PharmSci 360 Bioanalytics Track and Summer 2018 Workshops

The Bioanalytics Track Themes Announced for 2018 AAPS PharmSci 360!

A BRAND NEW meeting unlike any other, AAPS PharmSci 360 will combine all the energy and resources of a large scientific conference with the content depth of a small bioanalytical gathering.

All of the scientific programming this year 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 bioanalytics track:

THEME 1

Novel Therapeutic Modalities

The explosive growth in our understanding of molecular biology has provided a large number of targets to treat and cure diseases. Novel therapeutic modalities are being developed that use new approaches for molecular interactions and new mechanisms to overcome delivery barriers. These modalities may be totally new (e.g., cell therapies), seldom used (e.g., viral gene therapies, siRNA, peptides, millimolecules), combinations and carriers (e.g., tethered molecules, nanoparticles), or next generations of multispecific antibodies. Each of these modalities presents various bioanalytical challenges when measuring exposure (pharmacokinetics [PK]), immunogenicity, and pharmacodynamics (PD). 

These sessions will focus on the challenges bioanalytical scientists face and possible solutions during drug development of these novel therapeutic modalities.

THEME 2

New Technology and New Applications of Existing Technology

Sensitivity, specificity, accuracy, and precision are some of the characteristics that make robust assays. Recent advances in new technology, as well as the application of existing technology in new areas, are providing tools that enable bioanalysts to deliver more sensitive and reliable assays for PK, PD, and immunogenicity measurements. 

These sessions will bring forward the latest technology and solutions being employed.

THEME 3

Emerging Regulations Impacting Bioanalysis

National and international regulations for PK, PD, and immunogenicity measurements are advancing at the national, regional, and global level—in some cases as concerted efforts and more frequently as independent and not always aligned endeavors. Compounding the situation for bioanalytical scientists are the various interpretations applied among regulatory bodies, down to differences between individual interpretations of the same statements, which many times ignore the science. 

These sessions will bring forward the issues faced by bioanalysts, the scientific aspects of the experiments, and regulators who will provide their perspectives on current regulatory issues under consideration.

Check out the AAPS website to see the programming tracks and keynote speakers for all of our tracks and register today!

Update: Posters at PharmSci 360

AAPS President Chris McCurdy, Ph.D., and Executive Director Walt Marlowe, CAE, recently confirmed that:

• Each poster presenter will be assigned to a specific screen for 60 minutes—no more sharing screens!
• Poster titles will always be visible—AAPS is working with its software consultant to ensure poster titles and numbers are easy to see, even when a poster is in zoom mode.
• Screens will be numbered, and the app will have all the location info you need—posters will be easy to find.
• All screens will be unassigned for the 1st hour each morning for browsing—arrange to meet an author you may have missed!
• Posters will again be displayed in poster forums—Response to the topical networking spaces created by more than a dozen poster forums in 2017 was strong and positive. Expect to see these spaces again at PharmSci 360.

Find Your Neighborhood in the Solution Center!

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.

Learn more about the Solution Center. 

AAPS Partners on Leading Bioanalytical Meeting

CDER encourages collaborative efforts and data sharing among biomarker developers and users.

The American Association of Pharmaceutical Scientists (AAPS) and the Division of Pharmacy Professional Development at the University of Wisconsin–Madison are partnering to present the 19th Annual Land O’Lakes Bioanalytical Conference on July 9–12 in Madison, Wisc. This year, the conference’s theme is Emerging Therapeutic Paradigms: Supporting the Next Generation of Biomarker and Bioanalytical Research and Understanding the Shifting Regulatory Landscape.

AAPS members serving on the planning committees for both this conference and AAPS’ new meeting, PharmSci 360 (November 4–7, Washington D.C.), are coordinating the programming of the two events to ensure that scientists can thoroughly explore biomarker development, use, and regulation.

Presentations at Land O’Lakes will focus on emerging therapeutic paradigms and the shifting regulatory landscape. This is an excellent opportunity to connect with biomarker experts from around the world. Please join us and be a part of this exciting learning opportunity. 

Visit https://ce.pharmacy.wisc.edu/pd/bioanalyticalconf to learn more and register for this conference!

Biomarkers

Need a quick primer on biomarkers and their role in drug development? A biomarker is a defined characteristic that is a measurable indicator of a biological process. Biomarkers measure normal or pathogenic processes. They may also measure pharmacologic responses to therapeutic intervention. Biomarkers can have molecular, histologic, radiographic, or physiological characteristics. However, they do not assess how an individual feels, functions, or survives.

There are seven biomarker categories defined by the BEST (Biomarkers, EndpointS, and other Tools) Resource. A biomarker may fall under multiple categories depending upon the application. Visit http://bit.ly/UWiscBiomarkers to download a useful infographic about the seven types of biomarkers.

Biomarkers have the potential to reduce time and costs. This makes them an important facet of drug development. They have roles spanning early development to clinical trials. Examples of biomarker use include:

• monitoring safety of a therapy,
• determining if a treatment is having a desired effect on the body,
• predicting patients who might respond better to a drug, and
• predicting drug safety and efficacy.

Biomarkers have the potential to shorten clinical trial times with surrogate endpoints. A surrogate endpoint is “an endpoint used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives.” It does not measure the clinical benefit of primary interest in and of itself. It uses epidemiologic, therapeutic, pathophysiologic, or other scientific measures to predict clinical benefit or harm.

Biomarkers used as outcomes can speed up product development in certain disease areas. A conventional approach might measure the performance of novel therapies using clinical outcomes like mortality or disease progression. Accruing enough data for these clinical endpoints can take many years. Using a biomarker-driven approach allows quick prediction of drug efficacy and can shave years off product development.

While biomarkers are a powerful tool, there are barriers to their use in drug development:

• Lack of scientific evidence
• Lack of reproducibility of results
• Limited resources for biomarker development

The Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration is working to reduce barriers, and encourages collaborative efforts and data sharing among biomarker developers and users.  

Don’t miss out on this exciting opportunity to connect with experts and be a part of emerging biomarker trends.

Register today for the July Land O’Lakes conference.