Karen Lackey

Karen Lackey

Global Head of Integrated Drug Discovery, Evotec

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Karen is responsible for >1,100 scientists covering chemistry, biology, computational drug discovery and pharmacology in >12 therapeutic areas of disease expertise. Prior to joining Evotec, she spent six years in Academic Drug Discovery most recently as the Director, Arizona Center for Drug Discovery (ACDD) at the University of Arizona that serves as an organisational hub for supporting academic-based drug discovery throughout the state. Karen was also an entrepreneur in early stage biotechnology, contributing to 5 start-ups in platform technologies (e.g. PyramidBio). Her pharmaceutical roles (>25 years) included Vice President of Discovery Chemistry at Hoffmann-La Roche (USA) and Global Vice President in the Molecular Discovery Research Division of GlaxoSmithKline.

Jim Thomas

James N. Thomas, Ph.D.

Executive Vice President, Global Head of Biotherapeutics and President U.S. Operations

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Jim is leveraging his extensive experience in biotechnology and scientific leadership to help create global patient access to vital medicines through technological innovation. In his current role at Just-Evotec Biologics, Jim is helping to build biologics capability into the broader offering and capabilities of Evotec SE. Jim served as CEO and founding partner of Just Biotherapeutics. Prior to Just, Jim served as vice president of Process and Product Development within the Translational Sciences R&D organisation at Amgen. In this role, he led the development and application of all process, analytical and formulation technologies used to manufacture both clinical and commercial large molecule products. Jim was first exposed to biotechnology as a postdoctoral fellow at MIT almost 40 years ago, then worked as a scientist and leader at Genentech, Immunex and Amgen. Over the course of his career, he has contributed to the advancement of many important therapeutics including Activase®, Vectibix®, Enbrel®, Prolia®/Xgeva® and Repatha™. Jim has built teams, departments and functions passionate about creating and using innovative technologies to deliver to the needs of patients, and he and his team at Just – Evotec Biologics are continuing this important mission.

What role do Biologics play in the context of novel therapeutics?

Jim: Biologics are a significant and growing portion of the arsenal of therapeutics used to fight serious disease today. There are literally thousands of biologics in the development pipelines of companies around the world, and the number in development is projected to approximately double by 2025. Commercial approval of these drugs should also double in this time frame. Just – Evotec Biologics is using and continually improving a powerful platform to address the growing demand for biologics in the industry. We call this platform, J.DESIGN, and it will be applicable to greater than 70% of all biologics that will be discovered and developed over the next several years.

What are the challenges of developing well-behaving biotherapeutics and how does Just – Evotec Biologics overcome these challenges?

Jim: The molecular complexity of recombinant biologics has driven a very different approach to their discovery, development and manufacture when compared to small molecule drugs. Just – Evotec Biologics is capitalizing on the broad functionality and molecular similarity of antibodies to build a powerful engine for novel protein therapeutics. The systematic approach we’ve taken with J.DESIGN spans from the AI-driven design of J.HALSM, our Just Humanoid Antibody Library used in discovery, to the design and operation of commercial manufacturing facilities that can be deployed to different geographies. We call these facilities J.POD®s. Normally placed in multiple functional silos in large biopharma organisations, we’ve connected the components of J.DESIGN through a common and curated data reservoir. The core context and use of these data are for the design, selection, development and manufacture of antibodies or antibody-like molecules. The Key Performance Indicators that drive continuous improvement of J.DESIGN are product quality, speed to the clinic, lower development costs, lower manufacturing costs and deployable facility design to catalyse global access to biologics.

What is Evotec’s unique selling point with regard to the discovery and development of biotherapeutics?

Jim: Applying machine learning algorithms across this broad design space promotes efficient learning from the least expensive and most abundant data encoded in the DNA of antibodies, to validation of this learning through less abundant, more expensive, but most relevant data from GMP manufacturing at full commercial scale. This is a systems approach to platform definition and continuous improvement and it is unique in the industry, made possible by a number of factors that will be difficult for others to replicate. While enormously powerful for the reasons mentioned, the J.DESIGN platform will be most valuable when coupled to high quality therapeutic biology, whether that’s internally at Evotec or from external sources through partners. Central to our future success in biologics will be the building of efficient bridges between both internal and external biology and J.DISCOVERYTM, as we engage J.DESIGN through selection of the best therapeutic candidates from J.HALSM. With the right partners, we will efficiently move successful clinical candidates to the commercial market and help supply patients worldwide through a global J.POD® network.

Going forward – what is your vision, how will Evotec and Just-Evotec Biologics complement each other?

Jim: In the future, when we couple J.DESIGN to predictive tools like Evotec’s EVOpanOmics and EVOpanHunter, and fully harness Evotec’s pre-clinical development engine represented by INDiGO, we will have a powerful and very fast biologics lane on the Evotec digital autobahn to cures.

Historically, Evotec is well-known as small molecule player, what was the rationale behind building antibody discovery capacities?

Karen: We have created fully integrated, data-driven research and development capabilities from project ideation to fully enabled IND drug candidates (EVOiR&D). Our approach incorporates key elements to successful projects such as translational models in major disease areas, such as oncology, neurology, infectiousdiseases, women’s health, aging, inflammation, fibrosis, metabolic diseases, and biomarkers. It was a natural next step to expand beyond small molecules to incorporate multiple therapeutic modalities to align with our extensive target validation capabilities. Our aim is to deliver high quality drug candidates with ideal drug intervention strategies to make the greatest impact in treatment options for patients.

There are a lot of well-established antibody players, how does Evotec’s offering fit in this quite crowded space?

Karen: It is very important to apply the appropriate technology to solve the specific needs of the drug intervention strategy. The reason so many technologies exist is because there is no one technology that fits all the needs to discover and develop a biologic. Evotec invested in and supports the most promising approaches that will likely work in a majority of the biological targets. However, there are additional techniques being applied in the industry that are fit-for-purpose in subsets of targets. For those, we support the projects through our platforms such as pharmacokinetics, toxicity, immunogenicity, therapeutic translational models, and biomarkers. By being a comprehensive EVOiR&D organisation, we are able to bring as many high quality drug candidates to the clinic in a variety of partnership models.

Looking into the future – what is your vision, how will Just – Evotec Biologics/Evotec’s capabilities and capacities look like in 5 years?

Karen: The vision for the future is both exciting and attainable: deliver high quality biologics with comprehensive data packages to support clinical trials in patients in a lean process to ensure that the industry lives up to the promise of the investments made in the area. As you can see from the information shared in this DDup, many years of creative research have gone into the field – and we are at the stage of translating that into medicines that are affordable. Just a few years ago, biologics were considered high-end expensive medicines, accessible only to certain people. With the Just technologies in discovery and manufacturing, it is very real to bring this to many more diseases and smaller patient populations.

What are your USPs (or unique selling points) with regard to antibody discovery services?

Karen: As mentioned above, the USP for Evotec in this space is the capital efficient access to an autobahn of technologies that allows for a broad range of partnership options: from end-to-end discovery of the biologic agent to manufacturing with all of the necessary characterisations, translational models, and toxicity evaluations to support the project, to opportunities to supplement with just the components needed to drive a partner’s project to success.