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2018 PDA Cell and Gene Therapy Conference

Oct 23 - Oct 24, 2018
Bethesda, MD

Advancing into Commercialization

  • Conference
  • The Americas

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Program Highlights

Hear presentations from a lineup of distinguished industry and regulatory speakers including Dr. Peter Marks, MD, PhD, Director, CBER, U.S. FDA, who will present the Regulatory Perspective on Considerations for Development and Commercialization of Cell and Gene Therapies.

Overview

As part of PDA’s ongoing commitment to advanced therapies, the 2018 PDA Cell and Gene Therapy Conference will provide a broad overview of current innovations with a focus on what it takes to successfully steward these therapies toward approval and beyond. The Conference will be an ideal forum for sharing best practices and learning how industry is applying novel approaches to product development, manufacturing, and regulatory compliance with a focus on long term success. 

Plenary sessions will discuss the current state of the science with an emphasis on real world challenges companies are facing as they integrate process development, quality, manufacturing, and supply chain given the unique requirements of cell and gene therapies. Topics include next generation processing, analytical methods, quality systems implementation, control strategy and its link to product realization, quality risk management, aseptic processing, and regulatory compliance in an effort to provide insight into industry best practices. 

Don’t miss out on this important learning opportunity. Make plans now to attend the 2018 PDA Cell and Gene Therapy Conference.

Learning Objectives

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

  • Determine manufacturing and quality requirements for immunotherapies, cell, and gene therapy products.
  • Discuss how effective quality systems are central to the success of cell and gene therapy products.
  • Define strategies to accelerate new products to the market.
  • Interpret the latest trends in microbiological and adventitious agent control strategies.
  • Identify advanced analytical approaches that can be applied for quality control and real time release.
  • Explain delivery system design and manufacturing logistics for patient-centered therapies and precision medicine.
  • Summarize best practices for identifying and introducing new technologies.

Who Should Attend

Department 
Manufacturing | Product Development | Quality | Research & Development | Regulatory Affairs | Engineering | Laboratory | Science | Information Technology | Validation | Training | Clinical

Job Function 
Scientist | Executive and Mid-Level Management | Project | Management | Technical Services | Supply Chain | Manufacturing | Application | Risk Management

Conference Inquiries

Brooke Schneider, CMP
Manager, Programs
Tel: +1 (301) 656-5900 ext. 111
Email: [email protected]

Registration Inquiries

Tel: +1 (301) 656-5900 ext. 115 
Email: [email protected]

Exhibition/Sponsorship Inquiries

David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160 
Email: [email protected]

Agenda

  • Tuesday, October 23

    7:00 a.m. – 5:30 p.m. 
    Registration Open

    7:15 a.m. – 8:15 a.m.
    Continental Breakfast

    8:15 a.m. – 8:30 a.m. 
    Welcome and Opening Remarks from Conference Co–Chair 
    Michael Blackton, MBA, 
    Vice President, Quality, CMC, Adaptimmune, LLC

    8:30 a.m. – 10:00 a.m.
    P1: Navigating the Progress and Promise of Gene Editing
    Moderator: Michael Blackton, MBA, 
    Vice President, Quality, CMC, Adaptimmune, LLC

    Since the early 1980’s, gene editing has proven to be the key enabler in the development of game changing pharmaceutical products from recombinant human growth hormone to the latest anti PD-1 monoclonal antibody products. As the science progresses, the increasing accuracy and precision of gene editing has resulted in the development of novel cell and gene therapy products. These advances present unique regulatory challenges and previously unreachable opportunities for the industry. This session will explore the regulator’s perspective on gene editing, and also show how innovative gene editing strategies can be used to develop products that will potentially change how we think about drug development and biologic therapeutics in general.

    8:30 a.m. – 9:00 a.m. 
    Regulatory Framework for Gene Therapies Incorporating Human Genome Editing: A CBER Perspective
    Anna Kwilas, PhD, Product CMC Reviewer, CBER, FDA

    9:00 a.m. – 9:30 a.m.
    HLA Engineering of Pluripotent Stem Cells
    Gregory Block, PhD, VP Corporate Development, Universal Cells Inc.

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

    9:45 a.m. – 6:30 p.m. 
    Exhibit Hall Open

    10:00 a.m. – 10:45 a.m.
    Refreshment Break in Exhibit Area

    10:45 a.m. – 12:15 p.m. 
    P2: Applying Analytics to the Development and Manufacture of Cell and Gene Therapy Products
    Moderator: 
    Brian J. Hawkins, PhD, Scientific Applications Director, BioLife Solutions

    Despite recent clinical success, cell and gene therapy products remain complex therapies to both manufacture and distribute. This complexity can influence product consistency, lifecycle efficiency, and developmental costs.  This complexity also generates enormous volumes of data that must be effectively collected and managed. If applied correctly, this data can generate deep insight into the manufacturing process and product that are not typically observed at first glance, allowing for a greater understanding of the specific benefits and drawbacks of individual components within a particular workflow. This session focuses on the effective use of data analytics in cell and gene therapy product development and manufacturing to speed the delivery of these promising therapies the patients who most need them.

    10:45 a.m. – 11:15 a.m. 
    Coordinated Efforts to Develop a Robust Standards Infrastructure for Emerging Cell and Gene Therapy Products
    Sheng Lin-Gibson, PhD, Chief, Biosystems and Biomaterials Division, NIST

    11:15 a.m. – 11:45 a. m.
    Utilization of Statistical Process Control to Refine CQAs and Define Process Robustness
    David Smith, Head of Innovation and Engineering, Hitachi Chemical Advanced Therapeutics Solutions

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    12:15 p.m. – 1:45 p.m.
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA registration desk

    1:45 p.m. – 3:15 p.m. 
    P3: Automation of Cell Therapy Product Manufacturing
    Moderator: 
    Vijay Chiruvolu, PhD, Vice President,Process Sciences & Engineering, Kite Pharma (A Gilead Company)

    Although the field of cell and gene therapy is booming with renewed enthusiasm, the challenge of manufacturing these products in an efficient and cost-effective way still remains. Most of the current manufacturing processes rely on semi-automated or manual operations performed by scientists and technicians. This session will focus on some of the challenges and opportunities related to implementation of automation in cell therapy manufacturing such as technology selection, cost, stage of implementation, and regulatory implications.

    1:45 p.m. – 2:15 p.m. 
    Automated Approaches for the Process Development and Manufacture of Cell and Gene Therapies
    Qasim A. Rafiq, PhD, Associate Professor, University College London

    2:15 p.m. – 2:45 p.m. 
    COGs in the Machine: Process Automation as a Key to Commercialization
    Ian Gaudet, PhD, Director, Process Development, Miltenyi Biotec, Inc.

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    3:15 p.m. – 4:00 p.m.
    Refreshment Break in Exhibit Area

    4:00 p.m. – 5:30 p.m. 
    P4: Regulatory Considerations for Development and Commercialization of Cell and Gene Therapies 
    Moderator: Austin Caudle, 
    Associate Director, Business Development, IQVIA

    Product approvals in cell and gene therapy has been at the forefront of headlines around the world, particularly over the past year-and-a-half, due in part to updates to the regulatory structure as existing rules were not designed around these types of therapies. Because these therapies are so complex and differ significantly from traditional biological products, they present a variety of challenges to regulatory authorities, manufacturers, developers, healthcare providers, and patients. This session will examine some of the significant regulatory considerations that are impacting cell and gene therapies, including questions relating to designation of expedited programs available to sponsors of regenerative medicine therapies for serious conditions.

    4:00 p.m. – 4:30 p.m.
    Moving Beyond CAR-T: Non-Engineered Multi-Antigen Specific T Cells Can Drive Significant Therapeutic Benefit for Patients with Lymphoma, Myeloma, and AML
    Peter Hoang, President & Chief Executive Officer, TapImmune, Inc.

    4:30 p.m. – 5:00 p.m. 
    FDA’s Efforts to Advance the Development of Cell and Gene Therapies
    Peter Marks, MD, PhD, Director, CBER, FDA

    5:00 p.m. – 5:30 p.m.
    Questions and Answers/Discussion

    5:30 p.m. – 6:30 p.m.
    Networking Reception in Exhibit Area

    Wednesday, October 24

    7:00 a.m. – 5:15 p.m. 
    Registration Open

    7:00 a.m. – 8:30 a.m.
    Continental Breakfast

    7:15 a.m. – 8:15 a.m. 
    Cell and Gene Therapy Interest Group Breakfast Session
    Moderator: 
    Michael Blackton, MBA, Vice President, Quality, CMC, Adaptimmune, LLC

    7:15 a.m. – 7:45 a.m. 
    Vijay Chiruvolu, PhD, Vice President, Process Sciences & Engineering, Kite Pharma (A Gilead Company)

    7:45 a.m. – 8:45 a.m.
    Questions and Answers/Discussion


    8:30 a.m. – 10:00 a.m. 
    P5: Current Advancements in Product Realization and Lifecycle Management of Cell and Gene Therapy-Based Biopharmaceuticals
    Moderator: 
    EJ Brandreth, Vice President, Quality, Inovio Pharmaceuticals

    The development, clinical supply, and eventual commercialization of cell and gene therapy products involves unique challenges and opens new opportunities in the manufacturing process, as well as in the overall management of the product lifecycle. This session explores recent advancements, hurdles, and creative solutions to gene therapy products which the industry is embracing as these products advance from development through the clinical stages and approach commercialization.

    8:30 a.m. – 9:00 a.m. 
    Potency and DNA Plasmids: A New Paradigm
    Patrick P. Pezzoli, Director,  Product Characterization, Inovio Pharmaceuticals

    9:00 a.m. – 9:30 a.m.
    Rapid Interventions for EID Using Synthetic DNA Technology
    David B. Weiner, PhD, Executive Vice President, Director – Wistar Vaccine Center, W.W. Smith Charitable Trust Professor in Cancer Research, The Wistar Institute

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

    9:45 a.m. – 4:00 p.m.
    Exhibit Hall Open

    10:00 a.m. – 10:45 a.m.
    Refreshment Break in Exhibit Area

    10:45 a.m. – 12:15 p.m. 
    P6: Quality and Manufacturing Challenges in Cell and Gene Therapy
    Moderator: 
    Kimberly A. Carnes, Director, Quality Systems, REGENXBIO Inc.

    Cell and gene therapy manufacturing presents unique quality challenges. Effective risk management, efficient quality systems, and carefully designed facility and engineering controls are critical to successful manufacturing of cell and gene therapy products. This session will focus on the implementation of innovative quality systems and facility design controls to maintain high product quality standards while meeting cycle time demands, particularly as these products move toward commercialization.

    10:45 a.m. – 11:15 a.m.
    Quality Systems to Enable Rapid Vein-to-Vein Cycle Time
    Heather Francis, MSE, Director of Quality Systems and Compliance, Kite Pharma (A Gilead Company)

    11:15 a.m. – 11:45 a.m.
    Integrated Risk Control Strategy for Gene Therapy Supply: Advanced Manufacturing
    Thomas C. Page, PhD, VP, Engineering and Asset Development, FUJIFILM Diosynth Biotechnologies

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    12:15 p.m. – 1:45 p.m.
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA registration desk

    1:45 p.m. – 3:15 p.m. 
    P7: Navigating the Supply Chain and Logistics to Deliver Cell and Gene Therapy Products
    Moderator: 
    Audra Riley, Associate Director, Quality Systems, Merck & Co., Inc.

    Today, the possibility of treating many genetic and infectious disorders is a reality with regulatory market approval of cell and gene therapy products. As we enter a new era of commercial medicine, cell and gene therapy products present unique supply chain and logistics challenges from their traditional counterparts including both the materials and final product perspectives. This session examines procurement challenges in sourcing vectors and challenges associated with integrating the patient into the supply chain.

    1:45 p.m. – 2:15 p.m.
    Digital Solutions in Personalized Medicine: Best Practices to Drive Safety, Efficiency, and Scale
    Heidi M. Hagen, Chief Strategy Officer, Vineti Inc.

    2:15 p.m. – 2:45 p.m.
    Chasing Vector
    Richard M. Stout, Director, Global Sourcing & Procurement, Adaptimmune, LLC

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    3:15 p.m. – 4:00 p.m.
    Refreshment Break in Exhibit Area

    4:00 p.m. – 5:00 p.m. 
    P8: Panel Discussion
    Moderator: Michael Blackton, MBA, 
    Vice President, Quality, CMC,Adaptimmune, LLC

    As the world of cell and gene therapy advances, and as the industry and regulators gain experience and knowledge, strategies will evolve. This session will explore the current state of the industry, regulatory insight, and practical questions regarding cell and gene therapy. 

    Vijay Chiruvolu, PhD, Vice President, Process Sciences & Engineering, Kite Pharma (A Gilead Company)
    Anna Kwilas, PhD, Product CMC Reviewer, CBER, FDA
    Richard M. Stout, Director, Global Sourcing & Procurement, Adaptimmune, LLC
    David B. Weiner, PhD, Executive Vice President, Director – Wistar Vaccine Center, W.W. Smith Charitable Trust Professor in Cancer Research, The Wistar Institute

    5:00 p.m. 
    Closing Remarks from Conference Co-Chair
    Vijay Chiruvolu, PhD, Vice President, Process Sciences & Engineering, Kite Pharma (A Gilead Company)

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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Travel

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.

Hyatt Regency Bethesda

1 Bethesda Metro Center
Bethesda, MD

How to Get Here

By Air

More information coming soon.

By Car

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Other Options

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Directions

Registration Fees

Regular Price

Event Registration | October 23-24, 2018

Member

By August 13, 2018
$1,895

After August 13, 2018
$2,295

Non-member

By August 13, 2018
$2,174

After August 13, 2018
$2,574


Young Professional Member †

Member

By August 13, 2018
$948

After August 13, 2018
$1,148

† You must be a member to take advantage of this rate.


Government/Health Authority

Member*

By August 13, 2018
$700

After August 13, 2018
$700

Non-member*

By August 13, 2018
$800

After August 13, 2018
$800

*For this member type or discounted rate, online registration is not available and must be faxed in.


Academic

Member

By August 13, 2018
$700

After August 13, 2018
$700

Non-member*

By August 13, 2018
$800

After August 13, 2018
$800

*For this member type or discounted rate, online registration is not available and must be faxed in.


Student

Member

By August 13, 2018
$280

After August 13, 2018
$280

Non-member*

By August 13, 2018
$310

After August 13, 2018
$310

*For this member type or discounted rate, online registration is not available and must be faxed in.


Tuesday/Wednesday Only

Member

$1,348

Non-member*

$1,487

All prices in US dollars.

*For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to take advantage of this rate.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at [email protected] for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by August 24, 2018 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference, Workshops and Events: If your written request in received on or before August 24, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: Tape recordings are prohibited at all PDA events.

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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