End-to-end diagnostics implementation: Advocating for innovative solutions

Helen McDowell is a Director of Government Affairs, Access & Patient Advocacy at ViiV Healthcare and was elected as the Industry Liaison Forum industry co-chair in July 2021. Helen, who has worked in HIV for over 15 years, leads global public policy, access to medicine, advocacy and global public health initiatives, including public-private partnerships, for ViiV Healthcare. She is also an active member of GSK’s (ViiV’s majority shareholder) Global Health Leadership team.

Anton Pozniak is an Immediate Past President of the International AIDS Society. He is Consultant Physician in HIV Medicine at the Chelsea and Westminster Hospital and Professor in the Department of Clinical Research at the London School of Hygiene and Tropical Medicine UK. He became a Fellow of the Royal College of Physicians in 1996 and a life member of the British HIV Association in 2014.

Nelli Barrière is Project Manager of the Corporate Partnership Programme at IAS – the International AIDS Society. In 2016, she joined IAS to work on Industry Liaison Forum, and since then she was part of the Differentiated Service Delivery initiative and lead the Me and My Healthcare Provider campaign. Prior to IAS, she worked with Consumer Interaction department at Nestlé. She holds Master of Science in Health Economics and Health Policy from University of Lucerne.

Tammy Steuerwald is the Global Head of Regulatory Policy for Foundational Principles & Supranational Organizations. In her role, she collaborates with the global regulatory community to identify modern and flexible solutions that strengthen regulatory frameworks and speed access to quality products. Mrs. Steuerwald joined Roche in 2001 and served as the Director of Quality and Regulatory where she helped ensure compliance and advance innovation. Prior to joining Roche, she led various diagnostic labs including blood banking, hematology, coagulation, and chemistry. Mrs. Steuerwald holds a B.S. from Indiana University, and a J.D. and Health Law Certificate from the Indiana University Robert H. McKinney School of Law.

Kate Qi is a founder and CEO of SG Diagnostics, Singapore. Dr Kate is a scientist by training she has 10 years experiences in research and development of diagnostics devices. Graduated from Nanyang Technological University of Singapore, she is familiar of translating complex academic concepts into commercially successful products. She is passionate about getting high quality and accurate diagnostic solutions into the hands of those who would make the most difference. She founded SG Diagnostics in 2020, an IVD manufacturing company strategically stationed in the hub of South East Asia, aiming to address the accessibility of IVD products around the globe.

Averouz Maritz is a Quality Assurance and Regulatory Affairs Specialist at Medical Diagnostech (Pty) Ltd, South Africa. His academic background is in Biomedical Sciences and Medicines Development and he began his career as a Quality Assurance Manager at Commodity Exchange, Namibia in 2008. He then helped to establish a pharmaceutical plant for Doré Pharmaceuticals (Pty) Ltd in 2015, where he served as Research & New Business Development Executive. In 2020, he joined Cape Bio Pharms (Pty) Ltd, a biotechnology company in Cape Town, as the Head of Operations and GxP Compliance, where he helped the company design and implement its Quality Management System (QMS) and upscale from an R&D company to a Manufacturing site. Recently, he was employed by GIZ as the Lead Technical Advisor for ARV Regional Value Chain Promotion.

Mike Messenger is Head of Diagnostics at Medicines and Healthcare products Regulatory Agency (MGRA) and a visiting professor in the School of Medicine at the University of Leeds. He has worked in the Medical Technologies Industry for 20 years, with a career spanning Pharmaceuticals, Advanced Therapies, Medical Devices, In Vitro Diagnostics (IVDs) and Artificial Intelligence.

His ambition is to improve population health through the application of safe and effective medical technologies. His current role sees him leading scientific programmes to ensure safe and effective diagnostics are available to UK patients, including COVID19 tests, and developing the UK’s future IVD regulations and MHRA IVD change programme. His research focuses on refining and improving the methods, processes and environment for progressing innovation towards market approval and patient benefit.

He previously established the Leeds Centre for Personalised Medicine and Health and co-founded the National Institute for Health Research (NIHR) In-Vitro Diagnostic Co-Operative in Leeds. He has been a scientific advisor to UK, EU and Canadian government bodies, charities and the medical devices industry.

Anafi Mataka is a Project Lead at African Society for Laboratory Medicine (ASLM). He is a diagnostics expert with 17 years of experience ranging from the front line of health service delivery as a laboratory scientist to managing national, regional and international laboratory strengthening programs in limited-resource settings. At ASLM, Anafi provides leadership to several projects that include building laboratory and epidemiology workforce capacity for Antimicrobial Resistance in Africa and Asia; the accelerated adoption and implementation of SARS-CoV-2 antigen rapid diagnostic testing, including community testing for COVID -19. In addition, he is the focal point for ASLM education activities, implemented under the ASLM academy. Anafi has spent the last three years actively working within the flagship Laboratory Systems Strengthening Community of Practice (LabCoP)’s management team, fostering knowledge exchange, co-creation and joint learning among country teams across the continent and global experts.

He previously led ASLM’s work on acceleration and integrating point-of-care diagnostics tests into national health laboratory networks. Before ASLM, Anafi worked for the Elizabeth Glaser Pediatric AIDS Foundation as a country implementation manager introducing new point of care diagnostics for HIV Early Infant Diagnostic. In addition, he has served in the governments of Zimbabwe, Botswana, Eswatini in the ministries of Health.

Susie Braniff is a Scientist in the Prequalification IVD Assessment Team within the Division of Access to Medicines and Health Products at the World Health Organization. Key responsibilities of her role are coordination of the Expert review Panel for Diagnostics, team focal point for the Collaborative Registration Procedure and providing technical support for the assessment of IVDs. Prior to joining WHO in 2019, Susie was the Team Lead of the IVD Evaluations department at the National Reference Laboratory in Melbourne, Australia. This role encompassed product dossier review and laboratory performance evaluation of HIV and HCV diagnostics for the Australian Therapeutic Goods Administration and the WHO Prequalification program. In addition, Susie is an experienced training facilitator for laboratory capacity strengthening and has worked with National Health Laboratories in many countries in the Asian region to support accreditation to ISO 15189 standard.

Agnes Sitta Kijo is a Technical Officer, at the Facilitated Product Introduction (FPI) Team which is part of the Regulation and Safety Unit under the Regulation and Prequalification Department, WHO-HQ, Geneva, Switzerland. FPI Team is responsible for the Collaborative Registration Procedure for all medical products including in vitro diagnostics.

She was trained as a Pharmacist and holds Master of Science (MSc) in Pharmaceutical Technology with more than 21 years of experience in regulation of medicines and medical devices including in vitro diagnostics. During the 21 years, she held different technical, advisory and leadership roles which allows her to provide sound and relevant guidance/advice to regulators and regional harmonization initiatives globally. Agnes also has an extensive experience in medical devices regulation and regulatory harmonization initiatives for medical devices as she was previously the Manager for medical devices registration in Tanzania and the first Chair of the African Medical Devices Forum (AMDF). It was during that time when major milestones were recorded.