Clinical Pharmacology Themes | Keynote Speakers | Career Development | Job Hunting |Plenary Speakers | Submit Programming | Posters | Schedule-at-a-Glance | Solution Center
Clinical Pharmacology Themes for 2018 AAPS PharmSci 360
AAPS PharmSci 360 is just around the corner. See what this brand new meeting has to offer.
Scientific programming at AAPS PharmSci 360 is themed. Choose the track that matches your expertise and learn from your field’s hottest topics. Here are the themes for the Clinical Pharmacology track:
PBPK Modeling and Clinical Pharmacology in Regulatory Applications and Decision Making
The ability to accurately predict drug absorption and disposition during drug product development is increasingly relevant. Modeling and simulation tools and clinical pharmacology techniques provide a quantitative mechanistic framework for predicting and assessing systemic and tissue concentration-time profiles and can thus provide a valuable resource to support decisions at various stages (early development, late development, postapproval, and lifecycle management) of the drug development process, regulatory interactions, and personalized treatment. A significant step forward is the inclusion of PBPK modeling in submissions to regulatory agencies and acceptance of such models by the agencies to waive and/or supplement clinical studies and to support labeling.
Sessions will cover advances in these areas, current challenges, and future applications in regulatory filings and decision making.
Nontraditional Approaches to BE and Biosimilars and Application of Clinical Pharmacology to Minimize Barriers to Generic Drug Substitution
Demonstration of average bioequivalence (BE) is challenging for many molecules including highly variable drugs, narrow therapeutic index drugs, locally acting drugs, fixed-dose combinations, and nonoral routes of delivery. Having the same BE criteria for all classes of drugs and therapeutic areas poses undue technical, resource, and logistical burden. It also adds to the time and cost of drug development. This theme will focus on novel approaches to BE that are acceptable to the regulatory agencies and reduce barriers to generic medications while maintaining safety and efficacy.
The Biologics Price Competition and Innovation (BPCI) Act contemplated more affordable, generic substitutes for biologics, such as biosimilars, and created an abbreviated approval pathway. Despite BPCI approval, several scientific, legal, regulatory, and postmarketing barriers exist for entry of biosimilars.
This theme will explore clinical pharmacology-associated challenges and novel opportunities for scientific development, policies, regulations, and commercialization of biosimilars, including perspectives from emerging markets.
Pharmacogenetics, Big Data, and Population Pharmacokinetics in Personalized Medicine and Special Population
Personalized medicine aspires to individualization of the therapy. Advances in molecular genetics and biomarkers, and the ability to quantify that into a therapeutic regimen tailored to the individual patient, have gained significant attention. Also, the ability to model large datasets and population PK approaches enable a quantitative approach to dose selection and dosing regimen based on individual physiology and pathophysiology. However, individualization of drug therapy also raises numerous challenges such as the development of appropriate diagnostic tools for biomarkers, identification of correct disease targets, cost-effective devices, and developing accurate PK/PD models, among others.
Personalized medicine’s advances, challenges, and regulatory perspectives
will be discussed.
Other Tracks and Themes
- Picking the Winning Candidate
- Emerging Research Tools
- Preclinical to Clinical Translation
- Device-Drug Combination
- Formulation Development Challenges and Strategies
- Quality and Characterization Considerations for Formulation Development
- Process Controls, Manufacturing & Engineering Challenges and Related Strategies
- Continuous Manufacturing and Connected Processes Supporting End-to-End Approaches and Adapting to the Nonblockbuster Era
- Approaches to Master CMC of the Future
- Novel Therapeutic Modalities
- New Technology and New Applications of Existing Technology
- Emerging Regulations Impacting Bioanalysis
Visit the AAPS website to see all programming.
Clinical Pharmacology Keynote Speakers
AAPS is bringing the foremost thought leaders in pharmaceutical science to PharmSci 360! Keynote presentations will take place every day and relate to each of the five tracks.
Narendra Chirmule, Ph.D. (Biocon Research Labs)
Development of Biologics: Making Affordable High Quality Medicines by Leveraging Technologies and Data Analytics
Amita Joshi, Ph.D. (Genentech)
Pharmacometrics and Systems Pharmacology to Accelerate Decision Making in Today’s Phase-less Drug Development of Biologics
Jürgen Borlak, Ph.D. (Leipzig University)
Emerging Pharmacogenetics Practices and its Applications in Personalized Medicine
Kathleen Uhl, M.D. (U.S. Food and Drug Administration)
Nontraditional Approaches to Bioequivalence and Application of Clinical Pharmacology to Minimize Barriers to Generic Drug Substitution
Malcolm Rowland, Ph.D. (The University of Manchester)
The Evolution of Modeling and Simulation in Drug Development and Regulatory Applications
Visit the PharmSci 360 website to see all the keynote speakers.
Career Development Programming at PharmSci 360
GETTING YOUR FOOT ON THE RUNG OF THE LEADERSHIP LADDER
The Problem: You are ready to move into management, but your lack of leadership experience blocks your way. How will you ever get to the next level if no one will give you an opportunity to build your leadership credibility?
The Solution: Capitalize on leadership opportunities outside of the usual career ladder to build a foundation of leadership experience that can prepare you for the roles you want. This session is a must for anyone seeking to expand their leadership capabilities, but whose current position does not offer such chances for growth.
HOW TO SAY, "THIS ISN'T WORKING OUT"
Effective leaders know when and how to have this conversation to help their teams and their organizations find long-term success. Whether you have been in a supervisory role for 10 months or 10 years, you will not want to miss the tools and strategies discussed during this session. (A joint AAPS/ American Association of Colleges of Pharmacy presentation)
Participants can expect to learn how to:
- prepare for this conversation to give appropriate feedback when asked,
- balance candid, effective feedback with kindness and support,
- communicate constructive criticism in a nonoffensive way,
- avoid common mistakes by examining both sides of the issue,
- decide on the right place and time to have these crucial conversations,
- maintain your professionalism if emotions run high.
WORKPLACE ANXIETY: MOVING FROM STRESS TO STRENGTHS
“It’s not the load that breaks you down; it’s the way you carry it.”—Lou Holtz
Stress is a significant problem today. Learning to recognize and manage stress will help you develop the appropriate work-life balance, which will lead to increased job satisfaction and higher productivity.
WOMEN IN PHARMACEUTICAL SCIENCE POWER HOUR: TACKLING QUESTIONS HALTING CAREER PROGRESSION FOR WOMEN
Research shows that the number of women in senior leadership roles drops off significantly at higher levels of management in pharmaceutical organizations. This session will address some of the issues and impediments that challenge women in the pharmaceutical space and focus on strategies for connecting with women in pharmaceutical science across the globe through the AAPS community platform.
HOW TO CONNECT, CONVEY, AND CONVINCE WHEN YOU CONVERSE
Conveying research findings to others is as much a part of the scientific process as coming up with the findings in the first place. So, paying attention to the challenges of crafting papers and formal presentations is critical. But what about the less formal opportunities to convey scientific knowledge? Purposeful conversations call for many of the same communication tools as effective presentations—but with the added challenge that conversations are also opportunities to build relationships.
PEBBLES IN YOUR MOUTH: MASTERING THE ART OF SPEAKING CLEARLY
Communication breakdowns can be costly. On the R&D side, these financial losses often result from miscommunication between native and non-native English speakers. Conversations become critical when a mispronunciation or misunderstood use of language communicates an entirely different message than intended. This program targets some of the most common pronunciation and presentation struggles for non-native English speakers in an interactive, enjoyable, and nonthreatening environment. Participants leave with immediately applicable skills and increased confidence in their ability to communicate more clearly. These new skills will benefit you, your coworkers, and supervisors.
Job Hunting at PharmSci 360
PharmSci 360 will bring you the latest in pharmaceutical science and opportunities to polish your résumé and find the next step forward in your career.
- Upload your résumé to the online Career Center available only to registrants!
- Browse job openings, and contact companies attending PharmSci 360 hoping to meet candidates like you!
- Sign up to have your résumé reviewed! A professional working in your field will be available to discuss your résumé through our Résumé Review program. Seating is limited and booked in advance; sign up early at firstname.lastname@example.org!
- Submit an abstract before the Late Breaking Abstract deadline! Recruiters peruse AAPS’ 1,800 posters looking for their next hire. If you are job hunting, submit an abstract to present a poster.
- Submit a Rapid Fire proposal! Like posters, AAPS’ new Rapid Fire presentations are an opportunity to speak at the meeting and to appear on the agenda, where a recruiter can find you.
- Visit the LinkedIn Bar! Let an expert review your LinkedIn profile and advise you on polishing it.
Recruiters: Book a booth, post on the online job board, or sign up for the LinkedIn Bar with Kate Hawley.
Résumé Review volunteers: sign up with Joy Davis.
Job seekers: To post your résumé, look for an email from AAPS after you register for PharmSci 360.
2018 PharmSci 360 Plenary Speakers Sneak Peeks
Stephan Grupp, M.D., Ph.D.
Director of the Cancer Immunotherapy Program, director of Translational Research for the Center for Childhood Cancer Research at the Children’s Hospital of Philadelphia; and medical director of the Stem Cell Laboratory
The CAR-T Revolution: Opportunities and Challenges
Looking back, 2017 was the year that gene therapy and immunotherapy have really come into their own, with two Food and Drug Administration (FDA) approvals for CAR T-cell therapies. CAR T therapy is an engineered cell therapy/immunotherapy for cancer that works especially well in blood cancers like leukemia. The idea is to take T cells from patients, genetically engineer them into cancer -killing CAR T cells, then return them to the patients. The concept has been around for a while, but a CHOP-University of Pennsylvania collaboration showed for the first time how powerful this cell therapy could be, with the first adult and the first pediatric patients going into remission despite having a disease that was completely out of control.
Fast forward six years from our first patient, and where are we? We saw FDA approval of this therapy, the first gene therapy, and the first engineered cell therapy ever approved by FDA. Kymriah (tisagenlecluecel) was approved August 30, 2017, for the treatment of pediatric and young adult patients (up to 25 years of age) with B-cell acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. This approval has opened the door to a whole new field of medicine.
New treatments are under development. We are developing alternative targets for ALL other than CD19, which is the target for CTL019. We are testing a second-generation version of the recently approved therapy to see if it might work better or stay in the body longer. Many groups are working to initiate clinical trials in acute myelogenous leukemia, going after new targets. And there is now promising CAR T data in multiple myeloma, another difficult to treat blood cancer.
Hear more about this groundbreaking work at our opening session on Sunday, November 4!
Dany De Grave
Senior director of Innovation Programs and External Networks, Sanofi Pasteur; and Founder of Unconventional Innovation
AI in Pharma: The Future Arrived Yesterday
The use of artificial intelligence (AI) is all over the news these days. From self-driving cars to Facebook news feeds to Google maps showing you three ways to get to your destination.
A recent convergence of technological advances now brings AI to the forefront. We have entered an era of massive digital data generation, cheap data storage, and ever faster and more affordable computing power. All of a sudden several of the bottlenecks to use AI algorithms at scale have disappeared.
While AI might sound like a promise for the future, we should not fool ourselves: it is happening now, and it will impact all of us. AI tools can now read an amount of scientific literature in days when we humans would need years to do the same; they can model a complete clinical development of 10+ years in two weeks and identify never before detected causal relationships between data; they can design their own laboratory tests based on amounts of information you and I will have difficulty digesting. They are becoming our new partner in work.
This is fantastic news for the patients we serve, because AI is bringing us a step closer to understanding scientific unknowns and deliver on personalized medicine. Going forward we, in our pharma laboratories and research facilities, will have to adapt our way of working to this technology.
Wondering what this means for your work and what the future holds? Join us at our closing session on Wednesday, November 7!
Rapid Fire Programming Submissions Still Open
Have something to say? Rapid Fires are NEW this year and provide the perfect platform to introduce:
- hot topics and emerging trends affecting your field,
- preliminary research results that are not quite ready to publish, or
- controversial or debatable opinions.
Each speaker will get 10 minutes to present and three minutes for questions—that’s it!
Submit today, and share your thoughts! Deadline for submissions: August 31 at 5 pm ET
Have a Late-Breaking Abstract?
The late-breaking abstract submission period closes on September 5! Visit the PharmSci 360 website for the last chance to submit your abstract for PharmSci 360. Don't miss the chance to meet potential collaborators, editors, employers, and clients!
*There is a nonrefundable, per abstract submission administrative fee: $50 student, $100 nonstudent.
Brand New This Year! End-to-End Hot Topics!
Follow today’s hottest topics through the entire drug development process via our end-to-end hot topics! End-to-end topics have symposia in each of the five tracks.
- Immuno-Oncology: Advancement from Infancy to Products
- Rapid and Cost-Effective Delivery of New Drugs to Patients
The Most Innovative Hour of Your Day at AAPS PharmSci 360.
Poster Presenters Get 60 Minutes!
AAPS will again present thousands of posters this year, using the intimate, conversational poster forums introduced in 2017. But there are some exciting changes attendees will want to know about:
- NEW! Each poster presenter will have a dedicated screen for 60 minutes.
- NEW! Poster titles will always be visible, even in zoom mode.
- NEW! Screens will be numbered and easy to find on the app and on the floor.
- NEW! All screens will be available for browsing during the first hour each morning. Meet with the authors you missed!
There are poster forums in each neighborhood in the Solution Center. Attendees following a specific track will know exactly where to find that track’s posters.
Back by popular demand: digital screens and the Poster Café (where attendees can look up any poster at any time).
Meet Exhibiting Partners in the Solution Center’s Neighborhoods!
The PharmSci 360 Solution Center is divided into neighborhoods that mirror the five program tracks:
- Preclinical development
- Clinical pharmacology
- Manufacturing and bioprocessing
- Formulation and quality
You can visit any neighborhood, or spend your time in the one that focuses on the topics that matter most to you.
Each neighborhood includes or shares the following:
- Exhibiting Partners—meet scientific experts who can provide solutions to your challenges.
- Poster Forums—find experts and collaborators around specific topics.
- A Learning Lounge—listen to 20-minute Chalk Talks in an informal setting around your neighborhood topic.
- Huddle Rooms—join small, relaxed group meetings focused on the work challenges you face (meetings are preset by exhibiting partners).
Other key areas include:
Learn more about the Solution Center
- The Hub—find your community and learn how to best navigate the Solution Center.
- The Career Development Center—attend professional development sessions, speak with hiring companies, review your LinkedIn profile with an expert, and more.
- Partner presentations—learn about the latest topics through case studies, panel discussions, and roundtable discussions.