Clinical Trial and Regulatory (FDA) Comparative Analyst

Element 54 Therapeutics is a startup company focused on the neuroscience of fear and stress circuits. By modulating these circuits, patients can experience relief from disorders ranging from PTSD to anorexia nervosa. There has been an extreme lack of innovation in the feeding disorders space, and only mediocre results in the PTSD space. Element 54 Therapeutics has a treatment candidate in late-stage preclinical trials for fear-based psychiatric disorders and is now looking to determine the way forward for our asset.

The science behind an asset is typically thought of as paramount to the safety and efficacy necessary for the FDA approval of any product. However, the actual route to human use is a regulatory pathway, where the science of safety and efficacy needs to fit into the laws, regulations and guidelines governing drug and device safety.

As drug targets and their mechanisms for delivery become more and more complex, the regulatory space surrounding them will require experts who understand these mechanisms. This is an area of scientific expertise that will continue to grow in the next decades.

The deliverable for this externship will be the creation of a database of late development stage agents from ClinicalTrials.gov which will be compared against current approved pharmaceutical agents. From this database, a gap analysis will be completed from a scientific point of view and a regulatory point of view.

There will be 4 main stages for the workflow of this externship.

Stage 1: Create useful database of Phase 3 and promising Phase 2 pharmaceutical or device agents currently being tested for PTSD and anorexia nervosa. The majority of the work requested here will require mostly desk research and the ability to make a useful database, especially one that can trace connections to similar neurophysiological mechanisms.

Stage 2: Complete scientific analysis of major assets to determine mechanism of action, possible/known safety signals and mechanism of delivery. Analyze weaknesses in each approach, including references from the literature to support conclusions. Rank all agents by likelihood of approval in a competitive grid.

Stage 3: Research current and past regulatory and clinical trial data concerning Element 54’s therapeutic agent. Determine relative risk assessment of each incidence of competition. Rank risks.

Stage 4: Create a scientifically and regulatorily supported argument for Element 54’s agent in the PTSD treatment space.

By the conclusion of the externship the applicant will be able to:

• Demonstrate the ability to use medical and scientific information as the basis for creating relevant commercially applicable data.
• Create databases that are easy to understand and use for non-experts.
• Analyze and make critical supportable judgements concerning competitor’s scientific and regulatory strategies. Attempt to determine competitor’s roadblocks and how they did (or will) attempt to get around them.
• Learn about the regulatory framework for drug and device development, and how science is woven throughout the process. Begin to think about how these analyses might impact the end product, including competitive landscape analysis and clinical trials landscape analysis.

Qualifications