September 2017 Contents


2017 AAPS Annual Meeting and Exposition Hot Topics 

The 2017 Meeting Content Programming Committee announced their selection of hot topic programs, which aim to address the most critical scientific issues in the past two months. 


Fragile—Handle with Care: Drug Product Handling in the Real World 

Biotherapeutics are an essential arsenal in the fight against several diseases including cancer and immune diseases and are usually administered via intravenous (IV) infusions or subcutaneous injections. Given the complex nature of these drugs and their sensitivity to conditions such as temperatures above refrigeration level, shaking, etc., it is increasingly important to understand the conditions these drugs are exposed to and how their handling at the point of administration can affect their critical quality attributes, including aggregation or chemical modifications. All clinical and hospital pharmacists are faced with the challenges of preparing biotherapeutics and the stability and economics of such preparations. Recently, using a centralized intravenous additive service in Europe opened the possibility for IV bags to be prepared in advance, frozen, and thawed prior to administration, or just shipped in the liquid state from the pharmacy to the clinic. Given that all excipients used to protect the protein during drug product production are subsequently diluted in an IV bag, it is imperative to understand how the pharmacists and nurses prepare and use these fragile drug products. 

Sep17 AM1Recent reports on preparation of biologics in a hospital setting have shown that protein drugs were mishandled. This can expose biotherapeutics to conditions that can adversely affect their stability and their safety and efficacy. The contribution of sample handling and exposure of drugs to suboptimal conditions becomes even more complicated in developing countries, where cold supply chain might not be available. A communication gap exists between the drug developer‘s understanding of real world conditions and handling of their drug and the pharmacist’s understanding of the importance of careful handling of the biotherapeutics and the reasons behind these instructions. Challenges and recommendations for the end user and the developer, and approaches to close communication gaps will be discussed.

Make it Simple: Strategies to Understand and Enhance Patient Adherence 

Patient adherence to prescribed dosing regimen is a significant challenge in health care. In one study of clinical trial participants, 4 percent of patients never started their medication, 15 percent did not follow their regimen correctly, and 35 percent prematurely discontinued their medication. In another study, patient adherence to dosing regimen has been shown to drop to 50 percent within three months. The impact of nonadherence to prescribed regimen can be significant for patients, for payers, and for pharmaceutical companies. 

For the patient, nonadherence may cause drug exposure to drop below therapeutic levels (in the case of a missed dose), or to levels high enough to decrease tolerability (in intentional “catch-up” dosing or accidental double-dosing). This phenomenon becomes more important for medications where a minimum level of consistent drug exposure is required (e.g., to maintain reduction in viral load for HIV antiretrovirals). In these cases, nonadherence may have broader societal implications, such as the proliferation of mutant viral strains that are resistant to existing therapies. Objective measures of patient adherence patterns have the potential to facilitate product design to ameliorate these behaviors and to impact clinical trial design in a way that accounts for such patterns. This session will explore efforts to both measure and improve patient adherence through formulation, packaging, and associated technologies.

How the Patient Impacts the Industry: Challenges to Development of Pediatric Medicines 

The recognition and legislation that pediatric patients were often underserved with formulations manipulated from adult drug products marks a new focus of age-appropriate formulation development. Orally administered age-appropriate formulations encompass, but are not limited to, solutions, suspensions, dispersible tablets, chewable tablets, and multiparticulates. Multiparticulates, such as minitablets, granules, and pellets, have gained much attention due to generally good acceptability, high dosing flexibility, good dosing accuracy, absence of preservatives, and relative ease of taste-masking. However, there is limited information on the application of multiparticulates such as minitablets or pellets in pediatrics from an industrial commercialization perspective.

Development and manufacturing strategies for producing minitablets are different from strategies for producing conventional tablets. The miniature dimension of minitablets warrants additional considerations for tabletability, compressibility, compatibility with excipients and packaging components, and taste masking. In addition, in-process controls for minitablets are uniquely catered to the particles physical dimension. Dosing of minitablets also necessitates specific handling measures, administration approaches, packaging configurations, and potential devices for administration. These challenges are further compounded when applying regulatory requirements for pediatric medicines including device design, mixing with food, and achieving good dose accuracy at very low doses.

The multidimensional complexities of developing and manufacturing minitablets can present a steep learning curve to the formulation and analytical scientist. Thus, this session will share challenges and experiences gained to better guide the development of multiparticulate dose forms through minitableting.

Vector-Bor ne Diseases Hiding in Plain Sight: Zika and Chagas Disease 

Sep17 AM2Vector-borne diseases are transmitted by vectors, which include mosquitoes, ticks, and fleas. These vectors can carry infective pathogens such as viruses, bacteria, and protozoa that can be transferred to humans. Every year there are more than 1 billion cases and more than 1 million deaths from vector -borne diseases globally. This can only be expected to increase as globalization of travel and trade, unplanned urbanization, and environmental challenges such as climate change each influence growth and distribution of pathogen-carrying vectors. 

In the U.S., there are 14 vector-borne diseases of national public health concern. However, many cases remain unreported because in the early stages of infection, symptoms are nonspecific and may be misdiagnosed for other noninfectious disease states. This hot topic session will focus on two vector-borne diseases: Chagas disease and Zika. 

Infection by the Zika virus generally produces a low-grade fever, rash, and/or conjunctivitis in only about 20 percent of those infected. Association of Zika with microcephaly and other birth defects associated with infection during pregnancy in Brazil in 2015 led the World Health Organization to declare a Public Health Emergency of International Concern lasting nearly 10 months. During this period, Zika spread throughout the Americas. While this outbreak resulted in an enhanced effort to identify therapeutic regimens and vaccines, the nature of the virus and the target population presented unique challenges.

A recently published study provides epidemiological support for the Center for Disease Control’s estimates that approximately 300,000 people are living with Chagas disease in the U. S. Chagas disease is transmitted by the triatomine bug, which is the vector for the disease-causing parasite Trypanosoma cruzi. If untreated, roughly 30 percent of those infected will develop cardiac, digestive, or neurological disorders. Without treatment, many patients risk death from cardiomyopathy. Nifurtimox and benznidazole are the only two treatments available, however many patients abandon the lengthy treatment regime because of side effects. Neither drug is commercially available in the U.S. 

We will present the current state of drug discovery and vaccine development including how therapeutic targets are identified and validated for these diseases. We will discuss developability assessment of new and existing compounds in terms of physicochemical properties and the impact of their Biopharmaceutics Classification System classification on product development. We will conclude by summarizing the barriers to the drugs and vaccines for vector -borne diseases reaching the global market and collaborative research and development efforts that address these challenges.

For full program descriptions, updates, speakers, and schedule, use the annual meeting Web/mobile app

Why Stay in an Official AAPS Hotel? 

  • Lower room prices are guaranteed! AAPS convention rates are significantly lower than Web rates.
  • It’s free—no booking or service fees!
  • Convenient—real-time online service 24/7.
  • Proximity—all hotels are either within walking distance to the San Diego Convention Center or the San Diego Trolley system.
  • Community—spend quality time with colleagues before and after sessions in the relaxed atmosphere of the official hotels.
  • Reward points—earn points toward your personal hotel rewards program.
  • You are in control—edit or cancel your reservation at any time.
  • Fully manage your group booking, large or small.

Special Incentives for AAPS Registrants Only!

Hilton Bayfront: All AAPS guests staying at this property will receive 15 percent off full-priced spa services.

Hilton Gaslamp: Show your AAPS badge during dinner to receive a 10 percent discount at the New Leaf restaurant.

Marriott Gaslamp: Opt to waive housekeeping services, and receive 500 Marriott Reward points per night. 

OMNI: Zumbido (Coffee/Wine Bar) and McCormick and Schmicks (hotel restaurant) will offer 10 percent off with an AAPS badge. Restaurant discount does not include alcohol.

Westin: Show your AAPS badge and receive a 10 percent discount with at Pinzimini (hotel restaurant) and Ingredients Grab N Go (both offers exclude alcohol).

All hotel reservations should be made only through AAPS’ official housing company Experient. If contacted by someone claiming to be affiliated with AAPS housing, please alert AAPS, and do not make arrangements. Email ScuderiE@aaps.org or call +1.703.249.4789.

Rooms will be given out first come, first served, so book as soon as possible. Reservation deadline is October 16, 2017.

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