issues

September 2020

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COVER

SPECIAL FEATURE – Injection Devices: Will COVID-19 Deliver Growth to the Market?

Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.

FEATURES

SPECIAL FEATURE – Injection Devices: Will COVID-19 Deliver Growth to the Market?

Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.

FORMULATION FORUM – Formulation Development Strategy for Early Phase Human Studies

Jim Huang, PhD, says successful translation of discovery compounds into first-in-human and first-in-patient is one of the key challenges facing the pharmaceutical industry, and to achieve this, a rational formulation development strategy will be critical to avoid costly development failures, while speeding up the development timeline in a cost-effective manner.

DRUG DEVELOPMENT – Bringing New Drugs to Patients Faster by Integrating Traditionally Separate Pharma Development Functions

Nutan Gangrade, PhD, says reducing R&D project timelines saves on overhead in development while increasing the likelihood of primacy in the marketplace (which engenders significantly more sales) and describes new approaches drug developers are taking to streamline drug development.

GENE-EDITING TECHNOLOGY – The Importance of Assessing Off-Target Effects of CRISPR Gene Editing

Mark Behlke, MD, PhD, says gene editing raises legitimate questions and fears about possible risks and misuse, and given the relative technical ease and low cost of CRISPR gene editing, this is likely to find widespread use in both medicine and agriculture.

EXECUTIVE INTERVIEW – AMO Pharma: Identifying & Developing Cancer Pathway Therapeutic Candidates for Use in New Neurological Indications

Michael Snape, PhD, AMO Pharma’s Chief Scientific Officer, discusses the company’s research focus and efforts to understand and target the mechanism of action of CNS disorders associated with developmental delay with the potential to target neurogenetic disorders at their root cause.

DEVICE DEVELOPMENT – Mapping the Regulatory Strategy to Better Navigate Electronic Drug Delivery Device Development for Patient Safety & Security

Ahmed Mallek, Hadrien Gremillet, and Audrey Chandra say that along with technology advancement in the medical industry, the behaviors and needs of different stakeholders also evolve, resulting in a clear interest in electronic drug delivery devices for a variety of reasons.

PEPTIDE THERAPEUTICS – Oral Peptide Therapeutics – Opportunities Abound as Barriers Fall

John S. Vrettos, PhD, says numerous technologies are currently in development that are designed to enable the oral delivery of peptides. Though each has its unique set of properties and capabilities, all must overcome key obstacles to successfully deliver peptides via the oral route.

COMBINATION PRODUCTS – Development Challenges & Solutions

Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.

EXECUTIVE INTERVIEW – Nuritas Pharma: Life Changing Peptide Drug Discoveries for a Changing World

Nora Khaldi, PhD, Founder and Chief Executive Officer of Nuritas, discusses the company’s innovative approach to accelerating the discovery of novel therapeutic peptides that address unmet patient needs in multiple disease areas.

THERAPEUTIC FOCUS – The Future of Treating Alzheimer’s Disease: Aducanumab & Beyond

Hermann Russ, MD, PhD, and Alexander Gebauer, MD, PhD, believe the times when amyloid beta as a drug target have been dubbed a dead horse in the race for treatment of Alzheimer’s disease are now over.