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Alex Cruz Rodriguez

Associate | He/Him/His
Associate | He/Him/His
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Areas of Focus

Overview

Alex Cruz Rodriguez concentrates on drafting, negotiating, and advising therapeutic product and medical device clients on agreements supporting all stages of product research and development, including clinical trials.

Alex’s clinical trial experience includes coordinating, drafting, and negotiating CRO, consulting and study start-up agreements, global clinical trial agreements, data privacy agreements, and informed consents for clinical studies ranging from a client’s first Phase 1 study to large, complex, multinational, pivotal clinical trials.

During law school, Alex was a managing editor for the American Journal of Law & Medicine, one of the country’s leading health law journals. 

Alex is a member of OUTbio of Greater New York. Alex’s community involvement spans contributions in family law and immigration with Catholic Charities and public assistance work at the African Services Committee. Previously, Alex volunteered at Asian Americans Advancing Justice and the Latin American Association in Atlanta in citizenship workshops and benefit-related matters. During law school, Alex served as vice president of professional development at Boston University’s Asian Pacific American Law Student Association. He was a member of the Latin American Law Student Association, the Black Law Student Association, and OutLaw.

Alex is certified as an Information Privacy Professional (CIPP/US).

Career & Education

    • U.S. Securities and Exchange Commission
      Student Honors Program Extern, Enforcement Division
    • U.S. District Court for the Southern District of New York
      Judicial Internship
    • U.S. District Court, District of Massachusetts
      Judicial Internship
    • U.S. Securities and Exchange Commission
      Student Honors Program Extern, Enforcement Division
    • U.S. District Court for the Southern District of New York
      Judicial Internship
    • U.S. District Court, District of Massachusetts
      Judicial Internship

    • Law Clerk, Aterian, Inc. (formerly Mohawk Group Holdings, Inc.)
    • Law Clerk, Aterian, Inc. (formerly Mohawk Group Holdings, Inc.)

    • Boston University School of Law, J.D.
    • Emory University, B.A.
    • Boston University School of Law, J.D.
    • Emory University, B.A.

    • New York
    • New Jersey
    • New York
    • New Jersey

    • Member, OUTbio of Greater New York
    • Member, OUTbio of Greater New York

    • English
    • Spanish (native)
    • Italian
    • French
    • Korean (intermediate)
    • Arabic (intermediate)
    • English
    • Spanish (native)
    • Italian
    • French
    • Korean (intermediate)
    • Arabic (intermediate)

Alex's Insights

Client Alert | 7 min read | 10.01.26

SEC and FDA Formalize Information-Sharing Framework for Public Companies

On August 31, 2026, the U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) establishing a formal framework for the two agencies to share non-public information concerning FDA-regulated products and the companies and individuals engaged in their manufacture, distribution, and sale. The MOU was signed by SEC Chairman Paul S. Atkins and Acting FDA Commissioner Kyle Diamantas. It takes immediate effect and runs for three years, subject to renewal, modification, or termination. In a press release, Chairman Atkins described FDA-related disclosures by public companies as having “a significant impact on our markets” and identified the FDA as “a valuable partner in our efforts to administer and enforce applicable disclosure requirements under the federal securities laws.” Acting Commissioner Diamantas framed the MOU as protecting “both the patients who rely on FDA-regulated products, and the public trust that drives health care innovation.”...

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Representative Matters

  • Drafted and negotiated clinical study-related agreements for a venture-backed biotechnology company focused on kinase-inhibiting drugs for the treatment of cancers and immunological diseases, in support of a Phase III global study involving approximately 120 subjects across 35 sites worldwide, including the U.S., Germany, Greece, Italy, France, Spain, Poland, and the Netherlands.
  • Drafted, negotiated, and coordinated clinical trial and related agreements for a publicly traded, clinical-stage biologics biopharmaceutical company in connection with its Phase II global clinical trials targeting autoimmune diseases, including lupus and multiple-sclerosis, and involving more than 190 subjects across more than 90 sites worldwide, including Belgium, Canada, Finland, and Romania.
  • Drafted, negotiated, and coordinated clinical trial-related agreements for venture-backed biotechnology company for its early-phase clinical trial involving the company’s sonodynamic drug-device combination product in large U.S. research institutions.
  • Drafted and negotiated agreements with service providers for clinical and preclinical studies of therapeutic and medical device products, including master services agreements valued at over $10 million with large, multinational contract research organizations.

Alex's Insights

Client Alert | 7 min read | 10.01.26

SEC and FDA Formalize Information-Sharing Framework for Public Companies

On August 31, 2026, the U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) establishing a formal framework for the two agencies to share non-public information concerning FDA-regulated products and the companies and individuals engaged in their manufacture, distribution, and sale. The MOU was signed by SEC Chairman Paul S. Atkins and Acting FDA Commissioner Kyle Diamantas. It takes immediate effect and runs for three years, subject to renewal, modification, or termination. In a press release, Chairman Atkins described FDA-related disclosures by public companies as having “a significant impact on our markets” and identified the FDA as “a valuable partner in our efforts to administer and enforce applicable disclosure requirements under the federal securities laws.” Acting Commissioner Diamantas framed the MOU as protecting “both the patients who rely on FDA-regulated products, and the public trust that drives health care innovation.”...

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Practices

Industries

Alex's Insights

Client Alert | 7 min read | 10.01.26

SEC and FDA Formalize Information-Sharing Framework for Public Companies

On August 31, 2026, the U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) establishing a formal framework for the two agencies to share non-public information concerning FDA-regulated products and the companies and individuals engaged in their manufacture, distribution, and sale. The MOU was signed by SEC Chairman Paul S. Atkins and Acting FDA Commissioner Kyle Diamantas. It takes immediate effect and runs for three years, subject to renewal, modification, or termination. In a press release, Chairman Atkins described FDA-related disclosures by public companies as having “a significant impact on our markets” and identified the FDA as “a valuable partner in our efforts to administer and enforce applicable disclosure requirements under the federal securities laws.” Acting Commissioner Diamantas framed the MOU as protecting “both the patients who rely on FDA-regulated products, and the public trust that drives health care innovation.”...

View All Insights