SMIMIL172U Deal-making in the Pharmaceutical Industry
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.
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.
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.
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
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.
- Category
- Hours
- Class Instruction
- 35
- Exam
- 17
- Preparation
- 35
- Total
- 87
- Credit
- 3 ECTS
- Type of assessment
- Written assignmentWritten Assignment, 8-15 pages
- Aid
- All aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
- Exam period
We refer to the exam plan at the MIND programme's webpage
- Re-exam
To be announced at the MIND programme's webpage.
Criteria for exam assesment
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.
Course information
- Language
- English
- Course code
- SMIMIL172U
- Credit
- 3 ECTS
- Level
- Part Time Master
- Duration
- 27-31 March 2017
- Placement
- Autumn And Spring
- Schedule
- 5 days
- Course capacity
- 30 participants
- Continuing and further education
- Price
DKK 12,900 (non-EU/EEA citizens DKK 15,051). Fee includes course materials and meals. Prices may be subject to change.
- Study board
- Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences
Contracting department
- Department of Drug Design and Pharmacology
Course responsibles
- Anette Müllertz (15-68756c7b7b6c35747c73736c797b81477a7c756b35727c356b72)
Lecturers
- Jürgen Langhärig, Vice President Business Development, Serodus
- Mikkel Dalkiær, European Patent Attorney, Larsen & Birkeholm
- Jens Aakersø, Licencing Director, Novo Nordisk A/S
- Uffe Boesen, Partner, Xplico ApS
- Brian Sørensen, Lawyer, Marselis Advokater
- Annette Møldrup, Licencing Director, Novo Nordisk A/S
- Jan Bjerrum Bach, Lawyer, Jusmedico Advokatfirma
- Niels CB Nyborg, Non-clinical Project Director, Novo Nordisk A/S
- Morten Just Petersen, Director, Astion Pharma
- Annette Lykke, Equity analyst, Handelsbanken Capital Markets
The list of lecturers may be subject to change.