Cytel Blog

In the quest for clinical success, we all strive for evidence packages of the highest quality. If the clinical data is strong, then a promising new therapy is more likely to obtain approval from key stakeholders, such as regulators and payers . As a result, you’ll get the chance to develop a therapy that will help many patients (and you will likely gain returns on your investments). As we discuss in our new eBook on data strategy planning, a carefully planned data strategy can help mitigate risks to your programs and enable you to successfully achieve your goals.

Discover how to plan a data strategy that enhances your clinical programs and enables new therapies to reach patients in our new eBook.

In the high-stakes environment of clinical development, it is never too early to start protecting your valuable data assets with a first-rate strategy. So, keep reading to learn which planning approach to use, who should be involved, when it is best to start, and why it is well worth going to all the effort.

January’s Cytel Trial Design Innovations (CTDI) Webinar Series will feature Biostatistician and pioneering Bayesian trial-designer Pantelis Vlachos. Next week, Dr. Vlachos will speak on high-efficiency trial design for Event-Based Studies, particularly in oncology and cardiovascular trials. In this blog post, we offer a glimpse of Dr. Vlachos’ last CTDI Webinar (February 2019) on high-efficiency trial design using enrichment strategies.

Don't miss next week's webinar "Designing Event-based Studies: Reduce Sample Size and Increase Predictability"! Click on the button below to register.

In clinical development, data is the vital ‘foundation’ that supports your programs. To successfully bring a promising new therapy to patients, the quality of your evidence must be strong enough to gain approval from key decision-makers, including regulators, payers, and health technology assessment (HTA) agencies.

So, how can you strengthen the quality of your clinical evidence package? A key solution is to optimize your data strategy. As we discuss in our new eBook on data strategy planning, making just a few small changes to your planning approach can strengthen your ‘foundation’ and generate various benefits that enhance and expedite clinical development.

Download our free eBook to find out how to optimize your data strategy to boost success in clinical development.

With only two weeks left for this fabulous year to end, we would like to thank all our blog subscribers and new readers for following and appreciating the Cytel blog. This year, we collaborated with several experts from both within and outside the company to bring to you a range of interesting topics including real-world evidence, AI, challenges in rare diseases, patient-reported outcomes, data management, and our popular series “The Good Data Submission Doctor” and “Career Perspectives”. In this blog, we share with you the top 5 Cytel blogs that resonated most with our community in 2019.

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Cytel Inc. and Axio Research joined forces in June 2019, expanding our ability to solve the most complex analytical challenges for the life sciences industry. Cytel offers a full range of clinical data management services delivered by advanced analytics experts with global reach.

In this blog, we talk to Ronald Dumpit, who is based in Bremerton, Washington to find out more about his career path, current role at Axio and his interests outside of work.

PhUSE EU Connect 2019 was held in the beautiful city of Amsterdam between the 10th and 13th of November. This clinical data science conference comprised 19 Streams, including 150 papers, 24 posters and 3 engaging data scientists as keynote speakers. The event was well attended and had several interesting and innovative presentations. Caroline Terrill, Associate Director of Statistical Programming at Cytel UK, conducted a session “No Place Like Home: Managing Remote Programmers Remotely” and stood out as the winner in the Personnel Management category. Based on 5 years' experience of managing remote programmers, Caroline’s paper gives guidance on issues to be considered and traps to be avoided if you are managing people who work remotely.

In this blog, we share the presentations from our Statistical Programmers and summarize some of the sessions that our team members attended.

In association with Statisticians in the Pharmaceutical Industry (PSI) , UCB and Cytel hosted a symposium on September 11, 2019 at UCB’s offices in Slough, Berkshire. The primary agenda was to educate the audience on Artificial Intelligence (AI) approaches and their impact on clinical development.

With recent advances in AI, it is important for quantitative scientists to keep up to date with the most recent methods and be involved in guiding their application to the most pressing analytical challenges. This one-day event covered cutting edge examples of how data science and statistical sciences are intersecting, and its relevance to our attendees.

“Artificial Intelligence and associated methodology is becoming increasingly important to the Pharma Industry and its technical foundation in statistical theory means that PSI is naturally keen to promote good practice through its membership and established Industry links. PSI is proud to have set up a Special Interest Group in this field and is keen to broaden its links and membership.”

- PSI Data Science special interest group

In this blog, we share some of the key takeaways from the symposium. If you are interested in attending similar sessions, you can check Cytel’s list of upcoming events here.

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;

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.