Committee & Speaker Biographies

Patrick Blacha is currently Senior Advisor, Technical Service/Manufacturing Sciences (TS/MS) for Eli Lilly and Company. In addition to his current role, Patrick held senior leadership positions for Eli Lilly and Company in Parenteral Network TS/MS and site Quality. Prior to Lilly, Patrick held various leadership positions in Quality and TS/MS at Pharmacia, G.D. Searle Monsanto and Abbott Laboratories. Patrick has over 30+ years of quality assurance/quality control and technical services experience in API/Drug Product manufacturing and medical device assembly. He has extensive experience in guiding project teams in all aspects of product and process control strategies, integrating knowledge management and quality risk management throughout the product lifecycle. Patrick received his B.A. in chemistry from Catawba College and his M.C. in chemistry from North Carolina State University.

Tom Cosgrove is a partner in Covington’s Food, Drug and Device Practice Group. He joined Covington in 2017 from the Food and Drug Administration (FDA), where he was a senior official charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients. Mr. Cosgrove brings a wealth of experience to bear in helping clients navigate the complex world of pharmaceutical compliance and enforcement in the United States and around the globe.

At FDA, Mr. Cosgrove held senior leadership positions within the Office of Compliance in the Center for Drug Evaluation and Research (CDER), including leading the organization as Acting Director in 2016. Beginning in 2014, he led the Office of Manufacturing Quality (OMQ), where he was responsible for CDER’s enforcement activities covering current good manufacturing practice (CGMP) and drug quality. As Acting Director of CDER Compliance in 2016, Mr. Cosgrove oversaw OMQ as well as the offices responsible for enforcing FDA’s requirements for drug approval and labeling, human drug compounding, drug supply chain security and integrity, and clinical trials and bioequivalence studies.

Mr. Frick is a technical operations and quality executive with extensive experience managing transformational change in business-critical settings. Hands on leader who enjoys working in a fast pace environment. His experience includes execution and delivery of strategic priorities across a global network and developing talent within the organization. Innovative change manager who drives metric-driven quality enhancements, process improvements and operational efficiencies. Travis exudes a passion for personnel and business development, data integrity, and manufacturing process execution (and continuous improvement).

Sebastian Hanet is currently a Sr. Associate Data Scientist at Amgen within the Quality Data Sciences (QDS) group. In his position, Sebastian specializes in using natural language processing and machine learning to build end-to-end artificial intelligence applications to support manufacturing and quality related goals. Prior to QDS, Sebastian worked in the Operations Information Systems department where he helped support data science platforms and built visualization tools for scientists in Process Development.

Sebastian holds a B.S. in Computational and Systems Biology from the University of California, Los Angeles.

Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA Center for Drug Safety and Evaluation.  Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry, and preparing associated regulatory actions. She has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, Ms. Higgins spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District.  While working as the Pre-Approval Manager, she continued performing drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.

Michael is a member of the Date Integrity Center of Excellence at Merck & Co. Inc, manufacturing division, which defines the compliance expectation for Data Integrity as part of the Quality management system and provide s guidance for implementation.  He has 22 years of experience with software development and  GXP system validation, he has worked on the manufacturing, vendor and consulting sides of the business.  He has managed IT testing departments and Quality Validation departments supporting over 100 site based and enterprise systems.   He holds a Bachelor of Science, Computer and Information Sciences from Temple University.

Toni Manzano is Cofounder and CSO of Bigfinite, a SaaS company that is transforming manufacturing operations with the use of AI and IIoT technologies for pharmaceutical and biotech companies. For over two decades, he has led software projects for international pharmaceutical companies covering the entire production process and supply chain. Today, Toni is a part of the scientific committee with PDA Europe and with the AI Xavier Manufacturing team. He worked as a researcher at the University of Barcelona as a physicist and teaches big data and artificial intelligence in postgraduate courses at the UAB. He is also a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence. He has written numerous articles and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud.

As Director, Knowledge Analytics at Amgen, Brian leads Agile Product Development for the Quality Data Sciences organization, which is focused on applying machine learning and natural language processing to unlock insights in manufacturing and quality data. Brian also leads the advancement of Knowledge Management across the Operations business function, which includes process development, global manufacturing operations, quality, supply chain and engineering.

Brian joined Amgen in 2003 and has held roles of increasing responsibility focused on web, portal, collaboration and knowledge management. Prior to Amgen, he spent 5 years in the defense industry developing web applications and IT solutions for US Navy customers. Brian has a BS in Business Administration, Information Systems from California State University, Northridge. He is a Certified Scrum Product Owner (CSPO), Certified ScrumMaster (CSM) and serves on the executive committees of the Knowledge Leaders Council and The Conference Board Knowledge & Collaboration Council.

Tracy has been a GMP Inspector since 2011 and prior to joining the MHRA worked in the pharmaceutical industry for 22 years working across most dosage forms within Quality and technical roles. Her experience ranges from starting as a QC analyst to holding senior managerial and technical positions and she is an eligible Qualified Person in the UK. Tracy is currently lead of the MHRA Inspectorate Technology team responsible for providing guidance and strategy for new and emerging technologies and data integrity. To assist in MHRA pandemic efforts, Tracy is currently also participating in the MHRA Task Force for supply chain aspects.  Tracy is the deputy of the PIC/S Strategy and Development Sub Committee and leads specific PIC/S working groups.

Amy Muhlberg is a Staff Fellow at FDA in CDER’s Office of Pharmaceutical Quality in the Office of Policy for Pharmaceutical Quality, where she leads the development of guidance documents and responses to citizen petitions regarding drug product quality and manufacturing across the product lifecycle. She has two decades of FDA policy experience in trade associations, regulated industry, and on Capitol Hill. Amy earned her Ph.D. in Biochemistry from The Scripps Research Institute in La Jolla, California, and received her undergraduate degree in Biology from McGill University in Montréal, Canada.

Mark Newton is a Pharmaceutical Quality professional with 37 years of experience in data integrity, LIMS, validation of computer systems, analytical systems, risk management, and quality systems, especially in the regulated laboratory space. He held roles in QC Labs, Computer Systems QA, Laboratory Informatics and QA during his 34-year tenure at Eli Lilly and Company. As an independent consultant since retiring from Lilly in 2018, He has helped firms with forensic data reviews, good documentation practices, risk evaluation, flowcharting processes to identify data integrity gaps and improving quality systems.

Mark been actively involved in ISPE/GAMP publications for a decade, having contributed to the GAMP Good Practice Guide for Computerized Laboratory Systems (2012), Records and Data Integrity Guide (2017) and Data Integrity-Key Concepts Good Practice Guide (2018). He has also co-written articles with Robert McDowall on data integrity topics that have appeared in LC/GC Magazine.

Anne V. Renton is a Research Scientist in the Technical Service Manufacturing Science Organization at Eli Lilly and Company.  She previously worked in Quality Assurance and has been at Eli Lilly since 2002. She had over fifteen years’ experience in quality and manufacturing prior to joining Lilly. Her experience includes; quality risk management, six sigma initiatives, implementing lean manufacturing, optimizing manufacturing processes and quality system implementation.  Anne holds a Bachelor of Science degree from Indiana University and an M.B.A. from Indiana Wesleyan University.

Carmelo Rosa has a B.S., M.S., Psy.D. He started with the FDA in May 1990 as an Investigator for the Los Angeles District. Dr. Rosa later transferred to the San Juan District, where for 13 years he served as a pharmaceutical drug Investigator and 6 years as a Compliance Officer. He is member of the foreign drug inspection cadre. He has conducted many inspections of complex pharmaceutical inspections and other commodities regulated by the FDA that have resulted in significant regulatory actions initiated by the FDA. In August 2008 relocated to Maryland to work for CDER as Compliance Officer. In 2009 he was promoted to Team Leader at CDER/DMPQ/OC/ICB, and then to Branch Chief for the International Compliance Branch. He currently serves as the Director for the Division of International Drug Quality I. Dr. Rosa is one of the FDA officials responsible for the review of non-compliant inspections (domestic and foreign), and is involved in FDA’s decision to initiate an enforcement action against pharmaceutical manufacturing and testing facilities that fail to comply with CGMPs. Dr. Rosa has served as an invited Professor at the University of Puerto Rico, School of Law, where he teaches a course on Federal Regulations Enforced by FDA and a General Overview to the FD&C Act. He works very closely with International Regulatory Authorities in different collaboration initiatives. Dr. Rosa is the former Chair for the PIC/S API Expert Circle.

Karen Takahashi is a Senior Policy Advisor at FDA in CDER’s Office of Pharmaceutical Quality in the Office of Policy for Pharmaceutical Quality.  Karen is a co-author of the guidance for industry "Data Integrity and Compliance With Drug CGMP."  Prior to 2015, she spent fifteen years as a Senior Policy Advisor and Compliance Officer in CDER’s Office of Manufacturing and Product Quality.  At the beginning of her career, Karen was an Investigator with FDA’s New England District Office.  She holds a Master of Science degree from Boston University and a Bachelor of Science degree from the University of Wisconsin-Madison.