Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Module 1

60 mins

Overview of pharmaceutical licensing

This module begins with a complete overview of pharmaceutical and biotech licensing. Once completed, you will understand the strategic importance of licensing.

• An introduction to the licensing process
• Strategic issues – Reasons for licensing
• Preparing A licensing strategy
• Product champions
• Relationships with potential partners

Module 2

120 mins

Deal structure

Licensing deals come in many shapes and sizes. In this module you will examine the types and structures of deals that are commonly used in the (bio)pharmaceutical industry.

• Examine the various deal types
• Intellectual property to be licensed
• Levels of exclusivity
• Areas covered by the agreement
• Types of income
• Duration
• Royalty Stacking

Module 3

120 mins

Legal considerations

This module provides clarity on some of the legal elements of licensing. You will learn best practice for seeking exclusive discussion and confidentiality. You will also examine the different legal factors depending on whether you are in-licensing or out-licensing.

• An overview of the legal negotiations
• Learn how to set up confidentiality
• Samples and material transfer agreements
• When should you seek exclusive discussions and option agreements?
• Termsheet
• Clauses for inclusion in a licensing agreement

Module 4

120 mins

In-licensing process

You will understand why companies in-license and the process they follow in doing so.

• Who is in-licensing and why?
• Overview of the in-licensing process
• Action list for in-licensing activities
• Searching, identifying and approaching potential partners
  • Defining search criteria
  • Identifying in-license partners
  • Targeting potential opportunities
  • What do you offer a potential partner?
  • Contacting potential partners
• Evaluating inward licensing opportunities
  • Due diligence
  • Preliminary and full evaluation
  • Review common inward licensing issues

Module 5

120 mins

Out-licensing process

You will learn why companies out-license and the process they should follow. You will learn how to arrange successful confidential and non-confidential brochures, how to make sure approaches have maximum impact.

• Who is out-licensing and why?
• Deciding when and how to out-license
• Licensing action plan and the licensing team
• Creating an outreach plan
  • Outreach strategy
  • Presentational material for products in development
  • Presentational material for marketed products
  • Identifying out-licensing partners
  • Seeking and evaluating potential partners
• Evaluating outward licensing opportunities
  • Preliminary and full evaluation
  • Review common outward licensing issues

Module 6

120 mins

Managing relationships

To create a successful partnership, it is critical for both sides to forge a strong professional relationship. In this module you will examine how best to optimise relationships with individuals and companies.

• Establishing initial contacts
• Planning company visits
• Corporate presentational material
• Corporate presentation
• Data transfer and record-keeping
• Confidentiality
• Samples and materials transfer agreements
• Negotiating techniques

Module 7

120 mins

Product Valuation

The value of the product is often the sticking point during any negotiation. Calculating the deal value is not an exact science and requires many assumptions to be made. In this module you will learn the fundamentals of valuing a licensing agreement and review a basic model.

• Understand the basics of deal valuation
• Reviewing sales trends
• Why sales of marketed products need to be doubled by a licensee
• Review and build a basic financial model
• Structuring the licensing deal between companies, covering issues such as milestone and royalty payments.

Module 8

120 mins

Alliance management post deal

Once a deal is signed the partnership between both companies begins. In this session you will learn about deal implementation and the process that occurs.

• Issues to be resolved before signature
• Internal management issues
• Building a team
• What to do if it all goes wrong
• Learn from the experience

Dr Carlos Velez is the Founder and Managing Partner of Lacerta Bio, an international consultancy specializing in both in- and out-licensing of prescription and non-prescription product candidates and commercial products, across multiple therapeutic areas and markets. He also has extensive experience in business development and licensing, such as valuation, portfolio analysis and prioritization, and business planning. He has presented courses in business development and licensing at partnering events, and at locations in Europe and Asia.

Carlos is also the co-founder of Connexin Therapeutics, a company currently raising financing for the discovery and development of retinal neuroprotectants. Prior to the formation of Lacerta Bio in 2010, he was the Director of Business Development at Penwest Pharmaceuticals, where he was responsible for the out-licensing of internally-developed 505(b)(2) programs, as well as the scouting and analysis of in-licensing opportunities in neurology. Penwest was acquired by Endo Pharmaceuticals in 2010. He was also the Chief Business Officer of Lantic Therapeutics (UK) until 2012. Other previous employers include Forest Labs, Frankel Group (now Huron Consulting) and Genencor (now Danisco).

Carlos holds a B.S. in Pharmacy from the Albany College of Pharmacy, a Ph.D. in Pharmacy from the University of North Carolina at Chapel Hill, and an MBA in Technology Management from the Rochester Institute of Technology.