AAPS Scientific Programming Committee presents this overview of the 2021 AAPS National Biotechnology Conference (NBC).
| ANTIBODY THERAPIES: TACKLING NEW FRONTIERS |
VIEW SESSIONS |
| CELL-BASED THERAPIES: THE FUTURE OF REGENERATIVE MEDICINE |
VIEW SESSIONS |
| NEXT IN SEQUENCE? NUCLEIC-ACID-BASED THERAPIES: CURRENT STATE AND FUTURE PROMISE |
VIEW SESSIONS |
| CAREER DEVELOPMENT PROGRAMMING |
VIEW SESSIONS |
| NBC POSTER SOCIALS & CONNECT 360 |
VIEW |
| PARTNERSĀ |
VIEW |
View the full program and add sessions to your schedule today!
MONDAY
HOT TOPIC: Patient-Centric Immunogenicity Assessment Approach For Biologics In Oncology Clinical Trials
Current regulatory recommendations call for a risk-based approach for assessing clinical immunogenicity. The language used in the guidance is interpreted literally and, in many cases, implemented as a one-size fits-all for therapeutic modalities, regardless of a patientās risk profile. These factors need to be considered when assessing immunogenicity in the clinical setting. We propose a more patient-centric approach for immunogenicity assessment that minimize patient burden while provide adequate evolution of the potential impact of ADA in clinical outcome.
Monday, May 17Ā IĀ 2:00 pmā3:00 pm
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TUESDAY
PROLOGUE: Latest Trends in the Antibody Field
Tuesday, May 18Ā I 10:30 amā11:00 am
SYMPOSIUM: T-Cell Bispeciļ¬c Abs, Developments, Challenges, and Current Learnings
Tuesday, May 18Ā I 11:00 amā11:30 am
SYMPOSIUM: Preclinical To Clinical Translation Of Efficacy Of Immunomodulatory Bispeciļ¬cs
Bispecific antibodies (bsAbs) have great potential to enhance efficacy and reduce systemic toxicity. However, their clinical development is complex with many inherent challenges, including selection of relevant starting doses, and prediction of efficacious dose despite nonintuitive dose response relation- ships. Mechanistic modeling approaches are a powerful integrative tool to understand the complexities and aid in clinical translation, trial design, and prediction of regimens and strategies to reduce dose limiting toxicities of bsAbs.
Tuesday, May 18Ā IĀ 11:30 amā12:00 pm
SYMPOSIUM: Applications Of QSP Modeling In Clinical Development Of Bispeciļ¬c Antibodies
This learning session will help development scientists to leverage existing development experience of TDBs and learn what modeling and simulation tools (especially QSP modeling) can help to address very complex MOA and biology related pharmacological interactions of T-cell directing/engaging bispecifics.
Tuesday, May 18Ā IĀ 12:00 pmā12:30 pm
KEYNOTE: Mitigation Strategies For Immunogenicity Of Therapeutic Proteins: Therapeutic Drug Monitoring, The New Kid On The Block
Tuesday, May 18Ā IĀ 2:00 pmā3:00 pm
RAPID FIRES: Antibody Therapies
Tuesday, May 18Ā IĀ 3:30 pmā4:30 pm
HOT TOPIC: Efficacy of Tiragolumab (anti-TIGIT) and Atezolizumab (anti-PD-L1) Combination Therapy in Patients with PD-L1 Positive Metastatic Non-Small Cell Lung Cancer
Tuesday, May 18Ā I Ā 3:30 pmā4:00 pm
HOT TOPIC: Supercharging the Tumor Microenvironment with Engineered Cytokines
Tuesday, May 18Ā IĀ 4:00 pmā4:30 pm
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WEDNESDAY
RAPID FIRES: Formulation Challenges Of Antibody Therapies
Wednesday,Ā May 19Ā IĀ 9:00 amā10:00 am
PROLOGUE: Overview On Formulation
Wednesday, May19Ā IĀ 10:30 amā11:00 am
SYMPOSIUM: A New Era Of Biological Product Development
Monoclonal antibody (mAb) represent a successful drug class for treating treatments. Antibodies are unstable, both physically and chemically. mAb products often require a high dose for maximal efficacy, mostly marketed as a liquid or lyophilized formulation, and exhibit the high potential of protein aggregation. This session discusses the sensitivity of the antibody in response to environmental changes, the most critical task of drug product development is to maintain structural integrity and stability of the antibody through manufacturing, production, and product lifecycle.
Wednesday, May 19Ā Ā IĀ 11:00 amā11:30 am
SYMPOSIUM: Strategies For Enhancing The Stability Of Biologics In The Solid State
There is a need for new and improved stabilization mechanisms for biological products in frozen and solid-state formulations. Ideally, these formulations could avoid the cold-chain altogether by creating room-temperature stable formulations that require no specialized handling considerations. In this presentation, new and existing strategies for formulating and manufacturing biological products such as monoclonal antibodies will be discussed, including advanced characterization methods for predicting long-term stability and improving formulation design.
Wednesday, May 19Ā Ā I Ā 11:30 amā12:00 pm
SYMPOSIUM: A Hybrid Experimental-Computational Approach to Predicting and Controlling Protein-Protein Interaction
Monoclonal antibody (mAb) represents a successful and rapidly expanding drug class for treating cancer treatments and other chronic diseases. An in-depth understanding of the structural behaviors in all stages of drug product development from high-resolution experimental methods and predictive modeling is urgent and valuable.
Wednesday, May 19Ā Ā IĀ 12:00 pmā12:30 pm
KEYNOTE: Broadly Neutralizing Abs In HIV Therapy
Wednesday, May 19Ā Ā IĀ 2:00 pmā3:00 pm
THURSDAY
PROLOGUE: Overview of CMC for Antibody Therapies
Thursday, May 20Ā IĀ 10:30 amā11:00 am
SYMPOSIUM: CMC Strategies for Accelerated Development of Bamlanivimab: A Therapeutic Monoclonal Antibody for COVID-19
The COVID-19 pandemic has posed a serious challenge to the pharmaceutical industry both in coming up with effec- tive therapies and vaccines, as well as continuing to provide other life-saving medicines. What would be traditionally considered as āaccelerationā simply cannot meet the pandemic needs. We will discuss the opportunity for the scientific community to learn and be prepared for future emergencies.
Thursday, May 20Ā Ā IĀ 11:00 amā11:30 am
SYMPOSIUM: Delivering Therapeutic mAbs for COVID-19: What Can Be Done Ā in Just One Year?
Thursday, May 20Ā IĀ 11:30 amā12:00 pm
SYMPOSIUM: Rapid Ab Therapy Development and Approval in the COVID Universe
Thursday, May 20Ā IĀ 12:00 pmā12:30 pm
KEYNOTE: BamlanivimabāA Monoclonal Antibody For COVID-19
Thursday, May 20Ā IĀ 2:00 pmā3:00 pm
RAPID FIRES: Alternate Ā Antibody Modalities
Thursday, May 20Ā IĀ 3:30 pmā4:30 pm
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MONDAY
HOT TOPIC: PK/PD Considerations For CAR-T Therapies
Monday, May 17Ā IĀ 3:30 pmā4:30 pm
TUESDAY
PROLOGUE: Bioanalytical Strategies For Cell Therapies
Tuesday,Ā May 18Ā Ā IĀ 10:30 pmā11:00 am
SYMPOSIUM: Future Of CAR-T Cell Therapy
Tuesday, May 18Ā Ā IĀ 11:00 amā11:30 am
SYMPOSIUM: Immunogenicity Assays For CAR-T
Tuesday, May 18Ā Ā IĀ 11:30 amā12:00 pm
SYMPOISUM: Bioanalysis Of CAR-T Cell Therapies
Tuesday, May 18Ā Ā IĀ 12:00 pmā12:30 pm
KEYNOTE: Cell-Based Therapies
Tuesday, May 18Ā Ā IĀ 2:00 pmā3:00 pm
RAPID FIRES: Cell-Based Therapies
Tuesday, May 18Ā Ā IĀ 3:30 pmā4:30 pm
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WEDNESDAY
HOT TOPIC: Logistics AndĀ Shipping Of Cell Therapies
Wednesday,Ā May 19Ā IĀ 9:00 amā10:00 am
RAPID FIRES: Cell-Based Therapies
Wednesday, May 19Ā IĀ 9:00 amā10s:00 am
PROLOGUE: Programming Of Pluripoetnt Stem Cells
Wednesday, May 19Ā Ā IĀ 10:30 amā11:00 am
SYMPOSIUM: Cell Therapies: Ā Commercial Scale-Up
Wednesday, May 19Ā IĀ 11:00 amā11:30 pm
SYMPOSIUM: Scalable Manufacturing Strategies to Accelerate Clinical Testing of New hMSC-Based Therapeutics
Wednesday, May 19Ā IĀ 11:30 amā12:00 pm
SYMPOSIUM: Autologous vs. Allegenic, Challenges And Opportunities
Wednesday, May 19Ā IĀ 12:00 pmā12:30 pm
KEYNOTE: Vascular Tissue Engineering
Wednesday, May 19Ā IĀ 2:00 pmā3:00 pm
THURSDAY
PROLOGUE: Successful CAR-T Cell Therapy, A Patientās Perspective
Thursday,Ā May 20Ā IĀ 10:30 amā11:00 am
SYMPOSIUM: Multi-Dimensional CyTOF Technology For Comprehensive Profiling Of CAR-T Products, Challenges And Triumphs
Thursday, May 20Ā IĀ 11:00 amā11:30 am
SYMPOSIUM: Bioprocessing of Hypo-Immune iPSC: Toward Cost-Effective, High-Quality Allogeneic Cell Therapies
Thursday, May 20Ā IĀ 11:30 amā12:00 pm
SYMPOSIUM: Comparability Of Cell-Based Therapies: Challenges And Considerations
This presentation will focus on providing stakeholders with some guidance about best practices to follow to demonstrate comparability and major consideration and essential element of well-designed and executed comparability studies.
Thursday, May 20Ā IĀ 12:00 pmā12:30 pm
KEYNOTE: What Lessons Have Been Learned From Regulatory Review Of Cell Based Therapy BLAs?
Thursday, May 20Ā IĀ 2:00 pmā3:00 pm
RAPID FIRES: Characterization, Analytical and Quality
Thursday, May 20Ā IĀ 3:30 pmā4:30 pm
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TUESDAY
HOT TOPIC: Novel Lipid Vesicles Promoting DsiRNA Delivery And Gene Silencing
Nucleic acid-based therapy is promising but delivery is critical. Cationic lipids are considered the lead candidates to form nanocarriers for RNAi therapeutics. However, thereās lack of understanding the impact of lipid structures, nano-carrier surface modification on the effectiveness of nucleic acid delivery. This program will display a thorough study showcasing the critical factors in formulation design for achieving efficient delivery and effective gene knock down.
Tuesday,Ā May 18Ā IĀ 9:00 amā9:30 am
HOT TOPIC: Engineering Extracellular Vesicles For The Delivery Of Nucleic Acids
The aim of this session is to provide an overview of the field of silencing RAN therapeutics with focus on progress made, challenges in molecule design, delivery, and potential strategies to move the field forward. The talk will span multiple elements to provide a complete overview of the field.
Tuesday, May 18Ā IĀ 9:30 amā10:00 am
PROLOGUE: Progress, Challenges, and Future Opportunities In Development Of Nucleic Acid Based Therapeutics
Tuesday, May 18Ā IĀ 10:30 amā11:00 am
SYMPOSIUM: New Backbone Chemistry Enhances The Drug- Like Properties Of Stereopure Oligonucleotides In Preclinical Ā Studies
Tuesday,Ā May 18Ā IĀ 11:30 amā12:00 pm
SYMPOSIUM: Long-Lasting Analgesia via Targeted in situ Repression of NaV1.7 in Mice
Tuesday,Ā May 18Ā IĀ 12:00 pmā12:30 pm
KEYNOTE: Gene Therapy; Risks And Mitigation Strategies
Tuesday,Ā May 18Ā IĀ 2:00 pmā3:00 pm
RAPID FIRES: Nucleic-Acid- Based Therapies
Tuesday,Ā May 18Ā IĀ 3:30 pmā4:30 pm
WEDNESDAY
KEYNOTE: Formulation Considerations For Nucleic- Acid-Based Medicinal Products
An overview of the various modalities within the diverse category of nucleic acid-based medicinal products, including gene therapy products and genetic vaccines will be given. The session will highlight some of the current formulation and stability issues with these products, several ābut not allā of which require (ultra) cold storage under frozen conditions. A discussion of lessons we can learned will also be included.
Wednesday,Ā May 19Ā IĀ 9:00 amā10:00 am
PROLOGUE: Beyond The Liver: Lipid-Based Nucleic-Acid Delivery For Other Tissues
With the approval of ONPATTRO and the recent clinical success of SARS- CoV-2 mRNA vaccines by Pfizer/ BioNTech and Moderna, lipid nanoparticle-based delivery systems (LNPs) are transformative technologies to deliver nucleic acids such as siRNA and mRNA at therapeutic doses to successfully treat diseases. This presentation will address the unmet need and focus on new formulation and delivery strategies to circumvent the liver ābarrierā and target diseases including cancer (non-liver), infectious disease, and cystic fibrosis. This presentation will address the gap of how LNPs can transition to the treatment of other diseases by changing formulation and delivery.
Wednesday, May 19Ā IĀ 10:30 amā11:00 am
SYMPOSIUM: Brain Targeted Delivery of Dual Functional DNA Nanocomplex
Wednesday, May 19Ā IĀ 11:00 amā11:30 am
SYMPOSIUM: Global Solution Enables Nucleic-Acid-Based Therapeutics for Non Invasive, Triple-Targeted Brain Delivery
Lung delivery of nucleic acid therapeutics is challenging. Multiple companies are pursuing this approach and will share their learnings in this presentation.
Wednesday, May 19Ā IĀ 11:30 amā12:00 pm
SYMPOSIUM: Engineering āSmartā Particles For Cytoplasmic Delivery of Therapeutic RNA
This presentation will focus on addressing the challenge of cytoplasmic delivery using pH sensitive polymers for nucleic acid therapy.
Wednesday, May 19Ā IĀ 12:00 pmā12:30 pm
RAPID FIRES: Nucleic-Acid- Based Therapies
Wednesday, May 19Ā IĀ 2:00 pmā3:00 pm
HOT TOPIC: CMC/Clin Ops Logistics For Cell And Gene Therapies
Wednesday, May 19Ā IĀ 3:30 pmā4:00 pm
HOT TOPIC: Draft Guidance On Neurodegenerative Disorders/ Regulatory Perspective On Nucleic Acid /Viral And Cell Therapies
Wednesday, May 19Ā IĀ 4:00 pmā4:30 pm
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THURSDAY
SYMPOSIUM: Translational PK/PD Modelling For AAV GTs
Thursday, May 20Ā IĀ 11:00 amā11:30 am
SYMPOSIUM: Cas9 Related Ā Immungenicity Risks and Regulatory Perspective
Thursday, May 20Ā IĀ 11:30 amā12:00 pm
SYMPOSIUM: Clinical Update Ā On GaINAc-siRNAs
Thursday, May 20Ā IĀ 12:00 pmā12:30 pm
KEYNOTE: Title Pending
Thursday, May 20Ā IĀ 2:00 pmā3:00 pm
RAPID FIRES: Nucleic-Acid- Based Therapies
Thursday, May 20Ā IĀ 3:30 pmā4:30 pm
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CAREER DEVELOPMENT PROGRAMMING
Live LinkedIn Critiques
Join this live session led by a LinkedIn expert who will critique preselected LinkedIn profiles! We will also take your questions through a moderated chat-box during this event.
Monday, May 17Ā IĀ 12:30 pmā1:30 pm
Wednesday,Ā May 19Ā IĀ 12:30 pmā1:30 pm
Thursday,Ā May 20Ā IĀ 12:30 pmā1:30 pm
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#BuildYourOwnAcceleratorā¢Ā Ā Ā Ā Ā Ā Ā Ā Ā
Ebony C. Smith, M.S., PCC, Executive Coach, Ebony Smith & Associates, Inc.Ā Ā
If you want to take your management and leadership skills to the next level, experience the power of a coaching approach with your direct reports, team members and peers. This workshop prepares you to follow a structured and intuitive four step coaching model to elevate performance and boost employee engagement.
Monday, May 17Ā IĀ 2:00 pmā3:00 pm
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Coaching Basics for ManagersĀ Ā Ā Ā Ā Ā
Susan Morris, MEd., ACC, CPCC, President, Susan Morris Coaching
If you want to take your management and leadership skills to the next level, experience the power of a coaching approach with your direct reports, team members and peers. This workshop prepares you to follow a structured and intuitive four step coaching model to elevate performance and boost employee engagement.
Monday. May 17Ā IĀ 3:30 pmā4:30 pm
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Conquer the Curse of Knowledge and Build Bridges to Understanding
Lisa Scott, CCC-SLP, Founder, CEO, AccentuateĀ Ā Ā Ā Ā Ā Ā Ā
Communication āblind spotsā can prevent a good leader from becoming great. Strong communicators can recognize quickly when they need to reframe a statement or present data in a different way to explain their ideas more effectively. This session will appeal to leaders who need to explain their area of expertise clearly when they interact with others in and outside of their field. It is especially helpful for those in highly technical fields who want to seek funding or collaborate with others in different departments or disciplines.
Tuesday,Ā May 18Ā IĀ 9:00 amā10:00 am
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Cruising to Clear Speech
Lisa Scott, CCC-SLP, Founder, CEO, Accentuate
This session is designed for profession als who need to communicate their ideas clearly to others to move those ideas forward. Whether you are looking for ways to communicate with more confidence, to speak more precisely, or improve the quality of their voice, you will leave with techniques to practice to help you become a more clear and confident communicator.
Tuesday. May 18Ā IĀ 3:30 pmā4:30 pm
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Enhancing Leadership Opportunities in Research and DevelopmentĀ
Sheena Eizmendiz, Corporate Trainer / Executive Coach, Sheena Eizmendiz, LLC
This presentation highlights a professional development plan with a list of actionable steps for enhancing leadership skills in the areas of research and development. Attendees will gain specific insight into how they can reach their career aspirations with a variety of approaches, including experiential learning, exposure, education and reflection.
Wednesday, May 19Ā IĀ 9:00 amā10:00 am
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The Art and Science of Connecting with Your Audience
David P. Otey, MA, MBA, Principal Speaking Coach, Speaking of Solutions, LLC
How do you tell the story of your work? The basic unit of human interaction is not data. It is story. Modern neuro- science has much to tell us about the way the brain responds to a story. If you want your audience to Accept, Remember, and Take action on the information you present, you must first make a connection with your listeners at a human levelāhence, the A.R.T. of Connecting. This session will be ideal for Ā anyone who has been in field long enough to sense that disconnect between the career growth they have experienced and the value they see in their work.
Wednesday,Ā May 19Ā Ā IĀ 3:30 pmā4:30 pm
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Better Posters: How to Design and Present a Conference Poster
Zen Faulkes
Posters are challenging to create and present. This session will show you how to design conference posters that are clearer to your audience and more likely to start the conversations you come to a conference to have.
Thursday.Ā May 20Ā IĀ 9:00 amā10:00 am
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Unconscious Bias and Its Impact on Careers
Binodh DeSilva, Ph.D., Vice President, Bristol-Myers Squibb
Michele Gunsior, Ph.D., Principal Scientist, VielaBio
Understanding unconscious or implicit bias and its potential impact on the work environment is crucial to the success of any organization. This panel discussion will focus on identifying and understanding what unconscious bias is, and how it affects hiring practices and recruiting efforts, promotions, assignment of high impact projects, and building diverse teams. Attendees are encouraged to take the Implicit Association Tests (IAT) through Harvardās Project Implicit prior to attending.
Thursday,Ā May 20Ā IĀ 3:30 pmā4:30 pm
NETWORKING
Dedicated Virtual Exhibit Hall and Networking Time
Monday,Ā May 17 ā Thursday,Ā May 20Ā IĀ 12:30 pmā2:00 pm
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POSTER SESSIONS
Live Poster Collection
Monday,Ā May 17 ā ThursdayĀ May 20Ā IĀ 12:30 pmā1:30 pm
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POSTER SESSIONS HOURS
Tuesday,Ā May 18Ā IĀ 9:00 amā10:30 am
Wednesday, May 19Ā IĀ 3:30 pmā5:00pm
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New! Poster Socials at NBC
Table-hop and talk to authors live!
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Scientific posters and conversations with authors are an important part of any event for the pharmaceutical scientists who belong to AAPS ā including the National Biotechnology Conference (NBC). When you attend the NBC, youāll be able to connect with authors one-on-one in several ways:
- NEW! Poster Socials: Poster Socials are casual, live networking events that allow attendees to video-chat with individual authors in small groups, and to move between groups whenever they like. AAPS plans to offer at least 2 Poster Socials to accommodate attendeesā time zones.
- Special Poster Collections: One of the most popular programs at the 2020 PharmSci 360, Special Poster Collections are live sessions hosted by notable AAPS members. Each session features a few authors who discuss their research with their host and take questions from attendees.
- Connect 360: One of the most popular features at PharmSci 360, Connect 360 is a networking platform offered exclusively to attendees during the meeting. Participants can message authors, schedule meetings, and video-chat about their research.
- Poster Gallery: Posters displayed in the NBC Poster Gallery will include the ability to connect with authors by email and/or video-chat.
Do not miss this chance to see new research from around the world and chat personally with the authors who developed it. Register for the NBC now!
Connect 360 Returns for NBC
AAPS introduced Connect 360 at the 2020 PharmSci 360 and due to popular demand we will bring it back for the NBC. Connect 360 is an AI-driven, matchmaking tool that helps you find new contacts based on your shared interests. You can message other attendees and meet with them by video chat. You can also block your calendar so that other registrants know when you're available.
If you didnāt attend PharmSci 360 last year, we encourage you to watch our video tutorial to get familiar with this exciting platform.
Partners
Increase your companyās exposure while supporting the biotechnology communityābecome a thought leader, brand sponsor or recruiter at the National Biotechnology Conference!
Below is a glimpse of some of our available branding opportunities. Ā Contact AAPS Corporate Engagement at bd@aaps.org to discuss this emerging opportunity.
Registration Confirmations
Put your customized ad in every registration confirmation. Every participant receives their confirmation upon registration. Includes a Pre-Show Attendee List. Ad placement determined by AAPS.
Connect 360 Confirmations
Sponsor our networking platform, Connect 360. Your company will be featured in the Connect 36 launch email sent to all registrants and will be promoted as a premier sponsor in the exhibitor listing. Includes a Pre-Show Attendee List.
General Session Video
Promote your companyās product or service with a 15-second commercial video before the Opening or Closing Plenary.
Daily Symposia Recognition
See your companyās logo featured on the walk-in slides for all sessions. Select one day of the meeting to be featured. Walk-in slides run in a loop for 10 minutes before each session. 4 AVAILABLE
Virtual Poster Video Commercial
Sponsor posters in the area(s) of science that align with your companyās focus. You can showcase your Ā products and services in the poster viewing siteāone of the most visited content areas at an AAPS meeting! Your organizationās 15-25 second video clip can be featured prior to viewing a poster. Select a track, the Best Abstract Collection, or create your own Special Poster Collection. Then get a report of impressions and āAsk a Representative to Contact Me Laterā clicks. LIMITED TO 1 PER TRACK OR UNLIMITED CUSTOM SPECIAL POSTER COLLECTIONS
Continued Conversations
Tuesday, Wednesday, and Thursday, attendees will join chat room(s) to discuss topics related to the Ā three tracks, or to network with colleagues. BONUS: Thank your attendees by sending them a Starbucks card valued at $10 after the meeting.
LIMITED TO 1 SPONSOR PER TRACK
DEADLINE TO ORDER: April 19, 2021
View the full program, and add sessions to your schedule today!
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