Drug Development Immersion 2021

Drug Development Immersion is organized by Biotech Primer, Inc and will be held from Oct 20 - 21, 2021.

Who should attend:
Appropriate for those without a science background who need a foundational understanding of the drug development process.

Ideal for anyone who works in finance, law, marketing, human resources, business development, project management, IT, administrative support, supply chain, research development, non-clinical, clinical, quality assurance, regulatory affairs, policy, government relations and manufacturing.

Past participants include:
• Venture capitalists, bankers, analysts, financial managers
• Insurance brokers, real estate professionals
• Patient advocacy group staff, disease foundation members
• Policy makers, lobbyists, attorneys
• Consultants, public relations specialists, journalists
• University administrators, research institute support staff

Description:
This is a two-day, interactive course that explores the regulatory, commercial, and scientific factors that enable a drug to be successfully brought to market. Discussion features both small molecule drugs and biologics. Our instructors illustrate the corporate decision-making process with personal accounts, giving participants unique insight into strategic development. Learn from an industry expert what it takes to get a molecule from the bench into the marketplace. 

Drug Development Immersion was developed for the non-science professional who works within or services the biopharma industry.

Takeaways:
• Fluency in essential terminology and acronyms used in clinical development.
• In-depth look at the FDA and EMA regulatory process and sponsor interactions.
• Criteria for preclinical studies to support first in human clinical trials.
• Rationale, special considerations, and study design for both traditional and non-traditional clinical trial phases.
• Understanding of the launch process, life cycle management, and post-approval drug safety monitoring.

Additional details will be posted as soon as information is available.