The proliferation of new technologies and capabilities in healthcare introduces new risks. How can companies keep error from creeping into big data sets and AI output? How can companies deploy new technologies and capabilities so they interact effectively with legacy systems? Validation processes are an unglamorous but critical key to addressing these challenges. The FDA mandates critical systems, including software, used in manufacturing, storing and testing products be validated and kept in a validated state throughout their life cycles. Recently, the FDA has been encouraging life science companies to adopt computer system validation (CSV) software that enables a risk-based approach to validating computer systems. As a result, the market for CSV software is seeing robust growth. We highlight CSV vendors we see making inroads in the market with software solutions that better meet life science companies' CSV needs. We also provide an overview of pharma IT publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

Clinical trial supply chains are deeply interconnected. However, teams throughout the process often work in silos, making clinical trial supply management extremely complex and difficult. Given the pivotal role of supply chains in patient safety, clinical trial efficiency and overall trial success, pharmaceutical companies are increasingly focused on improving supply chain management, most notably by making greater use of supply chain software. We examine four areas where clinical trial supply chain management software is having a high-profile impact: randomization and trial supply management and forecasting, sample management, condition monitoring, and cell and gene therapy. We profile some of the technology solutions innovative companies offer in each of these areas. We also provide an overview of pharma IT publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

We explore the transformative effects ethical and clinically appropriate AI can have on patient experience and cost-saving efforts in healthcare, particularly in the administrative functions among payers and providers. Among the administrative functions where AI can have the greatest impact are eligibility verification, prior authorization, and claims adjudication. AI can streamline these often routine and resource-intensive interactions among payers and providers, resulting in reduced administrative burden and significant cost savings for many healthcare stakeholders. We examine AI’s potential in each of these three areas and highlight companies providing AI-based technology that can help payers, providers and other healthcare stakeholders realize this potential. We also provide an overview of payer and provider healthcare IT publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

The COVID-19 pandemic, which temporarily made remote healthcare a necessity, has been the catalyst for regulatory and societal changes that have made telehealth a mainstream healthcare delivery channel. Telehealth's increased prominence has spotlighted its ability to bend the healthcare cost curve while at the same time improving healthcare quality and healthcare access equity. These compelling benefits have prompted innovation in designing health plans that leverage telehealth technology to improve healthcare delivery and access. The advent of virtual health plans (VHPs) is an example. We trace telehealth's path from its early beginnings to its emergence into the mainstream and the advent of VHPs. We discuss several VHP providers and telehealth's promising future. We also provide an overview of payer and provider healthcare IT publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

Pharma sponsors are realizing they must address clinical trial site inefficiencies that have been a byproduct of (or have been neglected by) the otherwise largely successful efforts to make drug development more efficient with clinical trial technology. Historically, trial sponsors have mandated trial sites use each sponsors’ preferred clinical trial technology stack. As a result, sites’ needs and preferences have been overlooked, and sites have been overwhelmed with multiple disconnected solutions. To resolve this, sponsors are increasingly focusing on adopting site-centric technology for streamlining workflows, reducing administrative burden and compliance errors, and enhancing sponsor-site relationships. We highlight the key areas where we see site-centric technology making an impact – study start-up, source data collection, and imaging – and some of the innovative companies providing these solutions. We also provide an overview of pharma IT publicly traded stock performance and valuation, as well as sector M&A activity and private placements for the past two quarters.

The pharmaceutical industry's shift away from dependence on sales reps for commercialization, the broad evolution of healthcare in recent decades, and the effects of the pandemic on healthcare practices have set the stage for pharma companies' medical affairs (MA) function to join commercialization and research and development as a key pillar of the industry. Technology has been a key factor behind MA's emergence as pharma's third pillar. Digital tools have enabled MA to derive and communicate meaningful insights and evidence from the huge and complex mass of scientific data generated by the healthcare system. We discuss three areas where innovative technology companies are delivering powerful new tools for MA personnel: finding key opinion leaders, engaging and collaborating virtually, and generating insights and evidence. For each, we highlight some of the technology providers that offer compelling solutions. We also provide an overview of pharma IT publicly traded stock performance and valuation, as well as sector M&A activity and private placements for the past two quarters.

The increasing burden and costs associated with Alzheimer's disease and other neurodegenerative diseases have made early diagnosis and intervention a national priority. However, conducting clinical trials to develop therapies for neurodegenerative diseases is particularly challenging. Cognitive assessment technology is an important solution to this challenge. Applications for cognitive assessment technology extend beyond neurodegenerative diseases. Trial sponsors, regulators and physicians are increasingly interested in measuring and monitoring cognitive function during the drug development process to assess safety and risk for a broad spectrum of drugs. We think digital cognitive assessments, which trial sponsors have recently adopted out of necessity (often due to the pandemic) will continue to grow in popularity. We highlight some of the companies providing cognitive assessment technology to trial sponsors for a variety of applications. We also provide an overview of pharma IT publicly traded stock performance and valuation, as well as sector M&A activity and private placements for the past two quarters.

The pandemic was a catalyst that accelerated adoption of emerging technologies and business models. We summarize the major pharma process technology related trends and developments we see resulting from the pandemic. Key areas where transformations have accelerated include synthetic biology, outsourced drug development and manufacturing business models, and clinical trial processes. The pandemic's lingering impact among long-haul COVID-19 patients will likely result in future business opportunities. We also provide an overview of process technology publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

In our last Process Technology Quarterly Insights, we profiled what we termed the drug discovery rocket scientists: companies using unique model systems, data analysis and advanced algorithms to discover and advance drug candidates. This quarter we highlight a new entrant to the space, Vyant Bio (VYNT), formed from the merger of Cancer Genetics and StemoniX. Vyant is an interesting combination of Cancer Genetics' vivoPharm business, which focuses on preclinical and clinical drug development and testing, and StemoniX's class-leading human organoid and computational prowess. While the rest of the profiled "rocket scientist" group - Schrodinger (SDGR), BioXcel (BTAI), SimulationsPlus (SLP), Viva Biotech (1873.HK), and Codexis (CDXS) - entered a lower orbit during the quarter as their stock prices generally declined, we continue to believe this sector has the potential to fundamentally transform human health just as rocket science fundamentally transformed our economy and society. We also provide an overview of process technology publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

Recruiting patients for clinical trials is challenging and often the rate-limiting step in bringing a new drug to market, and recruitment delays are costly, resulting in lost potential revenue ranging from $600,000 to $8 million per day per drug. COVID-19 only amplified the challenges of patient recruitment, ultimately forcing trial sponsors to rethink and improvise on their trial strategies, typically by leaning more heavily on digital solution providers to enable decentralized clinical trials. One of the keys to realizing the full potential of decentralized trials is digital patient recruitment technology that identifies and attracts the largest possible pools of candidates for clinical trials. We profile several companies that have developed innovative technology solutions for identifying, attracting, and retaining high-quality pools of patients for clinical trials. We also provide an overview of pharma IT publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

Advanced data analysis, modeling, and model systems - quantitative domains that gained the moniker "rocket science" based on their successful and transformative application in aerospace - have also been successfully applied in several unrelated areas such as finance. But while these rocket science tools and capabilities have long held great promise in the field of drug discovery, they have generally delivered marginal benefits. We discuss advancements in science and technology we believe will enable the quant approach of using large amounts of quality data and analytics to more fully realize its potential in drug discovery and development. We profile a handful of companies successfully applying today's rocket science to drug discovery and development. We also provide an overview of process technology publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

Representing population diversity in trials is important given a review of 167 new molecular entities approved by the FDA between 2008-2013 showed approximately 20% had racial or ethnic differences in safety, efficacy and response. However, trial diversity remains a challenge for drug sponsors. New guidance from the FDA and others regarding how to broaden eligibility criteria to increase clinical trial enrollment of underrepresented populations provides a roadmap to addressing this challenge. eClinical technology vendors – companies that combine technology, applications, and services to automate clinical trial data collection, management and analysis and to automate other aspects of clinical trials – are providing the tools to make it happen. We highlight a handful of innovative companies whose software and other technology promote diversity and accessibility in clinical trial enrollment and participation. We also provide an overview of pharma IT publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

One of the most significant evolutionary vectors of our healthcare system is healthcare delivery - how the right people get the right treatment at the right time. In this quarterly, we briefly trace the past few decades of this evolution, from traditional delivery systems to integrated delivery networks (IDNs) to alternative delivery networks (ADNs), and we examine how COVID-19 is catalyzing the next evolutionary leap in healthcare delivery - the creation of virtual delivery networks (VDNs). Two key components of VDNs are technology-based virtual care solutions and value-based care strategies. We profile these two areas and highlight some of the innovative companies driving them forward. We also provide an overview of payer and provider healthcare IT publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

We explore in detail an example of the theme we discussed in our last Process Technology Quarterly Insights: how scientific wars and races stimulate innovation and create opportunities for new technologies and market entrants throughout the economy, including pharmaceuticals. In our example, Dyadic International (DYAI), an innovator in bioproduction technology, stands to see uptake of its technology platform for biopharmaceutical production accelerated by the urgency of developing and producing COVID-19 vaccines and treatments. We also provide an overview of process technology publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

Medical procedures are resuming following the two-month suspension early during the pandemic that saw the U.S. surgical cancellation and reschedule rate surge to 88%. However, medical technology company sales representatives have not seen access restored to pre-pandemic levels, and it appears likely they never will. This and lingering effects of the pandemic on procedure volumes portend a rockier outlook for medical technology companies. Nonetheless, we see pockets of opportunity for innovative medical technology products and services. In particular, we highlight companies that provide software that helps medical technology companies engage with providers as well as medical technology companies that offer providers especially compelling tools for improving patient health. We also provide an overview of medical technology publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

COVID-19 and its aftermath have intensified the already substantial challenges of bringing a drug through clinical trials and commercialization. However, we see an accelerating adoption of clinical trial software and technology-based solutions that overcome many of the COVID-19 obstacles as well as increase the speed and efficiency of clinical trials and commercialization efforts. We discuss the key relevant enabling technologies for clinical trials and highlight solutions that address COVID-19’s challenges to the commercialization process. We also provide an overview of pharma IT publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

In our first process technology quarterly insights report, we discuss how the worldwide effort to develop treatments and vaccines for COVID-19 will help transform global vaccine capabilities and be a catalyst to drive new, more productive technology platforms forward to commercialization. This effort will provide an additional tailwind on top of already healthy growth in the pharma service and technology sector. In this report, we discuss the types of companies best positioned to grow and profit as a result of these efforts. We also provide an overview of process technology publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

The novel coronavirus known as COVID-19 is dramatically affecting the business of healthcare, wreaking havoc on the front lines and consuming much of the available capacity of healthcare infrastructure across the U.S. and internationally. However, the crisis has also allowed for increased innovation and collaboration across the healthcare ecosystem in response to these challenges. In this quarterly insight, we highlight some of the recent trends including rapid-cycle diagnostic innovation, the effective deployment of enabling technologies in support of COVID-19 efforts, and the growth of virtual care. We also provide an overview of payer and provider healthcare IT publicly traded stock performance and valuation, sector M&A activity, and private placements during the quarter.

Economic and regulatory pressures, pricing scrutiny, new industry stakeholders, and the explosion of real-world data have caused life sciences companies to rethink their commercialization strategies. By leveraging data-driven digital technologies, these companies can generate the insights needed to improve commercialization and patient outcomes. In this white paper, we explore digital technology solutions related to the drug commercialization process, highlighting numerous promising opportunities in this emerging sector.

eClinical solutions help minimize drug development costs and improve efficiency by automating and streamlining the clinical trial process. They are key to optimizing return on investment in new drug development. In this white paper, we discuss the eClinical solutions market, including clinical trial management systems (CTMS), electronic data capture (EDC), and risk-based monitoring (RBM). We look at both the large eClinical solutions developers and the many smaller technology providers that are having an outsized impact on the direction of the market.

While stabilizing the individual health insurance markets has grabbed headlines, there is an increasing focus on how to solve the larger and more fundamental problems of the healthcare delivery system that are driving unsustainable cost increases. In this white paper, we discuss how the medication technology-enabled services market is addressing the problems of high and increasing prescription drug costs, a misalignment of incentives between payers and providers, and a lack of price transparency, and we profile some of the most important industry players in transparency, adherence, and medication management.

Molecular healthcare encompasses areas of industry development where we see significant opportunity over the next several years to improve healthcare outcomes and create substantial economic value. While molecular healthcare includes genomics, lipidomics, proteomics, transcriptomics, microbiomics, and metabalomics, to name a few, in this report we focus on the fast-moving area of genomics and the early-innings impact next-generation sequencing (NGS) is having on the proliferation of molecular diagnostics in the clinical setting. We also review genetic sequencing basics and profile the key publicly traded and privately held innovators and major players.

Transparency and precision medicine were two major themes at the 2015 AHIP Institute conference we attended in June. In this report, we highlight a few emerging private companies in both areas, but most of our discussion focuses on the broader population health market, encompassing precision medicine and the goal to make treatment decisions on an individualized basis down to the DNA level. With respect to transparency, we continue to see a need for improved sources of quality information to complement cost data.

Analytic tools and technologies have become critical across sub-sectors of healthcare, including revenue cycle management (RCM), clinical interventions, and population health management, and represent a multi-billion market opportunity we believe will be largely captured by a group of emerging vendors. Our focus in this white paper is the area of clinical, financial, and operational analytic solutions targeting healthcare providers (primarily hospitals and health systems) vs. those vendors serving payers or pharmaceutical companies. We look at emerging private companies in the sector as well as a handful of publicly traded healthcare analytics companies.