For novel drugs, demonstrating clinical “proof-of-concept” (POC) is a critical milestone on the road to success. Preparing a comprehensive development plan (CDP) – one that integrates early clinical trial designs and program strategy with other key disciplines (e.g., pre-clinical, regulatory, CMC, commercial) – can shorten overall timelines, reduce costs and increase success rates. Creating a thoughtful CDP that includes Phase I hybrid trials (with enrolment of healthy subjects and patients with the target disease) can help attain the earliest possible clinical POC. Planning a successful Phase I hybrid trial requires aligning the right therapeutic area, the right molecule, the right study design and endpoints, as well as considering regulatory requirements.
This free webinar explains what a CDP is and how pharmaceutical companies create and use CDPs, focusing on the central role of clinical pharmacologists in devising efficient drug development programs. We will explain what Phase I hybrid trials look like and how they provide an important advantage in early drug development.
In this webinar, you will learn how:
- A comprehensive development plan (CDP) can increase efficiency and success rates in early drug development
- Phase I Healthy Volunteer and Patient Hybrid Trials provide signals of potential efficacy
- CDPs are prepared and how Phase I hybrid trials are designed and conducted
Speakers
Paul Rothenberg, MD, PhD, Executive Director, Product Development Strategy, Covance Inc.
Dr. Paul Rothenberg joined the pharmaceutical industry in 1997 and has designed and led numerous Phase I/IIa programs and clinical pharmacology trials.
At Janssen (2004–2017), Dr. Rothenberg supervised physicians, scientists and clinical researchers to advance novel drugs from the lab into clinical trials in several therapeutic areas. Leading the Translational Medicine group in the Janssen CV/Metabolism department, Dr. Rothenberg was instrumental in the successful development of Invokana (canagliflozin) – the first approved sodium-glucose co-transporter (SGLT2) inhibitor for treating diabetes. As a core member of Janssen’s First-in-Human Committee, he was also responsible for evaluating/approving new Phase I programs in multiple therapeutic areas.
Dr. Rothenberg also led early clinical programs for novel drugs for obesity, diabetes and immunological disorders at Merck (2000–2004). At Novartis (1997–2000), he led the early clinical program for the first-in-class DPP-IV inhibitor for diabetes and supervised the translational portfolio in endocrinology and inflammatory disorders.
Dr. Rothenberg majored in biochemistry at Cornell University, graduated from the combined MD/PhD program at the Washington University School of Medicine (St Louis), was a resident at the Brigham and Women’s Hospital, Harvard Medical School and a post-doctoral research fellow at the Joslin Diabetes Center in Boston. As a research fellow in Boston, he investigated the molecular pathophysiology of diabetic insulin resistance and continued basic lab research in hormone receptor signal transduction while being a clinical faculty member of the University of Pennsylvania School of Medicine.
Message Presenter
Amitava Ganguli, BSc (Hons/Pharm), MBChB, MRCP (Edin), Senior Medical Director, Medical & Scientific Affairs, Clinical Pharmacology Services, Covance Inc.
Dr. Amitava Ganguli is certified in clinical pharmacology and internal medicine. He currently serves as lead physician on global drug development projects for Covance, providing medical/scientific expertise to project teams. He was an honorary senior lecturer in clinical pharmacology and therapeutics at the University of Liverpool and was qualified by the MHRA to undertake First-in-Man studies. He has worked across numerous therapeutic areas and has a special interest in hybrid trials and gaining early patient data in Phase I trials.
Message PresenterWho Should Attend?
- Medical Affairs
- Project Management
- Regulatory Specialist
- Physicians
- Clinical Operations
- Commercial and Sales
- Chief Medical Officer
- Chief Development Officer
- Medical Director
- Operational Director
- Clinical Development Director
- Scientists
- Clinical Development Manager
- Procurement Manager
What You Will Learn
- A Clinical Development Plan (CDP) can increase efficiency and success rates in early drug development
- Phase I Healthy Volunteer and Patient Hybrid Trials provide signals of potential efficacy
- How CDPs are prepared and Phase I hybrid trials are designed and conducted
Xtalks Partner
Covance
Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.
Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.
Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.
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