Alzamend Neuro, Inc is a clinical-stage biopharmaceutical company focused on developing treatments for Alzheimer’s disease and other neurodegenerative diseases. To advance the development of a new treatment called ALZN002, Alzamend sought to conduct a phase I/IIA clinical trial to evaluate its safety, tolerability, and preliminary efficacy.
Biorasi, LLC is a contract research organization or clinical research organization (“CRO”) engaged in the business of providing clinical research services, clinical research professionals, and contract clinical, technical, and other related services.
Alzamend asserted claims for breach of contract and fraudulent inducement after the ALZN002 Trial was derailed.
Biorasi filed a motion to exclude the testimony of Plaintiff’s expert witness Dr. Frederick H. Hausheer while Alzamend sought to exclude the testimony of Biorasi’s rebuttal experts, Emily Friedrich and Aimon Iftikhar.
Pharmacology Expert Witness
Frederick Herman Hausheer, M.D. is a physician-scientist and biopharmaceutical research executive with over 37 years of experience in clinical drug development, including extensive Phase I–III clinical trial management under FDA and other international regulatory frameworks.
He earned his M.D. from the University of Missouri-Columbia (completing medical school in three years), completed his internship and residency training there. He has held board certifications in Internal Medicine (since 1985) and Medical Oncology (since 1987). Hausheer completed a fellowship in Medical Oncology (in two years, with promotion to faculty) at the Johns Hopkins Oncology Center and Hospital, concentrating in Pharmacology and Experimental Therapeutics research and development.
Biomedical Engineering Expert Witnesses
Emily Friedrich is a licensed Project Management Professional certified in Good Clinical Practices. Friedrich also holds a Bachelor of Science in Molecular Genetics and Biochemistry with a minor in Chemistry from the University of Pittsburgh granted in 2007 as well as a Master of Science and a Doctor of Philosophy in Biomedical Engineering from Carnegie Mellon University.
She completed postdoctoral training at Northwestern University Feinberg School of Medicine in the Department of Surgery and held a Research Instructor position at the University of Illinois at Chicago in the Department of Pharmacology. Friedrich also served as a Biomedical Research Program Manager at a military treatment facility.
Dr. Aimon Iftikhar specializes in clinical research and development of medical devices with a focus on assessing clinical efficacy and accuracy in real-world settings. She has a Bachelor of Science degree in Biomedical Engineering with minors in Mathematics and Materials Science and Engineering from the University of Connecticut, a Master of Science degree in Biomedical Engineering from Carnegie Mellon University, and a Doctor of Philosophy in Bioengineering with a concentration in Tissue Engineering & Regenerative Medicine from the University of Pittsburgh.
Discussion by the Court
A. Biorasi’s Motion to Exclude Frederick Hausheer
i. Methodology
Though Biorasi contended that Hausheer relied exclusively on assumptions to form his opinions, Hausheer’s report cited an extensive list of references and supporting documents reviewed including training materials, training logs, resumes, protocol deviation logs, emails, meeting minutes, call notes, as well as various plans regarding protocol deviation, quality management, and risk management.
Biorasi also contended that Hausheer’s opinions are merely ipse dixit, but Hausheer explained that the conduct of the ALZN002-01 clinical trial “is guided by the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, which are universally recognized as industry standards of practice and are consistent with FDA regulations.” References to Good Clinical Practice guidelines are frequent throughout Hausheer’s report regarding industry standards for qualified personnel and training, trial plans, monitoring, quality management, and blinding and communication controls.
The Court found that Hausheer’s opinions are not based on mere ipse dixit, but rather the result of reviewing record evidence and measuring the evidence against established industry standards in the context of his own substantial professional experience.
ii. Helpfulness
Biorasi argued that Hausheer’s opinions are not helpful for the same reasons it argued they are unreliable. However, the Court already found Hausheer’s opinions to be based on a reliable methodology. Moreover, the Court found Hausheer’s opinions would assist the trier of fact.
B. Alzamend’s Motion to Exclude Dr. Emily Friedrich and Dr. Aimon Iftikhar
i. Qualifications
The Court found that both Friedrich and Iftikhar possess substantial clinical experience and possess certifications in the industry standards relied on by Alzamend’s expert, Hausheer.
ii. Methodology
Alzamend argued that because Biorasi’s proposed experts lack experience in double-blinded trials, their methodology is unreliable.
However, Alzamend cited no case law or statutory authority for its contention that rebuttal experts who possess both clinical experience and certifications in the relevant industry standards should be excluded because they lack adequate double-blinded clinical experience.
The Court found this methodology to be sufficiently reliable. Alzamend’s
assertions of lack of experience in double-blinded studies goes to the weight, not the admissibility of the testimony and may be the subject of cross-examination.
iii. Helpfulness
Alzamend argued that the rebuttal experts’ opinions are not helpful because they impermissibly usurp the role of the fact finder.
However, the Court found that the rebuttal experts’ opinions will assist the trier of fact in this case. The rebuttal experts’ assessment of the double-blinded trial, considering their substantial experience and analysis of industry standards, concerned matters that are beyond the understanding of the average lay person.
As to Alzamend’s categorical objections to credibility determinations, weighing competing evidence, or rendering factual conclusions, Biorasi contended that the rebuttal experts are merely pointing to evidence that contradicts the assumptions relied on by Hausheer. The Court agreed with Biorasi, and it is permissible for an expert to review facts and extrapolate opinions from those facts based on experience and industry standards.
Held
- The Court denied Biorasi’s Daubert motion to exclude the testimony of Plaintiff’s expert witness Dr. Frederick Hausheer.
- The Court denied Alzamend’s Daubert motion to exclude the testimony of rebuttal experts, Emily Friedrich and Aimon Iftikhar.
Key Takeaway
The qualification standard for expert testimony is not stringent and so long as the expert is minimally qualified, objections to the level of the expert’s expertise go to credibility and weight, not admissibility.
Case Details:
| Case Caption: | Alzamend Neuro, Inc. V. Biorasi, LLC |
| Docket Number: | 1:25cv20481 |
| Court Name: | United States District Court, Florida Southern |
| Order Date: | June 16, 2026 |
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