https://iqb.rutgers.edu/bootcamp2016
IQB 2016 The Institute for Quantitative Biomedicine (“Proteomics”), with field trips
Jan. 4-15, 2016 9:00am to 3:00pm (7 of work days over winter break, 2 days RU facility tours, 1 final presentation day)
GOAL: “Find” a molecule to treat non-small cell lung cancer, get an ivestigational new therapy application IND “approved”, perpare a New Drug Application NDA based on potential “found” drug, and finally present our findings/package to an Oncologic Drugs Advisory Committee/FDA Simulation who would reccomend our found drug for appoval or rejection by the FDA. (Panel made up of PHD in Chemistry, Professionals in the field that gave the lectures, as well as Professionals from J&J) (Drug prechosen erlotinib)
What I learned: How complex “curing” cancer is, how are drugs discovered, a lot of biomed/biochem, AMBER, medicinal chemistry, how drugs are processed in the body: PK and drug elimination pk equation for elimiation rate, PD and target binding and the biochem, drug ethics, and how toxicology/LD50 is test with different animal models, oncology drugs are unique when testing invivo and why side effects are so serious, AMBER II: finding if candidate drug will interact based on computer simulations, IRB and approval for phase I trial, phase 2 trials, phase 3 trials and population used in each and what kind of side effects are reported, and how many drugs fail at this stage, ethics of drug testing, double blind, double blind crossover, how drugs can fail to come to market even if they work it’s considered a failure because it didn’t achieve the target set intially before starting the phase trials, and how to prepare a package/presentation with a team and present to a mock FDA committee that approves or rejects a drug.
Monday 4th Nexus of Academe and Drug Discovery and Development What is cancer? Afternoon workshop: Target exploration
Tuesday 5th Signaling pathways, Protein Kinase and binding sites Evening workshop EGFR Molecular Visualization Workshop AMBER I, Simulating EGFR Breathing and Potential for Drug Binding *Amber is a suite of biomolecular simulation programs
Wednesday 6th What is medicial Chemistry? and Kinase Inhibitor Lead Discovery Evening worshop In silico Medicinal Chemistry Workshop
Thursday 7th ADME (Absorption/Distribution/Metabolism/Excretion) Small molecule Pharmacokinetics/Dynamics Evening worshop PK/PD workshop
Friday 8th Ethics Considerations/Informed Consent/IRB Toxicology testing in drug development **Selecting oncology drug candidate Evening Workshop: Tumor Genome Profiling Workshop
Monday 11th An Academia/Pharma Partnership that Led to Three Marketed Drugsfor Treating HIV Infection Patents Evening workshop Tumor Transcriptome Profiling Workshop AMBER II: Simulating EGFR Breathing and Potential for Drug Binding Amber is a suite of biomolecular simulation programs
Tuesday 12th Preparing the Investigational New Drug Application (IND) Design and Conduct of Phase 1/2 Clinical Trials Design and Conduct of Phase 3 Clinical Trials 3 Preparing the New Drug Application (NDA) Kinase Inhibitor Resistance Evening workshop Tumor Proteome Profiling Workshop
Wednesday 13th Statistical Analysis Workshop: Analysis of Tumor Profiling Data Tours: Keck Center for Collaborative Neuroscience, RDI2: A Look behind the Scenes at Advanced Computing Evening Preparation for Briefing Package/Oncologic Drugs Advisory Committee Simulation
Thursday 14th Tour: RUCDR Infinite Biologics, Bioimaging Evening Preparation for Briefing Package/Oncologic Drugs Advisory Committee Simulation
Friday, January 15th, 2016 Finalization of Presentation for the Briefing Package/Oncologic Drugs Advisory Committee Simulation LUNCH Main Event: Briefing Package/Oncologic Drugs Advisory Committee Simulation!
– BROCHURE
WHAT: Interdisciplinary Quantitative Biology Boot Camp: Drug Discovery and Development
Talks on fundamental and applied aspects associated with the myriad stages of drug discovery and development Decision-making and activities as employees of a hypothetical biotechnology company charged with developing new drugs Hands-on simulations and exercises using mathematical models, statistical methods, and computational chemistry; medicinal chemistry designs and analyses; modeling of pharmacokinetic and pharmacodynamic processes; and analyses of real cancer data that enable individual treatment planning Tours of some of Rutgers state-of-the-art facilities for interrogating biological phenomena Sharing of insights and information with teammates and the larger group as part of the drug discovery and development process Understanding of the processes involved in bringing a program from target selection, lead discovery/optimization, preclinical development, drug candidate selection, patenting, preparation of the Investigational New Drug Application, the clinical trials process, to the final FDA review/decision The Boot Camp will conclude with a student-led simulation of the Oncologic Drugs Advisory Committee (ODAC) meeting leading to FDA approval for the company’s new drug candidate A unique form of education and fun!
– My notes are written in the bootcamp folder for this blog github page