AUTM on the Air

Research Integrity and the High Stakes for Technology Transfer with Michael R. Samardzija


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Most people hear the phrase “research misconduct” and think it’s an issue reserved for academia. But the truth is, it can rock the entire innovation ecosystem. One altered image in a dissertation might sound small, but it can snowball into collapsed companies, hundreds of millions in losses, and a deep erosion of trust in science itself.

Joining me to dig into this reality is Michael R. Samardzija, Senior Counsel at Womble Bond Dickinson. Michael’s career is unique because he’s lived on both sides of the technology transfer world. He earned his PhD in Physiology and a Master’s in Exercise Physiology from Loma Linda University, then went on to get his JD from the University of San Diego. 

Over the past two decades, he’s worn many hats including Vice President of Research Affairs at Loma Linda University Health, where he launched the N3eight business incubator, Director of Intellectual Property at MD Anderson Cancer Center, and leadership roles at firms like Dentons and Bracewell & Giuliani. That blend of academic and legal experience gives him a rare perspective on the challenges TTOs face every day.

Michael recently put a name to something many of us have only seen in fragments what he calls “Research Misconduct’s Butterfly Effects”. It’s the idea that what looks like a single, contained problem in a lab can ripple outward, creating consequences for commercialization, partnerships, and the credibility of institutions. Today, he’s here to break down those connections and share what they mean for technology transfer professionals navigating this complex landscape.


In This Episode:

[01:29] Michael’s dual background in law and academia is outlined, including his leadership roles and IP experience.

[02:11] Michael explains “Research Misconduct’s Butterfly Effects” and why it matters for technology transfer professionals.

[02:59] Defining research misconduct with fabrication, falsification, or plagiarism, proven by preponderance of the evidence.

[04:04] Misconduct in publications can invalidate patents, licenses, and commercialization efforts.

[05:27] Michael shares how his career shaped his views on risk management for TTOs and the rising tide of retractions.

[06:03] Licensees may begin requiring universities to warrant patents that are free of misconduct, a risk institutions must prepare for.

[07:12] Tech transfer offices should consider sequestering underlying data to provide transparency for licensees.

[07:51] Organized fraud networks, “paper mills,” and systemic pressures to publish are fueling misconduct at scale.

[09:13] A student uncovers duplicate publications across different journals, leading to a retraction.

[10:18] Publication mills profit by selling authorship or fabricated manuscripts, creating an industry of fraudulent science.

[12:21] High-profile cases show faculty losing positions over fabricated or cherry-picked data, with countries like India now imposing strict punishments.

[13:49] International collaborations bring value but also increase risk when oversight standards differ globally.

[14:15] Case study of Athira Pharma illustrates how research misconduct spiraled into legal, financial, and reputational crises.

[15:06] Faculty at Washington State University discover dementia drug candidate Dihexa and form a startup.

[17:01] Millions in NIH funding and clinical trials follow, but manipulated images in early publications trigger scrutiny.

[18:22] The former graduate student admits to embellishing images, yet fundraising and IPOs continue, raising over $400M.

[20:04] A whistleblower files a False Claims Act suit, leading to DOJ involvement and company stock plummeting 40%.

[21:16] The case settles for $4 million, with ongoing investigations, shareholder lawsuits, and SEC concerns.

[23:02] Washington State University removes the student’s dissertation and launches an inquiry.

[24:12] Athira’s valuation collapses from $670M in 2020 to $25M in 2025, showing the profound damage of misconduct.

[25:00] Michael stresses the need for better due diligence, expert involvement, and clear standards on acceptable data/image alterations.

[27:21] TTOs should resist warranties but offer licensees access to original data for their own investigations.

[28:38] Retracted papers may serve as tools in patent prosecution or litigation, a double-edged sword for TTOs.

[29:09] Practical steps for TTOs include careful fraud language in agreements and collaboration with research integrity offices.

[32:01] Recommendations include close coordination with integrity officers, rapid response plans, and careful handling of inventor payouts.

[34:24] Michael advises TTO professionals to self-report suspicions quickly to protect institutional reputation.

[36:20] Tech Transfer professionals should innovate with integrity and stay vigilant against misconduct.


Resources: 

Michael R. Samardzija - Womble Bond Dickinson

Michael R. Samardzija - LinkedIn

Michael R. Samardzija - Loma Linda University

Office of Research Integrity (ORI), HHS

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