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2021 ATMPs Conference

2021 PDA Advanced Therapy Medicinal Products Conference

Oct 26 - Oct 27, 2021
Baltimore, MD

  • Conference
  • The Americas

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Overview

As part of PDA’s ongoing commitment to the future of the pharmaceutical industry, PDA will host the 2021 PDA Advanced Therapy Medicinal Products (ATMP) Conference on 26-27 October in Baltimore, MD. The Program Planning Committee is building an agenda to present solutions and tools currently facing the industry: Product Life Cycle Management, End to End, Regulations, Risk Assessment/Tech Transfer, Supply Chain Management and Manufacturing Network.

The conference will build on the theme of Clearing the Hurdles and Winning the Race to Save Lives by sharing best practices and learning how industry is applying novel approaches to product development, manufacturing, and regulatory compliance.

Don’t miss out on this important learning opportunity. Make plans now to attend the 2021 PDA Advanced Therapy Medicinal Products Conference in Baltimore!

Agenda

  • Day 1
  • Day 2
  • Tuesday, 26 October

    08:30 – 10:30 | Plenary 1: End User Perspective

    Moderator: Irving Ford, BMS

    The primary focus for ATMPs tends to be on the manufacturing process and a quick return of the product to the patient. Have you ever wondered what happens in between the manufacturing process and delivery of the product to the patient?

    This session will allow you to hear firsthand from medical experts who are on the frontline and who liaise between the manufacturing sites, the health care providers, and the patients.

    Join us as they share their unique role and the various roadblocks and challenges, they encounter in the world of ATMPs.
    Come and discover the ends and outs of the other side of ATMP manufacturing. You many never look at your process the same.


    Break

    10:45 – 12:15 | Plenary 2: Product Lifecycle Management for ATMP's - Early

    Moderator: David Geoghegan, Tmunity

    Managing ATMP Products through the clinical development process and into commercialization presents unique challenges. As more of these products make clinical progress, identifying the potential solutions will help technical teams anticipate and plan for successful product development. The goals of this session are to discuss those challenges and approaches to handling them.


    Break

    13:15 – 14:45 | Plenary 3: Product Lifecycle Management for ATMP's - Later

    Moderator: Darius Pillsbury, ValSource

    On the heels of the commercialization of multiple ATMPs globally (including many within this past year) and the quickly increasing number of ATMPs rapidly moving through development, organizations are finding themselves faced with the many hurdles presented in the later stages of the product lifecycle. In this session many of these challenges of the later stages of the product lifecycle are presented and solutions are provided by the speakers.


    Break

    15:15 – 16:45 | Plenary 4: End to End

    Moderator: Dayue Chen, Genentech

    It is universally recognized that CM&C for CGT products is significantly more challenging in comparison to traditional drug products. As a result, a comprehensive strategy is critical to ensure effective end-to-end control throughout the manufacturing process. This session provides some illustrations of the end-to-end manufacturing and its vital role in safeguarding product quality and process consistency.


    17:00 – 18:00 | Hot Topic: Retention

    Moderator: Irving Ford, BMS

    Like a moth to flame, so are persons drawn to ATMPs. With the explosion of ATMPs manufacturing facilities has come a need to hire the best and the brightest. To further complicate matter, many of these facilities are near each other or in locations that are alluring for potential employees.

    This, of course, creates a hiring and retention challenge. How does one recruit and retain talent when the competition is so great? What do you do when you have just invested in training an employee just for them to resign at the end of training to go work for another ATMP company? How do you determine what is their motivation for staying or leaving?

    Come and join us as we hear from speakers who are living this challenge and the tactics they are using to be successful.

  • Wednesday, 27 October

    07:15 – 08:15 | Hot Topic: Interest Group Update

    Moderator: Darius Pillsbury, ValSource

    08:30 – 10:10 | Plenary 5: Regulations

    Moderator: Lori Daane, bioMerieux

    This session will discuss regulatory considerations and standards.


    Break

    10:45 – 12:15 | Plenary 6: Risk Assessment/Tech Transfer

    Moderator: Katherine Giacoletti, SynoloStats

    Successful technology transfer for ATMPs can be complicated by a number of factors, including material safety considerations, high manufacturing variability, availability of material during early phases for process and analytical development runs, necessary process changes to facilitate scale-up, and the transition of a product from an academic development setting often used in early clinical phases into a GMP manufacturing environment for later stage development.

    This session will dive into some of these challenges and possible solutions, such as Quality Risk Management tools, effective CDMO-sponsor collaboration, and leveraging the Lifecycle Approach to Process and/or Analytical Validation.


    Break

    13:15 – 14:45 | Plenary 7: Supply Chain Management

    Moderator: MaryEllen Usarzewicz, BMS

    This session will address lessons learned during a crisis.


    Break

    15:15 – 16:45 | Plenary 8: Manufacturing Network

    Moderator: Peter Makowenskyj, G-CON Manufacturing

    With companies of all sizes rapidly advancing their internal pipelines in the ATMP space there is a major lack of capacity to meet current and future demand. Companies large and small are faced with many difficult questions to address how they advance through the clinics and eventually to commercial manufacturing. We will look at some of these difficult to answer questions and evaluate what has been done within this space to leverage lessons learned.

Highlighted Speakers

Dayue Chen
Dayue Chen
Genentech, Inc.
Lori L. Daane
Lori L. Daane
bioMérieux
Irving Ford
Irving Ford
Bristol-Myers Squibb
David Geoghegan
David Geoghegan
Tmunity Therapeutics, Inc.
Peter J. Makowenskyj
Peter J. Makowenskyj
G-CON Manufacturing
Darius D. Pillsbury
Darius D. Pillsbury
Valsource LLC
MaryEllen E. Usarzewicz
MaryEllen E. Usarzewicz
Bristol-Myers Squibb

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    Departments
    • Clinical
    • Engineering
    • Information Technology
    • Laboratory
    • Manufacturing
    • Product Development
    • Quality
    • Regulatory Affairs
    • Research/Development
    • Science
    • Training
    • Validation
    Job Function
    • Application
    • Executive Management
    • Management
    • Manufacturing
    • Project
    • Risk Management
    • Scientist
    • Supply Chain
    • Technical Services

Got a Question? We have answers

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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 Baltimore Inner Harbor

300 Light Street
Baltimore, MD

Make a Reservation
Hyatt Regency Baltimore Inner Harbor
  • Accommodations

    Joining us in person? Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Hyatt Regency Baltimore Inner Harbor. The rate is $219 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 27, 2021. 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 click on the reservation link above or call the Hyatt Regency Baltimore Inner Harbor at +1 (410) 528-1234. Be sure to tell the reservationist that you are with the PDA 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 48 hours prior to arrival unless otherwise specified on your reservation information.

  • Amenities

    Nestled in the heart of downtown, this AAA Four-Diamond Inner Harbor hotel offers a luxury gateway to this enchanting waterfront town. Take advantage of modern meeting venues within our hotel in Baltimore Inner Harbor - just steps from the Convention Center.

How to Get Here

By Air

Baltimore-Washington International Airport (BWI) is approximately 10 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 61 miles away, and Reagan National Airport (DCA), 45 miles away. Taxi fares from BWI are approximately $35 one way, not including tip, and will take about 20 minutes. One way taxi fares from IAD is approximately $120 (70 min ride) and from DCA about $90 (55 min ride).

By Car

The Hyatt Regency Baltimore Inner Harbor is located at 300 Light Street, Baltimore, MD 21202 At this time self-parking only is available for guest (no valet parking). Current rate is $30 overnight.

Other Options

The Hotel is conveniently located only four blocks from the Metro subway system (Charles Center Station) and only three blocks from the Lightrail (Pratt Street/Convention Center). To plan your trip please visit www.mta.maryland.gov/

Directions

Registration Fees

Early Registration
Registration Type Price by 31 August 2021
Member $798
Non-member $937
Govern./Health Authority/Academic Member $350
Govern./Health Authority/Academic Non-member $400
Student Member $140
Student Non-member $155
Young Professional Member $399
Regular Registration
Registration Type Regular Registration
Price after 30 September 2021
Member $1,117 $1,436
Non-member $1,312 $1,687
Govern./Health Authority/Academic Member $490 $630
Govern./Health Authority/Academic Non-member $560 $720
Student Member $196 $252
Student Non-member $217 $279
Young Professional Member $559 $718

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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Contact

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

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