Discovery and Development of Small Molecules and Biologic Therapies RFP

The University of Texas MD Anderson’s (MD Anderson) Therapeutic Discovery Division (TDD) discovers and develops small molecules and biologic therapies for targeted cancer treatment in defined patient populations. As a result, this Request for Proposal (RFP) is to obtain Contract Research Organizations (CRO) who can assist in this process.

This RFP has been divided into four (4) sections each defined by unique Scopes of Work (SOW). Each CRO(s) may submit proposals for one or multiple sections of this RFP. However, in order for submissions to be considered, CROs must answer ALL QUESTIONS within that specific section of the RFP.

SOW 1: Synthesis of Medicinal Chemistry Compounds Fee for Service (FFS) - based

• Synthesis of compounds with specific structural motifs that can be used for biological screening.
• Development and optimization of synthetic routes for target compounds. Isolation and purification of synthesized compounds, including chiral separations as needed.
• Perform rigorous quality control measures to ensure each compound meets the defined specifications for purity, structure, and yield. These specifications are typically >98% pure for final compounds and >95% pure for key intermediates.
• Registration information in structure data file (SDF) format using enhanced stereochemistry (V3000).

SOW 2: Synthetic Medicinal Chemistry Support – Full-time Employee (FTE) - based

The Medicinal Chemistry team within TDD requires ongoing services from approximately 5 to 20 FTEs to support synthetic chemistry activities.

• Synthetic route scouting, problem solving and validation,
• Synthetic chemistry support from mg to multi-gram scale (up to 10 grams) of targeted final molecules designed by MD Anderson Medicinal Chemistry scientists,
• Chemical library generation via high-throughput synthesis & purification.

The conducting of Absorption, Distribution, Metabolism, and Excretion (ADME) / Pharmacokinetics (PK) studies may also be required to include but not limited to:

• In vitro stability (microsome and hepatocytes) assays,
• In vitro plasma-protein binding, solubility, Log D, permeability measurements,
• In vivo pharmacokinetic experiments (mouse, rat, dog and, if available, cyno PK) by various routes of administration,
• In vitro safety pharmacology studies such as cytochrome P450 (CYP) and potassium ion channel (hERG) inhibition and drug-drug interaction studies.

Deliverables

1. Provide each compound in the amounts defined by MD Anderson with >90% purity (by liquid chromatography-mass spectrometry (LCMS), 1H-Nuclear magnetic resonance (NMR), and High-Performance Liquid Chromatography (HPLC)).
2. Assumed productivity to be in the range of 40 reactions per chemist per month. It is acknowledged that the number of reactions is based on routine synthetic chemistry, and large-scale preparations or complex chemistry may negatively impact the number of reactions run.
3. All experimental procedures will be fully documented in notebooks, and experimental procedures will be written up in American Chemical Society (ACS) publication format and will be available electronically upon request and provided within two weeks of a request.
4. Weekly status reports containing all details and supporting information/compound characterization will be provided. This information will include data required for compound registration as defined by the MD Anderson project lead, in an SDF file format using enhanced stereochemistry (V3000).

MD Anderson is to receive all Supplier(s) Proposals by the RFP close date communicated within the SciQuest Sourcing Director tool.

Proposals and final HUB Plans submitted via telephone, fax, or electronic mail (email) will be rejected. Only those submitted via this tool will be accepted.

Pricing "must be" submitted in this MS Excel format. ANY OTHER FORMAT WILL BE REJECTED.

A Subcontracting Plan (SP) is **required** as part of Respondent’s Proposal. A proposal that does not include a complete Subcontracting Plan at the time of submission will be considered non-responsive and will not be evaluated.

MD Anderson's committee members, comprised of key personnel as well as Supply Chain professionals, will evaluate and score approved Proposals.

MD Anderson may select the Proposal(s) that offers the "Best Value" for the institution based on the published selection criteria, its evaluation ranking, and the terms of Texas Government Code 2155.074.