Pandemic Preparedness: Managing Clinical Research During a Public Health Emergency

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical, Healthcare,
  • Monday, October 31, 2022

The unprecedented disruptions caused by the COVID-19 pandemic were felt across the drug development industry, triggering renewed interest from government, biotech and biopharma entities alike to invest in pandemic preparedness initiatives.

The PPD clinical research business of Thermo Fisher Scientific immediately recognized an industry-wide, unmet need to safeguard against future disruptions to the clinical development process and spearheaded the generation of a pandemic preparedness and rapid response delivery model. This program represents an executable action plan to deliver high-quality clinical data in the face of rapidly changing regulatory landscapes, compressed timelines and resourcing challenges.

The moderator and featured speakers will discuss how they integrated lessons learned from the COVID-19 pandemic into an operating manual to:

  • Streamline feasibility and startup processes
  • Build safeguards into bioprocess and manufacturing
  • Leverage digital tools to enhance regulatory intelligence and the patient journey
  • And more

Register for this webinar to learn what hurdles must be overcome while conducting effective clinical research in a pandemic scenario, and the advantages to having an established pandemic preparedness and rapid response model in place.

Speakers

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(Moderator) Vanessa Elharrar, MD, MPH, Vice President, Vaccines Business Strategy Lead, PPD Clinical Research, Thermo Fisher Scientific

Dr. Vanessa Elharrar brings over 16 years of clinical development experience in vaccines and HIV prevention to her current role. Trained in preventive medicine and public health, she is passionate about public health-focused research and has worked on more than 30 clinical trials to date.

Dr. Elharrar provides therapeutic expertise and early strategic guidance to vaccine clients on the successful implementation of their vaccine trials, including many COVID-19 programs. She joined the company in 2016 after spending 11 years at the National Institutes of Health where she served as a medical officer, deputy branch chief and director of HIV therapeutics research in the Office of AIDS Research. Her depth of experience managing clinical trials consists of leading Phase I-IV vaccine (SARS-CoV- 2, influenza, Zika, chikungunya, PIV, H7N9, hMPV and HIV prevention) clinical development and early engagement. She has experience in the CRO, government (NIH/NIAID), normative body (PAHO EPI) and non-profit settings and in public health, epidemiology and Phase IV planning and execution.

Dr. Elharrar holds a Bachelor of Science in physiology from McGill University, a medical degree from Indiana University School of Medicine and completed her residency in preventive medicine along with a master’s in public health at Johns Hopkins University.

Message Presenter
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Kelly Howard, Vice President, Commercial Operations Global Viral Vector Services and Advanced Therapies (mRNA, pDNA, Cell Therapy), Pharma Services, Thermo Fisher Scientific

As the senior commercial leader for the global businesses of both viral vector services and advanced therapies (pDNA, mRNA, cell therapy) groups at Thermo Fisher Scientific, Kelly leads all components of the global commercial operations team. Before this, she was the senior director of sales and an integral component of the genetic sciences leadership team for Thermo Fisher Scientific, driving business in the pharmaceutical, biotech, academic, clinical, government and public health sectors. Also of note, Kelly was part of the team which managed the Thermo Fisher Scientific COVID-19 testing response, dealing directly with private and public laboratories as well as the federal and state governments across the United States.

Kelly has strong technical expertise across multiple disciplines, including real-time polymerase chain reaction, qPCR, sanger sequencing, microarray, sample prep and next-generation sequencing (NGS) methodologies. She is highly regarded for her ability to build sales organizations and in implementing a team culture that has resulted in annually exceeding company revenue goals. She is also a skilled communicator adept at establishing rapport and collaboration across business units and the customer base.

Kelly holds her Bachelor of Science degree from Georgian Court University and a Master of Science in Molecular and Cellular Biology from the University of Medicine and Dentistry of New Jersey in addition to her mini-MBA from Rutgers University.

Message Presenter
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Jennifer Crager, Executive Director, Digital and Decentralized Solutions, PPD Clinical Research, Thermo Fisher Scientific

Jennifer Crager is the executive director of digital implementation operations within digital and decentralized solutions. In this role, she oversees the operations team who design and deploy digital solutions such as eCOA, televisits, eConsent and wearable/sensor devices.

Jennifer joined the business in 2019 and brings more than 20 years of industry experience in global research operations and eClinical technical solution strategy. Prior to that, she was head of technical solutions operations at another CRO and held leadership positions at three industry technology solutions companies focusing on the oversight of software development, customer support, training, quality assurance, technical delivery, and project management.

Message Presenter

Dr. Ilse-Maria Nolan, Senior Director, Regulatory Affairs, PPD Clinical Research, Thermo Fisher Scientific

Dr. Nolan is senior director of global regulatory affairs, and is responsible for leading the regulatory intelligence, policy and advocacy team. An industrial microbiologist and pharmacologist by training, Dr. Nolan has more than 20 years of clinical development experience, including positions of increasing responsibility at leading clinical research organizations and a top five pharmaceutical company. Through this experience, she has developed a strong track record of success in leadership, recognizing the need for and driving change, as well as policy formulation.

She is an advocate for regulatory affairs and plays an active role in industry associations, participating both as a steering committee and editorial board member. She currently serves as a member of several PPD clinical research business continuity teams, including those managing the COVID-19 pandemic and the conflict in Eastern Europe.

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Jenna McDonnell (BSc), Senior Director, Consulting, Innovation & Strategy, PPD Clinical Research, Thermo Fisher Scientific

Jenna McDonnell is senior director of consulting, innovation and strategy within digital and decentralized solutions. In this role she leads the consultancy pillar, which is driving forward the adoption of decentralized clinical trials while bringing forth innovative new solutions within the business and its clients. Jenna is the digital and decentralized solutions lead for COVID treatment and vaccine studies and is a subject matter expert in virtual sites and fully decentralized clinical trials. She joined the business in 2020 and brings 17 years of experience across clinical operations and decentralized clinical trials.

Message Presenter

Who Should Attend?

  • This webinar will appeal to:
  • Industry: Biotech and biopharma companies looking to develop assets for emerging pathogens, or that are eligible for emergency use authorization
  • Health care providers and clinicians: Involved in management of clinical research patients
  • Clinical research investigators and site directors: Exploring proactive solutions to conducting pandemic-related studies
  • Government agencies: Interested in rapid response delivery models to address public health emergencies

What You Will Learn

Attendees will gain insights into:

  • Recommended strategies for accelerating pandemic-related testing, manufacturing and clinical research programs while saving time and resources
  • How to de-risk study design with real-time global regulatory intelligence and guidance
  • Ways to use established processes to effectively run a study in a pandemic scenario
  • The advantages of having an established pandemic preparedness, rapid response plan in place before the next public health emergency

Xtalks Partner

PPD

The PPD clinical research business 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, PPD’s 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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