Life Sciences Online Courses

Transcription

1 Life Sciences Online Courses

2 Table Of Contents Table of Contents How to Register 3 Learn Biotechnology Online 4 Learn MedDevice Online 5 Learn Molecular Diagnostics Online 6 Learn Biosafety & Biorisk Online 7 Biotechnology Biotech 101: The Science That Drives Biotech 9 Biotech 201: The Technology That Drives Biotech 10 Biotech 301: The Drug Discovery Process 11 Genetic Engineering 12 Antibodies 13 Drug Approval, Manufacturing Quality & Regulation 14 Biomanufacturing 15 Pharmaceutical Manufacturing 16 Biosimilars 17 MedDevice Medical Device Overview & Regulation 19 Medical Device Development 20 Medical Device Approval & Commercialization 21 Molecular Diagnostics Diagnostics Role In Medicine Today 22 How Diagnostic Tests Work: Protein-Based Diagnostics 24 Statistical Features Of Diagnostics 25 Diagnostic Development & Approval 26 Biosafety & Biorisk Introduction To Biosafety Basics 27 Introduction To Biosafety Cabinets 29 Elements Of A Biorisk Managements Program 30 Basic Disinfection For Tissue Culture Laboratories 31 NIH Recombinant DNA Compliance & Institutional Biosafety Committees 32 OSHA Bloodborne Pathogens Regulations Training 33 Working With Animals 34 2 Copyright Biotech Primer, 2016

3 About BioTech Primer BioTech Primer Inc. is a private training company focused on the Life Sciences Industry. We deliver current, relevant training so professionals can better understand the science, business, and regulatory processes essential to the Biotechnology, Pharmaceutical, Molecular Diagnostics and Medical Device healthcare sectors. With continuously updated materials and industry expert content developers, BioTech Primer provides engaging online instruction. biotechprimer.com Our Content Expertise Biotechnology for Non-Scientists Molecular Diagnostics Medical Device Biosafety & Biorisk Our Training Options Onsite: In-house, customized training tailored for organizations worldwide Online: On-demand learning for individuals; customizable for organizations Open Enrollment: Prescheduled classes for individuals in convenient locations Digital: Free, easy to read WEEKLY e-newsletter keeps you informed of the latest science breakthroughs. Delivered every Thursday right to your inbox. WEEKLY.BiotechPrimer.com In Print: The Biotech Primer, a compendium of biotechnology knowledge Why Online? Learn at your own pace Learn on your own schedule Learn in any location that has access to the internet What You Must Know About Our Online Courses You have 3 days to view the course so best to sign up for one course at a time. You may review the course unlimited times within those 3 days You may download a PDF of all course materials; we do not give out the actual copy of the power point presentation You may take the assessment only one time Your assessment is graded and your grade appears on your course certificate Upon completion of the course you will be able to download your Certificate of Attendance 3 Copyright Biotech Primer, 2016

4 Learn Biotechnology Online Biotechnology for the Non-Scientist Online Courses Biotech 101: The Science Driving Biotech provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. This is the first part of a 3 part series: Biotech 101, 201 and 301. RUNNING TIME: 67 MINUTES ASSESSMENT: 20 MINUTES Biotech 201: The Technology Driving Biotech provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Learn the tools scientists use in the lab that enables discovery. This is the second part of a 3 part series: Biotech 101, 201, 301. RUNNING TIME: 52 MINUTES ASSESSMENT: 20 MINUTES Biotech 301: The Drug Discovery Process explains the process scientist s use in the lab to discover new therapeutics- including the 5 steps of Target Identification, Target Validation, Assay Development, High Throughput Screening, In Vitro Safety & Efficacy Testing. Learn the process scientists use in the lab to discover new therapeutics. This is the third part of a 3 part series Biotech 101, 201, 301. RUNNING TIME: 60 MINUTES ASSESSMENT: 20 MINUTES Genetic Engineering describes the structure and function of DNA and explains how DNA codes for protein. This information is then applied to a discussion of the genetic engineering techniques used in the production of biologic drugs. The course concludes with a brief overview of biologics manufacturing and the use of biologics in healthcare applications. Develop new insights into this core technology. RUNNING TIME: 50 MINUTES ASSESSMENT: 20 MINUTES Antibodies examines the versatile role of antibodies in current biotechnology applications. Starting with an overview of antibody structure, function and their natural role in the human immune system. The course then takes an in-depth look at methods of antibody production for biotech applications and at specific examples of antibodies used in research, therapeutic and diagnostic applications. Gain a better understanding of this pivotal molecule. RUNNING TIME: 52 MINUTES ASSESSMENT: 20 MINUTES Drug Approval, Manufacturing Quality & Regulation discusses the major regulatory agencies involved in drug approval; the major steps required for preclinical and clinical testing; and postapproval pharmacovigilance. The course concludes with an overview of good manufacturing practices and validation procedures. Understand the pathway from the lab to the clinic. RUNNING TIME: 57 MINUTES ASSESSMENT: 20 MINUTES Biomanufacturing summarizes the key steps of a biomanufacturing campaign, including cell line development, cell banking, scale-up, quality aspects, harvesting and purification. Understand the pathway from lab to production. RUNNING TIME: 55 MINUTES ASSESSMENT: 20 MINUTES Pharmaceutical Manufacturing defines and describes small molecule drugs and their synthesis. Key discussion topics include variations in drug formulation; case studies related to drug counterfeiting and contamination; and measures taken to prevent drug tampering. Integrate your understanding of key points in the supply chain. RUNNING TIME: 40 MINUTES ASSESSMENT: 20 MINUTES Biosimilars provide an overview of the science and biomanufacturing technology used to produce biosimilars. The course begins by taking an in-depth look at the connection between therapeutic protein structure and function. Next the course explains which biomanufacturing conditions can alter a biosimilar, causing it to function differently than the reference product. The course ends with some tested approaches to demonstrating biosimilarity that have been acceptable to the FDA and EMA. RUNNING TIME: 50 MINUTES ASSESSMENT: 30 MINUTES 4 Copyright Biotech Primer, 2016

5 Learn MedDevice Online Medical Devices Online Courses Medical Device Overview & Regulation defines the term medical device and explores the diversity of the industry by highlighting its various sectors and top companies. Device classification and differing approval pathways are discussed in detail. The course concludes with a discussion of quality system regulations and risk management plans. Acquire an understanding of the medical device industry s breadth. RUNNING TIME: 54 MINUTES ASSESSMENT: 20 MINUTES Medical Device Development gives a detailed overview of the five stages of medical device development: market opportunity evaluation, concept evaluation, engineering design, verification and validation and manufacturing transfer. Broaden your understanding of the entire development process. RUNNING TIME: 57 MINUTES ASSESSMENT: 20 MINUTES Medical Device Approval, Commercialization & Current Issues explains the medical device approval to product launch process. This includes the business preparations, manufacturing scale-up, reimbursement strategies and product launch decisions that accompany a successful regulatory outcome. Post-launch assessments and post-market surveillance are also considered. Be prepared for a successful launch. RUNNING TIME: 55 MINUTES ASSESSMENT: 20 MINUTES 5 Copyright Biotech Primer, 2016

6 Learn Molecular Diagnostics Online Molecular Diagnostics Online Courses Diagnostics Role In Medicine Today opens with examples of different diagnostics and the scenarios in which they are used. This introduction is followed by an overview of the science of genetics of disease, which is used in the development of personalized medicine and companion diagnostics. Boost your appreciation of the diversity of diagnostic devices and applications. RUNNING TIME: 41 MINUTES ASSESSMENT: 20 MINUTES How Diagnostic Test Work: DNA-Based Diagnostics explains the molecular science and technology used in a common set of diagnostic tools, including the various types of PCR, SNP chips, next generation sequencing and microrna techniques. Gain entry to the fast-pace field of molecular diagnostics. RUNNING TIME: 44: MINUTES ASSESSMENT: 20 MINUTES How Diagnostic Tests Work: Protein-Based Diagnostics focuses on antibodies: what they are, where they come from and how they work. Various antibody-based diagnostics, such as sandwich and bead immunoassays, multiplexed assays, lateral flow assays and protein chromatography are explained in detail. Develop an understanding of these diverse tools. RUNNING TIME: 40 MINUTES ASSESSMENT: 20 MINUTES Statistical Features Of Diagnostics explores the basic measurement concepts used in the development and evaluation of a diagnostic. These included variability and distribution, standard curve, accuracy, and sensitivity and specificity. Using these measurements participants learned how false negative/false positive are determined and how those results are compared to a Gold Standard to determine the likelihood of receiving diagnostic approval for marketing. RUNNING TIME: 47 MINUTES ASSESSMENT: 20 MINUTES Diagnostic Development & Approval describes the regulatory pathways for different categories of diagnostics, emphasizing the differences between in vitro diagnostics and laboratorydeveloped tests. Quality system regulations are extensively reviewed. The course ends with a discussion on methods for technology and economic evaluation of new diagnostics. Expand your diagnostics development acumen. RUNNING TIME: 50 MINUTES ASSESSMENT: 20 MINUTES 6 Copyright Biotech Primer, 2016

7 Learn Biosafety & Biorisk Online Biosafety & Biorisk Online Courses Introduction To Biosafety Basics provides an introductory framework to the practices and principles required for working with infectious biological agents. Emphasized topics include an introduction to infectious agents, assessment of biological hazards and risks, overview of laboratory safety, risk mitigation via personal protective equipment and biosafety cabinets, program management and biosafety guidelines and regulations. Learn the essential elements of maintaining a safe laboratory environment. RUNNING TIME: 68 MINUTES ASSESSMENT: 20 MINUTES Introduction To Biosafety Cabinets provides an overview of biosafety cabinets, including the different types, safe operation and work practices, proper decontamination methods and a review of the NSF/ANSI Standard. Gain a better understanding of this core safety feature. RUNNING TIME: 44 MINUTES ASSESSMENT: 20 MINUTES Elements Of A Biorisk Management Program summarizes the major practices and principles, as well as the tools necessary for companies to integrate biological safety and biorisk management techniques into their existing laboratory operations and programs. Leverage your existing knowledge into a comprehensive biosafety plan. RUNNING TIME: 53 MINUTES ASSESSMENT: 20 MINUTES Basic Disinfection For Tissue Culture Laboratories introduces disinfection methods for laboratories working with infectious agents. Emphasis is placed on common sources of contamination, choosing the right type of disinfectant, best practices for tissue culture laboratories and how to clean the laboratory and equipment. Enhance your understanding of this crucial biosafety step. RUNNING TIME: 40 MINUTES ASSESSMENT: 20 MINUTES NIH Recombinant DNA Compliance & Institutional Biosafety Committees highlights the history and current legislative initiatives for NIH compliance, how these may affect your institution and the operation of the Institutional Biosafety Committee (IBC), expectations of Principal Investigators, awareness of the IBC and its responsibilities, exempt vs. non-exempt experiments, as well as, what to expect during an NIH site visit/audit or facility inspection and common compliance challenges. It also provides a detailed look at the purpose, composition, responsibilities and management of IBCs. Requirements set forth by the NIH and other relevant institutions will be covered. Ensure proper understanding of biosafety regulations. RUNNING TIME: 44 MINUTES ASSESSMENT: 20 MINUTES OSHA Bloodborne Pathogens Regulations Training details current OSHA Bloodborne Pathogen regulations, how to determine if your organization is subject to its laws and how to properly integrate them into existing medical surveillance, health and safety programs. Promote proper compliance to workplace safety requirements. RUNNING TIME: 50 MINUTES ASSESSMENT: 20 MINUTES Working With Animals focuses on the special considerations of working safely with laboratory animals. A detailed look into animal laboratory equipment and animal laboratory best practices will be covered. Review critical skills. RUNNING TIME: 30 MINUTES ASSESSMENT: 20 MINUTES 7 Copyright Biotech Primer, 2016

8 Life Science Courses Online, On-Demand

9 Biotech 101: The Science That Drives Biotech Biotech 101: The Science Driving Biotech provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. This is the first part of a 3 part series: Biotech 101, 201 and 301. RUNNING TIME: 67 MINUTES ASSESSMENT: 20 MINUTES Biotechnology Is 1. Define Biotechnology Cells 1. Draw a basic cell structure and label the organelles 2. Explain the function of each organelle DNA 1. Draw a DNA structure 2. Explain the function of DNA Proteins 1. Understand how cells convert genes into proteins 2. Understand the correlation between protein structure and protein function Mutations & Genetic Variation 1. Understand the causes and types of DNA mutations 2. Understand how genetic variation can cause disease Personalized Medicine 1. Understand how genetic variation influences diagnosing and treating disease 2. Understand how genetic variation applies to personalized medicine 9 Copyright Biotech Primer, 2016

10 Biotech 201: The Technology That Drives Biotech Biotech 201: The Technology Driving Biotech provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Learn the tools scientists use in the lab that enables discovery. This is the second part of a 3 part series: Biotech 101, 201, 301. RUNNING TIME: 52 MINUTES ASSESSMENT: 20 MINUTES Cells Manufacture 1. Explain the process cells use to make proteins Recombinant DNA 1. Define recombinant DNA 2. List the steps used to make recombinant DNA Recombinant DNA Uses 1. Describe the uses of recombinant DNA 2. Clarify how recombinant DNA is used to create recombinant proteins 3. List the uses of recombinant proteins 4. Explain how scientists determine which cell to use when producing recombinant DNA 5. Rationalize the appropriate DNA transfer method based on cell type and plasmid Biomanufacturing 1. Write out the key steps in a biomanufacturing campaign 2. Explain the uses of cell banks, how they are created and how they are used 3. Label a diagram of the scale up process basics 4. Understand the challenges of product purification 10 Copyright Biotech Primer, 2016

11 Biotech 301: The Drug Discovery Process Biotech 301: The Drug Discovery Process explains the process scientist s use in the lab to discover new therapeutics- including the 5 steps of Target Identification, Target Validation, Assay Development, High Throughput Screening, In Vitro Safety & Efficacy Testing. Learn the process scientists use in the lab to discover new therapeutics. This is the third part of a 3 part series Biotech 101, 201, 301. RUNNING TIME: 60 MINUTES ASSESSMENT: 20 MINUTES Drug Discovery History 1. Disclose the various drug discovery strategies 2. Define rational drug discovery 3. List the steps of rational drug discovery Example of Drug Discovery 1. Give a detailed example of how rational drug discovery is used to develop a cancer therapeutic Target Identification 1. Explain how drug targets are identified 2. Understand therapeutic options are influenced by the drug target Target Validation 1. Disclose the characteristics of small molecule and large molecule (biologics) therapeutics 2. Explain how drug candidates are validated Testing the Target 1. Describe assays researcher s use to screen targets and drug candidates 2. List the questions and answers researcher s methodically go through to assure in vitro safety and efficacy for candidate drugs 11 Copyright Biotech Primer, 2016

12 Genetic Engineering Genetic Engineering describes the structure and function of DNA and explains how DNA codes for protein. This information is then applied to a discussion of the genetic engineering techniques used in the production of biologic drugs. The course concludes with a brief overview of biologics manufacturing and the use of biologics in healthcare applications. Develop new insights into this core technology. RUNNING TIME: 50 MINUTES ASSESSMENT: 20 MINUTES DNA Structure & Function 1. Label the parts of a DNA molecule 2. Render a drawing of how DNA is organized into chromosomes 3. Explain the function of DNA Protein Structure & Function 1. Explain how the structure of a protein directly influences its function 2. Depict how a gene codes for a protein Genetic Engineering Explained 1. Explain the function of restriction enzymes 2. List the steps used in PCR to make multiple copies of DNA segments 3. Understand how plasmids are made and how they are used in different cell lines 4. Define recombinant DNA 5. Understand how recombinant DNA is used to produce biologic drugs Recombinant Proteins in Healthcare 1. Explain the three general categories of therapeutics made using recombinant DNA 12 Copyright Biotech Primer, 2016

13 Antibodies Antibodies examines the versatile role of antibodies in current biotechnology applications. Starting with an overview of antibody structure, function and their natural role in the human immune system. The course then takes an in-depth look at methods of antibody production for biotech applications and at specific examples of antibodies used in research, therapeutic and diagnostic applications. Gain a better understanding of this pivotal molecule. RUNNING TIME: 52 MINUTES ASSESSMENT: 20 MINUTES Antibody Structure & Function 1. List the general functions of antibodies 2. Describe how and why the antibody-antigen interaction occurs 3. Label the variable and constant regions of an antibody and know their importance Antibody Role in Immune System 1. Define epitope and explain the importance of an epitope 2. List the steps of antibody production in the immune system Antibody Production 1. List the steps of antibody production in the lab 2. Compare and contrast polyclonal and monoclonal antibody production and uses 3. Explain how antibodies are humanized are why this is crucial 4. List the steps of engineering antibodies by phage display Antibodies Uses in Biotech 1. Describe how antibodies are used in therapeutics and diagnostics 13 Copyright Biotech Primer, 2016

14 Drug Approval, Manufacturing Quality & Regulation Drug Approval, Manufacturing Quality & Regulation discusses the major regulatory agencies involved in drug approval; the major steps required for preclinical and clinical testing; and post-approval pharmacovigilance. The course concludes with an overview of good manufacturing practices and validation procedures. Understand the pathway from the lab to the clinic. RUNNING TIME: 57 MINUTES ASSESSMENT: 20 MINUTES Regulatory Agencies & Compliance 1. Discuss the guidelines regulatory agencies use to ensure a safe, effective and high quality drug supply Preclinical Studies 1. Understand the role of preclinical safety testing in the drug approval process Pharmacokinetics & Pharmacodynamics 1. Define Pharmacokinetics and pharmacodynamics Clinical Development 1. Compare and contrast clinical and surrogate endpoints 2. Describe in detail, the main purpose of each phase of clinical testing 3. Summarize the time cycle and cost for each phase of clinical testing 4. Compare and contrast the various desirable FDA designations- fast track, accelerated approval, priority review Current Good Manufacturing Practices (cgmp) 1. Explain the cgmp principles 2. Define the idea of Quality By Design (QbD) as it relates to enhancing manufacturability Validation 1. Describe the requirements for supplier and raw material validation 2. Explain the three types of qualifications required for equipment validation 3. Define process validation 4. Explain various methods used in testing validation 14 Copyright Biotech Primer, 2016

15 Biomanufacturing Biomanufacturing summarizes the key steps of a biomanufacturing campaign, including cell line development, cell banking, scale-up, quality aspects, harvesting and purification. Understand the pathway from lab to production. RUNNING TIME: 55 MINUTES ASSESSMENT: 20 MINUTES Biomanufacturing Overview 1. Define biomanufacturing 2. List types of products produced 3. Label a diagram illustrating an overview of the biomanufacturing process Cell Lines & Banks 1. Discuss the different cell types used in biologics production 2. Explain the characteristics of a good cell line 3. Explain the uses of cell banks: how they are created and how they are used Scale-Up 1. List the key steps in protein manufacture 2. Explain how product quality is assured throughout the manufacturing process Fill & Finish 1. Describe bulk formulation in terms of stability, delivery and excipients 2. Explain the various factors considered in final fill 3. Give an overview of label, package and distribution requirements 15 Copyright Biotech Primer, 2016

16 Pharmaceutical Manufacturing Pharmaceutical Manufacturing defines and describes small molecule drugs and their synthesis. Key discussion topics include variations in drug formulation; case studies related to drug counterfeiting and contamination; and measures taken to prevent drug tampering. Integrate your understanding of key points in the supply chain. RUNNING TIME: 40 MINUTES ASSESSMENT: 20 MINUTES Pharmaceutical Manufacturing Overview 1. Define small molecule 2. Identify the key steps in pharmaceutical manufacturing Chemical Synthesis 1. Define active pharmaceutical ingredient (API) and excipient 2. Compare and contrast linear organic synthesis and convergent organic synthesis 3. Define enantiomer and how they are used to produce small molecule drugs API Purification 1. Explain small molecule purification methods- crystallization, distillation, column chromatography 2. Understand how FDA / ICH production and supplier validation ensures manufacturing quality control Formulation 1. Compare and contrast the four most common pharmaceutical formulations tablets, capsules, suspensions and emulsions Packaging 1. Understand pharmaceutical packaging regulations 2. Identify major anti-counterfeiting measures 3. Explain the small molecule supply chain, including cold chain management and shipping validation 16 Copyright Biotech Primer, 2016

17 Biosimilars Biosimilars provide an overview of the science and biomanufacturing technology used to produce biosimilars. The course begins by taking an in-depth look at the connection between therapeutic protein structure and function. Next the course explains which biomanufacturing conditions can alter a biosimilar, causing it to function differently than the reference product. The course ends with some tested approaches to demonstrating biosimilarity that have been acceptable to the FDA and EMA. RUNNING TIME: 50 MINUTES ASSESSMENT: 30 MINUTES Protein Function At the completion of this section you should be able to: 1. Define the term protein 2. List three examples of a protein 3. Describe three protein functions Protein Synthesis At the completion of this section you should be able to: 1. Arrange the steps of protein synthesis into the correct order 2. Label the parts of an amino acid 3. Explain why proteins fold 4. Deduce what happens when a protein folds properly and improperly Post Translational Modifications At the completion of this section you should be able to: 1. Define post translational modification 2. List the purposes for post translational modifications 3. Name two types of post translational modifications 4. Point out that both genes and cells influence the type of post translational modification and the degree to which the protein is modified Biologics At the completion of this section you should be able to: 1. Define biologics 2. List the functions of therapeutic proteins 3. Compare and contrast small molecule drugs with biologics Introduction to Biosimilars At the completion of this section you should be able to: 1. Define biosimilars 2. Contrast small molecule drug generics with biosimilars 3. Compare the EMA and FDA definitions of biosimilars The Product Is The Process At the completion of this section you should be able to: 1. Define biomanufacturing 2. Contrast the manufacturing process for small molecule drug and biologic 3. List the steps used in biomanufacturing in their correct order 4. Paraphrase the goal for each step of the manufacturing process CONTINUED ON NEXT PAGE 17 Copyright Biotech Primer, 2016

18 Biosimilars Biosimilars continued The Product Is The Process continued 5. Distinguish between master cell bank and working cell bank 6. Explain how different master cell lines, with the same gene, can produce different proteins 7. Identify where variations can occur between two different production campaigns 8. Itemize key formulation parameters 9. Give examples of where protein stability testing can be implemented Biosimilars Safety & Regulation At the completion of this section you should be able to: 1. Define immunogenicity 2. Predict all the outcomes of an immune response to a therapeutic protein 3. Define data exclusivity 4. Explain how companies can gain approval for a biosimilar 18 Copyright Biotech Primer, 2016

19 Medical Device Overview & Regulation Medical Device Overview & Regulation defines the term medical device and explores the diversity of the industry by highlighting its various sectors and top companies. Device classification and differing approval pathways are discussed in detail. The course concludes with a discussion of quality system regulations and risk management plans. Acquire an understanding of the medical device industry s breadth. RUNNING TIME: 54 MINUTES ASSESSMENT: 20 MINUTES Medical Device Overview 1. Identify the major sectors and top companies of the medical device industry 2. Understand the history of medical device regulation FDA Medical Device Classification 1. Diagram the FDA organizational structure for medical device 2. Classify medical devices into Class I, II, III based on risk assessment FDA Approval Pathways for Medical Device 1. Identify the major medical device approval pathways 2. Define predicate device FDA Regulatory Compliance for Medical Device 1. Explain how the Code of Federal Regulations (CFR) enforces regulatory compliance 2. Convey the purpose of GLP, GCP, cgmp 3. Describe what parts of the business and manufacturing practices must follow QSR protocols. Medical Device Risk Management Plans 1. Develop a risk management plan for a medical device Medical Device Regulatory Bodies Worldwide 1. List the worldwide regulatory bodies for medical devices 19 Copyright Biotech Primer, 2016

20 Medical Device Development Medical Device Development gives a detailed overview of the five stages of medical device development: market opportunity evaluation, concept evaluation, engineering design, verification and validation and manufacturing transfer. Broaden your understanding of the entire development process. RUNNING TIME: 57 MINUTES ASSESSMENT: 20 MINUTES Phase 1: Market Evaluation 1. List the five stages of medical device development 2. Evaluate market opportunities plan using customer requirements, product description, reimbursement information, and risk analysis Phase 2: Concept Evaluation 1. Evaluate feasibility of products conceptual design 2. Identify the key steps in product design Phase 3: Engineering Design 1. Design, document and test prototypes 2. Understand the importance of defining product requirement specifications Phase 4: Verification & Validation 1. Explain the process of verification and validation for engineering builds, packaging, labeling, human factors testing, and manufacturing Phase 5: Manufacturing Transfer 1. Explain the process of manufacturing transfer from small scale to large scale 20 Copyright Biotech Primer, 2016

21 Medical Device Approval & Commercialization Medical Device Approval & Commercialization explains the medical device approval to product launch process. This includes the business preparations, manufacturing scale-up, reimbursement strategies and product launch decisions that accompany a successful regulatory outcome. Post-launch assessments and post-market surveillance are also considered. Be prepared for a successful launch. RUNNING TIME: 55 MINUTES ASSESSMENT: 20 MINUTES Clinical Trials for Medical Device 1. Define Investigational Device Exemption (IDE) 2. Understand how the FDA classifies devices based on risk to patient Investigative Device Exemption (IDE) 1. List the different types of IDEs 2. Explain the process of obtaining approval to initiate human clinical trials to test a new medical device 3. Understand how identifying and testing a new device against the reference device is crucial when seeking FDA approval Regulatory Submission for Medical Device 1. Explain the time cycle for submission approvals Business Decisions for Medical Device Launch 1. List the challenges of launching a new medical device in terms of sales and marketing, reimbursement, manufacturing Manufacturing Scale-Up for Medical Device 1. Explain the challenges involved in scaling up manufacture in preparation for Manufacturing Scale-Up product launch 2. List the time cycle for manufacturing scale-up Reimbursement for Medical Device 1. Outline a reimbursement strategy for coverage, coding and payment Medical Device Product Launch 1. List the various pre-launch preparations that need to be completed 2. Develop a post-launch assessment and surveillance protocol 3. Convey which medical device reports are mandatory for the FDA 21 Copyright Biotech Primer, 2016

22 Diagnostics Role In Medicine Today Diagnostics Role In Medicine Today opens with examples of different diagnostics and the scenarios in which they are used. This introduction is followed by an overview of the science of genetics of disease, which is used in the development of personalized medicine and companion diagnostics. Boost your appreciation of the diversity of diagnostic devices and applications. RUNNING TIME: 41 MINUTES ASSESSMENT: 20 MINUTES Defining Diagnostics 1. Define diagnostic and biomarker 2. Explain the types of measurements employed by diagnostics Uses of Diagnostics 1. Give the purpose and examples of different diagnostic uses- screening, diagnosis, prognosis, drug selection, drug treatment, monitoring, and management Types of Diagnostics 1. Give the purpose and examples of different types of diagnostics- chemistry, immunochemistry, hematology, cytology, microbiology, infectious disease, imaging, and molecular The Science Behind Molecular Diagnostics 1. Understand the genetic basis of disease, personalized medicine and companion diagnostic 2. Describe the different types of DNA mutations Selecting a Treatment 1. Discuss the use of genetic variation in developing targeted diagnostics 2. Define companion diagnostic 3. Understand how a diagnostic can help ensure proper patient dosage 22 Copyright Biotech Primer, 2016

23 How Diagnostic Tests Work: DNA-Based Diagnostics How Diagnostic Test Work: DNA-Based Diagnostics explains the molecular science and technology used in a common set of diagnostic tools, including the various types of PCR, SNP chips, next generation sequencing and microrna techniques. Gain entry to the fast-pace field of molecular diagnostics. RUNNING TIME: 44: MINUTES ASSESSMENT: 20 MINUTES Polymerase Chain Reaction (PCR) Technology 1. Define DNA probes and explain their uses in diagnostics 2. Describe PCR technology 3. Explain PCR diagnostic applications Microarray Technology 1. Define Single Nucleotide Polymorphism (SNP) 2. Describe how SNP Chips work 3. Discuss the use of SNP chips in diagnostic applications Next Generation Sequencing (NGS) Technology 1. Explain the purpose of NGS 2. Describe how different NGS technologies work 3. Discuss NGS applications to diagnostics microdiagnostics Technology 1. Define microrna (mirna) 2. Discuss mirna s potential application to diagnostics development 23 Copyright Biotech Primer, 2016

24 How Diagnostic Tests Work: Protein-Based Diagnostics How Diagnostic Tests Work: Protein-Based Diagnostics focuses on antibodies: what they are, where they come from and how they work. Various antibody-based diagnostics, such as sandwich and bead immunoassays, multiplexed assays, lateral flow assays and protein chromatography are explained in detail. Develop an understanding of these diverse tools. RUNNING TIME: 40 MINUTES ASSESSMENT: 20 MINUTES Defining Protein Based Diagnostics 1. Define protein based diagnostic 2. Define biomarker Antibody Technology 1. Explain the structure and function of antibodies 2. Discuss how properties of an antibody can be exploited for diagnostic use Enzyme-Linked Immunosorbent Assays (ELISA) Technology 1. Explain how an ELISA works 2. Describe how an ELISA is used in diagnostic applications 3. Discuss the types of information given by an ELISA Bead Immunoassay Technology 1. Discuss the adaptation of ELISA to high throughput techniques, including multiplexed bead assays 2. Explain how bead immunoassays work 3. Describe how bead immunoassay is used in diagnostic applications 4. Discuss the types of information given by bead immunoassays Lateral Flow Assay Technology Lateral Flow 1. Define the term Immunochromatographic 2. Explain how lateral flow assays work 3. Describe how lateral flow assays are used in diagnostic applications 4. Discuss the types of information given by lateral flow assays Chromatography Technology 1. Explain how column chromatography works 2. Describe how column chromatography can be used in diagnostic applications 3. Discuss the types of information given by chromatography 24 Copyright Biotech Primer, 2016

25 Statistical Features Of Diagnostics Statistical Features Of Diagnostics explores the basic measurement concepts used in the development and evaluation of a diagnostic. These included variability and distribution, standard curve, accuracy, and sensitivity and specificity. Using these measurements participants learned how false negative/false positive are determined and how those results are compared to a Gold Standard to determine the likelihood of receiving diagnostic approval for marketing. RUNNING TIME: 47 MINUTES ASSESSMENT: 20 MINUTES Measures: Determining Unknowns 1. Understand how identifying and testing a new diagnostic against a gold standard is crucial when seeking FDA approval 2. Produce, use and interpret a standard curve Measures: Variability & Distributions 1. Interpret measurements and graphic distributions to determine if persons fall into a normal or abnormal range as it relates to diagnostic tests Examples of Test Distributions 1. Analyze various bi-model distributions to determine if patients fall within the normal or abnormal range for disease Measurement Considerations 1. For a diagnostic test to be useful the correct analyte must be measured Accuracy of a Measurement 1. Define accuracy Specificity & Sensitivity 1. Differentiate between sensitivity and specificity 2. Calculate and interpret sensitivity and specificity Positives & Negatives 1. Define false positive and false negative 2. Calculate and interpret percentages of false positives and false negative Risks of Diagnostics 1. Calculate and interpret positive predictive value 2. Understand how to use a ROC curve and interpret the strength of the diagnostic Examples of Diagnostics: Mammogram and PSA Testing 1. Explain the risks associated with screening for low prevalence diseases 25 Copyright Biotech Primer, 2016

26 Diagnostic Development & Approval Diagnostic Development & Approval describes the regulatory pathways for different categories of diagnostics, emphasizing the differences between in vitro diagnostics and laboratory-developed tests. Quality system regulations are extensively reviewed. The course ends with a discussion on methods for technology and economic evaluation of new diagnostics. Expand your diagnostics development acumen. RUNNING TIME: 50 MINUTES ASSESSMENT: 20 MINUTES Diagnostics: Regulation of New Clinical Tests 1. Summarize the regulatory pathway for different categories of diagnostics 2. Contrast In Vitro Diagnostics (IVD) and Laboratory Developed Tests (LDT) 3. Contrast oversight from Center for Medicare and Medicaid Services (CMS) with Food and Drug Administration (FDA) Approval Process for Laboratory Developed Tests (LDT) 1. Discuss the regulatory differences between LDT diagnostics and In Vitro Diagnostics (IVD) 2. Explain the regulatory approval process for LDT diagnostics Diagnostic Regulatory Pathways 1. List the regulatory burden of Class I, II, III diagnostics 2. Assess a diagnostics category as either Class I, II, III based on a diagnostic s risk profile 3. Differentiate between 510(k), De Nova 510(k) and Premarket Approval (PMA) regulatory pathways 4. Understand the general FDA submission requirements for IVD Quality Control of Diagnostics 1. Discuss the Quality System Regulations (QSRs) European Union Approval Pathways for Diagnostics 1. Give a synopsis of the EU diagnostic approval process Reimbursement for Diagnostics 1. Describe methods for technology and economic evaluation of new diagnostics 2. Explain the mechanisms for diagnostic testing reimbursement 3. Define standard reimbursement codes 26 Copyright Biotech Primer, 2016

27 Introduction To Biosafety Basics Introduction To Biosafety Basics provides an introductory framework to the practices and principles required for working with infectious biological agents. Emphasized topics include an introduction to infectious agents, assessment of biological hazards and risks, overview of laboratory safety, risk mitigation via personal protective equipment and biosafety cabinets, program management and biosafety guidelines and regulations. Learn the essential elements of maintaining a safe laboratory environment. RUNNING TIME: 68 MINUTES ASSESSMENT: 20 MINUTES Introduction to Infectious Agents 1. Identify certain diseases caused by prions, viruses, bacteria, fungi and parasites 2. Explain the different ways disease is transmitted Assessing Biological Hazards & Biorisks 1. Understand what the risk factors are when working with a biological agent 2. Understand how an infection can be prevented by modifying the agent or how it is handled Laboratory Safety Overview: Common Lab Hazards & Basic Safety Thinking 1. Identify the hierarchy of controls for working with biological hazards 2. Understand the difference between engineering controls and work practice controls 3. Know how to eliminate or replace sharps in the workplace Biorisk Mitigation: Personal Protective Equipment (PPE) 1. Know why personal protective equipment (PPE) is used, and what PPE is appropriate for the work area 2. Understand the limitations of the PPE 3. Know how to select appropriate PPE, based on tasks, work area, temperature, organisms, and chemicals in use 4. Know the difference between masks and respirators 5. Understand which respirator is appropriate for a certain application Biorisk Mitigation: Biological Safety Cabinets (BSC) 1. Explain what primary containment means 2. Know the difference between a biological safety cabinet (BSC), a fume hood, and a laminar flow clean air center Biorisk Mitigation: Laboratory Facility Considerations 1. Know how the risk group of an organism influences the design of the laboratory where it will be handled 2. Understand when a risk group may not correspond to the biosafety level of a facility 3. Understand the basic design differences between Biosafety Labs (BSL)-1, 2, 3, 4 4. Understand the difference between a disease spread by droplets and one spread by the aerosol or droplet nuclei route CONTINUED ON NEXT PAGE 27 Copyright Biotech Primer, 2016

28 Introduction To Biosafety Basics Introduction To Biosafety Basics continued Biosafety Program Management At the end of this section, you should be able to: 1. List the elements of a good biosafety program 2. List the basic topics a biosafety manual should cover 3. Understand why an occupational health program is important and what types of concerns should be addressed by this program 4. List some of the responsibilities of the Institutional Biosafety Committee (IBC) 5. Know when a biosafety officer is required (per NIH) 6. Understand what procedures an emergency response plan should cover Biosafety Regulations & Guidelines 1. List some of the primary US biosafety-related regulations 2. Explain how the various Federal regulatory agencies affect the practice of biosafety 28 Copyright Biotech Primer, 2016

29 Introduction To Biosafety Cabinets Introduction To Biosafety Cabinets provides an overview of biosafety cabinets, including the different types, safe operation and work practices, proper decontamination methods and a review of the NSF/ANSI Standard. Gain a better understanding of this core safety feature. RUNNING TIME: 44 MINUTES ASSESSMENT: 20 MINUTES Air Filtration 1. Define the function of a biosafety cabinet (BSC) 2. Explain the features of a HEPA filter 3. List the differences in retained particle size for HEPA, ULPA and SULPA filters Types of Biosafety Cabinets 1. Describe the types of BSCs and explain why they are different Working in the Biosafety Cabinet 1. Define what class II and III cabinets protect 2. Explain why UV lights are not recommended for use in a BSC NSF/ANSI State how often a BSC should be certified 2. Describe the different functional tests for BSCs Biosafety Cabinet Decontamination 1. Describe the primary method of decontamination 2. List the types of decontaminants approved by ANSI 3. Describe the two components that are critical during any method of decontamination 4. Explain what indicators are used to validate decontamination 29 Copyright Biotech Primer, 2016

30 Elements Of A Biorisk Managements Program Elements Of A Biorisk Management Program summarizes the major practices and principles, as well as the tools necessary for companies to integrate biological safety and biorisk management techniques into their existing laboratory operations and programs. Leverage your existing knowledge into a comprehensive biosafety plan. RUNNING TIME: 53 MINUTES ASSESSMENT: 20 MINUTES Starting a Biosafety Program 1. Describe the early steps involved in developing a biosafety program Operations 1. Describe the roles of the biosafety committee and biosafety officer(s) 2. Describe the roles of laboratory, facility, and security management 3. Describe the role of a lab worker and animal care personnel working in an occupational health program Implementation 1. Implement a biosafety or Biorisk program in your institution Operation Control 1. Identify laboratory operations that pose potential biological risk(s) 2. Explain why procedures need to be established in biosafety programs 30 Copyright Biotech Primer, 2016

31 Basic Disinfection For Tissue Culture Laboratories Basic Disinfection For Tissue Culture Laboratories introduces disinfection methods for laboratories working with infectious agents. Emphasis is placed on common sources of contamination, choosing the right type of disinfectant, best practices for tissue culture laboratories and how to clean the laboratory and equipment. Enhance your understanding of this crucial biosafety step. RUNNING TIME: 40 MINUTES ASSESSMENT: 20 MINUTES Introduction: Tissue Culture & Contamination 1. Identify the biosafety level to be used handling human tissue(s) 2. Describe how most contamination happens in a tissue culture lab Choosing a Disinfectant 1. Define decontamination 2. Identify where to find a list of approved disinfectants 3. Describe the appropriate use of alcohol for cleansing Best Practices for Tissue Culture Laboratories 1. Describe what personal protective equipment should be used in different scenarios 2. Explain methods for decreasing/eliminating cross contamination Standard Operating Procedures 1. Define which laboratory processes require a written standard operating procedure 2. Discuss special considerations of laboratory water baths as sources of contamination Cleaning & Waste Disposal 1. Explain how often floors, bench-tops, and other laboratory equipment be cleaned/disinfected 2. Describe the appropriate means to clean/dispose of contaminated flasks, bottles, trays, etc. 31 Copyright Biotech Primer, 2016

32 NIH Recombinant DNA Compliance & Institutional Biosafety Committees NIH Recombinant DNA Compliance & Institutional Biosafety Committees highlights the history and current legislative initiatives for NIH compliance, how these may affect your institution and the operation of the Institutional Biosafety Committee (IBC), expectations of Principal Investigators, awareness of the IBC and its responsibilities, exempt vs. non-exempt experiments, as well as, what to expect during an NIH site visit/audit or facility inspection and common compliance challenges. It also provides a detailed look at the purpose, composition, responsibilities and management of IBCs. Requirements set forth by the NIH and other relevant institutions will be covered. Ensure proper understanding of biosafety regulations. RUNNING TIME: 44 MINUTES ASSESSMENT: 20 MINUTES What Is Recombinant DNA? 1. Define recombinant DNA 2. Describe how recombinant DNA is made to make genetically engineered cells 3. Understand how genetically engineered cells are used History of the NIH Guidelines for Research Involving Recombinant DNA Molecules 1. Explain why the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) were established 2. How have the NIH Guidelines changed over the past 40 years Basics of Institutional Biosafety Committees (IBC) 1. List what is subject to the NIH Guidelines 2. Understand the expectations of the Principal Investigator (PI) and the Institutional Biosafety Committee (IBC) in terms of the NIH Guidelines Sections of the NIH Guidelines 1. List what the different appendices cover within the NIH Guidelines IBC Review of Infectious Agents Protocols 1. List the types of protocols the IBC is required review 2. List the types of protocols the IBC is not required to review Site Visits by NIH 1. Know what the NIH will audit during a site visit 2. List the components of a robust biosafety program 32 Copyright Biotech Primer, 2016

33 OSHA Bloodborne Pathogens Regulations Training OSHA Bloodborne Pathogens Regulations Training details current OSHA Bloodborne Pathogen regulations, how to determine if your organization is subject to its laws and how to properly integrate them into existing medical surveillance, health and safety programs. Promote proper compliance to workplace safety requirements. RUNNING TIME: 50 MINUTES ASSESSMENT: 20 MINUTES OSHA Biosafety Basics 1. Explain how people become infected 2. Identify products that are potentially biohazardous OSHA Bloodborne Pathogens Standard 1. State the OSHA Bloodborne Pathogens Standard 2. Explain the responsibilities and expectations of both employers and employees stated by the OSHA Bloodborne Pathogens Standard OSHA Work Practices 1. Describe standard microbiological work practices that should be used 2. Discuss special considerations involving sharps 3. Choose as appropriate disinfectants OSHA Emergency & Occupational Health Issues 1. Describe post-exposure requirements 2. Describe written procedures and documented training for personnel 33 Copyright Biotech Primer, 2016

34 Working With Animals Working With Animals focuses on the special considerations of working safely with laboratory animals. A detailed look into animal laboratory equipment and animal laboratory best practices will be covered. Review critical skills. RUNNING TIME: 30 MINUTES ASSESSMENT: 20 MINUTES Animal Biohazard Considerations 1. Identify hazards associated with work involving biohazards in the vivarium (animal laboratory Animal Facilities 1. Understand the Animal Biosafety Levels as described in the CDC s Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th edition 2. Identify the engineering controls and practices used within the vivarium Emergency Procedures 1. Understand safe operating practices in the vivarium 34 Copyright Biotech Primer, 2016