Skip To The Main Content
Committee & Speaker Biographies

Committee & Presenter Biographies

2023 PDA Annual Meeting

Apr 03 - Apr 05, 2023

  • Janmeet Anant

    Janmeet Anant, PhD

    • 2023 Annual Presenter
    • 2022 Annual Presenter
    MilliporeSigma

    Janmeet Anant, Ph.D., PMP, RAC serves as a Senior Regulatory Consultant at MilliporeSigma, specifically working on sterile injectables. Janmeet has consulted on regulatory requirements for CMC submissions for oligonucleotides, such as siRNA and viral-vector based gene therapies.  Janmeet has guided clients from large multi-national biopharmaceutical and emerging biotech companies through these niche therapeutic modalities, where limited established regulatory guidance exists at present.
    Janmeet has been a key member of the Paradigm Change in Manufacturing Operations (PCMO), which is a Quality Risk Management (QRM) team of the Parenteral Drug Association (PDA). In addition, Janmeet has served previously as an Executive Board Member for the Bioprocess Systems Alliance (BPSA), Vice-Chair of a subcommittee of the American Society of Mechanical Engineers - Bioprocessing Equipment (ASME-BPE) standard setting organization, and a member of the Regulatory Governance Team at BioPhorum. With over 20 years of experience in the biopharmaceutical industry, Janmeet has been consulting on complex regulatory strategy projects with biopharmaceutical drug manufacturers, leveraging skills from his Project Management Professional (PMP) and Regulatory Affairs Certification (RAC). Janmeet has a Bachelor of Science degree in Chemistry and a Ph.D. in Pharmacology.

  • Mimi Ang

    Mimi Ang, MS

    • 2023 Annual Presenter
    Genetech

    Mimi Ang (they/she) brings over 15 years of engineering and operations experience from Genentech and the food industry with deep knowledge in drug substance and drug product manufacturing, process engineering, equipment reliability, frontline troubleshooting, and quality investigations. Their breadth of experience started at Genentech's Operations Development Program and includes roles in Finance, Supply Chain, Operational Excellence, Manufacturing Sciences and Technology, and Facilities Engineering. Mimi is a Lean Six Sigma certified professional and well-versed in coaching process improvement methodologies, root cause analysis, and risk management tools.

    Mimi currently leads the SHERPA (Systematic Human Error Reduction via Process Analysis) program at the Vacaville site which is seen as a model for improving site-wide procedures across the Roche network. They are an empathic leader who delivers sustainable results while focusing on people development first.

  • Frederic Ayers

    Frederic B. Ayers

    • 2023 Annex Presenter
    • 2023 Annex Committee
    • 2023 Annual Presenter
    • 2022 PDAFDA Presenter
    • 2022 Micro Presenter
    • 2022 Micro Committee
    • 2022 Annex Dallas Presenter
    • 2022 Annex Dallas Committee
    • 2022 Annex 1 Palm Springs Presenter
    • 2022 Annex 1 Dublin Committee
    • 2022 Annex 1 Amsterdam Committee
    Eli Lilly and Company

    Fred, a 1999, graduate of Franklin College of Indiana with a Bachelor of Arts (B.A.) in Biology. While at Franklin College he was a 4-year student-athlete and participated in the institution's Leadership Program. After graduating, Fred spent time in the contract manufacturing industries, then joined Eli Lilly and Company in 2001. During his 20+ year career at Eli Lilly and Company, Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a Sterility Assurance Subject Matter Expert. For Lilly's Indianapolis Parenteral Manufacturing site, he had the responsibility to develop, implement, and continuously improve the site's sterility assurance programs. As a Global Advisor, Fred was responsible for ensuring Lilly Quality Standards and associated Sterility Assurance Programs evolve with global regulatory expectations. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter and contributor to PDA. He has been a PDA Midwest Chapter Board Member since 2014, serving as Chapter President from 2020-2021, and was recently nominated and selected to join the PDA Scientific Advisory Board.

  • Kakolie Banerjee

    Kakolie G. Banerjee, PhD

    • 2023 Annual Committee
    • 2022 Annual Committee
    MilliporeSigma
    Kakolie Banerjee is a Senior Scientist in the Virology and Microbiological Sciences department at Millipore Sigma. She has been part of the company for over three years as a Virologist in Process Solutions business, supporting BioProcessing efforts. Her work includes viral inactivation and clearance studies using model mammalian viruses and bacteriophage. Prior to that, she worked as a Staff Scientist at Sample6 (now known as Corvium Inc.), and helped developed an AOAC-Certified phage-based method to detect foodborne pathogens. Kakolie did her Ph.D. in Food Science from Pennsylvania State University, studying mechanisms of Shiga-toxin expression in E. coli O157:H7. Prior to that she got her bachelor’s degree in Life Sciences from the University of Delhi, and an M.S. in Food Safety from North Dakota State University investigating the molecular based detection of Fusarium spp.
  • Sarah Barkow

    Sarah Barkow, PhD

    • 2023 Annual Presenter
    Bristol Myers Squibb

    Sarah Barkow, PhD is Director of GxP External Engagement with Bristol-Myers Squibb Company. This includes working closely with PhRMA, BIO, IFPMA and other trade organizations and tracking regulatory and policy developments across the GxP realm. Sarah joined BMS from FDA, where she held multiple roles in CDER’s Office of Compliance, including as Acting Director, Manufacturing Quality Guidance and Policy Staff. At FDA, Sarah was instrumental in drafting multiple guidance and policy documents.

    Sarah has her PhD in Physical Chemistry from MIT.

  • Peter Bisp

    Peter Bisp, MA

    • 2023 Annual Presenter
    Novo Nordisk A/S

    Peter Bisp has 22 years of experience in Novo Nordisk from QC and API manufacturing. He holds a Masters in microbiology and has been working with bioburden test methods in QC as well as microbial risk assessments and covering different topics within bioburden protection of API manufacturing processes.

  • Brorson Kurt

    Kurt Brorson, PhD

    • 2023 Annual Presenter
    • 2018 Virus Forum
    Parexel International

    Kurt Brorson, Ph.D. is Vice President, Technical and line manager at Parexel International in the Regulatory Consulting Services group (RCS).  At Parexel, Kurt provides a full range of consulting services for the quality of biopharmaceuticals, with specific expertise in biomanufacturing, biotech product quality and risk-mitigation, biosimilars, transition products and viral safety/viral clearance.  He also acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined. Strategist known for inspirational leadership and successful oversight of cross-functional teams engaged in consulting, regulatory services and compliance improvement initiatives. Engaged in constant industry standards ideation and creation, technical report building, and program development that educated the whole industry.

    Prior to joining PAREXEL, Dr. Brorson was a Lab Chief in CDER/OPQ/Office of Biotechnology Products (OBP) at the FDA, with 26 years in the Agency.  At FDA, he was a reviewer, inspector and laboratory scientist, running a mission-focused research program project widely considered to be world-class in virus retentive filtration and viral safety of biotech products.  Dr. Brorson received his BA. in Biology from University of Chicago (Chicago IL) in 1984 and Ph.D. in Molecular Biology from California Institute of Technology (Pasadena CA) in 1990.

  • Jerry Chapman

    Jerry L. Chapman, MBA

    • 2023 Annual Presenter
    • 2022 Annual Presenter
    • 2021 Annual Speaker
    • 2021 Annual
    Redica Systems

    Jerry Chapman is Senior GMP Quality Expert at Redica Systems. He brings over 40 years’ experience in the pharma industry, including 31 years at Eli Lilly, where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality. He designed and implemented a comprehensive GMP Intelligence process to identify, analyze, and archive pertinent drug GMP regulations, inspection findings, trends, and best practices in the U.S. and internationally. Chapman was founder and chairman of the GMP Intelligence subgroup of the Midwest Discussion Group from 2005 to 2010. He was Senior Editor at International Pharmaceutical Quality for six years; Editor-in-Chief for Xavier Health; has been an invited speaker at PDA, AAPS, ISPE, and RAPS events; and has served as a consultant to the animal health and compounding pharmacy industries. At Redica Systems, Chapman works with the machine learning and data science teams building computer models that examine enforcement actions and other data and produce analyses the way an expert would in the past using hard copy documents and a highlighter. His articles detailing and analyzing current hot topics among the pharma industry and international regulators appear on the Redica Systems Conference Spotlight page.

  • Bikash Chatterjee

    Bikash Chatterjee

    • 2023 Annual Presenter
    Pharmatech Associates

    Bikash Chatterjee is CEO of Pharmatech Associates, a USP Company, and has worked in the biopharmaceutical, pharmaceutical, medical device, and diagnostics industry for 30+ years. He has designed the CMC and development programs incorporating patient-centric initiatives for multiple drug sponsors and has guided the successful approval of more than a dozen new products within the U.S. and Europe. He is a six sigma / lean manufacturing master black belt. Chatterjee has published more than 200 papers in industry and peer-reviewed journals. Chatterjee is a regular editorial and technical contributor to several industry journals and serves on the editorial advisory board for Pharmaceutical Manufacturing and Pharmaceutical Technology, and is a founding member of the CPhl expert industry advisory board. Chatterjee is the author of "Applying Lean Six Sigma in the Pharmaceutical Industry”. He holds a B.A. in biochemistry and a B.S. in chemical engineering from the University of California at San Diego.

  • Carrie Colella

    Carrie Colella

    • 2023 Annual Co-Presenter
    Lachman Consultants

    Carrie Colella is a Senior Director at Lachman Consultants whose 30+ years of pharmaceutical expertise includes Compliance and Quality Systems audits, training development, and project management. She is well versed in U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), and Medicines and Healthcare products Regulatory Agency (MHRA) requirements, as well as EU Medical Device Regulations, and ISO standards. Ms. Colella is proficient in GMP and GLP regulations and is experienced with GCP clinical trials. She has managed and directed complex compliance projects and continuous improvement initiatives and has led cross-functional teams from conception to operation.  Her expertise includes medical device, combination products, and OTC products (inclusive of topical dosage forms.

  • Robert Dream

    Robert Dream

    • 2023 Annual IG Leader
    HDR Company, LLC

    Robert Dream is an industry leader with broad experience in the biopharmaceutical industry from early process development to commercial manufacturing.  Product experience includes vaccines, recombinant proteins, mAbs, and ATMPs/C&GTs.

    Robert has been working in the biopharmaceutical industry for 30+ years, involved in manufacturing, regulatory compliance, facility design and qualification, process development and process validation, and CAPEX and OpEx planning.

    Robert assisted organizations to expand their operations and businesses worldwide, including planning, audits, CMC, and BLA/MAA preparations and submittals.  He has managed contracts and improved CAPEX and OPEX on many projects, and provided oversight, procurement, and program management for clients globally.

    His work has been published in numerous industry text books and technical journals.  Robert has participated in seminars and technical conferences for numerous organizations and lectured at universities and training organizations.  Robert has been an active member of PDA and ISPE since August1990.

  • David Frank

    David J. Frank, PMP

    • 2023 annual speaker
    Azzur Group

    David Frank, VP of Client Development, leads customer-facing initiatives for Azzur Group nationwide including: Azzur Cleanrooms on DemandTM, Consulting and Advisory Services, Labs & Training.  For the past decade, David has consulted some of the world’s largest companies in pharmaceuticals, medical devices, technology, and financial services, aligning people, processes, and technology to drive sustainable business results. He has been recognized over the past 20 years for leading award-winning teams and is passionate about developing individuals into leaders. David received his Bachelor of Arts in Economics from The Pennsylvania State University and is a Lean Six Sigma Master Black Belt and PMP.  David resides outside of Philadelphia with his wife Kristen and twin boys, DJ and Chase.

  • James Fries

    Jim (James) M. Fries

    • 2023 Annual Presenter
    • 2022 BioMan Speaker
    • 2022 Annual Presenter
    Rx-360

    Jim Fries is a success-based executive with more than 25 years of experience building medical device and diagnostic companies across all pathways, including growth-oriented commercial initiatives, regulatory, and market access. Jim has been involved in driving thought-leader panels and committees within the areas of vascular intervention, cardiometabolics, diabetes, orthopedics, and pharmaceutical quality, which has resulted in numerous guidelines and consensus papers. Jim became CEO of Rx-360 in February of 2018, as a way of fulfilling his personal lifelong commitment to patient safety. Jim's expertise includes:

    • Pharmaceutical Supply Chain Security
    • Remote Pharmaceutical Auditing
    • Managing Pharmaceutical Supply Chain Integrity and Material Quality During a Pandemic (COVID-19)
    • Data Integrity
    • Joint Audit Program® for the Pharmaceutical Industry
    • Utilizing Industry Consortia in Pharma
  • Mauro Giusti

    Mauro Giusti, Dr

    • 2023 Annual Presenter
    • 2022 PDAFDA IG
    • 2022 Annual IG Leader
    Eli Lilly and Company

    Dr. Mauro Giusti holds a Master Degree in Chemistry at University of Florence, he is Board Certified by National Chemist association and Board certified as Technical Director (Qualified Person) by the Italian Minister of Health.

    After serving as Army Officer, he joined Eli Lilly Italy in 1988.  He has covered several positions within the Lilly Manufacturing organization (Regulatory, Technical Services, Project Management, QC, QA, Operations, Technical Director/Qualified Person, Six Sigma Champion, Science and Technology, Procurement), dealing both with Lilly manufacturing plants as well as with Contract manufacturing in the Europe/Africa/Asia.

    Among the several experiences with Lilly, he has worked in USA from 1992 to 1994 and in United Kingdom from 1997 to 1999. In September 2019 he took his current role, as Senior Director, Site External Network.

    For more than 16 years he has served as a member of the Italy Chapter of PDA, with several participations to national and international forum both as speaker and as chairman. In November 2019 he has been appointed as Co- Chair for the Process Validation Interest Group. In August 2020 he has been appointed to the PDA Science Advisory Board (SAB). In December 2021 he has been appointed President, PDA Italy Chapter.

  • Beth Haas

    Beth J. Haas, MChE

    • 2023 Annual IG Leader
    Haas Pharma Consulting

    With over 30 years in the industry, Beth has versatile experience across product lifecycle phases covering CMC requirements, cGMP manufacturing, and CDMO management focusing on new product introductions and technology transfers for both APIs and drug products. She enjoys partnering with CDMOs across all platforms, working closely with procurement and supply chain to ensure compliance, and establishing strong relationships between the key functional areas to achieve regulatory approval. Beth is highly skilled in global team leadership, process development and engineering, quality risk management, GMP quality systems, and CMC regulatory filings. Currently, Beth co-leads the Technology Transfer interest group for PDA, was a co-leader for the recently released PDA Technology Transfer technical report (TR-65), and was an author on the ISPE Technology Transfer guide, 3rd edition.

  • Richard Hall Hall

    Richard Hall Hall

    • 2023 Annual Presenter
    Rattiinox S.r.l.

    Richard Hall Hall is a Mechanical Engineer by training, technical salesman by inclination and inquisitive by nature.

    He is a member of 4 ASME BPE task groups: CIP, Valve Certification, Vessel Certification & Appendix K (Valve Testing), ISPE, PDA, A3P and ASTM E55 where he leads the 57-member Clean by Design work group developing a new standard for the specification, design, manufacture and test of CIP-friendly manufacturing systems.

    Richard is passionate about improving stainless steel process equipment cleanability to enable robust CIP-cleaning cycles using much less time, water, energy and chemicals.

  • Emily Heffernan

    Emily Heffernan, PE

    • 2023 Annual Presenter
    • 2022 BioMan Speaker
    DPS Group

    Emily Heffernan, US Director New Process Technologies, is a process Subject Matter Expert (SME), specializing in biological process and facility design. Working in the life sciences for 20 years, she has gained expertise in designing facilities for monoclonal antibodies, vaccines, and novel therapies including cell and gene therapy production. She is industry-recognized for her subject matter expertise in multi-modal facilities where different product types are produced in the same facility, due to her deep knowledge of complex facility layouts, GMP flows, and regulatory considerations.
    A graduate of North Carolina State University, Emily holds two degrees: a Bachelor of Science in chemical engineering and Bachelor of Science in biochemistry. She is also a licensed Professional Engineer in the state of North Carolina and an active member of the International Society of Pharmaceutical Engineers (ISPE).

  • Kir Henrici

    Kir F. Henrici

    • 2023 Annual IG Leader
    • 2022 PDAFDA IG
    • 2022 Data Integrity Chair
    • 2021 PDAFDA Speaker
    • 2021 Data Integrity Committee
    The Henrici Group

    Kir Henrici has extensive industry experience serving as a quality and compliance consultant with special expertise in the area of Data Governance + Data Integrity, IT and Enterprise Data Management, leading global and site level data governance programs to include designing and executing protocol driven DI assessments, risk analysis, remediation plans and process improvements throughout the organization to ensure a holistic integration of DI principles and controls. She has gained global and diverse perspective and working knowledge of quality, compliance and technical challenges and solutions impacting companies around the world; supporting a range of initiatives including global data organizational area quality system audits and assessments; complex risk management and remediation plans; technical reviews of GMP electronic and manual data related to manufacturing and laboratories; and the enterprise harmonization of policies and procedures.

    Special achievements include the development and execution of product risk assessments driving the successful release of international drug product batches; the complex remediation for a generic drug company in receipt of a 483 and Untitled Letter which resulted in an NAI outcome for the subsequent FDA inspection; and Pre-Approval Inspection Readiness for a domestic biotech company and a medical device company, both of which yielded product approvals.

  • Julia Jenkins

    Julia Jenkins

    • 2023 Annual Presenter

    Focused on building the rare disease community and ensuring rare disease patients have a voice in public policy, Julia collaborates with individual patients, caregivers, patient organizations and advocates to ensure the work of the EveryLife Foundation for Rare Diseases continues to meet the needs of the community. Julia has served at the Foundation since its inception in 2009. Her expertise in grassroots organizing and legislative advocacy inspired her to launch Rare Disease Legislative Advocates, Rare Disease Week on Capitol Hill and Rare Across America, programs that unite and amplify the voices of rare disease patient advocates across state and federal legislatures. In 2012, Julia rallied the rare community during PDUFA V negotiations to ensure that all provisions that benefited rare disease patients were included into FDASIA, which was signed into law.  Julia’s leadership united the rare disease community to support passage of the 21st Century Cures Act in 2016 and the unanimous passage of newborn screening legislation in California and Florida. Julia is a board member of CAL Rare. She serves on the steering committee and co-chairs the policy working group for the Rare Disease Diversity Coalition. In addition, Julia serves on the Policy Board of the National Health Council.

  • blank-profile

    Andrea Johnston, PhD

    • 2023 Annual Co-Presenter
    BioPhorum

    Andrea joined BioPhorum in April 2022 as Phorum Director for Technology Roadmapping. Andrea has over 10 years’ experience of leadership and senior management in the medicines manufacturing sector leading integration of complex research projects at the industry-academic interface, driving the sector towards a future workforce and leading and managing large and complex teams across international sites to effectively deliver major flagship initiatives.
    She moved to BioPhorum from an Associate Director post in the leading international medicines manufacturing research and development Hub, CMAC. Prior to CMAC, Andrea worked as a Senior Research Fellow in major collaborative projects developing automated crystallization and pioneering machine learning applications. Her research career was a build on her work, from her PhD with AstraZeneca, in method development of advanced analytics for use in pharma.

  • Maik Jornitz

    Maik W. Jornitz

    • 2023 Annual Presenter
    • 2022 PDAFDA Presenter
    • 2022 Annual Presenter
    • 2022 Annex Dallas Presenter
    • 2022 Annex 1 Dublin Speaker
    G-CON Manufacturing, Inc.

    Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a 35-year veteran of the industry. He is a highly experienced in single-use bioprocesses, aseptic processing, and a subject matter expert in sterilizing grade filtration. He has published multiple books and book chapters and over 100 scientific papers on various bioprocessing and facility design topics. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces, including the EU Annex I response team. He is working member of ASTM E55, an advisory board member of the Biotechnology Industry Council, ICAV, Bondwell and board member of DIANT Pharma and Sunflower Therapeutics. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities frequently.
    Before joining G-CON end 2012, he worked 26 years for Sartorius, with his last role being the SVP for Global Product and Marketing Management Bioprocess. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.

  • Jason Kerr

    Jason Kerr, MBS, MBA

    • 2023 Annual Committee
    • 2022 Annual Co-Chair
    • 2021 Annual Committee
    • 2021 Annual
    • 2020 Annual Committee
    • 2020 Annual
    Redica Systems

    Jason Kerr is an experienced quality and regulatory professional and has been a champion in engaging, connecting, and promoting regulatory compliance in the dynamic biopharmaceutical landscape. Driven by data, he takes pride in providing the best possible outcome while remaining compliant and efficient. As a GXP Senior Specialist at Redica Systems, Jason’s goals include enhancing the quality and regulatory knowledge and advancing key topics, such as data integrity, throughout the industry. He previously worked at Amgen where he monitored global regulatory intelligence and identified quality requirements to be triaged, assessed, and implemented to ensure compliance. This included designing and implementing a system to track changes being implemented and provide regular updates to key stakeholders. Jason holds a BS in Biochemistry, a Masters in Business and Science focused on Clinical and Regulatory Affairs, an MBA, and holds a certificate in bioscience industry law and practice.

  • June Kim

    June Kim, PhD

    • 2023 Annual Presenter
    CEPI (Coalition for Epidemic Preparedness Innovations)

    June (Junghwa) Kim received her Ph.D from Chemical engineering at the University of Delaware. Since then, she has gained 17 years of industry experience including Life technologies, MedImmune and Celgene and accumulated broad experience in analytical and process development for biologics. She joined CEPI as CMC lead in 2022. She has been supporting and collaborating with industry, governmental and non-governmental organizations globally for vaccine and therapeutic development.

  • Ulrich Kollisch

    Ulrich Köllisch, PhD

    • 2023 Annual Presenter
    • 2022 PDAFDA IG
    • 2022 Data Integrity Committee
    • 2022 Annual Presenter
    GxP-CC

    Dr. Ulrich Koellisch has been on the forefront of the data integrity initiatives and in his previous 7 years has trained and supported many organizations in the pharmaceutical and biotech sector executing Data Integrity campaigns. Ulrich has experience in consulting for audit preparation and conduction in the GMP and the GCP area, is co-heading the PDA interest group Data Integrity and is an active participant in other industry knowledge groups.

  • Guido Kremer-van der Kamp

    Guido Kremer-van der Kamp

    • 2023 Annual Presenter
    • 2023 Annual Committee
    • 2022 Annual Committee
    • 2019 EU LogCMO Committee
    Merck KGaA

    Guido Kremer-van der Kamp has more than 25 years of experience in the BioPharmaceutical industry with single-use, multi-use, facility, and process design. He has held various positions with global responsibilities in process development, operations, consulting and technology management. He is currently Senior Consultant in the Global BioPharmaceutical Center of Excellence at Merck. Guido graduated in Biotechnology at the University of Applied Science in Mannheim with tenures at the National University of Singapore and a student fellowship at the Institute of Molecular and Cell Biology (IMCB) in Singapore.

  • Paul Lopolito

    Paul Lopolito

    • 2023 Annual Presenter
    • 2022 Annual Presenter
    STERIS Corporation

    Paul Lopolito is a senior technical services manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to process cleaning, cleaning validation and contamination control, 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 and has published several articles and book-chapters related to cleaning validation and contamination control. He earned a B.A. in Biological Sciences from Goucher College in Towson, MD.

  • Peter Makowenskyj

    Peter J. Makowenskyj, MEng

    • 2023 Annual Committee
    • 2022 PDAFDA IG
    • 2022 Annual IG Leader
    • 2021 ATMP US Committee
    • 2021 Annual Speaker
    • 2021 Annual
    G-CON Manufacturing, Inc.

    Peter has over 18 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know how.

    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. He is also very active within the PDA where he currently sits on the PDA BioAB, co-Leads the Biopharmaceutical Manufacturing IG, and  Mobile Manufacturing Task Force.

  • Kate Malachowski

    Kate Malachowski, PhD

    • 2023 Annual Committee
    Novavax

    Kate Malachowski is an Associate Director of Manufacturing Science and Technology (MS&T) at Novavax. In this role, she leads a team of scientists and engineers to support Novavax's global drug substance manufacturing operations, data trending, and CPV programs. She has also previously worked at Catalent supporting gene therapy projects and with the BioPhorum Extractables and Leachables work group. Before entering the biotech space, she worked in microscale medical and semiconductor devices at the Army Research Laboratory and Northrop Grumman. Kate holds a bachelor's degree in Chemical Engineering from Virginia Tech and a PhD in Chemical and Biomolecular Engineering from The Johns Hopkins University.

  • Amanda Bishop McFarland

    Amanda McFarland, MS

    • 2023 CCS Committee
    • 2023 Annex Presenter
    • 2023 Annex Committee
    • 2023 Annual Co-Chair
    • 2022 PDAFDA IG
    • 2022 Data Integrity Presenter
    • 2022 Annual IG Leader
    • 2022 Annual Committee
    • 2022 Annex Dallas Presenter
    • 2022 Annex Dallas Committee
    • 2022 Annex 1 Palm Springs Presenter
    • 2022 Annex 1 Dublin Committee
    • 2022 Annex 1 Amsterdam Committee
    ValSource, Inc.

    Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and a member of the Kilmer Regulatory Innovation team. She has a B.S. in entomology and an M.S. in mycology, both from the University of Florida. She can be contacted at [email protected]

  • Mic McGoldrick

    Mic McGoldrick

    • 2023 Annual Presenter
    • 2022 BioMan Speaker
    Merck & Co., Inc.

    Mic is currently an Associate Director of CMC Technical Advocacy & Policy at Merck Sharp and Dohme, Corp.  His background in the life sciences started with degrees in Microbiology, Chemistry, and Medical Technology and has experience with Vaccine and Biologics in the Pharmaceutical field for the last 30 years.  For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, and post approval submissions globally.  For a large portion of this time he led the evaluation of worldwide guidances and the expansion of vaccines into the Emerging Markets.  For the last seven years Mic has been working on CMC Policy for Vaccines and Biologics, advocating for reliance, harmonization and greater access of vaccines to patients.

  • Andrew OConnor

    Andrew O'Connor

    • 2023 Annual Presenter
    ERA Sciences

    Andy O'Connor is a lifesciences professional with 13+ years in the industry, currently focused on delivering software for the Life Sciences to deliver identified unmet needs.

    Andy is now a Founding Director of ERA Sciences, a Data Reliability company with the leveraging their 4 pillars of excellence to deliver reliable data: Data Integrity, Risk Management, Application Lifecycle Management and Stakeholder Engagement. Andy originally started as an IT analyst in a QC laboratory, implementing laboratory systems, eventually progressing to oversight of Data Integrity programs and defining Application Lifecycle Management (ALM) programs, utilising quality risk management and new agile methodologies to deliver systems that are lean & risk based. 

    When not driving new product development, Andy can be seen in a red jacket volunteering with the Mountain Rescue Team, based in Wicklow. Come say hi

  • Jeffrey Odum

    Jeff Odum, CPIP

    • 2023 Annual Presenter
    • 2018 Annual
    Genesis AEC

    Jeff Odum, CPIP, Practice Lead for ATMPs and Biologics at Genesis, is a globally recognized SME in Biomanufacturing Facilities that has over thirty years of experience in the design, construction, and commissioning of facilities in the biotechnology, and pharmaceutical industries.

    A recognized expert in biopharmaceutical manufacturing assets, Mr. Odum has authored over 50 published articles and four Industry reference books on subjects related to project management, GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities.  He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to next generation facility design, bioprocess manufacturing, project management and GMP compliance. Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP). He has led training efforts in fifteen countries in over 100 sessions, including training for global regulators from the US FDA, Health Canada, and the Chinese SFDA.

  • Ken Paddock

    Kenneth Paddock

    • 2023 Annual Co-Chair
    • 2022 Micro Presenter
    • 2022 Annual Committee
    • 2021 Annual Committee
    • 2021 Annual
    Baxter

    Ken Paddock is a Quality Sterility Assurance Director at Baxter Healthcare. As the Global Sterility Assurance (SA) Lead within the quality group, Ken is accountable for directing a global team of Regional Sterility Assurance Representatives to develop and implement a harmonized SA strategy plan across Baxter. In addition, his team provides quality oversight for microbial control and cleanroom behaviors at the facility level and is accountable for regional sterility assurance compliance. Ken has over 25 years of experience in the pharmaceutical industry including terminal sterilization (moist heat, radiation and ethylene oxide), product/process development and environmental monitoring programs.
    Currently, Ken is a PDA Chapter Board Member and has been elected to multiple positions within the chapter since 2010. In addition, he is a member of PDA’s Science Advisory Board.

  • Malav Parikh

    Malav Parikh, ME

    • 2023 Annual Committee
    Takeda

    Malav Parikh is an Associate Director in Takeda’s global Quality Compliance and Systems function. In his current role, Malav is focused on implementing a harmonized and sustainable QRM program embedded within the Quality Management System, including the creation of risk management procedures, tools, training, and workflows as well as consultation for risk-based strategies and assessments. Malav has a graduate degree in mechanical engineering and has had the privilege of being involved in various areas within the pharmaceutical, biotech, and medical device domain including new product introduction, supplier management, quality engineering, process validation, quality compliance, and quality analytics. Malav is also currently the co-lead for the PDA Quality Risk Management Interest Group (IG).

  • Diane M. Paskiet, MS

    • 2023 Annual Committee
    • 2022 Annual Committee
    West Pharmaceutical Services, Inc.

    Diane Paskiet has over 30 years of experience in the pharmaceutical industry. She is currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of pharmaceutical packaging and combination products. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is on the Product Quality Research Institute (PQRI)  Steering Committee and Chair of the Extractables and Leachables Parenteral Drug Product Working Group. Diane is also on the faculty of the Parenteral Drug Association Training Institute. She has author/co-author a number of papers and book chapters related to pharmaceutical packaging, delivery systems and combination products.

  • Hari Pujar

    Hari Pujar, PhD, MBA

    • 2023 PDA Annual Meeting Presenter
    Flagship Pioneering

    Hari is Chief Operating Officer of Tessera, as well as Operating Partner at Flagship Pioneering. He is a global Biopharmaceutical executive with 20+ years of value creation in the biologics and vaccine industry.

    Before Flagship, Hari served as Chief Technology Officer of Spark Therapeutics, leading the technical operations, process and technology development and quality assurance organizations. At Spark, Hari was responsible for growing and scaling the company’s cutting-edge technology capabilities for an expanding development pipeline.

    Prior to Spark, Hari was head of Technical Development & Manufacturing at Moderna Therapeutics. At Moderna, he built and led the technology and early manufacturing organizations that delivered on supply for more than a dozen clinical programs in a brand-new technology area. Previously, Hari held a variety of scientific and cross-functional leadership positions during 18+ years at Merck & Co in the company’s commercial, R&D and manufacturing divisions, culminating in the franchise leadership of pediatric and adult vaccines representing over $2B in revenue.

    Hari has a Ph.D. in Chemical Engineering from the University of Delaware and an MBA from the Wharton School at the University of Pennsylvania. He is a Fellow of the American Chemical Society and the American Institute of Medical and Biological Engineers.

  • Kara Quinn

    Kara Quinn

    • 2023 Annual Presenter
    ValSource, Inc.

    Kara Stockett Quinn is a Senior Consultant and subject matter expert (SME) in biopharmaceutical product development (nonclinical and clinical), technology transfer and validation, commercialization and pre-approval, licensure, and supply manufacturing. Her primary expertise is focused on Quality Systems, Regulatory Communications, Process Technology, and Clinical disciplines. She has extensive experience in direct health authority facilitation and communications. Ms. Quinn is an industry thought leader driving alignment in raw material risk assessment best practices, qualification standards, and novel excipient characterization.

  • Emma Ramnarine

    Emma Ramnarine, PhD

    • 2023 Annual Co-Presenter
    • PAC iAM
    • 2021 PDAFDA Speaker
    • 2020 Q&R Speaker
    • 2020 Annual Speaker
    • 2020 Annual

    Dr. Emma Ramnarine is an accomplished senior leader with 22+ years of global experience in the pharmaceutical, biotechnology and medical device industries in Analytical Science & Technology, Product Lifecycle Management, Outsourcing & External Collaborations, Risk Management, QC and Quality Management Systems. She was most recently Executive Director, Global Head of External Development Collaborations at Genentech/Roche, managing the external network for development, manufacturing, and clinical collaborations of Roche’s Biologics and Small Molecules development portfolio.

    She is a well-recognized industry thought leader and expert on QRM and risk-based applications, providing expertise and training for regulatory authorities and the industry. She is currently Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes, an initiative sponsored by Chief Quality Officers of more than 25 global pharma companies.

    Emma is currently Secretary of the PDA Board and is in the Board since 8 y. She was also on RAQAB, and has led several PDA Task Forces, Interest Group and Technical Reports (TR).

    Emma holds a PhD in Pharmaceutical Sciences from TU Dublin, Ireland, an M.S. in Pharmaceutical Sciences from the University of Connecticut, an M. Pharm. and a B. Pharm., both from the School of Pharmacy, SGSITS, Indore, India.

  • Stephan Roenninger

    Stephan Roenninger, PhD

    • 2nd EU Annual Meeting
    • 2023 PDA Annual Meeting Presenter
    • 2022 Q&R Speaker
    Amgen (Europe) GmbH

    Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. He represents Amgen in EFPIA MQEG and represents EFPIA on GMPs/inspections, in ICH training and ICH-QDG and before on ICHQ9, ICH Q-IWG and ICHQ7-IWG. In PDA he was at the board of directors and chaired RAQAB.

    Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators including FDA and PIC/S and the Parenteral Drug Association (PDA).

  • Mike Salem

    Mike Salem, MA

    • 2023 Annual Presenter
    Gilead Sciences

    Mike Salem is the Associate Director of Data Science - Quality Assurance at Gilead Sciences in Foster City, CA and is also a robotics professor for Brandeis University's online graduate programs. Mike has a B.S. and M.A. in mathematics from Arizona State University.

    He has worked in data science and technology for more than 14 years developing AI/ML solutions and products across multiple domains including robotics, finance, education and healthcare.

  • Joanny Salvas

    Joanny Salvas

    • 2023 Annual Presenter
    • 2022 Micro Presenter
    • 2022 Annual Presenter
    Pfizer

    Joanny Salvas is a senior manager at Pfizer, in the Global Technology and Engineering, Manufacturing Intelligence group. She has been developing and implementing Process Analytical Technologies and Rapid Micro Methods for nearly 15 years. She is certified 6sigma Black Belt, Project Management Professional (PMP) and Innovation Coach. Her background in engineering, process control, and multivariate data analysis enabled her to support many successful implementations of advanced control strategies in the Pfizer network. She leads the Pfizer Rapid Micro Method steering team responsible for establishing the strategy, the evaluation and implementation as well as the development of future microbiology analytics. She has a passion to learn and continuously drives innovation forward; she strives to use the best science possible in her projects.

  • Sebastian Scheler

    Sebastian Scheler, MSc

    • 2023 Annual Presenter
    • 2022 Innerspace June
    Innerspace GmbH

    Co-Founder, Managing Director and Chief Methodologist at Innerspace, a global provider of high-end virtual reality simulators. I am a psychologist by profession and have many years of experience in designing psychological methods for developing simulators for behavioral assessment and training of people in highly critical environments.
    At Innerspace, I am responsible for overall portfolio management, simulator methodology, and business relations with international clients and cooperation partners in the pharmaceutical industry. I am also a speaker at pharmaceutical events, author of several publications on simulator technology.

  • Susan Schniepp

    Susan J. Schniepp

    • 2023 Annual Presenter
    • 2023 Annual Committee
    • 2022 PDAFDA Committee
    • 2022 Annual Committee
    Regulatory Compliance Associates Inc.

    Susan Schniepp has over 40 years of quality assurance experience in the pharmaceutical industry. She has earned several awards from the PDA, including Distinguished Author Award, Distinguished Service Award, and Gordon Personeus Award.

    Sue’s publications include the book, Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, for which she was awarded the 2007 PDA’s Distinguished Author Award. She co-edited and contributed to the books Pharmaceutical Outsourcing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers.

    Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011- 2013 and from 2016- 2019 and is currently the Chair of the BoD (2022 - 2024). Sue has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working part of the working group writing a technical report relating to manufacturing data integrity issues and participating in PDA’s standard setting activity regarding purchasing controls.

    Sue is also an editorial advisory board member and columnist for Pharmaceutical Technology (since 2007) and BioPharm International Magazines. She holds a bachelor of science degree in Microbiology from Northern Illinois University.

  • Lauren Specchio

    Lauren Specchio

    • 2023 Annual Committee
    Baxter

    Lauren Specchio is an R&D microbiologist at Baxter within the field of sterility assurance.  Lauren provides subject matter expertise in the focus area of container closure integrity (CCI) supporting Baxter’s global platform.  She is an early career professional as she has been with Baxter for just under 5 years and she has been a member of the PDA Midwest Chapter since 2018.  She holds a Bachelor of Arts degree in Biology with a minor in Biochemistry from Augustana College.

  • Marius Stoffels

    Marius Stoffels, PhD

    • 2023 Annual Presenter
    Merck KGaA

    As a Product Manager for Digital Solutions, Marius Stoffels drives digitalization at the Life Science business of Merck KGaA, Darmstadt, Germany. His experience includes building business models and product strategies for digital products in the life science industry. In his previous role as a consultant, he gained extensive experience across strategy, supply chain, and digitalization in the life science and pharmaceutical industries. He holds a PhD from the University of Münster, Germany, where he investigated how companies use digital technologies to strengthen their competitive advantage.

  • Ed C. Tidswell, PhD

    • 2023 Annual Presenter
    • 2020 Micro Speaker
    Merck & Co., Inc.

    Dr. Tidswell is Executive Director within the Microbiology Quality and Sterility Assurance organization of Merck Inc. with ownership over sterility assurance and microbiology issues across all sterile and non-sterile products and manufacturing.  His prior appointments include senior global R&D, and quality leadership roles across diverse drug, device and biologics portfolios for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines.  Dr Tidswell actively publishes and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacturing.  Currently a member of the PDA Journal’s Editorial Board, and continues to serve on the USP Expert Committee for Microbiology.

     

  • Kristin Valente

    Kristin N. Valente, PhD

    • 2023 Annual Committee
    • 2022 Annual Committee
    Merck & Co., Inc.

    Kristin Valente is an Executive Director of Drug Substance Purification for Merck's portfolio of late-stage biologics and vaccines. She has over 15 years of technical experience in vaccines and biologics, encompassing process development, commercialization, and support of commercial manufacturing. In her current role, she leads a team of scientists and engineers to characterize late-stage large molecule assets for launch and commercial manufacturing.

    In her prior roles, she has advanced the field of host cell protein impurities, developed drug substance manufacturing processes, and provided technical support for commercial manufacturing of drug substance, drug product, and packaging. Kristin holds a bachelor's degree (Massachusetts Institute of Technology) and a doctorate degree (University of Delaware), both in Chemical Engineering, has published several impactful peer-reviewed manuscripts, and currently holds an Adjunct Faculty Position at the University of Delaware.

    She has been active in the PDA since 2018, with participation in conference planning, ECP engagement, and the science advisory board.

  • James Vesper

    James L. Vesper, PhD, MPH

    • 2023 Annual Presenter
    • 2022 PDAFDA Presenter
    • 2022 Innerspace June Speaker
    • 2022 Annual Presenter
    ValSource, Inc.

    James Vesper designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries. Beginning in March 2017, he became Director, ValSource Learning Solutions after establishing and being president of the firm, LearningPlus, Inc. At ValSource, he is leading a business unit that provides innovative learning solutions to pharma firms world-wide, leveraging the capabilities and expertise of ValSource consultants. He has had more than 35 years experience in the pharmaceutical industry.

    Dr. Vesper has written six books, including Root Cause Investigations for CAPA (2020) and multiple technical articles. His 5thEdition of GMP in Practice, written with Tim Sandle published in 2016 by PDA/DHI. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has been a mentor on six of the WHO’s unique learning program, Pharmaceutical Cold Chain Management on Wheels. He has trained health authority inspectors through WHO and PIC/S in US, Brazil, Taiwan, London, China, Greece, and Turkey.

  • Thomas Zahel

    Thomas Zahel, PhD

    • 2023 Annual Presenter
    Körber Pharma Austria GmbH

    Thomas Zahel is Head of Innovation at Körber Pharma Austria GmbH, with outstanding experience in statistics, algorithm development and turning complex challenges into easy concepts for biopharmaceutical companies. His background is in bioprocess engineering and he holds a PhD in applied statistics for process development and validation. He is most passionate about developing new statistical methods and turn them into intuitive data science tools.