About the Course:

This session provides profound insights into deciphering the Food and Drug Administration's biotech approval process. Robert LeBoyer -- a leading biotech analyst with nearly 25 years of experience -- discusses a variety of technology, clinical, regulatory, sales and marketing, and capital risks associated with evaluating biotech companies.

This course includes commentary on a variety of valuation issues that arise in connection with monoclonal antibodies, cell receptors, and intracellular signaling. A review of developments in cutting-edge technologies such as genomics, gene therapy and RNAi is provided. Drivers of biotech products targeted towards cancer, infectious diseases, cardiovascular diseases and orphan drugs is a particularly practical segment of this program.

This course illustrates financial analysis by providing a Product Pipeline Table, a Pipeline Valuation, a Biotech Company Revenue Projection, and a Comparable Company Table.

The following are among the issues discussed during this webinar:

• How can an analyst gain insight into the progress that a drug application is making (or failing to make) in the early phases of the drug approval process?
• How much weight should an analyst place on the recommendations of independent review panels when a drug is being reviewed for final FDA approval or rejection?
• What should an analyst look for when reviewing composition of matter patents? When reviewing therapeutic use patents?
• How import are forward and backward citations in determining the quality of a biotech company's patents?
• What kind of market surveillance reporting is required under Phase 4 of the FDA approval process?
• What impact might a biotech's dosing regimen have on the success of a new drug?
• What impact might a biotech's conflicts with other drugs have on the success of a new drug?
• How telling is the quality of a biotech company's board on the success of such biotech company's drugs?
• When can a biotech company be sued even if its drugs have gone through the FDA's approval process?

Course Leader: Robert LeBoyer, Founder & CEO, Parthenon Associates

Robert has dedicated more than 20 years to evaluating pharmaceutical and medical device companies. His research and analysis reaches beyond reviewing company financials and scientific issues. He has a keen understanding of the FDA's regulatory process as well as interpreting patent claims. He has long-standing relationships with the management teams of scores of biotech and medical device companies throughout the US and Europe.

Robert began his career at Prudential Securities where he followed biotechnology companies. He was a Senior Biotechnology Analyst at Brown Brothers Harriman; Genesis Merchant Group; Leerink Swan; Ehrenkrantz King Nussbaum; and, Medivalu. He served as Chief Financial Officer at SignPath Pharmaceuticals, Inc. and provided consulting services to the pharmaceutical and medical device industries for KPMG.

He spent two years in medical school and earned an MBA from Columbia University.

Course Length: Approx. 1.5 hours

$295.00 PER USER

Purchase Now:

Need help purchasing this course? Please contact Neomi Barazani at 609-919-1895 ext. 100 or at info@bdacademy.com.