We provide uniquely powerful solutions to our clients, accelerating their analytical and bioanalytical research and empowering them to improve patients’ lives: Dr. Daniel Magiera, Founder of Molecular MS Diagnostics

"Along with the personalized approach to every project, MMSD is focused and committed to developing a robust quality management system.”

Partnering with a typical CRO is costly and time-consuming because pharma /medtech companies deal with endless middlemen, time-consuming regulatory approvals, and endless paperwork. This leads to considerable delays in bringing the drug to market. Molecular MS Diagnostics, or MMSD, was created to help address this need, helping research laboratories speed up their drug development processes with its exclusive high-end R&D and GMP analytical services. The MMSD processes are streamlined to cut out middle approvals and parties to offer the most efficient and successful outcomes.

Dr. Daniel Magiera, the founder of MMSD, has a wealth of knowledge in this field, which inspired the creation of the company. His started as a senior analytical chemist providing various analytical solutions to both researchers and formulation chemists for synthesizing and formulating drugs. Dr. Magiera supported all analytical/bioanalytical aspects of a controlled release drug development company and built three pharmaceutical analytical/bioanalytical labs during the company’s expansion.

While serving as a bioanalytical/analytical director for a company developing controlled drug release products, Dr. Magiera noticed that the traditional analytical/bioanalytical techniques provided by large CRO R&D services had not evolved on par with the latest industry standards. Identifying this gap in the market laid the groundwork for the creation of MMSD—a company aimed at using the latest analytical solutions to handle all R&D and GMP analytical product testing needs for life science organizations and laboratories.

MMSD was founded in 2007.

The Silicon Review reached out to Dr. Magiera, and here’s what he had to say.

Interview Highlights

Q. Can you introduce us to your R&D analytical services? What are their key features?

We provide numerous analytical services, including assay and impurity HPLC testing for drug products, extractables and leachables testing, and counterfeit drug testing. For R&D bioanalytical services, MMSD provides plasma/blood stability assays, urine analysis of generic drugs/NCEs, and UPLC-MS/MS method development services. Many other services were added after the 2015 expansion such as stability testing, pre-formulation development, photostability testing, feasibility studies, and various other product development services to help laboratories shorten the timeline from R&D conception to drug commercialization.

Key features

The key differentiating factor is the MMSD edge — an R&D philosophy simply called ACE (achieve, communicate, execute) methodology.

The methodology entails following all the steps that MMSD employs to oversee an R&D solution for its clients. It starts with a detailed inspection of project specifications and a collection of amounts of relevant medical literature to be able to expertly interact with clients and find their core objectives. In the final phase, taking into account the client’s specified requirements, the selected equipment and staff are identified to efficiently execute a particular R&D/GMP project. The entire methodology is repeated to produce different solutions to any issues surrounding a client’s R&D drug development processes, regulatory testing needs, and drug testing schedule.

Along with the personalized approach to every project, MMSD is focused on developing a robust quality management system (QMS). The QMS ties MMSD’s analytical processes to their SOPs, which reassures regulatory agencies and clients about the quality of testing results produced. By emphasizing data integrity, MMSD ensured its QMS system generates high-quality reports and solid actionable data for clients that can be used to answer drug approval questions posed by regulatory agencies.

As regulatory agencies become more critical of data generation processes, highly advanced, analytical equipment-based assays are necessary to help answer those questions. MMSD deploys the highest grade of specialty analytical equipment to quickly identify drug formulation/raw material issues and troubleshoot various assays to avoid being subjected to rigorous regulatory questions.

Q. Can you provide us with one or two success stories describing the challenges your clients faced and how MMSD helped them overcome those challenges?

On one occasion, a client’s product was on a regulatory clinical hold. This was a critical situation because the client needed to complete the clinical study to obtain data necessary to present to a board of investors and move into their needed capital-raising rounds. Once MMSD was involved, it was able to adopt a HLPC assay that required derivatization and validated this critical method. Within four weeks, a validation was executed, and the product was tested, taking it off clinical hold and allowing the client to complete their study successfully. As a small-sized company free of middle management, MMSD was able to focus the attention of its entire workforce toward the completion of this specific project to stay ahead of all deadlines.

On another occasion, a company was facing stringent regulatory questions regarding the characterization of its polymers on a pre-approved product. The company did not have the capacity or the equipment to address this issue. MMSD stepped in and deployed its analytical expertise (ACE philosophy) and was able to use its specialized equipment to create a defined protocol and executed it. This created a quality-reviewed supplementary technical report that the client was able to use to answer every critical FDA question and re-launch the product, within three weeks.

Q. Tell us about the MMSD team. What value do they bring to the company?

The team at MMSD contributes their invaluable skills, experience, and commitment to producing high quality results that adhere to rigorous QA standards. Our staff consistently receive training on the newest FDA requirements for data integrity and are all cross trained as experts in multiple types of HPLC, ICP, and GC/MS techniques. Taking the time to cross train our team members in these multiple disciplines affords them with a unique opportunity to break down silos most staff in larger CRO companies encounter. Our commitment to reinvesting in our team is reflected daily in the high-quality services they provide our clients.

Q. What new endeavors is MMSD currently undertaking? Tell us, what is next for MMSD?

MMSD is making sure that the more the pharma and medtech industry shifts from tablets to device-oriented medications driven by groundbreaking technologies, the more it’s going to play a crucial role in that evolution. With the perfect amalgamation of continuous innovation, agility, and collaboration, MMSD will keep offering solutions that speed up drug development programs for pharma and biotech organizations.

Q. What’s the one thing you want MMSD to be known for?

MMSD is in the R&D business for life sciences. We provide uniquely powerful solutions to our clients, accelerating their analytical and bioanalytical research and empowering them to improve patients’ lives.

Daniel J Magiera | Founder

Dr. Magiera has more than 17 years of experience developing high-performance liquid chromatography (HPLC) assays and is an expert in sample preparation techniques used for mass spectrometry (MS) applications. His doctorate thesis, from Northeastern University, involved sample cleanup procedures such as solid phase extraction (SPE) and satellite HPLC to purify derivatized DNA adducts for trace detection using Gas Chromatography (GC)-MS. As a senior scientist at Muro Pharmaceuticals/Asta Medica, he established the impurities identification HPLC-MS/MS laboratory.

Prior to founding MMSD, Dr. Magiera designed and managed the LC-MS/MS applications lab at Cohesive Technologies, where he developed automated assays for pre-clinical, clinical, and high-throughput drug discovery. He helped establish generic protocols for fast method development and has helped pioneer the development of applications for a parallel LC-MS/MS platform using online sample preparation to analyze drugs and metabolites in biological fluids such as plasma and urine.

Dr. Magiera has co-authored numerous publications and served as a speaker for many industry conferences with topics covering analytical techniques such as HPLC, SPE, and automated high throughput drug analysis by HPLC-MS/MS.

Daniel is married and has two daughters. He enjoys golf.

“MMSD is constantly collaborating with clients and other companies to provide a variety of analytical and product development services to help more life science companies achieve their research objectives. In view of this objective, MMSD is partnering with MedCommence, a company that provides R&D, clinical, and regulatory expertise to help MedTech life science organizations launch their polymer innovations.”