Life Science Practice

Life Science & Drug Development

We partner with CROs, CDMOs, SMOs, E-Clinical, technology, specialty and full service providers to fill a range of positions from Associates to C-Level.

Drug Discovery is the initial stage (non-GLP) in the drug R&D process that aims to understand the nature and causes of a disease through identifying proteins known as “targets”, associated with the disease that are critical to the survival or spread of the disease-causing organism.  Through analyzing, testing, and re-testing tens of thousands of drug compounds, scientists and researchers seek to narrow these compounds to a select few that positively affect the disease target, often called “hits”, that will eventually lead to these compounds becoming drug candidates.

Drug Discovery Areas of Focus

  • Analytical Chemistry
  • Biologics
  • Compound Management
  • Computer-Based Design
  • Discovery Biology
  • Genomics
  • High Throughput Screening
  • Hit Identification
  • Large Molecule Research
  • Lead Generation
  • Lead Optimization
  • Ligand-Binding
  • Pre-Formulation and Material
  • Proof of Concept
  • Protein Science
  • Proteomics
  • Small Molecule Research
  • Structural Biology
  • Target Identification and Validation

Pre-Clinical is the 2nd stage in the drug development process, in which up to 250 drugs that passed through the Discovery stage are tested in-vitro (test tube) and then in-vivo (animal studies), adhering to Good Laboratory Practice (GLP) guidelines.  The goal is to identify up to 5 of the tested drugs that will be safe and effective enough to be submitted to the FDA through an Investigation New Drug (IND) application for approval before advancing to clinical, human trials.  

Pre-clinical Areas of Focus

  • ADME
  • Analytical Chemistry
  • Animal Models
  • Antibody Discovery
  • API Formulation
  • Bioanalytical Biologics
  • Bioanalytical Mass Spec
  • Biology
  • Cell and Protein Production
  • CMC Chemistry
  • DMPK
  • Drug-Drug Interaction
  • Formulation Development
  • Genotoxicity Studies
  • GLP
  • IND Application
  • In-Vitro and In-Vivo Pharmacology
  • In-Vivo Studies
  • Lead Compound
  • Metabolomics
  • PK/PD Studies
  • QA/QC
  • Regulatory Affairs
  • Safety Assessment
  • Toxicology Studies

Once a drug’s IND application has been approved, clinical trials begin on humans.  The drug is tested on increasing numbers of human patients over 3 phases (I, II, and III) of clinical trials following Good Clinical Practice (GCP) guidelines.  Generally-speaking, only 1 drug will survive the trials, be found safe and effective, and is submitted to the FDA through a New Drug Application (NDA) before it can be approved for market and commercialization (Phase IV).  

Phase I is the initial phase of clinical trials, often known as “first-in-man” studies, and is focused primarily on the drug’s safety, as it is tested on a group of approximately 20-100 generally healthy human patients using pharmacovigilance methods.  Single-ascending dose studies are first administered (Phase Ia) to small groups of patients before increasing to multiple-ascending dose studies (Phase Ib) new groups of patients.

Phase II is primarily focused on dosing studies (Phase IIa) and effectiveness studies (Phase IIb) of the drug, although safety continues to be monitored, and is generally administered and tested on approximately 100-500 patients affected by the disease or condition being targeted.

Phase I and Phase II Areas of Focus

  • Adaptive Design Studies
  • ADME
  • Bioanalysis
  • Bioavailability
  • Bioequivalence
  • Biosimilars
  • Cardiac Safety ECG Monitoring
  • Central Laboratories
  • Clinical Bioanalysis
  • Clinical Biostatistics
  • Clinical Data Management
  • Clinical Development
  • Clinical Monitoring
  • Clinical Operations
  • Clinical Pharmacology
  • Chemicals
  • Drug Safety
  • Drug-Drug Interaction
  • E-clinical
  • First in Human
  • GCP
  • Medical Affairs
  • Multiple Ascending Dose (MAD)
  • Patient Population Studies
  • Patient Recruitment
  • PK/PD
  • Early Clinical Trials
  • Precision Medicine
  • Process Development
  • QA/AC
  • Regulatory Affairs
  • Risk-Based Monitoring
  • Safety & Pharmacovigilance
  • Single Ascending Dose (SAD)

Phase III trials involve a much larger and diverse group of affected patients, with approximately 1000-5000 receiving the drug (Phase IIIa), is the longest and costliest, is key in determining the drug’s safety and effectiveness, and provides the basis for labeling instructions (Phase IIIb).  Upon successful completion of Phase III, a New Drug Application (NDA) is filed with the FDA and, if approved, can then be brought to market with ongoing surveillance and analysis (Phase IV).

Phase IV trials take place after the FDA approves the drug’s marketing and commercialization.  Here, trials are conducted to identify and evaluate the drug’s long-term effects for larger number of patients, which allows the new drug to yield more information about its efficacy, safety, and side effects.

Phase III and Phase IV Areas of Focus

Adaptive Design Studies
Bioanalysis
Biostatistics
Cardiac Safety ECG Monitoring
Central Laboratories
Clinical Bioanalysis
Clinical Data Management
Clinical Monitoring
CMC
Data Management
Feasibility
Functional Service Providers
GCP
Late Clinical Trials
Medical Monitoring
Patient Recruitment
Physician Recruitment
Post-Market Surveillance
Precision Medicine
Project Management
Protocol Development
Regulatory Affairs
Regulatory Writing
Risk-based Monitoring
Safety & Pharmacovigilance
Site Management

Manufacturing of drugs and their packaging begins in Pre-Clinical on a small-scale, is ramped up to a large-scale throughout the Clinical stage, and is a different process from drug to drug.  Each manufacturing facility must meet strict FDA guidelines for Good Manufacturing Practices (GMP), which is the part of quality assurance that ensure products are produced and controlled to the highest standards in facilities, equipment, and methods.  

Manufacturing Areas of Focus

  • Advanced Chemical Synthesis (ACS)
  • Antibody Drug Conjugates
  • API Development and Manufacturing
  • Cell Therapy
  • Clinical Trial Materials
  • Commercial Manufacturing
  • Dosage Manufacturing
  • Drug Product
  • Drug Substance
  • Fill & Finish
  • Generic API’s
  • Good Manufacturing Practice (GMP)
  • Highly Potent API’s
  • Labeling
  • Logistics
  • Mammalian Biopharmaceuticals
  • Microbial Fermentation
  • Packaging
  • Peptides
  • Peptides
  • Process Development and Validation

Positions of Specialty

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C-Level, Vice, President, Director, Associate