Check out this year’s line-up of engaging and inspiring industry and regulatory speakers.
Aaron R. Goerke has over 15 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 Roche Singapore Technical Operations. 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.
Kathy joined Amgen in 2002 and is the Executive Director of Site Quality. Kathy was born in Providence, RI. She attended high school in nearby Cranston and attended Dickinson College in Carlisle, PA where she studied physics and mathematics and played on the volleyball team. Upon graduation, she attended the University of RI for graduate physics courses. She started her career as a GC/MS analyst for an environmental laboratory in Syracuse, NY. In 1992, Kathy began a ten year career in various roles in the laboratory and validation departments at Merck Pharmaceuticals in West Point, PA prior to coming to Amgen.
Kathy’s roles at Amgen have included computer validation, Lab QA, CMQA Disposition, AR5 Production, QC, Quality Operations and her current role as Executive Director of Site Quality. Kathy lives in Cranston, RI. Her only daughter Karen is a junior at Stonehill College in Easton, MA.
Renee Morley is a Senior Technical Services Specialist for Contec, Inc. providing expertise and evaluation regarding industry best-practices and technical applications of disinfectants solutions, wipers, and mops for use in cleanroom and other controlled environments. She has over fourteen years of experience leading training on contamination control in cleanrooms and providing technical support related to critical environments, process research cleaners, and cleaning validation. Ms. Morley is a valuable resource in the areas of site evaluations, training and technical presentations, and educational seminars.
Ms. Morley was President of the Parenteral Drug Association’s Southeast Chapter (PDASE) from 2016-2019 and held other various positions within the organization including the Networking Chair. In 2018, Renee was the PDA Volunteer Spotlight which PDA awards to active volunteers in the organization. Renee received an MBA from Lake Erie College in Painesville, Ohio, and a BA in Marketing from Ohio University in Athens, Ohio.
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.
Mayda Mercado is a Biopharmaceutical and Cell & Gene Therapy Quality (GxP) Executive with over 28+ years of experience. She started at Smith-Kline Beecham-Clinical Reference Laboratories working in the areas Microbiology, Hematology , Immunology and Management. Then worked for Johnson & Johnson (Ortho Biologics, Centocor, and Jansen) in various leadership and managerial roles in management of QC Laboratories, Compliance, and Supply Chain. Then, she moved to Pfizer (Wyeth) to manage Biologics Quality Product Leaders, and Site Parenteral Quality Site Head. These experiences increased her knowledge of Global Regulatory Requirements and Operational Excellence transformation. She then moved to Merck to lead the Global Biologics Quality Network of sites where she managed commercialization and approval of key Biologics. Then she moved to start up facilities with a focus on Biosimilars; TPI & PFENex to lead and build the Quality Organization and CMC-Regulatory. She then joined Kite, a Gilead Company as an ED, Quality Site Head, and most recently advanced to a corporate role as Executive Director, Global Quality and Compliance in Santa Monica, California.
Mayda earned a Masters in Business Administration from University of Phoenix, a Bachelor in Medical Technology from University of Kentucky and a Bachelor in Biology from Interamerican University
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.
Brian is the Director of Manufacturing at the Kite Cell Therapy Manufacturing Facility in Frederick, MD. Prior to Kite, he accumulated 20 years of experience in the biotechnology field including positions at Eli Lilly, MedImmune/AstraZeneca, and Lonza in roles including process development, clinical and commercial manufacturing, and Manufacturing Sciences & Technology. Brian has degrees from Indiana University, Purdue University, and Johns Hopkins University, and lives in Maryland with his wife and three daughters.
Jim Watson has 25+ years of experience in the pharmaceutical industry. He is a Senior Director at Project Farma, has led development of Project Farma’s presence in the East Coast and been a leader on its cell and gene therapy task force. He started his career designing, building, and starting up membrane plants, to eventually managing large scale capital projects and leading engineering, maintenance, capital projects and EHS disciplines at a leading CMO. Jim has extensive experience in high purity utilities, large molecule biological processes and advanced therapies. He has worked for small and established pharmaceutical and biotech organizations launching early phase manufacturing strategy, conceptual design, user requirement specifications, verification, validation, facility turnover and facility operations. Jim graduated with a BS in Chemical Engineering from Worcester Polytechnic Institute and is completing an MBA through the University of Central Oklahoma.
Elliot Norry has served as Adaptimmune’s Senior Vice President and Chief Medical Officer (CMO) since January 2020 and was acting CMO since August 2019. Previously, Dr. Norry was Vice President and Head of Clinical Safety and Pharmacovigilance, and leader of Adaptimmune’s ADP-A2AFP program, having joined the company in July 2015.
Prior to joining Adaptimmune, Dr. Norry served as Safety Development Leader at GSK from 2009, where he managed clinical safety for a broad range of early and late stage products, including approval activities for pazopanib for the treatment of soft tissue sarcoma. He was also Chair of GSK’s Hepatic Safety Panel.
Prior to his roles in the biotech and pharmaceutical industry, Dr. Norry practiced adult internal medicine at Abington Memorial Hospital in Abington, Pennsylvania for 13 years. He holds a B.A. from Columbia College and an M.D. from New York University. He performed his residency in Internal Medicine at Temple University Hospital in Philadelphia and his fellowship in gastroenterology at Thomas Jefferson University Hospital in Philadelphia.
Patrick has over 20 years of experience in the Life Science industry working with biopharmaceutical and medical device companies across North and South America, Europe and Asia via software organizations and 9+ years with the engineering and consulting subsidiary of Novo Nordisk. During his time with Novo Nordisk, the company received the ISPE “Facility of the Year” for establishing qualified production in less than 12 months. Patrick has led sales and marketing teams in North America and Europe and has worked with biopharmaceutical customers to address drug serialization requirements. In his current role, Patrick is part of the Healthcare & Life Sciences industry vertical at Amazon Web Services (AWS) and is the WW Lead for Life Science industry programs.
Patrick received his B.A. from the University of North Carolina-Chapel Hil and live in Wilmington, NC.
Fausto is AI manager at GSK responsible for Digital Innovation projects and has a double PhD (Information Technology and Computer Science). He gained his second master’s and PhD while he was a Teaching Assistant at the University of California – Irvine. Fausto worked in multi-disciplinary teams and he has over 20 years of experience in academia and industry. As a software engineer, HPC and AI/ML expert, Fausto has a strong understanding of full hardware and software stacks and has worked on key projects at European and American government institutions and with key individuals like the Nobel Prize winner Michael J. Prather. After his time at NVIDIA Corporation in Silicon Valley, Fausto worked at the IBM T J Watson Center in New York before moving to the GSK Tech Digital innovation Lab in Stevenage where he is heading a team of experts. He and his team are leveraging AI, ML and Cognitive Computing to enhance the value of products to patients while also increasing GSK manufacturing productivity.
Marisa Joubert is a Senior Principal Scientist and Group Leader of the Attribute Impact Group in the department of Process Development at Amgen Inc (Thousand Oaks, CA). She has been at Amgen since 2008 as a pharmaceutical scientist in drug product development. Her group evaluates the impact of biotherapeutic attributes on the safety and efficacy of drug products. She is also the team lead of a multi-department cross-functional working group that assesses the risk of immunogenicity of key product quality attributes. She has received several awards for this work including the 2019 Innovation Award and the 2018 Excellence in Operations Award from Amgen, and the 2015 Ebert Prize from the American Pharmacists Association. Prior to joining Amgen, she was a Senior Researcher at the Council for Scientific and Industrial Research in Pretoria, South Africa, where she evaluated novel therapeutic agents for treating HIV-1. She received her PhD in 2006 from the University of California, Los Angeles, in Biochemistry and Molecular Biology.
Dr. Kaschif Ahmed has a Ph.D. in Chemical Engineering specializing in Advanced Process Control from the Illinois Institute of Technology. Kaschif has experience in modeling, optimizing, and controlling different systems such as fuel cell cars, coal gasifier, hybrid electric cars, bioreactors, and chromatography. Kaschif is currently an APC engineer in the Advanced Data Analytics group in Biogen developing models and advanced controls for biologics upstream and downstream.
Kate Hebert is a Senior Quality Assurance Training Specialist at Regeneron Pharmaceuticals, Inc. She earned a master’s degree in Curriculum Development and Instructional Technology from University at Albany, in Albany, New York. Her research interests include instructional design, curriculum design, and emerging technologies.
Cori Sandy is the Associate Director of Quality Systems at AveXis, a Novartis company, responsible for developing core quality systems for a new North Carolina gene therapy manufacturing facility. Prior to this, she was in a Corporate Quality role responsible for management of the quality management system (QMS) and development of a quality risk management (QRM) program. Cori has over 20 years industry experience in quality roles at Glaxo, Novo Nordisk, Biogen and AveXis. Experiences include quality remediation, aseptic processing, QC Chemistry, labelling/packaging, regulatory intelligence, QMS, QRM, data integrity, deviation and CAPA management, change management, and auditing. She is a Certified Quality Auditor (CQA), holds a BS degree in Business Administration and is currently attending NC State University for her MBA. Cori is a North Carolina native and lives with her family in nearby Apex, NC.
Ashley Giambrone is a Associate Manager in Continuous Improvement - Statistics at Regeneron Pharmaceuticals, Inc. She was an Assistant Research Professor at Weill Cornel Medical College in New York City, New York. She earned a doctorate degree in Biostatistics from University at Albany, in Albany, New York. Her research interests include categorical data analysis, teaching, and training program management.
Kevin D. Wojtas leads the Global Quality, Regulatory Compliance group for Takeda which includes leadership of the GxP Data Integrity Program across all sites and functions. He has 25 years of success in the Pharmaceutical and Medical Device industry including positions in Manufacturing, QC, IT, Validation and Quality.
Kevin has a passion for collaborating with global teams, supporting individuals on their career journey and finding ways to help Takeda improve the lives of patients.
Tom Whitehead is co-founder of the Emily Whitehead Foundation, which raises funds and awareness for pediatric cancer immunotherapy research. Tom and his wife Kari founded the Emily Whitehead Foundation in honor of their daughter Emily who was diagnosed at age five with an aggressive form of leukemia that failed to respond to chemotherapy. As a last hope, Emily was enrolled in a clinical trial and became the first pediatric patient in the world to receive CAR-T cell therapy. The therapy worked and Emily is now more than 7 years cancer free.
Greg R. Gara has over 25 years of experience in the biotechnology field specializing in designing, constructing, and starting up large and small scale manufacturing facilities throughout the world. Greg recently joined Sarepta as the VP of Pharmaceutical Engineering. Prior to joining Sarepta, he designed, constructed, and started up the facility located in North Chicago for AveXis, a Novartis company, led the team for the facility expansion in North Carolina, in addition to renovating the recently acquired Colorado site. Greg and his team were responsible for the design, construction, startup, and commissioning of the new facilities being constructed in Research Triangle Park and Colorado. Prior to AveXis, he led the facilities and engineering organization at Hospira prior to the Pfizer acquisition. Before joining Hospira, Greg spent 15 years working for Amgen and was part of the Cork Ireland construction project.
Dr. Jose Soto is currently the Director for Data Compliance and Governance at GlaxoSmithKline where is responsible for leading the identification of global data integrity standards and solutions for the control GxP Data and Documentation in support of the Global Data Integrity Strategy. He has over 19 years of experience in the Pharmaceutical Industry in QA and QC operations. He holds a Ph.D. in Chemistry from Texas A & M University.
Crystal M. Booth, M.M., is a Regional Manager a PSC Biotech and has over 20 years of experience in pharmaceutical microbiology, environmental monitoring, and quality assurance. She obtained her master’s degree in microbiology from North Carolina State University. Crystal is a seasoned award winning technical writer and author of Method Development and Validation for the Pharmaceutical Microbiologist. During her career, Crystal has worked in microbiology, consulting, quality assurance, CDMOs, R&D, and quality control laboratories. Crystal has developed and validated numerous microbial methods and has worked with many different product types.
Marc Glogovsky, MS, S.M. (NRCM) has over 20 years’ experience in the pharmaceutical industry, specializing in aseptic operations, contamination control, and risk-based environmental monitoring. He has written a number of publications involving rapid microbiology, environmental monitoring, Mycoplasma and MALDI-TOF microbial identification. Currently, he is a Senior Microbiology Consultant with ValSource, Inc. Prior to joining ValSource, he was responsible for managing the Environmental Monitoring Control division at Veltek Associates, Inc., and more than 10 years as a senior microbiology specialist at Merck KGaA. Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.
Marc is actively involved with Parenteral Drug Association, where he serves on PDA’s Science Advisory Board, Education Advisory Board, chairs the Microbiology/EM Interest Group, is a faculty member at PDA-TRI and has contributed to a number of technical report committees and is currently co-chairing the Microbial Data Deviation technical report and a revision of the Environmental Monitoring (TR-13) technical teport.
Amanda McFarland is a Senior Consultant for ValSource and in this role assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate a global risk management program by developing the procedures required and training the organization in the execution of consistent risk management tools.
Ms. McFarland currently serves as the PDA QRM interest group co-lead, the PDA SE chapter Secretary and is a faculty member of the Quality Risk Management Certificate Training Series at PDA training institute.
Jane Halpern, Ph.D. is an independent consultant for the biologic and biotechnology industries, specializing in regulatory strategy and CMC guidance.
Dr. Halpern has over 25 years of experience in biologics development and has held positions in government as well as both small and large biotech companies. She worked at the FDA, Center for Biologics Evaluation and Research (CBER) as a researcher/reviewer for 10 years where she reviewed applications for both investigational and commercial products. At CBER she participated in inspections and the development and implementation of regulations, policies, and guidance documents.
Dr. Halpern has held senior management positions at ID Biomedical Corporation, GSK Biologics, and Novavax Inc. At ID Biomedical Corporation, she led the global regulatory team that was responsible for obtaining FDA accelerated approval of a seasonal influenza vaccine and that supported the acquisition of ID Biomedical by GSK.
Dr. Halpern has been a committee member for previous PDA Vaccine conferences and currently serves as a co-chair of the PDA Vaccine Interest Group. She received her B.S. in Physiology from the University of California, Davis and her Ph.D. in Pharmacology from the University of Rochester.
Sabrina Restrepo, Ph.D. Director – Global Vaccines Technical Operations, Merck & Co. Inc. Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements for vaccines manufacturing, subject matter expertise in extractables and leachables, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, and vaccines technology transfers with External Partners. Recently, she was a recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing. Currently, she is the co-lead of the PDA Vaccines Interest Group.
Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, large molecule process characterization and improvement and development of biological wastewater technologies, respectively.
Sabrina has published four technical publications, received four recognitions within Merck, co-authored three BioPhorum Industry documents, and presented at numerous conferences.
She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.
Beth has focused much of her 28 year career performing new product introductions and technology transfers. She has commercialized 20+ products across a variety of industries including small molecule APIs, drug product, specialty chemicals, thin film, and commodity chemicals Using her knowledge of ICH guidances, she enjoys helping both large pharma and virtual companies identify key focus areas for product development, transfers, and scale-up. Her in-depth understanding of criticality enables her to guide organizations in defining accurate critical quality attributes, critical process parameters, and critical aspects for process equipment and laboratory systems. Beth joined the PDA Technology Transfer Interest group in 2015 where she has focused on building a generic tool for guiding technology transfer program management and most recently, worked with PDA on a wide ranging survey on Technology Transfer. She wants to build the PDA TT IG community with cross-functional expertise where knowledge on technology transfer strategies and best practices can be shared.
Peter Makowenskyj has over 13 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various technical roles in process solutions for the biotech industry prior to moving into management positions in technical and sales roles. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities with single use technologies. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their facilities utilizing G-CON’s pre-fabricated autonomous clean rooms.
Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University.