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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Europe Pharmacopoeia

16-17 May 2019, Geneva, Switzerland

  • Nadine Ritter

    Nadine M. Ritter, PhD

    Global Biotech Experts, LLC

    Nadine Ritter has been a protein scientist for over 30 years, with 10 years basic academic research in bone biology followed by 20+ years in biopharma CMC analytics.

    She received her BS in Biology/Chemistry from the University of Houston – Clear Lake, and her MA and PhD in Cell and Molecular Biology from Rice University, followed by an NIH postdoc at the University of Texas – Houston.

    Afterwards, she joined the biotech industry as a senior scientist at Abbott Laboratories for the development, validation, tech transfer and troubleshooting of protein analytical methods for a wide variety of proteins and peptides. Later, she became Director of Analytical Services at one of the first biopharma analytical CROs, BioReliance, where she managed contract R&D, GLP and cGMP laboratory operations in standard and state-of-the-art physiochemical and functional methods of analysis.

    In 2014, she launched Global Biotech Experts, a technical, regulatory and quality consultancy for biopharma products.

    For the last two decades, Nadine has been a writer, speaker and trainer in CMC analytical science and laboratory compliance for biotech products. She is on the Board of Directors of CASSS, and is a founding member of the CASSS CMC Strategy Forums. She is a member of the BioAB of PDA, and contributed to the PDA Method Qualification TR. She has been on the editorial board of BioProcess International from its inception, and has numerous publications on biotechnology analytical methods and laboratory quality practices.

    Nadine is frequently invited around the world to speak, consult and train for biotechnology product development, post-market changes, and compliance requirements for testing laboratories.

  • Frithjof Holtz

    Frithjof Holtz

    Merck KGaA

    Frithjof Holtz is a biologist and has been working for more than 28 years with Merck KGaA, Darmstadt, Germany, having years of experience in quality assurance and regulatory affairs. Besides experience in chemical manufacturing (excipients/APIs), he has also working experience in quality assurance for drug products (sterile/non-sterile).

    Furthermore, Frithjof has been working for more than 13 years in Regulatory Affairs (CMC) for pharmaceutical starting materials and consumables and their regulatory needs for their use in sterile/non-sterile drug product manufacturing and registration.

    Currently, he is responsible for the coordination of the advocacy & surveillance activities for Merck Life Science. In this role, he has gained additional expertise in regulations on sterile/biopharma drug substance/products. Besides this, Frithjof has many years of experience in working in industry associations as in Rx-360, APIC, EFCG, IPEC and PDA.

  • Ruth Miller

    Ruth K. Miller, JD

    PDA

    Ruth K. Miller is the Director of Regulatory Affairs for PDA. She manages the activities of PDA’s Regulatory and Quality Advisory Board, leading the team in shaping regulatory and policy documents globally. She is PDA’s primary point of communication with regulatory and policy bodies around the world.

    Before joining PDA, Ruth served in legal and regulatory roles covering the entire scope of the pharmaceutical supply chain. She was the Senior Director of Regulatory Affairs for a drug wholesaler trade association, working to impact U.S. federal and state regulations relating to the safe movement of pharmaceuticals, foods, and medical devices. She also has served as a regulatory and administrative law attorney in the U.S. Drug Enforcement Administration (DEA) Office of Chief Counsel; as Senior Counsel for the U.S. Pharmacopeia; and as an Associate in the food and drug practice of Covington & Burling, LLP, in the law firm’s Washington and London offices.

    Ruth holds a BA from The College of William and Mary in Virginia and a JD magna cum laude from the Boston University School of Law, where she was Executive Editor of the American Journal of Law and Medicine.

  • Paolo Tozzi

    Paolo Tozzi

    Novartis

    Paolo Tozzi’s career in the biopharmaceutical industry has spanned more than 18 years. So far, he has held positions of increasing responsibility in manufacturing quality including roles in validation, compliance, operations, and technology transfer.

    Currently, he is serving a dual role as Head of Pharmacopoeia Affairs and as a Global Program Manager for AS&T projects.

    Paolo received his MS in Pharmaceutical Chemistry and Technology from Siena University (Italy).

  • Ando Tsuyoshi

    Tsuyoshi Ando, PhD

    PMDA, Japanese Pharmacopeia

    Dr. Ando currently holds the position of Director, Division of Pharmacopoeia and Standards for Drug, Office of Review Management at the PMDA.

    His primary function is to manage the secretariat committee of Japanese Pharmacopeia (JP). Specific responsibilities include managing the secretariat of committee of JP and the PMDA’s technical activities in the Pharmacopeial Discussion Group (PDG), and also collaborating with WHO through the International Meeting of the World Pharmacopeias.

    Previously, he worked for PMDA as Review Director of Office of Drug IV, Review Director of Medical Devices III, Deputy Secretariat Director of Office of Review Innovation, Deputy Manager of Office of Review Management Pharmaceutical Affairs Consultation Group on R&D Strategy, Reviewer of Office of Biologics I, and also joined ICH-S7B (Expert) and ICH-Q11 (Topic Leader).

    He holds a Ph.D. in Pharmacology from Tokyo University of Pharmacy and Life Science.

     

  • Mihaela Buda

    Mihaela Buda, PhD

    EDQM

    Mihaela Buda is a Chemist with a Ph.D. in Pharmaceutical Chemistry from the Ruprecht-Karls University of Heidelberg, Germany. Following post-doctoral research in the Institute for Pharmacy and Molecular Biotechnology at the University of Heidelberg, she joined the Institute for Reference Materials and Measurement (IRMM) of the Joint Research Centre (JRC), a Directorate-General of the European Commission (EC).

    During her time with the IRMM, she was responsible for the development and certification of reference materials for quality control and calibration in bioanalysis. In March 2013, Mihaela joined the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe in Strasbourg.

    She is a Scientific Officer in the Biologicals Division of the European Pharmacopoeia Department, with responsibility for the scientific coordination of a number of working parties including Water for Pharmaceutical Use (WAT) and Dialysis Solutions (DIA) Working Parties.

  • Kevin Carrick

    Kevin Carrick, PhD

    United States Pharmacopoeia

    Kevin Carrick is the Director of Science & Standards in Global Biologics, USP.

    He leads a team that develops Documentary standards (Chapters and monographs) and Reference Standards that support biopharmaceutical quality assessment.

    Dr. Carrick and his team work with the five USP biologics Expert Committees, multiple Expert Panels, and internal and external laboratories on development of standards for diverse biopharmaceutical from proteins to cell therapies.

  • Sabine Kopp

    Sabine Kopp, PhD

    World Health Organization

    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.

  • Riviane Matos Goncalves

    Riviane Matos Gonçalves, MSc

    Brazilian Health Regulatory Agency

    Riviane Matos Gonçalves graduated in Pharmacy with an emphasis on Food Biochemistry from the University of Minas Gerais and subsequently obtained a Master’s degree in Pharmaceutical Sciences from the University of Brasília.

    She is a Health Regulation Specialist and has worked at the Brazilian Health Regulatory Agency (Anvisa) since 2005.

    She joined The Brazilian Pharmacopoeia in 2014. Since then, she has worked in the department of the Brazilian Pharmacopoeia Coordination in Anvisa.

    Riviane is currently a member of The Brazilian Nonproprietary Name Expert Committee of Brazilian Pharmacopoeia (CTT DCB) and offers executive support to The Pharmacognosy1 and The Herbal Medicines2 Expert Committees.

    1 Expert Committee responsible for chapters and monographs on Herbal Medicines in The Brazilian Pharmacopoeia

    2 Expert Committee responsible for the National Formulary on Herbal Medicines and The National Memento on Herbal Medicines

  • Aoife Mee

    Aoife Mee

    Novartis

    Aoife Mee is currently working as a specialist Project Lead for the reference standards program in Novartis.

    Aoife joined Novartis in 2007 and held various positions of increasing responsibility in QA/ QC including roles in stability, compliance and operations.

    In 2015, she joined the Novartis in-house reference standards program as team lead at the analytical services centre in Cork, Ireland and since then has been developing her expertise in reference standards qualification and quality systems for standards management.

    Since 2018, Aoife has led a global project for reference standards in Novartis, leveraging the expertise across the company to establish an enterprise Reference Standards Expert Network to drive harmonization of processes and procedures and best practice sharing within the company.

    Aoife graduated with a BSc in Biochemistry from University College Cork (Ireland).

  • Sandra Prior

    Sandra Prior, PhD

    NIBSC

    Dr. Sandra Prior joined NIBSC as Senior Scientist in 2015 working on the development of bioassay standards for therapeutic Monoclonal Antibodies (mAbs) and the investigation of structure-function in relation to the safety and efficacy of mAb products. She is also currently a member of the EDQM mAb working party expert committee. She has over 15 years’ experience in applied immunology and in vitro cell-based assay development. She obtained her PhD in 2000 from the University of Navarra (Spain) in collaboration with the Swiss Federal Institute of Technology (ETH-Zurich, Switzerland). Initially she worked in the field of bacterial vaccines investigating safety and protective mechanisms (NIBSC, Potters Bar, UK). In 2010, she joined Lonza Biologics (Cambridge, UK) where she worked as a Senior Scientist on bioactivity and immunogenicity assessment of biotherapeutics.

  • Andrew Rutter

    Andrew Rutter

    GSK

    As a Senior Director Primary Engineering Platforms, Andrew leads a team in GSK driven to change how existing and emerging technologies to transform manufacturing can be combined.

    As an Engineer, his career has taken him from Petrochemical Manufacture, via Techno-Economic Consulting, to Pharmaceutical Manufacture.

    His recent successes include delivery of a multistage continuous manufacture for one of GSK’s major products, reducing costs of manufacture whilst increasing precision.

  • Janeen Wilkinson Skutnik

    Janeen Skutnik-Wilkinson

    Biogen

    Ms. Skutnik is the Associate Director for Quality Intelligence at  Biogen, the the current Chair of IPEC Americas.  Her former positions include: Vice President at NSF DBA,.Director /Team Leader of Quality & Regulatory Policy at Pfizer, responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues. She has over 24 years experience and expertise in compendial activities, quality and regulatory policy, and has held a variety of positions with responsibilities in documentation, change control, analytical method validation and product launch. Ms. Skutnik earned a Bachelors of Science from the University of Connecticut in 1994. She is a member of the ICH IWG for ICH Q3D Elemental Impurities, and was also on the EWG for Q3D. She was the Chair of PhRMA’s Compendial Liaison Team (2000-2012); and the PhRMA Topic Leader for the ICH Topic – Q4B Regulatory Acceptance of Pharmacopoeial Interchangeability. She is the IPEC Delegate to the ICH Assembly and ICH Informal Quality Discussion Group.

  • Philip Travis

    Philip Travis

    Pfizer

    Philip Travis is Manager/Team Leader for Pfizer’s Compendial Affairs Group located in Parsippany, New Jersey, USA. He holds a BSc from the Pennsylvania State University.

    From 1996 to 2002, he was an analytical chemist supporting release testing for Excipients, Active Pharmaceutical Ingredients, and Drug Products.

    In 2002, he joined MSD’s Global Compendial Affairs Group. In 2004, he transitioned to Pfizer’s Compendial Affairs Group.

    Over the past 18 years, he has been extensively involved in the development and application of global Pharmacopoeial requirements. He has worked with industry and lead activities to promote the development of appropriate public standards through the European Federation of Pharmaceutical Industries and Associations; Consumer Healthcare Products Association, and New Jersey Pharmaceutical Quality Control Association.

    Philip chairs the USP Compendial Process Improvement Project Team.