We support all phases of antimicrobial drug development, from discovery through commercialization.

IHMA has unparalleled expertise in pharmaceutical, diagnostic, medical, and microbiology. This highly robust skillset ensures successful pathways for drug development, clinical trial support, regulatory approval and commercialization.

IHMA Offers Capabilities Needed to Effectively and Efficiently Support Drug Discovery and Early Development

The process of discovering new anti-infectives relies on the timely generation of relevant and informative data. IHMA has a full suite of technical capabilities, resources, and domain expertise that can be applied to support your discovery needs in a collaborative and flexible manner.

Capabilities

Bacterial Repository

An early key to anti-infective development is to determine the spectrum of in vitro activity against relevant bacteria encountered in clinical settings across the world. Within the IHMA Bacterial Repository, we have a continuously expanding collection of current phenotypically and genotypically characterized bacterial pathogens. These organisms are catalogued according to geography, year of isolation, resistance phenotype, specimen source, patient demographics, healthcare location, and other parameters. The Repository can be used to rapidly assemble custom collections to profile the anti-bacterial activities of any products in your discovery pipeline.

Specialized Microbiology Laboratory Services

IHMA has extensive experience and expertise designing and performing a wide variety of microbiological studies for discovery and early product development. These studies carefully investigate various aspects of drug-organism interactions and may include profiling the in vitro activities against bacterial collections assembled from the IHMA repository, bacterial killing, drug resistance development, drug interactions, quality control guidelines, etc. Our flexible and collaborative approach to such studies allows a study to be custom designed to meet the needs of any product’s development, no matter how unique.

Clinical Scientific Expertise

Our team of experienced clinical microbiologists and scientists can serve as a direct extension of your development team and provide advice on study design, perform data analysis, prepare regulatory-ready reports, and author and support scientific presentations and publications. IHMA highly recommends an integrated approach with our team so that we become thoroughly familiar with all microbiology aspects of a product and are able to provide effective advice and analysis. This familiarity can be invaluable as IHMA can assist you in planning subsequent steps in your product’s development.

We Provide a Broad and Robust Spectrum of Capabilities Critical to Successful Clinical Antimicrobial Development

Economic constraints, uncertain regulatory landscapes, and the continuous evolution of unique strategies for the prevention and treatment of infectious diseases all pose significant challenges to the design and execution of a product’s clinical development. To help meet these challenges successfully, IHMA offers a full suite of technical capabilities and domain expertise that can be applied to your development needs in a collaborative and flexible manner.

Capabilities

Central Laboratory Microbiology Services

As a CAP accredited, CLIA certified central microbiology laboratory, we offer the full spectrum of clinical and molecular microbiology capabilities needed to collect and process clinical specimens, culture and identify clinically relevant organisms, perform a wide variety of in vitro antimicrobial susceptibility tests, and molecularly characterize any organisms of interest. Importantly, our testing menu is not static as we will develop and implement assays uniquely required for any particular product’s development.

Specialized Microbiology Laboratory Services

In parallel with clinical trial support IHMA fully supports other laboratory studies that are an important part of a regulatory filing. These studies carefully investigate various aspects of drug-organism interactions and may be undertaken before or during the clinical development phase. Such studies include, but may not be limited to, bacterial killing, resistance development, drug interactions, and quality control guidelines.

Clinical Scientific Expertise

Our team of experienced clinical microbiologists and scientists can serve as a direct extension of your development team and provide advice on study design, perform data analysis, prepare regulatory-ready reports, and author and support scientific presentations and publications. We highly recommend an integrated approach with our team so that we become thoroughly familiar with all microbiology aspects of a product and are able to provide effective advice and analysis.

Our Broad and Robust Spectrum Of Capabilities Are Focused on Optimizing the Likelihood of Regulatory Success

A successful regulatory outcome depends on many factors including scientifically and clinically sound data presented in a concise and coherent manner. From the microbiology perspective, we can help ensure that these goals are met by offering a full suite of technical capabilities and domain expertise to produce data content in a fully customized manner designed to meet your submission requirements.

Capabilities

Central Laboratory Microbiology Services

As a CAP accredited, CLIA certified central microbiology laboratory, we offer the full spectrum of clinical and molecular microbiology capabilities needed to collect and process clinical specimens, culture and identify clinically relevant organisms, perform a wide variety of in vitro antimicrobial susceptibility tests, and molecularly characterize any organisms of interest. Importantly, our testing menu is not static as we will develop and implement assays uniquely required for any particular product’s development. This approach ensures production of any type of clinical microbiology data required for inclusion in a regulatory submission.

Antimicrobial Resistance Surveillance

Surveillance of antimicrobial susceptibility trends is critical for monitoring the initial and continued in vitro effectiveness of any antibacterial agent in clinical development. Such studies are usually undertaken within three years of expected filing. The data are essential to the submission for corroborating a product’s in vitro activity observed during clinical trials. IHMA’s experience in designing and conducting successful surveillance is unparalleled and encompasses every region in the world and any clinically relevant pathogen for which a product’s regulatory submission is being prepared.

Specialized Microbiology Laboratory Services

In parallel with clinical trial data, IHMA conducts other laboratory studies that are also an important part of a regulatory filing. These studies carefully investigate various aspects of drug-organism interactions and may be undertaken throughout the product’s development process. Such studies include, but may not be limited to, bacterial killing, drug resistance development, drug interactions and quality control guidelines.

Clinical Scientific Expertise

Our team of experienced clinical microbiologists and scientists can serve as a direct extension of your development team and provide advice on study design, perform data analysis, and prepare regulatory-ready reports. We highly recommend an integrated approach with our team throughout the development process so that all aspects needed for submission are met in a timely and accurate manner.

We have Extensive Experience in Supporting the Successful Launch and Continued Clinical Use of a Wide Variety of Antimicrobial Entities

Successful commercialization of a new antimicrobial agent is as challenging as successful clinical development and regulatory approval. At the core of successful commercialization is the timing of educating the global clinical and scientific community about the new product’s attributes, and the ability of local clinical microbiology laboratories to test the product against the organisms they encounter in their clinical settings. IHMA offers a number of solutions uniquely suited to be used in a collaborative and successful manner to help support a successful commercialization plan.

Capabilities

Antimicrobial Resistance Surveillance

The same surveillance initiative established for monitoring the initial and continued in vitro effectiveness of a new agent can also be designed to generate data critical to educating the medical world about any new product. Such studies are often run over several years and provide continuous and ongoing opportunities for education. IHMA’s experience in designing and conducting successful surveillance is unparalleled and encompasses every region in the world and any clinically relevant pathogen for which a product has been approved for use.

Clinical Scientific Expertise

Our team of experienced clinical microbiologists and scientists can serve as a direct extension of your team to provide advice on study design, perform data analysis, and prepare and present scientific publications that include abstracts, posters, slide presentations, peer-reviewed journal publications, and web accessible data and analysis. We highly recommend an integrated approach with our team throughout the commercialization process so that all aspects needed for commercial support are met in a timely and accurate manner.

Manufacturers Interface and Performance Program (MIPP)

The vast majority of local antimicrobial susceptibility testing done in clinical microbiology laboratories utilizes commercial systems and devices. The manufacturers of these devices must submit a 510K to the FDA to get clearance of testing newly developed drugs. While this process can be arduous, time consuming and expensive for the drug’s sponsor and the device manufacturer, it is critical in order to get a new product onto the test menu of the maximum number of laboratories as soon after regulatory approval as possible. Through MIPP, IHMA has unique capabilities and experience to coordinate this process between the sponsor and the diagnostic community to ensure that testing capabilities are achieved as soon as possible.

Antimicrobial Voluntary Evaluation Program (AVEP)

Even with the best planned and executed MIPP initiatives, there are unavoidable time gaps between when a sponsor plans on launching their product and when the product is available on commercial susceptibility testing devices for use by local laboratories. The AVEP program, unique to IHMA, is flexible and can be custom designed to fill this gap and allow laboratories to test a launched product until the product is available on commercial systems. This is accomplished by distributing Research Use Only (RUO) materials such as drug powders, disks for diffusion testing, MIC strips, or MIC microdilution panels to local laboratories so that they can immediately begin testing the new product against the clinical organisms they encounter.

Surveillance Data Link Network (SDLN)

Since 1995 IHMA has maintained this powerful internet tool to allow on line access to the data generated through our surveillance initiatives. This fully customized program allows sponsors real-time access to analysis of data regarding their product’s in vitro performance around the globe and compares this performance with those of many other comparator drugs. Timely access to such information can be extremely helpful to sponsors wanting to track what is happening with their drug on an ongoing basis

Specialized Microbiology Laboratory Services

There are times that post approval special studies may be needed to address issues or questions that arise with regards to your product. Such studies could carefully investigate various aspects of drug-organism interactions or evaluate organisms that are found resistant to the new product in laboratories around the world.