2019 AAPS PharmSci 360
The Manufacturing & Bioprocessing Track Themes Announced for 2019 AAPS PharmSci 360!
AAPS PharmSci 360 combines all the energy and resources of a large scientific conference with the content desupth of a small bioanalytical gathering.
All of the scientific programming is themed—so jump into the track of your expertise and dive deep into your field’s hottest topics with your peers. Here are the themes for the manufacturing and bioprocessing track:
THEME 1
Innovation in Conventional Manufacturing Technologies: Creating Flexibility, Cost-effectiveness, and Intelligent Systems
Information technology, automation advances, and enhanced understanding of unit operations in the last decade have led to significant improvements in the conventional manufacturing processes. These advances include process analytical technologies, modeling and simulation, data rich equipment outputs, and others that increase process flexibility and robustness, dramatically lowering cost and risk. Examples include single-use systems, smaller footprint processes, highly automated systems, multi-statistical process control tools, soft or spectroscopic process analytical technology sensors, and data management systems. Case studies in both chemical entity and biologics manufacturing will be featured highlighting important advances in this field.
THEME 2
Continuous Processing in Synthetic and Biologics Manufacturing
Pharmaceuticals have traditionally been manufactured using conventional batch manufacturing processes, characterized by discrete, disconnected unit operations and lengthy manufacturing cycles involving complex, scale-dependent equipment. Recent advances in manufacturing technology as well as business pressures to improve efficiencies have prompted the industry to consider a faster, more scalable, nimble, and efficient process: continuous manufacturing. Regulatory agencies are taking proactive steps to facilitate the pharmaceutical industry’s implementation of continuous manufacturing, to enhance the assurance of product quality, and to modernize the pharmaceutical manufacturing sector.
This theme will include case studies in both chemical and biologics manufacturing and bring together pharmaceutical companies, suppliers, regulators, and academics to accelerate adoption of continuous manufacturing and thus accelerate development of medicines to benefit patients.
THEME 3
Transition from Clinical to Commercial Manufacturing: Enabling Successful PPQs
Successful validation of manufacturing processes includes the stages of (1) process design, (2) process performance qualification (PPQ), and (3) continued process verification. It establishes scientific evidence that a process is capable of consistently producing quality product. Process design enables definition of manufacturing processes based on knowledge gained through development and scale up. PPQ then tests the process and the proposed control strategy to determine if the process is capable of reproducible commercial manufacturing. Continued process verification then provides ongoing assurance that the process remains in a state of control.
This theme will cover all three aspects of process validation with case studies and will provide insight into how the comprehensive development and scale up experience, spanning clinical manufacturing through commercialization, can be leveraged to assure successful validation of manufacturing processes.
Register today!
See the interactive schedule.
Announcing the 2019 AAPS PharmSci 360 Keynote Speakers!
Foremost thought leaders are headlining this year’s conference program.
Preclinical Development
Weida Tong, Ph.D.
(U.S. Food and Drug Administration)
To be announced |
Chris Leptak, M.D., Ph.D.
(U.S. Food and Drug Administration), invited
Regulatory Perspective on Biomarker Qualification and Impact on Drug Development
|
Thomas O’Connor, Ph.D.
(U.S. Food and Drug Administration), invited
FDA’s Continuous Manufacturing Journey: Past, Present and Future
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Paul Moore, Ph.D.
(MarcoGenics)
Applying Bispecific Antibodies to Enhance Immune Responses for Therapeutic Intervention
|
Clinical Pharmacology
Mats Karlsson, Pharm.D.
(Uppsala University)
Role of Modeling and Simulation in Dose and Dosing Regimen Selection and Optimization
|
Sam Guhan, Ph.D.
(Amgen Inc.)
To be announced
|
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Cristel Bergstrom, Pharm.D.
(Uppsala University)
Fit-for-Purpose Models for Formulation Optimization and Performance Evaluation in ADME |
Dan Howard, Ph.D.
(Novartis)
Clinical Pharmacology Paths for Small Populations
|
Christina Capacci-Daniel, Ph.D.
(U.S. Food and Drug Administration), invited
Process Validation Opportunities—A Regulatory Perspective
|
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William Slikker Jr., Ph.D.
(U.S. Food and Drug Administration)
To be announced |
John Davis, Ph.D. (Regeneron)
From Big to Small: Clinical Pharmacology Challenges and Opportunities, Particularly in Rare Diseases
|
Shishir Gadam, Ph.D.
(Juno Therapeutics)
To be announced |
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Filippos Kesisoglou, Ph.D.
(Merck & Co., Inc.)
Quantitative Biopharmaceutics—Translation from Preclinical to Clinical
|
Shiew-Mei Huang, Ph.D.
(U.S. Food and Drug Administration), invited
Regulatory Perspectives on Clinical Pharmacology Strategy for Development of New Chemical Entities
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Formulation & Quality
Lawrence X. Yu, Ph.D.
(U.S. Food and Drug Administration), invited
To be announced
|
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Paul Fielder, Ph.D.
(Genentech, Inc.)
Integrating Novel Predictive Approaches to Translation
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Yow-Ming Wang, Ph.D.
(U.S. Food and Drug Administration), invited
Regulatory Perspectives on Clinical Pharmacology Strategy for Development of Biosimilars
|
Hanns-Christian Mahler, Ph.D.
(Lonza)
Formulating Biologics—Quo vadis?
|
Bioanalytics
Kevin Bateman, Ph.D.
(Merck & Co., Inc.)
Shaping the Future of Bioanalysis: From Innovation to Implementation
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Manufacturing & Bioprocessing
Thomas De Beer, Ph.D.
(Ghent University)
Model-Based Formulation and Process Development and Design for Innovative Drug Product Manufacturing
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Justin Hanes, Ph.D.
(Johns Hopkins Medicine)
To be announced
|
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Russell Weiner, Ph.D.
(Bill & Melinda Gates Medical Research Institute)
The Challenges of Conducting Infectious Disease Clinical Trials in Low Income Countries: The Reality of Bioassays that Can Work under a Tree
|
Peter Marks, M.D., Ph.D.
(U.S. Food and Drug Administration)
A Holistic Approach to the Advancement of Cellular and Gene Therapies
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John Stults, Ph.D. (Genentech, Inc.)
Knowledge-Based Strategy to Establish Clinically Relevant Initial Commercial Specifications When Few Clinical Lots Are Available
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Lara Mangravite, Ph.D.
(Sage Bionetworks)
Open Science in Medicine: From Ideology to Methodology |
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Craig McKelvey, Ph.D., Ch.E.
(Merck & Co., Inc.)
What Enabling a Revolution in Hepatitis C Virus Treatment Can Teach Us about Solid Solutions
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John Wagner, M.D., Ph.D.
(Takeda Pharmaceuticals)
Precision Medicine: Hype and Reality, from Biomarkers to Wearables |
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Darrell J. Irvine, Ph.D.
(Massachusetts Institute of Technology)
Engineering Immunity in Cancer and Infectious Disease through Formulation Design
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Register today!
Best pricing ends August 21.
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Now Accepting Late-Breaking Poster Abstracts!
Deadline: August 21, 2019, 5 pm ET
Looking for a great opportunity to display your work and gain recognition? There is still time to submit your poster abstract during the Late-Breaking Abstract submission period!
The 2019 AAPS PharmSci 360 is the world’s premier pharmaceutical science conference. If you want to make an impression, this is the place to do it.
More than 1,700 posters will be displayed November 3–6, 2019, at the meeting in San Antonio, Texas. Make sure yours is one of them. Submit your abstract today!
Poster abstracts will be aligned with five robust tracks covering all aspects of the pharmaceutical sciences. Posters will be displayed according to tracks in poster forums, which increases your chance of being noticed by potential collaborators, journal editors, recruiters, clients, and other industry leaders.
There is a nonrefundable submission fee, per abstract, of $50 for students and $100 for nonstudents. Fees are payable by credit card only.
Submit your poster abstract today!
Learning Is Large in the Solution Center
AAPS is expanding the scientific and career programming on the Solution Center floor to make your PhamSci 360 experience even more beneficial and diverse. Be sure to include time in your schedule to visit and take part in some or all of these unique educational opportunities.
The Solution Center Features:
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Rapid Fires: Back by popular demand! From 3 to 5 pm every day, each track will feature a series of quick, informal presentations on almost any topic.
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NEW! Tech Challenges: Participate in a peer competition for the best presentation of new and innovative technologies through an application-based case study. Vote on your favorite, and the top technologies will face off before the Solution Center closes on Wednesday.
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NEW! Software Lab: Bring your laptop to this hands-on, interactive event as companies demonstrate their latest software technology. Preregistration is required.
- NEW! Startup Pavilion: Find novel science you have not seen before, and discover the next big thing.
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Partner Presentations: Learn from AAPS’ exhibiting partners as they present case studies and speaker panels in their areas of expertise, and pose your questions about their products and services, face to face.
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Career Development Classroom: This year’s focus is on strategic leadership, managing your career in a rapidly changing work environment, and working with other organizations, including potential clients and partners.
Review the Solution Center floorplan.
2019 Land O’Lakes Conferences
Developed and conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison, and in partnership with AAPS.
20th Annual Bioanalytical Conference
July 15 – 19, 2019
Innovation in Bioanalytical Research for Translational Medicine: New Modalities, New Technologies, and Evolving Regulations
This conference is designed to advance topics related to bioanalysis such as xenobiotics, metabolites, biologics, and biomarkers. An optional short course, Gene Therapy Fundamentals, is available. This year’s conference covers gene therapy, multiomics miniaturization, and bioanalysis regulation.
59th Annual Pharmaceutical Analysis Conference
August 12 – 15, 2019
Addressing Technical and Regulatory Challenges in Pharmaceutical Analysis
Learn about statistical techniques and their applications in the pharmaceutical industry at this conference, which will focus on navigating the technical and regulatory challenges. Industry leaders and regulators will present and answer the most common questions. Plenary sessions include the following:
- Current Challenges to Pharmaceutical Analysis
- Focus on Large Molecules
- New Technologies and Approaches for Increasing Laboratory Efficiency
- Global Regulatory Challenges to Pharmaceutical Analysis
22nd Annual Drug Metabolism and Applied Pharmacokinetics Conference
September 9 – 12, 2019
Found in Translation: Adaptive DMPK Strategies
Address drug safety evaluation and other topics related to drug metabolism and pharmacokinetics. There will be an optional short course on “Human Dose Projections.” This year we will discuss absorption, distribution, metabolism, and elimination in pharmacokinetics and pharmacodynamics. Plenary sessions include the following topics:
Endogenous Biomarkers
Target Mediated Drug Disposition
Microphysiological Systems
Disposition in New and Nontraditional Therapeutic Modalities