From Drug Discovery to First in Humans

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1 0 :: 2 v01 x y p.345 B xxx.:: B A x y pval«««[xy] -løøøø xxx.:: øøøø A PharmaTrain Centre of Excellence Non-Clinical Testing, Pharmaceutical & Early Clinical Development: From Drug Discovery to First in Humans Aveiro 31 October - 02 November, 2013 UCM 02

2 Non-Clinical Testing, Pharmaceutical & Early Clinical Development: From Drug Discovery to First in Humans Face-to-face course: 31 october 02 november 2013 Module Leaders: Bruno Gago, PharmD, PhD Invited Auxiliary Professor and Deputy Director of the Training Programme in Pharmaceutical Medicine, Dement of Health Sciences, University of Aveiro Sérgio Simões, PharmD, MSc, PhD Associate Professor, Faculty of Pharmacy, University of Coimbra. Vice-President, Bluepharma SA collaboration Lecturers: Adriana Santos, PharmD, PhD Ana Ordaz, BSc Bruno Gago, PharmD, PhD Catarina Pinto, PhD Gabriel Silva, PharmD Isabel Lapa, PharmD, PhD Joana Silva, PhD Luis Almeida, MD, PhD Sérgio Simões, PharmD, MSc, PhD Sonia Alfar, PharmD Sonia Castanheira, ChemEng Teresa Nunes, MD, MSc, MBA Tiago Figueiredo, PharmD ORGANISATION: Masters in Pharmaceutical medicine A PharmaTrain CENTRE OF EXCELLENCE Director: Luis Almeida, MD, PhD (l.almeida@ua.pt) Deputy Director: Bruno Gago, PharmD, PhD (bmgago@ua.pt) Associate Director: Miguel Forte, MD, PhD (miguel.forte@ua.pt) Dement of Health Sciences University of Aveiro Aveiro Portugal Tel Fax joanatuna@pharmaceutical-medicine.pt

Professor, Faculty of Pharmacy, University of Coimbra.

3 PART #01 31 october 2013 DAY 01 Pharmaceutical development: transforming drug substances into drug products 09:00-09:50 1. Pharmaceutical development of drug substance and up-scaling: manufacture and supply of materials; stability and storage; purity; compatibility; disposal Sonia Alfar, PharmD (R&D Dement, Bluepharma) 09:50-10:40 2. Pharmaceutical development of drug product and up-scaling: manufacture and supply of materials; stability and storage; purity; compatibility; disposal Sonia Castanheira, ChemEng (R&D Dement, Bluepharma) 11:00-11:50 3. Choice of formulations and delivery systems depending on the characteristics of compound and intended uses Gabriel Silva, PharmD (Head of Formulation Development, Bluepharma) 11:50-12:40 4. Testing formulations leading to final specification, including bioequivalence Gabriel Silva, PharmD (Head of Formulation Development, Bluepharma) 12:40-13:00 x. Discussion #01(cont.) Pharmaceutical development: transforming drug substances into drug products (continued) 14:00-14:50 5. Safety specifications; pharmacopoeias Isabel Lapa, PharmD, MSc (Head of Analytical Development I, Bluepharma) 14:50-15:40 6. The concept of blinding: preparing matching placebo and active-control products Bruno Gago, PharmD, PhD 16:00-16:50 7. Clinical trial product supplies: packaging and labelling; stability and storage requirements Tiago Figueiredo, PharmD (R&D Dement, Tecnimed) 16:50-17:40 8. Clinical trial product supplies: site distribution and disposing of remaining stocks Tiago Figueiredo, PharmD (R&D Dement, Tecnimed) 17:40-18:00 x. Discussion

4 01 november 2013 DAY 02 PART #02 Nonclinical Development 09:00-9:45 1. Trends in Nonclinical Development Bruno Gago, PharmD, PhD 09:45-10:30 2. Pharmacogenetics and pharmacogenomics 11:00-11:45 3. Population pharmacokinetics 11:45-12:30 4. Genetic factors influencing Pk, Pd and response to therapy 12:30-13:00 x. Discussion #02(cont.) Nonclinical development (continued) 14:30-15:00 5. The role of scientific and regulatory advice 15:00-15:45 6. Nonclinical development plan overview 16:00-18:00 7. Pratical exercice

Population pharmacokinetics 11:45-12:30 4. Genetic factors influencing Pk, Pd and response to therapy 12:30-13:00 x.

5 02 november 2013 DAY 03 PART #02(cont.) Nonclinical development (continued) 09:30-10:00 8. Differences between small molecules and biologicals Catarina Pinto, PhD (Head of Nonclinical Development, Luzitin) 10:00-10:30 9. The size, cost and administration of a nonclinical programme 10:30-10:45 10.The regular review of toxicology results Coffee-break #03 Early clinical development Chairperson: Luis Almeida, MD, PhD (University of Aveiro; Blueclinical) 11:00-11:45 1. Assessment of non-clinical data and risk as prerequisites before administration to man 11:45-13:00 2. The early clinical development plan: objectives, design, conduct and analysis; tolerability/safety, pharmacokinetics and pharmacodynamics; risk mitigation strategies first-into-man studies, including Phase 0 #03(cont.) Early clinical development (continued) Chairperson: Luis Almeida, MD, PhD (University of Aveiro; Blueclinical) 14:30-15:30 3. First-into-man studies, including Phase 0; risk mitigation strategies 15:30-16:30 4. Clinical pharmacodynamics and pharmacokinetics: ADME; determinants of PK parameters; bioavailability & bioequivalence 16:30-16:45 x. Discussion 16:45-17:00 Closing note Chairperson: Sérgio Simões, PharmD, MSc, PhD (University of Coimbra & Bluepharma)

The size, cost and administration of a nonclinical programme 10:30-10:45 10.

6 #01 Post-course e-learning workshops Design of nonclinical studies: Pharmacodynamics, safety pharmacology, toxicology, pharmacokinetics, toxicokinetics and supplementary studies Luis Ameida, MD, PhD (University of Aveiro, Blueclinical) #02 Gene therapy, somatic cell therapy, tissue, medical devices, device-drug combinations, vaccines: mode of action, use, safety, and benefit-risk balance #03 Therapy-related diagnostics Ana Ordaz, BSc (Medical Scientific Liaison, Novartis) #04 Common mechanisms of damage to organs: Their detection and elucidation Joana Silva, PhD #05 Molecular and cellular basis of toxic reactions Joana Silva, PhD

combinations, vaccines: mode of action, use, safety, and benefit-risk balance #03 Therapy-related diagnostics Ana Ordaz, BSc (Medical Scientific Liaison,

7 Non-Clinical Testing, Pharmaceutical & Early Clinical Development: From Drug Discovery to First in Humans This module is a mandatory of the curricular unit From Drug Discovery to First in Humans. To achieve the curricular unit objectives and learning outcomes the icipant should complement module icipation with other planned learning modalities, including a variety of written assignments. Curricular unit learning outcomes: On successful completion of this Module the icipant should be able to: 1. Discuss the choice and predictive value of the nonclinical testing programme as of the overall drug development plan for chemical and biological compounds. 2. Describe the integration of non-clinical tests into the overall drug development plan (including scheduling of toxicology tests with respect to clinical trials). 3. Outline the steps in the pharmaceutical development of a drug substance and final drug product (including chemical and biological compounds). 4. Describe the planning of clinical trial supplies for test substance(s) and comparators (active and placebo). 5. Provide an overview of non-clinical study requirements prior to First-in-Man studies. 6. Discuss the molecular and cellular basis of toxic reactions. 7. Outline the principles and practical application of pharmacokinetics & toxicokinetics. 8. Outline the early exploratory development in man. 9. Discuss the principles of clinical pharmacology and their application to clinical development. 10. Describe the influence of genetic factors in drug development and drug response. Course Project Manager: Ana Isabel Augusto, BSc (Master Student, anaaugusto@ua.pt) ENDORSEMENT External accreditation

Curricular unit learning outcomes: On successful completion of this Module the icipant should be able to: 1.

CLINICAL PHARMACOLOGY

0 :: 2 v01 x y p.345 B xxx.:: B A x y pval«««[xy] -løøøø xxx.:: øøøø -0.02-0.01-0.00 0.00 0.01 0.02.1.2 A PHARMATRAIN CENTRE OF EXCELLENCE EXPLORATORY & CONFIRMATORY CLINICAL DEVELOPMENT: CLINICAL PHARMACOLOGY