Check out this year’s line-up of engaging and inspiring industry and regulatory speakers.
Aaron R. Goerke has over 18 years of industry experience in supporting pharmaceutical and biotechnology companies in the areas of process development, manufacturing and quality systems. In his various roles, he has been responsible for developmental projects ranging from discovery to Phase III and supporting internal and external Biologics and Vaccine manufacture. Aaron’s recent roles include Head of Global Engagement and Deployment at Hoffmann-La Roche and as Head of Downstream Global MSAT at Genentech, which included responsibility for CMO technology transfers ensuing supply agility, maintaining Make-Assess-Release efforts ensuring supply to patients, and ownership of various network strategic initiatives. Efforts include serving as the Head of the Roche Process & Product monitoring program, establishing a Global Performance Analysis program spanning Large and Small Molecules and conceptualizing an IT solution in the age of “big data.” Aaron is currently Director of MSAT at Hoffmann-La Roche in Singapore. He holds a Ph.D. in Chemical Engineering from Stanford University and has published a large number of peer-reviewed journal articles and patents, had numerous external presentations and has been presented a number of academic and professional awards.
Melissa Seymour is the Vice President of Global Quality Control for Biogen, Inc., assuming responsibility for the comprehensive strategy and implementation for Global QC testing of Raw Materials, Drug Substance, Drug Product and Finished Goods worldwide. Prior to this, Melissa served as the Vice President of Corporate Quality with responsibility for global compliance and quality systems including management of Quality Systems, Internal and External Auditing and Global Affiliate GMP oversight. Melissa holds BS degrees in both Biological Sciences and Biochemistry from North Carolina State University and an executive MBA from Duke University. Melissa has over 20 years of experience in the quality arena including quality positions at Novo Nordisk pharmaceuticals and Glaxo Smith Kline. Melissa has been highly active in the Southeast chapter of PDA for the last 5 years as a member of the local board, serving as Vice-President, President, and most recently, Past President. She was recently elected to the Board of Directors for PDA. Melissa is an ASQ Certified Quality Engineer, Certified Quality Auditor and Certified Quality Manager and has previously served on the Board of Directors for the Rx-360 Consortium focused on supply chain security.
Candis Morrison is a Senior Clinical Analyst at the Food and Drug Administration in Silver Spring Maryland. Her work includes clinical reviews of; applications for New Drug Approvals, Investigational New Drug trials, as well as new indication supplements for the Division of Hematologic /Oncology Products 2.
Candis earned a Master’s degree in administration and psychiatric nursing. Her doctoral studies focused on stress and psychoneuroimmunology, and she earned her PhD in Health Education. She developed programs for, and taught nurse practitioner students, at the Johns Hopkins University School of Nursing while practicing in the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and the Johns Hopkins Bayview campus.
She has practiced in the areas of hematology and hematologic malignancies for more than twenty years, working with teams in which she contributed to protocols, worked with sponsors, and authored publications. She continues to practice in the Division of Lymphoid Malignancies at the National Cancer Institute where she is part of a multidisciplinary team caring for multiple myeloma patients on clinical trials.
When not working, Candis enjoys skiing, spending time with her five sons, and volunteering with animal rescue organizations in, and around, Washington, DC.
Arne has 20 years of experience in the Pharmaceutical Industry. He has worked in Analytical Development, Chemical Development, Pharmaceutical Development, Manufacturing Operational Excellence and Manufacturing Science and Technology.
In Novartis, he is the global program lead for ‘Predictive Processing’ and for Continued Process Verification. He serves as the lead author for the corporate quality standards for process validation and for CPV. Over the last years, he was instrumental in building the Manufacturing Science and Technology organization.
In PDA, he is engaged in the interest groups for CPV and Manufacturing Intelligence.
Arne holds a Ph.D. in Analytical Chemistry and a Master in Chemistry. He is also a Agile/ Scrum master and certified Kepner Tregoe trainer for situation, decision and problem analysis.
Mr. Caudle is Associate Director of Emerging BioPharma R&D Solutions at IQVIA, the Human Data Science Company™ that mobilizes unparalleled data, analytics, technology, and expertise through solutions connecting stakeholders to improve health. He has business experience across pharmaceuticals, biotech, and medical devices helping clients to proactively interpret regulations, understand processes and product technologies, make sound decisions, facilitate change, and drive business benefit. He assists Emerging BioPharma companies plan and implement highly targeted, data-driven clinical trials to advance an asset from first-in-man through global Phase III studies. Mr. Caudle currently serves as President-Elect on the Board of Directors for the Parenteral Drug Association in the Southeast U.S. and on several conference planning committees. He holds an MS in Food Science and a BS in Nutrition Science from Auburn University.
Dr. Kelly Waldron is currently a senior consultant with ValSource and a member of the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (formerly Dublin Institute of Technology) in Dublin, Ireland. She has particular expertise and a specialized focus on the development and implementation of innovative approaches to quality risk management (QRM) and has authored numerous industry and academic papers on the topic. Dr. Waldron’s expertise extends to various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality system design, quality strategy and planning, deviations/investigations, CAPA, change management, data integrity, audit and inspection programs and response, and design control. She holds a BA in biology from Boston University, an MBA in pharmaceutical management from Fairleigh Dickinson University, and a Ph.D. in pharmaceutical regulatory science (thesis in QRM) from the Dublin Institute of Technology. She currently resides in New Jersey, USA and can be reached at [email protected]
Morten Munk’s career is comprised of more than 30 years of experience within the global biopharmaceutical industry.
One common denominator for his approach is to have a holistic and a broad perspective on all aspects and steps in production of biopharmaceuticals. He believes; collaboration, knowledge sharing, and optimal use of all relevant technologies are the key factors in ensuring availability of the best product for the patient.
Morten joined Fujifilm as Director, Global Alliance Management in 2020. In 2001 he was one of the co-founders of CMC Biologics (now AGC Biologics), after working 14 years at Novo Nordisk.
Furthermore, Morten has authored or contributed to several technical articles and guidelines. He is frequently invited to give scientific and technical presentations at international conferences. Additionally, he is active in the biopharmaceutical community as member of scientific committees for various international conferences as well as volunteer in international industry organizations such as PDA, ISPE and BPOG.
Ghada Haddad is currently an Executive Director, leading the Global cGMP and Compliance Auditing Organization at Merck & Company. Prior to that she was the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree and a PhD and an MBA with over 22 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation. Haddad was the chair of the Paradigm Change in Manufacturing (PCMO) initiative: QRM in Packaging and Labeling, QRM for the Design, Qualification, and Operation of Manufacturing Systems task forces, co-chaired the Aging Facilities Points to Consider and co-chaired the 2018 and 2019 Annual PDA Conferences and the 2019 PDA Quality Week. She is also a faculty member for PDA’s Training and Research Institute and a Science Advisory Board member and a member of the PDA Board of Directors.
Mr. Zurbriggen has over 20 years of analytical lab experience, 10 of which focused on inorganic trace level analysis. As Technical Account Manager within the Technical Customer Support group of West, the focus of his role is to provide technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. He serves as the West subject matter expert on Extractables & Leachables, including elemental impurities.
Prior to this role, he was Supervisor of the Leachables/Stability group in the Analytical Labs division of West Pharmaceutical Services, Inc., the focus of his role was to develop and validate leachables methods. Mr. Zurbriggen holds a Bachelor of Science/Chemistry degree from the Gewerbliche Berufsschule Visp – Visp, Valais, Switzerland.
John Khoury is a 20+ year veteran and leader in the biotech / pharmaceutical industry. As a member of the Project Farma Leadership Committee, John has spearheaded Project Farma’s growth in the gene and cell therapy space. He has led and provided strategy on key partner initiatives including make vs. buy analysis, site and vendor selection, tech transfer execution strategies, and facility start-ups.<br>In addition to his experience in advanced therapies, John has extensive experience with small and large molecules including biologics and biosimilars. Over the past four years, he has led facility builds totaling over $500MM. During this time, he has worked with small and large biotech and pharmaceutical companies including gene and cell therapy startups and CMOs/CROs.
Tony Khoury is a 15+ year veteran and leader in the biotech / pharmaceutical industry. As a member of the PF leadership committee, Tony has spearheaded Project Farma’s growth in the gene and cell therapy space. Tony has extensive experience with small and large molecules including biologics, biosimilars, and gene and cell therapies. He has worked with small and large biotech and pharmaceutical companies including gene and cell therapy startups and CMOs/CROs. He has led global programs greater than $350+ million in the following disciplines: project management, turnkey facility builds, automation, validation, engineering and serialization track and trace.
Ms. Duffy has been with Merck since 1988, her entire career in the vaccine manufacturing field. Kim's first position was as a technician in viral vaccine manufacturing and she has held positions in Quality Control, Laboratory Operations, Vaccine Manufacturing, and Regulatory Affairs. Kim joined the Regulatory CMC group in 2007 and has managed global registrations and post-approval changes for a variety of vaccines; specializing in US, Europe, Japan, and China.
Chris Smalley has recently retired from Merck, where he had responsibility for innovative implementation and validation, including Single Use Systems globally. He now is a consultant for Valsource, focused primarily on Compounding Pharmacies. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier he had worked for the Johnson & Johnson family of companies, where he was a Plant Manager.
Chris retired after 21 years of service as a LtCol in the U.S. Air Force. Chris practiced as a compounding pharmacist across the military hospital system, compounding intravenous solutions and total parenteral nutrition products to meet physicians' orders. Chris is a graduate of the Philadelphia College of Pharmacy. His graduate education includes a MBA from Temple University Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from Temple University School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University.
Chris has been a member of the PDA Board of Directors, as well as a member of the PDA Science Advisory Board.