PDA Southeast Chapter: 2024 Fall Conference

Featured Presenters

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  Brittany Bell

  Manager, Manufacturing Quality, Kymanox

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  Brittany Bell

  Kymanox

  Brittany Bell has over 13 years of experience in biopharmaceuticals, combination products, traditional pharmaceuticals, and sterile compounding operations and compliance. Brittany has responsibility for quality oversight of external manufacturing, supplier management programs, auditing and gap assessments, implementing and maintaining phase-appropriate Quality Management Systems, and eQMS implementation, configuration, and validation. Her technical experience includes purification process development, process scale-up, technology transfer, process validation, manufacturing investigations and root cause analysis, CGMP quality and compliance remediation, and auditing. Brittany’s technical background and experience is combined with a passion for making quality and science-based decisions with the focus on patient safety to support clients in maintaining their Quality Management Systems, supporting production and quality processes, and delivering safe therapies to patients.

  Brittany is an ASQ Certified Quality Auditor. She graduated from North Carolina State University with a Bachelor of Science degree in Biological & Agricultural Engineering and pursued graduate level coursework at the Biomanufacturing Training and Education Center, including Upstream, Downstream, and Lyophilization principles.

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  Virginia Boldt

  Supply Chain Planner, Fusion Pharmaceuticals

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  Virginia Boldt

  Fusion Pharmaceuticals

  Virginia Boldt is currently the Supply Chain Lead at Fusion Pharmaceuticals. Prior to Fusion, Boldt was a Management Consultant at Accenture within the Life Sciences Supply Chain and Operations practice. Boldt has experience with cold chain distribution and shopfloor improvement projects and has supported initiatives to drive innovations in the life sciences industry. Prior to Accenture, Boldt worked in vaccine manufacturing at Merck. Boldt spent the majority of her tenure at Merck in Technical Operations, leading change control on a projects team supporting an E2E of several sterile liquid vaccines, and she also supported the Capital Projects organization at Merck, implementing lean manufacturing tools and techniques in Merck's capital projects. Boldt has a Bachelor of Science in operations research engineering from Cornell University. Boldt provides operational support for the ATMP and BioAB advisory boards within PDA.

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  Kelli Collin

  Senior Vice President, Quality, Shattuck Labs

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  Kelli Collin

  Shattuck Labs

  Kelli Collin is the Senior Vice President, Quality at Shattuck Labs, serving in this role since January of 2021. Previously, she was the Executive Director of Quality Assurance at Liquidia Technologies, leading the quality department for GMP, GCP and GLP operations. She has over 20 years of experience in quality assurance, covering all aspects of the pharmaceutical product lifecycle.

  Her professional and academic credentials include a bachelor’s degree in Biological Engineering and a Master of Bioinformatics from North Carolina State University. In addition, she holds a Master in Business Administration with a concentration in Supply Chain Management from the University of North Carolina Wilmington. She holds a graduate certificate in Pharmaceutical & Medical Device Law & Compliance from Seton Hall Law School. She is certified by the American Society for Quality as a Certified Quality Manager/Operational Excellence (CMQOE), and a Certified Pharmaceutical GMP Professional (CPGMPP). She has served the Raleigh section of ASQ as the Membership Chair, Scholarship Chair, and the Section Chair.

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  Wendy Haines, PhD, DABT, ERT, ASQ CQA, ASQ FELLOW

  Director of Toxicology & Quality Services, PharmEng Technology

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  Wendy Haines, PhD, DABT, ERT, ASQ CQA, ASQ FELLOW

  PharmEng Technology

  Dr. Wendy Haines is the Director of Toxicology and Technical Services at PharmEng Technology and has over 25 years of toxicology experience in both the research and biopharmaceutical arenas, encompassing toxicology, process design, analysis, validation, project/protocol management, and scientific writing. She has BS Degrees in Pharmaceutical Sciences & Biology from Campbell University, PhD in Toxicology from University of North Carolina, Chapel Hill and is a board-certified toxicologist (Diplomate of the American Board of Toxicology, DABT) and a Certified Quality Auditor (ASQ CQA). Dr. Haines has impacted human health laws at Environmental Protection Agency (EPA) starting in 1997, worked on the Genome Project between EPA and National Institute of Health (NIH), and later conducted her PhD at EPA performing directed research for the Office of Pesticides. Wendy was a study director and oversaw studies for both commercial clients and the National Toxicology Program (NTP). Next, Wendy moved from a contract laboratory setting to a consultant company providing toxicology, project management, and validation services to pharmaceutical and biotechnology manufacturers. Dr. Haines has conducted almost 400 product toxicology safety assessments for contract manufacturers and owner companies and provides guidance on product testing, worker safety programs, cleaning validation, and extractable and leachable projects.
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  Caitlin Kinard

  Senior Quality Specialist, Kymanox

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  Caitlin Kinard

  Kymanox

  Caitlin Kinard has over 10 years of experience across Quality Assurance, Compliance, and Quality Control functions in commercial pharmaceutical manufacturing organizations and professional services. Caitlin supports various life science clients with establishing or improving their Quality Management Systems to ensure they are effectively implemented for meeting regulatory and customer requirements. Caitlin regularly performs Quality Management System gap assessments and supports remediation of identified gaps. She has worked in CGMP-compliant operations, with subject matter expertise in deviations, CAPAs, change management, document management, training, inspection readiness, audit response, and Lean operations. She also possesses a laboratory background in analytical/biochemical testing and method validation.

  Caitlin graduated with Distinction from the University of North Carolina at Chapel Hill, earning a Bachelor of Arts in Exercise and Sport Science with a minor in Chemistry.

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  Pepper Landson

  Co-Founder & CEO, Pratego, Inc.

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  Pepper Landson

  Pratego, Inc.

  Pepper Landson is an accomplished healthcare executive with 30 years of experience in research and development, positively impacting over 100 programs. Her contributions include products for infectious diseases, neurology, and oncology. Her tenacity fuels innovation and her talents energize successful teams. In the last decade, she has focused exclusively on developing novel therapeutics to address chronic diseases of aging.

  In 2017, Pepper launched Praetego, a pharmaceutical company committed to improving health outcomes for neurodegenerative diseases. Praetego’s novel small molecules interrupt the formation of glycotoxins, specifically, Advanced Glycation End-Products (AGEs). Through Praetego she will revolutionize how we effectively limit the progression and the burden of Alzheimer’s Disease.

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  Paul Lopolito

  Director Technical Services, STERIS

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  Paul Lopolito

  STERIS

  Paul Lopolito is a technical services director for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to critical environment and process research cleaners, which includes field support, site audits, training presentations and educational seminars. Paul has over 25 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. Paul is a frequent speaker at industry events in North America, Europe, and Asia. Paul co-presents a master cleaning validation course at the National Institute for Bioprocessing Research in Dublin, Ireland and at the Biomanufacturing Training and Education Center in North Carolina, United States. Paul has published several articles and book-chapters related to cleaning and cleaning validation.

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  Mike Porter, MS

  Senior Director, Education, PDA

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  Mike Porter, MS

  PDA

  Mr. Porter is the Sr. Director of Education at PDA. With over 35 years in quality and leadership roles, he utilizes his extensive GxP knowledge across medical devices, manufacturing, laboratory, and clinical trials, along with his global experience and his collaborative engagement with people, to successfully implement efficient, effective, and sustainable quality management system solutions that are compliant with global regulatory requirements and industry best practices. He holds an M.Sc. in Biomedical Engineering from Clemson University and a B.Sc. in Engineering Science and Mechanics from Virginia Tech.
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  Melody Scott

  Director, Supply Chain, Amgen North Carolina

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  Melody Scott

  Amgen North Carolina

  Melody is currently the Director of Supply Chain for the Amgen North Carolina (ANC) site; in this role, she leads all Site Supply Chain activities. As a greenfield project, Melody is responsible for building the ANC Supply Chain team, processes and systems from the ground up including capacity planning, production planning, procurement and inventory control, warehouse operations, oversight of external service providers, transportation, data analytics, and ERP system ownership.

  Prior to joining Amgen, Melody spent 17 years at the Biogen RTP, NC site, where she held various roles of increasing scope and responsibilities within Manufacturing Operations and the Global Supply Chain. In her most recent role, she served as the Site Lead for the Industrial Engineering and Operations & Systems Improvement team, where she directed a team dedicated to business process optimization, continuous improvement, and operational excellence. Before Biogen, Melody held Process Engineering roles at bioMerieux and Phoenix Imperative, Inc. Melody has a B.S. in Chemical Engineering from Virginia Tech and a M.S. in Chemical Engineering from NCSU; she also earned her MBA from the Fuqua School of Business at Duke University.

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  Irina Tcherepanova

  Independent Consultant

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  Irina Tcherepanova

  Irina Tcherepanova, Ph.D. is an independent consultant. Previously, she served as Chief Operating Officer at CoImmune Inc., providing leadership in guiding regulatory strategies and with an expertise in navigating complex regulatory landscapes for emerging therapies.

  Her expertise lies in the areas of mRNA- and DNA-based drug substances, monoclonal antibodies, and recombinant protein drugs. Dr. Tcherepanova also has experience in cellular therapies including dendritic cell vaccines and cell and gene therapies for the treatment of immune disorders and cancer. Dr. Tcherepanova has a proven track record of achieving significant milestones, such as launching and supporting clinical trials as well as operational support for clinical drug products manufactured at an in-house cGMP facility.

  Dr. Tcherepanova contributions to novel therapies development, technology transfer supporting in-licensed and out-licensed agreements, and clinical operations underscore her commitment to advancing biotechnology and increase patient’s access to the novel therapies. She is an accomplished author of over 30 publications, >80 presentation at national and international conferences, and is regularly invited to review scientific manuscripts for international per reviewed journals, as well an holder of several patents for inventions.

  Dr. Tcherepanova received her Ph.D in Molecular Pharmacology from the Albert Einstein College of Medicine, followed by a post-doctoral fellowship in the Department of Pharmacology and Cancer Biology at the Duke University Medical Center.

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  Seneca D. Toms, MS, MSEH, RAC

  National Expert, Drugs, OMPTO, ORA, U.S. FDA

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  Seneca D. Toms, MS, MSEH, RAC

  U.S. FDA

  LT Seneca D. Toms is a U.S. Public Health Service Commissioned Corps Officer serving as a National Expert for Pharmaceuticals in the US FDA’s Office of Regulatory Affairs. He is responsible for providing technical advice and assistance within FDA headquarters, to field offices, and other federal agencies on issues related to pharmaceutical manufacturing. LT Toms has experience conducting complex finished drug, biotechnology, and active pharmaceutical ingredient inspections both domestically and internationally. He serves as an instructor at national trainings for FDA investigators on the topics of data integrity, computerized systems, sterile drug manufacturing, and conducting inspections. LT Toms received undergraduate degrees from North Carolina State University, a Master of Science in Biotechnology from Johns Hopkins University, and a Master of Science in Environmental Health and Graduate Certificate in Public Health from East Carolina University. He is an FDA Certified Drug Investigator, and Regulatory Affairs Certified (RAC).
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  Angelica Welch, BS

  ValSource

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  Angelica Welch, BS

  ValSource

  Angelica Welch is a MSAT consultant at ValSource with over a decade of biopharmaceutical purification experience.

  >She is a subject matter expert in manufacturing sciences and technology, specializing in design and support of downstream biologics operations. Angie's experience includes the full spectrum of process development, characterization, transfer, validation and operations support. Throughout her career Angie has supported operations in the lab and on the manufacturing floor.

  Angie earned her B.S. in Biochemistry from Worcester Polytechnic Institute and has a certificate from the University of New Hampshire for Professional Coaching.

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  Jared Wine

  Manager, Engineering, ValSource

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  Jared Wine

  ValSource

  Jared Wine is a Project Manager and Engineer at ValSource with about a decade of experience in biopharmaceuticals. He specializes in CQV Engineering and Project Management. Jared leads teams and manages complex projects which support clients through the design, build, test phases, as well as PPQ campaigns. Jared holds a B.S. in Chemical Engineering with a focus in Biology from the University of Rhode Island. He currently sits on the PDA SE Chapter Board of Directors.