Patients diagnosed with idiopathic pulmonary fibrosis (IPF) and other rare respiratory diseases often face a poor prognosis and limited treatment options. Although the two approved IPF treatments slow disease progression, there are currently no treatments that reverse the disease or offer a cure. Similar challenges are seen across many other rare respiratory diseases.
The complexities associated with diagnosing these rare diseases, understanding their root causes, and translating preclinical findings to clinical success make these challenging diseases for drug development. However, recent advancements and strategic approaches in clinical trials are offering hope to patients that additional treatments are forthcoming.
Biopharma and Biotech R&D is undergoing a transformative shift driven by data and AI. In clinical trials, RWD and AI-enabled trial design and execution promise faster development timelines, better quality, and higher probabilities of success. Over 100 AI/ML technologies have been submitted to the US FDA; with the anticipation that use of AI optimizes drug discovery, efficacy prediction, and repurposing of existing drugs. AI efforts are focused on key value areas that include designing smarter and more efficient trials, supporting the acceleration of patient recruitment and increasing retention and AI-enabled medical writing.
Register for this webinar to explore the changing landscape, recent advancements and proven strategic approaches to overcoming clinical trial challenges in rare respiratory disease research.
- AI ,
- Biotech ,
- Chronic Lung Diseases ,
- Clinical Research ,
- Clinical Trial Acceleration ,
- Clinical Trial Design ,
- Clinical Trial Strategies ,
- Clinical Trials ,
- CRO ,
- Drug Development ,
- Drug Discovery ,
- Idiopathic Pulmonary Fibrosis ,
- IPF ,
- Life Science ,
- Lung Disease ,
- Other Software ,
- Patient Recruitment ,
- Pharma ,
- Rare Diseases/Orphan Drugs ,
- Rare Respiratory Diseases ,
- Site Selection ,
- Sites ,
- Therapeutic Areas
Speakers
Francis Jones, PhD, Executive Director, Project Management, the PPD clinical research business of Thermo Fisher Scientific
Francis Jones is an Executive Director in the Infectious, Respiratory and Critical Care Diseases group with the PPD™ clinical research business of Thermo Fisher Scientific. He has more than 25 years of drug development experience working for both pharma and CRO companies. His role at PPD focuses on respiratory clinical trial strategy development, early engagement, proposal writing and helping clients design optimized clinical trials. Francis has extensive experience leading global clinical trials across a range of respiratory indications and earned his PhD in Pharmacology from Cardiff Medical School in the United Kingdom.
Message Presenter
Terri Denissen, Senior Director, Trial Project Oversight, the PPD clinical research business of Thermo Fisher Scientific
Terri Denissen is a Senior Director of Project Management within PPD’s Infectious, Respiratory and Critical Care Diseases group with the PPD™ clinical research business of Thermo Fisher Scientific. Additionally, she serves as the IPF Indication Champion for the Respiratory Pillar. In her role, she develops and shares disease-related intelligence to support clinical trial strategy and operations. Leveraging PPD’s extensive IPF study experience, she ensures successful strategies by understanding the competitive landscape, building key relationships and staying updated on the latest research to provide valuable insights for delivering successful clinical trials.
Message Presenter
Alex Auais, MD, Executive Medical Director, Medical Science & Strategy, the PPD clinical research business of Thermo Fisher Scientific
Dr. Auais is a Pediatric Pulmonologist with two decades of experience in Respiratory Clinical Development and Medical Affairs across both large pharmaceutical and biotechnology companies. As Executive Director of Medical Science and Strategy with the PPD™ clinical research business of Thermo Fisher Scientific, he provides strategic medical guidance to sponsors in the design and execution of clinical trial protocols, drawing on PPD’s deep expertise in respiratory drug development. Dr. Auais has led efforts across a broad spectrum of respiratory conditions, including rare diseases, and played a key role in the launch of the first approved therapy for idiopathic pulmonary fibrosis.
Message Presenter
Gino Pirri, Vice President, Head of Digital Products, the PPD clinical research business of Thermo Fisher Scientific
Gino leads the strategy, development & delivery of innovative digital platforms and solutions that transform the way clinical trials are executed. With a focus on digital automation, data intelligence & AI, Gino drives the modernization of clinical research through technology that improves trial efficiency, data quality and sponsor visibility.
He brings more than 25 years of experience in product and technology leadership in clinical research, with deep expertise in patient and site-based technologies, clinical development platforms, product management and user experience innovation.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Biotech and biopharma companies interested in rare respiratory studies
- Healthcare Providers and Clinicians involved in the management of clinical research patients for respiratory diseases
- Clinical Research Investigators and Site Directors
- Patient advocacy groups
What You Will Learn
Attendees will gain insights into:
- An overview of IPF and other rare respiratory diseases, including the current landscape
- Endpoint selection considerations
- Novel technologies and advancements
- Trial design strategies to minimize participant burden and maximize enrollment in rare respiratory studies
- Harnessing AI and advanced data analytics to enable real-time monitoring and decision-making, accelerate study timelines and enhance data integrity
Xtalks Partner
The PPD clinical research business of Thermo Fisher Scientific Inc.
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, their 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, they 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, they apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.
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