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Expertise

Mike Ryan

Executive Vice President, Europe

Expertise:

Consulting (Strategy Management & Regulatory), Stakeholder Engagement & Promotion (Patients, Payers, Providers)

With more than 25 years of experience in the life science industry, Mike has held global leadership positions in both clinical development and life-sciences software companies. Given this experience, he is highly experienced in the use of technology and understands its impact in simplifying the process of developing and delivering novel therapies and making them more accessible to patients around the world. He has worked with many biotech and pharmaceutical companies to develop clinical pathways that deliver upon the ultimate commercial goals required to ensure success for all stakeholders. Mike speaks at many global industry events to promote the idea of innovation in healthcare and to encourage a greater level of partnership between healthcare stakeholders.

Articles by Mike Ryan

European Parliament’s Revision of the General Pharmaceutical Legislation

The European Parliament has adopted a revision of the general pharmaceutical legislation, repealing and amending previous legislation with a set of compromise amendments. According to the European Commission, it has been called “the largest reform in over 20 years.” In this POV, EVERSANA’s experts, Mike Ryan, GM, Europe and Monique Martin, SVP, Value and Evidence, share information about the revision, its meaning, implications and importance, and what the amendments could mean if they ultimately become law. While this is not yet final legislation, the article offers best courses of action  for Marketing Authorization Holders with the aim to improve equitable access to medicines, make the region more innovation-friendly and streamline […]

Adapting to Change: Examining the Implications of New EU Regulations on Commercialisation from the Perspectives of Patients, Providers, and Pharma Companies

In April, the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) 2022 Patient W.A.I.T Indicator found that the average rate of availability for pharmaceuticals in Europe is 45%, down 2% on the previous year. Additionally, the access gap between the highest and lowest country was found to be 83% in the 4-year cohort, and 80% for longer timelines, with an average of 517 days from centralised approval for a new medicine to be available in a European market. The root cause of delay in availability can be attributed to many things, but it is primarily caused by variance in assessment for pricing and reimbursement by national Health Technology Assessment (HTA) […]

Successfully Navigating Self-Commercialisation in Europe
Successfully Navigating Self-Commercialisation in Europe

Introduction As discussed in our previous paper, Successful Launches in Europe: Complex, But Not Complicated?,,  Europe is one of the world’s largest and most important regions of focus for pharmaceutical and biotechnology manufacturers looking to treat patients and maximise the value of their products. However, the challenges of entering this market, particularly in terms of its complexity, can be intimidating and may deter some companies from launching themselves. Companies may prefer to out-license or sign agreements with distributors, which are the more traditional routes to market. However, these agreements result in less control for the manufacturer regarding all aspects of the launch strategy and decreased long-term company awareness and revenue […]

Read now: Successful Launches in Europe: Complex, But Not Complicated?
Successful Launches in Europe: Complex, but Not Complicated?

Europe represents a major pharmaceutical market – it accounts for 22% of the global market, second only to the U.S. in terms of market size and has a large population of over 500 million. Understandably, pharmaceutical and biotechnology companies looking to maximise their revenue consider Europe to be a key focus[1]. Indeed, looking at first-time drug launches by biotech companies, between 2010 and 2020, two-thirds of U.S. launches were followed by launches in other countries[2]. Our paper, “Successful Launches in Europe: Complex but Not Complicated,” discusses the challenges and opportunities associated with launching a pharmaceutical product in Europe. This paper emphasizes the need for pharmaceutical companies to adopt a comprehensive […]

The Future of Pharma – A Provocative Perspective

In this episode of AI For Pharma Growth, Dr. Andree Bates is joined by Mike Ryan, Vice President, Europe, EVERSANA. They discuss the future of pharma and the impact of recent advancements in healthcare. The industry is facing a unique moment, with technology opening up new possibilities for medical interventions and a greater focus on patient outcomes. The combination of artificial intelligence, big data, and shifting customer expectations are driving major changes in healthcare and pharmaceuticals. The industry must be prepared to embrace these changes and take bold steps to succeed in this new landscape. In this episode you will learn: Why healthcare is undergoing rapid change How technological advancements […]

New Medicines, New Access, New Frontiers

How psychedelics, cell therapies and other innovations are driving regulatory reform and new patient access Science is improving exponentially. What’s now possible, through new medicines, and entirely new categories of medicine, could only be dreamt of just a decade ago. Doctors and patients are naturally excited about the oncoming pipeline. But while science improves exponentially, regulators do not. Indeed, many of the checks and balances, as well as stakeholder attitudes, take much longer to reform. The pressure is on: regulatory evolution must be safe and sensible, yet every day’s delay will mean patients are left untreated. In this Impatient Health webinar, EVERSANA’s Mike Ryan, Executive Vice President, Europe, discusses with […]

A Partnership Q&A with EVERSANA and Shorla Pharma

As industry and patient needs progress beyond traditional commercialization models, new models are needed to deliver products to patients quicker, especially when launching in international markets.  Still asking yourself how to execute on a global pharmaceutical product launch? EVERSANA has the answer to this question and others that you’ll have when choosing a commercialization partner.   In this Q&A, EVERSANA’s Mike Ryan, Executive Vice President, EMEA, and Sharon Cunningham, CEO and Cofounder of Shorla Pharma, answer questions about how Shorla Pharma is bypassing the barriers of traditional commercialization models to launch its oncology portfolio globally with EVERSANA.  What qualities should you look for in a commercial services partner when preparing for commercialization?  Sharon: Shorla Pharma is a specialty pharmaceutical company (headquartered in Ireland with an office in Cambridge, Massachusetts) that develops and commercializes innovative oncology […]

Why Launching in Europe Is Unlike Launching Anywhere Else

Today, there are more than half a billion people in the European Union (EU) and United Kingdom (U.K.). Passing over this part of the globe puts patients and manufacturers at risk for negative outcomes. Launching a new therapy in the EU and U.K. has traditionally involved complex navigation of service providers, price sequencing and the rich diversity of patient and healthcare provider populations. As a result, bringing a pharmaceutical or biotech product to Europe has been, and continues to be, intimidating for most manufacturers. Many manufacturers still believe that the traditional launch model – signing a handful of disjointed partnerships – is the only way to launch a new product […]

Considering Commercial Success During Clinical Development: Maintaining a Global Perspective

Although commercial success is the ultimate goal of pharmaceutical research and development (R&D), many new treatments do not meet expectations and fail to achieve broad global reimbursement after initial regulatory approval., This causes therapies to underperform across international markets and, more importantly, limits access for patients in need. For example, only 56% of all new drugs approved by the European Medicines Agency (EMA) between March 2000 and March 2018 went on to receive a positive reimbursement recommendation by the National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK)—the country’s central health technology assessment (HTA) body. Several factors contribute to suboptimal global reimbursement, including a bias toward United States (U.S.) market characteristics and the compartmentalization […]

WEBINAR: Yes EU can! How novel treatments can avoid complexity and commercialize with impact across the European continent

Europe has a population of more than 450 million people, yet most manufacturers consider the U.S. the primary market for launch. In this webinar, EVERSANA’s Mike Ryan, Executive Vice President, Europe, discusses with other industry leaders how the EU’s landscape is changing in order for European states to increasingly become a priority market for commercialization. This conversation takes a closer look at the following topics: How to get past the perceived launch “red tape” in the EU Emerging regulatory, HTA, access, data and commercial routes that will begin to open up this market What a successful post-pandemic launch should look like and determine the steps you need to get there. Investments […]

WEBINAR: The New Path to European Pharmaceutical Commercialisation

Global healthcare and life sciences innovation continues to surge at an unprecedented rate. External disrupters such as Brexit, GDPR, new regulatory guidance, such as the Pharmaceutical Strategy for Europe, and the COVID-19 pandemic, are driving pharma and healthcare leaders to reevaluate long-standing strategies. If pharma companies want to remain globally relevant and competitive, they must reassess commercialisation strategies – particularly related to clinical trials, pricing and digital technologies and therapeutics. In this webinar, EVERSANA’s Mike Ryan, Executive Vice President, Europe, and other European commercial leaders from BMS, CSL Behring, Novo Nordisk and Takeda share insight on how to: Choose a commercial strategy that will provide efficient, synchronous, targeted outcomes for patients and providers across all EU countries and the UK Plan […]

Change Is Happening in the EU: What Pharma Companies Need to Know About the European Union’s New Pharmaceutical Strategy

For the first time, the European Union is undergoing a major overhaul of its pharmaceutical industry with the new Pharmaceutical Strategy for Europe, which was launched in late 2020.    Through this strategy, the European Union (EU) is making changes to its infrastructure with the goal of building a holistic, patient-centered, forward-looking pharmaceutical landscape for all EU member countries and patients.  Focusing on patient access, treatment affordability and sustainable innovation, the European Commission outlines four key areas in which they will take legislative and non-legislative actions to move this progressive, patient-centric plan forward:   Delivering for patients: Fulfilling unmet medical needs and ensuring accessibility and affordability of medicines    Supporting a competitive and innovative European pharmaceutical industry   Enhancing resilience: A diversified and secure supply chain, environmentally sustainable pharmaceuticals, crisis preparedness and response mechanisms   Ensuring a strong […]

A New Pharmaceutical Strategy for Europe

In late November, the European Commission announced the adoption of a new healthcare plan – the Pharmaceutical Strategy for Europe. This plan aims to strengthen the European Health Union while ensuring affordable patient access across the entire European Union and supporting sustainable innovation for pharmaceutical industries. What’s Changing, and Why? Until now, patient access and health data collection has been hindered by increasing drug development costs and, subsequently, pricing, as well as inconsistent drug availability across the European Union (EU). The onset of COVID-19 further emphasized the need to improve patient access, drug affordability, competitive pricing and overall crises preparedness and response in the EU healthcare system. In particular, the […]

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 revenue potential, and this success is contingent on understanding and managing a multitude of factors including legal and regulatory, speed and success of clinical trials, market access and reimbursement, value and evidence, data and analytics, patient support services, channel management, risk mitigation and monitoring – the list goes on. Read the full article.

Patient Recruitment & Retention: A Perspective From “The Other Side” [Webinar]

[Webinar: 23 Minutes] With over 20 years experience on the clinical research arena, Mike Ryan shares the importance of patient engagement from the clinical trial all the way across the drug development continuum. He highlights that although some patients might not qualify for the clinical trial, they should continue to be relevant as future clients/patients of the drug. Those patients could have an impact on the commercialization success and revenue of the product. In addition patients who do qualify and participate, should stay informed and updated on the status of the drug development. How does your patient recruitment and retention strategy looks like? Watch the webinar now.

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 is long and the failure rate high, ultimately impacting the price of products that do make it to market. Pharmaceutical and biotechnology companies assume the risk of these failed investments, and there are numerous market factors determining this failure rate, including: complex trial design and failure to meet endpoints; low patient recruitment, adherence, retention and […]

“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 we bring these products to a global market. Advancements in digital medicine will take us into a new frontier, but only if the infrastructure exists to dispense and measure these therapies. This nascent industry needs a commercial model that not only is valuable to payors, providers and patients, but that is also innovative and nimble. […]

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 and payers at launch.

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