Translating Nanomedicines: Principles of Nanomedicines R&D

The human body is a remarkably complex system where several nanoscale processes are occurring inside our cells and determining our health. Similarly, in nanoscale range, Nanomedicine brings multidimensional impacts to society that are sure to be debated for decades to come. There is increasing optimism that Nanotechnology, as applied to medicine, will bring significant advances in the diagnosis and treatment of diseases. Some of anticipated applications include Drug Delivery, Diagnostics, Gene and Cell therapy and, more recently, Theranostics. The importance of using Nanotechnology is also recognized by all worldwide agencies such as European

Medicines Agency (EMA), U.S. Food & Drug Administration, etc. Particularly, EMA highlights in its strategic reflection for 2025 the importance that these emerging technologies will have in future health care.

This course aims to bring together theoretical skills from other PhD Advanced courses of FFUL, but as a differentiating factor, to especially focus on Nanomedicines from design to its clinical use.

The course is unique in Portugal and with unusual characteristics in the international context. This course includes two modules. Specifically, for this first module, a set of seminars with several lecturers from different fields (academia, pharma industry, regulatory agencies, European Patent Office, etc.) will be carried out during 4 days of training. The last day (day 5) is for the evaluation. It is intended that students will acquire a multidisciplinary knowledge in the field of Nanomedicine and autonomously systematize the existing information based on scientific and technical literature that will support as a working basis for the development of a research project. Students will also develop skills for independent research work, individually and in research teams, as well as skills of analysis and discussion of economic consequences, socio-cultural and ethical implications of research and developments of Nanomedicines, including knowledge integration, and enhancing the identification of patentable results or of research outcomes liable to commercial exploitation.

Coordinator:

Ana Catarina Beco Pinto Reis 

Doctoral students in the context of their doctoral programs.

Researchers in training or belonging to research institutes or industry laboratories, aiming to develop nanomedicines.

This course will be held from December 11, 2023 to December 15, 2023 and has a total of 22.5h of course time.

Number of ECTS: 6 ECTS

Training hours are distributed as follows:

• Theory hours: 21h + 1h30*.
• Tutorial Hours: 7,5 h

The course will run for 5 days, from 09:00 am to 13:00 pm and 14:00 pm to 16:00 pm

Dia 1 (9-13h), Dia 2 (9-13h, 14-16h), Dia 3 (9-12h, 14-16h), Dia 4 (9-13h, 14-16h) e *Day 5 (10-11:30 am*, evaluation – written exam)

PROGRAMME

1. Contextualization of the R&D process of Nanomedicines (Phases; Market Context; Experimental Design in Preclinical and Clinical Research and Statistics applied to Health).
2. Regulatory Framework of the R&D process of Nanomedicine (Lifecycle and its Management; General Regulatory Framework for Medicines; Characterization of the Manufacturing Process and Scale-up).
3. Characterization Methodologies and Techniques of Quality attributes (I) and NonClinical and Clinical issues (II): Basic principles of Dynamic Light Scattering, Electrophoretic Light Scattering, Spectroscopy, Photoluminescence, Nuclear Magnetic Resonance, Calorimetry, Microscopy, Immunohistochemistry, Blotting techniques, Flow cytometry, Cell culture and Imaging techniques, In vitro/in vivo correlation, In silico models and pharmacokinetic modeling, in vivo models and Nanotoxicology.
4. Intellectual Property, Technology Transfer, Patents, Ethics, Business Models and Market opportunities.

PRELIMINARY TIMETABLE

• Day 1 (4 h):

Seminar 1: Contextualization of the Research and Development (R&D) process of Nanomedicines.

• Day 2 (6 h):

Seminar 2: Regulatory Framework of the R&D process and Pharmaceutical Development of a Nanomedicine.

• Day 3 (5 h):

Seminar 3: Characterization Methodologies and Techniques of Pharmaceutical Quality attributes of Nanomedicines (I).

• Day 4 (4 h/2 h):

Seminar 3: Characterization Methodologies of Non-Clinical and Clinical issues of Nanomedicines (II).

Seminar 4: Intellectual Property, Technology Transfer, Patents, Ethics and business perspective of the Nanomedicine R&D process.

• Day 5 (1.5 h):

Evaluation (written exam).

Applications and Registration: until November 14, 2023

Course Start and End Date: December 11, 2023 to December 15, 2023

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Access Habilitations:

Master in health-related sciences such as pharmaceutical sciences, biology, biochemistry, medicine, biomedical engineering, and others.

Selection and seriation criteria:

Curriculum evaluation and, in case of a tie, order of arrival of the application.

• Minimum number of trainees for operation: 8
  Maximum number of trainees for operation: 25

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Registration Fee:

• 250€ for general student enrollment

Note: FFUL doctoral students who wish to take the course as part of their 1st year compulsory component are exempt from paying the registration fee.

• School Insurance: 2.10

By application of paragraph e) of point 2 of Article 42 of the University of Lisbon’s Statutes, and taking into account the terms for the attribution of PRR funding under the “Impulso Adultos” program, the Organic Unit responsible for the coordination of each course may award academic performance prizes.

Access to the FenixEdu Platform:

• If you have never been a student at FFULisboa you must pre-register on the FenixEdu Platform.
• If you are a former student of FFULisboa and have already had an account campus@ulisboa or @edu.ulisboa.pt you should access the FenixEdu Platform and authenticate yourself with your account data.
• If you have lost access to your account, you can recover your password in the ULisboa users area.
• If you are a former student of FFULisboa and have never had an account campus@ulisboa or @edu.ulisboa.pt you must send an email to doutoramentos@ff.ulisboa.pt indicating your full name and ID document number.

Access the FenixEdu Platform.

• On the “Applicant” tab, choose the type of application Advanced Training Course – Translocation of Nanomedicines: Principles of Nanomedicines R&D
• Fill out the online form and attach all documents in digital format.
• Select the option “Submit”.

For information regarding the organization of the course, please contact the Academic Services: doutoramentos@ff.ulisboa.pt

For scientific information regarding the teaching of the course, please contact the Course Coordination.