Self-Assembling Nanocomplexes: Transmogrifying Ocular Biologics Delivery

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By Abhirup Mandal and Ashim K. Mitra

Ocular delivery of biologics has been challenging. It has been a constant source of exasperation for ophthalmologists and formulation experts over the last few decades. High-molecular weight, short half-lives, structural complexity, and poor permeability render biologics as the most challenging molecules to formulate and deliver across ocular barriers. Continue reading

Combination Therapy is Vital to Cancer Treatments

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By: Prathap Shastri

Quick Perspective on Old-Style Chemo Is Still A Mainstay In The Age Of Targeted Cancer Therapy

The comments from the doctors and the patients in this article are a valuable reminder of the importance of the work we do in developing novel drug candidates in search of prevention/cure for deadly diseases such as cancer. The new drug modalities, such as antibody-drug conjugates, bi-specific antibodies, fynomers, are all great examples of technology advancements and improved hopes for finding a cure for cancer. While all these new modalities offer unique advantages, they pose significant challenges during development including but not limited to the stability, scale up, exaggerated pharmacology, and off-target toxicity. Thus, combination therapy plays a vital role for treating cancer where it is critical to strike the balance between toxicity and pharmacodynamics. FOr example, the recent approval of a new drug (Kisqali) from Novartis showed improved efficacy in postmenopausal women with HR+/HER2- advanced or metastatic breast cancer following combination treatment with letrozole.

With one of the main themes for the 2017 AAPS Annual Meeting and Exposition being “Emerging Modalities for Oncology,” there is certainly no shortage of opportunities to share and mutual exchange of knowledge in the field!

PRATHAP SHASTRI works for the pharmacology group at AMBRX in san Diego, CA. Prior to joining ambrx, he worked at Charles river laboratories and Seventh Wave Laboratories within the DMPK group.

Genetic Engineering-Based Therapies for Infectious Diseases

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By David Warmflash

david-warmflashGene therapy is in a golden age and more and more physicians and laypeople are growing aware of it. There have been stories about it, including on the AAPS Blog, and it’s most obvious application is to correct genetic defects within the human genome. This means genes encoding proteins that we need, where an abnormal or absent protein causes disease. The classic case is an enzyme deficiency. Continue reading

3D Printing in Drug Product Development

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By: Ashley Johnson

010116_johnson_ashley002Recently, there has been increasing interest in using 3D printing (3DP) to manufacture drug products. Notably, in 2015, the Food and Drug Administration (FDA) approved the first 3D printed tablet, Aprecia Pharmaceutical’s Spritam for the treatment of epileptic seizures. Spritam is fabricated using the company’s ZipDose 3DP technology, which creates porous tablets that dissolve almost instantaneously in the mouth. In 2016, FDA released draft guidance for submission of medical devices fabricated by 3DP. In addition to these regulatory advancements, 3DP of pharmaceuticals has generated significant academic and industrial interest due to its ability to produce complex geometries and customizable material properties. Continue reading