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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Cell and Gene Therapy Conference

Advancing into Commercialization
Oct 23 - Oct 24, 2018 |
Oct 24, 2018 |
Hyatt Regency Bethesda | Bethesda, MD
  • Conference
  • Western Hemisphere Events
Exhibition: October 23-24, 2018
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Speaker Biographies

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: schneider@pda.org

Registration Inquiries

Tel: +1 (301) 656-5900 ext. 115 
Email: registration@pda.org

Exhibition/Sponsorship Inquiries

David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160 
Email: hall@pda.org

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 Perspective on Gene Editing
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, Senior Application Scientist, 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, 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 in Exhibit Area

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, MSc, 
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 Nenefit 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

7:30 a.m. – 5:15 p.m. 
Registration Open

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

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.
Case Study: Rapid Execution of a DNA Plasmid for Emerging Zika Outbreaks
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.
Industry Representative on Quality and Manufacturing Challenges in Cell and Gene Therapy
Heather Francis, MSE, Director of Quality Systems and Compliance, Kite Pharma (A Gilead Company)

11:15 a.m. – 11:45 a.m.
Industry Representative on Quality and Manufacturing Challenges in Cell and Gene Therapy
Thomas Page, VP of Engineering and Asset Development, Fujifilm Diosynth

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

12:15 p.m. – 1:45 p.m.
Lunch in Exhibit Area

1:45 p.m. – 3:15 p.m. 
P7: Navigating the Supply Chain and Logistics to Deliver Personalized Medicines
Moderator: 
Audra Riley, Director, External Quality Management, NewLink Genetics

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, personalized medicines present unique supply chain and logistics challenges from their traditional counterparts including both the raw materials and final product perspective.

1:45 p.m. – 2:15 p.m.
Industry Perspective on Supply Chain and Logistics to Deliver Personalized Medicine
Heidi M. Hagen, Chief Strategy Officer, Vineti Inc.

2:15 p.m. – 2:45 p.m.
Industry Perspective on Supply Chain and Logistics to Deliver Personalized Medicine
Richard Stout, Director of 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
Peter W. Marks, MD, PhD, Director, CBER, FDA
Richard Stout, Director of Global Sourcing & Procurement, Adaptimmune, LLC

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

Workshop 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 registration@pda.org 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 info@pda.org 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: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA events.

Hyatt Regency Bethesda

Hyatt Regency Bethesda
One Bethesda Metro Center
7400 Wisconsin Avenue
Bethesda, MD 20814 USA
Tel: +1 (301) 657-1234

Rate: Single/Double: $249.00, plus applicable state and local taxes.

Website: https://bethesda.regency.hyatt.com

Cut Off Date: Monday, September 24, 2018

(The PDA block of rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate). After the cut-off date, rooms will be available at the prevailing rate based on availability.

Hotel Accommodations

A block of rooms have been reserved for meeting participants at the Hyatt Regency Bethesda. The rate is $249 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 24, 2018. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Bethesda at +1 (301) 657-1234. Please make sure to tell the reservationist that you are with the PDA group attending the 2018 PDA Cell & Gene Therapy Conference to receive the PDA group rate.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 24 hours prior to the date of arrival by 3 p.m. to avoid cancellation fees.

Amenities

Just one mile from the MD/DC line, Hyatt Regency Bethesda is perfectly-positioned to allow you to take advantage of all Washington, DC has to offer. Located directly above the Bethesda Metro station (Red Line), you're walking distance to numerous area businesses and minutes from Maryland's best shopping, dining and cultural attractions. Take advantage of the hotel's Smart Phone Check-in and the 24 hour StayFit™ fitness center during your stay. The Hyatt Regency offers complimentary Wi-Fi in all guestrooms and public areas.

Area Airports

Reagan National - (DCA) is located 12.7 miles from the hotel and all major carriers service this airport

Dulles International Ariport - (IAD) is 25 miles away, all major carriers service this airport

Baltimore Washington - (BWI) is 35.2 miles away, all major carries service this airport

Ground Transportation

Taxi fares from Reagan National (DCA) are approximately $45-55.00 one way, not including tip, and will take about 30 minutes. One way taxi fares from Dulles (IAD) is approximately $75 and from Baltimore/Washington (BWI) is about $95.

Driving Directions

Hyatt Regency Bethesda hotel is located at 7400 Wisconsin Avenue, Bethesda MD.

Hotel Parking

Self-parking at the Hyatt Regency Bethesda is $12 daily/overnight. Valet parking is $18 daily or $30 overnight.

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA Cell and Gene Therapy Workshop offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This workshop will bring together industry experts from Manufacturing, Product Development, Quality, Research and Development, Laboratory Science, Validation, Regulatory Affairs, and Engineering.

At this conference you will be exposed to high quality attendees from a variety of manufacturing companies – making this a must attend meeting. In addition, high profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, Sales

Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
Email: hall@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4120

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