What you'll learn:
- Finding and evaluating generic drug market entry opportunities
- Branded drug lifecycle management
- Find generic drug entry opportunities
- Track drugs in development and explore new indications for existing drugs
- Study failed patent challenges to develop a better strategy
- Collect competitive intelligence by examining contractual disputes
- Track litigation to anticipate early generic entry
- Find and evaluate business opportunities
- Assess levels of generic competition
- Use drug price ranges to evaluate price elasticity
- Determine optimal prices before launch
- Evaluate buyer power with data on reimbursement segmentation
- Align distribution methods with information on where and how drugs are purchased
- Evaluate branded and generic market opportunities globally
- Anticipate 505(b)(2) and biosimilar approvals
- Strengthen new formulation patents by studying prior claims and litigation
- Adapt your gmp facility to capture changes in demand with brand erosion and generic launches as drug patents expire
- Position regulatory affairs to capture emerging opportunities
- Understand the roles of patents, trade secrets, trademark, and other forms of intellectual property protection in protecting branded pharmaceutical and biotechnology drugs
- Proactively adapt sourcing, purchasing, and supply chain management to anticipate changes in supply and demand with generic drug entry
GET INSIGHTS INTO THE BIGGEST REVENUE-CHANGING EVENTS
By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
Branded drug companies can experience precipitous revenue erosion as generic drugs rapidly gain market share. All the while patients, physicians, payers, pharmacists, and other healthcare stakeholders must race to keep up.
This course answers the following questions to help you adapt:
When will key drug patents expire?
How can I write stronger patents?
How can I defeat drug patents?
How can I find, evaluate, and plan for generic market entry opportunities?
How can I find proprietary out-of-court settlements and deal terms?
Comprehensive and actionable coverage of commercial, legal, and regulatory factors builds a solid foundation for strategic thinking. Diverse case studies build on this groundwork by analyzing and explaining real-work examples to form the underpinning for your tactical plans.
*INCLUDES FREE COMPANION TEXTBOOK
This course is the product of more than twenty years of providing guidance to drug development companies and other healthcare stakeholders.
Through developing the first website on the business of biotechnology in the 1990s (now owned by the New York Times), editing and publishing the Journal of Commercial Biotechnology, and leading data analytics for a subsidiary of Scientific American, I have had the fortune of spending considerable time at the bleeding edge of the commercial side of drug development.
The motivation to develop this course comes from my experiences running DrugPatentWatch, a comprehensive platform to help identify and evaluate opportunities around drug patent expiration and generic entry. In the early 2000s the first version of DrugPatentWatch was developed in response to repeated requests to answer the simple question: “When do drug patents expire?” As the platform matured, it became apparent that there was a strong need for a single source integrating broad strategic guidance to help stakeholders throughout the drug development and delivery value chain. This course was designed to meet that need.
As with my other publications, the focus of this course is on actionable intelligence. Because the legal and regulatory underpinnings of drug development and delivery are complex and change frequently, the approach taken by this course is to explain the current state of affairs and to provide representative examples to help you develop a deep understanding so you can quickly adapt to and capitalize on future events.
A primary objective of this course is to fill gaps in knowledge, helping you leverage your expertise, without being overly exhaustive. For readers seeking greater technical depth I provide links to some of the books and web-based resources that I found helpful.
Because strategic planning for branded drugs has many similarities to finding and prioritizing generic entry opportunities, this course has relevance for generic and branded companies alike. Likewise, distributors, payers, investors, and myriad other stakeholders will also benefit by understanding the commercial dynamics of pharmaceutical and biotechnology drugs.
I hope you enjoy this course as much as I did putting it together.
About the Author:
Yali Friedman, Ph.D. has more than 20 years experience providing business intelligence to life science companies. He was recently named one of the 100 most influential people in biotechnology by Scientific American. He is also author of the MBA-level textbook Building Biotechnology and publisher of the Journal of Commercial Biotechnology.
