Across industries personalization more than technology alone is driving efficiency, productivity, and profits. Smart homes reduce waste by matching electricity use to your lifestyle. Lean and its derivatives allow companies to tweak and tailor processes to meet their unique demands and dynamic route planning ensures efficient delivery of packages. Wherever you look, one-size-fits-all solutions are left behind. As the pharmaceutical industry faces increasing regulatory requirements, skyrocketing development costs, and demands to lower the cost of healthcare, what can we learn from other industries and which innovation(s) will make Pharma workflows smarter?
Smart Workflow and Workforce Management
Waste comes in many forms — underperforming supply chains, mismatched inventories, too large a workforce, to name a few — and its largest sources are often intrinsic to how a particular industry works. What incremental change to your workflows could possibly give you the 500% increase in output the Olds Motor Vehicle Company saw in 1901? To achieve such drastic improvements, Ransom E. Olds completely reimagined how you build an automobile. Instead of clustering teams to build one car at a time, Olds assigned each worker a limited number of sequential tasks and had cars move from worker to worker as they were built. As late-stage workers put finishing touches on one car, early-stage workers could begin assembling the next. Olds reasoned that using this assembly line approach, cars could be built faster and with much greater efficiency.
An Oldsian reinvention of an entire industry, however, may not be feasible in a highly regulated environment such as Pharma, and for every successful overhaul there are many costly failed attempts. But large improvements can also come from well-planned continuous incremental change.
To drive meaningful workflow improvement through small changes Taiichi Ohno and his colleagues at the Toyota Motor Corporation created what is known as the Toyota Production System (TPS), which has evolved into Lean and its many offshoots, such as Lean Six Sigma. Ohno realized that when a process is meticulously specified and workers’ actions are carefully timed and orchestrated, wasteful or broken processes can be easily identified.
The key to Toyota’s success is that by documenting each step of their process — clearly defining who does what when, where, and how — process improvements can be approached in a meticulously scientific manner. By carefully analyzing and formulating both problem and proposed solution in a quantifiable way, workflows can be optimized and personalized to maximize productivity to degrees that mirror Olds’ achievements.The pharmaceutical industry, especially its manufacturing arms, has been slower to adopt Lean than many other industries, in part because of the stricter regulatory requirements. However, Lean and similar techniques have now been used to accelerate clinical trials and improve assay turnaround times. And April 2016 marked the first FDA approval of a manufacturer’s change from batch to continuous manufacturing.
A second driver of efficiency and productivity is smart technology. Across industries companies have recognized that using static solutions optimized to meet average needs rather than smart technologies that adapt to fluid demands can be a source of great waste.
In the shipping industry, for example, no two loads are identical and unanticipated road closures translate into longer routes and costly delivery delays. To deliver mail to its 153 million delivery points, U.S. Postal Service vehicles travel approximately 4 million miles every day. When managing a fleet that covers such great distances in a single day it is easy to see how poorly planned routes can balloon into enormous but unnecessary expenditures. Using smart technology like its Intelligent Mail bar code system, GPS, and mobile delivery devices, USPS is able to collect minute-by-minute routing information for every postcard, letter, and package. This high level of visibility into its mail stream allows the postal service to continuously analyze and improve its processes. Importantly, these systems also allow dynamic routing — rather than following the same route every day or relying on carriers to determine the most efficient one, once items are scanned, an itinerary optimized for each day’s mail is automatically generated.
USPS rival UPS has been using dynamic routing since 2004. And as the Industrial Internet of Things grows, companies have emerged that provide ever more complex fleet-management solutions. Telogis and Greenroad, for example, provide hardware and software to dispatch, plan, and optimize fleets by plotting routes and providing real-time route updates as well as alerts to drivers for inefficiencies such as harsh acceleration or speeding. Other companies such as Metromile provide pay-per-mile insurance services. All of these companies have understood the savings inherent in providing individualized solutions — even such small changes as avoiding a chronically congested street corner or costly left turns that, unlike right turns, cannot be made on a red light, can lead to significant savings.
Smart technologies have also been adopted by the pharmaceutical industry. Digital health platform provider Validic, for example, allows fast and easy access to patient data collected through wearables or in-home clinical devices. Using Validic’s services allows healthcare providers and pharmaceutical companies to collect and analyze patient data remotely, which enables better treatment for patients and larger, more efficient clinical trials for the pharmaceutical industry.
Laboratories and manufacturing plants have also benefited from increasingly smarter technologies. Laboratory information management systems (LIMS) are now significantly more nimble and able to adapt to individual needs. These systems allow not only logging, tracking, and scheduling of samples but also electronic notebook integration, automated data collection, more efficient and customized data management, data analysis and reporting, and easier collaboration with internal and external partners. These integrated solutions are now able to support a drug’s entire path from bench to bedside.
As we imagine Pharma of the future, smart technologies, such as pills that allow real-time monitoring of drug efficacy and organs-on-chips that run in vitro diagnostic scenarios, are increasingly looked to as the key to productivity and profitability. Otsuka Pharmaceutical Co. and Proteus Digital Health are currently working with the FDA to gain approval for a smart pill solution to treat schizophrenia. Novartis has not only invested U.S. $24,000,000 in Proteus but has also partnered with Google to commercialize glucose-monitoring contact lenses and with Qualcomm to develop smart inhalers to treat chronic obstructive pulmonary disease (COPD). Significant investment has also been made in the development of organs-on-chips, which many hope will replace animal models and shorten or even eliminate clinical trials. Dutch-based Mimetas, for example, was recently selected by experts, including representatives from BASF, Sanofi, GlaxoSmithKline, and Abbvie, to develop an organ-on-a-chip model for neurotoxicity.
Not all of Pharma’s needs, however, can be met by improved workforce management and innovative technologies alone. Drug development costs increased by almost 600% from the 1970s to the 2000s and are approaching the $3 billion mark. Meanwhile, success rates dropped to approximately one in ten in 2013 from one in six in earlier years. To combat these increasing costs Pharma needs solutions that allow high-quality data collection and automation, all at lower cost, so that unpromising candidates can be eliminated in early development stages rather than be carried through into costly preclinical and clinical studies.
Innovative technologies and improved business practices alone cannot and have not accomplished this goal. There are no out-of-the-box solutions or algorithms that can adapt existing assays and workflows to meet the needs of each and every lead; the path each drug takes to market is simply too unpredictable. Each new molecule presents a new challenge, and pharmaceutical companies must dedicate entire teams to building assays and making existing technology work for their applications. Often compromises have to be made. This large and unnecessary drain on productivity could be eliminated by one thing: a workflow revolution that fundamentally changes the relationship between Pharma and its suppliers. A workflow revolution for Pharma that redefines partnership and enables truly customized solutions.
Carriers like UPS, USPS, and FedEx do not operate with off-the-shelf dynamic routing software, and the success of partnerships like that between Novartis and Google relies heavily on combining the partners’ expertise. A similar relationship could greatly benefit Pharma. By combining a manufacturer’s unmatched understanding of its products and how they can work together for improved results with a pharmaceutical company’s expertise in its specific drug target and lead, the tools required to bring a drug to market could be developed in record time. Being able to engage with a vendor that truly understands what it is like to work with regulatory bodies and has direct experience in the FDA approval process would add even more value to that relationship. Workflows could be customized to provide better data or data in formats that suit a specific program’s exact needs, allowing Pharma to eliminate poor drug candidates earlier, collect more informative data during clinical trials, and thus reduce attrition rates and the cost of drug development.
At a time when new technologies become available at astounding rates it is easy to look to technology alone for the solution to the rising cost of drug discovery and development. Such a technology-centric approach, however, overlooks the great potential that lies in partnerships, a potential that is widely accepted and realized in other industries and may just be the key to the truly smart and transformative workflows that Pharma has been searching for.