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Dr. Robert Kernstock For Bite of Science (October 9, 2012) You May Be Wondering Why I Am Here?... • • • • • Why Science? How Did I Get Here? What is Astellas? My Job Now? How are Drugs made? Why science, and ‘how did I get here’? Pharma: From ‘Bad Rap’ to Sought After Field “Old-School” Thought •Academic Science Nobel Aspirations •Pharmaceutical Science Money-Generating Current Thinking Current thought •Working Together! •Applied Science •Using Each Other’s Strengths •Sharing the Real Rewards Improving Quality of Life So Who is Astellas? Cardiovascular Infectious Disease Dermatology Urology Immunology Oncology Central Nervous System At Astellas, our mission is to identify safe and effective medicines for people all over the world U.S. Therapeutic Franchises Immunology Dermatology Cardiovascular Infectious Disease Urology Oncology Our Lab Stuff Flow Cytometry Ligand Binding Fluorescence Genotyping Cycles BioPharma: It’s Real World Science! Biology Pharmacodynamics Product Development Physical Science Industry Anatomy Physics Histology Genetic Engineering Academic Astronomy Drug Discovery Medical Science Liaison Chemistry Clinical Trial Research Science Career Opportunities in Pharma Regulatory & QA Pharmacovigilance PK Modeling R&D Science Gov’t Affairs Degree Science Liaison Sales & Marketing Business Dev’t So How Do Drugs Work? Cells in our bodies carry out molecular reactions to perform every function, for example: – Digesting your lunch – Moving your finger – Transmitting thoughts in your brain One molecule interacts with another, which interacts with another, and so on. – These cascades are called chemical pathways A mistake in one of the steps in a pathway can lead to disease. Drug molecules interact with a molecule in the pathway, changing their activity. How Do We Fulfill this Mission? Drug Discovery then Development Example Discovered The Discovery Process Pre-Discovery: Goal: Understand the disease and choose a target molecule. How: Scientists in pharmaceutical research companies, government, academics and for-profit research institutions contribute to basic research. 3 – 6 YEARS Discovery Goal: Find a drug candidate. How: Create a new molecule or select an existing molecule as the starting point. Perform tests on that molecule and then optimize it (change its structure) to make it work better. Preclinical Goal: Test extensively to determine if the drug is safe enough for human testing. How: Researchers test the safety and effectiveness in the lab and in animal models. The Development Process Drug Discovery then Development NUMBER OF SUBJECTS (1 year) (3-6 years) Preclinical Phase I (2 years) Phase II Number of Subjects (4 years) Phase III Phase IV NDA (2 yrs) Personalized Medicine • “The Dream” – Plug and play medicine based on individual’s gene signature – We are all unique and a ‘conglomerate’ of our biological relatives Personalized Medicine EML4-ALK fusions in Lung Cancer 1 ALK Tyr Kinase (Anaplastic Lymphoma Kinase) 1 EML4 1620 TM Basic 981 WD (Echinoderm microtubule-associated protein like protein 4) 1 Basic 496 1059 Tyr Kinase A fused gene EML4 is connected to ALK (in DNA) ALK fusions exist in 5% of lung cancer. A simple PCR test to detect fusion. Over 70% of ALK fusion + cancers are cured! Question & Answer Special thanks to Astellas and Center of Excellence in Education www.ibioinstitute.org www.finding-your-future.org (SCI: Science Career Investigation) www.scienceworx.org Mission of a Pharmaceutical Research Company Take the path from understanding a disease to bringing a safe and effective new therapy to patients. – – – – – – Select a molecule in a pathway => target Validate the target Discover the right molecule to interact with the target Test the compound in the lab for efficacy and safety Test the compound in the clinic for efficacy and safety Gain approval to get the drug to doctors and patients What Sets Astellas Apart Our Values At Astellas we are committed to providing patients, customers, community and employees with a bright future by changing tomorrow. Our Approach Astellas is different, not only because of what we do but because of how we do it. Our Focus In the U.S., we are intensely focused on five key therapeutic areas so we can develop a deep understanding of the disease, our customers and patient needs. A Commitment to Changing Tomorrow Our efforts align with our strong scientific orientation and a focus on the community we work and live in COMMUNITY SCIENCE AND EDUCATION SUSTAINABILITY Encourage employee involvement and volunteerism Building a strong foundation in science to ignite passion and interest in science among today’s youth Helping to improve the environment through internal and external practices State-of-the-Art R&D Facilities Astellas Research Institute of America (ARIA) • Based in Illinois, ARIA is committed to strengthening research in transplantation through: – Drug targeting research – Clinical biomarker translation research – Absorption, Distribution, Metabolism and Excretion (ADME) prediction research – Collaborations with delegate researchers (KOLs) ASKP1240: PK in 7163-CL-0101 < multiple dose simulation > / model= 720 80 mg (1.0 mg/kg) Phase 1 - Pharmacokinetics 1.0 0.1 ASKP1240: PK in 7163-CL-0101 < multiple dose simulation > / model= 720 0 20 40 60 80 100 120 140 20 20 20 40 60 80 100 Time (day) Time (day) Day 1, 14, 28, 42, 56 Day 1, 14, 28, 56 Day 1, 28, 56 Day 1, 7, 14, 28, 56 Establish Dose and Frequency 0 0 0 240 mg (3.0 mg/kg) 40 40 60 80 60 80 Time (day) Time (day) 100 100 Day 1, 14, 28, 56 120 120 140 140 0.10.1 1.01.010.0 10.0 0.10.1 1.01.010.0 10.0 0.1 1.0 10.0 Day 1, 28, 56 10.0 Day 1, 14, 28, 42, 56 0 0 20 20 40 40 60 80 60 80 Time (day) Time (day) 100 100 Day 1, 7, 14, 28, 56 120 140 120 120 140 140 0.5 – 2 YRS 5 – 7 YEARS The Approval Process Investigational New Drug (IND): Goal: Obtain FDA approval to test the drug in humans. How: FDA reviews all preclinical testing and plans for clinical testing to determine if the drug is safe enough to move to human trials. Clinical Trials: Goal: Test in human to determine if the drug is safe and effective. How: Candidate drug is tested in clinical setting in three phases of trials, beginning with tests in a small group of healthy volunteers and moving into larger groups of patients. Review: Goal: FDA reviews results of all testing to determine if the drug can be approved for patients to use. How: The FDA reviews hundreds of thousands of pages of information, including all clinical and preclinical findings, proposed labeling and manufacturing plans. They may solicit the opinion of an independent advisory committee.