Trend Tracking

Contributed by:

Taren Grom

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

In this special — 2018 Year in Preview — issue, PharmaVOICE’s thought leaders are tackling 10 trends that are expected to incite change in the year ahead. We will be looking at a variety of disparate topics that range from molecule to market in keeping with our publishing focus and philosophy:

2018 Year in Preview Trends
Agile Marketing
Alternative Healthcare Delivery
Artificial Intelligence
Bioethics
Brand Engagement
Pipeline Disrupters
Rare Diseases
Real-World Outcomes
Treatment to Wellness
Virtual Health Technology

The companies that comprise the life-sciences industry continue to face a world full of uncertainty, something they have been accustomed to over the past couple of decades. Pharma, biotech, and biopharma companies and their supporting partners face issues surrounding cost and pricing, innovation from molecule to market, customer — patient and physician — engagement, and regulatory hurdles. Layered on top are technologies that are evolving faster than companies and regulators can keep pace with, but they will need to because their main constituencies — patients and caregivers — are adopting new tools, solutions, and processes that make their life easier and healthier.

In addition, according to Deloitte, new and evolving technology advancements — more sophisticated electronic medical records (EMRs), wearable healthcare devices, next-generation sequencing, breakthroughs in genomics, immunotherapy, and gene therapy, and use of real-world evidence (RWE) and data analytics — are priming the life-sciences sector for disruption.

And with innovation comes growth. A quick look at Deloitte’s global healthcare numbers tells an interesting story.

Global healthcare expenditures are projected to reach $8.7 trillion by 2020, from $7 trillion in 2015, driven by improving treatments in therapeutic areas coupled with rising labor costs and increased life expectancy.

Healthcare spending as a percentage of gross domestic product (GDP) should also rise slightly, from an estimated 10.4% in 2015 to 10.5% in 2020. Government healthcare expenditures as a percentage of GDP are projected to rise more quickly in low-income countries than other income groups.

Chronic diseases are on the rise, assisted by rapid urbanization, sedentary lifestyles, changing diets, and rising obesity levels. By 2020, 50% of global healthcare expenditures — about $4 trillion — will be spent on three leading causes of death: cardiovascular diseases, cancer, and respiratory diseases.

Although pharma companies continue to deal with the repercussions of patent expiries and payers’ cost control efforts, the growing acceptance of sometimes high-priced innovative orphan drugs and ongoing industry consolidation are expected to drive sales growth for the next several years. Deloitte analysts report that in 2015 there was a drop in total global pharma sales, in nominal U.S.-dollar terms, due to exchange-rate effect and the impact of cost control efforts in several markets, but sales are expected to improve from now until 2020, growing at an average of 4.4% annually to total a projected $1.2 trillion.

Evaluate, predicts a slightly higher forecast for worldwide prescription drug sales at a robust 6.5% (CAGR) through 2022 to reach $1.06 trillion, with 32% of the 2022 increase in sales to come from orphan drugs — $95 billion.

These projections were made before the election of Donald J. Trump, and amid the uncertainty surrounding the Affordable Care Act and funding of the FDA and the NIH, time will only tell what the fall out will be as Congress continues to struggle with finding a replacement healthcare policy and recognizing the importance of funding science. Like everyone else, PharmaVOICE will continue to wait and see what happens and provide updates as they occur.

Speaking of updates, this year, PharmaVOICE also decided to take a look back on the trends we identified in 2015 (Year in Preview 2016) and 2016 (Year in Preview 2017) to see if we hit the mark or not. We tapped our esteemed community of thought leaders to provide us with a frank evaluation on a number of these trends to see how their predictions are holding up against today’s current market factors and if the industry is making progress or if it is stalled on the tracks. I encourage you to log on to our digital issue to read how these trends are tracking.

We stand by our tagline: Read. Think. Participate. We hope you enjoy this special Year in Preview issue.(PV)

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2018 What the Future Holds…

Marc Benjamin, CEO, Convergence, Point Media
2018 will be the year that cross-audience synchronization takes hold as a force that defines effective pharma marketing. The endpoint of marketing programs will lean heavily on the occurrence and content of individual patient/physician communications. For the first time, the conditions now exist to facilitate the marriage of data-driven audience targeting techniques and human audience perspectives that define the behaviors and beliefs that shape each patient’s medical treatment regimen. On the data side, the intersection of programmatic targeting, de-identified consumer health data, and precision geo-targeting raise marketers’ confidence that they can pair messaging to align individual patient attitudes with unique target physician segment messaging priorities. As to the content itself, improvements in nearly real-time crowd-sourced survey and stimulus/response tools allow brands to cultivate the most relevant and compelling messages to spark desired action.

David Connelly,CEO, Cmed
2018 will see the industry accelerate joining the dots when it comes to running digital clinical trials. Our industry has historically been slow to embrace new technology, often running dated systems that have limited interoperability. This results in clinical trial data being fragmented and aged by the time it can be reviewed.

Using modern technologies that have transformed our everyday lives, such as smart devices, apps, and sharing of information and media, clinical trials can be streamlined and costs reduced. All clinical trial data, whether from patients in the clinic or in their homes, including laboratory data, digital biomarkers and sensor data, ECG, medical images etc. can be captured live — or near live — held in one repository from the very start, and visualized through advanced analytics.

Increasingly, source data review will be reduced, simplified, or eliminated, data quality improved, and clinical data science will replace traditional data monitoring roles. Insights and analytics applied to data will become live and more sophisticated, with greater use of predictive algorithms and even artificial intelligence.

This immediacy of information and the ability to act will improve protocol compliance, patient safety, agility of trial design, and speed of decisions.

As more genetically modified cell treatments are developed, such as Kymriah from Novartis, the value of many Phase III trials will be increasingly questioned as continued “testing” under “rolling” licenses in real-world environments becomes possible. The convergence between the clinical trial and healthcare setting could even provide more evidence to support outcomes-based pricing.

Joachim Fruebis, Senior VP, Development, Bioverativ
There are several trends driving the increased interest in rare disease drug development. In general, the industry has seen a greater scrutiny of new therapies that demonstrate only a modest improvement over existing treatments, resulting in a more challenging environment for regulatory approval or meaningful reimbursement by payers. Additionally, indication areas that have historically played major roles in drug development, such as anti-thrombotic cardiovascular drugs, have seen market saturation with newer and more effective therapies. This increasing number of therapeutic options is making it more difficult to demonstrate superiority over existing products, often resulting in the need for large and costly clinical trials that are prohibitive to even the largest pharmaceutical companies due to feasibility and risk.

Considering this, developing therapies in the rare disease space presents a more attractive option. Unmet clinical need is generally high, making it easier to develop differentiated products, although we are starting to see significant me-too type development activities.
Development typically requires smaller patient numbers, though it may still require large global trials to identify rare disease patients.
Often trials can be faster, receiving favorable regulatory review options such as breakthrough designation and orphan drug status. These factors make development efforts, even by smaller companies, feasible. Novel technology platforms, including cell and gene therapy, are gaining in acceptance and are particularly applicable to rare, inherited, and monogenic diseases. Attractive reimbursement for drugs in areas of unmet need is not uncommon, but we are starting to see increasing pressure driven by competition and payer resistance. These factors, combined with the desire to develop therapies that can help transform patients’ lives, are driving more companies into the rare disease space.

Jeff Lee, President, mProve Health
With the trend toward modernizing clinical trials and exploring virtual trial study designs, we are seeing new technologies such as engagement apps, eConsent, BYOD, ePRO, alumni networks, wearables, sensors, etc., being deployed. While patient-facing technology can be a valuable asset for engagement and data collection, it can also place a burden on patients to learn new software and devices, access multiple systems, and be compliant with unfamiliar technology. In 2018, I expect our industry will focus on how to make it easier for patients to use clinical trial technologies. One clear path to doing that is merging and integrating technologies to reduce the number of touchpoints the patient has.

Today, many of the technologies I listed above are provided by “point solution” vendors, which often means that a single clinical trial will need to use several completely disparate systems. To address the challenges this creates, life science companies are looking to vendors to work closely together to streamline the patient experience. Our recent partnership with Greenphire, which integrated ClinCard payment information into mProve’s patient engagement app, is a good example of the type of cross-vendor collaboration needed. I hope that these types of partnerships are more widely embraced by solution providers. As an industry, we must act to ensure that we do not place an untenable expectation on patients. If we put patients first, we can find ways to merge our technologies and make joining a clinical trial as easy as buying products from the Apple Store.

Andy Mehrotra, CEO and Founder, EightSpokes
I find modern truth in ancient Chinese wisdom, that the journey of a thousand miles depends upon every small step along the way.
Nowhere does this ring truer than in the life sciences, where the success of complicated, multistep plans for drug development and commercialization ultimately depends upon the quality of work being delivered by each team member for every assigned deliverable.

However, companies are limited in their ability to assess execution along the way. Often, they can only gauge the quality of work retroactively, when it’s too late — this is unacceptable and will start to change in 2018.

Modern technology will finally enable real-time feedback from peers and managers throughout the lifecycle of a project so that every task achieves its intended outcome. Task members will receive relevant, timely assessment on their work so they can course-correct while their projects are still ongoing to improve overall quality, prevent costly delays, and increase productivity. Further, receiving on-the-job feedback and recognition will raise the team’s engagement with their work — something that, according to Gallup, has been lacking in organizations globally for decades and is particularly important to millennials, who now comprise the largest share of the American workforce. The increasing power of cloud computing is eliminating delays and making continuous improvement through ongoing feedback a reality moving forward.

Patrick Richard, Managing Director, Data Science, INC Research/inVentiv Health
One of the key trends that I’ve seen start to become a reality in the last year is the integration of data platforms to make more precise decisions. In our work we’ve seen less of a toe dip into using data regularly, and more of a proactive stance to make it a natural component of decision making. Examples of this can be seen broadly whether it is investment in a fully comprehensive data management platform, investment in internal or agency expertise, data automation, or all of the above. The refreshing part of this trend coming to life is that it doesn’t just involve data analysts either. Many of these platforms visualize data on the front end in a way that’s intuitive, actionable and relevant for the most part across teams. This allows strategists, marketers, creative professionals and of course data savvy team members to see the reality of what’s actually happening in order to make a connection with their audience. Finding the right patterns out of the data you have available are where many winning insights are going to be formed. This all comes back to the right technology stack, and a diverse group of minds to find those key answers that make a difference.

Andrei Soran, CEO and Chairman, Novaseek Research
@Nova_Seek
Data access will level the playing field, enabling life-science researchers to identify a much broader range of patients in local and community hospital settings than ever before. Historically, the challenging and painfully slow process of enrolling patients for clinical trials has taken place through physician referrals from large, urban care centers.

Today, hospitals large and small are able to present patient-consented EMR data, cutting-edge communications tools, and annotated prospective specimens to researchers, thereby allowing nonurban patients and their local physicians the ability to participate in the trial process.

Second, in addition to providing clinical researchers with access to larger populations of patients from a variety of geographical settings, hospitals and laboratories can use this valuable data and corresponding specimens as a means toward additional revenue streams.
Technology and data represent the great equalizer for life-science companies and hospital/large practices to advance medicine for patients while experiencing mutual benefit.

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