Molecular Profiles and Maryland-based Xceleron recently announced a collaboration to assist drug developers with improved efficiency during clinical development. In an exclusive interview with EPM, we found out what this means for pharma.
Michael Butler, chief executive officer at Maryland-based Xceleron, explained: “We believe that the Molecular Profiles-Xceleron partnership is very well positioned to add value to the pharmaceutical sector because it directly addresses the industry’s macro-need for improved efficiency (cost to market) and its micro-need to develop poorly soluble small molecule drugs. Both companies have grown by helping their customers to substantially improve upon (disrupt) the status quo and to do so with technology and a problem-solving scientific approach. By combining their expertise, the partnership promises to improve drug efficacy by properly characterizing drug disposition in preclinical and clinical development.”
Over the last 15 years, UK-based Molecular Profiles, a subsidiary of Columbia Laboratories, has established itself as a science-led leader in asset characterisation, formulation development and clinical trial manufacturing. Central to the CDMO’s approach, for more challenging to deliver drugs, is the application of a range of enabling technologies and characterization tools to explore nanomilling, solid dispersions and lipid-based formulation routes.
These are deployed through Molecular Profiles’ Enabling Technologies Rapid Screen platform, designed to quickly and robustly identify the best formulation approach. Using a combination of its consulting and clinical trial manufacture, it is unique in the world of formulation development and clinical production.
Talking about Xceleron’s role, Butler said: “Xceleron has similarly established itself as a technology leader. The company uses an analytical technology platform called Accelerator Mass Spectrometry (AMS) and combines that technology with proprietary analytical protocols. Their application in clinical development has produced a clinical pharmacology protocol that is demonstrably quicker (50%) and cheaper (75%) for the determination of drug disposition than has historically been the case. AMS is a highly sensitive, medium-throughput platform which is uniquely unaffected by matrix effects or by chemical classes. It is ideally suited to the elucidation of disposition of the most insoluble drugs in a range of tissue types for any class of drug molecule, irrespective of the formulation approach taken.”
The combination of Molecular Profiles and Xceleron can be viewed in the context of a Molecular Profiles’ ROADMAP to Clinical Trials platform, which it launched in 2014. This scientific approach and application of stage gating and screening technologies was designed with the aim of assisting clients in choosing a development pathway that will be the most time, cost and volume efficient route forward. Xceleron is presented here as enabling efficient clinical pharmacology investigations, although it can also support preclinical studies.
Claire Madden-Smith
Claire Madden-Smith, VP of commercial services at Molecular Profiles added: “A more granular view of the partnership is presented in the second schematic. Here we are highlighting a number of preclinical and clinical interactions. By working with Xceleron at the preclinical stages we can accelerate in vivo assessment through the ability to dose at low levels equivalent to as low as 5µg/mL without any risk on non-detection, thus helping to gain valuable data for poorly solubility drugs.
Clinically, there are two broad scenarios in which the partnership can deliver.
“Firstly, as Molecular Profiles approaches the need to investigate the clinical impact of its formulation efforts, Xceleron can deploy its network of partners and analytical approach to secure human drug disposition information, including absolute bioavailability, within six months. This approach can be taken as a one-off or can be used iteratively as part of ongoing formulation improvement.
“The second broad clinical interaction arises when Xceleron has helped a customer to understand its drug’s disposition and those results indicate low bioavailability for which formulation improvement may represent a solution. In such cases, Molecular Profiles’ scientists review the available information and recommend an efficient formulation approach. The improved formulation can be investigated using the same efficient clinical protocol by the team at Xceleron.”
It is hoped that the collaboration will appeal to drug developers in the US and Europe looking to improve efficiency during clinical development.
Butler concluded: “I believe our alliance with Molecular Profiles is firmly at the centre of a current opportunity and market need relating to a greater role for science and technology in early biopharmaceutics. Working within Molecular Profiles’ ROADMAP to Clinical Trials platform, we will give clients the option to investigate the impact of solid state and formulations on human disposition at a very early stage.”