Target Identification and Validation
Upon bringing a target of interest to Innovation Pathways a small molecule discovery strategy is devised. Innovation Pathways has extensive experience in selecting libraries to screen; following up on library hits and de novo design of active ligands.
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
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.
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
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.
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 stability of small molecules can be carried out at a number of high quality vendors in the USA and overseas.
in vivo assessment of compounds:
Screening Pharmacokinetics (iv and PO, single dose) can be carried out for less the $3,000 per molecule at high quality vendors overseas.
Pharmacology and IND enabling toxicology:
in vivo pharmacology:
Innovation Pathways has experience outsourcing 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 for less than $10,000 (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 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.
IND enabling toxicology:
There are numerous high quality vendors in the USA that provide pre-clinical toxicology assessment of small molecules to support IND filing. A growing number of vendors overseas are competing for this market niche and have driven down the cost of executing an IND-enabling toxicology package. Innovation Pathways has relationships with USA based companies and overseas companies with an excellent histories in providing IND-enabling toxicology services.
Innovation Pathways does not manage or design clinical trials. Separate consultants are required for this aspect of drug development.
Most licensing deals occur after Phase I or Phase II clinical trials. Innovation Pathways will support partnering activities through building a data package based on the experimental program that highlights the unique selling point(s) of that asset.