Diagnostics are important for the detection and prevention of disease, determination of treatment effectiveness, and improvement in overall health outcomes. As diagnostics can be used to develop an individualized treatment plan or predict a toxicity associated with a particular therapeutic, they are intimately associated with the field of personalized medicine. The ability to enhance patient care using personalized medicines has prompted pharmaceutical companies to increase their interest in the targeted therapy space. In fact, over the past 6 years, personalized medicines have represented more than 20 percent of FDA’s newly approved therapeutic molecular entities. Additionally, the diagnostic landscape is changing, with the advent of novel technologies and sequencing methods, and an increased focus on the role of software and novel algorithms.
As development accelerates, we can expect a growing need for clarity regarding regulatory submissions. For example, the co-development of a companion diagnostic to identify patients that will benefit from a new innovative treatment may present a regulatory challenge for companies wanting to bring them to market simultaneously via an accelerated approval pathway. Also, the need for rapid development of reliable diagnostics may cause companies to continually turn to regulators about the data necessary for approval.
At the NEW 2021 DIA Diagnostics and Personalized Medicine Conference, we will have an open dialogue about the challenges and trends in the development of diagnostics and personalized medicines today. Attendees will receive industry and regulatory perspectives on pathways for approval in the US and globally, the impact of potential legislative and regulatory changes, overcoming challenges in development, lessons learned from the COVID-19 diagnostic experience, and utilizing the patient voice.
Who should attend?
- Diagnostic and Personalized Medicine R&D
- Combination Product R&D
- Business Development
- Clinical Research
- Legal, Government Affairs
- Quality Assurance and Control
- Regulatory Affairs, Regulatory Operations
- Research and Development
- Identify key concerns and challenges experienced by the patient community in the use of diagnostic tests and describe mechanisms to integrate patient centricity into their development
- Explain the challenges and opportunities for the codevelopment of companion diagnostics and novel therapies for the treatment of disease
- Discuss the current and future regulatory landscapes for the approval of diagnostics tests globally
- Explain the use of digital health technologies in personalized medicine, and discuss the challenges and recent successes in their development and approval
Megan Doyle, JD, MPH • Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product
Amgen, United States
Susan Tiedy-Stevenson, MS • Senior Director
Hogan Lovells US LLP, United States
Maria C. M, Orr, PhD • Head of Precision Medicine, Biopharmaceuticals
AstraZeneca, United Kingdom
Mark Stewart, PhD • Vice President, Science Policy
Friends of Cancer Research, United States
Lakshman Ramamurthy, PhD • Head of Global Regulatory, Precision Medicine and Digital Health
GlaxoSmithKline, United States
Carly McWilliams, MBA • Head of Regulatory Policy
Roche Diagnostics, United States
Tiffany Levin, MPH • President, Association of Medical Diagnostic Manufacturers
Owner/President, 55th Parallel, LLC, United States
Donna Roscoe, PhD • Deputy Division Director, Division of Molecular Genetics and Pathology, CDRH
FDA, United States