Acumen BioPharma provides expert witness consulting and laboratory services to law firms engaged in intellectual property and antitrust litigation related to the pharmaceutical industry. Our expertise includes all aspects of manufacturing technology, regulatory, supply chain and commercial operations involved for branded and generics pharmaceuticals and biopharmaceutical products. Acumen BioPharma’s subsidiary registered as Integra Continuous Manufacturing Systems (www.integracms-pharma.com) is dedicated to consulting services in advance manufacturing technology to assist clients in the design and implementation of continuous manufacturing lines for pharmaceutical products.
Haley Guiliano LLP is dedicated to helping its clients resolve high-stakes intellectual property law challenges through a wide-ranging global practice. Our attorneys, patent agents, and technical advisors are leading professionals who have handled some of the largest and most influential intellectual property matters in the IP arena in recent years. We combine sophisticated legal and technical backgrounds with an in-depth understanding of complex business needs to provide our clients with individualized solutions that protect and advance their IP interests.
Dr. Fernando J. Muzzio is a distinguished Professor of Chemical and Biochemical Engineering at Rutgers University. For the last 28 years, pharmaceutical product and process design has been his main research and educational focus, with emphasis on continuous manufacturing, powder mixing, powder flow, segregation, compression, mixing and flow of liquids and suspensions, capsule filling, tablet dissolution, and tablet coating. He is the author of over 300 peer-reviewed scientific articles and book chapters. He is a frequent participant at FDA events, and in 2010-2014 he was appointed a voting member of the FDA committee on Pharmaceutical Sciences and clinical pharmacology.
Fernando Muzzio is the director of the National Science Foundation Engineering Research Center on Structured Organic Particulate Systems. The center focuses on pharmaceutical product and process design, with special emphasis on continuous manufacturing, particle engineering, and personalized medicine. Dr. Muzzio is also the director of the Rutgers/Janssen partnership in Advanced Manufacturing and the Principal Investigator of a major FDA research award focused on material properties, sensing, and process control in Continuous Manufacturing.
Professor Muzzio is also the president of Integra Continuous Manufacturing Systems, a supplier of comprehensive consulting services in continuous manufacturing, ( www.integracms-pharma.com) and the Chief Scientific Officer of Acumen Biopharma. Acumen Biopharma is a specialty consulting firm providing comprehensive expert witness and testing services in intellectual property and anti-trust litigation cases in the pharmaceutical industry. For additional information, go to acumenbiopharma.com
Dr. Muzzio has been an expert witness in numerous IP litigation cases, with a special focus on formulation and manufacturing processes for solid dose, inhalable, and suspension products.
Brian M. Gummow is currently a Counsel at Haley Guiliano LLP. For more than a decade, Brian has been counseling clients in the biotechnology, pharmaceutical, medical device, food processing, and consumer products industries on a variety of intellectual property issues, including patent portfolio development, patent prosecution, freedom-to-operate opinions, invalidity opinions, patentability opinions, patent interferences, post-grant challenges in the U.S. and around the world, and patent infringement litigations. He works with clients to develop strategies for obtaining and managing robust and enforceable patent protection in the United States and around the world. He also helps clients evaluate the competitive patent landscape and develop strategies to operate their business in view of competitors’ patents.