The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Interview with Thomas Wilke: Health Economics and Real-World Evidence Studies

October 20, 2020

In this interview with Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), we talk to him about his background and experience in Health Economics, understand the important considerations of real-world evidence studies and the impact of COVID-19 pandemic on the work of the health economics outcomes researchers who work at Ingress and Cytel. We also cover important HEOR topics such as its benefits for market access studies and real-world analytics (RWA) for regulatory submission.

Cytel and Ingress-Health will be contributing to a range of events at Virtual ISPOR EU 2020, on November 16th – November 19th. Our Real-World analytics teams will be collaborating to deliver a number of interactive workshops, issue panels, posters and podiums to showcase their work and share innovative insights in HEOR, evidence generation, knowledge synthesis and decision analysis.

Click below to download our full list of sessions at ISPOR EU

download the  sessions schedule

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Introducing Observational Studies – Three Trends for Statisticians

October 13, 2020

The combination of greater access to electronic health records, bigger electronic claims datasets, and the need for more clinical insight in ensuring patient safety, has made observational studies an important new tool in trial design. Observational studies typically take non-randomized data from outside of a trial and use quantitative and modeling techniques to draw conclusions from big datasets. While typically used for HEOR and market access, augmenting regulatory submissions with observational studies is gaining prominence. As with all data analyses, there is an implicit rule of ‘garbage in-garbage out,’ where data that is not up to the standard required for the formation of sound scientific judgment, should not be used. Sponsors should rely on the most sophisticated tools and advanced analytics to make the most rigorous use of available data.

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Biotechs and Medtechs, don’t forget your market access strategy (part 4 of 4): How to optimize your market access planning approach

December 5, 2019

Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel

In crafting your market access strategy, it can be valuable to follow these five best practices:

  1. Start planning as early as possible in the drug or device development process, to give yourself enough time to make informed, optimal decisions, and adjust your strategy when needed;
  2. Plan for global markets and seek early advice from payers and HTA agencies, where possible. There are many different agencies and payers to think about when you launch globally, so it’s vital to ensure you are sufficiently addressing the requirements of the priority markets. Even if you do not plan to commercialize by yourself in countries outside the US, careful, early market access planning with key global markets in mind can maximize the attractiveness of your asset to potential licensors or partners;
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Biotechs and Medtechs, don’t forget your market access strategy (part 3 of 4): Harnessing the value of market access planning

December 2, 2019

Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel

Addressing the myriad of considerations required for market access planning can be complex and time-consuming, so it is vital to give yourself enough time to make informed decisions. As such, starting to plan your market access strategy at least by early phase II or the proof-of-concept phase of device development can help you inform the design of the clinical program in such a way to ideally generate evidence credible and compelling to payer and HTA stakeholders, as well as regulators, in order to maximize the commercial success of your drug or device.

Planning early also gives you the opportunity to make adjustments along the trajectory of development as you gain new information and insights about the asset itself, as well as about the payer and competitive environment.

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Biotechs and Medtechs, don’t forget your market access strategy (part 2 of 4): The critical role of market access planning in clinical development

November 21, 2019

Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel

In my previous post, I established the importance of market access strategy in the clinical development process and why emerging biotechs cannot afford to overlook it.

Click on the button if you missed Part 1 or want to revisit it.

Read Part 1

It is imperative to start developing your strategy with market access due diligence and value story creation early in the product development (at least by phase II of drug development or the proof-of-concept phase of a device development). Impactful market access planning involves designing your clinical programs so they sufficiently address the evidence needs of market access stakeholders, patients, and regulators. This means demonstrating the value of your therapy to payers and HTA agencies by generating compelling and robust clinical trial data against appropriate comparators, augmented where possible and helpful with real-world evidence, health economic arguments, economic models and/or relevant patient-reported outcomes.

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Biotechs and Medtechs, don’t forget your market access strategy (part 1of 4): Why is market access strategy crucial to succeed?

November 14, 2019

Market access strategy is an integral part of the clinical development process to ensure success in global healthcare markets and vital access to patients

Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel 

In clinical development, it’s easy to underestimate the critical role that market access plays in the commercial success of a product. Understandably, organizations instead focus on the regulators, and the steps needed to secure eventual approval. However, ensuring the development plan is aligned with a well-planned market access strategy is essential to help the therapy actually reach the intended patients and realize its true commercial potential following regulatory approval. This is particularly crucial considering that payers and other key stakeholders demand compelling information on a drug’s/device’s value as well as justification of its pricing.

In this four-part blog series, I will address what can be done to optimize your market access planning, and why all that effort is really worth it.

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