Contract Formulation Company Profile - Metrics, Inc.

Metrics, Inc.
Metrics, Inc.

Headquarters
Greenville, NC

Location(s)
Greenville, NC

Years in Drug Formulation
12 Years

Spokesperson
Mike Ruff, Pharm.D, VP, Pharmaceutical Development

Areas of research
•	Small Molecule			Biological			Other

Drug Formulation Services Offered
•	Analytical method development	•	Bioavailability enhancement
•	Compatibility studies of active ingredients	•	Dosage form selection
•	Excipient compatibility	•	Formulation optimization
•	Formulation stress testing		in silico studies
•	Manufacture of clinical supplies	•	Novel delivery system
•	Packaging compatibility assessment	•	Particle size reduction
•	Preclinical studies	•	Solubilizing water-insoluble drugs
•	Stability studies	•	Taste masking/flavorings

Other Services Offered
	Disease Research	Target Identification
	Lead Identification	Early Safety Tests
	Lead Optimization	Pre-clinical Studies
•	IND Submission	Clinical Trials
	NDA Submission	Post-marketing Studies

Types of Drugs
•	Generics		•	Prescription			OTC

Dosage Forms
•	Capsules		Implantable
	Inhalation		Injectible
•	Oral		Parenteral
	Peptide and Protein	•	Tablets
	Topical

Company’s role in drug discovery and developmnet
Metrics is contract development and manufacturing organization that provides quality work to quality clients from quality people.

Company’s experience and expertise in drug formulation
Metrics’ team of formulation scientists have an average of 12 years’ experience in formulation and process development. This includes extensive experience in development of oral solid dosage formulations including: tablets, conventional capsules, bead-filled capsules, and liquid-filled capsules. Metrics has successfully formulated poorly soluble compounds and enhanced their bioavailability. We can provide release characteristics including: instant release, enteric coated, extended/sustained release, delayed release, controlled release and 0-order release. Metrics offers a wide range of unit operations including but not limited to: direct compression, wet granulation, roller compaction, bead coating, extrusion/spheronization, tableting, encapsulation and film-coating. Metrics also develops oral suspensions and solutions, as well as providing overencapsulationfor blinding of comparators.

Relationship with pharma companies
Metrics works on a contract and modified partner contract basis. The highly successful Metrics-client team approach pairs a senior formulation scientist with the client project team so that each client has direct communication with the lead scientist on their project. This enables timely decisions and quick movement to the clinic. The Metrics fast- track, first time in man system has been successfully applied to over 100 new chemical entities averaging only 24 weeks from arrival of API to delivery of phase I material to the clinic. This includes analytical, stability, and CMC regulatory documents as needed.

Factors critical for drug formulation
The early transfer of all relevant physico-chemical and toxicological information is an important first step, leading to a hazard assessment to determine the appropriate safe handling procedures for the active ingredient. Client needs such as the following are critical: The dose(s) desired, the dosage form (tablet or capsule), any preferred process or unit operations, the desired release characteristics, need for a matching placebo. From a technical perspective critical factors include: API stability, solubility, and likely oral bioavailability of the API, excipient compatibility, and product stability (chemical and physical). The regulatory requirements regarding excipient acceptability are also critical to ingredient selection. Metrics addresses these factors by completing a questionnaire during early technical meetings/teleconferences with the client.

Scientific/business/regulatory trends impacting drug formulation
One important trend is: the higher percentage of poorly soluble, poorly bioavailable compounds. These API’s frequently require bioavailability-enhancing formulation approaches. Another trend is towards more potent (toxic) compounds, largely due to the increased focus on development of oncology drugs. This requires the use of special isolation technology for handling and preventing cross-contamination. Finally, heightened concern over stability is another trend, resulting in an increase in drug-processing methods such as roller compaction.

The key business trend that is impacting the contract development and manufacturing business is twofold. One is the economic downturn and the reduction in venture back dollars in the development market. The second is the outsourcing direction that large Pharma is taking. One is shrinking dollars available to contractors and the other is expanding those dollars but on a selective basis. Other impacts are the China and Indian cost containments but this seems to be offset by the IP protection problems that still exist. On the regulatory front, the whole approval process has been slowed by the huge volume of applications.

How will roles of CROs and contract manufacturers change over the next few years?
One prediction is that contract development organizations like Metrics, will increase activities to become “approved vendors” for a growing number of large pharmaceutical companies seeking to increase efficiencies through outsourcing. Because a true team approach between the CRO and client provides the best outcomes, the current roles, which tend to be less integrated, may change for the better.