ࡱ> NQKLMq 6bjbjt+t+5AAh)*]4444444lTL}| : : i|k|k|k|k|k|k|$P|4 { | |44 |  4 4 i|4444 i|p=vv>44i| \3{|FIFTH ULLA SUMMER SCHOOL FOR POSTGRADUATE TRAINING AND RESEARCH -LONDON, 2001- Programme and Registration Booklet We are pleased to publish this booklet which provides information on the Fifth ULLA Summer School for Postgraduate Training and Research taking place in London from 21 August to 1 September, 2001. ULLA ULLA was founded in 1990 as the European University Consortium for Pharmaceutical Research, with the initials >ULLA= representing the founding institutions of the Faculty of Pharmacy (Uppsala University), the School of Pharmacy (University of London), and the Leiden/Amsterdam Centre for Drug Research. Joining subsequently were the Royal Danish School of Pharmacy and the Faculty of Pharmacy, Universit Paris-Sud in 1996 and 1998, respectively. Under the auspices of ULLA, these six institutions comprise a distinct pharmaceutical body whose goal is to provide a united platform for the facilitation of research and the administration of support for European students of pharmacy. It aims to provide young researchers from participating countries the opportunity to meet and exchange ideas with those conducting research in similar fields. It thus encourages the future academics in pharmacy to establish a strong network of colleagues throughout Europe. Such a network will allow for the swift and easy dissemination of both research results and methodological advancements alike. ULLA recognises that the increasing demand for expertise within the methodologically diversified and technologically evolving pharmaceutical disciplines can best be satisfied by bringing together established experts and young researchers for the co-development of novel methods. Ultimately, ULLA aims to produce competent postgraduates who will furnish the ranks of both industry and academia. To achieve these objectives, ULLA activities have so far included the exchange of undergraduates, postgraduates, and staff members. ULLA also provides funding for conferences and workshops, and also organises staff meetings for the facilitation of research collaboration. Furthermore, ULLA participates in the ERASMUS/SOCRATES exchange programme for both undergraduates and postgraduates, which provides students with the opportunity for periods of study abroad. The Summer School, however, remains ULLA=s most celebrated event. Summer Schools The collaboration initiatives of ULLA culminate in the Summer School, which represents the integration of the teaching and research programmes of the participating institutions. The PhD is an important feature of all six institutions and the ULLA Summer School has, therefore, become an integral part of the study programme for all PhD students in the first two years of their training. The inaugural ULLA Summer School was hosted by London in 1993, followed with Schools in Uppsala (1995), Leiden (1997) and Copenhagen (1999). The Fifth ULLA Summer School for Postgraduate Training and Research will take place at the School of Pharmacy, University of London, from 21 August to 1 September, 2001. Acknowledgements TC \l1 "AcknowledgementsWe would like to thank the following corporate sponsors for supporting the Fifth ULLA Summer School for Postgraduate Training and Research: AstraZeneca GlaxoSmithKline Programme of the Summer School and participation TC \l1 "Programme of the Summer School and participationA range of courses will be offered at the Summer School in London. Instructors and course leaders represent the ULLA institutions, other institutions of higher education, and the pharmaceutical and biotechnology industries. The courses will cover a broad spectrum of disciplines and subjects within the pharmaceutical sciences. PhD students from the ULLA institutions and from other university institutions are expected to meet in London. Young researchers from industry will have the opportunity to participate in a part or in the whole of the Summer School. In keeping with the objectives of previous Summer Schools, each participant is encouraged to widen his or her own body of knowledge by selecting courses that are not necessarily representative of his or her own research area. Courses last from 2 a day to 2 days in duration, so participants will be able to attend seven different courses during the Summer School. Saturday, 25 August will be reserved for the ULLA Symposium Non-viral Gene Delivery. The Symposium will be chaired by Professor Alexander T. Florence, Dean of the School of Pharmacy, London. John-Paul Behr of the Universit de Strasbourg, a leading researcher in the field of non-viral gene delivery, and Claus Lehr of the University of Saarbrken, an expert on nanoparticle delivery of gene plasmid, are two of the speakers involved. Furthermore, a poster session will run in conjunction with the Symposium, and the posters themselves will be displayed for the duration of the Summer School. All participants are required to prepare a poster featuring their ongoing research. The title of the poster should be sent together with the registration form. Participants are asked to submit a one page abstract on their research topic. An abstract booklet will be distributed to all participants at the time of the Summer School. It is mandatory that both ULLA PhD students and PhD students from other universities participate in all seven course days and the Symposium/Poster Day. Soon after the application deadline the successful applicants will receive a confirmation of registration, titles of the courses on which they are enrolled, travelling information, and guidelines for the abstract and poster. A brochure containing the final programme of the Summer School, including the titles of all posters, abstracts and the exact programme for the ULLA Symposium will be distributed to students upon arrival. Course programme TC \l1 "Course programmeAll students are requested to devise their individual course programme in consultation with their supervisor. Students can select from three levels of courses: enabling (ie. Scientific Writing), general (ie. European Patenting and Intellectual Property) or advanced (ie. Pulmonary Drug Delivery). Individual course programmes can be made up from any combination of levels. All courses demand significant interaction between teaching staff and students. Depending on the availability of equipment, some courses will involve practical training and workshops. Panel discussions and group work will also form part of some courses. Once again, by attending courses with other PhD students, participants will be exposed to and be part of the international scientific scene. In this context, students and staff will have the opportunity to exchange ideas and may make plans for future research collaboration. Instructors and course leaders will be encouraged to attend other courses and to be available for discussion after their own course. GENERAL INFORMATION TC \l1 "GENERAL INFORMATION 1. Venue The Summer School will take place at: The School of Pharmacy University of London 29/39 Brunswick Square London WC1H 1AZ Tel: 44 20 7753 5856 Fax: 44 20 7753 5920 2. Accommodation Students will be housed in Commonwealth Hall, located at the following address: Commonwealth Hall 1-11 Cartwright Gardens London WC1H 9EB Tel: 44 20 7685 3500 Fax: 44 20 7383 4375 The hall is within easy walking distance of the School. Double rooms have been booked for participants, who are required to specify on the registration form their preference for sharing a room with a colleague. Morning and evening meals will be served at the hall. Coffee breaks and a light sandwich lunch will be available at the School. Instructors will be housed at the Goodenough Club, located at the following address: The Goodenough Club 23 Mecklenburgh Square London WC1N 2AD Tel: 44 20 7769 4727 Fax: 44 20 7837 9321 Website:  HYPERLINK "http://www.club.lgt.org.uk" www.club.lgt.org.uk Likewise, the Club is within easy walking distance of the School. It is also proximate to Lambs Conduit Street, a trendy London street with colourful pubs and restaurants. 3. Admission Procedure The Summer School is open to a selection of PhD students from ULLA institutions, from other institutions of higher education, and to young industrial researchers. PhDs from ULLA institutions TC \l2 "PhDs from ULLA institutionsDuring the selection procedure, the various academic backgrounds of the candidates will be taken into account. ULLA strives to include participants with many different research strengths, thus creating a diverse learning environment. All selected participants are required to be present in London during the entire period of the School and to attend seven courses, plus the Symposium and Poster Day. Students will be awarded a Summer School certificate after having attended the mandatory seven courses. To apply, please complete the enclosed form, making sure to list three courses of preference for each day in order of priority. In the event courses become full, the organisers will place students in their second or third course choice. Every effort will be made, however, to ensure students are placed in their first choice of courses. As an ULLA Summer School student, participants will receive the following: course documentation, accommodation for eleven nights, all meals, and participation in social events. All other costs are at the participant=s expense. Other students and researchers from industry TC \l2 "Other students and researchers from industryThe Summer School is open to a limited number of participants from other universities and young researchers from industry. To apply, candidates should complete the enclosed application form and submit the additional documentation needed. This includes a letter of reference from supervising academic staff that also guarantees the payment of fees. Fees TC \l2 "FeesThe cost of the full programme for external PhD students will be 750. This registration fee covers all course documentation, accommodation for eleven nights, all meals, and participation in social events. The registration fee for young researchers from industry will be 1000 and includes all the same benefits of enrolment. PhDs or young researchers wishing to attend only a selection of courses are asked to contact Mr Mark T. Thomson to arrange the appropriate fees. 3. Language All courses will be taught in English. 4. Social Programme There will be social activities organised for all participants. These will include a boat tour of the River Thames, a trip to the London Eye, and a tour of the Tower of London. Participation in these events is included in the registration fee. There will also be free time during which participants may investigate the many sights and sounds of London. 5. Important Dates Application forms must be received -on or before 18 June 2001 for ULLA PhD students. -on or before 20 July 2001 for external PhD students and young researchers from industry. Abstracts must be received -on or before 6 August 2001 from all participants. Each participant will bring a poster that will be displayed for the duration of the Summer School. Timetable 18 June 2001 Application deadline for ULLA PhD students. Late June Confirmation of registration to ULLA PhD students. 20 July 2001 Application deadline for external PhD students and young researchers from industry. Late July Confirmation of registration to external PhD students and young researchers from industry. 6 August 2001 Deadline for abstracts. 21 August 2001 Check into Commonwealth Hall. 22 August - 31 August 2001 See Summer School Programme. 1 September 2001 Check out. 6. Local coordinators The application forms from ULLA PhD students are to be sent to the local coordinators: Faculty of Pharmacy, Uppsala University: Dr Eva Brittebo School of Pharmacy, University of London: Mr Mark T. Thomson Leiden/Amsterdam Centre for Drug Research: Professor Henk Timmerman Faculty of Pharmacy, Universit de Paris Sud: Professor Denis Labarre Royal Danish School of Pharmacy: Mrs Marianne W. Jrgensen 7. Further information For further information, please contact: Mr Mark T. Thomson School of Pharmacy University of London 29/39 Brunswick Square London WC1N 1AX Tel: 44 (0)20 7753 5856 Fax: 44 (0)20 7753 5920 Email:mark.thomson@ulsop.ac.uk ULLA Executive Committee The Summer School has been brought to you by the Executive Committee of the European University Consortium for Pharmaceutical Research, the members of which are: Professor A.T. Florence (London) Professor Tony Moffat (London) Mr Mark T. Thomson (London) Professor Birthe Jensen (Copenhagen) Professor Henning Gjelstrup Kristensen (Copenhagen) Mrs Marianne W. Jrgensen (Copenhagen) Professor Gerard J. Mulder (LACDR) Professor Henk Timmerman (LACDR) Dr Henk van der Goot (LACDR) Professor Lennart Dencker (Uppsala) Dr Eva Brittebo (Uppsala) Professor Hans Lennerns (Uppsala) Ms Yvonne Andersson (Uppsala) Professor Anne-Marie Quro (Paris) Professor Denis Labarre (Paris) Professor Patrick Couvreur (Paris) Mrs Danielle Buonanno (Paris) Mrs Joelle Pornin (Paris) Participant Registration Form Personal Details Name and title:  Age:  Nationality:  Male [ ] Female [ ] Organisation/institution:  Position:  Address:   State/Country  Telephone No.:  Fax No.:  Email:  Poster Title:  For ULLA PhD students only: Name of student (if any) with whom you would like to share a room - For external PhD students and young researchers from industry: Dates of arrival and departure - Course Preferences: Please study the enclosed course programme and indicate (by number) your top three course choices for each day. Please note that ULLA PhD students are required to participate in 7 courses. Date First Choice Second Choice Third Choice Wednesday, 22 August, 2001 . . . Thursday, 23 August, 2001 . . . Friday, 24 August, 2001 . . . Tuesday, 28 August, 2001 . . . Wednesday, 29 August, 2001 . . . Thursday, 30 August, 2001 . . . Friday, 31 August, 2001 . . . Signature of Student:  Name & Signature of Supervisor:  *Note: all non-ULLA affiliated participants are required to enclose a letter of reference from their supervisor or industrial manager stating both their ability to participate in high-level scientific courses and to pay the fees. ULLA PhD students please return form to local coordinator by 18 June 2001. All other applicants return forms by 20 July 2001 to: Mr Mark T. Thomson, Centre for Practice and Policy, School of Pharmacy, University of London, 29/39, Brunswick Square, London WC1N 1AX, England, tel: 44 20 7753 5856, fax: 44 20 7753 5920, email:  HYPERLINK "mailto:cpp@ulsop.ac.uk" cpp@ulsop.ac.uk Poster abstracts should be submitted to Mr Thomson by no later than 6 August 2001 Fifth ULLA Summer School for Postgraduate Training and ResearchCourse Programme21/08/0122/08/0123/08/0124/08/0125/08/0126/08/0127/08/0128/08/0129/08/0130/08/0131/08/0101/09/01Arrive8. Combinational chemistry 2. Scientific Writing 2. Scientific WritingSymposium & Poster DayStructured Social DayStructured Social Day3. Presentation skills1. Teaching & learning strategies 3. Presentation skills 4. Development of teaching skills Depart18. Cancer Chemotherapy: Worse than the disease? 16. Apoptosis in drug discovery & safety 9. Safety assessment of medicinal products 10. Drug research in humans: Practical & ethical aspects20. Phytotherapeutics in traditional and 'Western' societies 14. Drug transport to the brain: basic aspects and therapeutic implications5. Bioinformatics 12. Macromolecules in pharmaceutical science 24. Steroid action on the brain in health and disease 15. Microdialysis in drug research 22. Induction of drug metabolism: significance for drug use and development17. Applied protein purification 6. Medicinal chemistry: Basic course 29. European patenting and intellectual property 21. Pulmonary Drug Delivery 31. Novel techniques in bioanalysis26. Collodial systems for the delivery of oligonucleotides & peptides 23. Biopharmaceutics drug classification7. Near-infrared spectroscopy 19. Drug metabolism: recent developments & special approaches 27. Colloidal carriers25. Cloning vectors & strategies for bacteria 11. Licensing human medicines 13. Genomics in drug research and development: Possibilities and pitfalls 32. Design, Synthesis and Study of Drugs Targeted to DNA28. Introduction to PK/PD30. Natural products research  Course Title: Teaching and Learning Strategies Level: Enabling Course No: 1 Instructors: Mr Ian Bates, School of Pharmacy, London Professor Margareta Hammarlund-Udenaes, University of Uppsala Ms Reena Aggarwal, School of Pharmacy, London Description: Topics to be covered: curriculum design and development: the design of any course (from 3 hours to 3 years) is dependent on the successful design of the "curriculum" for the course, which paradoxically tends to be overlooked or even omitted in many courses! This session will examine curriculum design from a theoretical and pragmatic viewpoint, drawing on the experiences of the tutors. learning objectives and learning methods: methods to construct effective learning objectives, and examine the relationship with learning objectives and effective teaching methods and assessment protocols. effective teaching: the learner, the teacher, processes, outcomes. problem based learning methods: an examination of the nature of problem based learning and application to vocational courses. Objectives: The aim of the course is to provide an opportunity to develop skills and understanding of curriculum design and development, learning methods and effective teaching. Objectives of the Course: % To enable a participant to describe the principal features of the curriculum design process. % To enable the description of the principal components of a learning objective, and to be able to construct an effective learning objective from these components. % To enable participants to relate learning objectives with learning methods and learning assessment methods. % To facilitate participants to exchange experience which can be utilised by others. Prerequisites: The course is designed to permit participation by persons with existing experience and those who are without experience, in such a way as not to impede the acquisition of useful additional skills/knowledge. The course will allow persons who wish to focus more on adult/postgraduate learning to do so. Course Title: Scientific Writing A Framework for Writing a Scientific Paper Level: Enabling Course No: 2 Instructor: Professor Tony Moffat, School of Pharmacy, London Description: The course consists of interactive lectures, exercises in writing, and group discussion sessions to critique published abstracts. The programme is as follows: Interactive lectures on the requirements of papers and how to write them. Practical exercises in writing titles, conclusions, abstracts and objectives. Writing a summary of participants projects. Getting a list of references in the required style for publication. Group discussions on what makes a good paper or abstract, and what makes bad ones. Objectives: The aim is to give an understanding of the requirements to have a scientific paper or abstract published in the scientific press, and to give practice in developing the writing skills to meet these requirements. Specific objectives are: To understand the need for concise titles and abstracts for computer searching purposes. To choose the right journal and audience for the paper. To give an exact description of the methodology. To present data informatively. To be able to write conclusions accurately. To write concisely, accurately and informatively. Prerequisites: It is preferable, but not essential, that participants have written at least a conference abstract before attending the course. Participants should bring with them an example of a well written and informative paper in their field and be able to give reasons for its selection. Course Title: Presentation Skills Level: Enabling Course No: 3 Instructors: Mr Ian Bates, School of Pharmacy, London Mr David Webb, London Region Director of Clinical Pharmacy Dr Catherine Duggan, Academic Department of Pharmacy, Saint Bartholomews Hospital Description: Evaluation of technical language and material. The poster format for presenting data. Distinction between comment, opinion and fact. The oral format for presenting data. The course will offer a series of opportunities to discover and discuss. Your colleagues on the course will have differing views about writing and data presentation; to share these within the seminar group will be a valuable exercise. There will be guidance provided on presentation skills and media selection, but remember that these are skills, and can only be understood and improved by guided practice. We will examine ways to improve data illustration and simplify the presentation of research results. Later sessions will focus on oral presentation skills, with group work directed towards presenting material. Objectives: The course will provide an opportunity to improve and develop skills in data interpretation and presentation. The course will address and engage the abilities of the individual and provide practice in scientific presentation skills The day is designed for the participants to develop skills: % you may already have well developed skills - this is a good thing and you can share your insights with others in addition to having the opportunity to concentrate on more subtle aspects. % you may feel you do not possess sufficient skills in this area - in which case you will have the opportunity to develop some insight into this area of communications in a non-threatening environment. Prerequisites: It is the intention of the organisers that the day will be both enjoyable and non-threatening; it is a day to practice in association with your colleagues. Do not expect to go home with a large batch of lecture notes, but do expect to go home thinking about communication in science. Course Title: Development of teaching skills Level: Enabling Course No: 4 Instructors: Professor Mike Simmonds, School of Pharmacy, London Dr Les Fowler, School of Pharmacy, London Description: The course will focus on the contributions that teaching assistants / demonstrators may be expected to make to the supervision of laboratory classes and short research projects for undergraduates. The course will be structured as a series of discussions to which all participants are expected to contribute. The issues to be discussed include: the ways in which people learn; the purposes of practical classes; the role and tasks of teaching assistants in a practical class; the ideal behaviour of teaching assistants in their interactions with students; handling difficult situations; the skilled use of questions to facilitate learning; monitoring small group collaborative work. A variety of trigger material will be used for the discussions, including the participants own experiences and printed descriptions or videos of case studies. Objectives: The aim of the course is to enhance the contribution that the participants will be able to make to undergraduate education in practical classes and small group discussions. The objectives are: to bring together individuals who are interested in developing their teaching skills in order to share experiences, help overcome concerns and identify examples of good teaching practice; to increase understanding of learning processes; to assist the participants in evolving ways of managing students and to enhance self-confidence as a teaching assistant; to exchange ideas and experiences with the intention of improving the fundamental design and operation of undergraduate practical classes. Prerequisites: There are no specific prerequisites. The course is aimed, primarily, at research students and post-doctoral fellows with little or no experience as teaching assistants in undergraduate practical classes. The participation of some more experienced teachers would be welcome for the added value they could bring to the discussions - please contact Professor Mike Simmonds ( HYPERLINK "mailto:mike.simmonds@ulsop.ac.uk" mike.simmonds@ulsop.ac.uk) if you come into this category and are interested. Course Title: Bioinformatics Level: General Course No: 5 Instructors: Dr Andy Wilderspin, School of Pharmacy, London Dr Flemming Steen Jorgensen, Royal Danish School of Pharmacy Dr Margot Beukers, LACDR Dr Colin James, School of Pharmacy, London Description: Morning lectures Afternoon practical The lectures will cover Bioinformatics on the Internet sequences and sequence function relationships protein structures and 3D databases homology modelling structure-based ligand design During the practical exercises the participants will work with specific problems related to protein sequence and structure using Web-based tools. Objectives: to give the participants an introduction to bioinformatics to illustrate the use of the methods by specific examples of pharmaceutical relevance to provide hands-on experience with Web-based tools The course will consist of lectures and practical exercises. Prerequisites: Basic knowledge of chemistry and biochemistry is required. Course Title: Medicinal Chemistry: Basic Course Level: General Course No: 6 Instructors: Dr. H. van der Goot, LACDR Prof. Dr. Ad Ijzerman, LACDR Prof. Dr. Henk Timmerman, LACDR Prof. Dr. R. Leurs, LACDR Description: 08.30 - 08.40 IntroductionHenk van der Goot 08.40 - 09.40 Receptors and their mechanismsRob Leurs 09.40 - 10.40 Parameters in molecular pharmacologyAd Ijzerman 10.40 - 11.00 Break 11.00 - 12.00 Drug selectivityHenk Timmerman 12.00 - 13.30 Lunch 13.30 - 15.30 Models and parameters in QSARHenk van der Goot 15.30 - 15.50 Break 15.50 - 16.50 Molecular modelling and drug designAd Ijzerman 16.50 - 17.00 General discussion Objectives: This course will introduce several fields and disciplines contributing to the progress in medicinal chemistry. Topics to be included are: Parameters in molecular pharmacology; agonists and antagonists; radioligand binding studies. New developments in molecular pharmacology; signal transfer mechanisms; second messengers; receptor desensitisation. Drug selectivity; do we need selectivity in all cases? How selectivity may be reached. Quantitative structure-activity relationships; methods and principles; the Hansch approach; physicochemical descriptors; modern developments. Computer graphics and modelling studies; drug design. Prerequisites: The participants need some basic knowledge in the different fields mentioned under the objectives of the course. They should not be specialising in these fields, as the presentation will be at a basic level. Course Title: Near-infrared Spectroscopy/ New Trends in Analytical Luminescent Spectroscopy* Level: General Course No: 7 Instructors: AM: Dr Roger Jee, School of Pharmacy, London Dr R A Watt, School of Pharmacy, London Dr W L Yoon, School of Pharmacy, London PM: Dr Andr Rieutord, Paris Description: AM: Introduction to the technique of near-infrared (NIR) spectroscopy and its pharmaceutical applications. The fundamentals of near-infrared reflectance and transmission spectroscopy. Details of the chemical spectroscopy will be covered. Examples of the application of the technique to the identification of pure compounds such as pharmaceutical excipients and actives along with materials of natural origin (eg. plants) will be discussed. Setting up of quantitative methods of NIR spectroscopy will also be briefly considered. Outlines of some of the simpler chemometric procedures used to analyse NIR spectroscopic data will be included. A demonstration with some limited on-hands experience of near-infrared spectroscopy will be included as part of the course. PM: After some fundamental review of photo-physics, a brief and updated overview of the present luminescence techniques used in the entire domain of bio-analysis will be detailed. For this purpose, two major aspects dealing with luminescence for tracing alien species in the biological material and luminescence as a tool for probing the biological material itself will be developed: First, review some selected analytical approaches permitting the detection of the analytes (drug or xenobiotics) in the living material, both after sample pre-treatment and directly on the biological matrix. Concerning this point, the complexity and variability of the biological matrix will be stressed. Second, underlie the biophysical interest of using luminescence probes in order to directly monitor information at the molecular scale in the different cells compartments, for instance in membranes, nucleus, cytoplasmin order to measure fluidity, pH, polarity, conformation changes, supra-molecular interactions In order to create interactive conditions with participants, the instructor will discuss many practical examples. Objectives: AM: To introduce students to the technique of near-infrared spectroscopy and give them an idea of its capabilities and uses. PM: The goal is to deliver a clear and ready-to-use message concerning the potentiality of luminescence in the field of bio-analysis. Prerequisites: AM: Basic knowledge of analytical spectroscopy such as UV-visible and infrared spectroscopy would be desirable. A knowledge of the origin of spectra and the Beer-Lambert law will be assumed. PM: Basic knowledge of analytical chemistry. *This course comprises two day courses. Students are expected to attend both sessions. Course Title: Combinatorial Chemistry Level: General Course No: 8 Instructors: Dr. Pedro Hermkens, N.V. Organon, The Netherlands Dr. Angus Brown, Organon Laboratories, Newhouse, UK Description: 09.00 Combinatorial chemistry and the drug discovery process. Examining a modern organized drug discovery process within a pharmaceutical company we will identify where and how combinatorial chemistry plays a role. 10.00 Solid-phase Organic Chemistry. A renaissance. Solid-phase organic chemistry is enjoying a renaissance with its intensive use in the synthesis of combinatorial libraries. A selection of chemical reactions, linking strategies, and analytical techniques useful in the synthesis of combinatorial libraries will be discussed. 11.00 Coffee break 11.15 Solution phase chemistry and combichem. New techniques. One crucial advantage of performing parallel and combinatorial chemistry in solution is the fact that most organic reactions have been studied and developed in solution. Thus, many reaction protocols can be directly applied in a parallel format without having to go through tedious reaction development procedures. 12.15 Lunch 14.00 Automation / robotics Each approach towards combinatorial chemistry calls for automated or semi-automated systems for synthesis. There is a great need for flexible equipment that can handle reactions and further manipulation in solution as well as solid-phase chemistry. 15.00 Molecular diversity 16.00 Closure Objectives: The intense pressure to discover new therapeutics under conditions of stringent cost control and far shortened development times forces pharmaceutical companies to increase the efficiency of their drug discovery and development programs. New compounds have to be prepared and screened more rapidly. The emergence of high throughput screening (HTS) and combinatorial chemistry addresses, to a large extent, issues related to the synthesis and screening of large numbers of compounds in a relatively short time. However, one of the big challenges for the moment is to prepare libraries of compounds to meet a perceived need. For medicinal purposes, when the objective is to find a hit or lead substance from screening assays where no prior structural clue exists, it is customary to synthesise large arrays of compounds. Useful diversity, as hard as it is to define this term precisely, is required for this purpose. Recently, we see a drift from the preparation of single big libraries (>100.000 compounds) based on one chemistry-motive to multiple small libraries (100-1000 compounds) based on several drug motives with good drug-like properties. Therefore two challenges arise for organic chemists: (i) To develop new robust and reliable reactions either on solid phase or in solution. Although, we see an enormous increase in solid phase organic chemistry reactions, most of these are not sufficiently robust and reliable. (ii) To create new suitable (cheap) scaffold molecules with medicinal potential to be used for further functionalisation in a combinatorial fashion. This course proposes to address some issues in this rapidly emerging field. Prerequisites: The course will be presented at an introductory level and will be suitable for a wide range of students who have a basic knowledge of organic chemistry. A knowledge of medicinal chemistry and drug-discovery process would be useful but is not essential. Course Title: Safety Assessment of Medicinal Drugs Level: General Course No: 9 Instructors: Professor Gerard J. Mulder, Leiden University Dr David Snodin, British Medicines Agency Dr David Jones, British Medicines Agency Dr Henry Stemplewski, British Medicines Agency Description: In this course the approach, methodology and requirements of (preclinical) safety assessment of new medicines are introduced. In the morning session (interactive) lectures on various aspects of safety assessment will be given: Philosophy and practice of safety testing of medicinal products in the EU (Dr Snodin); Repeated dose toxicity and Reproductive Toxicity (Dr Stemplewski and Dr Jones); Genotoxicity and carcinogenicity (Dr Mulder); Regulatory aspects (Snodin) In the afternoon session the participants will be divided into small groups and discuss cases given to them. Each sub-group prepares a presentation on its case, which will be presented to, and discussed, by the whole group. Objectives: to make the participants familiar with major aspects of safety assessment of new medicines. to make the participants aware that a particular type of drugs raises specific safety issues. to give them some information about the regulatory process. to let them thinks about a practical example in the form of a cases study. Prerequisites: The participants should have basic knowledge of Pharmacology and Toxicology, as well as some knowledge of Pathology and physiology. Course Title: Drug Research in Humans: Practical and Ethical Aspects Level: General Course No: 10 Instructors: Prof dr A.F. Cohen, CHDR Dr Joop van Gerven MD PhD Dr Koos Burggraaf MD PhD Dr John Posner FRCP FFPM PhD Description: In this course all aspects of clinical drug research in humans will be covered. A drug study in man starts with a research idea and ends with a publication. This is not inherently different from a study in animals or in the chemical laboratory. However, studies in humans have to be done under very strict legal requirements. The amount of time and effort required for dealing with this can be huge and lead to disappointment. The course will deal with practical and ethical aspects and is an introduction. Objectives: To obtain an overview of the process of drug research in humans (patients and volunteers). Prerequisites: The course is intended for life science graduates or advanced students (including medical students and graduates) with an interest in human pharmacology. Extensive experience in this field is not a prerequisite. Course Book A guide to clinical drug research 2nd edition Adam Cohen and John Posner Kluwer Academic Publishers 2000 This book is required for course participants. Course Title: Licensing Human Medicines Level: General Course No: 11 Instructors: Professor Sven Frokjr, Royal Danish School of Pharmacy Representatives from Medicines Agencies and Industry Description: The course will provide an introduction to the procedures involved in registering a medicine for human use. The speakers, who have personal experience in various fields of the drug registration process, will emphasise the evaluation of quality, safety and efficacy the three main parameters that are determined before a product reaches the market. There will be an emphasis on the pharmaceutical evaluation of products although there will be presentations on toxocological assessment and on clinical aspects. Case studies will illustrate some of the key issues. Programme: Introduction (Sven Frkjr) The need for registration and the processes involved (Sven Frkjr) Pharmaceutical assessment (to be announced) Toxicity of medicine (to be announced) Clinical documentation industrial perspective (Eli Lilly) Objectives: All human medicinal products in Europe which are prescribed or sold to treat a specific indication are registered as a medicine for human use. How products achieve registration is revealed in this course. Prerequisites: Participants well need a basic knowledge of formulation development, pharmaceutics and pharmacology. Course Title: Macromolecules in Pharmaceutical Science Level: General Course No: 12 Instructors: Dr Stephen Brocchini, School of Pharmacy, London Description: Polymers are widely utilised in pharmaceutical science and in medicine. The indigenous properties of polymers are different than low molecular weight compounds. A significant amount of research is focused on how to exploit polymer properties for medical applications. This short one day course will serve as an introduction to polymer science and their medical applications. Discussion will focus on the use of polymers as materials, excipients and as molecules. Many applications relevant to drug delivery will be discussed. The morning session of the course will comprise lecture and discussion. The afternoon session will comprise case studies and a group exercise where each group will act as a company to develop a preclinical candidate for a specific application. Objective: To understand the basic chemical differences between polymers and low molecular weight compounds. To introduce polymer properties inherent in materials that can be processed into devices and water soluble polymers that can be used to conjugate a bioactive agent. To discuss drug delivery and where the applications which have been and are continuing to be addressed. To agree a simple statement describing the essence of drug delivery. To seek an understanding of how polymers may be useful to address drug delivery applications. To conduct a group exercise to develop a candidate polymer to meet an application endpoint. Prerequisites: Undergraduate knowledge of chemistry, biology and pharmaceutical science. Enthusiasm and a willingness to participate would be most welcomed. Course Title: Genomics in Drug Research and Development: Possibilities and pitfalls Level: Advanced Course No: 13 Instructors: Professor Gte Swedberg, University of Edinburgh Dr Claus Mldrup, Royal Danish School of Pharmacy Description: Day 1: Theoretical approaches: 8.30 am 9 am: Introduction 9 am 12 noon: Gte Swedberg Genomic and drug R & D in general: Bacterial genomics, analysis of virulence and drug targets The human genome, how can we use the data 1 pm 5 am: Claus Mldrup Introduction to pharmacogenomics Drug R & D by the use of pharmacogenomics Ethical, social and legal implications of genomics in general and pharmacogenomics in particular. Day 2: Practical approaches: Malaria research with drug and vaccine developments as examples. Group activities alternating between analysing examples from literature and computer exercises, with the possibility of application to students research projects Objectives: The development of genomics has raised hopes of getting new knowledge about disease mechanisms and thereby helping to develop new ways of preventing and treating diseases. However, the use of genomics also raises a number of questions about the limitations and ethical implications of the techniques involved. This course is aimed at introducing the possibilities and limitations of using genomics in pharmaceutical R&D through: generation of sequence data, analysis of RNA and protein, annotations; availability of databases, types of information that can be approached; detection of specific drug targets; linking metabolic data and genomic data; methods for functional genomics, i.e. putting the genomic data in the context of; cellular biology; CCT design and pharmacogenomics in the future; tools for bioethical reflections when doing genomic research. Prerequisites: Basic knowledge of molecular biology. Course Title: Drug Transport to the Brain: Basic Aspects and Therapeutic Implications Level: Advanced Course No: 14 Instructors: Professor Bert de Boer, LACDR Dr Elizabeth de Lange, LACDR Dr Margareta Hammarlund-Udenaes, Uppsala Description: The aim of the course is to give knowledge on basic aspects of blood-brain barrier (BBB) function, transport of substances across the BBB, as well as on methods to study this transport, both in vitro and in vivo. The course contains lectures and training in the design of experiments on BBB transport. Participants are invited to bring ideas and examples to the course for discussion. Objectives: After the course the participant will increase his/her ability to discuss physiological and methodological issues in BBB transport of drugs, will become more aware of the effects of drug influx and efflux across the BBB on drug concentration-time profiles in the brain, and will have been trained to design an experiment to study BBB transport. Prerequisites: Basic knowledge of physiology and pharmacokinetics. Course Title: Microdialysis in Drug Research Level: Advanced Course No: 15 Instructors: Dr Elizabeth de Lange, LACDR Dr Margareta Hammarlund-Udenaes, Uppsala Dr Susan Lunte Dr Rene Bouw Professor Alain Gardier, Universit Paris-Sud Description: Introduction of participants and short history of microdialysis (Elizabeth de Lange) Basic Principles of microdialysis and experimental setup (Rene Bouw) Coffee/tea Scopes of the use of microdialysis in pharmacokinetic research (Margareta Hammarlund-Udeneas) Scopes of the use of microdialysis in (neuro)pharmacological research (Alain Gardier) Discussion / questions Lunch Considerations in experimental design and quantification of microdialysis data (Elizabeth de Lange) Analysis of microdialysate samples (Susan Lunte) Coffee/tea Free discussion (all) Objectives: The aims and objectives of the course are to present basic features and applications of microdialysis as an in vivo technique in drug distribution and neuropharmacological studies. Special attention will be given to quantification of microdialysis data. In addition, limitations, advantages and considerations in the use of this technique will be discussed. Prerequisites: Basic knowledge of biochemical and pharmacokinetic principles. Course Title: Apoptosis in Drug Discovery and Safety Level: Advanced Course No: 16 Instructors: Dr J. Nagelkerke, LACDR Dr Bob van de Water, LACDR Description: Apoptosis or Programmed Cell Death plays a crucial role in the maintenance and control of cell mass. During foetal development obsolete cells are removed by apoptosis, not only because these cells no longer have a function but also to sculpt structures. For instance, fingers are formed by deletion of cells from foetal interdigital tissue. Also after birth apoptosis takes place. It keeps cell numbers constant and controls the immune system. Apoptosis is indispensable both in the control of the number and type of active immune cells as well as in the elimination of infected of maltransformed cells. For a correct execution of apoptosis the cell possesses a number of control systems. Both in the initiation as well as in the decision and execution phase apoptosis can be controlled. Defects in correct execution of apoptosis are linked to all major diseases like cancer, atherosclerosis, AIDS and auto-immune diseases. In this course we will start with an outline of apoptosis in health and disease and then continue by giving an overview of the different control mechanisms. Both will be done in lectures of 1.5 hours. Then the PhD students will form small groups in which they discuss the possibilities to develop new drugs to control apoptosis. Discussion is on the basis of papers that will be sent to the participants before the Summer School. At the end of the day the students will give a presentation of their conclusions. Objectives: To provide the students with an overview of where and when in the body apoptosis takes place. To discuss how defects in apoptosis are linked to disease. To demonstrate how and at which levels apoptosis can be controlled. To stimulate critical discussion of potential new drugs for control of apoptosis. Prerequisites: Knowledge of basic cell biology is an absolute requirement for this course. Course Title: Applied Protein Purification and Characterisation Techniques for Production, Crystallisation and Proteomics Level: Advanced Course No: 17 Instructors: Dr Andy Wilderspin, School of Pharmacy, London Dr Robert van der Heijden, LACDR Dr Jette Sandholm Kastrup, Royal Danish School of Pharmacy Dr Per Andrn, Uppsala Dr Kevin Welham, School of Pharmacy, London Dr Colin James, School of Pharmacy, London Mr Derek Marley, School of Pharmacy, London Description: In the present post-genomics era, proteins, including antibodies and recombinant proteins, play a central role in medical, biochemical, biotechnological and pharmaceutical research. In this course, both theoretical and practical aspects of protein purification, characterization and production will be presented. Strategies to follow and methods to use for the production of pure proteins are discussed. For production of recombinant proteins, an overview of the different hosts such as bacteria, yeasts, plants, animals, viruses, and insects cells will be given. Requirements for purity for the purpose of crystallisation will be described. The recent developments in proteomics technology (separation techniques, mass spectrometry) will be discussed. During the practicals protein purification methods will be demonstrated/ performed, some proteomics techniques will be demonstrated, and participants will have an opportunity to crystallise a protein. It is intended that guest speakers from industry will discuss production of individual proteins such as antibodies. Finally the systems biology approach will be given as an example for the integration of genomic, proteomic and metabolic data. Programme Introduction to protein purification Advanced methods for protein purification Production of pharmaceutical proteins as recombinant proteins and antibodies Protein purity - requirements for crystallisation Proteome analysis Practicals Objectives: To discuss the theoretical and practical aspects of protein purification strategies. To introduce the versatility of producing proteins by recombinant DNA technology. To gain an appreciation of the approaches to protein purification for crystallisation. To present specific techniques for protein purification and pharmaceutical protein production. To discuss proteomics, including 2D gel electrophoresis and mass spectrometry, with respect to protein purification and analysis. Prerequisites: The participants should have basic knowledge of biochemistry. Course Title: Cancer Chemotherapy: Worse than the Disease? Level: Advanced Course No: 18 Instructor: Dr Andreas Kortenkamp, School of Pharmacy, London Description: Surgery and chemotherapy can now cure many cases of cancer. But the available therapies often produce side effects so harmful that they compromise the benefits of treatment. This course will take a look at the basic principles of chemotherapy and the ways unwanted effects can be managed. In interactive group sessions, the pharmacology and toxicology of selected anticancer drugs will be reviewed. Current ideas about the scope for improvements and the limitations of chemotherapy are introduced. The course will focus on current disputes regarding the way in which cancer cells treated with drugs die. Objectives: To enable participants to: Describe the mode of action of major anticancer drugs and their toxicity; Describe the limitations of anticancer chemotherapy (drug resistance); Outline the importance of apoptosis as a mode of cell death; Appreciate current controversies regarding the way in which cells die upon administration of anticancer drugs. Prerequisites: Basic knowledge of causes of cancer, the development of the disease, and of cell biology. Course Title: Drug Metabolism: Recent Developments and Practical Approaches Level: Advanced Course No: 19 Instructors: Dr. JNM Commandeur, LACDR Prof.dr. NPE Vermeulen, Vrije Universiteit Amsterdam Description: This course will consist of three lectures to provide participants with the basic knowledge necessary for the subsequent case-study. The course will conclude with a plenary discussion of the findings of the case study. Lectures: 9.00-11.15 h The first lecture will discuss the relevance of drug metabolism in drug development. Topics include: role in pharmacokinetics, drug failure due to pharmacokinetic defects, interindividual variability, bioactivation to toxic metabolites. In the second lecture an overview will be given on the most important enzymes involved in drug metabolism. Topics include: reactions, substrate selectivities, multiplicity, regulation, genetic polymorphisms. In the third lecture the computational and practical approaches to study drug metabolism will be introduced. Topics include: available in vitro models, tools to identify enzymes involved in biotransformation, vitro-vivo extrapolations, high-throughput screening methods. Case-study: 11.15-15.00 h (including lunch) Groups of 3-4 participants will be provided with cases. Cases consist of a collection of experimental data which are illustrative for the various modern approaches to study or to predict drug metabolism. From these data, the participants should deduce which enzymes are involved, whether individual differences may occur and whether the drugs are susceptible for drug-drug-interactions. Plenary discussion of the findings: 15.00-16.30 h Objectives: The aim and objectives of this course are to introduce the participants to: the roles (i.e. bioactivation/bioinactivation) drug metabolism plays in drug discovery and drug development, the recent advances in the knowledge of drug metabolizing enzymes, and various practical aspects of drug metabolism studies. Prerequisites: Participants should have a basic knowledge of chemistry, biochemistry and drug metabolism. Basic knowledge of enzyme kinetics and some in vitro techniques is also advisable. Course Title: Phytotherapeutics in traditional and Western Societies Level: Advanced Course No: 20 Instructors: Professor Michael Heinrich, School of Pharmacy, London Dr Elizabeth Williamson, School of Pharmacy, London Ms Joanne Barnes, School of Pharmacy, London Dr Ulla Wagner Smitt, Copenhagen Description: Morning: Ethnobotany, indigenous pharmacopoeias and drug development; Foodplants of southern Italy; Ayurvedic medicine; Drug discovery and natural product libraries as a source of new drugs. Afternoon: Bio-Assay guided isolation; Standardisation of phytomedicines ; Clinical evaluation of phytomedicines . Objectives: In this one day series of lectures we will give an overview on the use of phytotherapeutics as they are used in traditional and 'Western' societies as well as on the research advances and the future needs in this field. Medicinal plants are currently high on the agenda of the public and both the medical and the pharmaceutical professions are confronted with raising demands. This requires among others expertise in fields which modern health care professionals may have considered to be obsolete or of no importance to the respective disciplines. We will discuss examples of research in ethnopharmacology, natural product chemistry and phytotherapy and look at the current role of these disciplines in drug discovery / development as well as on the role of medicinal plants in other societies (Ethnic Albanians in southern Italy, India, Mexico). Prerequisites: None Course Title: Pulmonary Drug Delivery Level: Advanced Course No: 21 Instructors: Dr Gerrit Borchard, LACDR C.-M. Lehr, Dept. of Biopharmaceutical Sciences and Pharmaceutical Technology, Saarland University Description: The lung is regarded as both a target site for topical delivery of anti-inflammatory drugs and gene delivery systems, and as a port of entry for the systemic delivery of (peptide) drugs. In this course we will describe the physiology of the lung in healthy and diseased state. From our own hands-on experience, we will introduce some cell culture, ex-vivo and animal models for the screening of pulmonary delivery systems. Showing several examples of recent developments in the field, we will discuss the obstacles formulation scientists are facing in pulmonary drug and gene delivery. Objectives: Obtain basic knowledge on physiological parameters of the lung in health and disease influencing drug delivery. Gain information on available screening models for pulmonary drug delivery and how to choose the right one. Understand limitations and opportunities of pulmonary drug delivery. Develop the ability to describe the formulation of pulmonary drug delivery system for a given compound (case study). Gain information on recent developments in the field. Prerequisites: Basic knowledge in cytology, drug delivery and formulation. Smokers are welcome, too! Course Title: Induction of Drug Metabolism: Significance for Drug Use and Development Level: Advanced Course No: 22 Instructors: Professor Matti A. Lang, Uppsala Dr. Paavo Honkakoski, University of Kuopio Description: A general introduction to drug metabolism and drug metabolising enzymes and to their role in PK/PD. Introduction to molecular mechanisms of gene regulation. Structure and function of genes for drug metabolism. Why are drug metabolising enzymes inducible? Molecular mechanisms of drug mediated gene induction. Induction, drug development and drug usage. Methods to measure induction by drugs under development. Course will consist of 5-6 h of lectures and 2-4 h of group work. As a summary of the group work the students should present a report on themes such as: How to integrate induction studies in drug development programmes, or Induction studies to improve strategies for pharmacotherapy; etc. Objectives: After successfully completing the course the students will: Have a basic knowledge on the molecular mechanisms of gene regulation and induction; Have a basic idea on what is known about the mechanisms of drug mediated gene induction and how does this fit into the general picture of gene regulation; get an idea on the future trends in the research on drug/gene interactions. The students will be introduced to the most important methodology used in induction studies, and will be able to describe the significance of induction studies in drug development programmes as well as for drug therapy. Prerequisites: Basic course in pharmacology and pharmacokinetics. Basic course in biochemistry, cell- and molecular biology. Course Title: Biopharmaceutics Drug Classification Level: Advanced Course No: 23 Instructors: Professor H.G. Kristensen, Royal Danish School of Pharmacy Professor Hans Lennerns, Uppsala Description: Biopharmaceutical Classification System definitions Processes of drug dissolution Mechanisms of drug absorption Gastrointestinal physiology Industrial perspective of Biopharmaceutical Classification System Objectives: To develop pharmaceutical products for oral use it is crucial to identify the rate limiting step(s) of the intestinal absorption process of the drug. Consequently, well-designed biopharmaceutic investigations will increase the understanding of the intestinal absorption process for a specific drug, and make it feasible for an efficient and scientifically supported pharmaceutical formulation design. The rate and extent of drug absorption (fa) from a solid dosage form during its transport through the small and large intestine includes: dose/dissolution ratio, chemical degradation/metabolism in the lumen, complex binding in the lumen, intestinal transit, and effective intestinal permeability (Peff) . The major biopharmaceutic factors affecting fa is dissolution rate, solubility and effective intestinal permeability. Drug transport across the intestinal barrier, i.e. Peff,, occurs by passive diffusion and/or active transcellular transport. In many cases the Peff is considered to be the rate-limiting step in the overall absorption process, as well as poor intestinal permeability of drugs constitutes a major bottleneck in the successful development of candidate drugs. However, in the drug discovery today several new pharmacological targets, for instance intracellularly localised receptors, and the use of high throughput techniques will bring more lipophilic compounds into the drug development. This means that dosage form disintegration, drug dissolution and solubility in the gastrointestinal fluids will be a crucial step in the design, development and optimisation of a solid oral drug product. The aim of this course is describe the process of dissolution, mechanisms of drug absorption as well as gastrointestinal physiology. Prerequisites: The basic principles of oral drug delivery, pharmaceutics, biopharmaceutics, pharmacokinetics, pharmacokinetics and gastrointestinal physiology. Course Title: Steroid Action on the Brain in Health and Disease Level: Advanced Course No: 24 Instructors: Professor Menno R. Kruk, Leiden University M. Oitzl, Medical Pharmacology LACDR R. de Rijk, Medical Pharmacology LACDR Description: Circulating stress hormones easily enter the brain and exert profound effects on brain functions underlying mood, cognition, behaviour, neuronal survival, immune response and endocrine regulation, including the control of their own release. Animal models and experimental paradigms will be discussed - ranging from gene expression to behaviour - to study stress hormones in the pathogenesis of brain diseases. Topics: 1 Systematic validation of experimental models Kruk 2 Steroids and the immune response de Rijk 3 Steroids in mood and cognition Oitzl 4 Steroid effects on aggression impulse control. Kruk 5 mRNA measurement and detecting gene polymorphisms de Rijk Format: Morning: Short introduction into the general (1) and the specific topics (4) Assignment instructions to participants on the critical reviewing of publications concerning the four specific topics Study of the publications Afternoon: Preparation of presentations on the assigned topics Plenary presentations Assessment of models and approaches by general vote Objectives: Participants will learn to apply a set of systematic generally accepted criteria to critically evaluate a set of publications on a specific biomedical problem. Criteria used are related to predict and construct validity. Procedure Participants will work in pairs. Each pair will receive a different set of publications related to one of the topics introduced in the morning. Each pair will prepare a critical presentation on these publications, using the usual tools for scientific criticism, as well as the validation criteria introduced in the morning. Students should point out the limitations of the presented approach, improvements on the approaches in the publications, and suggest additional critical experiments. Presentations Presentations and discussion will be plenary, with all students and teachers present. The opinion on the validity of the approaches will be assessed by a general discussion and a vote of the audience. Prerequisites: a general understanding of transduction mechanisms a general understanding of the regulation of gene expression a general understanding of endocrine mechanisms and feedback. We recommend participants unfamiliar with the field of endocrine regulation look up a chapter on corticosteroid effects and regulation in a good textbook e.g. Berne and Levy, Roades and Pflanzer, Rang and Dale or any other good textbook. Course Title: Cloning Vectors and Strategies for Bacteria: Basic course Level: Advanced Course No: 25 Instructor: Associate Professor Tuomo Karjalainen, University of Paris-Sud Description: First part: Cloning vectors (i) Structure of a procaryotic gene; (ii) Different cloning steps; (iii) Why clone?; (iv) Cloning tools: enzymes, cloning vectors (plasmids, bacteriophages, cosmids) Second part: Cloning strategies (i) Choice of vector; (ii) Choice of host for cloning; (iii) Isolation of procaryotic and eucaryotic genes: Construction of a genomic or cDNA library; cloning by DNA homology; cloning based on purified protein; cloning using PCR; subcloning; identification of bacterial genes necessary for survival in vivo or genes regulated by environment (classical genetics, STM, IVET etc.) Third part: Examples Examples of genes that have been cloned in our laboratory Objectives: This very basic course has set as its first aim to expose the participants to basic concepts: what cloning means and how it is done most commonly in a laboratory working on bacteria. The level of the course is such that it should be accessible even to those with little previous knowledge on cloning vectors or methods. The second aim is to provide the participants an overview on the most commonly used cloning strategies to identify bacterial genes. An overview of the more recent and complex methodologies such as signature-tagged mutagenesis to identify bacterial virulence determinants will also be given. To enforce the concepts, examples of cloning strategies used to identify Clostridium difficile virulence-associated genes in our laboratory will be presented. Prerequisites: The participants should have some basic notions of bacterial DNA, RNA and proteins and bacterial structure and virulence. Course Title: Colloidal Systems for the Delivery of Oligonucleotides and Peptides Level: Advanced Course No: 26 Instructors: Professor Patrick Couvreur, Universit Paris-Sud Professor Elias Fattal, Universit Paris-Sud Description: Oligonucleotides and Peptides/Proteins are biomolecules with very high potential in therapeutics. However, these molecules are unstable in biological media and they are generally poorly diffusing through most of the biological barriers (epitheliums, endotheliums, cell membrane, endosomal/lysosomal membranes etc.). Their short half-life or/and poor bioavailability are important limitations for their development in medicine. Thus, it is actually widely accepted that the design of new delivery systems to improve the administration of oligonucleotides and/or peptides is an important challenge for the pharmaceutical scientist. The course will be divided in two parts: delivery of oligonucleotides and delivery of peptides. Part 1: Delivery of Oligonucleotides (ODN) introduction about the ODNs and their mechanism of action nanospheres and nanocapsules for the delivery of ODN pH-sensitive liposomes for cytoplasmic delivery of ODN cationic emulsions for ODN transport Part 2: Delivery of proteins/peptides Introduction to peptide delivery (Transport and Metabolism) Nano- and Microparticulate systems for the subcutaneous and oral delivery of peptides Implantable delivery systems for peptides Mucosal delivery of Antigens Objectives: The objective of the course is to give background information on oligonucleotides and peptides in order to highlight the problems associated with their administration, transport and targeting. From that statement, different tracks will be given to the students of how to improve the administration of these molecules. The aim is to make aware the students of the need to conceive new drug delivery systems tailored for oligonucleotides and peptides. Prerequisites: Students need to have correct background in physico-chemistry and biopharmacy. It is not needed that they have special competences in Molecular Biology or Drug Delivery. Course Title: Colloidal Carriers Level: Advanced Course No: 27 Instructors: Professor Denis Labarre, Universit Paris-Sud Dr. Gillian Barratt, Universit Paris-Sud Dr. Ruxandra Gref, Universit Paris-Sud Dr. Mat Paternostre, Universit Paris-Sud Dr. Christine Vauthier, Universit Paris-Sud Description: Drug carrier systems seek to change the distribution of an active substance and thus increase its pharmacological efficacy and/or reduce its toxicity. The therapeutic potential of the drug carrier system depends on the in vivo fate of the carrier. Colloidal carriers (liposomes and nanoparticles) can be administered through different routes (i.v., s.c., i.m., topical, oral). After i.v. administration, colloidal carriers are removed from the circulation by phagocytosis preceded by opsonisation. Plasma proteins and macrophages are strongly involved in these phenomenon. The course includes: presentation of the therapeutic potential of colloidal carriers; preparation of liposomes and polymeric nanoparticles; physical and chemical characterisation of these systems; blood-compatibility of nanoparticles; interactions with cells, strategies for targeting; methods of biological evaluation; PEGylated polymers for stealth nanoparticles; polysaccharides coated nanoparticles; present status and future of colloidal carriers. Objectives: After having given an overview on the potentiality of colloidal drug carriers, the aims of the course are: to present different the types of colloidal carriers; to show how to make and characterise them; to introduce the biological environment with which they interact and which determines their in vivo fate; and finally to propose some strategies which could be followed to design stealth and/or addressed carriers by taking into account such parameters. Prerequisites: A correct background in physico-chemistry is needed. A basic knowledge on polymers would be appreciated. Course Title: Introduction to PK/PD Level: Advanced Course No: 28 Instructors: Assistant Professor Rikard Sandstrm, Uppsala Professor Margareta Hammarlund-Udenaes, Uppsala Professor Mats Karlsson, Uppsala Marie Sandstrm, MSc, Uppsala Description: The course covers the absorption, distribution, metabolism and excretion of drugs in the human body. The connection between pharmacokinetic and biopharmaceutical parameters and how they affect drug absorption. The oral route for drug absorption will be highlighted. Calculations and interpretations of key parameters that describe events in pharmacokinetics and pharmcodynamics after single as well as after multiple drug dosing. The course also covers the connection between drug concentration/time profiles and pharmacological effect, drug dosing strategies, inter-individual variability in drug disposition and drug interactions. During the course different methods for measuring will be examined, and different models for describing drug absorption, plasma protein binding, distribution kinetics, hepatic and renal elimination and the pharmacokinetics of metabolites will be studied. Objectives: After the course the students shall have required basic knowledge and understanding in the fields of pharmacokinetics and pharmacodynamics. The students shall have the ability to interpret the effect of different parameters on a drugs absorption, distribution, elimination and pharmacological effect. Prerequisites: Basic knowledge in Pharmacology and Physiology. Course Title: European Patenting and Intellectual Property Level: General Course No: 29 Instructors: Marianne Johansen, Managing Director, European Patent Attorney Anne-Marie Lademann, Business Development Manager, Patents & Licensing Description: Morning: Welcome and introduction to the field of IPR Basic principles of patenting (novelty, inventive step, industrial applicability, exceptions to patenting) Claims drafting Work shop The importance of patenting Patenting strategies Patenting within the pharmaceutical field, especially with an overview to European practice Afternoon: Patent term extensions Opposition and appeal Infringement legal aspects Third parties patent rights in relation to freedom to operate Case stories Discussion of issues raised by the participants Objectives: This course will provide the participants with an overview of the basic principles for patenting especially within the pharmaceutical field. Traditionally, patenting within the pharmaceutical field is of utmost importance in order to ensure a return of investment of the research and development costs invested by the medicinal industry. Therefore, the course will deal with the importance of identifying patentable developments in the daily research and development work, and it will deal with patenting as a strategic tool at management level. The course will also provide the participants with an overview of important legal aspects related to IPR such as laboratory notebooks, data protection, extension of patent term, experimental use etc. At the end of the course the participants will have a general knowledge of: The basic principles for patenting and claims drafting How to read and use the patent literature in research and development The importance of avoiding infringing others patent rights The importance of ensuring at a very early stage in the research and development work- the freedom to enter the market without infringing others patent rights The importance of an interaction between the different departments in a medicinal company with respect to the overall patent policy of the company Prerequisites: None Course Title: Natural Products Research Level: Advanced Course No: 30 Instructors: Prof. Dr. Rob Verpoorte, LACDR Prof. dr. Lars Bohlin, Pharmacognosy, Uppsala Dr. Soeren Brogger Christensen, DFH, Copenhagen Dr. Per Moelgaard, DFH, Copenhagen Description: The lectures will cover bioactive natural products basic aspects of chemotaxonomy strategies for drug development from natural sources biodiversity as source of leads for drug development industrial use of natural products biodiversity treaties The course will include a workshop in which the participants in small groups will do a case study on drug discovery based on natural products programmes. Objectives: To provide the participants an overview of drug development by exploration of biodiversity (bioprospecting). To let the participants individually develop an approach to natural products leadfinding. Prerequisites: Besides a basic knowledge in pharmaceutical sciences no special knowledge or skills are required. Course Title: Novel Techniques in Bioanalysis Level: Advanced Course No: 31 Instructors: Professor Douglas Westerlund, Uppsala Dr Per Andrn, Uppsala Description: Novel techniques and methods for the qualitative and quantitative analysis of drugs and related compounds in biological materials from sample preparation through separation and detection to method validation will be described. New developments in sample preparation are presented, from principles for direct introduction of biological fluids (e.g. restricted access materials, turbulent flow chromatography, micellar electrokinetic chromatography); on-line liquid-liquid extraction; to off-line solid phase extraction including the use of molecular imprinted polymers (MIP). Techniques for the determination of non-protein bound fractions of drugs (ultrafiltration, microdialysis, LC- and CE-techniques) will also be included. The features of the separation techniques HPLC, capillary LC, capillary electrophoresis (CE), capillary electrochromatography (CEC), and chip technologies will be presented. Possibilities and limitations of different detection techniques with a special emphasis on mass spectrometry (electrospray ionisation, MS, [MS]n) will be given. Applications in pharmacokinetics, metabolism, neurotransmitters and neuropeptides, and therapeutic drug monitoring will be described. Guidelines for method validation will briefly be discussed. Objectives: Students will learn about the state-of-the-art and current trends in bioanalytical methodologies. The knowledge will be important for the development of methods in the areas of pharmacokinetics, metabolism, pharmacology and toxicology in pre-clinical and clinical studies. Participants will acquire knowledge in order to select suitable sample preparation, separation and detection techniques for actual bioanalytical problems in respective area. They will further be informed about the basic requirements on method validation for bioanalytical assays. Prerequisites: Participants should have basic knowledge on physico-chemical properties of organic compounds, equilibria in solution, composition of biological fluids and tissues, sample preparation techniques (liquid-liquid and solid phase extraction), chromatography and capillary electrophoresis, photometry, fluorescence, electrochemistry and mass spectrometry. Course Title: Design, Synthesis and Study of Drugs Targeted to DNA Level: Advanced Course No: 32 Instructors: Dr Mark Searcey, School of Pharmacy, London Professor Laurence Patterson, School of Pharmacy, London Dr Mark Searcey, School of Pharmacy, London Dr Kevin Welham, School of Pharmacy, London Dr Colin James, School of Pharmacy, London Description: Most antitumour agents used in the clinic exert their biological effect through an interaction with DNA and this continues to be a fruitful and interesting area for the development of new drug entities. New DNA binding ligands may be derived from nature (e.g camptothecin, bleomycin, the duocarmycins or distamycin A), can be the product of drug design programmes (e.g. amsacrine, AQ4N) or may be the consequence of a combination of both of the above. In this course, we will examine the process of design, synthesis and study of small molecules that are targeted to DNA. Design aspects will involve the use of molecular modelling techniques and computational methods, while synthesis involves the study of natural product total synthesis combined with ligand design and the application of solid phase and combinatorial methods to design a library of DNA binding agents. Methods for the study of drug-DNA interactions using both physico-chemical and electrophoretic techniques will also be discussed. Objectives: The course will give the participants a taste of scientific research at the chemistry/biology interface and of how methods of pharmaceutical chemistry can be combined in the design of new drug entities. It will provide a framework in medicinal chemistry that can be applied to the study of other ligand-macromolecule interactions that have potential therapeutic relevance. Prerequisites: Basic knowledge of medicinal chemistry and an interest in drug design.  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