TLS data
 

Events and Networking

Expand Your Network at One of Biocom’s 150+ Annual Events

The Basics of Biotech

When:

Mon Mar 25 15:30:00 GMT 2019 - Tue Mar 26 23:30:00 GMT 2019

Where:

Biocom - McGraw Conference Room
10996 Torreyana Road Suite 200
San Diego, California 92121

Register

Basics of Biotech is a comprehensive, two-day course meant to provide you with an overview of the development of biopharmaceuticals from the bench top to commercial scale manufacturing.  The course will start with foundational basics and give a detailed overview of the entire process from discovery to commercialization.  As an attendee, you will learn the science behind biotech products, the clinical research process, regulatory filings and scale-up for manufacturing.  Different types of products, such as biologic drugs, biosimilars, personalized medicine, stem cell and regenerative medicine, will be outlined.
 
Learning Objectives:
Over two days, this interactive course will…
•    Explain the biotech processes, what they are and how they work
•    Explain the biotech lab, what it looks like and how it operates
•    Explain the biotech product development process
•    Examine the evolution of biotech manufacturing
•    Relate each step to the previous steps, and provide you with a seamless, consistent overview
•    Provide you with an understanding of basic science, terminology, and common areas of failure in product development
​•    Prepare you to improve in your current role, or be ready to enter the biotech field with some foundational understanding

Who Should Attend
This course will benefit anyone who is new to the biotech/biopharma industries, or those who need a refresher. There is no level of prerequisite knowledge or understanding necessary to attend. Additionally, this course will be of value to those who support
any step within the development process including outside vendors.

Course Instructors:


Dr. Jason Carstens has over 20 years of process development, GMP manufacturing, and CMC project management experience in the biotech industry. Dr. Carstens is currently the Chief Operating Officer and a Principal Consultant at Pluristyx, Inc., an advanced therapy tools and service company that he co‑founded which serves customers in the rapidly growing field of regenerative medicine and cellular therapies. Pluristyx has a line of pluripotent stem cell-based products and also offers contract development, manufacturing, and consulting services.  Prior to Pluristyx, Dr. Carstens was VP of Manufacturing and Development at Nohla Therapeutics, a Seattle based cell therapy company developing clinical products from hematopoietic stem cells. Dr. Carstens also spent five years as the Director of Cell Therapy Process Development and Manufacturing at the Fred Hutchinson Cancer Research Center in Seattle. While at Fred Hutch, he worked on a variety of autologous and allogenic cell and gene therapy products including CAR T-cells, TIL, antigen specific T-cells, hematopoietic stem cells, and B-cells for use in human clinical trials. Dr. Carstens also spent 13 years at CMC Biologics as the Director of Upstream Process Development where he was responsible for cell line and cell culture process development supporting manufacture, transfer, and scale-up of more than 50 unique recombinant proteins, antibodies, and biosimilars.  Dr. Carstens also has an appointment at the University of Washington as an Affiliate Associate Professor. He earned his PhD in Chemical Engineering from the University of California at Berkeley and a BS in Chemical Engineering from the University of Washington.

Dr Ben Fryer is the CEO and co-founder of Pluristyx Inc. providing GMP pre-expanded pluripotent stem cells, contract development services, and consultancy for groups and company developing cell and tissue therapies.  Ben has almost 25 years of experience as a leader and scientist in large pharma, academia, and start-up companies developing combination biopharmaceutical products and cell therapies. He has worked to generate GMP/ clinical grade pluripotent stem cells from early banking through large scale expansion using scalable, closed-loop, suspension reactor processes to manufacture cell therapies for diabetes and heart disease. Ben is an inventor on multiple issued patents and patent applications including a bioreactor based, stem cell suspension expansion and differentiation process and a product currently marketed by Thermo-Fisher™ as Nunclon-Vita. Ben earned his BA from Colorado College, his PhD from UPENN, and studied as a post-doctoral fellow in the Howard Hughes Laboratory of M. Celeste Simon at the University of Pennsylvania investigating the role of oxygen sensing and signaling in cancer and stem cell development.

 

Course Description
 

 

Price of Admission

Member

Today's Price: 1495.0

Important Dates

Amount

Registration before

Registration before

Registration before

1495.0

Refund before Fri Mar 15 00:00:00 GMT 2019

1495.0

Refund before

Refund Before

*Refunds will no longer be accepted after

Non-Member

Today's Price: 1995.0

Important Dates

Amount

Registration before

Registration before

Registration before

1995.0

Refund before Fri Mar 15 00:00:00 GMT 2019

1995.0

Refund before

Refund Before

*Refunds will no longer be accepted after

  • AGENDA - CLICK HERE

    Course Agenda – Day One:
     
    Introductions
    Part 1:  Overview of the Biotechnology Industry

    1. Basic Biology
      1. Cellular Biology
      2. Microorganisms (bacteria, virus)
      3. DNA/RNA/Proteins
      4. PCR and Genetic engineering
     
    1. Product Categories
      1. Traditional pharmaceuticals (antibiotics, attenuated vaccines, pharmaceuticals, generics)
      2. Biologics (recombinant proteins, antibodies, and biosimilars)
      3. Antibody-Drug Conjugates
      4. Regenerative medicine advanced therapy (RMAT)
      5. Live virus
     
    1. Pre-Clinical and Clinical Trials
      1. FDA Phases of Product Testing for Commercial Approval
      2. Role of Clinical Research Organizations (CRO)
      3. Description of each phase up to NDA or BLA
     
    1. Biotechnology economics
      1. Market Size
      2. Drug development costs
      3. US and global economy
     
    Part 2:  Biologics
    1. Production and purification of a biologic
      1. Mammalian production process
        1. Expression System (cells, vector)
        2. Master and Working Cell Banks
        3. Seed Train
        4. Production Process (Cell Culture - Batch, Fed-batch, Perfusion)
        5. Purification
        6. Fill and Finish
      2. Bacterial production process
        1. Expression system
        2. Production (Fermentation)
      3. Drug Conjugates
     
    1. Biotech operations and product development
      1. Discovery Research
      2. Pre-clinical
      3. Development
      4. Manufacturing
      5. Quality
      6. Clinical
     
    1. Regulations
      1. Regulatory Agencies (FDA, EMA, JP)
        1. Risk Based Approach
        2. ICH
      2. Regulatory document types and activities
        1. IND
        2. BLA
        3. Process Validation
        4. PAI
        5. 483s
     
    1. Manufacturing Facilities
      1. Layout and Design
      2. Equipment and Utilities
      3. cGMP Requirements
      4. Quality Systems
     
    1. Manufacturing Strategy and Challenges
      1. Outsourcing (manufacturing, testing)
      2. Supply Chain
      3. Scale-up or Scale-out?
      4. Process changes / site changes
      5. Capacity planning
     
    Course Agenda – Day Two:
    Part 2:  Regenerative Medicine Advanced Therapy (RMAT)
    1. Overview of Stem Cells and Immunology
      1. Blood, Hematopoiesis, and Hematopoietic Stem Cells (HSC)
      2. PBMCs, T-cells and B-cells
      3. Non-HSC Stem Cells: Mesenchymal, Embryonic, and Induced Pluripotent stem cells
     
    1. Stem Cell Transplants – HSCs: the original cell therapy
      1. Donor matching
      2. Starting tissue: bone marrow, mobilized stem cells, cord blood
     
    1. Organ Transplants – the practice and the promise
      1. History of solid organ transplants and issues with field
      2. Promise and growing need driving cell and tissue manufacturing
     
    1. Cell Therapy Manufacturing Processes
      1. Overview of general manufacturing operations
      2. Autologous vs allogenic starting tissue
      3. Scale-up vs scale-out
      4. Cryopreservation
      5. Drive towards automation and closed processing
     
    1. RMAT Product Types
      1. CAR T-cells
      2. Tumor Infiltrating Lymphocytes
      3. Other Immune Cells
      4. Mesenchymal Stem Cells
      5. Pluripotent Stem cells
      6. Gene Therapy
     
    Part 4:The Business of Biotech
     
    1. Product Development Cycle
      1. Discovery to commercialization (timeline, costs)
      2. Challenges: where and when to manufacture and how much to make
     
    1. Company Strategies
      1. Intellectual Property, Patents, and Trade Secrets
      2. Small Biotech
        1. Spin-outs, Academic starts, and Licensing
        2. Funding, partnerships, venture capital
        3. Going to market
        4. Exit strategies
      3. Big Pharma
        1. Internal Innovation vs external collaboration/acquisition
    General Q&A/Wrap-up
     
    a0d5A00000Kp21EQAR

    Go
  • AGENDA - CLICK HERE

    Course Agenda – Day One:
     
    Introductions
    Part 1:  Overview of the Biotechnology Industry

    1. Basic Biology
      1. Cellular Biology
      2. Microorganisms (bacteria, virus)
      3. DNA/RNA/Proteins
      4. PCR and Genetic engineering
     
    1. Product Categories
      1. Traditional pharmaceuticals (antibiotics, attenuated vaccines, pharmaceuticals, generics)
      2. Biologics (recombinant proteins, antibodies, and biosimilars)
      3. Antibody-Drug Conjugates
      4. Regenerative medicine advanced therapy (RMAT)
      5. Live virus
     
    1. Pre-Clinical and Clinical Trials
      1. FDA Phases of Product Testing for Commercial Approval
      2. Role of Clinical Research Organizations (CRO)
      3. Description of each phase up to NDA or BLA
     
    1. Biotechnology economics
      1. Market Size
      2. Drug development costs
      3. US and global economy
     
    Part 2:  Biologics
    1. Production and purification of a biologic
      1. Mammalian production process
        1. Expression System (cells, vector)
        2. Master and Working Cell Banks
        3. Seed Train
        4. Production Process (Cell Culture - Batch, Fed-batch, Perfusion)
        5. Purification
        6. Fill and Finish
      2. Bacterial production process
        1. Expression system
        2. Production (Fermentation)
      3. Drug Conjugates
     
    1. Biotech operations and product development
      1. Discovery Research
      2. Pre-clinical
      3. Development
      4. Manufacturing
      5. Quality
      6. Clinical
     
    1. Regulations
      1. Regulatory Agencies (FDA, EMA, JP)
        1. Risk Based Approach
        2. ICH
      2. Regulatory document types and activities
        1. IND
        2. BLA
        3. Process Validation
        4. PAI
        5. 483s
     
    1. Manufacturing Facilities
      1. Layout and Design
      2. Equipment and Utilities
      3. cGMP Requirements
      4. Quality Systems
     
    1. Manufacturing Strategy and Challenges
      1. Outsourcing (manufacturing, testing)
      2. Supply Chain
      3. Scale-up or Scale-out?
      4. Process changes / site changes
      5. Capacity planning
     
    Course Agenda – Day Two:
    Part 2:  Regenerative Medicine Advanced Therapy (RMAT)
    1. Overview of Stem Cells and Immunology
      1. Blood, Hematopoiesis, and Hematopoietic Stem Cells (HSC)
      2. PBMCs, T-cells and B-cells
      3. Non-HSC Stem Cells: Mesenchymal, Embryonic, and Induced Pluripotent stem cells
     
    1. Stem Cell Transplants – HSCs: the original cell therapy
      1. Donor matching
      2. Starting tissue: bone marrow, mobilized stem cells, cord blood
     
    1. Organ Transplants – the practice and the promise
      1. History of solid organ transplants and issues with field
      2. Promise and growing need driving cell and tissue manufacturing
     
    1. Cell Therapy Manufacturing Processes
      1. Overview of general manufacturing operations
      2. Autologous vs allogenic starting tissue
      3. Scale-up vs scale-out
      4. Cryopreservation
      5. Drive towards automation and closed processing
     
    1. RMAT Product Types
      1. CAR T-cells
      2. Tumor Infiltrating Lymphocytes
      3. Other Immune Cells
      4. Mesenchymal Stem Cells
      5. Pluripotent Stem cells
      6. Gene Therapy
     
    Part 4:The Business of Biotech
     
    1. Product Development Cycle
      1. Discovery to commercialization (timeline, costs)
      2. Challenges: where and when to manufacture and how much to make
     
    1. Company Strategies
      1. Intellectual Property, Patents, and Trade Secrets
      2. Small Biotech
        1. Spin-outs, Academic starts, and Licensing
        2. Funding, partnerships, venture capital
        3. Going to market
        4. Exit strategies
      3. Big Pharma
        1. Internal Innovation vs external collaboration/acquisition
    General Q&A/Wrap-up
     

    a0d5A00000Kp21EQAR
    Go

Register