The Year Ahead…

Contributed by:

Taren Grom, Editor

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

We ask more than 130 experts, what needs to happen to address inefficiency and productivity to achieve aspirational goals for healthcare in the future.

For this year’s special 2020 Year in Preview issue, we posed 20 provocative questions to our community of thought leaders, who represent all aspects of the life-sciences industry. We curated responses from more than 130 experts — the good news is that they don’t all agree with each other. This was the point. We wanted to push the envelope to understand how the industry’s influencers think about aspirational goals in terms of health, what needs to happen to address inefficiency and productivity, and what the future might hold for all of us as individuals who may be patients, patient caregivers, or patients-in-waiting.

We hope these questions, and our thought leaders’ answers, incite you to think beyond the status quo and urge you to adopt an aspirational mindset to evolve the healthcare industry. (PV)

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What if…
We provided our community of thought leaders with the opportunity to ask their own what if questions.

What if … innovation were better funded?

Paul Balagot
Chief Experience Officer, precisioneffect
What if we introduced an innovation tax to fund basic medical research? Also, what if we focused on digital innovation to keep elders in their homes?

What if … life-sciences companies and providers joined forces to unlock the value of healthcare data?

Jean Drouin, M.D.
Co-Founder, CEO, Clarify Health Solutions
Healthcare providers and life-sciences organizations have a tremendous opportunity to work together to realize the full potential of accessible, interoperable, and actionable patient data. Imagine if we could improve the patient experience by adopting a more holistic approach, one in which all relevant data shape healthcare decisions in real time. Insights from healthcare information beyond traditional research settings, including EMRs, claims and billing, product and disease registries, personal devices, and social and behavioral determinants of health sources, can help us get there.

Real-world data (RWD), of which provider-based data is a key component, is already used to precisely define the types of patients who would benefit most from a given therapy. Beyond simple measures of physical health, RWD can also provide a better picture of a patient’s quality of life, productivity, and even financial security. Such insights can enable smarter R&D focus, more tailored clinical trial design, clearer value messaging to payers, and better-informed healthcare decisions. For example, leveraging RWD during clinical development can avoid costly trial recruitment delays by linking patients of interest to specific sites of care. In addition, RWD can be used to develop and implement synthetic control arms, which reduce the number of patients needed to conduct clinical studies and ensure that all recruited patients potentially benefit from an experimental therapy through the trial’s treatment arm. Finally, by building precise value messaging based on RWE, the industry can maximize access and affordability to ensure that those patients most likely to benefit from a given therapy are able to receive it.

These types of innovations would not be possible without health outcomes data from provider records. Continued progress down this path is critical and requires greater collaboration between the stakeholders creating life-saving therapies and those at the helm of delivering care to patients.

What if … AI and automation reduced the cost of pharmacovigilance by 90%?

Updesh Dosanjh
Practice Leader, Technology Solutions, IQVIA
With regulators encouraging doctors to report more adverse events and patients sharing their stories online, pharmacovigilance (PV) data is compounding faster and from more sources than ever before. The push from regulators and industry bodies to generate more in-depth trend data is also drastically adding to the overall costs of PV reporting.

Industry regulations have been cited by more than 50% of global life-sciences CEOs as a top disruptive business trend. PV departments are looking to mitigate these costs and manage the increasing complexity of PV processes.

Traditionally, PV departments have resisted rapid technology changes, fearing loss of control within a highly regulated industry. However, with more than 70% of PV spending being on case processing, the adoption of AI and AI-supported automation has been seen as necessary for reducing these costs and freeing money for more data analysis and staying ahead of new regulations. Results from this drive for new methods have been variable due to most vendors’ limited industry knowledge and the adoption of inappropriate AI models from nonclinical industries. As companies with deeper experience enter the market, it is only a matter of time before we radically change PV cost structures. The focus has been to reduce case processing costs, but little if any effort has been invested into leveraging new technology in the complex areas of data analysis and risk assessment, which is the real promise of AI.

Imagine being able to Google the entire history of your PV data and access meaningful results without any training. As precision medicine becomes the new standard for treatment, the ability to derive precise and rapid insights from your data will be mandatory. This is the real promise of AI-enabled PV.

What if … longitudinal records played a role in prescribing?

Michelle Hoiseth
Chief Data officer, Parexel
Imagine if we could create longitudinal patient records that allowed us to develop clinical data sets for therapies from clinical development into the prescribing environment? By making this reality, drug development processes as well as the patient experience could be transformed for the better.

What if … clinical trials were in-sourced?

Suresh Katta
CEO, Saama Technologies
The pharma industry must take control of its own future, and learning to in-source clinical trials would be a monumental step toward self-directing that future. Since the pharma industry began outsourcing clinical trials, the average number of years for drug development has gone up tremendously, and the costs have skyrocketed to billions from millions. By in-sourcing clinical trials, the majority of the pharma workforce would have an opportunity once again to interact directly or indirectly with the patients for whom they are developing drugs. There is an opening for the pharma industry to embrace the technology that would allow it to in-source clinical trials and have the tech leaders report up to the C-suite. Many other industry segments have already taken this path successfully. By in-sourcing and intertwining with the technology innovation curve, the pharmaceutical industry can minimize first, and then slowly eliminate the age-old, laborious, erroneous, time-consuming manual procedures for running clinical trials.

With the right education and obvious incentives, technology-driven, newly discovered and simpler automated processes can accomplish a number of critical goals, including recruiting patients at the right levels in a timely fashion, designing better protocols with cognitive systems, validating study feasibility through clinical neural networks, conducting long drawn-out Phase I, II and III trials digitally, and fulfilling regulatory requirements through modernized applications.

What if … eClinical solutions providers offered their teams ongoing opportunities to collaborate and create new technologies without corporate mandates or regulatory restraints?

Cindie Kazmer
Senior Director, Project Management, Cenduit LLC
The industry should establish a creative forum for innovation and personal growth, we call it a hackathon, which provides the freedom to explore without having to adhere to preconceived notions about how the technology must be used. By giving development teams the license to innovate, a hackathon creates camaraderie and creativity as teams form to develop solutions and proofs of concepts. The ideas and data that emerge from a hackathon can inform development direction and become a part of a company’s future development calendar. Ultimately, these innovations can lead to incremental changes as well as breakthroughs that have the potential to result in better site experiences, and better patient outcomes.

What if … the promise of personalized medicine was realized?

Peter Keeling
CEO, Diaceutics
Pharma stands to profit by putting value back into its precision medicine commercialization efforts. Doing so starts with understanding the transformative partnership between optimized testing and better treatment outcomes. Appropriately investing early on in the timely incorporation of better testing into everyday clinical practice may lead to better testing/better treatment/better return on investment (ROI). This requires that pharma include funding in drug-launch budgets for the launch and awareness promotion of tests associated with a target therapy. History has shown that pharma still gains a meaningfully superior market share for therapy when brands promote and invest in the diffusion of a particular improvement in testing whether competitors benefit. For example, within the immune-oncology (IO) space in non–small cell lung cancer, Merck’s Keytruda has clearly benefited from embracing this type of “better testing, better treatment” promotion to great competitive effect versus other IO therapies launched at the same time. In this way, pharma maximizes patient reach — and patients benefit with better health outcomes. The financial rewards for pharma have been documented, amounting to as much as $30 to $60 of additional treatment — otherwise lost — for every $1 invested in testing.

Given that at least one-third of patients are still missing out on therapy, we believe there is equal to or greater value, expressed in patients/outcomes and health economics in improving the diagnostic journey for cancer patients than in the introduction of a new smart therapy alone. Together, they are transformative. And given the dominant economic focus on better therapy, without a balanced focus and investment on improving the real-world testing ecosystem, the promise of precision medicine remains unfulfilled.

What if … the federal government made marijuana legal?

Dr. William Levine
Founder and Chief Scientific Officer, CannRx
The federal government will inevitably develop a system to legalize cannabis. The industry is too large and affects too many people to remain solely as a state-based system. There are many different scenarios in which this may take place. The National Cannabis Industry Association (NCIA) is promoting a hybrid system that combines the pharmaceutical, dietary supplements, cosmetics, and alcohol regulatory systems. The NCIA refers to this novel concept as “de-scheduling” and it creates a completely new concept track for cannabis. Clearly, the government is concerned about a number of factors; safety, efficacy, quality of the products as well as false marketing or unsupported claims to the consumer. One of the overriding issues that the cannabis industry is grappling with is that of isolated cannabinoids. There is extensive data and many decades of ethnobotanical use of cannabis to provide a reasonable profile of safety. But if we increase the concentration or isolate single cannabinoids, we can no longer rely on that database to provide safety data. It is a simple concept; if you change the substance, both the pharmacologic effect and the toxicity profile can also change.

I believe that the federal government will use the existing agencies, FDA and FTC, to monitor cannabis, but will slightly modify the program to accommodate the existing industry.

What if … we could diagnose mental health more accurately?

Antony Loebel, M.D.,
President and CEO, Sunovion Pharmaceuticals
Imagine if we could improve quality of life for patients with various mental health conditions by diagnosing more accurately using new technical advances and finding novel therapeutics that actually change the course of illness over time.

What if … huge data sets could unleash huge rewards?

Michelle Marlborough
Chief Product Officer, AiCure
The organization and structuring of data is a constant challenge in our industry. It was not too long ago that aggregating data across studies was a huge amount of effort. The realization that data standards were important started to solve that problem, until the volume of data available to us sky rocketed.

We now have the ability to amass exabytes of data, if we so desire. Our technological advances continue to enable the development of these data lakes, moving us away from needing to make strict upfront decisions around how data should be structured and managed. There are important concepts that can be taken from our past attempts to standardize, most notably, that early data standardization was prioritized around understanding the use and context of the data. This key principle should be reapplied now. We need to have a clear goal or strategy for the data that is being collected. In the simplest terms, a question to be answered will ensure that the focus becomes on collecting the right data to solve the problem, not just collecting data for the sake of collecting data, which might as well be called data hoarding.

What if … patients were the ultimate decision-makers in the drug development process?

Sy Pretorius
Executive VP, Chief Medical & Scientific Officer, Parexel
This simple idea could impact many aspects of drug development. For example, patients would own their personal health data and decide where and how it could be used to develop new drugs. Likewise, information about clinical trials would be easily accessible and patients could access this information via their mobile phones. Endpoints would be selected based on what patients cared about most, supporting the development of therapies that make a difference in patients’ lives.

What if … we put the same care and investment into integrating and supporting clinical development teams as we do in integrating eClinical technology systems?

Brenda Reese
Founder and President, phaseUP
Most trials are run by a mix of internal and external groups. Making sure the overall team is cohesive, collaborative, and communicating before the program starts can make the difference between a trial that runs smoothly and one that needs a rescue, or fails.

What if … millions could be released from the burden of anxiety and depression they battle ever day?

Shawn Singh
CEO, VistaGen Therapeutics
Anxiety and depression are overwhelming more than 20 million Americans every day. The global scourge of these debilitating disorders exceeds 300 million. We have a critical need for new therapeutic solutions for those struggling with these cruel disorders.

Breakthrough medicines that are fundamentally different from current treatments are a key part of the new solution paradigm. To complement “talk therapy,” patients need faster-acting medicine that can be taken at home (not in a clinic), without risk of addiction, hallucinations, sedation, or other side effects and safety concerns.

The emerging use of ketamine for depression is an example of out-of-the-box thinking by pharmaceutical researchers. Ketamine, widely used for anesthesia since 1970, was long overlooked as a solution for depression due to its dissociative effects and abuse potential. Now, ketamine’s rapid antidepressant effects in treatment-resistant patients has captured the global spotlight, enhanced by the FDA’s recent approval of a nasal spray formulation called Spravato. Ketamine therapy must be administered and monitored in a clinic. While, ketamine offers hope for millions who do not benefit from standard antidepressants, we now need to go beyond ketamine to fast-acting antidepressants that can be taken at home, without ketamine’s side effects and safety concerns.

What if … we broke the silos throughout pre-commercialization to post-commercialization?

Greg Skalicky
Chief Revenue Officer, Eversana
If we think about all the services and solutions that touch a newly launched brand in the market, we can all agree that innovations in therapeutic development have advanced beyond traditional product launch strategies and service models. In every step of the product lifecycle, we see pockets of transformation. And the problem is exactly that — “pockets” of transformation. The pipeline in regenerative medicine, for example, is focused on the complexity of pricing, which it must, but what about logistics — everything from chain of custody to temperature monitoring — and the risk that comes along the supply chain through patient support?

Pockets of innovation may address these concerns, but to effectively launch a product — from clinical research to trials, to in-market, to post-commercialization — I argue that traditional service silos stand in the way of true healthcare transformation. Ask yourself, do disparate service providers look at the lifecycle in the same way you do? Do they understand how everything from pricing and payer outreach informs the 3PL, specialty pharmacy, hub, and pharmacovigilance solutions? Let’s break down these traditional service silos to create a seamless patient experience that’s strong enough to withstand loss of exclusivity or competing products. This innovation and vision supports integrated solutions that put the patient at the center, because when we do, patients get access to efficient, effective, and innovative healthcare.

What if … we lived in a world without disease?

Ben Wiegand, Ph.D.,
Global Head, World Without Disease Accelerator, Janssen
We hope to make disease history such that it is read about in history books versus experienced by family members, friends, and loved ones. Through the elimination of disease, the focus becomes maintenance of health and ensuring an active, healthy lifespan.

For bonus content go to bit.ly/PV1119-WhatIf

 

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