Your Healthcare Legal Team
Our Team
Alfredo "Fred" A. Barrera, III
Fred's practice involves assisting pharmaceutical, biotech, and medical device companies with preclinical and clinical development, as well as contract drafting and negotiations for a wide range of issues including CMC (supplies, packaging, distribution), quality agreements, research agreements, CDAs/NDAs, master agreements, and clinical trial agreements for U.S. and ex-U.S. sites, including countries in Europe, the Middle East, Africa, Asia and South America). He has drafted and negotiated numerous commercial and licensing agreements for branded and OTC products in the U.S. and in emerging markets. Fred also provides legal review of ICFs, patient advertising and recruitment materials, publications, posters and presentations prior to public dissemination for his clients.
Fred's approach involves working closely with in-house counsel and/or the clinical team/business team to identify priorities and manage deadlines. His background with litigation helps identify and address risks and develop practical solutions. He provides straight forward legal advice and prepares a negotiation strategy to find the best way forward while protecting the company. His experience and reasonable rates allow his clients to routinely rely on his services for overflow support when large projects, new studies or a high volume of activity requires using outside counsel that can promptly address their needs.
Following graduation from law school at the University of Houston, Summa Cum Laude, Fred served as a law clerk to the Honorable John H. Hannah Jr. of the United States District Court for the Eastern District of Texas. He then worked for eight years at a large Houston law firm where he was part of the litigation section. Fred's practice focused on life sciences, including commercial disputes between companies involved in drug development and personal injury defense involving patients injured in clinical trials. Fred has experience in state and federal courts as well as dispute resolution through arbitration administered under domestic and international rules.
Prior to attending law school, Fred worked as a senior engineer in the offshore engineering department of the American Bureau of Shipping where he helped with regulatory compliance, offshore fire safety, lifesaving and project management for offshore production facilities.
Contact him:
mobile: 281.221.3348
https://www.linkedin.com/in/fred-barrera-b535427/
Licensed in Maryland, District of Columbia and Texas
Michelle D. Barrera
Michelle brings a unique real world experience perspective to her healthcare clients synthesizing her many years of experience as a Registered Nurse, Hosptial Administrator and attorney. As a graduate of The University of Texas School of Law, alumnae of a top international law firm in Houston, Texas, former Chief Operating Officer of a major healthcare institution and with over 15 years of senior management and consulting expertise within world renown healthcare systems, she has a developed a straight-forward style that practitioners not only appreciate—they can relate to. During the course of her career, Michelle has helped employed, academic and independent physician groups and licensed practitioners with legal issues and operational support from contracting and employment issues, to licensing Board Investigations, all aspects of healthcare risk management, malpractice defense litigation and appeals. Michelle assists our pharmaceutical, biotech, and medical device companies with preclinical and clinical development, as well as contract drafting and negotiations for a wide range of issues including research agreements, CDAs/NDAs and clinical trial agreements.
Additionally, Michelle prides herself on supporting quantifiable change through the effective engineering of operations efficiencies. From streamlining simple office processes to drafting policies and procedures to ensuring compliance with regulations, Michelle has the experience and know-how to improve your practice. She has experience developing detailed plans, goals and objectives for implementation throughout organizations as a healthcare consultant in conjunction with her legal practice and continues to offer those services to clients at a consultation rate.
Contact her:
michelle@barrerabarreralaw.com
mobile: 281.896.2817
https://www.linkedin.com/in/michelle-barrera-fache-1282987/
Licensed in Maryland, District of Columbia and Texas
WhitneyKate Sullivan
WhitneyKate Sullivan
Whitney Kate (“WhitneyKate”) Sullivan, Esq. leverages her diverse professional experiences to assist clients facing a wide range of legal challenges. WhitneyKate is a graduate of the University of Hartford and the Elisabeth Haub Law School at Pace University. Prior to joining the firm, she represented clients in multi-million-dollar real estate transactions in New York City, helped victims and their families navigate personal injury cases, and provided legal and operational support for small business owners and non-profits. Before launching her law career, WhitneyKate worked in the publishing industry as an editor and blogger for a fiction review magazine, as a press kit writer, and as a bookseller. These professional experiences have honed her knack for copy editing, branding and creative thinking. WhitneyKate also earned her certification in mediation through the New York City Community Dispute Resolution Center, the Institute for Mediation and Conflict Resolution.
WhitneyKate joined Barrera & Barrera LLP in 2022. She works closely with pharmaceutical and biotech clients as well as health care providers to meet their contracting needs, enthusiastically leveraging her past to bring a unique perspective to the world of life sciences law under the expert guidance of Michelle and Fred.
Contact her:
WhitneyKate@Barrerabarreralaw.com
mobile: 209.500.2060
https://www.linkedin.com/in/whitney-kate-sullivan/
Licenced in New York