This webinar discusses the strategic contributions of a contract research organization as a partner to support the clinical development process.
Between the concept of a novel chemical, biological, or advanced therapeutic medicinal product and the commercial debut of a therapeutic entity fall innumerable business decisions. Will a developer pursue an idea to fruition and seek intermittent funding for each aspect of discovery, development, manufacturing, and commercialization? Or will a sponsor opt to bring development to one of several inflection points, at which options for further development — including out-licensing, portfolio pruning, or modifications in program timelines — become viable as an alternative stratagem? Many factors play a role in the decisions, but an awareness of the strategic ramifications of clinical and regulatory insights designed to “de-risk” investment decisions is key to ensuring optimal engagement with investors, partners, and other entities interested in financially supporting, acquiring, or partnering. Indeed, lead identification and candidate optimization including choice of therapeutic target disproportionally influence the earliest stage development programs for small to midsize pharmaceutical companies, representing one of the more significant inflection points in the discovery to development transition.
The ability of a potential partner to support the clinical development process — either through a portfolio review (in the case of platform technology) or the development of a comprehensive clinical development plan — becomes a differentiator in the ability to prosecute clinical development. Strategic in addition to transactional relationships extending through discovery and development facilitate the development and commercial success of advanced technologies targeting increasingly nuanced patient populations. An ability to engage strategically, to prudently choose potential clinical indications and to create highly functional integrated project teams provides an affirmation of the often-stated adage in the financial/development community, “talent gets picked up quickly”.
Join this webinar to explore the critical role of contract research organizations in supporting the clinical development process and the strategic decisions that shape the journey from concept to commercialization in the pharmaceutical industry.
Michael F. Murphy, MD, PhD, Chief Medical and Scientific Officer, Worldwide Clinical Trials
Dr. Murphy is the Chief Medical & Scientific Officer and an original founder of Worldwide Clinical Trials, a full-service, therapeutically focused, clinical research organization active in over 60 countries with dedicated services in central and peripheral nervous system disorders, cardiometabolic disorders, immune-mediated inflammatory disorders, oncology and orphan products. He is a Founder and Research and development Editor for American Health & Drug Benefits™, and for over two decades, he has been a lecturer within the Harvard-MIT Division of Health Sciences Technology on clinical trial methodology for board-certified/board-eligible Research Fellows. He is the recipient of the Clinical Research & Excellence (CARE) Lifetime Achievement Award. PharmaVoice selected him as one of the 100 Most Inspiring People in the life-sciences industry.
Who Should Attend?
This webinar will benefit Vice Presidents, Directors, Managers, Department Heads, Scientists and Researchers working at pharmaceutical and biotechnology companies.
- Clinical affairs
- Clinical R&D
- Clinical research
- Clinical operations
- Medical affairs
- Project management
- Regulatory affairs
- Strategic planning
What You Will Learn
- Integrated project teams with complementary vision and services amplify organizational competency and highlight the importance of investing in the management of a program as much as in the drug
- One asset with multiple potential indications can be both a blessing and a liability in the absence of target segmentation and a critical review extending beyond product rationale
- A clinical development plan for each indication is a living business document, a multivariate instrument informing the timing and the extent of investment decisions, as it incorporates regulatory, clinical and commercial solutions providing maximal flexibility
Worldwide Clinical Trials
Worldwide Clinical Trials (Worldwide) is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications, from discovery to reality. Our full-service clinical development capabilities include bioanalytical laboratory services and Phase I-IV clinical trials, as well as post-approval and real-world evidence studies – all powered by our talented and accessible team of clinicians, scientists, and researchers who bring their first-hand expertise to each clinical program.
At Worldwide, we understand that each customer and project are unique, so we take a collaborative and personalized approach to identify and meet specific needs and goals. Anchored in our company’s scientific heritage, we are therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. We apply this deep therapeutic knowledge to develop flexible plans and quickly solve problems in the rapidly evolving clinical development landscape.
Our team of 3,000+ professionals spans 60+ countries, and believes that through collaboration, and a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays an important role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.