As we strategized how to present this "last magazine" of PharmaVOICE, we wanted to do something a little different. Instead of our annual Year in Preview issue, we asked our community of thought leaders to reflect on the past 20 years and share their perspectives on the major breakthroughs, which in many cases continue to shape the industry; their short-term strategies and focus given shifting priorities as a result of the global COVID-19 pandemic; their "blue ocean" ideas that will shape the next frontier of the life-sciences industry; and finally, what the biggest opportunities are for their organizations in their various sectors. And they did not disappoint.
As always, we are immensely grateful to our community of thought leaders for providing their valuable insights and commentary. We look forward to continuing the conversation with these visionaries and change agents in January with the re-launch of PharmaVOICE as a daily, digital Industry Dive publication. Please join us as we continue to cover the industry from molecule to market in a new and exciting format.
Susanne Fiedler, Ph.D.
Chief Commercial Officer
Next Frontier: Women’s health issues are still fraught with stigma. Their struggles and symptoms are often dismissed, downplayed, or ignored entirely. Unmet needs in women’s health have huge impacts on individual women — spanning career, well-being, productivity, leadership potential, and so on. They also have significant impacts on families, communities, and economies. Women and women’s health will thrive when there is a healthy ecosystem of research and innovation dedicated to better understanding the unmet medical needs women face throughout their lives. I am looking forward to the next frontier, where we can unlock the value of scientific innovation and collaboration to create a better and healthier every day for every woman.
VP of Clinical Development and Digital Health
REFLECTIONS: Over the past two decades, the single biggest driver of breakthrough transformational change — truly momentous change — in the life-sciences industry has to be the evolution of digital. Digital tools, the internet, communication technology, mobile apps, eCOA, ePRO, CTMS, RT visual data, digital payments, DCT, remote monitoring, eCTDs, eCRFs, EDC — all fall under the digital umbrella, and all of this has transformed how we work and what’s possible as a result.
Director & Head, Medical Communications Strategy
Biggest Opportunity: The power of data is still largely untapped. Understanding HCP behavior by analyzing behavioral data can not only address knowledge needs from a marketing perspective, but also provide insight into treatment patterns against diagnoses and clinical results. This has been a work-in-progress with population health initiatives.
Additionally, a significant opportunity exists for the further expansion of value-based agreements within the pharmaceutical industry. Given the rapid consolidation of private practices into larger health systems, greater control can be exerted to ultimately optimize disease management strategies at a lower cost. For pharma, fixed contracts can be negotiated which showcase the synergistic relationship of benefit and mitigated burden of longer-term costs. From here, pharma can further showcase its impact with adherence tools to support HCP monitoring activity. All of the above are ongoing efforts and the potential can be further unleashed with increased sophistication of data processing infrastructures.
Chairman and CEO
Next Frontier: Gene therapy/gene replacement is the emerging new frontier.
Cameron Durrant, M.D.
Chairman and CEO
Next Frontier: Managing the cost of healthcare and deploying existing resources more smartly and balancing that versus completely novel treatments.
VP, Data Product
Biggest Opportunity: Life-sciences organizations have long been able to use real-world data (RWD) to find HCPs who have historically prescribed a given medication. But in the coming years, life-sciences companies that will be able to set themselves apart are those that are able to layer AI-driven algorithms on top of their real-world datasets to solve high-impact awareness, access, and adherence challenges. The biggest untapped opportunity is the use of RWD and AI to reach providers with more timely and relevant information at critical junctures throughout the patient care journey. This results in quicker therapy initiation and highly personalized adherence programs to help patients stay on their doctor-recommended course of therapy. There is a vast opportunity for life-sciences companies to use AI-based solutions to bridge the gap from data to insights to execution, bringing everything together into one seamless closed loop. In the short run, companies need to focus on identifying steel thread use-cases where value can be returned quickly on these projects. In the long run, there is enormous value in deploying RWD+AI to further personalize message delivery for life sciences and to better understand how treatments are related to patient outcomes.
Managing Partner, Chief Strategy Officer
Biggest Opportunity: Healthcare marketing and communications face unprecedented challenges in terms of breaking through the vast wave of content that envelops customers each and every day. How do we ensure that our messages stand apart and get heard? An enormous opportunity exists to avoid the same old formulas and approaches, which depended on incomplete assumptions of what customers actually think, feel, want, and need. By going deeper, asking more penetrating questions, and interpreting what we hear with greater psychological nuance, we can engage customers in ways that more harmoniously resonate with their true, authentic selves. We can thereby do less “selling” in favor of conducting more genuine and mutually beneficial conversations.
Reflections: Momentous change in the life sciences is, to some extent, the goal. It’s very difficult to pinpoint just one, but certainly the scientific advancements and innovations across so many therapeutic categories is top of mind. All of us have benefited from these advancements in one way or another — from more comprehensive antibiotics to minimally invasive surgical procedures to breakthroughs in heart disease and stroke research. For me, seeing universal hepatitis C treatments evolve to the point where the word “cure” can now be used has been extraordinary. The improvements in treating cystic fibrosis have also been remarkable to witness. And, of course, the significant advances in cancer treatments that have improved the lives of so many. It’s clear that mapping the human genome has and will continue to pay dividends across a wide spectrum of disease states. We’re seeing patients are more engaged now with their overall wellbeing than ever before and the expectation of convenience and transparency in their health-related experiences is high. This, along with increased measurement of outcomes at every level, has mandated truly transformative technological approaches, which in turn has led to significant changes in the business of life science. Digitization of health has been shown to improve health outcomes and is helping to get us closer to the promise of personalized medicine. We’re also seeing significant changes in clinical discovery and commercialization with increasing tech enablement, a trend that is predicted to continue to drive rapid change in life sciences for years to come. Nowhere has this been demonstrated more profoundly than in the pace at which COVID-19 vaccines were developed and approved this past year.
Mary-Ann Etiebet, M.D.
Associate VP, Health Equity
Merck & Co. Inc.
Short-Term Focus: I believe leaders across the life-sciences industry will play a pivotal role in advancing health equity. But our industry cannot solve these challenges alone. Often the conversation around health equity is limited to what the healthcare delivery system can do, but when you refocus on the goal — more equitable health outcomes — you realize that it is a bigger conversation and that only a whole-of-society approach will get us there. We need to align with community-based organizations and collaborate across sectors to co-create solutions and hold ourselves accountable to health equity commitments. For example, by working with organizations like Black Health Matters, the National Urban League, and the Lazarex Cancer Foundation, Merck is recruiting and engaging clinical trial participants who are racially, socioeconomically, and demographically diverse to ensure our research includes patients from the communities we aim to serve.
Chief Creative Officer
Biggest Opportunity: One of the biggest opportunities our industry has seen in the last two decades is harnessing the power of digital tools and virtual experiences. As an industry, we may have all been a little late to the party, but now it’s truly on, and some of the most significant and dramatic strides in digital immersion and user experiences are being made in pharma and life-sciences marketing right now. This has us the most excited.
President and CEO
Reflections: There are a few momentous changes that I believe have impacted the life-sciences industry. First, the science is always the cornerstone of change in this industry. The life-sciences industry continues to lead the world in innovation, a fact that was recently evidenced by the COVID vaccine development. Second, there has been a change in the capital markets. Companies are doing IPOs earlier than ever before. Third, the shift to virtual business practices during the pandemic will have a major impact on communications in the industry moving forward. It could allow collaboration within the industry to span different organizations and countries with the potential for more rapid innovation.
Product Manager, Immune Cells
Short-Term Focus: Initially, cell and gene therapies were exclusively autologous in nature and thus limited to primary cells from the patient as starting material. As new off-the-shelf allogeneic therapies enter the clinic, researchers have more flexibility in their starting material originating from either primary cells, such as natural killer (NK) cells or modified T cells, or from induced pluripotent stem cells (iPSC) and mesenchymal stem cell (MSC) derived immune cells. There are pros and cons to either strategy and it will be interesting to see not only how researchers’ preferences develop over the next year, but also how supply chain networks are strengthened to meet the changing demands.
Chief Digital Officer, RDS Technology
Next Frontier: Every industry uses data and simulation to launch a new product. The use of simulation and modeling to launch new drugs to market is the next frontier.
Co-founder and CEO
Reflections: The arrival of true personalized medicine is transformative. In 2004, I served as co-founder and executive director of Proposition 71, California’s $3 billion stem cell research initiative, because I believed in the enormous potential of regenerative medicine. And today, patients’ own cells are being re-engineered to cure late-stage cancer and other previously untreatable conditions. And we’re still only at the beginning. The science continues to leap ahead — just look at CRISPR — and now we all need to collaborate to bring down costs, open up access, and make personalized therapeutics part of mainstream medicine.
Chief Innovation Officer
Next Frontier: The most exciting frontier is already rippling in the rare disease space: truly personalized medicine. We already see the success of genetically targeted treatment, but the bluest ocean is in designing each person’s total treatment plan for their personal genome, their lifestyle, and their medical history. The opportunity for life-sciences to wrap around one patient’s needs will be built on unprecedented levels of patient engagement, data sharing, and care coordination; these models are out there now, and pharma can play a unifying role.
Christopher Brown, Ph.D.
Chief Technology Officer and
Reflections: Over the last 20 years, there has been an explosion of “omics” of knowledge discovery. It started with genomics, and is now rapidly shifting to proteomics, metabolomics, and beyond. The promise of genomic information improving the understanding of healthy and aberrant biology led to the creation of an entire industry segment in tools, and that’s happening again now with proteomic and metabolomic developments. These fields are going to completely change the degree of visibility we have into the state and trajectory of biological systems.
Biggest Opportunity: Life-science market insights processes are woefully behind other sectors in managing data and making it more actionable. Clients need both speed and access to achieve their research objectives. The No. 1 opportunity we’d like to unlock is in digitization. Much of pharma insights work remains manual and disparate. Clients want experts gathering and analyzing their insights, yet usually experts are waylaid by automatable tasks, creating a slower, inefficient, expensive process — one with higher risk of human error and an inability to effectively manage data. The No. 2 opportunity is reaching HCP audiences worldwide who are pivotal to innovation. Most survey panel and HCP community providers neglect HCP user experience and relevancy, but it’s vital to HCP engagement, high participation rates, and a fair exchange of value for time, to ultimately achieve brand loyalty. Tech-enablement that furthers digitization of data and strong panel management that respects HCP time will speed innovation.
William Feehery, Ph.D.
Biggest Opportunity: Quantitative systems pharmacology (QSP) is the next frontier in biosimulation, and it has enormous potential to improve R&D and inform decision-making across the drug discovery and development process. QSP combines computational modeling and experimental data to examine the relationships among a drug, biological system, and disease process. QSP leverages vast amounts of biological and pharmacological data to conduct computer-based trials with virtual patients, helping us to understand disease pathophysiology and identify and test therapeutic strategies. This latest technology is already being applied to optimize vaccines, combination therapy for oncology, and gene therapy. Using QSP, we can address critical questions such as what is the best target and modality for pharmacological intervention to treat a given disease? Or how do we predict human response (dose) to a novel mechanism based on preclinical data? It is an exciting field that allows us to tackle the toughest challenges in drug R&D.
President, Consulting and Chief Commercial & Strategy Officer
Reflections: There have been many momentous changes but for me the clinical innovation of specialty drugs has transformed patient care and the life-sciences industry. In two decades we have seen many diseases, including cancer, HIV/AIDS, and MS move to conditions that can be either cured or chronically managed. It’s really unbelievable progress that we are seeing continue to escalate with COVID vaccines and treatments. With these changes are new patient access needs but I view that as a positive problem and another area where our industry is innovating to support patients.
VP, Product Strategy
Next Frontier: Clinical trials are seen as a care option with a doctor and demystified to the general public. Truly personalized options are made more available to humans around the globe that are tailor made for them based on data and predictive modeling to improve effectiveness and safety for all.
Biggest Opportunity: We are continuing to see growth opportunities in Asia/Pacific. As the second-largest pharmaceutical market globally, China has shown vitality in drug development due to advances in life sciences and technology and an optimized regulatory environment. China is pioneering many innovative areas for drug development, such as patient-centric clinical trials, real-world data/evidence, and decentralized clinical trials. We can expect continued significant biopharmaceutical investment in the region that will drive CRO market growth.
Chief Marketing Officer
Biggest Opportunity: The biggest opportunity to unlock in our sector of the life-sciences community is patient empowerment. Early phase drug development has a cascading effect across the rest of the pharma life cycle, even the smallest strategic decisions having significant, potentially multi-billion dollar consequences further downstream. By circumventing the traditional communication roadblocks between pharma companies and patients through influential, well-informed, and trustworthy patient ambassadors, the industry has an unprecedented opportunity to listen and integrate end user insights like never before. Therapeutics that otherwise might not be considered — and others that shouldn’t be — can stand the test of patient input. And clinical trials, often stubbornly resistant to change and challenged by a paucity of qualified subjects and alarmingly low retention, may finally flourish thanks to patients guiding and motivating other patients to better understand and enthusiastically participate in them.
Bill Byrom, Ph.D.
VP, Product Intelligence and Positioning
Reflections: Digitalization. Going back 20 years, electronic data capture (EDC) was still in a slow adoption phase and only used in less than a quarter of clinical trials. Paper-based processes were cumbersome, manual, and slow. Now, technologies like EDC and RTSM are used in almost every clinical trial. We’ve seen similar increases in the use of other clinical trial technology (e.g., eCOA), which has transformed our processes, efficiency, and ability to collect greater volumes of data for increased insights into the impacts of our new treatments. This has radically changed our working practices and has driven the need for new regulatory interpretation and guidance on applying the same fundamental regulatory framework to our changing operating models.
Senior VP & Principal
Short-Term: As the point of care (POC) continues to expand, there is still plenty of room for innovation within the electronic health record (EHR). POC access rose to the forefront during the COVID pandemic, calling attention to the many ways we can make care more accessible. However, the one platform that remains a constant source of truth supporting all other forms of care delivery is the EHR. Regardless of how care is delivered, the patient’s health data must end up in the EHR, and it all comes back full circle because the EHR is where physicians still spend the most time, and where they are when making decisions about therapy for patients. There are new ways to apply data using AI-driven technology to deliver tailored, relevant messaging to physicians in real-time. Opportunities within the EHR are still highly untapped. As manufacturers continue to embrace the application of advanced analytics at POC, they’ll find many novel opportunities within the EHR.
President of Shimmer Americas
Short-Term Focus: Developing a clear path to having digital endpoints accepted by global regulatory agencies is the most important factor in enabling digital health technologies. Until we have accepted digital metrics for evaluating patient health, it will be impossible to realize the full benefit of digital health technologies. Many organizations are wrestling with this challenge, including the Digital Medicine Society (DiMe), the Open Wearables Initiative (OWEAR), the Critical Path Institute, and the Clinical Trials Transformation Initiative to name a few.
Anne Quinn Young
Multiple Myeloma Research Foundation
Reflections: Sequencing of the human genome because it unlocked a depth of data and unleashed cutting-edge tools that could be applied to transform the treatment of and enable cures for many different diseases.
Next Frontier: For years, we’ve been moving from a world focused on leveraging chemistry to one that embraces biology. However, we are just now starting to see the tangible outcomes associated with this shift. The promise of biology is not just in the medicines and treatments we can create, but in how biology can fundamentally change life-sciences R&D more broadly. Plant-based “meats,” new ways of promoting and expanding agriculture, new, more flexible, more sustainable materials are all part of this revolution. In the coming years, the industry will need to substantively change the way in which it researches, tests, and manufactures products. Likewise, global health authorities will need to consider new guidance for these products and new ways of quickly assessing both safety and efficacy as products are brought to market.
Reflections: The life sciences’ adoption — and integration — of advanced technologies across the industry has been a game changer. Harnessing the power of things like machine learning, artificial intelligence, and augmented reality, for example, has paved the way for new therapeutics, personalized patient care, and using data-driven approaches to communicating and connecting more effectively with key stakeholders on a global scale.
CEO and Co-Founder
Next Frontier: We’re likely to see changes in the economics of running trials. The overall costs will come down, but the budgets will be allocated differently. Research and commercialization will grow and become more connected in a way that serves patients and caregivers. As a result, the opportunity to participate in clinical research will become significantly more accessible and be part of how physicians make care decisions for their patients on a day-to-day basis. We also expect an increase of new medications that will make it past preclinical assessments and into clinical trials, meaning that better treatments can be available to patients faster.
Jules Mitchel, Ph.D.
President and CEO
THI Pharma Services Inc.
Biggest Opportunity: Accelerating the clinical trial and regulatory review processes as has been experienced using COVID-19 as an example.
President and Chief Commercial Officer
Next Frontier: The next frontier for clinical trials is in-silica research, also — confusingly — called virtual trials. In this future of research, “subjects” are computer models, data is real world data (RWD), and the experiments are conducted through computation — not human observation and measurement. There are already some good examples of this. The Economist recently reported on one from the UK, but it will be a very long time before this is a significant disrupter to clinical research.
Ethan Settembre, Ph.D.
VP and Head of Research
Biggest Opportunity: Long-term benefits of mRNA have yet to be fully unlocked. As this technology develops, we look for embodiments that can allow for very quick design and translation to new approaches that can enable true personalized medicines. Further work also needs to be done to simplify good manufacturing practices leaning more toward desktop systems that can enable distributed manufacturing, even in hospitals. This can transform access to new technologies that can protect the population both from pandemics as well as faster and potentially more effective treatments for non-infectious diseases.
CEO, inVibe Labs
Reflections: The most momentous change impacting the life-sciences industry is the gradual realization of “the quantified self.” We have on average 37 trillion cells in our bodies, so imagine the data stored within each of us. Until recently, the “digital exhaust” was unmeasured and lost. Thanks to the digital health revolution that has transformed the consumer electronics industry with sophisticated, device-driven biometrics, we are inching closer to the dream of not only diagnosing and managing diseases, but actually preventing them. From my vantage point, advanced biometrics has also taken the form of voice-activated inputs for primary market research. For the first time in history, life-science companies have direct access to the voices of patients and HCPs, which can be analyzed using a dynamic combination of human linguistic expertise leveraging advanced ML technology. The “brave new world” of digital health has arrived, and we’re just beginning to scratch its electronic surface.
Executive Director of Agency Sales
Biggest Opportunity: We need to do a better job remembering why we are in healthcare/marketing communications and always remember the audience and the reasons to communicate. HCPs are looking for efficiencies and ways to stay on top of the industry, and patients are looking for great information and methods to keep themselves on treatment plans. Better outcomes and empathy along the way are the goals. But I think the most significant area to unlock is the holistic communication approach that can happen when reaching HCPs and their patients with measurement. Everyone is talking about the importance of omnichannel strategies, but it remains unclear which brands truly embrace them. Do marketers know which channels are outperforming others, how it’s impacting sales and taking share? If a brand faces a highly competitive, crowded treatment environment, they should ask themselves — how can we stand out?
Kevin Knopp, Ph.D.
CEO and Co-Founder
Reflections: The biggest change I’ve seen in the biotech and life-sciences space over the past two decades has been a dramatic increase in the number of venture-backed small biotechs chasing an incredibly diverse biotherapeutics pipeline. These are very well-funded entities moving at lightning pace, and exploiting cutting-edge biology. Life-sciences tools have been really challenged to keep pace with the speed of these new/emerging therapeutic classes and it has demanded a ton of innovation in the tools space.
Amir Kalali, M.D.
Reflections: The pandemic has probably had the most profound impact. It has highlighted the work of the life-sciences industry, forced the industry to evaluate how we conduct our work, interact with patients, and the future nature of work.
Director of Marketing, ADME-Tox
Reflections: Cryopreservation of human hepatocytes and other liver cells significantly improved preclinical in vitro modeling and accelerated drug discovery. Before that, research program timelines were constrained by availability of fresh cells from deceased donors. Because of the logistical challenges in receiving donor livers, isolating cells, and shipping them to drug discovery labs it was difficult to schedule in vitro research programs using human hepatocytes. As an alternative, researchers used hepatocytes from preclinical species. Cells from these species are frequently adequate for drug screening assays but their functional differences, compared with human cells, mean they are not always predictive of in vivo human pharmacokinetics. Cryopreservation also enabled development of complex 3D and multi-cellular models. For example, micropatterned co-cultures with hepatocytes and fibroblasts are effective for long-term, complex toxicity, metabolism, and efficacy models, and micropatterned tri-cultures with hepatocytes, fibroblasts, and Kupffer cells are used to investigate long-term immune-related and inflammation-mediated liver injury.
Charles Heffernan, B.S.Che.E.
Senior Process Specialist, ATMP SME
Next Frontier: The next frontier for the life sciences is being able to repair or modulate the causes of disease within the human body at the level of cell operation, gene expression, and/or genetic code. Our understanding of cellular biology — the complex interplay of DNA, RNA, and proteins within the cell — and mechanisms for modulating the biology are rapidly expanding. We are in the midst of the next wave of biotechnology and will see both a rapid expansion of new, advanced therapies concurrent with continued growth of existing therapy types.
Short-Term Focus: The trend toward internationalization is one I’m tracking closely. Think about how Netflix releases shows like Squid Game to the entire world at the same time. It was, at one point, the No. 1 watched show in 90 different countries. The fact that people everywhere, from Korea to India to Norway to Canada, were talking about the same show at the same time, says a lot about how small our world is getting. I believe this is going to happen with HCP marketing. Brands are starting to think about reaching HCPs across countries, rather than region by region. Think about what this means in terms of expanding global access to health information and medical innovations. By level-setting the knowledge of doctors across the world, we move one step closer to democratizing healthcare for all.
VP Account Management, Patient Engagement
Short-Term Focus: Access and affordability in specialty therapy areas that involve complex drug regimens remain a top challenge. There is a lot of opportunity for innovation in patient support programs, where technology solutions can simplify and streamline therapy initiation and adherence. Adherence begins at the point of prescription, from raising awareness with the physician when a patient qualifies for therapy, to making sure the patient gets the medication, to ensuring they have ongoing support throughout the course of therapy. Pharma manufacturers can use digital solutions to augment touch points and implement more personalized patient engagement support programs that fit into the patient’s lifestyle. Technology can help manufacturers create highly customizable engagement programs that help support adherence by providing access to educational resources, dosing reminders, nursing services, motivational messages, and other resources that patients can access directly on their mobile phones.
Co-Founder and CEO
Reflections: There have really been two momentous changes in the last two decades that have impacted the life-sciences industry, as well as facilitated a landscape that has helped people-focused companies like Health Union to thrive. The first momentous change has been the incredible breakthroughs — a mixture of therapies and approaches to care — in various oncology and rare disease conditions. In improving survival rates and quality of life for people with these conditions, these breakthroughs have given countless patients and caregivers hope while also making room to focus on other aspects of living with these conditions, like emotional and mental health and well-being. The second impactful change has been the industrywide shift, largely thanks to an evolution of technology and digital media tools, toward empowering greater patient knowledge and self-advocacy. As a result of these tools and the explosion of social health, people increasingly have the ability to share, learn about, and manage their condition.
Next Frontier: The next frontier is health equity. Today, the incentives in our healthcare system are not aligned to deliver equitable access to care across all populations. Changing those incentives to improve health access and drive more patient-centric care should be our collective goal.
Short-Term Focus: We have come to the strategic conclusion that the best Phase II coordination partners for startup biotechs like ours will be those that have Internet-enabled, COVID-accelerated efficiencies to lower clinical trial burdens. The savvy use of technology should be able to decrease clinic visit requirements, improve dosing regimen compliance, and increase patient interaction in ways that yield both richer PRO statistics and a more holistic understanding of a patient’s experience on trial medications. Phase II partners that can leverage technological advantage across multiple trial sites will help young biotech companies complete critical Phase II trials more quickly and less expensively, making fundraising easier and helping more drugs move to market more quickly than traditional clinic-driven models.
Senior VP, Head of U.S. Commercial Operations
Dr. Reddy’s Laboratories
Short-Term Focus: It’s a very competitive marketplace. While we may feel that we’re doing something unique from a product selection standpoint or that we have a unique capability, the reality is that if you look across the competitors out there, somebody is doing what we’re doing. One of the big challenges is to continue to be quick to market with products. You’ve got to continue to innovate, select the right products to develop, and quickly come up with strategies where you can try and differentiate your products. You also need to make sure that you are as cost-competitive as possible, because the market dynamics are competitive and changing rapidly. If you are late to market, you’re going to struggle to get market share. And if you’re not cost-competitive, you will not succeed in a particular product and hence the long-term viability of an asset may or may not exist.
Reflections: Adherence still persists as a problem for the healthcare industry and pharma marketers. Adherence is complex but needs industry collaboration to solve it. Everyone plays a specific role. We believe that through deep patient understanding in a personalized way, we can shift the behaviors to drive trust and better patient behaviors to result in better patient outcomes. If we all listen to patients and give them what they want in a way that specifically works for them, this would be a win-win for all key stakeholders in the healthcare industry. Collaboration and cross-channel pollination should be the next frontier. Digital and human are complementary and need to work together. They make each other stronger.
Executive VP Product & Quality Management
Reflections: The shift from paper to the digital collection of trial data unlocked opportunities.
TCS ADD Platforms
Biggest Opportunity: Enabling operational models that simultaneously drive openness, creativity, and competitiveness between different organizations and stakeholders involved in clinical and healthcare research.
VP, Head of Digital Business Transformation Neurology
Biggest Opportunity: Monitoring of patients’ symptoms through digital biomarkers is a big opportunity — for example, wearable technology devices that monitor the progression of a disease like Parkinson’s. Technology like this is imperative for the patient, but also helps to collect data that help physicians better understand their patients and the lifecycles of their disease. Many times, there is no way to track how well someone is responding to a treatment outside of check-ins, which leaves gaps that patients must fill in themselves.
These gaps can be subjective based on how someone is feeling at the time, and it’s easy to make blanket statements about time between visits. As such, many physicians rely on patient diaries to track progress, but this can become a burden to the patient. Digital biomarkers provide a way for patients to be engaged in their treatment unconsciously, showing concrete data of how well their bodies have responded to treatment.
Senior Director of Industry Sales for Specialty Accounts & Digital Strategies
Short-Term Focus: As a response to the pandemic, many life-sciences manufacturers have expanded services in areas such as financial aid, virtual assistance, online communities, and adherence tools. With life-science investments directed at developing broader support resources, a renewed industry focus on registering and retaining patients in these platforms will be seen. Given their role in prescribing and overseeing medication adherence, communicating with healthcare providers about enhancements to patient support is equally important. Historically, many patients learn about and enroll in patient support programs at the doctor’s office. As in-person visits stabilize, placing educational materials at the point of care can encourage deeper conversations about enrollment and program engagement, both of which are critical to patients’ therapeutic successes.
Chief Growth Officer
Biggest Opportunity: We believe the biggest opportunity to unlock is connecting scientific research data and real-world evidence. We speak about research for every body and every biology. However, our industry largely keeps the knowledge it’s learned within the walls of our research and development funnels. We believe the biggest opportunity to unlock is for patients to access and understand their own biology, their own health, and how research can not only benefit them but also benefit future generations based on the data we collect.
Biggest Opportunities: There is a lot of intent, research, and adoption around AI and ML technologies. Life sciences has an incredible opportunity to transform the clinical development lifecycle with efficiency throughout the end-to-end process. Cloud data technologies and systems interoperability provide the foundation for these advanced automation approaches, and they have the potential to greatly accelerate our end-to-end data strategies and, ultimately, help bring treatments to patients faster.
Ethica Group LLC
Biggest Opportunity: The creation of an insurance competitive environment so consumers can shop for the most economical plans regardless of where they live.
Rich Christie, M.D., Ph.D.
Chief Medical Officer
Biggest Opportunity: Novel measurements of a patient’s response to treatment, like digital biomarkers, are an uncapitalized resource to improve a clinical trial’s objectivity. Rather than relying solely on clinical assessments or patient self-reported data, digital biomarkers can measure subtle changes in a patient’s behavior that otherwise might be missed. Because of their consistency and automation, digital biomarkers represent a paradigm shift in assessing the effectiveness of a treatment plan and elevating the integrity of data. But the proprietary nature of digital biomarker algorithms keeps researchers from exercising and interrogating them, hindering their validation and improvement. Open-source platforms can break down these barriers and democratize access to algorithms so the scientific community can contribute to these methods and comment on their reliability. By building trust in the public domain through open-science access, we can further validate digital biomarkers as a means to understanding disease.
Kamala Maddali, Ph.D.
Health Collaborations LLC
Reflections: Innovative methods for understanding human biology have revolutionized the life sciences. Successful cross-collaborations have been achieved between medical, engineering, science, technology, and communications. Redefining “traditional medicine” to be “precision medicine” is the most successful example.
Global Head of Markets
Next Frontier: The next frontier for the life-sciences industry is the creation of trusted, one-to-one physician partnerships. Imagine working collaboratively with doctors to create the best portfolio of medications and support services that empower them to offer a personalized patient care journey. The best pharmaceutical companies are already dissecting how their portfolio wraps around customers toward a segment of one. Moving forward, alliances can be forged at a similar one-to-one level with doctors using advanced, analytics-driven technology. Many companies are already using AI to build more meaningful relationships with physicians, extracting critical context from every data source and past engagement to make the interactions that follow more relevant and proactively responsive to their unique needs. It’s exciting to think about where we’re headed next.
Founder and CEO
Next Frontier: ClinTech, the exciting new category of purpose-built, AI-based clinical insights and automation platforms will facilitate quantum, or next-generation, computing technology that will make in silico research the norm. Imagine the impact a digital counterpart of the entire human body would have on drug R&D. A full-body digital twin would empower clinicians to simultaneously evaluate how a prospective therapy will affect multiple organs and slingshot the concept of precision medicine to a new level.
Individualized patient models could be treated computationally with a variety of drugs to identify the therapy best suited for a person experiencing a particular disease. Though not yet a reality, this “blue ocean” is not all that far off.
Carla Grandori, M.D., Ph.D.
Co-Founder and CEO
SEngine Precision Medicine
Next Frontier: Drugging the undruggable. The end of biochemical assays and using AI, degraders, RNA encoded medicines, and nanoparticles to drive delivery to specific tissues — the future is extremely bright for drug development. The next generation of chemists will work in tandem with molecular and cell biologists to tackle the entire human genome of 20,000 genes.
Eric Ostertag, M.D., Ph.D.
Reflections: I was the first graduate of the gene therapy program at the University of Pennsylvania almost two decades ago. Since then, I have seen incredible advances in the field of gene therapy. Today, we are closer than ever to my lifelong dream: to create cell and gene therapies that don’t just have the possibility of prolonging life but could potentially provide single treatment cures for cancer and other genetic diseases.
CEO and Chairman
Next Frontier: I think we have just witnessed that next frontier with the pandemic, which will have an impact for many decades. The drug development path has been long and complicated and expensive, and at times has not yielded an ROI nor an ROE (return on energy). There are many cancers and disease states where patients, who need new drug treatments, and are waiting a long time and this can be frustrating to. AI has the power to change this. I am about to release a second book next March titled “The Double Bottom Line: How Compassionate Leaders Captivate Hearts and Deliver Results.” As leaders, we must adopt a new leadership model for the next generation of innovation and to approach our problems with compassion — truly understand the problems before us and show empathy plus action to have the greatest impact.
Longhorn Vaccines & Diagnostics
Biggest Opportunity: The COVID-19 pandemic has created a tremendous increase in the number of laboratories and overall laboratory capacity specifically in molecular testing. These labs have developed very good direct to consumer reporting systems. There is a big opportunity to expand and improve overall testing across all diseases and conditions and keep these laboratories operational and profitable. At-home, pharmacy, grocery store, and other non-traditional sample collection locations will drive significant volumes of many sample types, increasing predisease and early disease diagnosis. Test manufacturers are developing new assays and syndromic panels that can differentiate between multiple pathogens. Point-of-care diagnostics will continue to grow, but robust automated tests will drive growth.
Lindsay McNair, Ph.D.
Chief Medical Officer
Biggest Opportunities: One of the biggest opportunities to unlock is making clinical trials accessible to more people. There are so many approaches including improving public education and awareness of clinical trials, decentralizing clinical trials to expand access in under-served communities and reduce participant burden, and updating the traditional thinking about participant expense reimbursement and compensation so that financial considerations don’t dissuade potential participants. We also need to ensure that all studies look carefully at eligibility criteria, building on excellent work over the last few years in the oncology area, so that we avoid unnecessarily excluding people from research because “that’s the way we’ve always done it” and we make our study populations as expansive as possible so that study results translate to “real world” settings. And, finally, we need to make sure that our study designs and conduct, including our communications and language, are culturally appropriate, welcoming, and inclusive of every community.
VP and General Manager of Life Sciences PointClickCare
Next Frontier: We’ve seen “big tech” enter the healthcare arena, and I believe that this investment will continue for the future. The pandemic has driven pharma and life-sciences companies to turn more to technology to alleviate their challenges. We expect this collaboration to pave the way and enhance future healthcare innovation, new medicines, and more. The ability to analyze real-time data and apply predictive analytics to target treatment is the next level of care. Imagine simple diagnostic tools that use artificial intelligence that analyze everyday speech. These can be embedded into a caregiver’s daily workflow within a long-term care home and routinely identify patients at risk of developing Alzheimer’s disease. Couple this with big pharma’s ability to digest this data, then focus research efforts on prevention and treatment, and you have a powerful combination.
John Potthoff, Ph.D.
Elligo Health Research
Next Frontier: Healthcare data is currently fit for use — patient care and billings. How do we evolve to healthcare data with as much quality as clinical trial data?
Next Frontier: We must begin to effectively tap into e-Life records using the data and information to design and implement smarter and unbiased trials. e-Life records capture a wealth of data that can be used to predict better outcomes of drug safety and efficacy.
Senior VP, Provider Services
NMDP/Be The Match
Next Frontier: An exciting advancement is the use of mis-matched donors for transplant. We have some clinical research underway to reduce the reliance on human leukocyte antigens (HLA) matching in the future, which will take, for example, the odds of an African-American patient finding a match from 23% today to over 90% in the future. Early data are very promising. If this is successful, which we have high confidence it will be, we may have to change our name to "Be The Mis-Match."
CEO and Scientific Lead
Next Frontier: A huge variety of digital health services and applications, many of which have the potential to improve and optimize care, have been developed in recent years. The next frontier is enabling these tools to enter medical practice. This will require a whole system approach that trains and reassures the workforce, builds, and deploys the required infrastructure, and sets standards for system interoperability. We also need alignment of legislation and policy across regions.
Co-founder and Chief Operating Officer
Biggest Opportunity: Within immuno-oncology, small molecule agents can become vital in unlocking elusive anti-cancer immune effects in future therapeutic regimens. This is a core focal point within our own work, but beyond ourselves we feel overall that this could represent a meaningful approach to patient care, and perhaps to cost management, in the future.
Bas van Driel
Next Frontier: We consider that within pharma, 3D printing will provide a vast range of opportunities. It could offer huge potential in pharmaceutical manufacturing, from enabling personalized medicine to accelerating the drug development pathway. We are focusing and investing heavily in 3D printing and our team of experts is deeply involved to understand the technology and being able to support our customers with the right excipients.
Reflections: The ability to share data, experiences, and to provide patient care online has helped accelerate advances in treatment and understanding in rare disease. Accessibility online has empowered patients, and helps researchers share their learnings and expertise which can inform clinical development.
CEO and President
Next Frontier: The next frontier for us is the market opportunity of digital healthcare and digital therapeutics. The ongoing COVID-19 pandemic and the mandatory enforcement of social distancing measures have created a significant demand for remote healthcare solutions and for digital health platforms. Digital health solutions represent a relatively new concept, which was introduced into mainstream healthcare a few years ago. We believe digital technology solutions will possess the potential to reshape the practice of healthcare-integrating the fragmented healthcare system, address ecosystem affordability and accessibility and patient affordability. Our digital therapeutics platform will have standalone software applications, web-based portal, active, personalized coaching support, digital coaching and artificial intelligence (AI) enabled support. We believe this new approach where technology interfaces with medicine is the new frontier.
Next Frontier: Providing the full digitization of the patient journey without losing personal interaction with patients would be my main goal. If the lockdown has taught us anything, it is that we all need human interaction and communication. When a patient is in a moment of fragility, they don’t want to talk to a machine, which is why the personal approach can’t be lost in this process of digitization and decentralization. What we are doing in digitizing the patient journey has to be done in a way that allows for personal communication with patients, while removing the burden of administration. For life sciences more widely, we are going to see increasing numbers of small population studies, with drugs targeted at much smaller, rarer groups. There will always be a place for large 10,000-patient studies but there are a growing number of smaller studies offering valuable discoveries.
Biggest Opportunity: Targeted drug delivery, which produces minimum side effects, better compliance, better health economics, will allow for buy-in from the insurance companies and clinicians. Nontoxic technologies for a wide range of indications will be crucial as consumers take charge of their health and try to get as much information as possible about therapeutic options.
Short-Term Focus: AI and ML techniques will certainly improve efficiency within drug discovery and R&D processes, which will enable biopharma sponsors to put more product candidates through the pipeline faster. We are only starting to see the tip of the iceberg in this regard and, since we are sitting on a treasure trove of data, the possibilities are endless. I foresee tech vendors being able to efficiently mine this data and help drive better critical thinking and decision-making throughout the entire process, reducing risk, and improving success rates. This concept of “knowledge” is not new but it is new in clinical trials and is set to dramatically change how we work. The role of data scientist or data analyst will become crucial as these techniques improve the way we work.
Next Frontier: We must reimagine healthcare delivery. Currently, there is too much of a single-dimensional focus on cost vs. value. How can we ensure the improvements made during the pandemic, including the collaboration between drug manufacturers, research groups, countries, and their regulatory agencies remain in place? Personalized medicine will be the next standard of care. Significant progress is already being made with tailored cancer treatments by looking at genomic anomalies in cancer patients and delivering drugs that specifically target these anomalies. With a better understanding of human genomes, a broad range of medicines will be tailored to fit the genetic profiles of patients. With the help of technology, the life-science sector will be able to use genetic code to more rapidly generate drugs that are targeted to specific segments of the population. In addition, technology like wearables and data analytics will improve monitoring of patients’ health, making the connection between patient and life-science practitioners more fluid.
Chief Technology Officer
Greater Than One
Reflections: Over the past two decades, both the world of science and world of technology have seen advances that are momentous. Mapping of the Human Genome ushered in a new era of medical discovery and led to the development of new treatments and has upended traditional pharma product development. In technology, the more powerful processing capability, mobile computing and even the Internet has impacted every facet of society, from purchasing and consumers, to targeted and predictive marketing and analytics. We are just starting to realize how these advances will merge with artificial intelligence and their impact on the services economy.
Justin Chen Li
Next Frontier: The next frontier in cancer detection is not only creating more accurate tools for diagnosis, but also adding value to the patient-physician care cycle by raising adherence rates. Patient adherence is notoriously low for cancer types where the standard of care is inaccurate, inconvenient, or invasive, and disproportionately so for patients living in rural areas with insufficient access to credible screening or surveillance solutions. To increase adherence and effectuate earlier detection of cancer at a broad scale, we need tools that are widely accessible, easy to administer, and effective in analyzing the presence of even the earliest malignancies. Blood tests can offer a convenient and non-invasive way to detect cancer early, especially for patients who have reduced access to care or are otherwise not adherent to screening protocols.
Biggest Opportunity: The life-sciences industry has literally saved the world in this pandemic. It has shown it can adapt to an extreme situation. The biggest opportunity is to keep this momentum. The industry now needs to accelerate the changes that have started. Digitization, digital health, virtual trials, or new processes in order to shorten development timelines are part of these changes. But, more importantly, patient-centric changes such as precision and personalized medicine will contribute to a more efficient and humane medicine.
Vincent Keunen, M.Sc.
Next Frontier: Patient-mediated research will be the blue ocean and will deeply and disruptively change the landscape for life-sciences companies. Not only will this disrupt how studies are conducted (clinical trials but also real world evidence studies, quality of life studies, etc.), but it will also redistribute the cards for the industry. In addition to the research sector, the care sector will be equally touched by this move to patient-centric care, with patients becoming health consumers, voting with their money. And we believe that the care and research sectors will start to communicate better and align their initiatives through patients. PEP — patient empowerment platforms — will bridge the gaps between patients, care, and research stakeholders.
Next Frontier: Henry Ford said, “If I’d asked customers what they wanted, they would have told me, ‘A faster horse!” People don’t know what they want until you show it to them. Therefore, I believe virtual and physical healthcare delivery will completely blur and become one and the same. Think about a time when we move the total cost an organization spends on field force and DTC into development of tools/experiences that: tie into individual existing self-reported, self-tracked health metrics; accurately identify your own condition by virtue of the ability to test against a host of known biomarkers ranging from genetic to organic; send an individual the Rx and supporting therapeutic recommendations using Amazon, Alibaba, or other account using courier or drone; and follow-up with virtual or real support by virtue of dispensing fees paid back to and reimbursed through the e-pharmacist.
Founder and CSO
Biggest Opportunity: It has become increasingly clear that many diseases (e.g., cancer, kidney and heart disease, as well as infectious diseases) and conditions (such as physical trauma) that activate the immune system produce a similar collection of symptoms that are classified under the terms cachexia and sickness depression syndrome. These symptoms include loss of body mass, multiorgan damage, and malaise and depression; and are linked to proinflammatory cytokines from the immune system. Administration of cytokines can replicate most, if not all, of the above symptoms, and a major target for cytokine actions is the brain. Over the past 20 years of research, whole body inflammation has been demonstrated to be part of many diseases. Systemic cytokines produce increases in brain cytokine levels and inflammation. Controlling brain proinflammatory cytokines or blocking their effects is a huge opportunity for drug development in combating the nervous system effects of many diseases, which can be life threatening and/or have an adverse effect on quality of life. As an example, brain inflammation is now recognized as a symptom/contributing cause of Alzheimer’s disease.
Chief Technology Officer
Next Frontier: We can imagine the next frontier in life sciences to be nanomedicines, which offer extraordinary potential to prevent and treat disease. These products can have a multitude of engineered activities, such as targeting specific tissues or cell types, and can perform several functions to achieve therapeutic effects. Far more complex than the medicines today, these nanomedicines will have multiple functions built into one. This type of product will be designed and produced in complex ways, and will require combined expertise of chemists, biologists, computational scientists, and development and manufacturing professionals.
Biggest Opportunity: Data can provide healthcare marketers with a lot of information. But the key is knowing how to understand and use those data to make a measurable difference in the moments that matter most for all stakeholders.
Clare Grace, Ph.D.
Chief Patient Officer
Next Frontier: COVID-19 highlighted to the world the importance of clinical research and the need to bring new therapies, including vaccines, to market safely and efficiently. We need to build on this momentum and further increase understanding of clinical research as an integrated approach to patient medical care. To achieve this goal, we must think creatively on how we can increase awareness through targeted information campaigns. We also need to dispel long-standing myths and misconceptions about clinical research, particularly among Black, Latinx, Asian, and Indigenous communities — traditionally underrepresented populations in clinical research. We need to underscore why participation in clinical research is vital to bring new therapies to patients in need and why that research must accurately reflect those who will ultimately use the medication. To further address health inequities, we also need to ensure that clinical research is part of the education and training curriculum for all medical personnel.(PV)