In-license and Out-license in the Biopharmaceutical Industry

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Synopsis

The course aims to equip participants with practical knowledge of the criteria needed to out-license their products successfully to pharma, biotech or drug development companies.Closely linked on the other side of the coin is what pharma companies look for when they in-license products; what their evaluation criteria are and how they go about the process of a multi-million dollar deal.

This is a hands-on programme under the guidance of trainers who are making in-licensing and out-licensing deals actively and globally. Uniquely, we will have two trainers, a scientist evaluator and a seasoned business developer who will spar and challenge each other (and the participants!) through real life case studies. We will illustrate the differences in thinking about the opportunities, but with the common objective of value-add and developing a successful product that can ultimately help patients. You will appreciate the need to work as a multidisciplined team to in and out-license successfully.

We will touch on the cultural differences between the West and the East in their approaches to marketing and licensing their products, as well as how to make a compelling pitch. Participants are welcome to bring their own licensing case study and get tips on how to make them attractive and compelling to a partner and how to make a successful deal! If you would like to take advantage of this opportunity, please contact the trainers in advance for a brief of the case. Your chance to receive a no-obligation consultancy! For a limited follow-up period, the trainers will offer to coach and mentor participants.

Objectives

After the in-licensing module you should have an in-depth understanding of:

1.	How in-licensing could contribute to the depth and breadth of your company’s assets and objectives
2.	What internal and external expertise you need to conduct an evaluation and due diligence
3.	What data is essential and compelling to a pharma or drug developer
4.	What are the deliverables after a due diligence
5.	Identifying and contacting the appropriate individuals within organisations

After the out-licensing module you should have an in-depth understanding of:

1.	What internal homework you need to conduct before out-licensing
2.	Who should be involved in the process, how to get their buy-in and how to pitch
3.	The entire process of planning and strategy development for out-licensing a product
4.	Professional preparation of all the necessary and compelling out-licensing material
5.	Identifying and contacting the appropriate individuals within organisations

Course Outline

IN-LICENSING CURRICULUM

1.	Why In-license?
2.	Where to find these opportunities?
3.	Setting up an internal Knowledge Warehouse
4.	The steps in the evaluation and the due diligence of a product or technology What to look for in Manufacturing, Preclinical, Clinical, Regulatory, Commercial and Intellectual Property? Where were the data generated? Is the data robust? Is the scientific data compatible with regulatory requirements at the FDA or EMEA or a Health Authority? What additional scientific data are needed to convince partners and or health authorities? Coming up with an R&D programme and resources needed. What is the minimum IND package required? How to bridge gaps? Is the product / technology really in the stage that the licensor thinks it is? Role of Material Transfer Agreements, Feasibility Studies and Options Identifying the risks and structuring a deal to mitigate the risks & deal concepts Benchmarking using business intelligence

OUT-LICENSING CURRICULUM

1.	Why Out-License
2.	Preparing the Licensing-out package Prioritise your out-licensing objectives and relevant conceptual deal structures Have a deep understanding of the scientific and commercial opportunity of your product in the marketplace Realistic expectations of your product; development stage, attributes and weaknesses - What resources will it take to get your product to the market? - Consolidating and analysing your data. Do you need to supplement it?
3.	Create the Licensing-out package How to get buy-in from the Project Team, form the core out-licensing team Prepare a non-confidential Teaser. Differentiate your product and company Prepare target product profile and confidential-data in a virtual dataroom Prepare Legal documents, CDA, MTA, Term sheets, Heads etc
4.	Prospecting and Pre-partnering discussions Identify and attract prospective partners Get to the right evaluators, form networks, gather intelligence throughout process Refine licensing strategy and define timelines

Training Methodology

The trainers will use real-life projects, focus on operations and real case studies, at different stages of development as well as contributed cases. Active participation is encouraged to make the curriculum memorable and implementable in your daily work. Critical and risk analyses, as well as macro and medium term business planning will be stressed.

The BD&L courses are designed to cover the entire spectrum of Business Development & Licensing (BD&L) in the pharma industry. Follow up modules will cover other aspects of the BD&L profession like communications, business intelligence, risk evaluation, valuation, legal and IP strategies. All these modules have curriculums that are practically designed with the company’s business and corporate development objectives and strategies as a focal point.

Special Discount

Public rate	Early Bird Discount	Corporate Discount	NUS Staff / Student	NUS Alumni
$3,500	15% discount Registration must be made before 10 Oct 2009	5% discount Applicable only for group sign ups of minimum 3 pax	20% discount	10% discount

*Kindly note that the discount does not stack. Registrants are entitled to privileges under one discount tier only.