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2017 PDA Cell and Gene Therapy Workshop

Research to Reality - Manufacturing Challenges to Cell Therapy
Apr 05 - Apr 06, 2017 |
Apr 06, 2017 |
Anaheim Marriott | Anaheim, CA
  • Workshop
  • Western Hemisphere Events
Exhibition: April 5-6
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Following PDA’s flagship Annual Meeting is PDA’s first Cell & Gene Therapy Workshop that provides a venue for obtaining the latest and most comprehensive information on a broad range of topics related to the field. The Workshop is the ideal forum for sharing best practices and learning how industry is applying novel approaches for development and commercialization of pharmaceutical and biopharmaceutical products.

The theme of the 2017 Workshop is Research to Reality - Manufacturing Challenges to Cell Therapy. In selecting this theme, the goal was to design an inclusive event that encompasses the wide ranging interests of all PDA members. Relevant information that is also important to both small molecule pharmaceutical and biopharmaceutical industries will be covered, such as developing control strategies, managing a complex supply chain and leveraging automation for increase capacity, but with specific application as it relates to gene and cellular therapies. Taking full advantage of the Meeting being held in a region of the United States known as a hot bed for innovation, novel approaches and future strategies for bringing products to the market will figure prominently on the program.

Plenary sessions will focus on current and future applications for these emerging therapeutic entities, including the emerging fields of immunotherapy, gene and cell-based therapies. Emphasis is placed on science and technologies needed to bring these innovative products to market and ultimately to the patient. Additional plenary sessions further explore current and future trends in process development and manufacturing including topics on next generation processing and facilities, application of big data for process design and optimization, and accelerating the industry response to healthcare needs.

Don’t miss out on this important learning opportunity. Make plans now to attend the 2017 PDA Cell & Gene Therapy Workshop.

Learning Objectives

At the completion of this event, attendees will be able to:

  • Determine manufacturing and quality requirements for immunotherapies, gene and cell therapy products
  • Describe continuous manufacturing applications and flexible facility designs of the future
  • Demonstrate how big data can be applied to design and optimize manufacturing processes
  • 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

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

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

Contact

Jason Brown
Senior Manager, Programs & Registration Services
Tel: (301) 656-5900 ext. 131
Email: brown@pda.org

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

Exhibition Inquiries
David Hall
Vice President, Sales
Tel: +1 (240) 688-4405
Email: hall@pda.org

Wednesday, Apri 5, 2017

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

1:00 p.m. - 1:15 p.m.
Welcome and Opening Remarks
Michael Blackton,
Vice President, Quality, CMC, Adaptimmune, Ltd., Ltd.

1:15 p.m. - 2:45 p.m.
P1 - Opening Plenary Session: The Promise of Cell Therapy
Moderator: Michael Blackton
, Vice President, Quality, CMC, Adaptimmune, Ltd., Ltd.

Session Description: Cell therapy is just beginning to deliver on the promise of understanding and treating a variety of ailments, injuries, and other medical conditions. It's impact is evident in treatments that have helped thousands of patients with certain forms of cancer and tissue and bone injuries. As clinical trials continue and more knowledge is gained, options for potential treatments increase. This session will address future opportunities and methods of using cell therapy to help patients.

1:15 p.m. - 1:45 p.m.
TCR as a Novel Cancer Therapy
Gwendolyn Binder-Scholl, PhD, Chief Technology Officer, Adaptimmune, Ltd., Ltd.

1:45 p.m. - 2:15 p.m.
Innovative Usage of Cell Therapy
Industry Presenter Invited


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

2:45 p.m. - 3:30 p.m.
Refreshment Break in Exhibit Area

3:30 p.m. – 5:00 p.m.
P2 – Material Challenges for Cellular and Gene Therapy Products
Moderator: Karen Walker
, Global Head of Technical Development & Manufacturing, Cell & Gene Therapies Unit, Novartis

Session Description: Materials used in the manufacture of pharmaceutical or biopharmaceutical products have been in focus over the past several years as the role they have and the importance of that role through the development lifecycle is understood. In the area of cellular and gene therapies, the challenges grow as material batches are even smaller than for biopharmaceutical manufacturing, are often themselves biologically active, and are often "custom manufactured". This session will explore these challenges and some ideas for dealing with this complex landscape.

3:30 p.m. - 4:00 p.m.
Viral Vector Developments
Johannes Van der Loo, PhD,
Director, Clinical Vector Core, Children's Hospital of Philadelphia (CHOP) (Invited)

4:00 p.m. - 4:30 p.m.
Raw Material Safety
Industry Representative Invited

4:30 p.m. – 5:00 p.m.
Questions and Answers/Discussion

5:00 p.m. – 6:15 p.m.
Networking Reception in Exhibit Area

Thursday, April 6, 2017

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

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

8:30 am. - 10:00 a.m.
P3 - Managing the Product Lifecycle – Process Change, Comparability, Process Validation Considerations
Moderator: Vijay Chiruvolu, PhD,
Senior Director, Kite Pharma

Session Description: Cell therapy product development is a complex process, and development priorities typically shift through a product's lifecycle. Before market licensure, the emphasis is on ensuring product safety and efficacy during clinical trials, understanding of product characteristics and demonstration of manufacturing process control. Process optimization and capacity improvements activities are often performed within the regulatory and quality framework and may require comparability and process validation considerations. A strong analytical development program with emphasis on extensive product understanding is key to the success of process optimization though out the product lifecycle.

8:30 a.m. - 9:00 a.m.
Balancing Regulatory Requirements with Process Optimization for Commercial Feasibility In Advanced Stage T Cell Therapy Products
Phillip Bassett,
Head of Process Development, Adaptimmune, Ltd., Ltd.

9:00 a.m. - 9:30 a.m.
Cell & Gene Therapy/Product Lifecycle
Margit Jeschke,
Global Head, Analytical Development, Cell and Gene Therapy, Novartis AG

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

9:45 a.m. - 5:30 p.m.
Exhibit Area Open

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

10:45 a.m. - 12:15 p.m.
P4 - Managing the Supply Chain: Vein-to-Vein and Across the Globe
Moderator: Karen Walker,
Global Head of Technical Development & Manufacturing, Cell & Gene Therapies Unit, Novartis

Session Description: Managing the supply of pharmaceutical products is complex and fraught with points where tampering or counterfeit can occur. For years Pharmaceutical companies have developed mechanism to secure the supply chain for these products. Now with the increased focus on cellular therapies as potentially curative therapies, the complexity increases. Companies need to find ways to deliver small volumes (single batch – single patient) to the right patient every time and in time to preserve the integrity and efficacy of these novel therapies. Learn how two companies are dealing with these challenges.

10:45 a.m. - 11:15 a.m.
Chain of Identity
Jian Irish, PhD,
Senior Vice President, Supply Chain, Kite Pharma

11:15 a.m. - 11:45 a.m.
Evolving CART-T Supply Chain
Kimberly Lounds-Foster,
Corporate Vice President, Global Supply, Celegene

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

12:15 p.m. – 1:30 p.m.
Lunch

1:30 p.m. - 3:00 p.m.
P5 – Manufacturing Systems
Moderator: Michael Blackton,
Vice President, Quality, CMC, Adaptimmune, Ltd.

Session Description: Cell therapy development and production poses unique challenges that are testing existing technologies and practices. Current production facilities and processes may be state of the art, but they still may not be appropriate for successful manufacturing of cell therapy products. This session will explore strategies to safely, effectively, and efficiently plan and conduct the necessary cell therapy production operations.

1:30 p.m. - 2:00 p.m.
Enabling Development & Production of Future Medicines
Dolores Baksh,
Innovation Leader, Cell Therapy Technologies, GE Healthcare

2:00 p.m. - 2:30 p.m.
Achieving Cost Effective Cell Therapies with Automation
Brian Hanrahan,
Manager, Cell Therapy, Invetech

2:30 p.m. - 3:00 p.m.
Questions and Answers/Discussion

3:00 p.m. – 3:45 p.m.
Refreshment Break in Exhibit Area

3:45 p.m. – 5:15 p.m.
P6 - The Future Path of Cell and Gene Therapy
Moderator: Vijay Chiruvolu, PhD,
Senior Director, Kite Pharma

Session Description: Novel approaches for cell and gene therapies currently under development provide promising opportunities beyond the initial success of autologous CAR T cell products directed against hematological malignancies. Introduction of applicable technologies such as rAAV mediated genome engineering, and an increase in biological and process knowledge has introduced prospects such as safety switches, enhanced efficacy, and allogeneic products. The purpose of this session is to explore the implementation of novel tools and strategies, and how the field will increase in industrial feasibility.

3:45 p.m. - 4:15 p.m.
Highly Characterized Processes to Produce Novel Cell Therapies for the Clinic
Claudia Mitchell, PhD,
CEO, Universal Cells
4:15 p.m. - 4:45 p.m.

The Future of Gene Therapy
J Fraser Wright, PhD,
Co-Founder & Chief Technology Officer, Spark (Invited)

4:45 p.m. - 5:15 p.m.
Questions and Answers/Discussion

5:15 p.m.
Closing Remarks & Adjournment
Vijay Chiruvolu, PhD,
Senior Director, Kite Pharma

2017 PDA Cell and Gene Therapy Workshop Registration | April 5-6, 2017

Member | Non-member

$800


2017 PDA Annual Meeting and 2017 PDA Cell and Gene Therapy Workshop Registration | April 3-6, 2017

Member

Before January 20, 2017
$2,545

January 20 - February 17, 2017
$2,995

After February 17, 2017
$3,245

Non-member

Before January 20, 2017
$2,804

January 20 - February 17, 2017
$3,254

After February 17, 2017
$3,504

All prices in US dollars.

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

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.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 5th 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 February 2, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. 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 Workshop/Events: If your written request in received on or before February 2, 2017 , 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 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. Recordings are prohibited at all PDA conferences.

Anaheim Marriott

Anaheim Marriott
700 West Convention Way
Anaheim, CA USA 92802
Tel: +1 714-750-8000
Reservations: +1-877-622-3056

  Make Your Reservation Online

Rate: Single/Double: $229.00, plus 15% state and local taxes, and a 2% Anaheim Tourism Improvement District Assessment and Tourism Taxes.

Website: www.marriott.com/Anaheim

Cut Off Date: Thursday, March 2, 2017 (A 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 Anaheim Marriott. The rate is $229 for single or double occupancy, plus 15% state and local taxes and a 2% Anaheim Tourism Improvement District Assessment and Tourism Taxes.  Reservations must be secured by Thursday, March 2, 2017. 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 11:00 a.m.

To make reservations, individuals may call the Anaheim Marriott at +1-877-622-3056. Please make sure to tell the reservationist that you are with the PDA group attending the 2017 PDA Annual Meeting 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 72 hours prior to check-in to avoid cancellation fees.

Amenities

The Anaheim Marriott is conveniently located near Downtown Disney, Honda Center and Angel Stadium of Anaheim.  You can take a 15 minute walk to the Anaheim GardenWalk featuring outdoor dining, shopping and entertainment.

The guest rooms and suites feature contemporary decor and upscale amenities including plush bedding. After a day of sightseeing or meetings, enjoy a workout in our state-of-the-art fitness center, soak up sun at the pool, enjoy a snack on the dining deck or cozy up near a fire pit.  Enjoy an unforgettable Southern California stay at the Anaheim Marriott!

Travel

Area Airports

John Wayne Airport - Orange County (SNA) is located 14 miles Northwest of the Anaheim Marriott.

Long Beach Airport (LGB) is located 19 miles East of the Anaheim Marriott.

Los Angeles International Airport (LAX) is located 35 miles Southeast of the Anaheim Marriott.

Ground Transportation

John Wayne Airport- Orange County (SNA):

  • Taxi service to the Anaheim Marriott is approximately $45 one way, not including tip.
  • Alternate transportation: Super Shuttle; fee: $11 USD each way (per person); reservation required.

Long Beach Airport (LGB)

  • Taxi service to the Anaheim Marriott is approximately $70 one way, not including tip.
  • Alternate transportation: Super Shuttle; fee: $35 each way (per person); reservation required.

Los Angeles International Airport (LAX)

  • Taxi service to the Anaheim Marriott is approximately $120 one way, not including tip.
  • Alternate transportation: Super Shuttle; fee: $17 each way (per person); reservation required.

Super Shuttle Reservations can be made online via www.supershuttle.com.

Driving

From Katella Avenue/Disney Way/Civic Center/Disneyland. Merge onto South Anaheim Way. Proceed to East Katella Avenue and turn left. Turn left again onto South Harbor Boulevard. Take the first right onto West Convention Way. Make a U-turn and the hotel will be on the right.

Hotel Parking

Onsite Parking at the Anaheim Marriott is $25 daily. Valet parking is $30 daily.

Sponsorship and Exhibit Opportunities are Available!

The 2017 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=3162

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