The Latest Biotech Updates
Artificial Intelligence for Drug & Biological Products – Credibility of AI Models for Context of Use – The “Model Risk” Paradigm
The FDA has recently issued draft guidance (non-binding recommendations) for drug and biological product sponsors and computer programmers regarding the use of Machine Learning (ML) and artificial intelligence (AI) to support regulatory decision-making about the safety, effectiveness, or quality of drugs.
FDA Issues Draft Guidance for Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics
On December 5, 2024, the FDA’s Center for Drug Evaluation and Research (CDER), along with the Center for Biologics Evaluation and Research (CBER) and the Oncology Center of Excellence (OCE) issued draft guidance concerning expedited programs for serious conditions.
9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs
In United States v. California Stem Cell Treatment Center, Inc. , the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the Food, Drug, and Cosmetic Act (FDCA).
FDA Proposes the Establishment of the Center for Clinical Trial Innovation
The FDA announced the new Center for Clinical Trial Innovation to serve as a central hub to support innovative approaches to clinical trials.
Clinical Trial Design Best Practices
Clinical trials are essential for healthcare decisions. Poorly designed trials risk the safety of participants and produce unreliable data.
Artificial Intelligence and the Implications for Drug Manufacturers (FDA Discussion)
The FDA’s Center for Drug Evaluation and Research (CDER) issued a discussion paper on the role of Artificial Intelligence.
The Capital Raise – Best Practices for Biotech
Biotech and life-science companies are often in need of appropriate capital to execute the company’s mission.
Clinical Trials – Protection of Human Subjects and the Role of Institutional Review Boards (IRB)
In the second part of the clinical trials series, we examine the duties and obligations of Sponsors and Clinical Research Organizations (CRO) as it relates to the protection of human subjects who participate in clinical trials.
Clinical Research Organizations (CRO) – Patient Recruitment & Privacy Considerations
In the selection of a Clinical Research Organization (CRO), the Sponsor must ensure that the CRO has careful policies and procedures in place to safeguard protected patient information.
FDA Provides GUDID Submission Requirements Guidance
FDA guidance regarding consumer health products and the enforcement of Global Unique Device Identification Database submission requirements.
FDA Issues NDA and BLA Recommendations Warranting RTOR
FDA issues guidance and recommendations for New Drug Applications (NDA) and Biologic Laboratory Applications (BLA) which implicate oncology therapies and warrant Real time Oncology Review (RTOR).
Gene Editing & CRISPR Technologies – The Emerging Legal Questions
The therapeutic, ethical and legal implications of gene editing and CRISPR technologies are both profound and complex. However, before we delve into the potential panacea of gene editing technologies, a basic framework and understanding of how it all works is...
Ismail Amin, Esq.
Founder/Partner
Ismail is a multi-jurisdictional practitioner with substantial experience in business, securities, and biotechnology transactions and disputed matters. Ismail has handled disputes all over the world and throughout the United States on behalf of Fortune 500 companies and mid-sized privately held companies in diverse fields such as biologics, biotechnology, banking, financial services, and securities regulation.
In the Board Room – Ismail has counseled the firm’s healthcare provider and business clients in acquiring or selling assets while maximizing return and minimizing risk. He has helped clients acquire or sell over $5 billion worth of healthcare-related assets, including hospitals. Moreover, Ismail has substantial experience in various forms of mergers and acquisitions involving both acquiring and targeting clients. Additionally, Ismail has guided healthcare and biotech clients with various Food & Drug law, and FDA regulatory issues including filing for Pre-Market Approval and 510(k) submissions. Ismail started the “Biotech Bulletin” and writes extensively on emerging issues before the FDA for biologics and biotechnology companies.
Ismail is also the exclusive IR Global advisor for Crypto and Digital Assets for the Nevada market.
With respect to disputed matters, Ismail has considerable trial and arbitration experience, having been involved in over 85 trials and arbitration across multiple jurisdictions from the inception of his legal career. He has successfully litigated shareholder accounting disputes, complex, securities-related actions, trade-secret matters, trademark/trade-dress infringement claims, and commercial matters. Also, Ismail has substantial experience before the USPTO, having litigated multiple TTAB proceedings involving trademark disputes.
Ismail is admitted to practice law in California, Nevada, Texas, North Carolina & New York. Ismail attended the University of California, Irvine, and obtained a double major in International Studies and Political Science. Thereafter, Ismail attended law school at Pepperdine University, and currently serves on the Dean’s Council. In 2019, Ismail earned his Graduate Certificate from Stanford University in Genetics & Genomics. In 2022, Ismail earned his Master’s degree in Biotechnology, Enterprise & Entrepreneurship from Johns Hopkins University. Most recently, Ismail earned his Master’s in law at Georgetown Law Center’s LLM program in Securities & Financial Regulation.
Ismail is proud to serve as a Board Member for Endure to Cure – a non-profit organization that brings emotional boosts to children in cancer treatment and provides a helping hand to their families. Finally, Ismail is a global Alder member.
In addition to practicing law, Ismail is a licensed pilot, avid marathon runner, and Muay Thai Kickboxer. Ismail is proud to have earned his Abbot Labs’ 6-star medal for completion in all 6 of the World Marathon Majors.
