While COVID-19 undoubtedly brought great chaos and crises last year, it also fuelled incredible innovation and collaboration across the life sciences industry. We saw new diagnostic tests and promising vaccines developed in record time; companies and health authorities come together to speed critical drugs to patients; and new digital ways of working emerge across product development and commercial operations.
Looking ahead, the industry is showing no signs of slowing down—and digital will be key in making that happen. As companies continue opening digital channels to accelerate commercial and drug development, we’ll see new operating models reshape the industry and drive powerful transformation for years to come. Here are Veeva’s top life sciences predictions for 2021, from our panel of industry experts.
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Unified systems will allow for sustained innovation in the industry
—Chris Moore, President, Veeva Europe
The year 2020 reset what was possible in life sciences. Whether it was Roche introducing a new diagnostic test within months of the COVID-19 outbreak or regulators such as the MHRA moving swiftly to approve new vaccines, a number of advancements happened in the industry. The question now is how to maintain this forward momentum in a sustainable way.
Many companies will use this imperative to unify clinical, regulatory, quality, safety, medical, and commercial functions through end-to-end digital platforms. Instead of relying on disjointed systems that slow down progress and require longer hours from teams, they’ll opt for more connected solutions that remove redundant processes and duplicate information. On the commercial content side, for example, we’ll see medical, legal, and regulatory (MLR) reviews dramatically accelerated through such platforms.
Unified systems will also allow companies to connect with physicians, CROs, CMOs, CSOs, and patients in new, more productive ways. With less friction and greater collaboration happening in the industry, companies will be able to continue moving at the speeds it reached in 2020, resulting in more efficient development and delivery of treatments to society.
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Digital will make way for two-way HCP engagement
—Paul Shawah, Executive Vice President, Strategy
In 2020, digital adoption skyrocketed across commercial organisations. According to our industrywide Veeva Pulse data, the use of virtual meetings increased more than eightfold, while rep-sent email went up sevenfold since January.1 But up until now, these channels have primarily been used for outbound HCP engagement, leaving untapped opportunities to leverage digital to its full potential.
This year, companies will explore new inbound engagement channels that make it easier for doctors to quickly find the people, information, and services they need, when they need it. With a greater focus on customer-centricity, this type of two-way engagement will ensure that companies are available when doctors need them most, making it more efficient to get the right treatments in the hands of the right patients.
While the shift will be gradual and require significant change management, two-way engagement will result in much more relevant and mutually beneficial interactions between doctors and the industry. The companies that do it best will have digital tightly woven into their field strategies and rep relationships to deliver a seamless, integrated HCP experience across channels.
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Post-COVID uncertainty will make operational efficiency an imperative
—Tom Schwenger, President and COO
Regardless of external circumstances, companies have always been looking for ways to work smarter and more cost-effectively to better serve their customers. But the mounting financial pressures of COVID-19 and the uncertainty it will bring in 2021 are driving a greater need for life sciences organisations to gain operational efficiency in order to protect their future.
One such strategy will be the emergence of flexible profit-and-loss (P&L) strategies that allow companies to quickly scale operations up and down without impacting their bottom line. For example, companies will increasingly outsource workstreams related to manufacturing, sales, data management, and more. This will deliver large-scale efficiencies as well as the ability for companies to rapidly shrink or expand investments depending on their situation this year.
Process automation and digitisation will drive further efficiencies while also providing greater insight into business performance. From data collection and data quality oversight in clinical trials to digital sales call tracking on the commercial side, there are countless ways technology will help automate repetitive, manual processes while reducing human error. With more accurate data, companies will be able to make more informed decisions and quickly adapt to any unexpected changes in the future.
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Asymmetric engagement models will strengthen the field
—Rob Steere, Vice President, Commercial Strategy
The evolution of telehealth and the industry’s shift toward EMR has significantly changed the way doctors interact with patients in recent years. In a similar fashion, we’re now seeing how the life sciences industry’s adoption of digital is also changing the way doctors interact with reps and driving the need for new engagement models.
Each clinic, institution, and HCP will have different preferences for how they want to engage with life sciences companies—be it through remote meetings, in-person visits, email, or virtual events—making it critical for reps to tailor their approach based on the individual customer. This will drive a shift toward asymmetric engagement models that leverage a mix of different customer-facing roles and channels.
Unlike traditional field models where all reps were organized by territory and focused on the same engagement tactics (primarily in-person meetings), the asymmetric approach is hyperlocal and all about tailoring engagement based on customer preference. Some reps may only engage in digital channels, while others leverage a combination of virtual and in-person channels—it will vary across the field based on the preferences of their target audience and evolving technology.
Companies will be able to get even more precise about how they engage customers with industrywide benchmark data that captures individual HCP preferences and behavior. With data to fuel better decisions around channel mix and asymmetric models that enable omnichannel flexibility, field teams will reach a new level of productivity and effectiveness in engaging HCPs this year.
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Specialised medicine will change the makeup of the field force
—Dan Rizzo, Vice President, Global Commercial Business Consulting
Life sciences companies have historically measured commercial success based on HCP-oriented metrics like number of prescriptions or refills. But the industry’s shift toward specialised medicine has been forcing many to reevaluate what success looks like in recent years.
Now that the focus is on much smaller populations, metrics like patient acquisition and retention are equally, if not more, important. This pivot toward patient-centric engagement—along with the field’s recent adoption of digital channels—will change the way commercial teams operate in 2021.
The highly specialised and personalised nature of treatments like CAR T-cell therapy have made it especially critical for patients to have access to the right resources and expertise they need to make informed health decisions. With COVID-19 continuing to limit face-to-face interactions between doctors and patients this year, we expect to see traditional barriers between life sciences companies and patients increasingly break down, giving commercial teams the opportunity to engage in more direct patient interaction.
Meanwhile, digital channels will continue to play an important role in engaging HCPs, and that will drive further change in the makeup of the field force. Digital-first reps will increasingly enter the fold, along with a greater number of MSLs and nurse educators who leverage a mix of virtual and in-person channels. In fact, we’ll likely see a gradual reduction in reps and an increase in MSLs and nurse educators engaging HCPs in the coming year.
While this will require new skills and training for a large part of the team, commercial operations will benefit from higher productivity and improved customer experiences, as well as the ability to scale the field in support of more launches from more brands.
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Executive mandates for digital-first engagement will accelerate commercial content creation
—Pooja Ojala, Vice President, Commercial Content
One of the unexpected benefits of HCP engagement going digital last year was the opportunity for reps to spend more quality time with doctors. When compared to traditional, face-to-face visits, virtual meetings extended the amount of time HCPs were able to meet with reps by roughly six times (from an average of three minutes to 19 minutes). Rep-sent emails also drove significant HCP engagement, with an average open rate of 37%.2
Building on the success of digital in 2020, we expect to see an industrywide shift toward digital-first strategies that will enable greater efficiency and effectiveness in HCP engagement—especially as it relates to commercial content.
The need to keep content at pace with the shift to digital has gained CEO visibility, leading to companywide mandates to speed content creation. While these efforts have traditionally been led by IT, the growing complexity of content now requires involvement across various areas within the commercial space—namely, regulatory, medical, commercial operations, brand, and even agencies.
As a result, we’ll see more companies leverage modular content as a way to gain operational efficiency while maintaining their focus on compliance. Unlike traditional content strategies that require each new asset to be built from scratch, a modular approach simply reassembles existing, pre-approved content blocks, or modules, for use in different channels and regions. This flexibility will be key in enabling faster content creation at scale, as well as more personalised content that’s tailormade for individual customers.
Evolving consumer expectations and preferences around digital will also push the industry toward new content channels and formats in 2021. For example, we anticipate seeing a notable surge in video, as well as emerging self-serve and AI-driven content channels that more closely mirror B2C experiences. Throughout it all, data will play a critical role in helping companies refine, iterate, and adapt their digital-first strategies for the future.
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Product development will go digital to speed medicines to patients
—Jim Reilly, Vice President, Vault R&D
In response to the pandemic, the industry made Herculean efforts to minimise disruption and (in some cases) speed product development last year. From simpler trial designs and faster protocol development to decentralised trials and new regulatory approval pathways, there have been countless examples of pharma companies and health authorities coming together to innovate and collaborate more efficiently.
We expect to see acceleration across all areas of product development—clinical, regulatory, and safety—as more companies opt for modern, digital applications over manual, paper-based processes in 2021. On the clinical side, for instance, the EU Clinical Trial Regulation (CTR) portal will come online this year, which will result in the harmonisation and streamlining of the clinical trial process across the whole of the EU, rather than the current state of seeking trial approval through each national authority.
Moving forward, digital will also accelerate clinical trials by eliminating data and workflow silos that often exist between sponsors, CROs, sites, and patients. In safety, the shift toward centralised adverse event collection and dissemination will help companies see additional efficiency gains while improving pharmacovigilance document quality. With more effective ways to collaborate throughout the product lifecycle, digital will help drive innovation and accelerate the delivery of life-changing medicines to patients.
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An aggressive push toward supply chain transparency will lead to more patient-centric quality outcomes
— Mike Jovanis, Vice President, Veeva Vault Quality
Over the last several years, the life sciences industry has been increasingly externalising its manufacturing operations using suppliers and contract services partners. While this has helped companies deliver innovative therapies faster and scale more cost-effectively, it has also made it more challenging to ensure adequate oversight of quality.
In 2021, we expect to see an industry-wide shift toward newer, more transparent ways of working as the role of quality oversight increasingly expands beyond traditional boundaries. Using modern, cloud-based systems that provide dynamic security and data integrity controls, sponsors, contract manufacturers, and suppliers will be able to share content, data, and workflows much more easily, creating a single source of truth for quality information.
Not only will this reduce product release cycle times and ensure continuity of high-quality therapies to patients, but it will help companies be inspection-ready with full traceability of quality across the global supply chain. With greater transparency throughout the manufacturing network, we’ll eventually see the industry move toward more patient-centric approaches to quality that will drive greater customer satisfaction and safety.
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Clinical trials will evolve to better serve the needs of patients
—Henry Levy, General Manager, Vault CDMS, Site, and Patient Solutions
Getting participants to finish a clinical trial has never been easy due to the heavy burden placed on patients. In 2019, dropout rates rose to 19.1% in late-stage studies globally from 15.3% in 2012.3 And COVID-19 disruptions and restrictions have only deepened the need for change as the industry looks to end its reliance on paper.
In response to these compounding factors, we expect to see clinical trials evolve in 2021 to better serve the needs of patients. Whether through an electronic consent process, remote data collection, or virtual visits made possible in a decentralised trial model, there are numerous ways we’ll see sponsors, CROs, and sites make it easier for patients to participate in trials while improving stakeholder collaboration over the course of a study.
The digitisation of trials will also help enhance the diversity of patients participating in trials by expanding the reach and access of studies. Sponsors can help spearhead this effort toward greater diversity by specifically seeking out research sites in underrepresented geographies, while CROs invest in more support for investigators in areas with minority populations.
By giving patients an easier way to participate in clinical trials and showing them their commitment to diversity in the coming years, life sciences companies will be able to improve study outcomes and drive more effective drug development.
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Real-world evidence will see real-world application
—Richard Young, Vice President, Vault CDMS
While the industry has been talking about using real-world data in clinical trials for more than a decade, it wasn’t until 2020—with the urgency and rapid digitisation brought on by COVID-19—that companies finally started viewing it as essential, rather than a nice-to-have.
Computers, mobile devices, wearables, and other biosensors hold a wealth of information about patients. From sleep quality and heart rate to step count and calories consumed, there are various lifestyle-related data points that study administrators can now use to supplement the data they’re collecting in a controlled setting.
With the FDA and other regulators starting to accept this type of real-world data, we see an exciting opportunity to improve product development, health decisions, and diagnostics related to all therapeutic areas. While it is certainly still in its early days, the infrastructure, regulatory environment, and technology have all reached a place where real-world data can scale and consistently contribute to clinical development.
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Data management will modernise to keep up with rapidly evolving MedTech regulations
—Seth Goldenberg, Vice President, Vault MedTech
Increasing regulations from the FDA—and more recently, the European Union Medical Device Regulation (EU MDR)—have created a new sense of urgency for medical device companies to improve data collection and analysis throughout the total product lifecycle. Manual processes and legacy systems are no longer going to cut if companies want to ensure compliance, reduce risk, and allow for innovation moving forward.
As a result, we expect to see the MedTech industry shift toward more connected and transparent ways of managing its various forms of data in 2021. On the clinical side, for example, more robust, modern infrastructures will help companies track, analyze, and share much larger and diverse data sets stemming from more complex studies both pre- and post-market. In areas like product recall management, device tracking, and claims management, real-time data visibility will help improve product quality and audit readiness as well.
In this new world where data collection is never going to stop, and regulations will continue to rapidly evolve, the companies that invest in more modern approaches to data management will have the agility they need to adapt for the future.
