Pandemic Preparedness: Agility in Vaccine, Diagnostics and Therapeutics Development

Life Sciences, Pharmaceutical, Pharma Manufacturing & Supply Chain, Drug Discovery & Development,
  • Friday, November 01, 2024 | 12pm EDT / 9am PDT / 4pm GMT / 5pm CET
  • 60 min

Pandemic preparedness is a continual process to ensure that when the need arises, drug developers, industry partners and government agencies can come together to proactively address emerging public health threats.

Close and careful coordination across stakeholders is vital to successfully addressing emergent and present threats to public health, especially when response is needed on a global scale. Key to preparation is the advanced identification of resource gaps and strategic response blind spots. This introspective analysis is critical to creating a strong foundation for robust pandemic response strategy by enabling the early identification of partners who can effectively support response efforts.

Coordinating with multiple partners, especially in times of crisis and uncertainty, is not without its challenges. This webinar will explore how a full-service clinical research organization (CRO) having contract development and manufacturing organization (CDMO) capabilities approaches pandemic preparedness to ensure a comprehensive and coordinated response with the necessary agility and speed to address public health emergencies.

The expert speakers will discuss how they can collaborate to expedite therapeutic and vaccine development when time is of the absolute essence and share real-world examples and lessons learned.

Register for this webinar today to learn how to enhance pandemic preparedness by establishing relevant partnerships that can help expedite therapeutic and vaccine development.

Speakers

Dr. Vanessa Elharrar, MD, MPH, Global Medical Officer, Vaccines and Government and Public Health Services, PPD Clinical Research Business of Thermo Fisher Scientific

Dr. Elharrar joined the PPD clinical research business of Thermo Fisher Scientific in 2016 with more than 11 years of experience at the National Institutes of Health, where she served as a Medical Officer, Deputy Branch Chief and Director of HIV therapeutics research at the Office of AIDS Research.

A Physician Executive who is board certified in Preventive Medicine and Public Health, with more than 18 years of experience in vaccines and HIV clinical research, Dr. Elharrar is an active participant and program committee member of the Boston Biotechnology Summit since 2017, helping connect European and Boston-based companies.

Dr. Elharrar holds a Bachelor of Science in Physiology from McGill University and an MD from Indiana University School of Medicine. She completed her residency in Preventive Medicine along with a Master’s degree in Public Health (MPH) at Johns Hopkins University.

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Olivia Aspite, Executive Director, Lab Operations, PPD Clinical Research Business of Thermo Fisher Scientific

Ms. Aspite has been supporting clinical trials for more than 20 years as a Vaccine Lab Scientist, Project Management Key Client Support and most recently as the Global Lead of Lab Operations supporting materials management, kitting, logistics, investigator site services and sample management for PPD Central Labs.

She has had the opportunity to support studies in all therapeutic areas, including oncology, autoimmune and infectious disease vaccine megatrials. During the COVID pandemic, she supported both vaccine and large global treatment studies.

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Jennifer Crager, Executive Director, Digital Implementation, Patient First Digital Solutions, PPD Clinical Research Business of Thermo Fisher Scientific

Ms. Crager has been in a management role within the clinical research technology space for more than 20 years. She oversees technology strategies, design and implementation for a wide range of digital solutions, including eCOA, eConsent, televisit, eSource, CTMS and wearables. She has worked at a number of solution provider companies overseeing software development, customer support, training, quality assurance, technical delivery and project management.

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Allison Grande, Senior Business Development Manager, Public Health, Thermo Fisher Scientific

Ms. Grande is a leader in the global health sector, with 15 years of experience creating innovative programs and launching new business initiatives in emerging economies. At the start of the COVID-19 pandemic, she served as Associate Director of the Global Markets Team at the Clinton Health Access Initiative, shaping the WHO’s diagnostics strategy and leading supplier negotiations to increase test allocations for lower- and middle-income countries.

In 2021, she joined Thermo Fisher Scientific and developed the Global Health Equity (GHE) business. She currently serves as Senior Manager, Public Health, leading business development and strategy for GHE and US Public Health. Allison holds a Master’s degree in International Development, specializing in Development Economics, from Johns Hopkins University School of Advanced International Studies.

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Kelly Howard, VP, Commercial Operations, VVS Global & Advanced Therapies, Thermo Fisher Scientific

Kelly Howard serves as the Vice President of Commercial Operations at VVS Global & Advanced Therapies. She is a results-driven leader with decades of experience in sales and management, supporting clients in the pharmaceutical, biotech and CDMO sectors on a global scale.

Known for her exceptional communication skills, she adeptly establishes rapport and works effectively both internally and externally to achieve mutually beneficial outcomes. Kelly holds an MS in Cellular and Molecular Biology from the University of Medicine and Dentistry of New Jersey.

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Dr. Lisa Kierstead, Executive Director, Vaccines Lab, PPD Clinical Research Business of Thermo Fisher Scientific

Dr. Kierstead’s experience spans infectious disease and oncology, including dengue, norovirus, pneumococcus, meningococcus and melanoma. She has extensive experience working with clients to move vaccine candidates through the clinical development pipeline, including regulatory submissions.

Before joining the PPD clinical research business of Thermo Fisher Scientific, Dr. Kierstead was a Research Fellow at Merck Research Laboratories in vaccines and biologics. She was responsible for the development and validation of assays and the testing of clinical samples in support of vaccine programs.

Dr. Kierstead received her PhD in Microbiology and Immunology at the Milton S. Hershey Medical Center of The Pennsylvania State University. Her studies focused on the cellular T lymphocyte responses to infection with Herpes Simplex Virus types 1 and 2.

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Pam Launt, Executive Director, Biostatistics & Programming, PPD Clinical Research Business of Thermo Fisher Scientific

Ms. Launt is an Executive Director for Biostatistics and Programming with more than 25 years of experience in clinical research. She oversees all statistical aspects for clinical trials from protocol design through to final reporting.

Ms. Launt was actively engaged in overseeing the statistical conduct for more than 20 studies during the COVID-19 pandemic, resulting in more than 15 EUA or full market approvals across more than 100 countries. The programs included umbrella designs, platform trials and basket trials, demonstrating the company’s exceptional technical expertise and adaptability in delivering operationally and inferentially seamless trial designs.

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Dr. Debra Schaumberg, VP and Global Head, Strategic Development Consulting, PPD Clinical Research Business of Thermo Fisher Scientific

An internationally recognized expert in ophthalmology clinical research, Dr. Schaumberg brings to the life sciences community more than 25 years of expertise and experience leading clinical, regulatory and medical affairs strategy. She has developed and led numerous research and development programs spanning the spectrum of early to late clinical development through medical affairs, including all aspects of evidence generation and integration for drugs, biologics, devices and diagnostics.

Dr. Schaumberg leads strategic development consulting within the PPD clinical research business of Thermo Fisher Scientific. She heads a team of senior scientific strategists and scientists who work collaboratively with biotech and biopharma clients to facilitate acceleration of access to medical products through strategic input into preclinical, clinical and regulatory strategy, driving program optimization, innovating evidence generation, and creating value through the advancement of scientific knowledge and insights to meet the needs of the clients’ internal and external stakeholders.

Previously, Dr. Schaumberg served on the faculties of Harvard Medical School and the Harvard TH Chan School of Public Health, and the University of Utah School of Medicine. She formerly served as the Global Medical Director for Ophthalmics and as the Head of Medical Evidence at Shire. She has authored hundreds of scientific publications, lectures and scientific presentations. Dr. Schaumberg received her ScD from the Harvard TH Chan School of Public Health, an MPH from the Johns Hopkins Bloomberg School of Hygiene and Public Health, a research fellowship at the Johns Hopkins School of Medicine, and OD summa cum laude from the Illinois College of Optometry.

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Who Should Attend?

This webinar will appeal to:

  • Employees of biopharma and biotech companies involved in site selection, study management and forecasting and patient recruitment for clinical research and/or clinical trial initiatives
  • Investigators/Site Directors of clinical research sites
  • Individuals involved in pandemic preparedness, emergency response to public health threats, infectious disease and vaccine research and development initiatives

What You Will Learn

Attendees will learn about:

  • The importance of pandemic preparedness and how it can be achieved
  • What it takes to manufacture pharmaceutical products and launch clinical trials during a public health emergency
  • The pivotal role of laboratory services and how scale can be achieved in the face of emergent health threats
  • How real-world evidence (RWE) and mathematical modeling capabilities have taken on new importance in expedited clinical development programs
  • How decentralized solutions ensure clinical research continues in times of uncertainty

Xtalks Partner

Thermo Fisher Scientific Inc

The PPD clinical research business is part of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, our capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, we serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, we apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.

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