Industry Practice

Our firm specializes into the Life Science and Drug Development market with an even more specific focus into the Contract Research and Contract Manufacturing marketplace CRO’s, CMO’s, SMO’s and single specialty providers. Our experience and relationships in drug development from discovery through commercialization has positioned us to be one of the top Executive Search Firms in this industry, and some of our core strengths include:

DISCOVERY

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 a 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 (“hits”) and that will eventually lead to them becoming drug candidates.

Discovery Positions
  • Analytical Services
  • Antibody Discovery
  • Analytical Chemistry
  • Biologics
  • Discovery Biology
  • Cell and Protein Production
  • Compound Management
  • DMPK
  • Discovery Biology
  • Hit Identification
  • High throughput screening
  • Immunoassays & Biotherapeutics
  • Proteomics & Metabolomics
  • Preclinical Bioanalytical
  • Pre Formulation & Material
  • Protein Science
  • Structural Biology
  • Safety Assessment
  • Toxicology
  • Target ID & Validation
  • Formulation Development

 

PRECLINICAL

Pre-Clinical is the 2nd stage in the drug development process, in which up to 250 drugs that passed through Discovery are tested in-vitro (test tube) and then in-vivo (animal studies), following 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 IND application before advancing to clinical, human trials.

Preclinical Positions
  • Animal Models and Target ID and validation
  • ADME
  • Bioalalytical Biologics
  • Bioanalytical Mass Spec
  • DMPK
  • Drug-drug interaction
  • In Vitro & In Vivo Pharmacology
  • Formulation Development
  • QA/QC
  • Toxicology studies

 

EARLY PHASE CLINICAL 

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 in a group of approximately 20-100 generally healthy human patients using PV methods.

Phase IIA is primarily focused on the dosing (Phase IIa) and effectiveness (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.

Early Phase Clinical Positions
  • Adaptive Design Studies
  • Bioavailability
  • Bioequivalence
  • Biosimilars
  • Clinical Bioanalysis
  • Central Laboratories
  • Clinical Biostatistics
  • Clinical Monitoring
  • Clinical Pharmacology
  • Clinical Data Management
  • Cardiac Safety ECG Monitoring
  • Drug Drug Interaction
  • First in Human
  • Phase I/IIa and Early Clinical Trials
  • Patient Recruitment
  • Patient Population Studies
  • Phase II/III Clinical Trials
  • Pharmacokinetics/Pharmacodynamics
  • Precision Medicine
  • Safety & Pharmacovigilance
  • Single Ascending Does (SAD)
  • Regulatory Affairs
  • Multiple Ascending Dose (MAD)

LATE PHASE CLINICAL

Phase III trials involve a much larger and diverse group of affected patients, with approximately 1000-5000 receiving the drug. This phase is the longest and costliest, is key in determining the drug’s safety and effectiveness and provides the basis for labeling instructions. 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).

Late Phase Clinical Positions
  • Adaptive Design Studies
  • Biostatistics
  • Clinical Bioanalysis
  • Central Laboratories Clinical Monitoring
  • Clinical Data Management
  • Cardiac Safety ECG Monitoring
  • Data Management
  • Functional Service Providers
  • Feasibility
  • Medical Monitoring
  • Patient Recruitment
  • Project Management
  • Precision Medicine
  • Protocall Development
  • Regulatory Affairs
  • Regulatory Writing
  • Risk-based Monitoring
  • Site Management
  • Safety & Pharmacovigilance

 

MANUFACTURING

A GMP (Good Manufacturing Practice) is a process the ensures products are consistently produced and controlled through quality standards. The is goal is to minimize risks involved in any bio-pharmaceutical production that can not be extinguish through testing a final product.

GMP (Good Manufacturing Patrice) completes all aspects of the productions cycle starting from materials, premises and equipment to the training and quality control of the staff.  Significant details within written procedures are essential for each process that could impact the quality of the finished product. Systems to provide documented evidence of the correct procedures are consistently followed at each step in the manufacturing process.

Manufacturing Positions
  • Advanced Chemical Synthesis
  • Antibody Drug Conjugates
  • API Development and Manufacturing
  • Cell therapy
  • Commercial Manufacturing
  • Clinical Trial Material’s
  • Drug product
  • Drug substance
  • Dosage form development and manufacturing
  • Formulation Development
  • Fill & Finish
  • Generic API’s
  • Highly potent APIs
  • Mammalian biopharmaceuticals
  • Microbial fermentation
  • Process development/Validation
  • Packaging, labeling, logistics