I Am The Law

Scientist to Regulatory Lawyer: Getting Medical Devices to Market

What does it take to bring medical devices to the market? It’s a question lawyer Randy Prebula thinks about every day. Randy is a partner at a global law firm who specializes in the regulatory world of medical devices and technology. In this episode, he shares how he transitioned from a more than 20-year career as a scientist into the world of law and how that informs his legal work. He breaks down FDA’s emergency use authorization, what qualifies as a device versus a drug, how products navigate FDA approval pathways, and why risk-benefit analysis drives every FDA decision. He also reflects on what it was like working in this field during the COVID-19 pandemic, helping to bring one of the first at home COVID-19 tests to market. Randy is a graduate of the Catholic University of America. This episode is hosted by Kyle McEntee. Mentioned in this episode: Colorado Law School Learn more about Colorado Law [https://i-am-the-law.captivate.fm/colorado] Loyola Law School Learn more about Loyola Law School [https://i-am-the-law.captivate.fm/lls] Access LawHub today! [https://i-am-the-law.captivate.fm/lawhub]

Early Career Clarity: From Immigration to Financial Litigation (replay)

Nathania Reyes litigates commercial disputes on behalf of financial services organizations like banks. Nathania recounts her journey from uncertain law student to finding her place in civil litigation. She describes her diverse experiences, including immigration and in-house internships, a judicial clerkship, and her transition to private practice. She emphasizes the importance of work-life balance at her current firm, how the Hispanic Bar Association has shaped her career to date, and how she's expanding her expertise in various commercial litigation areas. Nathania touches on networking and business development, highlighting the value of persistence in the face of rejection. Nathania is a 2017 graduate of Rutgers University School of Law. This episode is hosted by Kyle McEntee. Mentioned in this episode: Colorado Law School Learn more about Colorado Law [https://i-am-the-law.captivate.fm/colorado] Loyola Law School Learn more about Loyola Law School [https://i-am-the-law.captivate.fm/lls] Access LawHub today! [https://i-am-the-law.captivate.fm/lawhub]

How Lawyers Are Using AI and Where They Draw the Line

Artificial intelligence has arrived in the legal profession. In this special episode, Kyle and Katya examine AI's growing role in the world of law from criminal defense to M&A and much in between. Over the past few months, they've asked every guest a simple bonus question: How has AI affected your practice? The answers offer a window into a profession in transition—curious, conflicted, and actively determining AI's proper role in law. Practitioners share how AI streamlines document review and accelerates research, while candidly discussing serious limitations and risks. This highlights how lawyers are still learning to navigate the technology. Feature voices: 1. Eric Bernheim, Episode 120, Behind the Lease: Supporting Restaurant Expansion Through Real Estate Law 2. Alexis Taitel, Episode 121, From Clerkship to Private Practice: Research, Writing, and Challenging Assumptions 3. Venetia Mayhew, Episode 122, Second Chances: Rewriting Life Through Clemency 4. Joe Stephens, Episode 126, Trial by Algorithm: Helping Lawyers Navigate the AI Revolution 5. Asha Sharma, Episode 127, Administrative Hearings and Human Stories: Social Security Disability on the Frontlines 6. Audi Syarief, Episode 129, Trading in Gray Areas: How Sanctions Shape International Business 7. Rachel Frank, Episode 131, Understanding the Appeal: Supreme Litigation from First Draft to Oral Argument 8. Elise Bennett, Episode 133, Cool Little Dudes and Legal Battles: Environmental Protection from the Courtroom to the Community 9. Molly Henry, Episode 137, Navigating International Waters: Arresting Ships and Managing Crises on the Seas 10. Michael Kohagen, Episode 139, At the Center of the Transaction: Coordinating Business Deals from Start to Finish This episode is hosted by Kyle McEntee and Katya Valasek. Mentioned in this episode: Colorado Law School Learn more about Colorado Law [https://i-am-the-law.captivate.fm/colorado] Access LawHub today! [https://i-am-the-law.captivate.fm/lawhub] Loyola Law School Learn more about Loyola Law School [https://i-am-the-law.captivate.fm/lls]

At the Center of the Transaction: Coordinating Business Deals from Start to Finish

Michael Kohagen structures mergers and acquisitions for clients across the deal spectrum, from family businesses selling for $5 million to headline-grabbing deals. He explains how smaller deals offer closer client relationships—often working directly with owners who lack M&A experience but know their business intimately. Michael walks through the deal process from confidentiality agreements and letters of intent through due diligence and purchase agreements, emphasizing his role coordinating specialists while drafting core transaction documents. He discusses how AI is beginning to change document review, why most M&A deals fail (time drag and initial misalignment), and how his central role creates both pressure and satisfaction. Michael is a graduate of the University of North Carolina School of Law. This episode is hosted by Kyle McEntee. Mentioned in this episode: Colorado Law School Learn more about Colorado Law [https://i-am-the-law.captivate.fm/colorado] Loyola Law School Learn more about Loyola Law School [https://i-am-the-law.captivate.fm/lls] Access LawHub today! [https://i-am-the-law.captivate.fm/lawhub]

Environmental Law in Government: Managing Competing Interests and Natural Resources

Duncan Kemp, a state government lawyer, took an unconventional path to environmental law. After working in college athletics fundraising and earning an MFA in Creative Writing, he entered law school part-time with a clear goal: protecting natural resources. But landing that environmental job proved harder than expected. Today, he manages litigation for one of Louisiana's largest landowners—from boundary disputes and coastal erosion cases to pipeline enforcement and exotic animal seizures. Duncan discusses balancing conservation with hunting traditions and economic growth, and coordinating litigation across agencies. Plus, he talks about the satisfying trade-off between lower government pay and a better work-life balance. Duncan is a graduate of Southern University Law Center. This episode is hosted by Kyle McEntee. Mentioned in this episode: Access LawHub today! [https://i-am-the-law.captivate.fm/lawhub] Colorado Law School Learn more about Colorado Law [https://i-am-the-law.captivate.fm/colorado] Loyola Law School Learn more about Loyola Law School [https://i-am-the-law.captivate.fm/lls]