Regulatory Sciences for Biologics and Vaccines: Accelerating Development and Enabling Manufacturing Innovation

An ECI Conference

April 23-26, 2017
Lansdowne Resort
Leesburg,  Virginia, USA

Call for Abstracts!                           Register Now!

Please forward this link to colleagues who may be interested in the conference topic.

About This Conference

This conference will explore how regulatory sciences can be used to accelerate the development and availability of biologics and vaccines and to enable manufacturing innovation.  It will be unique with its focus on the science driving regulatory advances – analytical characterization, process design, materials sciences, real time release, quality-by-design and personalized medicine – and in bringing together participants from each of the four major groups – regulators, academics, non-government organizations and industrialists — involved in regulatory innovation for intimate discussions on these topics in a format that maximizes the time for discussion and interaction.

It will bring together academic scientists/engineers who are focused on manufacturing innovation such as continuous biomanufacturing or in-field/at patient bedside production/release of biologics, industrial scientists/engineers interested in process innovation (real-time release, process intensification, multiparameter process and product characterization), scientist/engineers at not-for-profit organizations dedicated to increasing access via process/product innovation (process optimization, novel delivery, thermal stability) and scientists/engineers at the National Health Authorities focused on applying regulatory science to enable product and process innovation.

The venue for this conference, the Lansdowne Resort, is conveniently located in northern Virginia, less than an hour from Washington, DC, with easy access either from the nation’s capital or from nearby Washington Dulles International Airport. The format of ECI’s conferences provides morning and late afternoon or evening sessions in which major presentations are made. Poster sessions are held during the evening social hours. Available time is included during the afternoons for ad hoc meetings, informal discussions, and/or recreation. With more than 50 years of scientific conference experience at ECI, we believe that this format has been instrumental in generating ideas and disseminating information to a greater extent than is possible through more conventional forums.

CONFIRMED KEYNOTE AND PLENARY LECTURERS

Tony Lubiniecki, Senior Fellow, Janssen Pharmaceuticals R&D
Robert Meyer, Director, Virginia Center for Translational and Regulatory Sciences, University of Virginia
Tony Mire-Sluis, Head of Global Quality, Astra Zeneca
Katey Owen, Deputy Director, The Bill and Melinda Gates Foundation
Jayanthi Wolf, Director, Global Regulatory Affairs, Merck & Co Inc/MSD

 

BRIEF DESCRIPTION OF SESSIONS

ORAL SESSION TOPICS

Accelerating Development: This session will highlight examples of opportunities for accelerating CMC development and the science and risk based justifications supporting the resulting strategy and scope of CMC filing information.

Approaches to innovative and streamlined manufacturing and release: Opportunities to streamline drug substance, drug product and device manufacturing and release including continuous processing, single use technologies and next generation sequencing.

It’s all about the analytics: Specifications for release and stability, characterization of complex mixtures such as polyclonal antibodies, multi-component vaccines and/or microbial populations, and the impact of increasingly rigorous methods.

Managing products in an increasingly complex global environment: Talks will be solicited that highlight both the challenges of operating in a global environment and the opportunities for simplification and alignment, including global implementation of continuous improvements.

Risk based characterization and comparability: Comparability for materials used in toxicology studies through launch, use of intermediate cell lines, extent of product characterization at each stage of development, and phase-appropriate assay development.

Vaccines – accelerating development for rapid responses to emerging diseases: Talks will be solicited on topics such as the use of platform technologies, innovative regulatory approaches, and advance preparedness to accelerate the development of vaccines in response to emerging diseases, epidemics and threats.

WORKSHOP TOPICS

Characterization of complex products: This workshop will be a companion to the analytical oral session and will focus on the characterization of complex biologics and vaccines. Goals could include developing a position paper on how to set specifications for release and stability of complex mixtures.

Combination products: Challenges and Opportunities: This workshop will focus on scientific justification for current drug-device combination product regulations and their challenges and opportunities.

Hot topics: Participants will be surveyed to identify a topic that they would like to address in a workshop. The goal could be to develop industry comments on upcoming regulatory guidances or to initiate development of a white paper.

Managing products in an increasingly complex global environment: This workshop will be a companion to the oral session on the same topic. The goal of the workshop would be to initiate development of a position paper with suggestions for simplifying the global supply chain and regulatory environment.

Vaccines – novel adaptive pathways to accelerate vaccine development, innovation and access: This workshop will be a companion to the oral session on vaccines. The goal would be for participants to share opportunities and issues for the rapid development of vaccines in response to emerging crises. The goal would be to initiate development of a white paper outlining opportunities for improvements in the available pathways for vaccine development, innovation and access.

Preliminary Agenda

Conference Organization

Co-Chairs:

Prof. Antonio Moreira
Vice Provost for Academic Affairs
University of Maryland, Baltimore County

Dr. David Robinson
Owner and Principal Consultant
Robinson Vaccines and Biologics LLC

ORGANIZING COMMITTEE MEMBERS (20 September 2016)

Wolfgang Berthold, bbphc GmBH (Germany)
Arindam Bose, AbiologicsB, LLC
Gabriele Dallman, Biopharma Excellence (Germany)
Wei-Shou Hu, University of Minnesota
Beth Junker, BioProcess Advantage LLC
Lynne Krummen, Genentech
Tony Lubiniecki, Janssen Pharmaceuticals R&D, LLC
Jose Menezes, Instituto Superior Tecnico (Portugal)
Tony Mire-Sluis, AstraZeneca
Todd Ranheim, Takeda
Thomas Ryll, Immunogen
Sangeetha Sagar, Sanofi
Gene Schaefer, Janssen Pharmaceuticals
Ken Surowitz, Dr. Reddy’s
TG Venkateshwaran, Merck
Weichang Zhou, WuXi Biologics (China)

Abstract Submission

  • Deadline for abstracts for oral presentations:  March 1, 2017
  • Deadline for abstracts for poster presentations:  March 15, 2017

One-page abstracts should be submitted as soon as possible and no later than the deadlines noted above.  The abstract should include both the significance of the research as well as results that will be discussed in order to allow a scientific assessment of the work by the organizers.

Click HERE to submit your abstract.

You will be asked to indicate:

  • If your abstract is for an oral and/or poster presentation
  • The session(s) for which it is being submitted
  • If you are a graduate student
  • All abstracts should be submitted electronically and submissions must follow the template provided at this link.

Major Sponsors

Please click on the logo to visit the website.

Conference Venue

Lansdowne Resort is a Washington, DC-area full-service hotel/conference center located in Leesburg, Virginia.  It is situated in the heart of Virginia wine country on nearly 500 acres overlooking the scenic Potomac River.  Recognized as one of the finest certified IACC (International Association of Conference Centers), Lansdowne’s 50,000 square feet of total meeting space has earned an impeccable reputation as the mid-Atlantic’s destination for flawless meetings and conferences.

Activities abound at Lansdowne, and range from a modern health and fitness center to a five-pool aquatic complex and three lighted hard courts for tennis.  It is the home to The Golf Club at Lansdowne – the centerpiece for 45-holes of championship golf.  The three unique courses designed by Robert Trent Jones II and Greg Norman include the challenging 9-hole Sharkbite Course.  The 12,000 square foot Spa Minerale features 13 treatment rooms and a wide range of services.

Each bedroom is appointed with comfortable bedding, oversized chairs and ottomans, marble-accented bathrooms and HD LCD televisions.  Each room also has a work desk with full internet access.

The conference rooms feature ergonomically designed conference chairs.  There is a continuously replenished refreshment break offering a variety of unlimited beverages and snacks.

Address:  44050 Woodridge Parkway, Leesburg, Virginia 20176

Travel Information

Lansdowne Transportation:  Landsdowne is an approximately 45-50 minute drive from Union Station in Washington DC.  One can take the Metro to Reston, Virginia and then a taxi to Lansdowne.

For those driving, there is no charge for parking.  Driving directions can be found HERE.

Lansdowne Resort provides a paid shuttle service for arriving and departing flights at Dulles International Airport (IAD).  The shuttle leaves Lansdowne every half hour starting at 6 am and ending at 11 pm.  Departures from Dulles will leave every half hour starting at 6:30 am and ending at 11:30 pm.  ECI hopes to negotiate a discounted fare for conference participants.  This will be announced at a later date and a transportation reservation form will be available when registration opens.

Please note that there is no shuttle to either Reagan National (DCA) or Thurgood  Marshall (BWI) airports.  You will need to contact Super Shuttle.

Conference Fees and Registration

Conference Fees

All conference fees are inclusive. They include registration, accommodations (Sunday, Monday, and Tuesday nights), all meals and breaks, taxes, and gratuities from the reception and dinner on Sunday through lunch on Wednesday. Incidental fees (telephone calls, faxes, spa, laundry, etc.) are billed to your personal account by the hotel.

ALL PARTICIPANTS (INCLUDING MEMBERS OF THE ORGANIZING COMMITTEE AND INVITED SPEAKERS) ARE REQUIRED TO REGISTER.

The conference fees are:

Register on or before March 13, 2017 Register after

March 13, 2017

Participant (single occupancy or sharing room with a guest; guest fee additional) US $1,989.00 US 2,189.00
Participant (sharing a room with another participant) US $1,640.00 US $1,840.00
Bona fide Graduate Student (sharing a room with another student) (Those in this category must send proof of current status – copy of current Student ID can be faxed to 1-212-514-6030 or emailed to Kathy@engconfintl.org) US $1,225.00 US $1,425.00
**Fees for Guest/accompanying person sharing bedroom with single occupancy participant. (Includes all conference included meals) US $485.00 US $485.00
**Fees for Guest/accompanying person sharing bedroom with single occupancy participant. (ROOM ONLY) US $70.00 US $70.00

If you plan to bring children to the conference, please contact ECI (info@engconfintl.org) for pricing.

Conference Registration

You will need a login name and password to register for ECI conferences through our online system. If you have been a recent participant at an ECI conference or have submitted an online application or request for information about an ECI Conference, you may already have an account with us. If you know your login information, please use it.

If you are not sure whether you already have a login and password, please click on automated password retrieval and enter your e-mail address before creating a new account. If we don’t have a valid email address on file for you, a pop up window will appear stating that no records were found. Click “OK” and then follow the instructions to create a new account.

If you have any questions or experience any difficulties, please email tressa@engconfintl.org.

Pre- and Post-Conference Reservations:  If you are planning to arrive early (before April 23) or to stay after the conference (after April 26) you MUST make hotel reservations directly with the hotel.  Use the appropriate form on THIS PAGE to make your reservations.

Special Notes for Payment

We suggest that you register as soon as possible to be certain that you will have a hotel room at the conference rate.  Late registrations will be accepted on a space available basis.

All participants are encouraged to register before March 13, 2017.  There is a discounted price for registering before this date and hotel space cannot be guaranteed for registrations received after this date.  Your registration is not officially confirmed until we receive payment of the amount due.  ECI reserves the right to cancel your room registration if payment is not received. Your invoice/receipt will automatically be e-mailed upon of receipt of your registration.

Because of contractual guarantees made with the hotel for room and meal functions, no shows, late arrivals, missed meals and early departures cannot receive fee adjustments.  If you have a disability and may require accommodation in order to participate fully in this conference, please indicate this when you register. An ECI representative will contact you to discuss your specific needs. If you have special dietary requirements (e.g., vegetarian or a food allergy), please make a note on your registration.  The chef needs to know this information in advance if we are to accommodate you. ECI will attempt to accommodate special requests such as Kosher or Halal meals, but such meals may not be available at all conference sites. Any additional costs for special meal requests must be paid by the participant to ECI.

Payment must be made by credit card (Visa, MasterCard, Amex), check or money order drawn on a U.S. bank in U.S. dollars, payable to ENGINEERING CONFERENCES INTERNATIONAL. Checks or money orders in any other currencies are NOT ACCEPTABLE.  Payment is made on the web site except for those who are sending payment by wire transfer or have a purchase order from their company/institution.

WIRE TRANSFER PAYMENT: If you are planning to make payment by wire transfer, please contact ECI for the bank information. You must add $30 to cover ECI bank charges. Please reference your full name and the conference title.  Either fax a copy of your bank transfer papers to ECI (Fax: +1-212-514-6030) or email a scanned copy to kathy@engconfintl.org.  This is very important – otherwise it is extremely difficult to trace your payment and you may not receive a receipt prior to the conference.

Cancellation Policy: Cancellation must be received by ECI in writing at least 28 days prior to the start of the conference in order for a full refund (less a processing fee) to be considered. The ECI auditors require that refunds for all conference cancellations be processed after the conference so that the necessary back-up information (e.g., hotel list of those in-house) can be attached to the refund request and ECI can verify that the hotel has not charged a cancellation fee.

Cancellation fees:

  • Cancellations received more than 28 days prior to the conference start date are subject to a processing fee of 4% of the total fee, plus any direct expenses incurred by ECI.
  • Cancellations received 15 – 28 days prior to the conference start date are subject to a $250 cancellation fee plus any direct expenses incurred by ECI.
  • Cancellations received 8 – 14 days prior to the conference start date are subject to a $500 cancellation fee plus any direct expenses incurred by ECI.
  • No refunds will be issued for cancellations received less than 7 days prior to the conference start date.
  • No refunds will be issued due to inclement weather or travel disruptions/cancellations.

Registrations can be transferred without incurring any penalty or cancellation fee.

Denied or delayed visa

If a participant is forced to cancel due to a denied or delayed entry visa, ECI will issue a full refund provided that ECI has been notified of a potential visa issue at least four weeks prior to the conference start date.

Change of payment method

If an attendee who has already paid the conference fee with a credit card requests that the fee be refunded to that card so that it can be paid in a different manner (e.g., charged to an alternate credit card, or paid via check or bank transfer), a processing fee of 4% of the total fee amount will apply.

Disclaimer

It may be necessary for reasons beyond the control of ECI to alter the content and timing of the program or the identity of the speakers. In the unfortunate circumstance that an event is cancelled, ECI is not liable for any costs incurred by participants in connection with their attendance.

Smoking is prohibited at ECI conferences and conference functions.

Should you have specific questions regarding your registration, please contact Kathy Chan (Kathy@engconfintl.org).

General Information about ECI

Engineering Conferences International (ECI) is a global engineering conferences program, originally established in 1962, that provides opportunities for the exploration of problems and issues of concern to engineers and scientists from many disciplines.

The format of the weeklong research conference provides morning and late afternoon or evening sessions in which major presentations are made. Available time is included during the afternoons for ad hoc meetings, informal discussions, and/or recreation. This format is designed to enhance rapport among participants and promote dialogue on the development of the meeting. We believe that the conferences have been instrumental in generating ideas and disseminating information to a greater extent than is possible through more conventional forums.

All participants are expected both to attend the entire conference and to contribute actively to the discussions. The recording/photographing of lectures and presentations is forbidden. As ECI conferences take place in an informal atmosphere, casual clothing is the usual attire.

Engineering Conferences International
32 Broadway, Suite 314, New York, NY 10004
T: 1-212-514-6760 F: 1-212-514-6030 E: info@engconfintl.org