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.
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.
Joe has over 10 years of experience in leading and supporting cross-functional teams in Capital Projects, Medical Device, and Validation in the Pharmaceuticals, Biotechnology and Gene Therapy Industry, Food and Beverage, and Aerospace industries. Joe is a Director at Project Farma supporting the Mid-West and East Coast Operations and has extensive experience leading local and global teams up to 30+ team members in Capital Projects, Commissioning & Qualification, Engineering, and Project Management in the pharmaceutical and biopharmaceutical industry.
He has held multiple roles ranging in a wide variety of scope and responsibility from Project Management, Engineering Technical Lead, and Commissioning and Qualification Lead for Gene and Cell Therapy Facility Builds, Medical Device, Business Strategy, Technical Operations advisement and Facility Remediation. Joe has a strong technical background in Upstream, Downstream and Fill and Finish processes through the project life cycle from conceptual design through implementation with a proven adaptability to new situations demonstrated by successful projects in a variety of companies and industries involving new or improved facilities, infrastructure, utilities and process equipment.
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.
Cory Proctor has over 10 years of experience in capital projects, medical device, and validation in the Pharmaceuticals, Biotechnology and Gene Therapy Industry. He has extensive experience leading teams of 20+ team members in Project Engineering, Project Management, Commissioning & Qualification, and Automation in the pharmaceutical and biopharmaceutical industry. Cory is currently the Director of West Coast Operations at Project Farma. He has held multiple project lead roles with the most recent being Project Manager for a gene therapy Tech Transfer. He has led diverse, cross-functional teams of up to 25 throughout the entire project lifecycle including project initiation/funding requests, business case development, conceptual design, basis of design, detailed design, construction, commissioning/qualification, validation, project close-out/purchase order closure. He has also managed and supported development of regulatory approach, project strategies and user requirements specifications for primary and secondary package inspection and track and trace serialization in alignment with the industry guidelines, US and foreign regulations.
Ramila Peiris manages Biogen’s Applied Analytics and Operations Team and is responsible for developing and deploying data management and analytics solutions for process monitoring and process diagnostics. He is an experienced data science professional with over 10 years of experience in the biopharmaceutical industry.
Ramila has a master’s degree and PhD in Chemical Engineering, with specializations in process modelling and optimization. He is passionate about driving innovation through digital transformation and using advanced data analytics techniques to unearth business value from data.
Dr. Vasu Rangadass, PhD is the CEO at L7 Informatics, Inc. provides software and services that enable synchronized solutions for science + health. L7’s novel Enterprise Science Platform (ESP) is a scientific process and data management (SPDM) solution that enables life science and healthcare companies to connect people, processes, and systems to accelerate discoveries and drive precision healthcare.
Prior to L7 Informatics, Dr. Rangadass was the Chief Strategy Officer at NantHealth following its acquisition of Net.Orange, the company he founded to provide an enterprise-wide platform - Clinical Operating System (cOS) to simplify and optimize care delivery processes in health systems. As CEO of Net.Orange, Vasu is patented and developed an innovative healthcare framework (cOS™ - Clinical Operating System™) that results in superior performance for Healthcare Organizations and revolutionized the way healthcare IT systems are architected.
Holding several patents in “Master Data Management” (MDM), Enterprise "Operating Systems", and Workflow Management (as well as extensive process experience in the Life Sciences, Healthcare, Automotive, High-Tech, Consumer Packaged Goods and Retail industries), Vasu has extraordinary proven experience in large-scale enterprise transformation.
Kathleen Souza is an R&D Manager in the Virology & Microbiological Sciences Group. She has over 30 years’ experience in the field of microbiology. Her work has focused on the biopharmaceutical industry, and she currently leads a team developing products and methods for microbial retention, microbial integrity of single-use products, bioburden & sterility testing, preservative & santitant effectiveness, environmental monitoring and microbial detection. She is an author of the PDA Technical Report on Alternative Methods for Mycoplasma Testing focused on detection technologies for mycoplasma. Additionally, she is co-chair of the TR45 revision on Depth Filtration and Prefiltration.
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.
Derek Gallo is the Director of Global Technology Transfer at Thermo Fisher Scientific. Derek Gallo is the current head of Technology Transfer for the Drug Product division across North America and Europe at Thermo Fisher Scientific. He is passionate about developing new best practices and tools for the global and site project management teams to improve and evolve how teams manage TT projects – both internally and for customers within the CMO space. In this current role Derek supports over 100 TT projects with launching 30-40 new products annually. Prior to this role, Derek managed a tech transfer team who was responsible for 16 new product launches. Derek has experience in steriles, solid dosage, soft gel, and biologics within the pharma industry and previously held roles including as a project manager, validation engineering, R&D, and production operations.
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.
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.
Tony has over 25 years of parenteral manufacturing experience primarily focused in operations and technical services. He is currently working as Plant Manager for the Fresenius Kabi Grand Island Production Unit. Tony received a Master of Science degree in Molecular Biology and Biotechnology from East Carolina University. Tony has also been a PDA member for over 20 years.
Russell E. Madsen is President of The Williamsburg Group, LLC, a consulting firm located in Gaithersburg, Maryland. Prior to forming The Williamsburg Group, he had served PDA as Acting President and was Senior VP Science and Technology. Before joining PDA, he was employed by Bristol-Myers Squibb Company as Director, Technical Services, providing technical and general consulting services to Bristol-Myers Squibb operations, worldwide. He is Vice-Chairman of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products, a member of the USP Microbiology Expert Committee, Chairman of the USP Visual Inspection of Parenterals Expert Panel, a member of Pharmaceutical Technology’s Editorial Advisory Board, and an Honorary Member of PDA. He holds a Bachelor of Science degree from St. Lawrence University and a Master of Science degree from Rensselaer Polytechnic Institute.
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.