Deal-making in the Pharmaceutical Industry

Course content

The course offers a comprehensive overview of pharmaceutical deal making processes on different levels of complexity, including pharmaceutical due diligence.

Pharmaceutical industry, biotech and Contract Research Organizations (CRO) often exchange pharmaceutical services, pharmaceutical inventions or potential drug candidates. Such pharmaceutical business to business (B2B) deals are often complex and require critical assessment of scientific validity, process, quality, IPR and valuation. Pharmaceutical due diligence is defined as the process in which a potential buyer investigates and evaluates the item(s) (e.g. products and services) to be exchanged in a pharmaceutical deal. A pharmaceutical due diligence often comprises non-clinical and clinical data, CMC, quality aspects, IPR, regulatory compliance and legal aspects.

The course offers you to engage in actual deal-making cases from Pharmaceutical industry, CROs and Biotech. The course is aimed at current and future leaders of pharmaceutical deal-making processes and specialists involved in any part of this.

Through experience sharing and thorough analysis of real cases, the course will support you in optimizing your specialist inputs and improve your collaborations, thus improving pharmaceutical deal-making efficiency.

Lecturers and participants in this course represent pharmaceutical industry, biotech and CROs and you will have good opportunities to network.

Education

Master's Programme in Industrial Drug Development - electives

Elective for Master of Industrial Drug Development (MIND) students and other part-time master's students at the Faculty of Health and Medical Sciences (subject to study board approval) and open for freelance students who meet the admission criteria.

The course is intended for drug development professionals who need a comprehensive overview of pharmaceutical deal-making processes on any level, including pharmaceutical due diligence.

Learning outcome

At the end of the course, students will be able to:

Knowledge

  • understand the concepts, significance and stakeholders of intellectual property rights, including amongst others, patents, freedom to operate and exclusivity

  • describe an overview of types of pharmaceutical deals and related due diligence

  • identify major phases and key challenges from relevant specialist areas to various types of pharmaceutical deal-making

  • list relevant and critical specialist areas (incl. preclinical scientific validation, preclinical and clinical safety and toxicology, manufacturing, regulatory, business and IPR) to a variety of pharmaceutical deals

  • understand the generic value chain and valuation of assets in pharmaceutical deal-making

  • recite major regulatory requirements for each specialist area, and the impact on the pharmaceutical deal-making process

 

Skills

  • demonstrate skills to represent sponsor and/or receiver (Pharmaceutical industry, Biotech or CRO) in pharmaceutical deal-making and due diligence within your specialist area

  • demonstrate a comprehensive overview of pharmaceutical deal making processes, including pharmaceutical due diligence (PDD)

  • apply benefits from a large network and experience sharing within pharmaceutical due diligence cases in own and complementary specialist areas

  • discuss and prioritize key issues for evaluation and assessment in various cases of deal-making

 

Competencies

  • integrate information, communication, specialist and process knowledge in order to manage and contribute to complex pharmaceutical deal making processes

  • identify key challenges in pharmaceutical deal making processes and to take responsibility for solving these, in cooperation with other specialists.

The course is organized as an intensive 5-day course comprising lectures, workshops and project cases.
Before start of the course, participants should prepare a case on the basis of their own experience, with regard to deal-making processes they have been involved in. The case should be in the form of a written report according to guidance that will be made available in due time before course start.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

ECTS
3 ECTS
Type of assessment
Written assignment
Written Assignment, 8-15 pages
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

To achieve the grade passed, the student shall (in an adequate level) be able to:

Knowledge

  • understand the concepts, significance and stakeholders of intellectual property rights, including amongst others, patents, freedom to operate and exclusivity

  • describe types of pharmaceutical deals and related due diligence

  • identify major phases and key challenges from relevant specialist areas to various types of pharmaceutical deal-making

  • list relevant and critical specialist areas (incl. preclinical scientific validation, preclinical and clinical safety and toxicology, manufacturing, regulatory, business and IPR) to a variety of pharmaceutical deals

  • understand the generic value chain and valuation of assets in pharmaceutical deal-making

  • recite major regulatory requirements for each specialist area, and the impact on the pharmaceutical deal-making process

 

Skills

  • demonstrate skills to represent sponsor and/or receiver (Pharmaceutical industry, Biotech or CRO) in pharmaceutical deal-making and due diligence within your specialist area.

  • demonstrate a comprehensive overview of pharmaceutical deal making processes, including pharmaceutical due diligence (PDD)

  • discuss and prioritize key issues for evaluation and assessment in various cases of deal-making

 

Competencies

  • integrate information, communication, specialist and process knowledge in order to manage and contribute to complex pharmaceutical deal making processes

  • identify key challenges in pharmaceutical deal making processes and find solutions for solving these.

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 35
  • Class Instruction
  • 35
  • Exam
  • 17
  • English
  • 87