MSc program Pharmaceutical Design and Engineering. Peter Heegaard, Head of Studies DTU Veterinary

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1 MSc program Peter Heegaard, Head of Studies DTU Veterinary

2 There is a need for Pharma graduates Pharma industry in its widest sense (see next slide) Research institutions (public and private) Consultants

3 Pharma industry Contributes to the definition of study contents and obejctives and to the adjustment of these over time Provides project proposals and space for Master thesis projects and participates as project supervisors* Teaches some parts of some of the courses *There should ideally be projects addressing all parts of the pharma process and they should be combinable into the team work of the integrated project. Master project should reflect student specialization

4 Pharma is expensive and heavy in R&D investment

5 Pharma is complicated and time consuming Drug Discovery Preclinical Clinical Trials FDA Review Scale-Up to Mfg. Post- Marketing Surveillance PRE-DISCOVERY ~ 5,000 10,000 COMPOUNDS 3 6 YEARS 250 IND SUBMITTED 5 PHASE PHASE 2 PHASE 3 NUMBER OF VOLUNTEERS ,000 5, YEARS NDA SUBMITTED ONE FDA- APPROVED DRUG YEARS INDEFINITE

6 Pharma is highly regulated

7 Pharma is changing

8 The innovation gap

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10 The master programme relates to needs of the Pharma industry Open collaboration with Pharma industry through - Input for master programme - Master thesis work (6+ months), preferably situated in industry - Post-master thesis course + teaching at specific courses Providing candidates with the skills sought for, i.e. - Specialists with a common pharma language trained in crossdisciplinary team work aiming to emulate Pharma working environment - Engineering attitude (solving problems) - International environment from the University (>30% of Masters students are foreign) - University academia focus is maintained (ideas and skills) - team-based pharma projects for Master thesis projects, continuing dialogue

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12 Grafisk kursusoversigt 1. semester 2. semester 3. semester 4. semester Introduction to Pharmaceutical Engineering (10 ECTS) Assay Technology Drug Delivery Projektkursus Micro- and Nanotechnology in Diagnostics and Medicine Kantidatspeciale (30 ECTS) Projektkursus III (5ECTS) Eukaryotic Cell Biology and Diseases Quality by Design Chemoinformatics in Drug Discovery Molecular Medical Microbiology Development and Production of Vaccines and Diagnostica Projektkursus II Valgfrie kurser Valgfrie kurser (10 ECTS) Valgfrie kurser (10 ECTS) Generelle retningskompetencer Teknologisk Specialisering Valgfrie kurser Kandidatspeciale 30 ECTS 35 ECTS 25 ECTS 30 ECTS

13 Grafisk kursusoversigt 1. semester 2. semester 3. semester 4. semester Introduction to Pharmaceutical Engineering (10 ECTS) Assay Technology Drug Delivery Projektkursus Micro- and Nanotechnology in Diagnostics and Medicine Kantidatspeciale (30 ECTS) Projektkursus III (5ECTS) Eukaryotic Cell Biology and Diseases Quality by Design Chemoinformatics in Drug Discovery Molecular Medical Microbiology Development and Production of Vaccines and Diagnostica Projektkursus II Valgfrie kurser Valgfrie kurser (10 ECTS) Valgfrie kurser (10 ECTS) Generelle retningskompetencer Teknologisk Specialisering Valgfrie kurser Kandidatspeciale 30 ECTS 35 ECTS 25 ECTS 30 ECTS

14 Integrated project with four parts Project Management I 2. Semester 3 week period: Industry presents projects Groups formed Project management techniques presented and applied Project Management II 3. Semester 13 week period: Project split up in individual work packages for each student Agreement with supervisor(s) Individual work with project Meetings with group Master Thesis (30 ECTS) 3. semester, 3 week period, 4. semester 13 week period Individual work with project Defense of project Commercialization and Patenting 4. Semester, 3 week period: Groups study commercial aspects of project Communication of scientific results through patents, scientific paper writing, business plans, and through popular media.

15 Candidate qualifications Detailed knowledge of specific parts of the pharma process (either discovery, development, production- the specialization) combined with a deep understanding of the whole pharma process An operational common pharma language Knowledge and training in mediating and optimizing pharma team work and output

16 Specific focus: Biopharma (this is generally where most new pharma development takes place + new challenges + new areas of knowledge compared to traditional DTU knowledge) Keywords: The candidates will be able to maintain a broad overview of the pharma proces and will understand methods and scientific areas across the different disciplines employed

17 The T shaped Master template Master: Common pharma language Understanding systems Understanding pharma processes Deep academic specialization skills PhD Evolving into Deeper academic specialization skills PhD generic skills (research)

18 DK Pharma industry supporting the program There is a need for candidates with specialist knowledge within discovery, development and production of drugs COMBINED with a general understanding of the whole pharma process, including discovery and design phases, targets and in vivo considerations as well as preclinical and clinical testing, IPR protection, and production, also including legislation.