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.

COMBINATION CORNER - Keys to Avoiding Common Pitfalls in the Development of Product Requirements for Drug Combination Products February 28, 2017

Jerzy Wojcik says it is more important than ever to bring the right team together early in a project to capture product requirements correctly. The cost of missing needs or requirements goes up exponentially as development proceeds, and many of these requirements can be identified early in the project if the right individuals are at the table.

BIOMARKERS - FDA’s Design Control Requirements for Biomarkers in Drug Development February 28, 2017

Kaiser J. Aziz, PhD, says the availability of validated biomarker-drug companion products will enable the molecular diagnostics and pharmaceutical industries to develop and rely on new genomic biomarkers in order to elucidate disease pathways, stratify patient populations, and monitor safe and effective use of these products.

ADVANCED DELIVERY DEVICES - Disruptive Delivery Technology Partnerships Are Key to Pharmaceutical Life Cycle Management January 16, 2017

Michael D. Hooven, MSME, believes in the challenge to deliver innovative therapies that address unmet patient needs while delivering profitable growth, and the industry is responding by embracing disruptive technology that can concurrently help on both fronts and also speed time to market for pharmaceutical products and services.

COMBINATION PRODUCTS - 6 Guidelines to Follow When Developing Combination Products January 13, 2017

Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.

TRAINING DEVICES - Best Practices & Considerations in Developing Effective Training Devices for Injectable Healthcare Markets September 3, 2016

Joe Reynolds says training devices are often used to create consistent onboarding experiences for patients through the use of novel technologies and mechanisms that fully simulate the mechanical aspects of the injection experience. And while these devices appear to be fairly simple at first glance, numerous design and engineering challenges must be addressed.

SPECIAL FEATURE - Injectable Drug Delivery: Key Trends Define Device Design Now & in the Future August 31, 2016

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.

COMBINATION CORNER - Keys to a Robust Combination Product Design Verification & Validation June 30, 2016

Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.

COMBINATION CORNER - How to Approach OTS Devices for Your Combination Product May 3, 2016

Lilli Zakarija, MSME, MBA, cautions that while OTS devices are already “developed” and on the market, they should still go through the device development design control process from the perspective of the combination product, and then let the design control process determine if the device meets the specific requirements of the CP.

ADVANCED DELIVERY DEVICES - How Data Hubs & Smart Devices Are Enabling the Rise of Therapeutic Ecosystems January 8, 2016

Stephen Allan discusses how unique collaborations between tech and biotech reflect a new paradigm in how therapeutics are being commercialized and marketed under the new pay-for-performance healthcare model.

DRUG DEVICE MARKET - Joining Forces: Global Markets for Drug-Device Combinations November 19, 2015

Kevin James and Kevin Gainer of BCC Research indicate the development of the market for combination products is closely related to the drug delivery systems sector, which represents a vast area of research and the demand for sophisticated drug delivery devices behind many novel product developments.

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…..