Navigating the Investigational New Drug (IND) Application Process

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical, Drug Discovery & Development, Drug Safety,
  • Wednesday, March 06, 2024 | 1pm EST (12pm CST / 10am PST)
  • 60 min

Discover an informative webinar delving into the investigational new drug (IND) application process, a pivotal milestone in drug development. The IND application is an important milestone in drug development. An IND aims to demonstrate every aspect of the drug is safe for human exposure. Sponsors need to evaluate IND readiness to ensure they have enough data to support the initiation of clinical trials. Submission of an incomplete IND lacking important studies or data can lead to a clinical hold, thus delaying clinical trials and increasing costs for the sponsor.

Join this webinar to explore the drug development process with specific insights into The Food and Drug Administration’s (FDA) regulations, including an overview of the required content for a successful IND application and recommended interactions with the agency to ensure success.

Speaker

Paula Garcia Calavia, Pace Life Sciences

Paula Garcia Calavia, PhD, Director, Regulatory Affairs, Pace Life Sciences

Dr. Paula Garcia Calavia currently functions as Director of Regulatory Affairs at BioPharma Global, a division of Pace(r) Life Sciences. Paula has experience in drug development, particularly in medical therapeutics and diagnostics. Her regulatory education includes the completion of a drug discovery, development and regulation course at UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).

Paula has broad regulatory experience in feasibility and strategy consulting, novel data analysis, authoring regulatory documents for FDA and EMA, preparing clients for FDA meetings, interacting with regulatory agencies and leading a team of professionals focused on regulatory affairs. She has worked on diverse projects covering all stages of drug development, from early first-in-human trials to Phase III trials and a variety of indications including oncology, hematology, gastroenterology, immunology and COVID-19. She is particularly interested in drug development and regulations for rare diseases with unmet medical needs.

Before joining Pace(r), Paula worked as a Research Scientist in R&D towards the development of rapid diagnostic tests for infectious diseases, such as influenza virus and norovirus. Her academic background includes a Master of Chemistry (MChem) in Forensic and Investigative Chemistry, with a focus on drug detection and quantification from fingerprint samples, and a PhD in Cancer Bio-nanotechnology, where she worked in the development of nanoparticles for targeted photodynamic therapy using cancer in vitro models and various nanomaterials, both from the University of East Anglia in the United Kingdom.

Message Presenter

Who Should Attend?

This webinar will appeal to professionals in the following fields:

  • Regulatory affairs
  • Quality assurance (QA)
  • Quality control (QC)
  • Compliance Officers
  • Clinical research and development
  • Pharmaceutical Manufacturers
  • Clinical operations
  • Legal and compliance

What You Will Learn

Attendees will gain insights into:

  • Practical tips and recommendations for successfully navigating the IND application process including actionable insights to enhance the chances of regulatory success
  • Overview of required data to support IND opening and the initiation of clinical trials
  • Proactive measures to minimize the risk of clinical holds and prevent unnecessary clinical trial delays including tips for companies to optimize their IND submissions and improve overall efficiency
  • The recommended interactions with the FDA throughout the IND process and strategies to enhance communication with the agency for a smoother regulatory pathway

Xtalks Partner

Pace Life Sciences

Pace(r) Life Sciences provides a full suite of contract CMC development, clinical trials materials manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Our network of CDMO sites consists of GMP analytical testing laboratories and manufacturing support service centers. Our experienced, highly trained industry experts and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. More at pacelifesciences.com.

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