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

An ECI Conference

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

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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:  February 15, 2017
  • Deadline for abstracts for poster presentations:  February 27, 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.

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.

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