Formulation and Quality Themes for 2018 AAPS PharmSci 360

AAPS PharmSci 360 is just nine weeks away. 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 Formulation and Quality track: 

THEME 1

Device-Drug Combination

Formulation design and optimization is moving toward more patient-focused and combination considerations to maximize outcomes. This theme will discuss multiple options to achieve this, including prefilled syringes, auto-injectors, large volume administration options, etc. The development process includes formulation selection, design control, stability, and manufacturing considerations. In addition, new developments such as fixed-dose combinations of proteins and sustained release of chemical entities will be included.

THEME 2

Formulation Development Challenges and Strategies

We are seeing continued improvement and innovation in formulation design strategies. Novel formulation technologies can overcome low bioavailability, poor solubility, and stability; create alternative routes of administration; manage surfactant degradation; and improve manufacturability of chemical entities. There are also novel formats and administration in biomolecules, including fusion proteins, oligos, intravitreal formulations, high dose, high concentration, etc. This theme will cover the latest advances in formulation development.

THEME 3

Quality and Characterization Considerations for Formulation Development

This theme will cover multiple aspects such as polysorbate degradation, (sub)visible particle characterization/quantification methods, peptides technology, and biological consequences. Modeling and simulation approaches that are used to predict critical quality attributes in formulation and process selection will also be discussed. So will regulatory aspects such as impurities profiling, excipients modernization and testing, harmonization, specifications, new drug substance formats (co-crystals, amorphous).

PharmSci 360's Other Tracks and Themes

• Picking the Winning Candidate
• Emerging Research Tools
• Preclinical to Clinical Translation 

• PBPK Modeling and Clinical Pharmacology in Regulatory Applications and Decision Making
• Nontraditional Approaches to Bioequivalence and Biosimilars, and Application of Clinical Pharmacology to Minimize Barriers to Generic Drug Substitution
• Pharmacogenetics, Big Data, and Population Pharmacokinetics in Personalized Medicine and Special Populations

• 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. 

Formulation and Quality 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.  

Wim Jiskoot, Ph.D. (Leiden University)

Lessons Learned from 30+ Years of Attempts to Become a Formulation Scientist

Jamie Moore, Ph.D. (Roche)

Particles in Liquid Drug Products: Causes, Impact, and Strategy

Matthew Burke, Ph.D. (GlaxoSmithKline)

Transforming the Patient Experience through Long Acting Injectable/Implantable Formulations: New Opportunities and Technologies

Robert O. Williams III, Ph.D. (University of Texas at Austin College of Pharmacy)

Formulating Poorly Water Soluble Drugs: Importance of Process Selection

Ashley Boam, M.S. (U.S. Food and
Drug Administration)

FDA Perspective on Development of Drug-Device Combination Products

Visit the PharmSci 360 website to see all the keynote speakers.  

2018 PharmSci 360 Plenary Speakers

NEW TO THE LINE UP!

Craig Venter, Ph.D.

Regarded as one of the leading scientists of the 21st century, Venter is most known for his numerous invaluable contributions to genomic research. He is cofounder, chairman, and chief executive officer of Human Longevity Inc. (HLI), the genomics-based, health intelligence company focused on extending the healthy, high performance human life span.
HLI combines the largest database of genomic and phenotypic data with machine learning to drive discoveries and revolutionize the practice of medicine.

Don’t miss this once in a lifetime talk at our opening session on Sunday, November 4!

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 (CHOP); and medical director of the Stem Cell Laboratory. The CAR-T Revolution: Opportunities and Challenges

Dany De Grave

Senior director Innovation Programs and External Networks,
Sanofi Pasteur; and founder of Unconventional Innovation

AI in Pharma: The Future Arrived Yesterday

Career Development Programming at PharmSci 360

Master crucial conversations.

Your ability to hold a crucial conversation at work is key to your ability to lead a team, meet goals, and collaborate with your colleagues. Learn how be “heard in the herd” in the Career Development Center at AAPS PharmSci 360. Add these sessions to your schedule on the
PharmSci 360 app, and look for them in the Career Development Center, located in the Solution Center (Exhibit Hall).

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)

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 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 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 misuse 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 non-threatening 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 your supervisors.

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.

Find a Job at the PharmSci 360 Career Development Center

Upload Your Résumé to the PharmSci 360 Career Development Center

The online PharmSci 360 Career Development Center helps employers attending PharmSci 360 find the candidates they seek. Upload your résumé and get found! Once you have registered for the event, you will receive an email giving you access to the online center.

• Upload your résumé.
• Browse job openings.
• Contact companies attending PharmSci 360 hoping to meet candidates.
• Book an interview!

While you are in the Career Center, take time to meet exhibiting companies hiring now.

Don’t miss the LinkedIn Bar, where you can get a free critique of your LinkedIn profile. AAPS members have told us that LinkedIn is the social media platform they turn to first—make sure you are putting your best foot forward online.

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. 

Résumé Review Appointments Available

Sign up to have your résumé reviewed! AAPS arranges for a professional working in your field to meet with you to discuss your résumé through our résumé review program. Seating is limited and booked in advance, so sign up early! Email resumereview@aaps.org to book a review.
 

Posters at AAPS PharmSci 360

AAPS will again present 1800+ posters this year, using the intimate, conversational poster forums introduced in 2017.

• Each poster presenter will have a dedicated screen for 60 minutes.
• Poster titles will always be visible, even in zoom mode.
• Screens will be numbered and easy to find on the app and on the floor.
• All screens will be available for browsing during the first hour each morning, so you can 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 you can look up any poster at any time).

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   

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
• Bioanalytics
• 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:

• 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.