October 2020

COVER

PLATFORM TECHNOLOGY - Morphomer(TM) & SupraAntigen(TM) Platforms: Targeting Misfolded Proteins in Neurodegenerative Disorders

Andrea Pfeifer, PhD, details the efforts to develop the therapeutic and diagnostic tools necessary to enable precision medicine approaches targeting the right protein, at the right time, in the right patient.

FEATURES

PLATFORM TECHNOLOGY - Morphomer(TM) & SupraAntigen(TM) Platforms: Targeting Misfolded Proteins in Neurodegenerative Disorders

Andrea Pfeifer, PhD, details the efforts to develop the therapeutic and diagnostic tools necessary to enable precision medicine approaches targeting the right protein, at the right time, in the right patient.

FORMULATION FORUM - Parenteral Sustained Delivery of ASD-005 Liposomal Formulation: A Case Study in Applications of Lipid-Based Nanoparticle Carriers

Jim Huang, PhD, presents an investigation aimed at studying the administration of a liposomal form of a third-generation β-blocker, ASD-005, by injectable route of administration to efficiently manage emergency hypertension and congestive heart failure.

ASSAY DEVELOPMENT - Case Study: How Custom Assay Development Helped Spur Precision Medicine Research in Multiple Myeloma

Steven Gross, MS, provides a behind-the-scenes look at the CMMC assay development process (from 2010 through today) to show how pharmaceutical companies can effectively partner with a laboratory to design customized assays that complement their drug discovery and development programs.

PEGYLATION - PEGylation - Three Decades of Product Approvals & Technology Development

Esay Okutgen, PhD, Alper Orhan, MSc, and Josef Bossart, PhD, believe with the 30-year anniversary of the first product approval using PEG (polyethylene oxide polymer) conjugation, it seems an appropriate occasion to review the evolution of the technology (PEGylation) and subsequent product approvals.

CDMO CASE STUDY - AJILITY: Streamlining Drug Product Manufacturing

Dustin Campbell says the AJILITY platform takes the burden off clients and allows his company to drive, manage, and support their drug product manufacturing, maximizing speed and success, while prioritizing these programs are driven to completion.

DRUG DELIVERY - Recognizing the Patient Potential for Transdermal Drug Delivery

Sally Waterman, PhD, and Vasiliki Nikolaou, PhD, explain how transdermal drug delivery patches have the potential to significantly improve not only the outcome of treatments, but also the quality of life for those patients using them.

EXECUTIVE INTERVIEW - Immunic Therapeutics: Developing Next-Generation Oral Drugs in Chronic Inflammatory, Autoimmune & Infectious Diseases

Daniel Vitt, PhD, Immunic’s Chief Executive Officer and President, discusses his company’s pipeline of selective, small molecule therapies aimed at treating chronic inflammatory and autoimmune diseases, and its recent progress.

DEVICE DEVELOPMENT - Designing Devices for Inhaled Drugs

Andreas Meliniotis explains how there is plenty of opportunity for the development of new, improved devices to ensure inhaled drugs can be accessible for a wide range of patients and can treat various diseases and conditions effectively.

OVER-ENCAPSULATION CAPSULES - Double-Blind, Zero Bias: Over-Encapsulation — The Right Tool for Blinding Studies?

Julien Lamps believes that while many blinding options are available to drug sponsors and external clinical research partners, over-encapsulation remains a popular choice for its dosing simplicity, trial efficacy, patient accessibility, and cost-effectiveness.

EXECUTIVE INTERVIEW - Enteris BioPharma: Pioneers in Oral Formulation Development

Dr. Rajiv Khosla, CEO of Enteris BioPharma, discusses how his company’s innovative oral formulation technology is helping the pharmaceutical industry overcome the hurdle of low bioavailability to reshape treatment categories and expand market opportunities with minimal financial and regulatory risks.

OSD FORMULATIONS - Dissolving Bioavailability & Solubility Challenges in Formulation & Development

Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.

CUSTOM DEVICE SOLUTIONS - Device Design Will Act as Competitive Distinguisher in a Post-Patent Expiry Biosimilar Market

George I’ons dissects the different factors that will determine biosimilars’ adoption and pace of advancement against their original counterparts, namely clinical confidence in the biosimilar and patient confidence in the drug delivery device.

IMMUNOGENICITY TESTING - Regulatory Updates for Immunogenicity Assessment of Therapeutic Proteins

Leon Shi, PhD, Lan Li, MS, and Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.