To Annemarie Ableitner-Kurz, Principal Consultant at NDA, the most rewarding moments are when an investigational therapy gains approval to proceed into clinical trials in humans. For over 20 years, she has played a pivotal role in moving preclinical research to the stage where a compound can be tested for its potential to improve lives. 

Imagine a regulatory consultant sitting at her desk, working on a high-level nonclinical plan for a project where no studies have been done yet. Her job is to fill this plan with the necessary regulatory requirements while keeping the unique characteristics of the drug in mind. Not all rules apply to every product, so she carefully considers which studies are needed and discusses these plans with the client, explaining why certain studies are essential and others are not. This is a glimpse into the kind of projects Annemarie works on and the tasks she performs. Her approach to regulatory planning is rooted in her extensive work experience and background in pharmaceutical science. 

Annemarie’s career began in basic science research, when she completed her PhD in neuroscience at the Max Planck Institute. She spent over 10 years working as a postdoc researcher in pharmacology and toxicology, researching areas like pain pathways, opiate tolerance and addiction. This foundational experience provided her with a solid understanding of the science behind drug development. Eager to gain more practical experience, she decided to take the next step and become directly involved in developing therapeutic compounds.  

“I started with basic science, researching molecular pathways and investigating the activities of new compounds; then I took the chance to move to industry and to advance such compounds with novel mechanisms of actions to clinical development and bring new medicines to patients”. 

Transitioning to the industry, Annemarie received training in safety pharmacology, pharmacokinetics and toxicology, deepening her understanding of the requirements for drug development. She served as a senior manager, where she was responsible for nonclinical aspects of both early and late-stage drug development projects through regulatory submissions. Moving on to regulatory affairs, she leveraged her prior experiences to further align her knowledge with evolving regulations and innovative technologies. She continued to adapt and learn, staying updated with evolving technologies and regulatory requirements. 

Annemarie now applies her expertise as a Principal Consultant at NDA where she advises both EU and US clients on their nonclinical programs. Her role involves guiding them towards preparing successful submissions for regulatory approval, minimizing deficiencies, and ensuring smooth progress towards the first-in-man stage or later stages of clinical development. She emphasizes the importance of prospectively advising clients to facilitate their entry into human clinical trials or regulatory approval with minimal issues.  

Annemarie is committed to driving projects forward, finding the most efficient pathways to progress them, and overcoming challenges along the way. She emphasizes the importance of collaborating with clients to navigate through uncertainties. She says, “I enjoy finding solutions to problems and making sure our projects succeed. It is important to understand and discuss any risks involved in a project, and to recommend to clients the best ways to deal with them.” 

Annemarie's role involves considerations of both CMC and clinical aspects, requiring close collaboration with colleagues to address any overlapping concerns effectively. Explaining how she collaborates with her colleagues, she says “At NDA, we have a collaborative workspace, and I can easily reach out to and receive support from other subject matter experts. This teamwork helps us improve and support our clients better as they develop their projects.” Annemarie’s key milestones include successful interactions with regulatory agencies on nonclinical programs, successful submissions of INDs, CTAs, and PIPs as well as NDAs, BLAs, and MAAs. 

Every project has a specific goal depending on the stage of development, and Annemarie’s role involves aligning her evaluations and recommendations with these goals. She asks questions like, “Is this nonclinical program appropriate and will it gain regulatory acceptance to initiate first-in-human trials? Are we prepared for phase two or three clinical trials? or is the submission package complete?” Based on the findings, she advises how these may be resolved or addressed best. Explaining this, she says: “We make sure that all relevant nonclinical scientific and regulatory aspects are carefully considered bearing in mind the characteristics of the drug. In the end, it helps to bring new medicines more rapidly to people who need them.” 

From Annemarie's experience, having a broad expertise is beneficial for nonclinical consultants because designing an effective nonclinical program involves looking at data from a number of different areas. For those starting out their career, she suggests building a strong foundation with a broad expertise, staying flexible and taking any challenge as an opportunity to further improve.