Paula R. Katz, J.D., is Director of Manufacturing Quality Guidance and Policy in CDER’s Office of Compliance. She leads an interdisciplinary staff of senior compliance officers and technical experts who focus on CGMP enforcement and drug quality policy issues. Ms. Katz frequently advises Center and Agency leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and enforcement strategy. Ms. Katz has chaired Agency working groups and directed the development of guidance for industry, regulations and legislation; managed responses to Congressional oversight and other stakeholder inquiries; and conducted domestic and international inspections, case evaluations, and enforcement actions. She is a frequent presenter at industry and agency meetings, conferences and training events. Prior to joining the FDA in 2009, Ms. Katz was a litigation associate at a large law firm in Washington, D.C., where her practice included regulatory compliance, white collar crime and general commercial litigation. Ms. Katz is a graduate of the University of Virginia and the University of Virginia School of Law.
Lisa Alexander is the Vice President of Quality and Regulatory for Brammer Bio, a cell and gene therapy CDMO with operations in Florida and Massachusetts. She is excited about her role in driving Brammer’s mission to enable clients to improve patients’ health by providing process development, clinical and commercial manufacturing services.
Lisa has more than 25 years of experience in the biotechnology field, supporting the development of novel biologics and diagnostics products from research through to commercialization in the U.S. and European markets, with leadership roles at organizations such as SeraCare Life Sciences, Xcellerex, Millipore Corporation and Amgen. Her early career began in the laboratory and included quality and operational roles at GTC Biotherapeutics, Q-One Biotech and Marathon Biopharmaceuticals. Lisa has a B.S. in bio-psychology from Tufts University, an M.S. in occupational and environmental health and safety from Anna Maria College, and an MBA from Northeastern University. She is committed to the personal and professional development of others, particularly women in the workplace.
Khandan Baradaran, Ph.D., is Vice President and Head of Quality at Dimension Therapeutics. Dr. Baradaran has extensive expertise in the areas of viral safety, gene therapy vector development, vaccine development and assay technologies. She has held positions of increasing responsibility in regulatory affairs, quality control and quality assurance, most recently as Vice President and Head of Regulatory Affairs and Quality Assurance at Dimension. Prior to joining Dimension Dr. Baradaran was responsible for early and late stage rare disease development programs utilizing novel medical device and gene therapy approaches at Shire Pharmaceuticals. Before joining Shire Dr. Baradaran was at Biogen, where she was Global Regulatory Lead for AVONEX®, an MS drug that is marketed in more than 100 countries. Prior to Biogen, Dr. Baradaran played significant roles in the submission and approval of KALBITOR® and FLUCELVAX®, as well as several clinical dossiers at Dyax Corp. and Novartis Vaccines and Diagnostics. Dr. Baradaran received her B.A. degree in molecular biology from Wellesley College and her Ph.D. in virology from Harvard University.
Robert W. Beall, PMP, AD, ProPharma Group has 30 years of industry experience working with products in both the consumer goods and pharmaceutical arenas. He has led international product transfers utilizing both internal company transfers and CMOs at Boehringer Ingelheim, Biogen and Bayer HealthCare LLC. Robert developed a technology transfer process for implementation and monitoring the program. He is currently leading creation of ISPE’s Process Validation Good Practice Guide. He is a graduate of the Rochester Institute of Technology (RIT) with a B.S. in engineering and has completed advanced degree studies at Syracuse University, University of Michigan and The Ohio State University, as well as completing his PMP certification. He is an international speaker/author for multiple industry forums.
Scott is currently Director of Chemistry for Stealth Biotherapeutics in Newton, MA. In his current role he is responsible for outsourcing and management of all aspects of API to support the non-clinical and clinical programs at Stealth.
Scott has over 19 years of experience in the pharmaceutical industry, working previously for Alkermes in Waltham, MA; two large Pharma companies – Wyeth & J&J; two CROs – Cambridge Major Labs & SAFC Pharma; and a small molecule HPAPI CRO – Tetrionics. Working with small molecules, including opiate alkaloids and peptides, he has filled a variety of roles across process development, project management, process safety, process improvement/excellence, experimental design, research/manufacturing, due diligence, auditing and contract management.
Scott has a Ph.D. in organic chemistry from UW-Madison under Prof. Edwin Vedejs.
Amnon is Senior Director QA at Genzyme’s Allston Landing Facility in Boston. His prior work includes ARIAD Pharmaceuticals, Eli Lilly & Co, Amgen, ImmuLogic, Cellcor Therapies and Massachusetts General Hospital. Amnon has more than 25 years of R&D and biopharma experience, including the complete life cycle of biotech/small molecule drug development from discovery through process/method development, facility construction/validation, GCP quality, QA systems and operations, product commercialization, and post-launch disposition and compliance. Amnon is experienced in the due diligence, qualification and QA oversight of contract manufacturing and distribution organizations and contract labs across the US, Europe and Asia/Pacific.
Amnon collaborated closely with global SMEs from the FDA, EMA, biopharma companies, consultants and academia in developing the PDA Technical Report: TR No. 56: Application of Phase-Appropriate Quality Systems and GMP to the Development of Therapeutic Protein Drug Substance. He is co-author of PDA Technical Report 65: Technology Transfer. He has delivered training and seminars at PDA and ISPE venues as well as in the academic setting.
Amnon has a B.S. in biology from the University of Massachusetts and a Master’s degree in biology from Harvard – Extension.
Dale Herbranson earned his Ph.D. in analytical chemistry from Kansas State University. He has spent 17 years in analytical, formulation development, product transfer and quality roles in the direct pharmaceutical industry with experience in small and large volume parenterals, tablets, capsules, transdermal patches, nasal sprays, and controlled substances. Dale has worked at West for more than 16 years in various roles including drug delivery development (nasal sprays, targeted release capsules supporting IND, ANDA, analytical, clinical and regulatory), Vice President of Quality Assurance, and most recently as the Vice President of Quality and Regulatory for the Tech Group (contract manufacturing part of West) supporting medical device components and assemblies, drug-device final packaging and labeling, and various other food and beverage packaging components.
Heidi Hoffmann, Senior Director, Manufacturing at Sutro Biopharma, has 22 years of experience in biotechnology, specializing in process development, technology transfer, and the manufacturing of vaccines and biological therapeutics. Directly after receiving her Ph.D. from the University of California, Berkeley in 1994, Dr. Hoffmann began her career at Aviron, where she worked on process development and the production of vaccines for EBV, PIV and influenza (FluMist?). She then joined Valentis, where she led the team responsible for process development, technology transfer and clinical production of plasmid DNA for gene therapy. In 2002, Dr. Hoffmann returned to vaccine work by joining VaxGen, where she was responsible for process development and manufacturing of anthrax vaccine. Later, she transitioned into a technology transfer role, hiring and leading the VaxGen oversight team for the successful transfer of production of Bristol-Meyer Squibb’s Orencia? (abatacept) into the Celltrion manufacturing facility in South Korea. After the completion of that project, Dr. Hoffmann joined non-profit Global Solutions for Infectious Diseases (GSID) as Project Director responsible for coordinating the outsourcing of process development and the manufacture of HIV vaccines. Dr. Hoffmann joined Sutro in February 2011 to direct scale-up and cGMP manufacturing of protein therapeutics using Sutro’s proprietary cell-free protein expression system.
Todd Mabe is the Head of Commercial Biologic Drug Substance for External Quality where he leads seven teams of 18 professionals (site managers, batch record reviewers and translation services) who oversee the quality of product manufactured at seven CMOs for Genentech/Roche. He is involved in the CMO lifecycle for selection, implementation, management and decommissioning. His team ensures that quality expectations are met for deviation management, change management, lot release, CAPA, APR, risk management, regulatory filings and inspections. In addition he provides management oversight for product transfers of commercial drug substance to CMOs.
Prior to his new assignment, he was the Principal Technical Manager of Validations for two new Roche bulk API (E-coli and CHO) facilities in Singapore. He was the Quality Lead for Quality, Engineering & Validation efforts. These include commissioning, computer systems, utilities, facilities, equipment, QC methods, technology transfers, cleaning and process validation. He supported all regulatory expectations for licensure. Additionally, he managed the Singapore Risk Management activities.
He was a Validation Quality Manager in Corporate Quality Systems & Support for Genentech supporting the development and establishment of validation policies/standards and quality system process improvements. He revised the Genentech validation quality policy. He has been involved in process validation efforts (licensure of Lucentis and Rituxan v1.2), quality policy revisions and quality approval of Genentech validation documents.
His past experiences in the biotech and pharmaceutical industries include QC release testing and quality management. He has been a validation manager and a quality consultant for multinational companies. He has experience in establishing and maintaining quality systems for validation, document management, change control, discrepancy management, training, validation document strategic development, execution and approval; analytical method validation; and the engineering of pharma and biotech facilities. His efforts helped Roche receive the 2010 “Facility of the Year Award” in Singapore.
Isabel Molina is a Quality and Validation professional with more than 20 years of experience working in the biotech industry on an international scale. Having worked at pharmaceutical companies with varied business models, growth conditions and corporate cultures, such as Bayer Healthcare, Novartis and Chiron, she now holds a position at Genentech/Roche in External Quality. At Genentech/Roche, she supports global Contract Manufacturing Operations with a focus on the implementation of Pharmaceutical Quality Systems (PQS) and Quality Risk Management (QRM). Ms. Molina received her degree in biology from U.C. Berkeley and is a member of the Parenteral Drug Association (PDA).
Susan Qu, Ph.D., MBA, is currently the Integrated Risk Manager for External Manufacturing, Sanofi Biologics. Susan has 15 years of experience working in the biopharmaceutical industry. She earned her Ph.D. in Biomolecular Analytical Chemistry from Emory University and started her career as a research scientist responsible for macromolecule characterization method development and biopharmaceutics preformulation study. Her career transitioned to project management for establishing effective quality management systems after she earned her MBA from Babson College. In her current role, Susan is working transversally with different functional groups within Sanofi to establish an integrated risk management program to holistically review the CMO risks from critical perspectives such as quality, business continuity, supply chain, finance, contract, regulatory, technology, etc. The program helps to identify risks for escalation and communication, promote internal cross-functional collaboration, and prioritize mitigation activities.
Brid Rooney, BSc, MPhil, is Head of External Manufacturing Quality Assurance for Biologics at Sanofi. She has 23 years of experience in biopharmaceutical operations, including roles in manufacturing, technical support and quality assurance. In her current position she leads a team responsible for compliance oversight of Sanofi products manufactured, tested and/or distributed by CMOs and business partners located in the USA and Europe. She has experience in establishing effective quality management systems and in maintaining successful partnerships throughout the product life cycle. Current initiatives include deployment of an integrated risk management program involving the identification of potential hazards or risks, analysis and evaluation of risks, risk control, risk review, and communication to relevant stakeholders.
Stan Russell is currently Head of Quality – Due Diligence, Partnerships and Integration at Shire. He started his career at Abbott Laboratories in 1989 after receiving his B.S. in chemical engineering from Northwestern University. With Abbott, Stan progressed through product/process development and project management roles, implementing novel manufacturing and business processes in synthetic and biologic pharmaceuticals, nutritionals, and diagnostics. In 2001, Stan joined the consulting firm Automated Systems, Incorporated (ASI). In nine years at ASI, he drove the expansion of engineering and quality systems solutions into new markets and progressed from an individual consulting position to a role on the Senior Leadership Team. Stan transitioned to Baxter Healthcare in 2010 and led global quality operations and programs in the IV solutions arena. In 2014, he moved to Baxter BioScience (subsequently Baxalta, now part of Shire) to lead the quality team responsible for the development and commercialization of in-licensed products in the oncology and immunology franchises. Outside the office, Stan enjoys family-focused activities with his wife, son (20) and daughter (18); as well as volunteering, including a medical mission trip to Ecuador in 2014 with his wife and several friends.
Adnan Sabir is currently employed by Kowa Pharmaceuticals of America, a subsidiary of a Japanese company, leading QA/CMC activities. Previously he was a Principal Consultant and Founder of “Pharma Consulting Services, Inc. (PCS),” where he provided solutions for regulatory issues, the implementation of QbD/PAT, and the risk-based development of products to big and small pharma companies globally. He has more than 30 years of hands-on and management experience and a proven track record for formulation and process development and technology transfer working in brand and generic industries such as GSK, Solvay, Actavis and UCB. He also served as a Vice President of R&D at Dr. Reddy’s Lab for three years in 2009 establishing product development optimization. He has significant knowledge in CMC, cGMP, 21 CFR Part 11 and ICH Guidelines, Serialization, and FDA regulations. He is a frequent speaker at various meetings in the United States and other countries globally.
Eric Smart is the Senior Advisor, Aseptic Manufacturing at Singota Solutions and President of Fountainhead Pharmaceutical Consulting. Prior to his current roles, he was President of Piramal Pharma Solutions’ aseptic manufacturing business based in Lexington, Kentucky. Eric earned his B.S. in chemistry from Vanderbilt University and an MBA from the University of Maryland. After serving eight years as an officer in the United States Navy, he began a career that has spanned 24 years in the pharmaceutical contract manufacturing industry. Eric’s experience includes leadership roles in sales and marketing, operations, laboratory services, and executive management at a number of contract development/manufacturing companies, including roles at Albemarle, AlliedSignal/Honeywell, Organichem, AMRI and Coldstream Laboratories/Piramal Pharma Solution. He has significant experience in the mergers and acquisitions of pharmaceutical manufacturing operations in the US, Europe and Asia. Mr. Smart has played key roles in a number of CDMO startups and has experience in the design and qualification of both API and sterile drug product manufacturing facilities. He also led the project management functions in both drug substance and drug product manufacturing companies.
Following the successful sale of Coldstream Laboratories to Piramal Pharma Solutions, Eric established Fountainhead Pharmaceutical Consulting, which provides services to a wide variety of pharmaceutical, biotechnology and CMO companies in the areas of manufacturing operations, project management, vendor selection and due diligence. Most recently, Eric accepted a position with Singota Solutions as an advisor as they install and qualify a state-of-the-art automated sterile fill operation. Eric and his wife live in the Rocky Mountains of northwest Montana.
Dan Trimberger has been with Momenta Pharmaceuticals since December 2005. Dan is responsible for quality assurance and compliance activities. Prior to joining Momenta Pharmaceuticals, Dan was Senior Manager at Osicient Pharmaceuticals where he was responsible for developing the quality systems for a startup company. Dan has had various roles in compliance, auditing and validation. Dan has a B.S. in chemical engineering from Clarkson University.
Eva M. Urban, Senior Manager for Celgene Corporation, Global Quality Risk Management, has 24 years of experience in biotech/biopharmaceutical custom manufacturing organization (CMO) services and in the biopharmaceutical industry.
She was working in R&D, manufacturing, quality assurance/compliance and the quality systems area. During this time some key activities and achievements are as follows: She was the lead of cross-functional teams for biotechnological API (active pharmaceutical ingredient) tech transfer, process qualification, scale up, and process validation and production (biotechnological and chemical synthetic steps), and was responsible for the first commercial cGMP API production campaign in the biotech plant. For the new biopharmaceutical production plants, she was responsible for strategy and the establishment of quality systems as cleaning/cleaning validation, clean utilities/environmental monitoring and for the site internal quality audit program based on risk-based approaches. Primary focus areas were also host health authority inspections and project evaluation, and she was lead auditor for internal and external audits.
In 2011, Eva joined Celgene, working for CMO quality oversight of sterile lyophilized drug product. Currently her passion is establishing a Global Center of Excellence Risk Management by leading and supporting several cross-functional initiatives and corresponding teams, and implementing efficient and harmonized risk-based approaches.
Eva has a MSc. in biology (biotechnology) from University Kaiserslautern (Prof. Dr. T. Anke), Germany.