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Accelerating CMC Workshop

Innovation and Convergence in a post COVID-19 world


Speakers

  • Ben  Thompson

    Ben Thompson

    • Vice President, CMC and Non-clinical Regulatory Affairs
    • GlaxoSmithKline, United Kingdom

    Ben is the Global Head of CMC and Nonclinical Regulatory for GSK. After completing a Bachelor’s degree in Biochemistry at the University of Cardiff, he started his career in Quality Assurance supporting Drug Substance manufacturing. After several years in the manufacturing environment, Ben moved to a role in Regulatory Affairs and over the past 15 years has held leadership roles in pre-and post-licencing of Small Molecule, Biopharmaceutical and Cell & Gene Therapy product areas, prior to his current role of leading the CMC and Nonclinical Regulatory function.

  • Frank  Montgomery, PhD

    Frank Montgomery, PhD

    • Global Head Regulatory CMC, GRAPSQA
    • AstraZeneca, United Kingdom

    Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He then moved to Ciba Central Research in Discovery Chemistry then to AstraZeneca Process R&D. Frank led the Process R&D team for AstraZeneca’s project in the FDA’s CMC pilot program for implementation of ICH Q8, leading subsequent consultations with PMDA, EMA & Health Canada. Frank moved from a technical role to Regulatory Affairs and is now Global Head Regulatory CMC for small and large molecules across AstraZeneca/Medimmune. He is a member of ICH Expert Working Group as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

  • Susanne  Ausborn, PhD

    Susanne Ausborn, PhD

    • Global Head International Regulatory Policy
    • F. Hoffmann-La Roche Ltd., Switzerland

    M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry. Susanne is with Roche since 2001, being currently Global Head International Regulatory Policy. Susanne has extensive experience with global filings, is a strong advocate for global regulatory convergence and is engaged in numerous workshops/ meetings with regulators from various emerging markets around the globe. Currently, she is the Vice Chair of EFPIA IREG, Chair of the EFPIA Russia network and member of EFPIA Middle East network.

  • Sylvie  Meillerais, MSc

    Sylvie Meillerais, MSc

    • Director Global CMC Policy
    • MSD (Europe) Inc., Belgium

    Sylvie has been engaged in regulatory policy activities for 20 years, through positions in Brussels trade associations, including EFPIA. She joined MSD as Director Global Regulatory Policy in June 2015, where she is now Global CMC Policy Director. Sylvie’s expertise and knowledge of the European pharmaceutical environment serves to drive regulatory policy activities in the areas of CMC and Quality in the EU and globally. She is an active member of the EFPIA Manufacturing and Quality Experts Group and of the Middle East network, where she leads the Life Cycle Management efforts. She is further engaged in IFPMA CMC & Quality policy activities. Sylvie holds a Maîtrise in Biochemistry from the University of Bordeaux II.

  • Ursula  Busse, PhD, MBA

    Ursula Busse, PhD, MBA

    • Head of Regulatory Intelligence & Policy
    • Boehringer Ingelheim, Germany

    Ursula is the Head of Regulatory Intelligence and Policy at Boehringer Ingelheim (BI) and in charge of global regulatory intelligence and regulatory policy activities. Prior to her current role, Ursula held leadership roles in Quality Intelligence and External Affairs, Biopharmaceutical Operations and CMC Regulatory Affairs at Novartis. Before joining Novartis in 2006, she worked for startup biotechnology companies in Canada for 10 years, in research, development, Quality Assurance and CMC Regulatory Affairs. Ursula holds a Master’s degree in Biology from Tübingen University (Germany) and a PhD in Cellular and Molecular Biology from Laval University (Québec, Canada), coupled with an MBA she earned with honors.

  • Tim  Chesworth

    Tim Chesworth

    • Senior Director Regulatory Affairs
    • AstraZeneca, United Kingdom

    Tim joined AstraZeneca in 2007 to lead a team responsible for developing delivery devices for AZ’s new drug portfolio. This encompassed all dosage forms and had a significant focus on inhalation and injection devices. Tim’s current role is to lead the Medical Devices & Combination Products group within AstraZeneca Regulatory Affairs. The group is responsible for developing and implementing regulatory strategies and processes for both new and existing medical devices and combination products. This encompasses conventional pharmaceuticals, biologics and AZ’s activities in Digital Health. Tim is a leading member of a number of medical device & combination product industry groups and associations.

  • Alastair  Nixon

    Alastair Nixon

    • Director, Submission Publishing
    • GSK, United Kingdom

    Alastair has worked in various roles in pharmaceutical product development, before moving into regulatory publishing at a major clinical research organisation. He then headed the International Regulatory Operations function at SmithKline Beecham and GSK, and as Director of Publishing, he led the UK based publishing team, working on the implementation of eCTD in the company. Alastair is now Director, Submission Standards at GSK, responsible for ensuring that GSK’s strategy with respect to electronic submissions and IDMP is aligned with external requirements. He is a member of the EFPIA IDMP Sub Group and active on several European projects, such as eAF and DADI. Alastair has a BSc (Hons) in Applied Chemistry from Aston University in B'ham.

  • Sara  Torgal, MPharm

    Sara Torgal, MPharm

    • Senior Manager, Scientific Programs
    • DIA, Switzerland

    Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for communicating with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific topics and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East region. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

  • Marianne   Ashford

    Marianne Ashford

    • Senior Principal Scientist, Advanced Drug Delivery, Pharmaceutical Sciences, R&D
    • AstraZeneca, United Kingdom

    Marianne Ashford is a Senior Principal Scientist in a global role in Advanced Drug Delivery Department within Pharmaceutical Sciences at AstraZeneca. Marianne is responsible for applying drug delivery approaches to enable the progression of innovative medicines and is working to enable novel targets through targeting and intracellular delivery. She has been instrumental in introducing nanomedicines to into the Oncology portfolio and the building of the internal capability in nanomedicines/delivery science. Marianne holds Honorary Professorships at the Universities of Nottingham and Manchester and is a Fellow of the Controlled Release Society. She serves on Editorial Boards of Journal Pharmaceutical Sciences & Journal Controlled Release.

  • Samvel  Azatyan, MD, PhD

    Samvel Azatyan, MD, PhD

    • Team Lead, Regulatory Convergence and Networks (RCN/REG)
    • World Health Organization (WHO), Switzerland

    Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 20 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.

  • Tina  Engraff

    Tina Engraff

    • Policy officer, DG Health and Food Safety,
    • Unit B5 - Medicines: policy, authorisation and monitoring, , European Commission, Belgium

  • Hugo  Hamel, MBA, MSc

    Hugo Hamel, MBA, MSc

    • Manager, Radiopharmaceuticals and Monoclonal Antibodies Division
    • Health Canada, Canada

    Mr. Hamel spent his last 20 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), where he is currently Division Manager of the Radiopharmaceuticals and Monoclonal Antibodies (Inflammation) Division. During his career with BRDD, Mr. Hamel was involved with reviewing the CMC information pertaining to CTAs, NDSs and Post-Marketing changes associated with Biotherapeutics and represented Health Canada on the WHO drafting group in charge of developing the WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products. Mr. Hamel is also a member of the ICH Q12 IWG and leads its implementation in Canada.

  • Representative Invited

    Representative Invited

    • Health Canada
  • Torsten  Kneuss

    Torsten Kneuss

    • Quality Product Steward/Head of Project Office Medical Devices
    • Bayer AG, Germany

    Torsten Kneuss studied Business Administration and Engineering. Since 1999 he has been working with pharmaceutical packaging materials, medical devices and combination products, including several years within the field of quality control, development, operations, and pharmacovigilance. Since October 2020 he is, as a Quality Product Steward Medical Devices and Head of Project Office Medical Devices, responsible for devices and combination products within Bayer AG.

  • Sau L Lee, PhD

    Sau L Lee, PhD

    • Deputy Director of Science, OPQ, CDER
    • FDA, United States

    Sau (Larry) Lee is a Senior Biomedical Research Scientist (SBRS). He is a Deputy Director of the Office of Testing and Research in the Office of Pharmaceutical Quality (OPQ), and the chair of the OPQ Emerging Technology Team. He is leading the effort in advancing OPQ research and in manufacturing science, complex drug substances and products, as well as in developing the regulatory policy, scientific standards as well as computational and modeling tools supporting quality review and inspection in OPQ. In early 2013, Larry was promoted to Expert Regulatory Scientist in recognition of his expertise in evaluation of complex drug substances and products.

  • Nawaf Matar Almutairi, MPharm

    Nawaf Matar Almutairi, MPharm

    • Regulatory Affairs Expert
    • Saudi Food and Drug Authority , Saudi Arabia

    Regulatory Affairs Expert at Saudi_FDA with a demonstrated history of working in the pharmaceutical industry . Member of ISO Committees. Skilled in Pharmaceutics, Pharmacovigilance, Healthcare, Clinical Research, and Regulatory Affairs. Strong quality assurance professional with a Master's degree focused in Pharmaceutical Sciences from King Saud University.

  • Sean  Barry, PhD

    Sean Barry, PhD

    • Executive Pharmaceutical Assessor
    • Health Products Regulatory Authority (HPRA), Ireland

    Dr Barry is an Executive Pharmaceutical assessor at the HPRA and a member of the EMA BMWP and an alternate member of the EMA BWP. His regulatory expertise includes evaluation of quality/CMC data of new product applications, scientific advice, variations and clinical trials for biological products (mAbs, recombinant proteins, biosimilars and ATMPs). He is Rapporteur/Co-Rapporteur (quality) for several EMA centralised biological products. He is actively involved in developing the use of Prior Knowledge in regulatory filings and in new regulatory approaches to address CMC challenges in accelerated and adaptive pathways. Seán has a degree in genetics from Trinity College Dublin and a PhD in Molecular Biology from University College London.

  • Christopher  Downey, PhD

    Christopher Downey, PhD

    • Review Chief, OBP, OPQ, CDER
    • FDA, United States

    Christopher (Chris) Downey is a Review Chief in FDA/CDER’s Office of Biotechnology Products (OBP). He was been with FDA since 2012, and currently oversees CMC reviews of therapeutic proteins, including new molecular entities and biosimilars. He received his PhD in Biochemistry from the University of Colorado at Boulder and did postdoctoral research at the University of Colorado and Georgetown University Medical Center.

  • Amanda  Matthews

    Amanda Matthews

    • Senior Director, GCMC for Combination Products & Medical Devices
    • Pfizer R&D, UK, United Kingdom

    Amanda has 22 years industry experience working at Pfizer, UK. Her career started as an Analytical Chemist before moving into the Regulatory group. For the past 17 years Amanda’s focus has been providing strategic support to global development programs and lifecycle management for a range of medical device and combination products. Amanda is an active participant in industry associations, namely CPC and EFPIA focusing on drug-device combinations and has significantly contributed to many advocacy position papers from Industry on this topic. Amanda is a contributor to ISO/TC84 and worked on the recent ISO 20069 standard for assessment of changes to drug delivery systems as well as contributing to ISO 11608 revisions.

  • Laurence  O'Dwyer, RPh

    Laurence O'Dwyer, RPh

    • Scientific Affairs Manager
    • Health Products Regulatory Authority, Ireland

    Laurence is a qualified pharmacist. He joined the Health Products Regulatory Authority in 2004 and worked as a quality assessor for almost 12 years before being appointed to his current role of Scientific Affairs Manager in April 2016. Laurence is actively involved in the implementation of a number of initiatives related to the HPRA’s strategic goal to support health product innovation, including the HPRA’s Innovation Office. He is also co-chair of the EU Innovation Network (EU-IN), which has a joint mandate from the European Medicines Agency and the Heads of Medicines Agencies.The EU-IN brings together representatives from innovation offices across the EU medicines regulatory network to facilitate the development of innovative medicines.

  • Matt  Popkin, PhD

    Matt Popkin, PhD

    • Director, CMC Strategy
    • GlaxoSmithKline, United Kingdom

    Matt Popkin achieved a degree in Chemistry from the University of Bristol & a PhD from University College London. Following postdoctoral research, he joined GSK to work as synthetic chemist in 2000. Since then he has worked in several roles in the CMC development and registration of novel medicines. Currently Director, CMC Strategy and Advocacy for CMC Regulatory Affairs. Matt represents GSK on the Manufacturing & Quality Expert Group of EFPIA, where he was a member of the ICH Q11 Implementation Working Group, who developed the Q&A on API Stating Materials completed in 2017. Since its inception in 2019, he has represented EFPIA on the new ICH Informal Quality Discussion Group.

  • Norman Robert Schmuff, PhD

    Norman Robert Schmuff, PhD

    • Associate Director for Science, OPMA, OPQ
    • FDA, United States

    Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He is currently the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives, including the Pharmaceutical Quality/Chemistry, Manufacturing, and Controls structured data project. He is also serves as a delegate to the International Organization for Standardization's (ISO) Technical Committee (TC 215) on health informatics which deals with the IDMP standards. Currently he is Associate Director in FDA’s Office of Process and Facilities in CDER. He has never served time in prison.

  • Christian  Wetter, PhD

    Christian Wetter, PhD

    • Technical Regulatory Advisor
    • Roche, Switzerland

    Christian Wetter is an organic chemist and holds a Ph.D. from the University of Marburg. He started his professional career at Roche in 2004 in Chemical Development before moving to Novartis to Regulatory CMC in 2009. Since 2020 he has been a Regulatory Advisor in Small Molecule Development at Roche. Christian has worked on small molecule, peptide, oligonucleotide and device development projects in various phases of development and commercial lifecycle. He is part of the European Pharma Oligonucleotide Consortium (EPOC) and is currently leading its regulatory subteam.

  • Stuart  Finnie, DrSc, MS

    Stuart Finnie, DrSc, MS

    • Director, CMC Regulatory Affairs
    • AstraZeneca, United Kingdom

    Dr Stuart Finnie is a Regulatory Affairs professional with over 20 years of experience within the Pharmaceutical Industry. Working within the field of Chemistry, Manufacturing and Controls (CMC) he has developed experience of both synthetic and biological molecules from development through to life-cycle management. Currently, he is working as a director within AstraZeneca’s Regulatory CMC Group, focussing on the life-cycle management of their biological product portfolio.

  • Bjorg  Hunter, MSc

    Bjorg Hunter, MSc

    • Department Manager, RA NextGen Drug Device
    • Novo Nordisk A/S - Soeborg - Soeborg, Denmark

    Bjorg Hunter holds a BSc in Design and Innovation Engineering from Technical University of Denmark and an MSc in Biomedical Engineering from Aarhus University, Denmark. Bjorg started her career at GSK in 2010 where she has held positions with increased resistibility stating in the device development area both in R&D and Regulatory fields. In 2020 Bjorg took up a new position in NovoNordisk where she is leading the RA Device Combination Products department within RA CMC and Devices. Bjørg has also been very active in external advocacy, including driving industry positions on behalf of EFPIA.

  • Connie  Langer, MSc

    Connie Langer, MSc

    • Director, Global CMC
    • Pfizer Inc, United States

    Connie Langer is a chemical engineer and Director at Pfizer Global Product Development in Groton, CT. Connie holds a BS and an MS, both from the University of Connecticut, and a Drug Development Certificate from Temple University. She has 23 years of increasing responsibility in the pharmaceutical industry including extensive experience implementing science- and risk-based approaches in support of innovative products. She is currently accountable to provide global regulatory strategy and submissions for investigational studies, new commercial registration applications, and license maintenance. She is a member of both ISPE PQLI® ICH Q12 and RQHC Modernization of Module 3 Working Teams and chair of the IQ ICH Q12 Working Group.

  • Wassim  Nashabeh, DrSc

    Wassim Nashabeh, DrSc

    • VP, Regulatory Policy & International Operations
    • Genentech, United States

    Dr. Wassim Nashabeh is the Vice President and Global Head of Regulatory Policy & International Operations for the Roche Pharmaceutical Group. In this capacity, Wassim has oversight of all technical outreach activities with global health authorities, industry associations and scientific organizations. Wassim is a member of the ICH Management Committee and Assembly on behalf of BIO. Wassim is a CASSS Fellow and the chair of the CASSS CMC Forum Global Advisory Board as well as a member of the APEC Regulatory Harmonization Steering Committee and Harmonization Centre, a Visiting Expert at Duke-National University of Singapore Medical University Centre of Regulatory Excellence.

  • Rodrigo  Palacios, MBA

    Rodrigo Palacios, MBA

    • Regulatory Policy Lead
    • F. Hoffmann-La Roche, Switzerland

    Rodrigo Palacios is an Associate Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA in Regulatory Technology expert groups. He is a member of the Accumulus Consortium Leadership Team and co-chairs its EU subcommittee. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

  • Dmitriy  Rozdestvensky, MD, PhD

    Dmitriy Rozdestvensky, MD, PhD

    • Head, Division for Coordination of Common Market for Drugs and Medical Devices F
    • Eurasian Economic Commission, Russian Federation

    Dr. Razhdzestvenski has over 16 years' experience in the Regulatory Affairs system. He has medical background and also graduated as a clinical pharmacologist. Starting as an assessor in the Belarus Center of Expertise and Testing in Health Service, he worked as a Head of Clinical Pharmacological Laboratory, Ministry of Health, Republic of Belarus till 2014. Since 2014 Dr. Razhdzestvenski is working at the Eurasian Economic Commission in the Division for Coordination of Common Market for Medicinal Products and Medical Devices Formation, which is coordinating activities on Common medicines market regulations development in Eurasian Economic Union.

  • Joel  Welch, PhD

    Joel Welch, PhD

    • Associate Director for Science and Biosimilar Strategy, OBP, OPQ, CDER
    • FDA, United States

    Joel Welch is the Associate Director for Science& Biosimilar Strategy in the Office of Biotechnology Products in the Office of Pharmaceutical Quality at the US Food and Drug Administration. He is responsible for assessing emerging, complex, or precedent-setting issues impacting science policies of the office with particular emphasis on the biosimilar program. He also serves as the Rapporteur for the ICH revision to Q5A(R1) and the Vice Chair for the Emerging Technology Program. In his time at FDA, he has also served as a Review Chief, Team Leader, Primary Assessor and Regulatory Project Manager. Prior to joining FDA, he spent 6 years in industry supporting late state analytical development of small molecules.

  • Mike  Abernathy

    Mike Abernathy

    • Executive Director, Global Regulatory Affairs
    • Amgen, United States

    Michael Abernathy, Executive Director, leads Amgen’s Global RA CMC function. The extent of Michael’s responsibilities traverses molecular discovery, early and late-stage clinical development and approved life-cycle programs. He also founded Amgen’s RA CMC External Engagement function targeting activities that comprise a CMC focus, promoting company and industry initiatives, engaging with Health Authorities around the world and contributing to industry organizations. In 2020, Michael was selected to the non-profit Accumulus Synergy Executive Leadership Team as the CMC Use Case Lead, focused on transforming the filing and review of CMC content into an automated and cloud-based eco-system.

  • Simon  Bennett, MSc

    Simon Bennett, MSc

    • Director, EU Regulatory Policy
    • Biogen, United Kingdom

    As Director of EU Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities. Simon started at Biogen in 2003 in the clinical group before moving into Regulatory Sciences and undertaking increasingly senior roles across regulatory product development and lifecycle management. He has been working in regulatory policy since early 2016. Prior to joining Biogen, Simon worked in medical communications in different therapeutic areas. He is a biologist by training with an MSc in medical parasitology.

  • Raphael  Sanches Pereira

    Raphael Sanches Pereira

    • Health and Regulation Expert / Office Manager
    • ANVISA, Brazil

    Manager of Office for Quality Evaluation of Small Molecules (GQMED/GGMED) since october/2019. Previously manager of Office for Quality Evaluation for Registration of Small Molecules. Also acted as deputy General Manager of General Office for Small Molecules and Biologics in 2018 and assistant for Registration Directory at ANIVSA. Previus experience in analytical method development and validation, especially degradation products, and API manufacturers representation to brazillian pharmaceutical companies.

  • Ragini  Shivji, PhD, RPh

    Ragini Shivji, PhD, RPh

    • Principal Quality Specialist
    • European Medicines Agency, Netherlands

    Ragini Shivji is a pharmacist, with a Ph.D. from the University of Nottingham, UK. She worked for a number of years for the UK MHRA as a senior pharmaceutical assessor on a range of biotechnology / biological submissions. She has worked for the European Medicines Agency for nineteen years in the Quality Office, where her role as a principal quality specialist requires input into many aspects of biotechnology / biological applications with a focus on vaccines, particularly influenza and pandemic preparedness and currently COVID-19 vaccines.

  • Jonathan  Sutch, PhD

    Jonathan Sutch, PhD

    • Medicinal Technical Specialist, BSI & Team group member
    • BSI Group, United Kingdom

    Dr Jonathan Sutch is a medicinal specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 2 years ago.

  • Diane  Wilkinson, PhD, RPh

    Diane Wilkinson, PhD, RPh

    • Senior Director, Global CMC Regulatory Affairs
    • Astrazeneca, United Kingdom

    Diane Wilkinson was awarded her PhD in Pharmaceutical biotechnology at Manchester University. A 30 year career in the Pharmaceutical Industry. A strong advocate for regulatory harmonisation, as well as the use of science, risk based CMC approaches and acceptance of these, to help bring accelerated access to medicines for global patients, Diane is a member of EFPIA biomanufacturing team, involved in 2018 workshop with EMA/FDA on CMC acceleration strategies. Diane is also a member of EFPIA IQDG, member of Vaccines Europe COVID CMC Team and is VE representative for CEPI COVID Manufacturing SWAT, collaborating with Gavi, WHO, Bill Gates Foundation, IFPMA and the CEPI Reg. Advisory Group.

  • Abdullah H. AL-Hatareshah, MSc, RPh

    Abdullah H. AL-Hatareshah, MSc, RPh

    • Executive Director for Regulatory Affairs
    • Saudi Food and Drug Authority, Saudi Arabia

  • Mohammed H. Aldosari, PhD

    Mohammed H. Aldosari, PhD

    • Biologics CMC Expert
    • Saudi Food and Drugs Authority, Saudi Arabia

    Dr. Mohammed Aldosari is a scientific assessment expert of biological medicinal products at Saudi FDA (Saudi Arabia) since 2008. Mohammed is a pharmacist by education and gained the master degree in biotechnology from Macquarie University (Australia) and doctoral degree in biopharmaceutical biotechnology from Utrecht University (Netherlands). He has been involved in the development of investigational biological drugs (Novel/Biosimilar). Mohammed has over 10 years of regulatory experience in CMC assessment for different biological medicinal products such as monoclonal antibodies, recombinant hormones/enzymes, vaccines and biosimilars. He published several scientific papers related to development and regulation of biological orphan drugs.

  • Ibrahim  Algayadh, PhD, MSc, RPh

    Ibrahim Algayadh, PhD, MSc, RPh

    • Scientific Evaluation Senior Expert
    • Saudi Food and Drug Authority, Saudi Arabia

    Dr. Ibrahim Algayadh is a Senior Expert in Drug Evaluation and Regulation at SFDA and he is registered and licensed as a Consultant Pharmacist at Saudi Commission for Health Specialties. He is a member of ICH S5 (R3). He obtained his PhD in Pharmaceutical Sciences with specialization in Pharmacology and Toxicology from the University of Louisiana, USA in 2017, having obtained his Master degree in Toxicology from the University of Birmingham in 2009 and his Bachelors from the School of Pharmacy, King Saud University. He has had a number of scientific articles published in peer-reviewed journals. Since joining the SFDA, he has been involved in several scientific evaluation, strategic projects, consultations, SOPs, guidelines and regulations.

  • Isabelle  Colmagne-Poulard, PharmD, MBA, MSc

    Isabelle Colmagne-Poulard, PharmD, MBA, MSc

    • Director, International Global Regulatory Affairs & Scientific Policy
    • Merck KGaA, Switzerland

    Isabelle has joined Merck Serono since 2005 where she has held growing managerial roles in RA and RA CMC as Head of Department. She is actively engaged in international regulatory policy as member of IFPMA Biotherapeutics WG and IFPMA Regulatory Strategy Committee since 2015. She takes part in several initiatives and sub-teams including EFPIA IREG LCM WG, and ICH Q12. Prior to joining Merck, she has worked for several Companies in areas of small and large molecules including in Clinical Development for Servier Laboratories, and assumed various manufacturing site managerial responsibilities within Sanofi GMP QA & RA. Isabelle holds a MSc and a Pharm. D from Lyon (France) coupled with an MBA from Paris (EAP) High Business School.

  • Brian  Dooley

    Brian Dooley

    • Quality Specialist
    • European Medicines Agency, Netherlands

    Brian Dooley has worked as a quality specialist in the Pharmaceutical Quality Office of EMA since 2016, working mostly on centralised marketing authorisations and scientific advice, and supporting the development of scientific guidelines by the CHMP, QWP and BWP. He has supported the ICH Q12 drafting process since 2016 and is the EU deputy topic lead in the Q12 Expert Working Group since mid-2018. From 2008 to 2016, Brian worked as a pharmaceutical assessor in the IMB/HPRA (Ireland). He holds a B.Sc. in Pharmacy (2005) and M.Sc. in Pharmaceutical Medicine (2015) both from Trinity College Dublin, Ireland.

  • Representative Invited

    Representative Invited

    • European Commission - DG SANTE
  • Musaad Saleh Al-Ghasham

    Musaad Saleh Al-Ghasham

    • Senior Scientific Evaluation Specialist
    • Saudi Food and Drug Authority , Saudi Arabia

  • Yahya I. Al-Nujaym, MBA

    Yahya I. Al-Nujaym, MBA

    • Director for Standards
    • Saudi Food and Drug Authority, Saudi Arabia

  • Abdullah M. Alrashed

    Abdullah M. Alrashed

    • Scientific Evaluation Specialist II
    • Saudi Food and Drug Authority, Saudi Arabia

    Currently the Scientific Evaluation Specialist II at the Executive Directorate of Product Quality Evaluation (Variations and Re-Registration Department of the Saudi Food and Drug Authority.

  • Mark   Pellett

    Mark Pellett

    • Director, Regulatory CMC,
    • AstraZeneca, United Kingdom

  • Milton  Bonelli, DrMed

    Milton Bonelli, DrMed

    • ICH Management Committee Member and Scientific Advice Officer
    • European Medicines Agency, Netherlands

    Dr. Bonelli is the ICH Management Committee representative for the European Medicines Agency, where he works as Scientific Advice Officer. He is a Doctor in Medicine (Univ. of Rome) specialised in clinical pharmacology and has published various articles accounting for his professional research activities. This was mostly in the area of molecular oncology and stem cells, focused on the use of patient-derived tumor samples for the development of drug screening assays. Since joining the EMA in 2011 and before moving to his current role, he has worked in (and led) the non-clinical and clinical pharmacology support office providing scientific analyses and support for initial MAs and Scientific Advice procedures.