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Maria Lundberg on a Holistic Approach to Therapeutics Development

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Cytel recently announced the launch of its Therapeutics Development Team, bringing together quantitative, computational, regulatory, and strategic drug development capabilities. For this edition of the Industry Voices series, Maria Lundberg, Managing Director of SDS Life Science, a Cytel company, discusses a holistic approach to therapeutics development and how this recently expanded team supports clients across the globe.

SDS recently joined Cytel — for those less familiar, can you provide an overview of the expertise this group adds to Cytel’s Therapeutics Development Team (TDT)?

SDS comes with a range of expertise, serving critical aspects of the drug development cycle, starting early with pre-clinical expertise, such as toxicology and pharmacology, covering CMC, clinical development, and regulatory affairs. And, of course, statistics for trial design and real-world evidence studies. A value driver for our clients has been the depth and breadth of our organizational competency. We have roughly 30 PhDs in relevant disciplines — just about half our staff.

We are excited to be part of the launch of Cytel’s Therapeutics Development Team, combining our science and data-based approaches, entrepreneurial spirit, and world-class technology.

Having served in leadership roles in the pharmaceutical industry for decades, I’d love to delve into your experience. Could you give us a snapshot of your background, and what brought you to your current role?

My career path was anything but linear. I am from Lund, a city in southern Sweden, where AstraZeneca, Astra at the time, had a large business. Given my interest in joining their organization, I called Astra to ask about the recommended path to pursue a career with them. They suggested I either major in pharmacy in Uppsala or chemical engineering in Lund. Since relocating to Uppsala was not preferable to me, I studied chemical engineering in Lund. Shortly thereafter, I started my career at AstraZeneca.

After a couple of years, I decided to take my career in a different direction. I ventured into process engineering, became a manager, and have been involved in leadership roles ever since. This is the aspect of my career that resonates with me the most. I love working in environments where I can make meaningful contributions and can share my enthusiasm with the entire team. I like bringing people together to collaborate on a common goal, fostering teamwork without competition, and concentrating on what truly matters. The outcomes have been gratifying; seeing people work together and amplifying each other's capabilities.

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As the newest addition to Cytel’s Therapeutics Development Team, can you comment on what it means to provide a holistic approach to therapeutics development, and how it relates to your expertise in drug development? How does this approach increase drug and medical device development efficiency?

Our Team has a breadth and depth of expertise, which has been especially useful for early virtual or smaller start-ups, where funding may be scarce, and every penny has to be prioritized. In addition, we provide the client with support throughout the development process, ensuring the right decisions are made — guiding them through all stages and helping them overcome obstacles.

For example, a small pharma company has a great idea, but little expertise in-house and needs a partner to go to market. In partnering with us, they receive the required help, following an efficient process, to advance to the first clinical trial and then further if they succeed. Within Cytel, we have fantastic expertise in how to make clinical studies more efficient, smarter, and with fewer patients. So altogether, we adopt a comprehensive and holistic approach.

There are, unfortunately, many opportunities for wrong turns in therapeutics development. Still, with the guidance of experts that have decades in the industry, you will have the help needed to navigate any detours. By implementing intelligent and innovative solutions, we can effectively drive time and cost savings and increase the chance of success.

Our Therapeutics Development Team works with a wide variety of clients around the world. How does such an organization tailor its approach to working with and meeting the needs of very different clients?

When engaging with clients, our primary focus is to listen, listen, listen. Each organization has unique needs, staff capacities, and funds — our first step is determining their needs and how we can partner to guide them along the way. Every drug development project is different, there is never a straightforward one, and we are prepared to meet each client where they’re at and customize and adapt our approach accordingly.

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A strategic focus of Cytel’s Therapeutics Development Team is to provide support for drug companies getting projects clinical-phase ready. How do we support this process?

To get projects clinical-phase ready, i.e., taking a project from molecule to a Phase I clinical trial, clients benefit from a streamlined process we’ve created that makes life easier, especially for smaller, virtual pharma companies. We manage the whole journey, including sourcing of lab, CRO, and CMO work. At the same time, we help create the best trial design for Phase I, paving the way for Phase II. With this simplified system, we prioritize activities and studies and help save time and limit costs on the way to clinical trials.

Integrating trial design with regulatory strategy is essential for the successful development and approval of a new drug or device. What might this look like?

Regulatory strategy and study design fit together; the study design can be ever so clever, but if not approved by authorities, what’s the point? Working closely together is a cost saver with regard to both money and time.

Our expertise is strategically focused: we help companies discuss with regulatory bodies what they need to do to reach the market. While we are not limited to only working in specific therapeutic areas, we have focused a lot on oncology because that's what the research pipelines look like today.

A first step for drug developers should be to consider their regulatory strategy. When partnering with a sponsor, our primary objective is, first, to look at what regulatory authorities require to approve a drug. That is our starting point: the regulatory strategy needed to gain approval from regulatory bodies. And we have a lot of experience integrating trial design with regulatory strategy and working with regulatory authorities — primarily in the U.S. and Europe — on designing studies suited for regulatory needs. Then we use the disciplines we have at hand, including a fantastic statistics toolbox, to design the optimal way to get the drug on the market, offering more intelligent solutions within regulatory strategy.

Locking in a regulatory strategy is such a critical — and often overlooked — step in outlining your clinical development plan.

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Thank you for sharing your perspective with us today! I’ll ask one final question: what are you most excited about going forward?

I'm still new to Cytel, but I'm so excited about the new Therapeutics Development Team identity. The Team recently met in Athens, and it was such a pleasure all getting together for the first time from across the globe. The meeting boosted our feeling for TDT as a gang of experts that can really make a difference for our clients. Together, with our breadth AND depth, we can work with clients to accelerate new drugs to market. We are really looking forward to working together with clients, both new and familiar.


Learn more about our Therapeutics Development Team

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