At FDA's request, the Reagan-Udall Foundation for the FDA (the Foundation), in collaboration with Friends of Cancer Research (Friends), launched the COVID-19 Evidence Accelerator. The Evidence Accelerator convenes experts in health systems research, regulatory science, data science, and epidemiology […]
Demonstrating the Value of Drugs for Rare Diseases – 8 Common Challenges and How to Address Them Before They Arise
No matter how robust in design, clinical trials can never fully address the uncertainty surrounding the comparative effectiveness and safety of a novel product in the real world. This is particularly pertinent in rare diseases for several reasons: small sample sizes and heterogeneous populations […]
How to Put AI + Predictive Analytics To Work
Big data, artificial intelligence, machine learning, and predictive and prescriptive analytics are all the buzz. Everyone's talking about the incredible potential of these technologies. But generating real value from AI is nearly impossible if you don't have the right organizational and strategic […]
Insurance Design and Pharmaceutical Innovation
This paper studies how insurance coverage policies affect incentives for pharmaceutical innovation. In the United States, the majority of drugs are sold to Pharmacy Benefit Managers (PBMs), which administer prescription drug plans on behalf of insurers. Beginning in 2012, PBMs began adopting “closed […]
Global Biosimilars Pathways and Clinical Development Activity
Since the introduction of the first biosimilar guidelines in 2005, the biosimilars field has continued to evolve. Almost 30 biosimilar molecules are currently marketed in the United States and Europe alone. While Europe has long led the way in terms of biosimilars guidelines and clinical […]
Telemedicine adoption grew in most EU5 markets as COVID mitigation measures took hold
Use of telemedicine rose substantially in most of the EU5 markets in March and April, fresh data from DRG’s Taking the Pulse® EU5 2020 physician survey show – but use actually dropped in Germany. This infographic explores some of the nuances of telemedicine trends in Germany, the U.K., France, […]
Mitigating COVID-19-related healthcare disruption
Just several months into the COVID-19 crisis, the healthcare ecosystem has been disrupted in innumerable ways, whether you approach it as a payer, provider, administrator, developer of tests and treatments, or from the viewpoint we all share - that of the patient. As countries around the world […]
Marketing during COVID-19: A guide for pharma solution providers
As with everything else, the current coronavirus pandemic has turned the world of marketing upside down. As a result, all business development champions are left with a critical dilemma: to spend, or not to spend? Fortunately, marketers have been reacting to downturns, recessions, and depressions […]
State of Patient Centricity 2020: Advancing from Patient-first Intentions to True Co-creation
This envelope-pushing Economist Intelligence Unit (EIU) report, sponsored by Medidata, explores how achieving patient centricity in clinical trials needs to evolve beyond patient engagement initiatives to patient co-creation and how these mutually-beneficial partnerships will transform both the […]
Alternative Policies for Pricing Novel Vaccines and Drug Therapies for COVID-19
This report provides a brief overview of approaches to manage the pricing of preventive therapies such as novel vaccines, and treatments in times of public health emergencies. Starting with a summary of experience and lessons learned from previous epidemics and the annual flu vaccine, we will then […]
Bayesian Methodologies for COVID-19 Drugs, Devices and Biologics
Expert statisticians at Cytel have spent the past three and a half months designing and deploying dozens of trials for COVID-19 trials. A new whitepaper describes the critical uses of Bayesian methodologies employed by Cytel statisticians, in their search for effective therapies, prophylactics and […]
Excellence In Payer Engagement: Strategic Outputs From A Roundtable Discussion
Payer engagement is a strategic priority in the pharmaceutical industry. From successful collaboration to efficiently communicating value propositions, effective payer engagement can lead to the development of optimal pharmaceutical pricing and market access strategies. At a recent roundtable […]
Evidence Generation and Communication: A Guide to Getting Started in HEOR/Market Access Medical Writing
Health economics and outcomes research (HEOR) and market access agencies provide specialist consultancy support to pharmaceutical and medical device companies throughout the lifecycle (early phase, pre-launch, launch and post-launch) of a technology (pharmaceutical drug or medical device). The […]
Preparing for ICER assessments: key recommendations for manufacturers
In this free market access whitepaper, Nicole Lodowski, Principal at PRMA Consulting, explains how pharmaceutical and medical device manufacturers can prepare for the ICER assessment process. Cost constraints and value-based decisions are becoming key priorities in the US healthcare system. […]
Optimizing Patient Recruitment: Download Whitepaper
A number of trials recently disrupted by the COVID-19 pandemic are now in the process of re-assessing recruitment timelines, and establishing new recruitment targets. Recruitment projections, though, are only as good as the starting assumptions with which a forecast is made and the models […]
How Healthcare Providers and Payers Drive Outcome-Based Analytics
Healthcare data is growing at an astronomical rate, prompting a new era in healthcare organizations. However, this presents the challenge of managing and analyzing extremely large data assets. To stay competitive, healthcare providers and payers need technology to collect, store, analyze, and […]
New Primer and Ebook on Synthetic Control Arms
Cytel has recently published a new ebook on synthetic control arms, and a new scientific primer as well. The rising costs of clinical trial completion and the greater availability of data, make the uses of synthetic control arms a cost-effective option in a number of clinical trials. These […]
Get Drugs & Devices to Market Faster
Drugs & Devices to Market Faster with 21 CFR Part 11 Compliance
All parts of the product development cycle—clinical trial management, regulatory affairs, commercialization, and everywhere in between—have invested in technologies to support operational efficiencies and productivity gains. But there has always been a gap in these technologies: the inability to […]
COVID-19 is impacting HTA priorities and processes
Navigating global market access requirements in a dynamic environment As the COVID-19 crisis unfolds, the pharmaceutical and medical device industries are responding with new products, processes and solutions in record time. Many health technology appraisal (HTA) boards are prioritising these […]
Leveraging Simulation to Patch a Clinical Trial Broken by COVID-19
The basic structure of a randomized comparative clinical trial is quite simple. A candidate population that meets the admissibility criteria is recruited. Each candidate who consents to participate is randomly allocated to an experimental treatment or to one or more “controls.” The participants are […]
A Systematic Approach to Assessing Real-World Research Questions Supported by Digital Enablement
Multiple strategies, each with their individual advantages and drawbacks, may be employed to answer a research question, but determining the optimal strategy – the one that will bring you to your answer in the most effective and efficient way possible – that is the true challenge in our industry. […]
Version 4.1 of the AMCP Format: Introducing a Trio of Dossiers to Support a Product Throughout its Lifecycle
On December 23, 2019, the Academy of Managed Care Pharmacy (AMCP) released Version 4.1 of the AMCP Format for Formulary Submissions. This new version of the AMCP Format describes three types of dossiers that manufacturers may choose to develop: Unapproved Product Dossiers, Approved Product Dossiers, […]
Patient Preference Studies in HTA Decision Making: A NICE to Have?
There has been a lot of recent discussion about the potential role of patient preference (PP) data in support of reimbursement decisions. In January 2020, the National Institute for Health and Care Excellence (NICE) published a paper that provided more detail on the use of patient preference data. […]
Trends in Medical Device Purchasing, Evaluation of Value, and Advice for Manufacturers
This interview was conducted by Ann Menzie, MS, Senior Director, Evidence Synthesis, Modeling & Communication, Evidera, in conjunction with ongoing efforts to provide relevant and up-to-date information to help our clients develop and execute their evidence generation and market access […]
Integrated Scientific Advice during the COVID-19 Pandemic
The process of seeking scientific advice from regulatory agencies and health technology assessment (HTA) bodies has expanded in recent years and more pharmaceutical companies are looking to take advantage of the opportunity. The most prolific providers of this scientific advice is the European […]
US FDA’s Emergency Use Authorization (EUA): Applicability for Marketed and/or Investigational Products for Treatment of COVID-19
The Emergency Use Authorization (EUA) is a statutory authority which allows the US Food and Drug Administration (FDA) to help strengthen the nation’s public health protections against chemical, biologic, radiological, or nuclear (CBRN) threats by facilitating the availability and use of medical […]
Surprises You Don’t Want When Adopting eCOAs for Use in Clinical Trials: Cautions for Decision Making and Planning
The surge in the digitalization of communications over the past ten years is not only shaping our day-to-day lives but is also seeping through to scientific methodology such as clinical outcome assessment (COA) data collection methods in clinical trial research. COA tools are used to measure […]
Digital Approaches in the Era of COVID-19: Interviews with Science 37 and Medable
Recently Mariah Baltezegar, MBA, Executive Director and Head of Peri- and Post-Approval Virtual Trials with Evidera, and Niklas Morton, MSc, Senior Vice President and Global Head of Digital Services with PPD, spoke with leaders of Science 37 and Medable, two companies Evidera and PPD partner with […]
Evidence Generation Using Innovative, Technology-Driven Data Collection
Electronic medical records (EMR) are now widely implemented in healthcare organizations, and health information exchange (HIE) technology has been widely used to link patient information across different electronic sources. This offers an opportunity to connect to and communicate with EMR systems to […]
Digital Therapeutics: Past Trends and Future Prospects
Digital therapeutics (DTx) are a digital health category defined by the Digital Therapeutics Alliance as products that "deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease." DTx are […]
