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For more than<\/span> a year and a half, Shoshana Shendelman has been at the epicenter of one of the biggest stories in the country: the raging campus battles over Israel\u2019s war on Gaza. Earlier in the year, Columbia University, an institution deeply entwined with Shendelman\u2019s life, was the site of the first major university protest encampment. And the university cracked down, inviting police<\/a> onto its New York campus where they made violent arrests<\/a>.<\/p>\n Shendelman, who got two masters\u2019 degrees and her doctorate from Columbia and whose child currently attends the school, had sat on the board of trustees of the university since March 2023. According to a recent New York Magazine story<\/a>, Shendelman was one of the most active board members in the pro-Israel camp pushing for action to restore order on campus. The university meted out harsh punishments<\/a> for student protesters, short circuited due process<\/a>, and, critics say, stifled pro-Palestine speech<\/a>.<\/p>\n The hard-line faction of trustees had long since gained the upper hand on the board, but the campus \u2014 and the nation \u2014 continued to be rocked<\/a> by the debate over Israel\u2019s war on Gaza, including as part of an onslaught from Donald Trump\u2019s administration that has cost the school hundreds of millions<\/a> in funding.<\/p>\n In November, tumult would reach Shendelman\u2019s life \u2014 not, however, in her role on the Columbia board, but in her professional career. In the six months that followed, Shendelman would see controversy erupt over the pharmaceutical company she started and led \u2014 including allegations from the federal government of statutory and regulatory violations in clinical trials, and a shareholder lawsuit alleging fraud on her part. Shendelman has since denied doing anything wrong, but she lost her leading roles at the firm.<\/p>\n She maintained, however, her position on the Columbia board of trustees as the body pushed for harsh responses to pro-Palestine protests and sought to consolidate power over the school. Now, the controversies around her pharmaceutical work are raising questions about her role on the university board.<\/p>\n <\/p>\n \u201cKeeping Shendelman on the board is just one more indication of how deeply the board has lost its way.\u201d<\/p><\/blockquote>\n <\/p>\n \u201cAt a moment when the board of trustees is leading with a very heavy and misguided hand, keeping Shendelman on the board is just one more indication of how deeply the board has lost its way,\u201d said a tenured professor at Columbia\u2019s Irving Medical Center who asked to remain anonymous for fear of retaliation from the university.<\/p>\n Shendelman did not respond to inquiries from The Intercept. Columbia\u2019s administration did not offer responses to questions for the board of trustees by press time.<\/p>\n Shendelman had been the CEO of a pharmaceutical firm called Applied Therapeutics, a company hoping to bring two drugs to market. Shendelman was a central figure in the firm. She had founded the company; fundraised for it, including taking it public; and spearheaded the development of its lead drug candidate, govorestat, as well as its clinical studies.<\/p>\n Then on November 27, Applied Therapeutics announced that govorestat was rejected<\/a> by the U.S. Food and Drug Administration. On the same day, Shendelman was issued a stern warning<\/a> by the FDA. In a letter addressed to her, the agency\u2019s Center for Drug Evaluation and Research, which regulates drugs, called out Applied Therapeutics for the deletion of sensitive data ahead of an FDA inspection and failing to disclose crucial information about \u201cerrors\u201d made during clinical trials for their lead drug candidate. The problems, the FDA said, amounted to apparent statutory and regulatory violations. (Applied Therapeutics did not respond to The Intercept\u2019s request for comment.)<\/p>\n <\/p>\n <\/p>\n In a podcast interview<\/a> this month, Shendelman said there were no safety or efficacy concerns about govorestat, and that it had been rejected by the FDA for bureaucratic reasons. (The FDA letter said Applied Therapeutic\u2019s failure to disclose certain information to the agency created issues with performing \u201can evaluation of the safety and effectiveness of the drug.\u201d)<\/p>\n Following the regulator\u2019s letter, the company\u2019s stock price tanked, dropping 80 percent in three days. Within weeks, shareholders filed a lawsuit<\/a> against Applied Therapeutics, Shendelman, and another company officer, alleging that Shendelman in particular had known about problems with clinical trials since May 2024, and committed securities fraud by failing to disclose information about the issues to investors in a series of rosy public statements. The stock continued to rise on this incomplete information, the suit alleges, and Shendelman sold off stocks totaling more than $6.6 million at an \u201cartificially inflated share price,\u201d as the suit put it. The majority of the sales, more than $4.7 million worth, came in a three-day flurry in August 2024, just days after Shendelman gave a positive assessment<\/a> of the company\u2019s FDA application process to investors.<\/p>\n In separate responses to the lawsuit, Applied Therapeutics denied<\/a> all wrongdoing, and Shendelman\u2019s lawyers moved to dismiss<\/a> the claims. They argue that none of the claims in the suit constitute fraud, that she sold only a fraction of her shares in the company, and that the allegations are based purely on \u201cconjecture, hindsight, and allegations that Dr. Shendelman was unduly optimistic about the possibility of approval.\u201d<\/p>\n On December 19, a little over three weeks after the FDA issued its letter, Shendelman signed an agreement that terminated<\/a> her employment at the company she had founded. According to the agreement, Shendelman would be paid millions on her way out.<\/p>\n Even amid the dramatic changes at work, Shendelman\u2019s role at Columbia remained steady. Five months after leaving Applied Therapeutics, she remains on Columbia\u2019s powerful 21-member board of trustees as the body undertakes what critics say is a broad power grab<\/a> at the university.<\/p>\n Her role on the board has stirred little controversy thus far, but the contours of her unceremonious exit from Applied Therapeutics are taking on heightened relevance amid a crisis at Columbia that has escalated dramatically since Trump took office.<\/p>\n \u201cI am appalled to see the FDA\u2019s warning letter, and the impending class action lawsuit regarding Applied Therapeutics for their mishandling of data collection and storage,\u201d said a second professor at Columbia\u2019s Irving Medical Center, a medical doctor who asked for anonymity for fear of professional retaliation.<\/p>\n Until shortly after The Intercept sent requests for comment to Columbia and Shendelman, her board of trustees biography listed<\/a> her as the vice chair of the \u201cClinical Advisory Board\u201d of Columbia\u2019s Irving Medical Center and its Vagelos College of Physicians and Surgeons. There\u2019s little online information about a clinical advisory board, except a 2022 letter<\/a> from the head of the medical center announcing its formation. Hours after The Intercept sent questions about the clinical advisory board, the word \u201cclinical\u201d was removed from Shendelman\u2019s trustee biography, which now described her as a vice chair of the board of advisors at the medical center.<\/p>\n <\/p>\n \u201cColumbia students and faculty are finding ourselves wondering about the real commitments and values of our board.\u201d<\/p><\/blockquote>\n <\/p>\n \u201cIt\u2019s a fundamental responsibility for all of us who conduct research at the medical center to do that work in accordance with the highest standards of ethical research,\u201d said the first, tenured medical professor. \u201cI don\u2019t understand how we can have someone in a senior advisory position who doesn\u2019t adhere to those same standards.\u201d<\/p>\n The school is undergoing an unprecedented upheaval. Columbia\u2019s governance structure used to be a triumvirate, with the board of trustees, the president of the university, and the university senate each playing influential roles. Amid the row over pro-Palestine student protests, however, the trustees appointed<\/a> one of their own as acting president of Columbia. Now, the administration and board are seeking an overhaul<\/a> of the university\u2019s storied senate, a democratically elected body and the only<\/a> part of the three-pronged governance structure where students and faculty hold mandated positions.<\/p>\n Looming over the power struggle is Columbia\u2019s protracted $400 million fight with the Trump administration \u2014 a fight where, according to New York Magazine, critics think the hard-line pro-Israel wing of the board of trustees are ushering in Columbia\u2019s capitulation. In the battle with Trump, the trustees and their allied university administration have shied away<\/a> from answering to the senate, faculty, and other stakeholders. Among the students and faculty raising questions about the need for greater scrutiny of the trustees, Shendelman\u2019s record at Applied Therapeutics is seen as a vindication of their concerns.<\/p>\n A third member of the Columbia faculty who asked for anonymity to avoid retaliation from the university said, \u201cWhether it\u2019s cooperating with the Trump attacks on science and dissent, the horror and cost of the Hadden affair<\/a>, or now this, Columbia students and faculty are finding ourselves wondering about the real commitments and values of our board far more often than we should.\u201d<\/p>\n The FDA conducted an inspection in the spring of 2024 into Applied Therapeutics\u2019s lead drug candidate, govorestat. With govorestat, Applied Therapeutics hoped to bring to market the first FDA-approved therapy for a rare pediatric metabolic disorder. The inspection was carried out under an FDA program to ensure compliance with standards around human test subjects in clinical trials.<\/p>\n The FDA investigation that followed reviewed the inspection report, related documents, and the company\u2019s response. On November 27, the regulatory agency sent a letter addressed to Shendelman.<\/p>\n \u201cThis Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between April 29 and May 3, 2024,\u201d the letter says.<\/p>\n Applied Therapeutics, inspectors found, likely ran afoul of the Federal Food, Drug, and Cosmetic Act, as well as federal regulations that govern clinical studies. In a dense summary of a long back-and-forth with the company, the FDA specified two categories of deficiencies with the clinical trials.<\/p>\n The first was a failure to give FDA inspectors access to records related to clinical trials. On March 25, 2024, the FDA had informed Applied Therapeutics about a forthcoming inspection. Two days later, according to the letter, a third-party vendor deleted electronic records for all 47 subjects in one part of its clinical trials.<\/p>\n <\/p>\nThe Board<\/strong><\/h2>\n
\n Photo: Timothy A. Clary\/AFP via Getty Images<\/span>
\n <\/figcaption><\/figure>\nWarning Letter<\/strong><\/h2>\n