COMBINATION PRODUCTS – Device Development for Pharmaceutical & Biologic Combination Products October 4, 2016

Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.

Respiratory Drug Development eBook – Increased Focus on Respiratory Drug & Device Development Makes Treatment More Personal June 26, 2019

This e-Book highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.

SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services June 5, 2019

Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.

Caris Life Sciences Receives FDA Breakthrough Device Designation May 13, 2019

SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development April 30, 2019

Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.

MULTIPARTICULATE FORMULATIONS – Using Multiparticulate Technology to Develop Pediatric Drug Products February 28, 2019

Sven Stegemann, PhD, Matt Shaffer, Samantha Saville, and Jaspreet Arora, PhD, believe as pediatric formulations are expected to continue as a core research area in pharmaceutical technology, MP technologies have the potential to play a key role.

DEVICE REGULATIONS – The New Medical Device Regulation & the Applicability of Article 117 to Medicinal Products January 8, 2019

Louise Place focuses on the impact of Article 117 in Europe on the combination of a drug and a device, where the primary mode of action is performed by the drug and the two products are combined in a single, integral product that is exclusively for use in the given combination and not reusable.

Cartridge Filling: Combination of Features That Can Help Gain a Competitive Edge December 5, 2018

By 2050, it is projected that the proportion of people aged 65 and older will be more than double that of children aged 5. This global phenomenon is also leading to an increasing number of people suffering from chronic diseases, such as diabetes and osteoporosis.

WEARABLE INJECTORS – BD Wearable Drug Delivery Devices: An Attractive Proposal October 2, 2018

Beth DiLauri sets out the fundamental case for the adoption of wearable injectors, outlines the specific barriers they overcome, and describes how the design and development of the BD Libertas(TM) is an attractive proposal for pharma companies.

SPECIAL FEATURE – Injection Devices: As Self-Injection Grows, Drug Delivery Gets Smarter August 28, 2018

Contributor Cindy H. Dubin reviews some of the innovative and novel technologies developers are deploying to make self-injection easier and improve patient adherence.

Credence MedSystems Closes $12.8-Million Financing to Support Ongoing Development & Scaling of Innovative Delivery Products August 7, 2018

Credence MedSystems, Inc., an innovator in injectable drug delivery devices, recently announced the closing of a Series B financing resulting in gross proceeds to the company of $12.8 million.

SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: CDMOs Are Innovating for 21st-Century Medicine June 6, 2018

Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs about the innovations they are developing for next-generation patient care, and how many are making investments that are enabling them to offer more services under one roof.

SOLID FORM SCREENING – Phase Appropriate Strategies for Solid Form Discovery & Development May 31, 2018

Pingyun Chen, PhD, describes a rational, fit-for-purpose strategy for solid form screening and selection to ensure a successful yet cost-effective progression of drug candidates from discovery, clinical trials, and commercialization.

INTEGRATED DELIVERY SYSTEMS – The Value of an Integrated System for Combination Products May 31, 2018

Theresa Bankston, PhD, says the fact that many of these therapies are designed for home delivery by patients or caregivers via subcutaneous injection, combined with increasing complexity of longer-acting formulations, larger injection volumes, and longer injection durations, has raised the bar for seamless injection delivery technology.

ORALLY INHALED PRODUCTS – Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products April 3, 2018

Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.

SPECIAL FEATURE – Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges March 14, 2018

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.

Enable Injections Achieves ISO Certification to Meet Mounting Demand for Drug Delivery Device Combination Products January 8, 2018

DEVICE REGULATIONS – Early Preparation Will Pay Big Dividends as EU Enacts New EU Device Regulations January 8, 2018

Joanne Emmett says current directives are giving way to new regulations that require Class III and implantable devices to undergo clinical investigation to show that they are equal or superior to other products on the market.

SPECIAL FEATURE – Platform Technologies – Derisking & Transforming Drug Development September 29, 2017

Contributor Cindy H. Dubin, in this second annual report, speaks with several exciting and innovative companies whose platform technologies are transforming drug development.

DRUG DEVELOPMENT – To De-Risk Patient Acceptance of Biologic Drugs, Focus Early on Delivery September 11, 2017

Jeannie Joughin, PhD, asks what does a pharmaceutical company do when everyone wants more effective new therapies but no one – including third-party payers – wants to pay the price for their development? De-risk the drug development process, in every possible way.

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