Rewatch our Fight the Fakes Week webinar!
Event highlights
The world has never seen a global vaccine rollout on the scale of the COVID-19 response. Ten to fourteen billion doses of vaccine are estimated to be required to protect the global population against death and severe illness while controlling transmission. Vaccine manufacturers, regulatory authorities, logistics experts, healthcare systems, and healthcare practitioners are facing the challenge of producing and delivering these billions of doses while ensuring that every dose administered is safe and effective. High global demand and insufficient supply have resulted in the vastly inequitable global distribution of COVID-19 vaccines, and these factors also have created economic incentives for the deliberate falsification of vaccines.
On 6 December 2021, during the 4th Fight the Fakes Week, USP and Fight the Fakes Alliance hosted a panel discussion focusing prevention, detection and response framework to substandard and falsified medicines, building on the recently launched USP White Paper providing strategies and tools to use in global settings while confronting the expected rise in substandard and falsified COVID-19 vaccines. With the participation of the relevant stakeholders, the meeting aimed to discuss the strategies and interventions and gain insights on the problem from different regions around the world.
Agenda
Welcome
Adam is Senior Director, Access & Product Management at Medicines for Malaria Venture (MMV), a Geneva-based Product Development Partnership engaged in the discovery, development and delivery of novel antimalarial medicines. In this role he is responsible for MMV’s portfolio of in-development and launched drugs for uncomplicated malaria, and is also MMV’s lead in the area of falsified and substandard medicines.
Adam is Chair of the Fight the Fakes Alliance, a new multi-stakeholder non-profit association dedicated to the fight against substandard and falsified medicines.
In this role Sireesha oversees USP’s work with regulators and policy makers around the world as well as with multilateral organizations (such as WHO, PAHO, APEC) to help improve global health through public standards and build trust in the supply of safe, quality medicines. Sireesha also works closely with international member organizations who are part of the USP Convention, which includes patient organizations, industry associations, and governments. She represents USP in a variety of forums involving the international regulatory authorities and ministries of health, professional and trade organizations, non-governmental organizations, and the news media.
Sireesha has worked for over twenty years primarily in the Biopharmaceutical sector in the US and in the South Asia markets. She started her career with Johnson & Johnson, followed by Valeant Pharmaceuticals International, based in the US. In India, Sireesha worked at the Indian School of Business with the Dean of the ISB, in the development office. She returned to biopharmaceuticals with Dr. Reddy’s Labs in the Biologics division, as the Director, Strategic Initiatives and later as the Program Manager for two Biosimilar Programs. Later at USP in India, as Regional General Manager, South Asia, USP, Sireesha oversaw Strategic Marketing, Market Research and Analytics, USP Education programs and the Government and Stakeholder Relations functions. Her team worked with the Pharmaceutical, Biotech, Food and Dietary Supplement industries as well as Indian regulators, policy makers and trade organizations, to promote the use quality standards in drugs and food.
Sireesha has a Bachelor’s in Business Management from Bangalore University, a B.A in Economics from Rutger’s University, USA and a Post Graduate Program in Management from the Indian School of Business.
Panel Discussion
Pernette Bourdillon Esteve has over 12 years’ experience in International Public Health, operating both at technical and policy levels.
She initially joined WHO in 2012 as Analyst for the global surveillance and monitoring system for substandard and falsified (SF) medical products. Since February 2019, she leads the WHO team dealing with Incidents and SF medical products. This team analyses qualitative and quantitative data to then implement bespoke projects in countries to prevent, detect and respond to SF medical products. These findings also inform strategic policy decisions within the Member State mechanism on SF medical products.
Before joining the WHO, Pernette worked for the United Nations Office against Drug and Crime, UNITAID, and the French Foreign Affairs Ministry, and the private sector.
She trained in public health (management of health structures and organisations; logistics; etc.) and holds a Political Science Masters’ in development economics. She speaks English, French and Spanish.
Yvette Madrid, PhD is the Vaccine Programs Director within Global Health and Manufacturing Services at US Pharmacopeia. She holds over 20 years of experience in vaccines and immunization and in expanding health product access garnered through work with organizations such as International AIDS Vaccine Initiative (IAVI), PATH, UNITAID, and the World Health Organization (WHO). From 2014-2019 she was a member of WHO’s Strategic Advisory Group of Experts (SAGE) Decade of Vaccines Working group. She holds a doctorate from the Massachusetts Institute of Technology in chemical engineering.
Associate Professor in the Butler University College of Pharmacy and Health Sciences. He received his Bachelor of Science in Pharmaceutical Sciences and Doctor of Pharmacy degrees from Purdue University. He completed a PGY1 pharmacy practice and PGY2 health-system pharmacy administration residency at The Ohio State University Medical Center while also obtaining a Masters degree in Health-System Pharmacy Administration from The Ohio State University.
Dr. Hertig has lectured and published on a variety of leadership, administration, patient safety, and health policy topics, and is a member of the Editorial Advisory Board for The Joint Commission Journal on Quality and Patient Safety. He holds various national and international appointments, including advisory roles with the US Food and Drug Administration and the Patient Safety Workgroup of the International Pharmaceutical Federation.
Dr. Hertig is a member of the Board of Directors for the Alliance for Safe Online Pharmacies – Global, where he leads efforts to reduce the patient safety impact of illegal and counterfeit online drug distribution worldwide.
He has served as President of the Indiana Society of Health-System Pharmacists and is Immediate-Past Chair of the Legislative and Regulatory Council for the Indiana Pharmacist Alliance. Dr. Hertig received the Glen J. Sperandio award, honoring the Indiana Health-System Pharmacist of the year, the “Excellence in Innovation” Award, and the Medication Safety Pharmacist of the Year award in the State of Indiana.
Oksana Pyzik is the Founder of UCL Fight the Fakes chapter & Academic Chair of the wider FTF Alliance, with the organisational mission of raising awareness on substandard and falsified medical products.
She is also a UK registered Pharmacist with experience across primary care, academia and in global public health. Since 2013, Oksana has held an academic post at the UCL School of Pharmacy as a Lecturer in Global Health & Pharmacy Practice as well as Global Engagement Lead. She serves as a Global Health Advisor & sits on the Board of Trustees of the Commonwealth Pharmacists’ Association since 2017.
As a member of the WHO-FIP SF expert working group, Oksana also advises NGOs and start-ups around global health issues such as pharmacy education, access to quality medicines and digital health. In 2020, Oksana was named one of Britain’s Top 35 Women under 35 by Accenture & Management Today for her work in global health.
Maria Fernanda Hurtado serves as International Policy and Operations Director at FIFARMA. Lawyer from Universidad de los Andes in Colombia with a Master’s degrees in International Business and Intellectual Property from the London School of Economics and the University of Turin, respectively. She has built a very diverse professional profile, having the possibility of developing her career in important positions in the public and private sectors, which allows her to have a unique, comprehensive and deep vision of the challenges and opportunities of the life science world.
She believes in public-private partnerships as a driving force to successful and impactful sustainability agendas
Closing Remarks
Sireesha Yadlapalli, Vice President, International Government and Regulatory Affairs, USP
