September 24-25, 2020, Rockville, MD
Dr. Moore currently holds the position of Sr. Manager, Pharmacopeial Collaboration at the United States Pharmacopeia.
Dr. Moore's primary function is to lead strategic, technical, and scientific aspects related to USP's harmonization and collaborative activities with global pharmacopeias.
Specific roles include managing USP's technical activities in the Pharmacopeial Discussion Group (PDG), coordinating prospective and retrospective harmonization activities with partner pharmacopeias, collaborating with WHO through the International Meeting of the World Pharmacopeias, and supporting ICH initiatives through USP's observer status to the ICH Assembly.
Previously, Dr. Moore worked for USP as a Scientific Liaison and Manager for Pharmacopeial Harmonization in the Excipients Group. Dr. Moore has nearly 20 years’ experience in the fields of Compendial Science and Pharmaceutical Analytical Support.
He holds a Ph.D. in Inorganic Chemistry from the University of Pennsylvania and a B.S. in Chemistry and Biology from LeMoyne College.
J. Mark Wiggins is Owner and Compendial Consultant with Global Pharmacopoeia Solutions LLC, which he formed after more than 30 years’ experience in the pharmaceutical industry. He was previously Director of Compendial Affairs at Merck & Co., Inc., (known as MSD outside the US and Canada), with more than 15 years’ experience submitting new and revised monographs to pharmacopoeias, as well as optimizing processes for review and response to proposed compendial changes from around the world. Mr. Wiggins has been an active participant in pharmaceutical industry associations in the US, UK, and Europe, and represented PhRMA on the ICH Q4B Expert Working Group to harmonize pharmacopoeia general chapters. Mr. Wiggins has published numerous papers, including an introduction to the concept of the "Ideal Pharmacopoeia," "Compendial Globalization," and the industry perspective on the pilot project for “Prospective Harmonization” of API monographs. He also co-authored a comprehensive series of twelve articles on pharmacopoeia compliance that were published as online regulatory sourcebooks. He has been an invited speaker at international meetings on compendial harmonization, including the Ph. Eur. workshop "Quality of Medicines in a Globalized World," and in discussions with pharmacopoeias and regulators in the US, UK, Europe, Japan, China, Korea, and India.
Joseph Albanese, Ph.D. holds a doctoral degree in Chemistry from the University of Delaware. Dr. Albanese has more than 25 years of pharmaceutical industry and managerial experience. He is currently the Director of Analytical Strategy and Compliance at Janssen Research and Development, LLC. Joe provides oversight of regulatory intelligence that impact developmental and commercial products. He is the single point of contact for China projects such as Pharmacopoeia, Product Importation, and Generic Consistency Evaluation. He is defining a strategy to ensure all projects in development comply to key emerging markets regulations for analytical development and stability. He is also responsible for the compendial vigilance process for all Janssen ensuring compliance with US, European, Japanese, British, Chinese, Indian, and Russian pharmacopoeias.
Joe is active in industry working groups; PhRMA Limited Duration Key Item Team for compendial issues with USP, the EFPIA Biotherapeutics subteam for the elaboration of biotherapeutic compendial standards, and the USP General Notices Project Team. He is active in industry trade organizations such as NJPQCA and PDA. Joe has held various analytical and quality positions throughout his career, including leading an analytical method/validation laboratory, quality control laboratories for small molecules and biotherapeutics products, and laboratories for product stability management.
As Principal Scientific Affairs, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging.
Since 2015 Bettine is an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass).
Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She is active in the PDA Glass Handling Task Force and co-chairing the European PDA Interest Group Packaging Science as well as the Pharmacopeia Interest Group.
In 2015 she published the book "When Glass Meets Pharma".
She is a frequent speaker at industry conferences and has chaired and moderated several conferences for the PDA and other formats. This is adding to numerous trainings and publications that she has provided.
Dr. Boltres is a (bio)chemist by training, with a diploma in chemistry and a PhD in biochemistry.
Graham leads Pfizer’s Global Quality Intelligence and Compendial Affairs group. He is the chair of Efpia’s Technical Development Group (TDEG) and is the Efpia Topic Lead for ICH Q12 Product Lifecycle Management. He was appointed to the British Pharmacopoeia Commission in 2010 and chairs the MC2 Expert Advisory Group and AQbD Working Party.
Between 2012-2018, he was Chairman of the ASTM International E55 Technical Committee developing pharmaceutical manufacturing standards and continues to serve as a member of the E55 Executive Committee. He is a past chair of Pfizer’s QbD Council, and previous roles include Technical Director supporting Wyeth Europa Manufacturing and External Supply, and Director Formulation Development for Wyeth Consumer Healthcare (Richmond, VA). Graham is a pharmacist with a Ph.D. in pharmaceutics.
Gina Marsee is Director, Compendial Compliance and Advocacy at Merck located in West Point, PA, USA. She holds a bachelor’s degree in Chemistry & Biology from the University of Tennessee and has worked in the pharmaceutical industry for 29+ years holding various leadership roles within Quality, Compliance, and Regulatory Affairs. Prior to joining Merck, she was Site Head of Quality & Regulatory Affairs at Thermo Fisher Scientific API manufacturing site in Greenville, SC. She previously worked at Pfizer as Director of Quality and Regulatory Policy. Gina participates with various industry groups, pharmacopoeia organizations, and regulators on contemporary compendial related matters. She advocates for harmonization/convergence of public standard in support of availability of quality medicines for patients globally. Gina was a delegate member to the USP 2020 Convention and holds a position on IPEC America's Executive Committee and recent co-chair of the USP Prescription/Non-Prescription Stakeholder Forum. She is an active member of the PDA Pharmacopoeia Interest Group and Planning Committee for the PDA 2020 Pharmacopoeia Conference.
Dr. Haruhiro Okuda is a former Director-General of National Institute of Health Sciences (NIHS). After obtaining PhD degree in medicinal chemistry from University of Tokyo, he joined the Pharmaceuticals and Medical Devices Evaluation Center, the predecessor of PMDA, and was engaged in review of new drug approval application. From 2002 to 2020, he worked for NIHS, and served as Head of Division of Organic Chemistry, Head of Division of Drugs, Deputy Director-General and Director-General. He worked to harmonize regulation on quality of chemical drugs for over 10 years as a member of ICH. After retirement form NIHS he continues to be engaged in preparation of Japanese pharmacopoeia and PDG activity as a visiting researcher of NIHS.
James Pound joined the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in 2008. He has worked in a variety of roles within the British Pharmacopoeia (BP) & Laboratory Services Group and in 2017 was promoted to the role of Group Manager and Secretary & Scientific Director of the BP Commission.
He is a senior leader within the Agency and has responsibility for both the pharmacopoeia and the Agency’s regulatory laboratory testing activities.
He holds an honours degree in Chemistry and has previously worked in a variety of roles focused on analytical chemistry for both multinational pharmaceutical manufacturers and independent UK analytical laboratories.
Mrs Cathie Vielle graduated in Pharmacy in 1996 from the University of Strasbourg. Since 1996 she has held several positions in QA compliance and in supply chain departments in an international pharmaceutical company.
In September 2005, she became Head of Quality Department at a manufacturing site for worldwide markets (e.g. Europe, USA, Japan). She joined the EDQM in May 2009, as Head of the European Pharmacopoeia Department.
Erin Wang is an Associate Senior Consultant for Compendial Affairs at Eli Lilly and Company, USA. She is responsible for representing Eli Lilly and Company in global pharmacopeial related activities.
Erin received her B.S. degree from Tianjin University (China) in Material Science and Engineering, M.S. degree from Western Kentucky University (U.S.A.) in Analytical Chemistry. She was certified with U.S. Regulatory Affairs Certification in 2006.
Erin started her Lilly career as an analytical chemist for biotech API’s quality control. Subsequently, Erin managed analytical projects to support new product launch in the areas of purchased material and injectable product quality control.
Erin has been actively involved in U.S. PhRMA project team in developing ICH Q3D guideline for Elemental Impurities. She has been invited to speak at numerous global venues on a variety of compendial topics, including an emphasis on global pharmacopoeia harmonization and industry perspective for compendial requirements.
Sarita K. Acharya is a Scientific Liaison in the Department of Global Biologics at United States Pharmacopeia (USP), currently leading multiple projects including vaccines. She is a former employee of GSK Vaccines in Rockville, Maryland, Macrogenics and Janssen Pharmaceutical where she acquired vast technical experience in assay development, qualification, validation, and method transfer for both early and late stage of biologics as well as vaccine products. She is an accomplished and result-oriented individual with broad experience in product development, Quality Control (QC), CRO and GLP/GMP as well as CMC experience. She obtained her Master of Science degree in Biotech Management from University of Maryland Global Campus and her Bachelor’s degree from City University of New York Hunter College.
Svein Rune Andersen is the Head of Regulatory Affairs – Europe at CEPI, where he is responsible for supporting vaccine developers in regulatory matters and interactions with regulatory authorities globally. He is a biochemist by training and holds a PhD in Vaccinology and Immunology from University of Oslo. Before joining CEPI in February 2019, he held a position as Scientific Director at the Norwegian Medicines Agency (NOMA) where he was the head of the Department for Vaccines and Biologicals for 9 years. <br>Dr Andersen has been member of Expert Group 15 (Human Vaccine and Sera) of the European Pharmacopoeia, EDQM, since 2006. He has been the chair of Expert group 15 since 2016. <br>Dr Andersen has also been Norway’s representative to the Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), member of Vaccine Working Party (EMA), where he was acting as vicechair from 2017-2019 and member of EMA's Biologics Working Party (BWP) from 2007 to 2015.
Dr. Matthew Borer obtained his Ph.D. in Analytical Chemistry from Indiana University, Bloomington. He has subsequently dedicated his career to pharmaceutical analytical chemistry, including expertise in areas such as reference standards, compendial affairs, method development, establishing control strategies, and technical leadership. Dr. Borer is currently the senior technical and strategic leader for the global reference standard program at Eli Lilly and Company. In this role, he is responsible for all corporate reference standard materials that support drug development and manufacturing. He also is a technical consultant for the Lilly Compendial Affairs department, building relationships with global pharmacopoeia agencies and developing technical strategies associated with compendial compliance. Dr. Borer is an active volunteer at the United States Pharmacopeia, currently serving as Chair of the 2015-2020 Biologics Expert Committee 4 - Antibiotics. Dr. Borer is also a member of the China National Institutes of Food and Drug Control National Drug Reference Standards Committee. He has been invited to speak at numerous global venues on a variety of analytical chemistry topics, including an emphasis on reference standards, compendial science and strategy, standardization of bioassay tests, and metal impurity testing.
Dr Chris Burns joined NIBSC in 2005, initially as a Principal Scientist and then Head of the Endocrinology section. In 2017, he took over as Head of the Division of Biotherapeutics. He has more than 20 years’ research experience obtained initially through doctoral studies and post-doctoral academic research in the fields of diabetes and stem cells at King’s College London and more recently at NIBSC. He has published more than 50 refereed publications and sits on a number of national and international committees and advisory boards relating to medicine safety, international standardisation and the harmonisation of diagnostic tests. He works closely with the World Health Organisation, EDQM, the European and US Pharmacopoeias and the International Federation of Clinical Chemistry and Laboratory Medicine. His research interests are focused in two major areas. The first underpins the activities of the Division of Biotherapeutics at NIBSC and involves the characterisation of biological medicines such as glycoprotein hormones and monoclonal antibodies using physico-chemical and biological assays, and the development of novel and improved methods for these analyses. The second is a program of work using cellular reprogramming to generate induced pluripotent stem cells for studies into the safety of stem cell therapies.
Dr. Ganio joined the staff at ASHP as Director of Pharmacy Practice and Quality in January of 2018. As a member of the Center on Medication Safety and Quality team, his responsibilities span the practice of pharmacy and include drug shortages, pharmaceutical quality, sterile and non-sterile drug compounding practices, hazardous drug safety, and other practice-related topics.
Dr. Ganio earned his Pharm.D. from the Rutgers University Ernest Mario School of Pharmacy and his Master’s degree in Health-System Pharmacy Administration from The Ohio State University College of Pharmacy. He completed a PGY1 Pharmacy Practice residency at The Ohio State University Wexner Medical Center. Dr. Ganio is a Board Certified Pharmacotherapy Specialist (BCPS) and is a Certified Professional in Healthcare Information and Management Systems (CPHIMS).
Dr. Ganio has nearly 20 years of hospital and health-system experience. His previous job roles have included clinical pharmacy practice, pharmacy informatics and technology, and outpatient oncology pharmacy operations. He has extensive knowledge of drug shortage management, pharmaceutical quality, pharmacy informatics and automation, medication billing and reimbursement, sterile compounding, and outpatient infusion and ambulatory-care practice models.
Alistair Gibb is the Editor-in-Chief of the British Pharmacopoeia and manager within the Inspection, Enforcement and Standards Division of the Medicines and Healthcare products Regulatory Agency (MHRA). His focus as a leader is ensuring that British Pharmacopoeia standards, and their delivery, continue to support the quality of medicines in a changing pharmaceutical landscape. His current activities in this area includes the implementation of the MHRA strategy for pharmacopoeial standards for biological medicines, which focuses on collaborative models for how the MHRA’s standards can continue to support innovation and contribute to public health.
Pharmaceutical biologist and Chemist graduated from UNAM. He has degrees in "Regulation" by the Ministry of Economy and in "Editorial processes" taught by UNAM and the National Chamber of the Mexican Publishing Industry. Currently is the Technical and Publications Manager at the Pharmacopoeia of the United Mexican States. Since 1999 he has been a normative member of the COFEPRIS Subcommittee on Standardization of Health Supplies. At the Mexican Pharmacopoeia he is also the internal coordinator of the Generalities and Inclusion and Exclusion Committees, previously he has been the internal coordinator of the Additives, Critical Systems, Biotechnology Products, Interchangeability Tests, Medical Devices and Natural Products committee; also led the projects of the Herbal Pharmacopeia, and the issuance of the first Supplement specialized in medical devices. Responsible for the chapters of History and Pharmaceutical Regulation. Directly collaborated in 29 FEUM publications and in 82% of the current official Mexican health input regulations. He has been a visiting professor since 2013 in the National School of Public Health and since 2007 for the topic of Health Regulation in several universities. He has given 100 conferences in various forums on health regulation. In October 2018 he entered the National Academy of Pharmaceutical Sciences.
Susanne Keitel, PhD, is director of the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe, the oldest pan-European organisation. After 10 years in R&D in the research-based pharmaceutical industry, Dr. Keitel held a number of senior leadership positions at the Federal Institute for Drugs and Medical Devices (BfArM), Germany, including the overall responsibility for pharmaceutical quality, prior to joining the EDQM in 2007.
Dr. Keitel is a licensed pharmacist and obtained her PhD in pharmaceutics from Free Univsersity Berlin, Germany.
Sabine Kopp is Lead of World Health Organization’s (WHO) Norms and Standards for Pharmaceuticals Team. Among the various positions she held in WHO were Secretary for the International Nonproprietary Names (INN) Programme, Acting Team Coordinator for Quality Assurance and Safety of Medicines, Lead of the Medicines Quality Assurance Group, Programme Manager for the Quality Assurance and the Anticounterfeiting programmes and Acting Secretary of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). She was also actively involved in the WHO Member State mechanism on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products.
Sabine is Secretary of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and responsible for the coordination of WHO's activities related to the development and maintenance of international guidelines, GXPs, standards related to Medicines Quality Assurance and the International Pharmacopoeia, i.e. the normative work related to Medicines Quality Assurance within WHO, spanning from development and manufacturing to distribution and supply of medicines, and regulatory guidance such as stability requirements and interchangeability of multisource medicines. She also oversees WHO’s External Quality Assurance Assessment Scheme for quality control laboratories, serves as Secretary for the international meetings of world pharmacopoeias and is involved in activities aimed at enabling synergies and convergence globally.
Diana Kwan, PharmD is the scientific liaison for the Healthcare Safety & Quality Expert Committee at USP. She has been in this role for four years. Her responsibilities include providing guidance and support to the Expert Committee work plan. This includes the development and publication of USP’s independent drug classification system, USP Drug Classification (USP DC), a tool to provide guidance towards the design and comparison of balanced formularies. In addition, Dr. Kwan facilitates collaboration with stakeholders such as FDA and Institute for Safe Medication Practices (ISMP) to identify and support solutions to emerging medication safety issues. She represents USP in the CDC PROTECT meetings to protect children from unintended poisonous ingestion of medications. Dr. Kwan is passionate about solving problems and is the facilitator for her department’s IDEA meetings, to implement bottom up solutions and promote a culture of inclusion, efficiency, and performance. She is a dedicated preceptor to 4th year pharmacy school students and work with students to develop presentation and project management skills to encourage students in future non-traditional pharmacist careers.
Dr. Morris is the Executive Director of the American Association of Pharmaceutical Scientists (AAPS). She leads the staff team that supports all operational aspects of the Association and works with the AAPS Board of Directors and other Volunteer Leadership Committees on the strategic and direction-setting activities that guide the work of the scientific society. Prior to that, she was Vice President of Scientific and Regulatory Affairs at the Parenteral Drug Association (PDA). Until 2018, Dr. Morris held several scientific senior leadership positions at the United States Pharmacopeia (USP), including as the Global Head of Biologics and Senior Vice President of Compendial Science. Before joining USP in 2003, Dr. Morris worked in the biopharmaceutical industry, with an expertise focus on analytical development and product characterization. She completed her postdoctoral research at the National Institutes of Health. She holds a Ph.D. in molecular virology from the Medical University of Luebeck, Germany, and a master’s degree in biology from the Carl von Ossietzky University of Oldenburg, Germany.
Ronald T. Piervincenzi, PhD, has served as Chief Executive Officer of the United States Pharmacopeia since February 2014. Dr. Piervincenzi provides strategic leadership to USP’s global staff of over 1,200 across 10 global sites. His transformative vision has launched key USP initiatives in bringing quality across the healthcare spectrum, upholding USP’s reputation as a quality leader since its founding in 1820. Dr. Piervincenzi brings more than 25 years of industry experience across the pharmaceutical sciences, research and business strategy. Before joining USP, Dr. Piervincenzi was Vice President of Development Sciences with Biogen and was a partner and leader in McKinsey & Company's global pharmaceutical and medical products practice for over 12 years. Dr. Piervincenzi earned his M.S. and PhD from Duke University in Biomedical Engineering, with research focused on protein engineering. He is the proud co-founder and chairman of the board for the Newark Mentoring Movement.
Christian K. Schneider, M.D., is Director of the National Institute for Biological Standards and Control (NIBSC), UK, a centre of the Medicines and Healthcare products Regulatory Agency (MHRA). Previous positions include Medical Head of Division Medicines Licensing and Availability at the Danish Medicines Agency, and Head of Division "EU Co-operation/Microbiology" at the Paul-Ehrlich-Institute, the German Federal Agency for Vaccines and Biomedicines. Previous Roles at the European Medicines Agency include Chair of the Biosimilar Medicinal Products Working Party (BMWP; 2007-2016), Chair of the Committee for Advanced Therapies (CAT; 2009-2013), and co-opted member of the Committee for Medicinal Products for Human Use (CHMP; 2007-2011, co-opted for the area of "Quality and safety (biological), with expertise in Advanced Therapies - Gene, Cell and Tissue Therapies"). Christian K. Schneider was working for more than two years as a postdoctoral researcher at the Max-Planck-Institute for Neurobiology, Neuroimmunology (Martinsried, Germany), where he worked in experimental immunology in the field of T cell immunology of inflammatory myopathies and multiple sclerosis. During his clinical career, Christian K. Schneider worked in clinical immunology and hemato-oncology (Department of Internal Medicine III, University Erlangen-Nuremberg, Germany).
Brian Serumaga, PhD is the Senior Manager - Personalized Medicines for the Healthcare Safety and Quality Collaborative Group and Scientific Liaison for the Compounding Expert Committee at the United States Pharmacopoeia (USP). In this role, he manages the compounding activities at USP and coordinated the activities of the compounding expert committee which develops compounding documentary standards for the USP-NF. He has a degree in Pharmacy, Masters in Public Health and a PhD in Pharmaceutical Policy. He completed a post-doctoral fellowship in patient safety and medicines use at the University of Nottingham. He was also a fellow in pharmaceutical policy research in the Department of Population Medicine at Harvard Medical School. His practice interests are in compounding, medicines quality, safety and policy. He is a registered pharmacist in Virginia, a member of ASHP and APHA.
Dr. Marilyn Stebbins completed her undergraduate studies at UC San Diego and her Pharm.D. at UC San Francisco School of Pharmacy. After the completion of her Pharmacy Practice Residency at the UC Davis Medical Center she spent 7 years developing and implementing pharmacist-run clinics at the VA Outpatient Clinic in Sacramento. As faculty in the School of Pharmacy since 1996, Dr. Stebbins’ work has focused on developing innovative practice models in the physician group practice setting with a focus on care for under served populations. With the need for more community-based practioners her goal has been to extend her work in the physician group setting and to develop innovative team-based practice models in the ambulatory and community pharmacy setting as well as in transitions of care. Her current research interests are in comprehensive medication management in vulnerable populations and the need for an accurate medication list in all settings.
Pam Traxel serves as the Senior Vice President for ACS CAN, the advocacy affiliate of the America Cancer Society. Pam is responsible for helping ACS CAN develop relationships with companies and individuals to help further the fight against cancer through dynamic partnerships, events, and forums. Pam began her career with ACS CAN in 2007. She has been integrally involved in helping to establish ACS CAN as a nationwide advocacy organization that influences and shapes public policy at all levels of government to impact our mission and to represent the voices of all cancer patients and their families.
Manisha Trivedi is a licensed pharmacist, with a PhD in Pharmaceutical Sciences (India).
She has been with the Indian Pharmacopoeia Commission since 2012 and has served in variety of scientific roles including scientific and regulatory compliance activities related to the development and maintenance of reference standards for active pharmaceutical ingredients and impurities included in Indian Pharmacopoeia. Drafting monographs, general chapters, method development as well as verification, she has also been providing hands on training for various analytical instruments to government analysts, drug inspectors, analysts of small and medium enterprises(SME) in pharma, research scholars, students and other international delegates.
She is Deputy Quality Manager in the Reference Standard Division of IPC to ensure compliance with ISO 17025, ISO 17034 (Reference Material Producer) and ISO 17043 (Proficiency Testing Provider).
Shigeki TSUDA, MS, Pharmacist, Ministry of Health and Welfare from 1983-2004, Experienced posts such as those related to quality and safety of medicines and international affairs, PMDA from 2004-2007 as Directors of Pharmaceutical Standards Division, and International Affairs/ Human Resources Development Division. In 2007, (then) Society of Japanese Pharmacopoeia. Senior Managing Director of PMRJ (foundation) since 2012. Also serves as an associate member in 3 JP committees.
Jaap Venema is Chief Science Officer for USP. He leads the organization’s scientific strategy and is responsible for the development of quality standards for medicines, dietary supplements, food ingredients and healthcare, including collaborations with other pharmacopeia and scientific groups. Dr. Venema guides USP's exploration of emerging technologies that may inform future quality standards and oversees the development and revision of USP documentary and reference standards, which continuously evaluates and revises standards to reflect current best practice. Dr. Venema also serves as Chair of the Council of Experts. This body guides and approves the draft standards developed by USP’s numerous expert committees, comprised of nearly 1000 scientific experts from academia, industry, healthcare, as well as government agencies.
Dr. Venema’s more than 25 years’ experience in global research and development and academic research informs his scientific leadership at USP. He previously served in a variety of scientific leadership positions at Solvay, Abbott and AbbVie in drug discovery and development in vaccines, pain care and immunology, and developed a global scientific and medical strategy for biotherapeutics. Before his transition to industry, Dr. Venema was a post-doctoral fellow at the European Molecular Biology Laboratory in Heidelberg and a Fellow of the Netherlands Academy of Sciences at the Free University of Amsterdam.