, he helped me to see my potential and capabilities. Throughout my experience as Dave’s mentee, I truly learned how to lead… not by micro-managing or directing, but by arming people with the right tools and empowering them to get smarter than you are, and then letting them lead.
- And, not mentioned as often but perhaps the most deserving of my thanks are my parents, Jon & Debbie Sandberg. They both taught me that gender doesn’t matter (you can always beat the boys) and that hard work pays off.