ADVANCED DELIVERY DEVICES - Implantable Drug-Eluting Devices: A Novel Approach to Patient Care October 6, 2015

Samuel D. Trohman, MBA, Joey L. Glassco, Elena Draganoiu, PhD, and Carey Boyum present developmental and commercial examples of non-biodegradable drug-eluting devices, along with the versatile properties of thermoplastic polyurethanes for the development of effective drug delivery systems.

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 October 5, 2015

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.

Drug Development & Delivery to Launch Innovation Networking Event September 22, 2015

Mylan Launches First Bioequivalent Alternative to Combination Asthma Therapy June 12, 2015

ADVANCED DELIVERY DEVICES - Design & Evaluation of a Polymer-Based Prefillable Syringe for Biopharmaceuticals With Improved Functionality & Performance May 4, 2015

Sagarika Bose, PhD, and Kevin Constable address the design of a new commercially available polymer-based prefillable syringe with enhanced performance features when combined with complex biopharmaceutical drug products.

EXECUTIVE INTERVIEW - SOLIZE: 3D Data-Based Engineering & Manufacturing to Accelerate Delivery Device Development May 4, 2015

Yoshiki Matsuda, Director of SOLIZE, discusses how his company can create new and innovative solutions to accelerate the development of devices and combination products built thereon.

SPECIAL FEATURE - Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products March 31, 2015

Contributor Cindy H. Dubin finds that CMOs are embracing development projects in an effort to establish longer-lasting partnerships with their pharma and biotech clients. These contract developers are deploying innovative techniques aimed at improving solubility and fast-tracking products to market.

Bellerophon Therapeutics Selects Flextronics to Manufacture Next-Generation Device March 30, 2015

Combination Product Technology to Reach $31 Billion; Sector Attracting Massive Developmental Companies March 10, 2015

COMBINATION PRODUCTS - Human Factors & Combination Products March 2, 2015

Richard Featherstone explains how manufacturers of combination products are being asked to provide rigorous data on the safety of product when intended users use them. These challenges are not going to diminish, but with a focused approach and some sound HF principles, manufacturers can navigate the challenges successfully.

SPECIAL FEATURE - Analytical Testing: A Critical Element in Drug Development January 8, 2015

Contributor Cindy H. Dubin interviews several industry experts who believe there is intense competition to develop cutting-edge therapies and get them through development quickly to take advantage of patent exclusivity. And one of the critical elements in the drug development process is analytical testing.

SPECIAL FEATURE - Injectable Drug Delivery: Safer, Simpler, Smarter Devices September 4, 2014

Contributor Cindy H. Dubin speaks with some of the leading companies operating in the injectables arena, and discovers this ever-evolving sector is witnessing some very specific and eye-opening trends that are affecting the market’s growth.

Delivering Value From Drug-Device Strategic Partnerships June 17, 2014

EXECUTIVE INTERVIEW - 4P Therapeutics: Developing New & Innovative Transdermal Products June 3, 2014

Drug Development Executive: Steven Damon, Founder of 4P Therapeutics, discusses his vision for the company and how 4P intends to create new and innovative transdermal products that meet the needs of patients, physicians, and payers.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise April 2, 2014

Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.

FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products – A Review (Part 2 – Analysis) April 1, 2014

Tugrul T. Kararli, PhD, MBA, Kurt Sedo, and Josef Bossart, PhD, believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and in a series of three articles, examine the past, present, and future of these products with the intent of understanding their whats and whys.

ADVANCED DELIVERY DEVICES - New Drug Delivery & Stabilization Platforms Gaining Global Interest March 5, 2014

Sam de Costa, PhD, believes the launch of two stabilization and drug delivery platforms that have the potential to revolutionize the delivery of vaccines, therapeutics, and diagnostics, while significantly cutting costs, has attracted sharp interest from pharmaceutical and biotech companies around the world.

ADVANCED DELIVERY DEVICES - Engineering the Perfect Click for Drug Delivery Devices January 7, 2014

Chris Hurlstone says device developers – whether human factors experts or industrial designers, mechanical engineers, or risk analysis teams – know engineering of the click is critical, yet this aspect of device design, like many others, is frequently not given the attention it deserves.

ADVANCED DELIVERY DEVICES - The Reconstitution Revolution October 15, 2013

Alan Shortall believes with dual-chamber syringes and other emerging device technologies now addressing key market requirements for intuitive reconstitution and injection, the pharmaceutical market for therapies suitable for reconstitution and mixing at the point of delivery is poised for significant rates of growth.

SPECIAL FEATURE - Hand Held Devices: New Technologies Right the Wrongs of Earlier Devices October 4, 2013

Contributor Cindy H. Dubin highlights in this annual report that new devices are coming to market that not only address the trends of home care and a need for delivering larger doses, but are also cleaning up the spotty reputation of early stage devices.

WHITEPAPER - Addressing Regulatory Challenges for Ophthalmic Combination Products

Going forward, sponsors developing ophthalmic products formulated for delivery as eye drops must be prepared to pursue development programs that address the regulatory requirements for drug-device combination products. Partnering with a contract manufacturing organization (CMO) that has experience bringing such products to market is essential…..