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[Infographic] Defining the Digital Space
Despite the increased popularity of Digital Therapeutics and Digital Medicines, there is still ambiguity around their definitions. This infographic provides clarity and defines the Digital Healthcare Space. Digital Therapeutics (DTx) Evidence-based digital solutions making direct therapeutic (and frequently drug-like) claims and regulated by the FDA, usually as Software-as-a-Medical Device (SaMD). Digital Medicine A broader category […]
What is Your Data Integration and Analytics Platform Strategy?
If I Could Only Ask Two Questions, the First One Would Be: What is Your Data Integration and Analytics Platform Strategy? It’s really simple, data analytics drives decisions. In the healthcare industry, we use data to better understand the complexity of disease, improve forecasting and communications with patients, design more effective clinical trials, predict trends, […]
What kind of clinical data is required for FDA clearance of a Digital Medicine?
What kind of clinical data is required for FDA clearance of a Digital Medicine? It depends. Digital therapeutics and digital medicines that are subject to FDA regulation are considered medical devices. The amount of clinical data required by FDA generally depends on risk. Many moderate risk (class II) medical devices seeking 510(k) clearance are required […]
Looking To Launch Or Commercialise In The US?
Launching a product is a serious undertaking, requiring a seamless approach to building a commercialisation strategy that includes all the variables needed to maximise the investment across the product’s lifecycle. Nowhere is this more true than the world’s largest market, the United States (US). We know that a successful product launch is critical to maximising […]
Oncology Treatment Access in 2020 and Beyond
2020 promises to be eye-opening as the coming election will surely provide clarity to the path that we will be taking for oncology treatment access. From international reference pricing, acceleration of biosimilars and generics, and allowance of reimportation – pressure continues to mount to reduce pharmaceutical prices, especially those used to treat cancer. Much of […]
Realizing Value from Digital in the Healthcare Environment [Webinar]
[WEBINAR – 20 MINUTES] The advancements of Digital Therapies are promising but commercial success is not always guaranteed. This presentation explores the pitfalls and challenges of selling products into the uniquely complicated and regulated healthcare market. It will lay the groundwork for digital companies to have successful commercial strategies and be able to: Answer questions […]
The New Roaring 20s: How Outsourced Commercialization is the Revolution We Need
The “Great Gatsby Era” was an exciting time of new prosperity, infinite creativity and dramatic social change. Long-standing social norms and traditions gave way to the “mass culture” and consumerism that modernized American society. “What will they think of next?” was a popular expression that defined the era. On the 100-year anniversary of this revolutionary […]
Increase Your Speed to Market
Commercial Strategies for a Successful Product Launch. With the launch of new blockbuster drugs becoming less frequent, there is increased scrutiny on the importance and success of clinical trials, mandatory to determining the safety and efficacy of a developing product. The road to commercialization is daunting – the process of bringing a product to market […]
Improving the Impact of an Oncology Patient Access Program
Our client, a specialty pharmaceutical company focused on the research and development of new therapies in two high-cost complex drug categories, sought to benchmark its patient assistance program against those of its competitors in order to improve relationships within target oncologists’ offices. The Challenge The client needed to assess the image of its patient assistance […]
“Ask the Expert” About Digital Therapeutics
The promise of digital health – from wearables to mobile health apps – could revolutionize healthcare by improving adherence, reducing costs, and making treatments more personalized. Mike Ryan shares insight on the opportunity to set a commercialization standard in the digital therapeutics market that meets customer need, works with regulators and payors, and defines how […]
Strategies to Ensure Market Success of a Rare Disease Product Launch
Small patient populations, complex administration, high costs of therapies, and government policy interventions are just a few obstacles in rare disease. EVERSANA’s Managing Director, Bill O’Bryon, and Senior Director, Diann Johnson, outline key insights to consider in your launch strategy: Market dynamics impacting rare disease therapies The entire rare community: patients, caregivers, providers & advocates […]
Ask the Expert – Digital Therapeutics
From reimbursement strategies, distribution, dispensing, patient engagement and adherence programs, EVERSANA offers integrated solutions to alleviate the barriers facing the adoption of digital therapeutics. Mike Ryan, Executive Vice President of Europe and Asia Pacific, discusses how EVERSANA is leading the commercialization of digital therapeutics with an innovative and nimble commercial model valuable to patients, providers […]
Putting Healthcare IoT in the Home
The Internet of Things are digital tools that enable patients and providers to stay connected by exchanging data in new and exciting ways. The advent of these tools, such as wearables, allow healthcare providers to monitor patients in the home setting by collecting critical health information in real time. This allows for earlier intervention and […]
After FDA Approval, Can Gene Therapies Achieve Marketing Success?
Without a doubt, gene therapy is transforming healthcare by revolutionizing patient care from conventional treatment models to curative therapy models. There are more than 7,000 distinct types of rare and genetic diseases and 400+ million individuals suffering from a rare disease. With a market that is fragmented, there is a need for an innovative, end-to-end […]
Navigating the Cycle of Supply Chain Complexity
As the industry evolves with new regulatory guidelines and product-specific handling requirements, manufacturers now require an agile business model with integrated distribution services. In his new point of view article, Danny Williams, explains how manufacturers can break the cycle of complexity within the supply chain to better connect patients to therapy, leverage distribution operations to […]
Global Biosimilar Competitor Assessment – Who Wins in Biosimilar Access and Why?
The introduction of biosimilar products has created interesting changes in payer behavior across the global markets. For both innovator and biosimilar companies, it has been an effort to understand the demands of payers and succeed in what looked like a ‘winner-takes-all’ opportunity. As the first round of biosimilar introductions has passed, there are some interesting […]
Innovative Therapies Call for an Integrated Drug Safety and Compliance Model
In this article, Herbert Lee, PharmD, Senior Vice President, Medical Communications and Pharmacovigilance, makes the case for an integrated approach to ensuring the safe and effective use of medications by patients. From emerging therapies to innovative technologies, the healthcare industry is changing – demanding that we do business differently. Working in one of the most […]
Navigating Channel Distribution in a New (and more complex) Biopharma World
Every twist and turn in the bench-to-bedside commercialization journey introduces increasing regulatory complexity, product-specific special handling requirements, and evolving industry guidelines. With more than 300 client case studies to draw from, we’ve found three opportunities (or pitfalls) that manufacturers must address in their channel distribution strategy: How quickly can you get your product into your […]
Driving the Commercialization of Regenerative Medicine
With more than 7,000 distinct types of rare and genetic diseases and 400+ million individuals suffering from a rare disease, regenerative medicine holds the hope for a cure – transforming healthcare by revolutionizing patient care from conventional treatment models to curative therapy models. With the advancement of new technologies coupled with the creation of new […]
The Impact of Technology on Advancing Diabetes Care
Statistics from the World Health Organization report that over the past 25+ years, the number of people around the world diagnosed with diabetes has almost quadrupled to 422 million. According to the Centers for Disease Control, diabetes is the seventh leading cause of death in the United States with an annual financial impact of $327 […]
Gene Therapy for Rare Disorders
With only three approved products in the marketplace, how do we build a regenerative medicine ecosystem that delivers more value to patient’s faster?
‘Tis the season for pharma in China, as the government expedites uptake of new urgently needed drugs
PRICENTRIC BRIEF: Universal health insurance coverage for 1.3 billion people means China must increase uptake of “clinically urgently needed new drugs” already approved in the US, EU, and Japan Mostly oncology products are being imported, along with HIV/AIDS medicines Pharma is agreeing to steep discounts to be reimbursed on China’s national drug lists THE DETAILS […]