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Course Detail

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Course Features

  • Understanding your customers
  • Affiliate marketing
  • YouTube Course (Includes certification)

Alan Minkys

Instructor in Marketing

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  • 20 hours on-demand video
  • Full Lifetime Access
  • Access on Mobile and TV
  • Certificate of Completion

Course Content

11 sections • 28 lecture • 19h 33m total length

AAV Gene Therapy Manufacturing explains the design, function, and features of adenoassociated virus (AAV) systems, details on specific platforms used for transfection, and methods of validation and purification after the gene therapy product is created.

Antibodies examines the versatile role of antibodies in current biotechnology applications. It takes an in-depth look at antibody production for biotech applications and offers specific examples of antibodies

The Biology of Biotech provides an overview of the most important biological molecules and systems used in biotechnology to make novel therapies and diagnostics. The Biology of Biotech online class lays used in biotechnology to make novel therapies and diagnostics. The Biology of Biotech online class lays the groundwork for the biopharma industry by focusing on cells, DNA and proteins and how these are manipulated by researchers to discover new products. If you are a non-scientist who wants to better understand the science driving research and discovery, this class is the perfect place to start.

Biomanufacturing introduces the intricacies and difficulties involved in manufacturing biologics. Biologics are produced in living cells, unlike small molecule drugs that are synthesized in glasswear. To understand the biopharma industry, you need know how biologic medicines are produced. Biomanufacturing is for everyone in the biopharma industry, especially for those new to drug production, drug development or product launch.

Biopharma Business Acumen was developed for those who need to better understand the unique considerations encountered by industry executives. The Oxford English Dictionary defines acumen as “the ability to make good judgments and quick decisions” and this course explores four areas in which good judgement and quick decisions can only be managed if one understands the basics of financing vehicles, intellectual property law, life cycle management choices, and drug pricing challenges.

Biosimilars provides an overview of the science, biomanufacturing technology, and regulatory requirements for receiving approval to market biosimilar products. The class begins by taking an in- depth look at the science, specifically how a therapeutic protein’s structure dictates its function. With this foundational knowledge, users understand how biomanufacturing conditions can alter a biosimilar, causing it to function differently than its reference product. The class ends with some tested approaches to demonstrating biosimilarity that have been acceptable to the FDA and EMA.

Clinical Development 101: General Principles sets the stage for the entire clinical development process. Learn who conducts trials, how trials are conducted and the various regulatory elements that must be performed throughout Phases I-IV trials.

Clinical Development 201: Phase I explores the prerequisites, purpose, design, and conduct of Phase I trials. Topics such as bioequivalence, pharmacokinetics, pharmacodynamics, endpoints, selection of dose, and more are explained in detail.

Clinical Development 301: Phase II/III considers the purpose, design, and conduct of Phase II and III clinical trials. Learn the various trial design approaches, endpoint choices, statistical considerations, and special regulatory designations.

Clinical Development 401: Phase IV surveys the ongoing post-approval clinical assessments required by regulatory agencies. Learn how drug risk management is accomplished through detecting, assessing and reporting adverse effects using real-world data.

Diagnostic Development and 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 class ends with a discussion on the economic evaluation of novel diagnostics. Diagnostic Development and Approval helps anyone in the diagnostics industry expand their diagnostics development acumen.

Diagnostics’ Role In Medicine Today introduces the ever-expanding molecular diagnostics industry. Diagnostics save lives by helping to pinpoint the exact cause and location of disease. Learn the purpose of each type of diagnostic, the science behind personalized medicine, and how companion diagnostics help doctors prescribe medication and dosage correctly the first time. If you are new to this area of health care, Diagnostics’ Role in Medicine Today will provide a solid foundation on which to build your diagnostic acumen.

Drug Discovery of Biologics explains the steps involved in discovering new biologics, with a special focus on therapeutic antibodies. Learn the criteria used by researchers to for early target screening, select, validation, optimization, and determining when a drug target should be transitioned from discovery to development. Bonus content includes information on antibody diversity, affinity maturation, and key CMC challenges and how to overcome them.

Drug Discovery of Small Molecules explains the steps involved in discovering new therapeutics. This process includes early screening for targets, target validation, lead optimization, and determining when a target should be transitioned from discovery to development. Learn how new drugs are discovered and optimized prior to being tested in pre-clinical and clinical trials.

How Diagnostics 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-paced field of molecular diagnostics by taking this class.

How Diagnostics 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 chromatography are explained in detail. Develop an understanding of these diverse tools and how to interpret results, knowledge that can be applied in research, drug development, and patient care.

Immunology 101 provides an overview of how the human immune system works. Understanding how the human body naturally fights disease is often the first step in creating novel therapeutics. Many of today’s blockbuster biologics are modifications of our immune system’s molecules and cells, including antibodies, T-cells, B-cells and cytokine inhibitors. If you are a non-scientist who wants to better understand the amazing immunotherapies that will play a large role in the next health care wave, Immunology 101 is the perfect place to start.

Immunology 201 online class builds on Immunology 101 class to give a detailed description of the two types of immune system, the non-specific and the specific immune systems. This class will put all the details of the immune system into practice, taking you on a journey from how disease occurs to how your body fights disease. By understanding this complex process, you will have a better understanding of how these steps are exploited by the biopharma industry to create cutting-edge immunotherapies in biotechnology.

Introduction to Genetic Engineering online class explains the process and the power of genetic engineering. Genetic engineering is the deliberate modification of genetic material (DNA). It is used extensively in research, drug discovery, drug development and biomanufacturing. Biotechnology is built on genetic engineering and therefore it is a “must know” topic for those who work in or with the biopharma industry.

Medical Device Approval and Commercialization explains the medical device approval process from initial regulatory submission through commercialization. Learn the diverse best practices accompanying a successful regulatory outcome, including manufacture scale-up, reimbursement strategy, product launch and post-launch assessment. If you are working in the diagnostics industry, this class gives you a game plan to undertake a successful launch.

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32 Courses • 702 Video Tutorial

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