Preclinical Development Inquiry

The preclinical trial of therapy against Alzheimer’s disease (AD) is an essential and complex step. It functions as a bridge between candidate discovery and clinical development since it constantly provides us with new information on pieces of the complex AD puzzle. Analysis of this information is likely to reveal patterns of pharmacological interactions instead of the single potential drug target. A group of well-trained, knowledgeable medicinal biochemists in Alzheimacy with decades of experience in preclinical research are willing to work with leaders and scientists from academia, pharmaceutical and biotechnology companies around the world to further develop more promising and stringent therapeutics for AD.

Target Discovery

Up to now, there is still no evidence to identify the exact cause of AD, despite the widely accepted hypothesis of the accumulation of the protein amyloid in the brain. Herein, identifying a target is essential for your novel AD treatment. Moreover, in early drug discovery pipeline, target discovery, including identification, characterization, and validation, is a critical process that can’t be ignored. Our capabilities in target discovery include:

  • Whole Genome Sequencing
  • Computer-aided Target Identification and Validation
  • Gene Expression Profiling
  • Natural Bioactive Compound Target Identification
  • Gene Manipulation
  • Structure Determination
  • Functional Analysis
  • In Vivo Target Validation
  • Cell Wall Targets Identification
  • Identification of Biomarkers by ORFeome Phage Display

Hit Identification

Medications for AD, no matter chemical ones or biological ones, are extremely restricted due to a variety of factors. Under such conditions, identifying novel alternatives to more efficiently target the active sites with less adverse effects tends to be urgent. Hit identification is a procedure to identify the binding of right small molecules with the targets and relative function modification. Starting hits with high-quality ones makes AD drug progress from preclinical to clinical faster as well as lower attrition rates. Our capabilities in hit identification are spread over all disciplines as follows:

  • Compound Libraries
  • Antibody Discovery
  • High Throughput Screening
  • Fragment-Based Screening
  • Phenotypic Screening
  • Secondary Screening

Hit to Lead

It is an unmet clinical need and an underlying driving motivation for the development of effective AD therapeutics on account of its severe impair to human health. Hit to lead, also recognized as lead generation, is an early stage in drug discovery to transform active hits with some liabilities to promising lead compounds that are potential to become an approved drug. Our techniques for the hit to lead are listed below:

  • Hit Characterization
  • Developability Assessment of Biopharmaceutical Candidates
  • Molecular Engineering
  • Antibody Expression
  • In Vitro Pharmacodynamics

Lead Optimization

The initiative design of selective compounds for the treatment of AD without undesirable and potentially toxic side-effects is difficult and usually results in a postponement in reaching the clinical testing stage. Lead optimization is a complex and iterative process that translates new chemical entities (NCEs) into possible candidates with the lowest risk of failure in the latter critical stages of drug development at a short notice. Alzheimacy has prominent technical platforms and world-class medicinal chemistry team that is specialized in conducting lead optimization with the goal of disposing of your compound as a preclinical candidate to treat AD, including:

  • In Vitro ADME
  • In Vitro Toxicity Test
  • In Vivo PK Studies
  • Pharmacology and Pharmacodynamics Studies
  • Process Development

Pharmaceutical Preparation

The pharmaceutical preparation is a process to combine your AD therapy with the final clinical product, and it has become a significant part in preclinical evaluation within the field of pharmaceutical. Alzheimacy assists our clients to develop effective solutions with the purpose of avoiding unreasonable risks and eliminating delays of your AD therapies into clinical phase trials. Our integrated capabilities in pharmaceutical preparation include:

  • API Production
  • Process Scouting and Optimization
  • Scale-up
  • Impurity Characterization and Management
  • Reference standard preparation and characterization
  • Quality Control
  • Pre-formulation Development
  • Formulation Development

Pharmacological and Pharmacodynamics Investigation

Currently, animal models mimicking human diseases play significant roles in non-clinically characterizing the pharmacology and pharmacodynamics of therapies towards AD to forecast the possible adverse responses of medications in humans. Alzheimacy has superior pharmacological and pharmacodynamics conditions by properly designing and employing animal models to facilitate therapy development on AD, including:

  • Customized Models
  • Popular Models
  • Disease Models
  • In Vitro Pharmacology

Pharmacokinetics Study

The pharmacokinetics of drugs in the central nervous system of AD patients is greatly affected by protein binding, drug efflux transporters, and physicochemical properties. Our capabilities in pharmacokinetics study cover:

  • Protein Binding Assay
  • Metabolic Stability
  • Metabolite Identification
  • Permeability Assays
  • Pharmacokinetics Assays
  • Dose Response Assessment
  • Interspecies Scaling
  • PK/Bioanalysis for the Samples
  • Pharmacokinetics Disease Models
  • Toxicokinetic Study

Safety Assessment

The drug safety profile is a crucial indicator to determine whether the new therapies could enter the final clinical trials and final market approval, and also a necessary parameter to be tested. Alzheimacy aims to offer both non-GLP and GLP safety programs ranging from cytotoxicity to biopharmaceutical toxicology, thus further backing the initiation of AD therapeutics in clinical trials. Our safety assessment options include:

  • Pathology Study
  • Cytotoxicity Evaluation
  • Drug-Drug Interactions
  • In Vivo Toxicology
  • Biosafety Testing

If you are interested in learning more about the preclinical development of AD therapeutics, please feel free to contact us, and we are looking forward to working with you in the near future.