Skills Required by Pharmacologists and Physiologists in Today s Pharmaceu:cal Industry

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Harold Watts
6 years ago
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1 Skills Required by Pharmacologists and Physiologists in Today s Pharmaceu:cal Industry Iok- Hou Pang, PhD Pharmaceutical Sciences!! University of North Texas Health Science Center!

2 Outline of Presenta:on Skills Related to Today s Trends in Therapeu<c Approaches (Non- tradi<onal Pharmaceu<cal Agents) Drug Discovery Process in Pharma Comparison between academic & industrial research Differences between large & small pharma 2

3 Trends in Therapeu:c Approaches (Non- tradi:onal Pharmaceu:cal Agents) Biological An<body An<body- drug conjugate Fusion protein Gene Therapy RNA Interference 3

4 An:body Since mid 1980s, dozens were approved for human use In 2013 One approved Itolizumab (psoriasis) Three NDA submived Vedolizumab, Ramucirumab, Obinutuzumab Many in Phase III Trials Cancer, rheumatoid arthri<s, psoriasis, asthma, Alzheimer s disease, SLE, mul<ple sclerosis 4

5 An:body- Drug Conjugate Brentuximab vedo<n (Adcetris) Hodgkin lymphoma Anaplas<c large cell lymphoma Trastuzumab emtansine Approved 2013 Breast cancer 5

6 Fusion Protein Aflibercept (Eylea ; VEGF Trap) Fusion protein of key domains from human VEGF receptors 1 (VEGFR1) and 2 (VEGFR2) with human IgG- Fc Binds to VEGF- A & PLGF Approved for Wet AMD Macula edema due to CRVO 6

$Gene Therapy Correct gene<c disorders 1800+ gene<c disorders in humans; only a small frac<on can be treated by tradi<onal means CFTR in Cys<c fibrosis$

7 Gene Therapy Correct gene<c disorders gene<c disorders in humans; only a small frac<on can be treated by tradi<onal means CFTR in Cys<c fibrosis RPE65 in Leber congenital amaurosis β- Thalassemia Hemophilia Deliver therapeu<c proteins TNFα Fc for rheumatoid arthri<s Oncoy<c viruses Glioblastoma 7

8 RNA Interference SiRNA Cancer AIDS- related non- Hodgkin s lymphoma Liver cancer Various solid tumors Re<nal Diseases Diabe<c macular edema Age- related macular degenera<on Asthma Respiratory syncy<al virus infec<on Familial Adenomatous Polyposis 8

9 Trends in Therapeu:c Approaches (Non- tradi:onal Pharmaceu:cal Agents) Biological Gene Therapy RNA Interference Different from tradi<onal small molecule drugs Chemical physical proper<es Pharmacokine<cs Molecular kine<cs Drug discovery process Regulatory requirements 9

10 Drug Discovery Process in Pharma Comparison: Academic vs Industrial Research Drug Discovery Process Differences between Large & Small Pharma Skills for Pharmaceu<cal Industries Research Beyond Research 10

11 Comparison Academic vs Industrial Research Academic Generate & distribute knowledge Publica<on & patent Teach Projects likely more opportunis<c More individualized approach Project leader = Captain of a ship More ownership & control of project Industrial Generate product & profit Patent, trade secret, publica<on Convince peer & management Projects are highly goal- oriented Always team approach Project leader = Captain of a team Reassignment not uncommon 11

12 Typical Drug Discovery Process Management Approval Target Iden:fica:on Hit to Lead Lead Op:miza:on Proof of Concept Clinical Research 12

Target Iden:fica:on - Omics Bioinforma<cs

13 Target Iden:fica:on - Omics Bioinforma<cs Biochemistry, Physiology Disease Mechanism Iden<fica<on of Possible Targets Confirma<on/Valida<on of Target Team Members: Academic Collaborator Biochemist Cell Biologist Pharmacologist Physiologist Chemist Development of Screening Assay(s) Discovery of Lead Class Drug Discovery Target 13

14 Hit to Lead Compound Procurement Compound library Synthesis Licensing In Vitro Efficacy Assay Biochemistry Cell or Tissue Molecular Modeling & Design Team Members: Med Chemist Organic Chemist Biochemist Cell Biologist Pharmacologist Physiologist Pharmaceu<cs Licensing In Vivo Efficacy Assay Lead Iden<fica<on 14

15 Lead Op:miza:on Genotox herg Acute Tox Lead Large- Scale Synthesis Formula<on Clinical Candidate Lead Backup Detailed Mechanism Studies In Vivo Efficacy Stability Team Members: Project Manager Org Chemist Med Chemist Physiologist Pharmacologist Pharmaceu<cs Toxicologist 15

Clinical Candidate Proof of Concept Scale-

Formula<on Stability ADME Chronic Tox IND

Members: Project Manager Clinical Researcher

16 Clinical Candidate Proof of Concept Scale- up & GMP Synthesis Analy<cal Chemistry Formula<on Stability ADME Chronic Tox IND Prepara<on Metabolite Characteriza<on Team Members: Project Manager Clinical Researcher Regulatory Affairs Analy<cal Chemist Chemist Pharmacologist Pharmaceu<cs ADME Expert Toxicologist Clinical Study Design, Planning, Execu<on 16

17 Typical Drug Discovery Process Management Approval Target Iden:fica:on Hit to Lead Lead Op:miza:on Proof of Concept Clinical Research 17

18 Features of Small Pharma Less formalized process Smaller teams More efficient Jack- of- all- trades Research by phone Smart screening instead of high throughput screening One- trick pony 18

Skills Required in Pharma - Research - Team dynamics management Communica<on Relevant to audience Concise ü How to educate your supervisor & peer?

19 Skills Required in Pharma - Research - Team dynamics management Communica<on Relevant to audience Concise ü How to educate your supervisor & peer? General knowledge in drug discovery process General knowledge and apprecia<on of other disciplines Medicinal Chemistry Analy<cal Chemistry Pharmacokine<cs Pharmaceu<cs 19

20 Skills Required in Pharma - Beyond Research - Project Manager Licensing/Business Development Science Intelligence Regulatory Affairs Clinical Research Technical Writer Technical Trainer 20

21 Thank You Iok- Hou Pang, PhD iok-

How Targets Are Chosen. Chris Wayman 12 th April 2012

How Targets Are Chosen. Chris Wayman 12 th April 2012 How Targets Are Chosen Chris Wayman 12 th April 2012 A few questions How many ideas does it take to make a medicine? 10 20 20-50 50-100 A few questions How long does it take to bring a product from bench