Alterações empresariais sustentadas pelo conceito de engenharia do Produto Patrício Soares da Silva, MD, PhD

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1 Alterações empresariais sustentadas pelo conceito de engenharia do Produto Patrício Soares da Silva, MD, PhD 1

2 Summary Hypothesis Generation Candidate Development Commercialization Target Identification and Validation Assay Development Lead ptimization Human First Dose Phase 1 Phase 2 Phase 3 Registration Global Launch Lead Generation The Cost of Drug Discovery and Development Average cost to discover and develop a new drug = $800 million Average length of time from discovery to patient = years nly one NCE (new chemical entity) out of 10,000 Leads will make it to launch. Current opportunity New technologies have emerged 2

3 Paradigm shift in R&D and medicine Clinical definition of disease diagnosis Molecular definition diagnosis and predisposition Future challenge Patient-tailored therapy 3

4 Future challenge Patient-tailored therapy 4

5 5

6 R&D in BIAL s mission in R&D Seek novel therapies Identify new biological targets for pharmacological intervention Develop new medicines 6

7 Main research areas Porto Bilbao SNC disorders Cardiovascular disorders Allergic disorders BIAL Facilities - Portugal 7

8 Source: Sites companies BIAL s R&D 93 collaborators (21 PhD) from 7 nacionalities Contracts with 77 R&D institutions ( ) > NCEs ( ) 6 new medicines R&D investment annually R&D Investment in main Southern European companies (% sales) BIAL invests more than 20% of its sales in R&D projects 8

9 R&D resources Non-clinical research Medicinal chemistry & analytical chemistry Pharmacology, biochemistry, molecular and cellular biology, metabolism and pharmacocinetics Forlumation Clinical research Human pharmacology Clinical pharmacology 9

10 Determination of isoelectric point Research before treating patients Target Selection Lead Finding Lead Candidate ptimization Selection & evaluation Phase I Phase II Phase Product III approval Biochemistry & Molecular Biology Molecular Informatics Medicinal Chemistry Scale-up Chem Exploratory Pharmacology Toxicology, Pharmacokinetics & Metabolism Bioanalysis Production & purification of rs-cmt IPTG Progression in purification U I CMT CMT 10

11 Mol Pharmacol 62, ,

12 Target selection Mol Pharmacol 62, , 2002 CNS Drug Reviews, 13, ,

13 pic50 experimental Development of a structural model of human S-CMT Ramachandran rat CMT human CMT Structure overlay (active site) Seq homology > 80% Development of novel drugs: QSAR predictive model ver 70 structure-based electronic descriptors plus physico-chemical properties Training set: 32 compounds; Validation set: 13 compounds PLS Model: 4 principal components, R 2 = 0.96, Q 2 = Determinants of enzyme interaction pic50 predicted SIMCA-P 11-05/11/30 11:45:36 AM APPLICATIN in DISCVERY: - ver 350 novel structures conceived in silico - Circa 150 novel compounds synthesized at Bial - in vitro potency: IC µm 13

14 Search for new lead candidates (structure hopping) Commercial databases > 600,000 chemicals In silico Virtual Screening - Chemical groups of interest - Calculated Physico-chemical properties - Predicted higher activity 74 chemicals selected for procurement and biological testing 21 HITS with more than 80% in vitro enzime inhibition (28% success rate) Pharmacological tests Toxicity evaluation Few excelent candidates Lead optimization program > 300 new related structures synthesized and tested 1 lead compound selected Lead Finding & Assay development Chemical library Cl Cl N S N H S F N S N Cl S S Cl Cl NH Cl S Cl Cl NH Cl Tissue culture Tissue homogenates N N NH H Leads S N N In vivo 14

15 µg/ml µg/ml µg/ml µg/ml Remaining compound (%) C %C Enzyme activity (% of control) Lead ptimization Enzyme activity in cell lines IC 50 in homogenates Log [Compound] (M) Metabolic stability in microsomes Transport studies in Caco H H - N + Candidate 25 0 A B C D E F G H I J K L M N Candidate evaluation cardiovascular respiratory CNS gastrointestinal endocrine renal metabolic profile rodents, dog, rabbit non-human primates, minipig, Pharmacokinetic peofile BIA BIA BIA BIA MTD embryotoxicity acute toxicity chronic toxicity Carcinogenicity Time (h) Time (h) Time (h) Time (h) 15

16 BIAL pipeline Antiepileptic Eslicarbazepine Acetate Zebinix * Development timeline * proposed EU trade name. 16

17 BIAL in the World BIAL is active in more than 30 locations in 4 continents. 17

18 Portugal Top 10 Pharmaceutical Companies Portugal Market Share of BIAL Main Products 18

19 Portugal BIAL Main Therapeutic Areas BIAL Group - Sales/Revenue /

20 Alterações empresariais sustentadas pelo conceito de engenharia do Produto Patrício Soares da Silva, MD, PhD 20

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