“There is immense value in listening and learning — not only during prosperous times, but during times of uncertainty. I’ve spent the last few months having deep, strategic conversations with customers and employees to gain a better understanding of what we are doing well and where opportunities exist. Listening and learning from customers enables us to maintain our commitment to them, always, but it doesn’t end there. As a result of listening and learning from customers, we are taking decisive action to drive their and our success.”

“There are a few traits that I think are critical to leadership through uncertainty, which include showing continued optimism, being a great motivator and having the courage to be able to stay focused despite all the current noise. Drug development is a risky business that requires years of investment … (but) persevering during challenging times requires the courage to closely scrutinize your strategy and course correct if necessary. 

There are far more quality drug candidates than there are people and capital to develop them, and that gap has grown significantly during the past year. We’ve always been incredibly selective with our acquisitions, and now the bar is higher because there are more opportunities available.”

“During uncertain times, people need to be communicated to transparently, even if that creates some anxiety. Hiding information or trying to downplay potentially negative situations erodes trust and breeds suspicion. Transparency is not easy, but it is refreshing and treats people with a high degree of respect.

I think cash-strapped organizations should use any opportunity to strengthen their balance sheet, even if it is a little unpopular with their largest shareholders. You can only weather economic turmoil if your balance sheet is strong enough to survive the storm. Otherwise, you're going to sink no matter how great your ability to execute. Furthermore, a dwindling balance sheet may cause an exodus of key personnel as they begin to worry about their economic situation.”

“The leadership trait I see as critical during volatile times is agility. Whether it’s COVID, the war in Ukraine, legislative changes, capital market volatility or any other unknown, you have to be willing to make decisions with 85% of the data. You’re never going to have 100% certainty, so you have to take calculated risks, then continually evaluate where you stand and be prepared to change course when necessary. You have to let go of confirmation bias, whether it’s related to R&D or operational strategies; to incorporate new evidence and allow it to guide your decisions. Perseverance and tenacity are critical to staying the course, but that doesn’t mean staying wed to strategies that are no longer viable. Companies have to be nimble — like speedboats versus tankers.”

“Grit and resilience are key; the ability to make tough decisions; and understanding that it is about life-work integration, not work-life balance. If you ask my kids why I work, they’ll say, to help the world. If you ask our team who they hope to see most at our next leadership meeting, it’s our baby boy who was born less than 24 hours after a company all-hands meeting. There is indeed a lot of uncertainty and it’s in those moments that leaders have to recognize there is no perfect answer, and that difficult decisions need to be made to ultimately preserve and build shareholder value.”

“People are motivated by a sense of purpose, and they want to work for organizations where they can experience fulfillment and belonging. To attract talented, brilliant people who want to make patients’ lives better, give them an opportunity to connect to their sense of purpose, do work that matters to them, and be part of a culture that sees them as a whole person.”

“I’ve learned over the course of my career to be more empathetic, especially during challenging times. We all wake up trying to do the right thing every day, which is to help patients. We stay laser focused on three strategic priorities, which comprise the framework for everything we do. Additionally, we make sure long-term commitments don’t get drowned out by near-term thinking. For us, category-defining R&D is the path to sustainable value and we never lose sight of it. Finally, we emphasize innovation, including operational innovation, which is essential to ensuring efficiency during tumultuous times.”

“In 2023, AI will slowly but resolutely emerge from development discouragement to value momentum and industry change — growing through a cycle of promise to performance. In the new year, both AI and machine learning are set to produce an era of rapid new pathways for life sciences, ultimately impacting our understanding of population health, improving global data, refining clinical trial methods of execution, and helping with the development of new vaccines and cures.”

“The most meaningful innovations will be those that get at the heart of patients’ experiences during a clinical trial. Just as genomics transformed the precise treatment of cancer care, the behavioral measurements captured by AI-powered tools can revolutionize our understanding of a drug’s impact. For example, video- and audio-based digital biomarkers that objectively capture a patient’s behavior and daily experience can help inform not only what interventions and support may be most effective, but what adjustments are needed to their treatment plan.”

“Healthcare is one of the most data-rich industries and patient-level personalization of that data will be transformative. Keeping patients at the heart of everything and understanding that every patient is different means it will be critical to turn granular insights into actions, to make an impact at every step of the care journey. This is especially important in rare diseases where using AI, such as predictive patient findings, will be critical to meeting underserved and underrepresented patients where they are.”

“There is a huge opportunity to improve patient outcomes by harnessing the potential of complex data and technology. When our team analyzes real-world data, we don’t just see numbers or patterns — we see the promise of these insights to uncover the next breakthrough in medicine and meaningfully impact patients’ lives. Given the sheer volume of data and processes, we believe applying AI and machine learning throughout the drug development process could help us match the right treatment to the right patient at the right dose, transforming the way we treat cancer and other serious diseases.”

“The use of curated real-world data from unstructured sources, such as electronic health record notes and images, combined with rapid advancements in artificial intelligence, such as natural language processing and machine learning, are going to be transformative for drug development. We are already beginning to see this enhance clinical trials, fueling the rise of synthetic control arms to model comparators and prospective evidence generation to see how drugs and treatments perform over time.”

“Smarter clinical decision support tools using machine learning and vast training sets of data will drive faster diagnoses, more finely tuned treatment strategies, and reduce waste in healthcare spending. The amount of error within current standards of care is staggeringly high. As data collection and portability continues to advance, new and smarter support tools will emerge — tools that can learn from previously successful treatment paths to guide clinicians to personalized care options that are far more likely to work.”

“The cell therapy space has grown rapidly, with autologous chimeric antigen receptor (CAR) T-cell therapies demonstrating groundbreaking clinical results in hematological cancers. However, the next evolution in immunotherapy currently under investigation is allogeneic T-cell therapy, which has the potential to leverage a healthy donor’s immune system, be produced in large quantities and stored in advance of patient need ready for rapid delivery as an off-the-shelf treatment. With the first-ever approval of an allogeneic T-cell immunotherapy anticipated by the end of 2022, this milestone opens the door for further opportunities in oncology and autoimmune conditions.”

“Undoubtedly, the biggest transformer is the movement toward biologic cures instead of pharmacological cures. Using the body’s own biological processes to cure disease shows tremendous promise. A prime example of this is the mobilization of immune components to eliminate cancer cells, a major focus of recent cancer research. But we are also seeing developments in chronic diseases such as arthritis, psoriasis and even diabetes.”

“The biggest technology transformers in clinical trials will be those that automate the manual, repetitive tasks we have in our operational processes. Technology that allows study teams to focus on more complex activities, anomalies and study-specific nuances will drive higher data quality, deeper insights and new levels of efficiency, optimizing clinical trial processes, enhancing safety and accelerating the delivery of new medicines to patients. AI and machine learning-based technologies that support smarter decision-making processes will also reshape the market going forward.”

“As we move to a value-based care model further upstream in the clinical lifecycle of an investigational product, we will have to start focusing beyond just the traditional outcome measures to also include the evaluation of outcomes related to symptoms, mood, quality of life and side effects. We must also begin to use technologies that reduce the burden on the patient to capture these endpoints. The introduction of ePro and eCOA assessments — in addition to wearables such as watches that track heart rate, activity, sleep, etc. — that can be easily integrated into the participant’s life is one way we are seeing the expansion of outcomes being evaluated.”

“The continuing development and regulatory acceptance of digital biomarkers is changing drug development and healthcare delivery. The growing adoption of digital biomarkers is enabling pharmaceutical companies to significantly accelerate the pace of R&D. This growth is fueled by an increasing number of patient-friendly wearable sensors that can capture multiple physiologic signals, combined with artificial intelligence and machine-learning algorithms to identify safety and efficacy signals much earlier in clinical trials for drug development programs, while providing early warning for timely interventions in clinical care settings.”

“We are going to see an increased convergence of medical science and data science in the use of prescription digital therapeutics that can augment or replace traditional pharmaceutical treatments. For some of the most prevalent and costly chronic conditions, digital therapies that leverage smart devices we all carry with us brings about a paradigm shift in how healthcare is practiced and delivered. We will move from managing symptoms to tackling the root cause of disease, with the promise of reversing disease progression, reducing patients’ dependence on prescription drugs and lowering the cost of care that is threatening our healthcare system.”

“Genetic engineering has the greatest potential to revolutionize drug development in the next decade and beyond. Advances in understanding the genome and improvements in gene editing, gene insertion and delivery technologies are finally emerging and converging to unlock the potential of cell and gene therapies to fundamentally transform the treatment of cancer, rare diseases and beyond.”

“The therapeutics market for 2023 and beyond will be radically reshaped by our increasing ability to integrate multiple signals into targeted therapies. Through techniques developed by the field of synthetic biology, cell-based therapies will respond to multiple physiological indicators to achieve fine control over the timing and localization of activity. Protein sensors that encode Boolean logic will transduce signals from cell surfaces at high speed to enable rapid feedback in defined environments. In turn, protein-based therapeutics will incorporate multifunctionality by accessing expanded building blocks at the amino acid and nucleotide levels that nature has yet to explore.”

“There is a tremendous need for technology that addresses one of the largest opportunities to improve healthcare outcomes: medication non-adherence. Alarmingly, approximately 50% of patients do not take their medication as prescribed (and) 69% of medication non-adherence has been attributed to patient behaviors such as procrastination, forgetfulness and confusion. Technology that prevents patient behavior from enabling medication non-adherence, such as long-term subdermal drug implants that guarantee adherence, are under development and have the potential to completely change medicine as we know it.”

“Drug development is associated with a high risk of failure, and the highest risks come at the earlier stages. The application of physics- and data-based computational approaches to early-stage drug discovery has the opportunity to transform the identification of clinically relevant biological targets, as well as of chemical matter for these targets. It can also influence the speed by which this chemical matter can be advanced into clinical development. The marriage of the data processing and interpretation power of AI/ML approaches with the prospective predictive power of physics-based methods is likely to have the (biggest) impact on drug discovery timelines over the next decade.”

“The biggest technology transformation in healthcare will be through enabling the use of a huge amount of real-world data, engagement and financial data. Our sector is still very far away from harnessing the power. I see the technologically enabled data mesh with digital networks to build a data supply chain that can help us deliver value across the patient value chain. The sector has to solve this problem well to deliver truly patient-centric solutions.”

“As the pharma industry moves toward continuous, modular and digital production, we expect to see broader adoption of 3D printing (3DP) technology in pharmaceutical development and manufacturing. 3DP technology can produce complex products at speed and scale while maintaining consistent quality, as well as tailor treatments for smaller patient populations, like those with rare diseases. Additionally, 3DP treatments can be programmed to target hard-to-reach areas of the body, enabling controlled, precise release of medicine in a specific location, at a specific time, and in specific quantities. This could be game-changing for companies creating new products, or alternatives to existing products.”

“It’s got to be wearable technology, the continuous data streams they create, and the insights that can be derived from them. The ability to understand a patient’s physiology at all times in a real-world setting unlocks so much potential for drug development and health in general. In 15 years, we'll be wondering how we ever approved drugs without continuous data streams.”

“I can say it was a culture shock to come from pharma to tech when it comes to innovation. SOPs, committees, red tape and procedures leave little to no room for innovation. An innovative culture is not one where you use the same procedures and think differently. It is culture where innovation comes first in everything such as performance reviews, product development, new procedures, new ways of discovery, new ways to look at the data and still be compliant. The culture needs to embrace people who take on risk, fail fast and look for ways to improve things not 10% but think about changing the problem for a 10X return.”

“Invention and innovation are often used interchangeably in business, but they are not the same. Few companies, or people for that matter, are true inventors. Many of us aspire to be decent innovators, that is, taking the substrate created by inventors and making it work better. Through that lens, all business should be focused on innovation — the iterative and incremental process of making a company better.”

“To achieve real, breakthrough innovation, company leadership must empower employees to take on external challenges and these efforts may require changes in both process and metrics. In diving into these efforts, company metrics need to support and illustrate learning, even if that is from failed experimentation. This approach requires fundamental changes and behaviors in the organizations and must be supported holistically — from the C-suite down.”

“Innovation must not be for innovation’s sake but focused on key challenges. Companies need to spend the time to get closer to their customers, really understand their problems and, most importantly, take full ownership of those problems. We then need to create opportunities for cross-functional and diverse teams to tackle those customer issues. We need to ensure clear and measurable outcomes and objectives are tied to those customer issues so that we know, when we solve those issues, what impact it will have on the customers and company.”

“Fostering the right business culture takes three steps. The first is to connect people to purpose. Purpose allows a common language to emerge, and language is fundamental to culture. Consider the word innovation: it’s derived from the Latin for renewal. Peter Drucker famously wrote, ‘the purpose of a company is to create a customer.’ The goal, therefore, is always self-generating business renewal and the best way to renew your customer pipeline is by innovating the customer experience.”

“There are three key steps to create an innovative culture. First, engage your employees — each needs to feel their input to innovation is valued by the organization. Second, formalize your innovation program — ideation platforms that are regularly engaged with by your employees will foster development of groundbreaking ideas for your organization. And third, recognize that incremental (improvement) is OK — as much as the big innovation is often lauded by management, you have to also recognize the continuous improvements that make a difference each and every day.”

“Innovation means coming up with new ideas, understanding their value and iteratively testing and expanding toward scale and maturity. Organizations get hung up at the idea stage, but often the innovation gap is really about what’s done — or not — with those ideas to move them forward. To change this culture, be really specific about what would be different if an idea ‘came true’ — if we knew X or could do Y, then Z would happen. Then, build the shortest-path tests to validate those claims, and aggressively prioritize ideas that pass those tests.”

“Innovation does not stem from a single person, department or independently within a company’s walls. It is derived from a commitment to internal collaboration combined with external market inspiration. As such, fostering a team-oriented culture that incorporates ideas across stakeholders — inclusive of employees, clients and end-users — sparks the best ideas and ultimately the most meaningful solutions.”

“Innovation requires a company to take risks and requires corporate-committed financing for new technology development while motivating entrepreneurial development teams willing to persevere through the peaks and valleys of development.”

“An investment in innovation should deliver on KPIs or solve problems/create deliverables more efficiently than the traditional method. Any agency thinking it can make money the same way moving forward as it did even last year is out of touch, so understanding and developing impactful innovation is critical. A well-structured pilot can go a long way to getting buy-in for broader adoption.”

“Reward employees for taking risks and encourage workers to ask and answer questions that have not been previously asked, or asked in a certain way. Innovation should always serve the company’s goals, so it’s critical to effectively communicate that vision to employees. Finally, establishing a patient and customer-centric culture fosters growth, while focusing on execution enables the delivery of solutions to those who need them most.”

“Innovation can only thrive when leaders create truly innovative environments where staff are free to express themselves and are not constrained by bureaucracy and unnecessary rules. This is challenging in companies that need to operate to GxP but it is still achievable if leaders think deeply about where rules and standards are required and where they are not. Innovation also can only thrive in environments where leaders are prepared to accept that staff will make mistakes as they try new things.”

“An innovative culture does not come easily. Technology needs to be built in an agile way, which is very difficult to do if the business itself is not agile. You also have to invest in developing the technology of tomorrow, because that gives you an ongoing roadmap of capabilities. When you buy technology from somewhere else, innovation stops at the point at which you paid for it.”

“We’d like to see a restructure of Small Business Innovation Research (SBIR) grants to get innovative technologies from small companies across the biotech ‘valley of death.’ The current limitation for an SBIR grant — fewer than 500 people in the receiving business — means small companies with great ideas lose grants to companies large enough to fund development internally. Something simple like restricting SBIR grants to companies with fewer than 20 people or with less than $2 million in life-to-date capital raised would cause a rush of new innovation to come to market.”

“Our job is to walk in their shoes to understand the journey, so we can genuinely provide value. A simple rule we follow is: Focus on what patients truly need and want. Through ongoing relationships with patient advocates, we endeavor to see their disease and its burden from their perspective. For example, when patients shared how off-putting it feels to hear the term traditionally used for pre-filled injection syringes, ‘auto-injector,’ we identified the term ‘self-care delivery,’ which is empowering and reflective of its benefit.”

“For many people the consumer experience has evolved to the point where there is almost no human interaction. The industry can put more healthcare information in the consumer’s hands so they can make better educated decisions. We need to provide a better experience for all constituents within the research and healthcare ecosystem. We especially need to make it easier for patients to interact with technology. We need to consider quality of life and the patient's actual experience, and the way they're feeling on a drug. Give them a proper user interface, and innovate around that interface so they feel they’re in as much control as possible.”

“There are three key things the healthcare industry needs to focus on to meet patient expectations. First, they need to prioritize approaches that truly meet patients where they are. Second, they need to authentically communicate not just the benefits of their treatments, but also the risks and challenges. Finally, with data privacy being such an important topic, the industry needs to give consumers a clear understanding of how and why their data is being used. The biggest roadblocks the healthcare industry faces in terms of optimal patient engagement revolve around how and when companies communicate with patients. For communication to truly be meaningful to patients and, as a result, lead to engagement, it must be timed to meaningful moments and tailored to actual needs being experienced during their health journeys.”

“Patients are the greatest disrupter in life sciences. It’s our responsibility to integrate the patient perspective, genuinely and authentically, into everything we do to optimize care for all. While industry has sharpened its focus on patient-centricity, patient insights must be embedded throughout the continuum, from driving our science to how we deliver medicines. Keeping patients’ needs front and center is inherently tied to our purpose and must be seamlessly integrated into our strategy and operations — not an afterthought.”

“The industry must adopt the ethos of patient-mediated research. It means utilizing solutions that collect the data patients want access to, as well as the data that healthcare systems, institutions and doctors need. If the industry wants to deploy solutions that have global patient appeal and utility, they require processes to truly understand patient needs. They also need to avoid the traditional ‘tunnel vision’ that often leads to them focusing on technologies that serve the needs of one clinical trial at one particular time point. Rather, they should think about solutions that serve patient needs throughout the patient journey: today, tomorrow and the next day.”

“Today, we see vertical integration taking place within the payer, provider and pharmacy industries; it would be interesting to ask the consumer if they believe this has favorably or unfavorably impacted their healthcare experience. We should set the bar based on how they respond, and then hold the stakeholders accountable to value the patient experience at the same level as quality, cost and clinical outcomes. The keys to patient engagement are personalization, system simplification and creating incentives — while avoiding unintended disincentives. The healthcare ecosystem today gravitates toward homogenization. That drives disparities, dissatisfaction and disenfranchisement.”

“There are so many variables in the patient experience: cost and affordability, physician dialogues and interactions, as well as access to information and services. It may not be possible to make every patient/customer experience perfect, but our business is working to engage with patients and advocates earlier and more frequently to learn from their experiences and incorporate that feedback on our plans. We aim to bring advocacy organizations and patient ambassadors into conversations with clinical development, marketing, medical affairs and patient services teams to ensure patients have a voice in designing our programs.”

“The growing complexity in healthcare treatments is limiting the ability of both patients and professionals to identify the right treatment for a patient. This information overload will present a growing obstacle to delivery of positive patient experiences until we begin to understand how to implement personalized medicine. Once we understand how genetic factors impact each patient’s treatment, we should be able to reduce the complexity and reach a model of shared decision making where the medical professionals are partnering with patients and their families to decide on the best course of treatment. Companies need to focus on providing fact-based educational materials on their therapies that are disconnected from marketing.”

“We should strive to trend toward a state where a high percentage of U.S. consumers are raving about their experiences within the healthcare ecosystem. We need to design, or redesign, patient-facing products and services that prioritize the experience of the patient, keeping sponsors/payers in mind but as a secondary or tertiary business user. Before trying to achieve better patient engagement, the industry needs to first understand what are barriers to good patient experiences in the first place. Yet, we lack much of this data. Currently we collect clinical outcomes data, but we do little to better understand patient trial experiences. By collecting data such as ‘how was my last visit’ and correlating it with patient dropout, we can better understand drivers of patient churn and improve clinical trial experience.”

“To most successfully engage participants, organizations must understand participant needs and hurdles, recognizing that these may differ from person to person. Two keys to adopting a more consumer-driven approach are: offering flexibility and keeping participants informed. Offering flexibility means giving participants options. For instance, this could relate to where and how trial activities are completed, how participants get to the research site, method of reimbursement, etc. Keeping participants informed shows them that they are a valued partner in the trial, whether sharing resources about their treatment or disease or providing insights about the trial itself."

“By providing different options for how to engage with a trial, including moving trials to communities where patients live or offering options for more virtual engagement and follow-up, patients can choose the ones that are best for them. Clinical trials have yet to be disrupted like other industries. Two-sided marketplaces have revolutionized the ride sharing and hospitality industries. Even in banking, there are personalized options for people: you can go to the bank in-person, use an app, go online or call. We should learn from what’s already happening in these spaces and use it to revamp how we’re approaching clinical trials.”

“While technology can certainly improve the patient experience, it needs to be combined with real-human interaction. We’ve found a healthy mix of personalized support from a dedicated team, along with an intuitively designed mobile application, increases compliance/retention rates in clinical trials. CROs should include patient advocates in the process when designing a clinical trial. A lack of understanding, including specific needs and/or challenges faced by a particular cohort, will lead to a trial design that doesn’t sufficiently engage the population, and ultimately, trial failure.”

“To meet expectations of clinical trial participants today, we need to identify — and remove — patient burdens, inclusive of time, travel-related headaches and out-of-pocket expenses. Recent Greenphire data analysis indicated the distance from a patient's home to the site location is 67 miles one way, creating tremendous burden. Fortunately, growing trends toward patient centricity and the use of technology in various patient-facing capacities has the opportunity to minimize barriers which in turn can improve overall patient engagement.”

“Clinical research, at its core, is scientific. Yet all too often, the industry fails to recognize or account for the human experience when planning or executing a trial. In an effort to shift that narrative, we must continually measure and validate patient-centricity throughout the life cycle of a product to make sure we're meeting the evolving needs of patients. In practice, that looks like involving patients in our efforts alongside leveraging data and technology to support patient-worthy decision making. At an organizational level, it's also critical to develop a culture where everyone — regardless of their specific roles — is keeping patients top of mind.”

“Companies typically work alone on disease awareness, diagnosis and treatment options. It would benefit patient care and engagement if companies could find a way to work together to create cohesive disease awareness and diagnosis campaigns and a primary source of information/options as opposed to a series of independent options.”

“Healthcare leaders need to lean into the industry’s digital acceleration, identifying new avenues to make meaningful connections with patients throughout their journey. Healthcare leaders should invest in tools to meet expectations, especially in areas where patients often cite pain points. For instance, healthcare affordability continues to be top of mind. Investing in technology, including financial navigation solutions, can help healthcare organizations proactively identify financially at-risk patients, and automatically enroll them in relevant financial resources.”

“Healthcare is a two-way street, and companies need to recognize the influence patient voices can have in guiding a humanistic, patient-centric approach. Yet, clinical trial teams are overwhelmed and studies are increasingly global and complex.

As innovators, we must bridge these two realities. The challenge is to develop pragmatic solutions that automate burdensome processes for study teams and patients while ensuring unique protocols and the unexpected can be managed quickly so patients have a seamless experience and trial timelines stay on track. Prioritizing the patient and validating study team challenges leads to adaptable, flexible and intuitive solutions — all of which are critical to see better patient engagement.”

“The industry needs to anticipate all of the challenges that are facing patients and have solution options in place to resolve those challenges, such as: patient educational materials, home healthcare services and patient transportation and study expense reimbursement.

 Minimizing known barriers such as lack of awareness, lack of access, lack of trust, inconvenience and socioeconomic challenges makes clinical trials more accessible to all patients. Companies can also utilize patient advisory boards, patient panels or focus groups to gather insights into patient challenges and motivations related to their specific conditions and their attitudes toward clinical trials overall.

“Our industry needs to partner with healthcare professionals who are at the frontline of delivering the customer experience. These professionals are facing a changing tide in how healthcare is delivered and consumed. Helping them understand those changing expectations and ways in which it’s possible to deliver that personalized customer experience is critical. Leveraging omnichannel approaches in the day-to-day within healthcare professional office settings, even at a small-scale, is something the industry should support by offering significant expertise and tools to help meet that high bar of a customized experience.”

“A consumer-centric approach to patient engagement will require brands to relinquish some control and build solutions beyond the medication. Patients expect their healthcare service and support to be holistic and meaningful. Pharmaceutical companies have started to address this through patient support programs, however they must go much farther. By offering services and support that help customers manage their daily lives more easily, more accurately, and in real-time are a few ways to build great service in.

 Additionally, social media now provides opportunities for pharmaceutical companies to invite customers into the conversation to co-create and bring a level of authenticity that continues to expand in value. All in all, a customer vs. brand-centric approach is the way forward.”

“Few companies truly focus on the customer across functions — sales, marketing, medical, etc. This leads to limited personalization for the patient experience because engagement is not based on a holistic understanding of their content and engagement preferences. Therefore, companies need to develop ‘one’ customer micro journey with insights from compliant, sophisticated and integrated data layers to yield dynamic hyper-segmented personas that can be measured and optimized. Lack of the right engagement data, siloed data and limited use of AI/ML are the biggest roadblocks. Stitching together different data sources, often from multiple vendors, is still an obstacle. Lastly, without organized quality data sets from unstructured sources, companies cannot leverage sophisticated technologies like AI/ML, which can be used to predict next best actions for patients across channels to create frictionless experiences.”

“We have a responsibility to give patients all the rights that consumers have in other industries — more choice, more cost transparency — and honor the vulnerability they are carrying in healthcare. A long spanning debate about when someone becomes a ‘patient’ has raged. However, patients are first and always a person — a mother, pianist and employee. Organizations can start by capturing and respecting preferences and honoring them, as well as making ease an organizational key metric and measuring it across all touchpoints.”

“The healthcare industry not only has access to the technology and resources necessary to meet consumer expectations, but also to the blueprints from other industries that have already seen success from empowering customers. There is a significant business benefit to delivering superior patient experience, so the ROI is there to invest. Pharmaceutical companies, payers and providers use multiple solutions for data management and customer engagement, with teams and technologies often operating in silos. That poses a significant challenge for achieving a single customer view across the enterprise making it difficult for these systems to work together to deliver timely and relevant patient communications.”

“As we look to the future, it will be important for sponsors and CROs to establish a well-thought-out technology, data and integration strategy that lays the foundation for a hyper-personalized patient experience. A key obstacle is that each market has varying requirements (e.g., data privacy, regulatory, banking) as well as expectations and needs. Even within a particular market, patients' preferences and ways of interacting can differ. Therefore, solutions that enable better patient engagement, must have a global focus with regionalized capabilities and patient-level flexibility.”

“While healthcare has unique requirements around privacy and security, there is no doubt solutions can and will expand to meet the industry’s needs and correspondingly consumer's expectations. A big part of it is simply recognizing that patients are customers. Healthcare has tried to embrace this attitude, yet acceptance has been conditional. Healthcare stakeholders want to control patient data, as well as determine when, where and how patients should be treated. Rather than asking the patient what they need, how they want to be communicated with and then accommodating, assumptions are made and often fall short. Plus, many organizations suffer from ‘ostrich’ syndrome: they would rather not accept the fact that patients increasingly have choices. Patients can and do leave companies that are not responsive or do not treat them like valued customers, and oftentimes the healthcare entity has no idea.”

“The most advanced technology may work for some patients, but it’s not going to work for all. This could mean that the technology landscape gets even more complex, but we can’t just expect one platform to solve all our problems. Vendors must be willing to integrate and work with each other to give patients technology options. Protocol designs need to be written with all eligible patients in mind. But to figure out what options patients crave we understand that patients need to be brought into discussions before sponsors finalize protocol assessments and requirements. Undefined expectations will always be elusive; we must engage patients earlier in the drug development process.”

“Managing patient expectations is important, but sometimes legal language required to do so, can make the message incomprehensible to the average patient. Informed consent documents use language far above the comprehension of most patients, and often leave out the most important details to assuage patients' concerns. If the legal language requirements can be separated from the basic information about the disease and the trial, it may improve understanding and correct misconceptions that may mistakenly lower or raise expectations.”

“One of the biggest roadblocks is technology that is overly complicated or hard to use. Patients, like most of us, have different levels of comfort when it comes to using tech. This discomfort is then further exacerbated by the challenges they are already facing in terms of their disease. Vendors need to more actively partner with patients, sites and sponsors to design easy-to-use applications that support data collection without negatively impacting our participants' daily life.”

“Companies need to ‘eat their own dog food.’ The people working on solutions will learn a lot about consumer usage if they put themselves in the position and mindset of a patient or trial participant. In addition, treat UX/UI design as being as important as technical features since the best technology is useless if people don’t use it. Engagement precedes adherence to protocols but both are necessary for optimum results and both require planning, communication and products/technology designed with end-users in mind.”

“Few areas of healthcare have been as historically overlooked and underfunded as women’s health. We must prioritize addressing these disparities to build a more sustainable future. This begins with expanding access to important products such as contraception, and requires more investment in areas where significant therapeutic gaps exist, like endometriosis, preterm labor and postpartum hemorrhage. It will require an innovation ecosystem with other companies as well as academics, regulatory agencies, legislators and community organizations who share our vision of a healthier every day for every woman.”

“We need to embrace all the differences that make up our society — racial, ethnic, gender identity, sexual orientation, abilities, age, socio-economic status and others. Each carries a unique set of practical, medical, scientific, regulatory and ethical considerations that are critical to building trust and designing trials that don’t create inherent barriers to participation. The more we can change our industry-perspective on diversity and inclusion in trials, the better equipped we will be to develop treatment options that are most representative and effective.”

“HCPs are an important source for referrals. We need to make it easier for clinicians to know what’s available and how it can benefit their patients. We also need to let them know they won’t lose their patient when referring them to a clinical trial.

Low-income and underrepresented populations may not have the same access to healthcare. Partnering with community leaders, health centers and partners can help to get people the right care earlier. We should strive for long-term relationships and collaborations, and at minimum share findings regarding how patient contributions helped advance the understanding of the research topic. That kind of engagement is purposeful and builds trust.”

“Addressing inequity in the U.S. healthcare ecosystem cannot be achieved by industry or healthcare providers alone. It’s essential to include underrepresented communities in the conversation and actively listen to their experiences and insight into systemic issues that can/might prevent access to healthcare. Recent developments, including updated FDA guidelines, signal that DE&I is moving from the fringe of healthcare to stand as a vital pillar of the drug and treatment development landscape; however, stakeholders must commit to challenging the accepted norms of traditional practices, using insights provided by underrepresented communities to shape a system that benefits all.”

“To drive representative recruitment and participation in clinical trials, pharma should review their research model and build trust with high-risk populations. Upstream partnerships with healthcare providers in high-risk communities, outreach, and measurement of trial rates are key in this effort. Second, organizations should develop culturally appropriate and inclusive patient education materials and leverage digital tools to drive engagement, if possible. Lastly, companies should focus on affordable access to innovations by breaking down cost barriers to patients’ spending on health.”

“The first and most critical step is to spend more time talking and listening to patients and our care partners. Often, our industry makes assumptions about what we believe patients will want in a clinical trial experience and speaks for them. Instead, when patients are asked, we are very forthcoming about sharing process improvement feedback. These conversations are invaluable opportunities for the industry to operationalize those insights and design truly patient-centric trials. Like consumer-facing industries, taking the time to listen and encourage options that allow patients to choose what is best for our needs helps to alleviate the medical and practical barriers.”

“We must remain vigilant in keeping trials patient-centric. The pandemic challenged the industry to adopt more flexible and nonstandard research practices and tools — transportation services, remote visits, data-triggered micropayments after completion of trial activity, etc. — to increase access. By innovating and embracing new technologies, we can remove financial, logistical and other barriers to participation. Digital travel solutions can help eliminate the logistical hassle of finding a ride by providing car service and appointment alerts that make participation easy and more comfortable. It's a way of providing access, inclusion and care to participants who may not be able to access it otherwise.”

“To speed the inclusion of underrepresented patient populations in clinical trials, we should first consider what we can learn from real-world data (RWD). First, RWD can be used to improve the efficient design of more inclusive clinical trials by identifying potential trial sites that are enriched with patients of interest and generating estimates of expected sample sizes in subgroups. Second, RWD offers a platform to conduct pragmatic trials that often better represent patients in actual clinical practice, and can assess whether treatment effectiveness may vary across patients of different backgrounds.”

“One of the most accessible yet sometimes under-considered steps companies can take is the incorporation of use-case strategy in early-stage clinical and commercial planning. Understanding target audiences and how their demographics and psychographics will impact the gap between intended and real product compliance and persistence is critical to forming development strategies to address these very real dynamics head-on. For example, issues such as cold storage and self-administration can become significant barriers, and incorporating for these in drug development, labeling, distribution and commercialization strategy from an early stage can help ensure that patient needs are addressed.”

“I think using diverse companies to reach diverse populations is the answer. It is not a mass communication strategy; it will take a number of different, diverse companies to overcome these barriers. Thankfully, with technology, it is easier to reach all patient populations — only if we use empathy and put in the effort.”

“At a study level, companies can make it an explicit goal within the patient recruitment plan as a starting point. It’s important to note that access, cost and trust barriers need to be overcome to achieve that goal. To address access and cost, study sponsors can offer to cover certain expenses for trial participants including travel to reach communities that are distant from the study site.”

“One of the most important steps the industry can take is to increase the number and locations of clinical research sites and investigators. We need to be reaching into communities that are diverse, and yet there are no clinical trials being run in such locations. In order to move the needle though, there needs to be a comprehensive approach by first reaching into physician groups and medical offices offering education about clinical research, training about the requirements and the operational components of a clinical research study, from the site’s perspective, such as training and support on how to negotiate contracts and budgets for clinical trials, GCP, etc. After providing training, physicians who continue to want to participate in research should be offered experienced investigator/research staff mentorship while taking on their first few studies, as well as staff augmentation to support the additional clinical trial workload that may not be able to be covered by existing site staff.”

“What we’ve seen in the field is the need for more focus not just on diversity in trial enrollment, but on equity. Some of the issues facing clinical trials with regard to diversifying enrollment include a lack of awareness, mistrust of the healthcare system and accessibility to participation. To make the trial setting more equitable for all participants, industry leaders need to substantially expand current recruitment methods by developing solutions that meet potential study participants where they are, with language that is inclusive and accessible, trial staff that are representative of the population, and an understanding that trust doesn’t happen overnight but rather after consistent commitment to better outcomes.”

“We need to stop relying on the same sites we’ve always used. Technology can help here. We can deploy an electronic platform to new frontier sites that makes it easier for them to keep up with the complex documentation of clinical trials. Or we can build feasibility software that helps sponsors quickly see the patient populations at these new-to-research sites and understand how these sites can contribute to trials. Additionally, sponsors and CROs need to partner with those sites to develop solid community outreach and engagement initiatives. Understanding, of course, that change will not come overnight and these initiatives have to live outside the context of a single study budget.”

“Moving the needle on this complex problem requires cross-industry collaboration between healthcare sites, life sciences companies and communities across the U.S. We are launching a cross-country clinical trials diversity network pilot alongside several healthcare sites and life sciences companies to engage and activate communities in a differentiated way. We hope to learn from the pilot and start to leverage learnings across the clinical trial landscape. In addition, decentralized clinical trial models — for select types of clinical trials — could help increase patient diversity as well.”

“There are several steps we can address as an industry, but one to prioritize to reach more diverse patients is rethinking site strategy and selection. It is necessary to utilize a combination of community-based sites that are new to clinical trials, research sites that see diverse populations but that we as an industry might not be as familiar with, and sites that are research-experienced but have historically underperformed in the enrollment of diverse patient populations.”

“It comes down to three main actions companies should be doing now to create individual employee experiences: how leaders and managers engage, how they prioritize and how they recognize their talent. In our new reality of remote and hybrid work cultures, those three things can be difficult if companies are not intentional with their actions. Companies need to stop solely focusing on how to best entice people to come back to the office and start focusing on creating best practices to ensure a successful hybrid culture with the right technology. Focus on results no matter where the work is done, stay connected to your teams and celebrate the successes both in the office and remotely.”

“Aligning employees around shared goals is the best way to create a robust culture and collective mindset. Once you have defined the company’s goals and objectives for the year ahead, ongoing communication through a variety of channels, such as town hall meetings, intranet articles and small group meetings with the CEO, will reinforce the goals and galvanize the workforce around a common purpose. Meeting the challenge head-on and getting creative about ways employees can maximize their in-person time can unite teams and create bonds that transcend the miles between colleagues. It is a challenge that can be transformed into an opportunity.”

“The organizations that succeed amidst market disruptions will be the ones that focus on putting humans at the center of their business strategies. Companies should empower and upskill managers and people leaders. This means providing managers with the set of tools to enable their success and their teams’ success, setting a clear vision of what is expected to empower employees to own the outcomes of their work, and creating an inclusive environment by proactively seeking and listening to employee perspectives to allow for ongoing dialogue of how work outcomes can be most effectively delivered in a hybrid world.”

“We also must consider employee wellness as a barometer of success, because when our people are empowered to prioritize all aspects of their health and well-being — physically, mentally, emotionally and financially — they are more present and fulfilled in their work life, in their families and in their communities.”

“Small companies like ours employ highly skilled and specialized people; attractive compensation will never be enough to retain them. We work hard to build a culture where people feel committed to shared success and are intolerant of toxic workplace behavior. We actually believe our corporate values and refer to them often: respect, tenacity, compassion, creativity and alacrity. When people feel ownership and camaraderie, they enjoy coming to work and will be loyal.”

“Ensure that you are listening to your employees by gathering regular feedback which could be from employee engagement surveys, stay interviews or one-on-one discussions. Create action plans from the feedback that are shared with employees. Create clear guidelines about when and how work is done. Ensure that all employees, particularly those who are not in the office, continue to have access to leadership and opportunities. Establish communication expectations, be mindful about the type, amount, and scope of meetings, and educate managers and employees to ensure they understand all guidelines and expectations.”

“Kyowa Kirin is not immune from the larger macro issues of burnout and turnover, which have accelerated as a result of the pandemic. In response, we’ve tried to offer employees more flexibility with how they work and engage them in committees and conversations to improve our benefits, our workplace culture and our talent development programs.

We believe that to retain top talent we have to do more than just ensure that our compensation package is competitive. We've focused on five areas that we believe are important to today's workforce: flexible work arrangements and work-life balance, well-being, reward and recognition programs, offering a vibrant workplace culture to engage employees and upskilling opportunities and talent development programs.”