SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services
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.
Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.
Patrick Le Gal explains how his company deployed a quality by design approach to manage all the unavoidable competing requirements and to propose a solution that balances performance, robustness, and usability.
Brian Ogilvie, PhD, and Andrea Wolff explain the implications of the new timing requirements and best practices for negotiating them efficiently and effectively moving forward.
Hillel Cohen, PhD, outlines the evolution of biosimilar approvals and describes the process of analytical and clinical testing followed in the development of a biosimilar, with use of data from the scientific literature.
MARKET BRIEF – Nothing Degrading About Saving Lives: E3 Ligands Recruiting New Drugs Into the Clinic
Marianna Tcherpakov, PhD, discusses underexploited strategies, traditional approaches that can be optimized, novel techniques beginning to emerge and pay dividends, and results propelling this field toward better clinical outcomes.
FORMULATION FORUM – Amorphous Formulations for Insoluble Drugs: Rational Design & Practical Approaches on Formulation Screening & Development
Jim Huang, PhD, discusses the issues associated with amorphous formulations, including solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, stability in aqueous solution, in vitro in vivo performance, and process and scale-up.
EXECUTIVE INTERVIEW – Synteract: Advances in Pediatric Clinical Research & the Promise for the Future
Dr. Martine Dehlinger-Kremer, Vice President, Pediatric Development at Synteract, reviews current and significant challenges in pediatric clinical research, advancement of regulations surrounding them, and where the industry is headed.
In conclusion of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, reviews and compares current Phase 3 and Registration-stage products with products first approved since 2014 in the United States, Japan, or Europe.
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration
Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.
Marc Brown, PhD, Jon Lenn, PhD, and Jeremy Drummond, PhD, believe it is essential the lead (and potentially a back-up formulation depending on any risk factors identified) has been optimized and characterized to demonstrate it will maintain its quality and performance as well as provide the best chance of measurable success in the clinical setting.
EXCLUSIVE ONLINE CONTENT
The global sequencing market should grow from $10.7 billion in 2018 to $24.4 billion by 2023, with a compound annual growth rate (CAGR) of 18.0% for the period of 2018-2023.
PHASTAR recently announced today it has entered into a technology partnership with Medidata Solutions, Inc. PHASTAR will deploy several solutions from the Medidata Rave Clinical Cloud, including Rave EDC, Coder, eCOA, and RTSM.
Kymab & LifeArc Enter Strategic Partnership to Discover New Medicines Using Kymab’s IntelliSelect Technologies
The agreement will enable LifeArc to enhance its antibody drug discovery capabilities into new medicinal products with Kymab’s proprietary IntelliSelect technology platforms.
Loxo Oncology, Inc. recently entered into a strategic partnership agreement with Amoy Diagnostics Co., Ltd. and PREMIA Holdings (HK) Ltd.
Aclaris Therapeutics, Inc. recently announced positive results from a Phase 2 open-label clinical trial of ATI-502 (AGA-201), an investigational topical Janus Kinase (JAK) 1/3 inhibitor, in patients with androgenetic alopecia (AGA), a condition commonly known as male/female-pattern baldness.
iBio, Inc. recently announced the activation of its new cGMP sterile fill-finish services operation via the signing of a supply agreement with a clinical-stage biopharmaceutical company developing breakthrough gene and cell therapies.
Gilead Sciences, Inc. and Nurix Therapeutics, Inc. recently announced a global strategic collaboration to discover, develop, and commercialize a pipeline of innovative targeted protein degradation drugs for patients with cancer and other challenging diseases.
Sanofi and Google will establish a new virtual Innovation Lab with the ambition to radically transform how future medicines and health services are delivered by tapping into the power of emerging data technologies.
Array BioPharma Acquisition Will Accelerate Pfizer’s Position as a Major Player in Colorectal Cancer
Following the news that Pfizer has agreed to acquire Array BioPharma in a deal worth approximately $11.4 billion, Tajekesa Chapman, PhD, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the potential of this buy-out on the treatment of colorectal cancers.
IVERIC bio, Inc. and Catalent Biologics recently announced they have entered into an agreement for production and manufacturing of GMP-grade adeno-associated virus (AAV) vector for IVERIC bio’s gene therapy product candidates.