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2017 GLOBAL DRUG DELIVERY & FORMULATION REPORT - Notable Technologies, Approvals, Transactions, Pipelines & Perspectives
This third annual report, a collaborative effort between team members at Drug Development & Delivery and PharmaCircle, provides a look back at 2016 in terms of approvals and developments in the area of drug delivery and formulation. The report continues to cover the following significant key points of interest, with the belief that understanding the past, even the recent past, can provide insights to what is possible.

NEEDLE-FREE INJECTION - Portal PRIME: A Digitally Controlled, Cloud-Integrated Jet Injection System
Patrick Anquetil, PhD, and Gaspar Taroncher-Oldenburg, PhD, report on Portal PRIME, a needle-free and digitally controlled jet injection device that is breaking new ground for injectable drug delivery.
GALECTIN-DIRECTED THERAPIES - Targeting Galectin-3 Protein in Drug Development
Peter G. Traber, MD, believes we are only at the beginning of understanding the full potential of gal-3 targeted therapy, and the future likely holds additional high affinity, specific, galectin inhibitors that are bioavailable by routes other than the two currently in development.
CELLULAR MICROENCAPSULATION - Cell Encapsulation for Drug Delivery & Disease Treatment
Gerald W. Crabtree, PhD, indicates drug or treatment delivery that employs microencapsulation, one of many promising developments in the field of regenerative medicine, offers not only treatments but also potential cures for a wide variety of maladies.
SPECIAL FEATURE - Bioavailability & Solubility: New Approaches to Enhance Drug Performance
Contributor Cindy H. Dubin highlights many of the latest techniques to enhance bioavailability and solubility, how to determine the right technique for your compound, and how some companies are realizing faster time to market as a result.
BIODEGRADABLE FIBERS - Enabling Controlled Pharmaceutical & Biologic Delivery for Next-Generation Medical Applications
Kevin Nelson, PhD, discusses how wet-extruded fiber eliminates the traditional limitations of pharmaceuticals and biologics that may be incorporated into implantable medical devices with melt extrusion or electrospun fibers, microspheres, or nanoparticles.
PROTEIN THERAPEUTICS MARKET - Technology Advances Spur Market Growth of Protein Therapies
Laurie L. Sullivan and Shalini S. Dewan, BCC Research Analysts, believe with the advent of genetic engineering and recombinant DNA technology, it is now possible to produce a wide variety of human proteins, and that these novel technologies have lifted the market for therapeutic proteins to new heights.
SPECIAL FEATURE - Platform Technologies: Not Just for Big Pharma
Contributor Cindy H. Dubin recently spoke with several companies that are debunking the theory that access to the latest technological platforms to aid efficient drug discovery and development is limited to Big Pharma, which can more easily justify the costs of creating and operating innovative platforms.
SPECIAL FEATURE - Injectable Drug Delivery: Key Trends Define Device Design Now & in the Future
Contributor Cindy H. Dubin spoke with some of the world’s leading device developers about their current injection technologies and how their devices are addressing the current trends and opportunities in the industry.
GLOBAL FORMULATION REPORT - Notable Technologies, Approvals, Transactions, Pipelines & Inflection Points
This Global Formulation Report is a joint initiative by Drug Development & Delivery and PharmaCircle LLC, covering several areas of significant interest in today’s ever-challenging pharmaceutical and biotechnology industries.

-10 Notable Drug Delivery & Formulation Approvals of 2015
-10 Notable Drug Delivery & Formulation-Related Transactions of 2015
-10 Notable Drug-Device Approvals of 2015
-10 Notable Fixed-Dose Combination Drug Approvals of 2015
-Drug Delivery
ANTIGEN-SCREENING SYSTEM - Perfecting the Promise of T Cell Therapies for Infectious Disease & Cancer
Jessica B. Flechtner, PhD, explains how the information and insights gleaned from ATLAS, Genocea has been able to successfully define targets of human T cell responses that become central to novel vaccines and immunotherapies, and demonstrate success in a clinical setting.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges
Contributor Cindy H. Dubin speaks with leading syringe developers and contract manufacturers to discuss how they are overcoming industry challenges and provides a look at some of the innovative advancements in prefilled syringe technology.
LIPID NANOPARTICLES - EnCore(TM): Facilitating Delivery of RNAi Therapeutics to Treat Cancer
Marc T. Abrams, PhD, and Bob D. Brown, PhD, explain how nanoparticle technology has the potential to enable tumor bioavailability even in the absence of a targeting ligand.
CLOUD COMPUTING - Using Quantum Molecular Design & Cloud Computing to Improve the Accuracy & Success Probability of Drug Discovery
Ed Addison and Shahar Keinan, PhD, explain how cloud computing combined with the continued influence of Moore's Law has provided an unprecedented opportunity to apply inexpensive high-performance computing to drug discovery.
NANOSCALE COMPLEXES - A Novel Nanotechnology-Based Platform to Optimize Combination Cancer Therapies: Rational Development & Improved Delivery Using CombiPlex®
Barry D. Liboiron, PhD; Arthur C. Louie, MD; et al describe how CombiPlex addresses the challenges facing the traditional development path of many contemporary drug combinations and provide clinical proof-of-principle evidence that this approach can yield marked improvements in efficacy and patient outcomes.
SINGLE-USE MARKET - Rise of Single-Use Technologies & Systems in Biopharmaceuticals
Kevin James and Shalini S. Dewan of BCC Research believe eliminating the risk of contamination is the greatest challenge faced by manufacturers of biopharmaceuticals, and currently, this requires high-level monitoring of critical manufacturing processes. Single-use technology aids biopharmaceutical manufacturers in overcoming this challenge by reducing or eliminating the need for sterilization between batches, thereby improving operational efficiency.
FORMULATION DEVELOPMENT TECHNOLOGY - A Novel Drug Delivery System That Offers Zero-Order/Near Zero-Order Release Profile of Low-Dosage Strength Tablets Containing Highly Soluble Actives
Thomas B. Gold, PhD, was awarded a US patent; the intellectual property centers on formulation development technology that allows for the steady, continuous release of API over a particular duration of time to mitigate variations or spikes in therapeutic benefit.
SPECIAL FEATURE - Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
This Global Formulation Report is a joint initiative by Drug Development & Delivery and PharmaCircle LLC, covering several areas of significant interest in today’s ever-challenging pharmaceutical and biotechnology industries.
SPECIAL FEATURE - Excipients: Enhancing the New, Poorly Soluble APIs
Contributor Cindy H. Dubin interviews several excipient manufacturers who share their insights about the role excipients play in formulating and manufacturing drugs for improved bioavailability, solubility, and delivery.

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