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Druggability
Did you every consider that your most potent molecule may not be the one you should develop? That compound with picomolar binding affinity may be far too unstable or insoluble or metabolically labile to ever make it to market.
PharmaDirections designs and manages material-efficient "druggability" studies to assist in lead selection or to elucidate potential roadblocks in developing specific molecules. Parameters that may be considered include:
- Chemical stability
- Metabolic stability
- Solubility
- Permeability/Bioavailability
- Crystallinity
- Powder characteristics
- Cost and complexity of synthesis
- Polymorphism
- In-Vivo testing
Strategic Planning
Drug development is an exceptionally complex process, and you are more likely to be successful when you have a detailed map of tasks, costs, and timing. PharmaDirections has developed a proprietary expert system called PathfINDAr™ which we use to help our clients chart a path from lead identification through INDs and proof-of-concept studies and onward toward their NDAs and BLAs.
To suit our clients’ needs, we generate strategic plans with various levels of detail, from "30,000 foot" overviews for presentation to venture capitalists to multi-tiered Gantt charts with hundreds of detailed tasks ready to be executed. Our plans can be tailored to a specific goal or can incorporate all aspects of development, including:
- Lead selection
- API process development and manufacturing
- Formulation and analytical development
- Pre-clinical/toxicology studies
- Drug product manufacturing
- Regulatory/filings
Predictive PK Modeling
Although silicon will never fully replace in vivo studies in drug development, advanced computer models, in the hands of PharmaDirections experts, can dramatically streamline dosage form development. Our computer-assisted "rational formulation" approach puts our pharmacokineticists in the driver’s seat in optimizing products for enhanced bioavailability or controlled release.
Using all available data for your compound and a complete computer simulation of the GI tract, we develop a sophisticated model of drug absorption and disposition and use this model to guide the development of dosage forms meeting your objectives. This targeted approach results in quicker development, a reduced number of animal and/or clinical PK studies, and often in IP opportunities for our clients when unexpected results are generated in silico and verified in vivo.
Predictive PK modeling is also an excellent tool for assessing the feasibility of modified release dosage forms or bioavailability enhancement. Once a model is developed, a variety of release profiles and types of dosage forms can be tested in silico at minimal cost. In many cases we have provided our clients with data pivotal in convincing investors to support a modified release program. In other cases, we have saved clients from sinking millions into programs with little or no chance of success.
Preclinical Strategy
Preclinical studies are the foundation upon which clinical development is built. Just as the correct placement of reinforcing rods is critical to the strength of a concrete footing, a well constructed preclinical strategy is critical to the strength of an IND.
PharmaDirections combines the talents of board-certified toxicologists and experts in various fields of pharmaceutical development to formulate a matrix of preclinical studies optimized to support all potential clinical objectives as cost efficiently as possible. We can use PathfINDAr™ to identify all the tasks necessary to support an IND enabling program.
We recognize that each drug product is a little different from any other and that no two preclinical programs are likely to be identical. Our experts have the experience and critical thinking ability to cater a plan to fill your needs within a minimal number of costly studies.
ADME/PK
The worth of pharmacokinetic and ADME data lies in how it is analyzed and interpreted. Whether you are screening compounds or interpreting clinical results, PharmaDirections’ ADME/PK experts can help you design and implement studies for maximum impact as well as making the most of the data you have on hand.
We use industry standard tools, such as Winnonlin® and Gastroplus® but go a step further in providing not just pharmacokinetic parameters but also a deeper scientific insight into how those parameters impact the development pathway and the design of optimal dosage forms.
Activities we support include:
- Human dose prediction from animal data
- Dose regime selection
- Hepatic microsomes or S9 fraction
- Identification of CYP450 Enzymes
- Structural Determination of Metabolites
- Feasibility for controlled release dosage forms
- Intellectual Property Generation (Learn more)
Consulting
PharmaDirections is a preclinical and formulation development solution for early stage life science companies. We have structured our organization to capitalize on the wealth of pharmaceutical talent we possess and on our speed of execution.
We can augment your staff with experts in specialized areas or provide a interim management team for young companies. With access to our 100+ pool of experts in a cross section of fields, you are sure to acquire the right resources at the right time.
- Investor Due Diligence
- Technology Assessment and Gap Analysis (more...)
- Strategic Consulting
- Interim Management
- Toxicology study design and monitoring
- ADME/PK study design
- Drug-drug interaction studies
- Bioanalytical
Project Management
In our experience, preclinical and CMC issues can be a storm in the making, seemingly quiet until a problem arises and everything else is held up because of it. The need for excellent project managers in development is well appreciated, however good people are relatively hard to find.
The complexity of preclinical and CMC development is not always well understood and this under-appreciation all too often results in toxicology, formulation, and analytical problems rearing their ugly heads at the most inconvenient times. We have on hand the scientists and project teams who have expertise in all preclinical fields, Our project managers knit them together into a cohesive group that keeps a program on track.
We will design and manage complete preclinical, CMC and product development programs for virtual biotech companies. We provide the expertise and infrastructure of a big pharma R&D group without their bureaucracy and overhead.