Services Overview

Target Identification and Validation

Innovation Pathways devises a small molecule discovery strategy for biological targets of interest. Innovation Pathways has extensive experience in selecting libraries to screen; following up on library hits and de novo design of active ligands.

 

Funding

Grant Writing: Early stage research programs benefit from non-dilutive capital investment. Innovation Pathways has experience in writing grants to government and private funding sources. Without seed money a program can often not generate the data needed to raise Angel and Venture funds.

 

Screening Hits or Fragments

Developing a Chemistry Strategy

As a chemistry project leader for over a dozen pre-clinical programs, Dr. Barry Hart has successfully advanced programs starting from chemistry library screening; hit-to-lead prosecution and “fast follower” molecular design

Library Screening:

Selecting the appropriate libraries to screen and proper follow up on active hits can be the difference between a novel target becoming a valuable asset or a dead end.

Hit-to-lead prosecution:

Through the use of SAR, molecular modeling, and creative application of drug design principles Innovation Pathways can improve potency and bio-pharmaceutical properties of a lead series.

“Fast follower” molecular design:

Many drug targets have been actively pursued by pharmaceutical companies or academic laboratories. A thorough understanding of the intellectual property surrounding molecules that target a specific protein can lead to a new, patentable, class of compounds that act at the same target but with improved properties. Innovation Pathways has expertise in identifying novel intellectual property in crowded chemical space.

Indentifying a Chemistry CRO:

Dr. Barry Hart has partnered with chemistry CROs in the United States, Canada, Europe, and Asia to bring the skill set needed to a program at the best possible price. Depending on the needs of a specific program an integrated chemistry CRO strategy can be implemented.

 

Intellectual Property Assessment: Patent writing, patentability and freedom to operate, due diligence

Due Diligence:

Evaluate the Intellectual Property landscape around a small molecule asset to verify the suitability to prosecute a chemical series or in-license a compound class.

Patentablility and Freedom to Operate:

Together with a qualified Patent Agent, or Patent Attorney, Innovation Pathways can establish the freedom to operate and patentability of an invention, particularly as it relates to small molecule pharmaceutical development of a specific target.

Patent Writing:

Once a lead series has been identified a provisional patent needs to be filed. Innovation Pathways has extensive experience writing patents for pharmaceutically active small molecules.

 

Lead series optimization to identify a Clinical Candidate:

Coordinate the profiling of promising compounds for target specificity, in vitro metabolism, pharmacokinetics, pharmacology. Design molecular solutions to issues encountered during in vitro and in vivo evaluation of compounds. Identify a scalable, synthetic route to supply GLP material needed for IND enabling toxicology experiments.

in vitro assessment of compounds:

The potency, selectivity and in vitro ADME evaluation of small molecules can be carried out in a capital efficient fashion

in vivo assessment of compounds:

Screening Pharmacokinetics (iv and PO, single dose) can be carried out or integrated with a biological end point to achieve a preliminary PK/PD study

 

Pharmacology and IND enabling toxicology:

in vivo pharmacology:

Innovation Pathways has experience coordinating pharmacology models in CNS, oncology and fibrosis indications. The cost of the pharmacology model depends on the complexity of the model and number of companies that provide the service. Tumor xenograft models can be carried out in a cost effective fashion. (vehicle, positive control, single dose of compound). Experiments can be expanded to include multiple doses of compound and PK/PD measurements.

Process Chemistry and API preparation for Toxicology and clinical trials:

A scalable synthetic chemistry route for the API must be identified to prepare material for IND enabling toxicology. In addition to preparing material on scale the necessary CMC issues must be addressed to ensure a smooth toxicology evaluation and transition into human clinical trials.

Toxicology:

Innovation Pathways has expertise to manage fourteen day and 28 toxicology studies in rodents. Relationships with outside vendors can be used to evauate compounds in higher species.

 

Clinical Trials:

Innovation Pathways does not manage or design clinical trials. Separate consultants are required for this aspect of drug development.

 

Partnering:

Most licensing deals occur before Phase I or Phase II clinical trials. Innovation Pathways looks to build value in the asset to support partnering activities at the pre-clinical stage.