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Hone your skills with CPD accredited training courses led by world class industry experts.

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Here are details of the accredited training we ran in 2018 

Comparability Workshop

Christopher Bravery
Christopher Bravery

9:00 – 17:00, Monday 22 January
Price: $895


Why you should attend:

Achieving quality, and therefore safety and efficacy on a global scale when considering biologicals combined with a lack of regulatory guidance, is one of the most difficult challenges facing the cell and gene therapy community. Whether you’re approaching full commercialization, starting to consider future strategies or reassessing your current manufacturing process, this course will define key areas to emphasis and implement comparability on a global scale.
 

Participants of the course will:

  • Outline the fundamentals of comparability
  • Learn about the increasing complexities of the biologicals
  • Understanding how existing specifications are not comparability
  • Learn how to apply the principles of comparability to highly variable products

Gain visibility of common mistakes and how to avoid these consequences
 

The content:

The objective of comparability is to ensure the quality, safety and efficacy of the drug production process by a changed manufacturing process, through collection and evaluation of the relevant data to determine whether there might be any adverse impact on the drug product due to the manufacturing process changes.

Change is inevitable and necessary both in development and over the post-approval product lifecycle.  Whenever changes are made it is necessary to confirm they do not adversely impact the quality, and therefore safety and efficacy, of the product; this requires data beyond meeting current specifications. 

Click here to learn more about Christopher Bravery

Who should attend?

  • Business Development
  • Manufacturing Professionals
  • Scientific Leads
  • Regulatory Affairs Professionals
     

 

Product & Company Valuation

partik frei
Dr. Patrik Frei

9:00 – 17:00, Monday 22 January
Price: $895

Why you should attend:

Whether you raise money, try to out or in-licence products as a business development or you would like just a basic understanding of how valuation works, this is the ideal introduction course for you. As a total beginner or even if you already have some valuation experience, the specific application of valuation in the biotechnology and life sciences field of this course will give you a great introduction or refresh of this complex topic.
 

Participants of the course will:

  • Learn how to assess a company prior to the valuation
  • Understand the key value drivers for a biotech and medtech company valuation
  • Learn concept, tools and techniques for the valuation
  • See what investors are focusing on before investing in a life sciences company
  • Be able to calculate the value of a company in a case study
  • Learn the key components of a therapeutic product valuation
  • Do a case study to value a proposed licensing deal and determine if the terms are acceptable
  • Learn about structuring a deal between a pharma and a biotech company based on up-front, milestone and royalty payments.

 

The content:

Valuation in Life Sciences is probably one of the most difficult tasks. What deal terms can you ask for or what should be the equity share to a new investor? These are critical question for most life sciences companies. However, valuation is more than just numbers – its about the assumptions and about understanding the business, so it comes down to the potential of a product or company and the associated risk.

The concept of this course is to provide an introduction to the financial and business aspect of valuation. With a combination of a practical based presentation followed by two case studies (one for a company valuation and one for a product valuation and licensing deal), the participants will be able to learn hand-on, how to do a valuation. The provided Excel model for the product valuation (rNPV) can be used and will be provided as a take-home tool as well. The case studies will be done in groups to also allow networking during the course and provide interactive learning.

Click here to learn more about Patrik Frei

Who should attend?

Anybody active in the life sciences industry and involved in fundraising, licensing, technology transfer and business development. Often participants are biotech or pharma executives, investors, technology transfer officers, consultants, business development or pharma executives. Both people with either a pure finance or a scientific background can benefit from this introduction course.

 

 

 

 

Half Day Training

Authoring the Common Technical document

Christopher Bravery
Christopher Bravery

11:15 – 15:30, Thursday 25 January
Price: $495

Why you should attend:

The common technical document does not allow for flexibility, if you’re currently going through the process or considering future strategies, this in-depth workshop will give you the tools to complete this document efficiently. Understanding the verity of sections, focuses and the preferred formats will save you a countless man hours.
 

Participants of the course will:

  • Understand the structure of the ICH common technical document module 3 CMC/Quality.
  • Learn how to format your text and data: do and don’ts.
  • Gain visibility on which sections are descriptions, which data and which require discussion
  • Learn which types of data belong in each the individual sections
  • Understand how to use the CTD for a continuous manufacturing process
  • See where to put the vector manufacturing details for ex vivo modified cells
  • Learn how the sections work together; to ensure you’re no unnecessarily repeating information
     

    The content:

    This in-depth course will give you complete visibility of the numerous purposes each section requires, how they link and whether it requires a descriptive or data driven response. It will give you the framework to input the data and highlights preferable styles, figures and tables when compiling this document.

    The ICH Common Technical Document was developed to standardize the way information is shared with regulators, and is accepted or mandatory by agencies following ICH (e.g. EU, US, Japan, Canada etc). The CTD is used for all types of medicinal product but the purpose of each section may not always be clear for ATMP.

    Click here to learn more about Christopher Bravery
     

Who should attend?

  • Manufacturing Professionals
  • Regulatory Affairs
  • Scientific Leads

Quality-by-Design

anthony davies  jerrod denham
Anthony Davies & Jerrod Denham

9:00 – 12:30, Monday 22 January
Price: $495

Quality by Design (QbD) is a science- and risk-based approach to pharmaceutical development. Applied to manufacturing processes, it is intended to ensure a rational and cost-effective approach to product quality. Both the EMA and FDA have systematically assessedQbD elements of regulatory filings and, especially since the FDA’s 2011 Process Validation Guidance and the ICH’s Q8 through Q11, it has become an intrinsic part of regulatory guidance.

However, understanding and adoption of the principles of QbD has remained relatively limited in the field of cell and gene therapy. We strongly believe that its methodologies are critical to the successful development of ATMPs and that they should be incorporated as early as possible into the science of manufacturing. This workshop will both demystify the fundamentals of QbD and provide concrete examples of its application to this field. You will leave with a crystal-clear understanding of P Diagrams, RAMM matrices, the QTPP and many more tools which you can immediately use to improve your products and processes.

 

    

 

 

  • "The event reflected the fantastic growing enthusiasm around cell and gene therapy, including small and large companies, investors and regulators. It was great to see everyone so engaged and so positive. The event really gives you the “pulse” of what is happening right now in cell and gene therapy."
    Anne-Virginie Eggimann,
  • “Great program, great people, great venue.”
    Klaus Kühlcke
    Managing Director, EUFETS GmbH
  • Dynamic, interesting and highly interactive event that promotes exchange and networking in highly specialized field of gene therapy.”
    Nathalie Clement
    Associate Director, Powell Gene Therapy Center, University of Florida
  • "Phacilitate provides a unique forum, bringing together research, process development, and commercial leaders on the cutting edge of cell, gene, and immunotherapy. A great conference for anyone wanting a comprehensive view of the field."
    Dr James Trager
    Vice President, Research & Product Development, Dendreon
  • "It was all business. I’ve never been to an event where over 80% of the conversations I had were constructive to my business objectives."
    Kurt Gielen
    Acquisition & Business Development Manager, BioMedical Materials, Chemelot Campus B.V.
  • “Great way to expand network with global experts in cell and gene therapy who are facing similar challenges.”
    Steven Goodman
    Director, Strategy and Engagement, GSK