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2019 ATMPS

Practical Application of Phase-Appropriate GMP & Quality Principles to Clinical Development of ATMPs

Jun 06, 2019
Vilnius, Lithuania

There has been a surge in clinical development of Advanced Therapy Medicinal Products (ATMPs), also known as Cellular and Gene Therapy (CGT) Products in the USA.

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Overview

There has been a surge in clinical development of Advanced Therapy Medicinal Products (ATMPs), also known as Cellular and Gene Therapy (CGT) Products in the USA. Many startup companies, hospitals, universities, and now even large biopharmaceutical companies, are planning or have already entered into manufacturing these genetically engineered virus and human cell products for clinical studies. While the ground rules for good manufacturing practices (GMPs) and Quality of recombinant protein and monoclonal antibody manufacturing and control are well established, for the ATMPs these are still under development.

ATMP manufacturing and control presents unique GMP and Quality challenges, such as the heightened concern about the safety and consistency of the starting material, the safety and quality of the raw materials added during processing, the need to protect against adventitious agent contamination during the entire manufacturing cycle, the limitations of the analytical methods available to characterize these virus and cell products, and the reality that the administered clinical medicinal product is a complex living organism.

Patients in these clinical development programs need to be protected by common sense GMPs and Quality. The available regulatory authority guidance documents (both EMA and FDA) for ATMPs will be thoroughly examined. In addition, the core principles presented in PDA’s 2016 Technical Report 56 ‘Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Bulk Drug Substance (API)’ will be adapted to ATMPs.

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Agenda

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  • Thursday, 6 June 2019

    9:00
    Welcome & Introduction

    9:10
    Understanding the Basics

    • Painting the terminology landscape: ATMP, HCT/P, GMP, Quality System, etc.
    • Introduction to the risk-based, phase-appropriate GMP and Quality approach
    10:30
    Coffee Break

    11:00
    Major Differences, and the Regulatory Consequences

    • Viruses/cells are not biologic proteins
    • GMP and Quality consequences of the differences between gene / cell-based medicines and protein-based medicines
    12:30
    Lunch Break

    13:30
    Regulatory Authority (EMA/FDA) Expectations

    • Regulatory authority risk-based considerations to ATMP GMPs and Quality
    • Regulatory authority guidances for a phase-appropriate approach to ATMP GMPs
      and Quality
    15:00
    Coffee Break

    15:30
    Industry Practice in Applying Phase-Appropriate GMPs and Quality to ATMPs

    • Adapting PDA Technical Report 56 as a model for phase-appropriate ATMP GMPs
      and Quality
    • Lesson learned from industry

    17:30
    End of Training Course

Trainers

John Geigert
John Geigert
Biopharmaceutical Quality Solutions
Bio
John Geigert
Biopharmaceutical Quality Solutions

John Geigert is President of BioPharmaceutical Quality Solutions, which for the last 15 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical industry. He has over 40 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development at Cetus Corporation in Berkeley. At these companies, he helped lead the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products now commercially available in the U.S. and in Europe. John Geigert has served on the PDA Board of Directors, currently chairs the PDA Biopharmaceutical Advisory Board, and has served as an expert member of the USP Biotechnology Committee. He is the author of the book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics 2nd Edition, and has written extensively for RAPS Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series)), Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series). John Geigert obtained his B.S. in Chemistry from Washington State University and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this course, you will be able to:

    • Explain the importance and underlying GMP and Quality principles for manufacturing, control and compliance of ATMPs during clinical stages of development
    • Appreciate the GMP and Quality similarities and differences between protein medicinal products and ATMPs
    • Appropriately apply phase-appropriate GMPs and Quality Principles to the clinical development of ATMPs
  • Who Should Attend

    Who Should Attend

    This course is designed for those involved or interested in the manufacturing, quality and GMP compliance of ATMPs during clinical stages of development, including Senior Managers, Directors and Managers/Supervisors, QA/QC, Regulatory, Manufacturing and Process Development personnel.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Radisson Blu Hotel Lietuva

Konstitucijos pr. 20
Vilnius, Lithuania
Phone: + 370 (0) 5272 6272

Radisson Blu Hotel Lietuva
  • Accommodations

    Hotel Website

    The Radisson Blu Hotel Lietuva, in Vilnius, stands on the banks of the River Neris. The hotel is in the heart of Lithuania’s capital, near rich historic sites such as the Old Town and Vilnius Cathedral. Old Town is also the place for shopping. Wander around the cobbled streets and explore the wide range of stores and markets. You’re close to an array of transport options, including bus and train station, while the airport is just 9 kilometers away.

    The hotel’s Riverside restaurant serves a varied breakfast buffet and a selection of international and Scandinavian dishes. Guests can visit the Skybar, located on the 22nd floor and offering views of the Old Town.

    PDA Europe has reserved a limited number of rooms until the 15th April 2019.
    Book Your Room for the PDA Group Rate.

    Single Room € 120 per night*
    Double Room € 135 per night*

    *Rates are per room and night, including the following services and benefits free of charge:
    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airport: Vilnius International Airport - VNO
Airport Phone: +370 612 44442

By Car

9 km, 17 min by car. The Radisson Blu Hotel Lietuva is located at Konstitucijos pr. 20, Vilnius.

Other Options

Train/bus: 8 minutes to downtown Vilnius. Then taxi or bus 5 km to Radisson Blu Hotel Lietuva on Konstitucijos pr. 20. You can also go by bus to the city center.

The Vilnius train station is about 5 km south of the hotel.

Just outside the station, you can easily find a bus that takes you to the hotel. Buses leave the station frequently and the ride to the hotel takes about 20 minutes. There’s a bus stop only 100 meters from the hotel.

Directions

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All Participants €895

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