BioHighland Consulting LLC provides scientific, technical and strategic consulting to the biotech and pharmaceutical business at all stages of drug discovery and development
Peter R Young is a former biotech executive with hands on experience in multiple platforms (small molecules, peptide and antibodies), stages (target validation, candidate selection, preclinical development, early clinical/ translational studies) and therapeutic areas (cancer, autoimmune, metabolic, cardiovascular, renal, pulmonary, CNS, anti-viral) as evidenced by multiple regulatory drug filings, publications and patents.
At BioHighland Consulting LLC, specific consulting projects are discussed and tailored to each client's needs and budget
Hands-on knowledge of underlying biology, in vitro/in vivo models for compound progression, biomarker discovery and clinical designs for testing new drugs.
Examples include Neurodegeneration, Oncology, Immunological Diseases, Hematopoiesis/Renal, Infectious Disease, Cardiovascular/Metabolic and Pulmonary
Discovery and characterization of targets
Design and Implementation of drug discovery screens
Discovery and implementation of biomarkers in clinical trials.
Planning and management of research project priorities and timelines
Incorporation of patent strategy into research priorities
Review and editing of non-clinical sections of IBs, INDs, orphan drug applications and translational components of clinical protocols and CSRs (submitted multiple examples to Regulatory bodies)
Review and editing of papers for submission to journals (Published > 120 papers in peer reviewed journals)
Review and editing of technical sections of patent applications (Inventor on > 40 issued US patents)
Review and editing of presentations for multiple audiences
Conduct of both in-and out-licensing opportunities in multiple therapeutic areas
Research to support testing of PIKfyve inhibitor in ALS
Design, IND submission and conduct of POC Phase 2 biomarker study of apilimod dimesylate (PIKfyve Inhibitor) in a genetic subset of ALS subjects (NCT05163886; https://clinicaltrials.gov/study/NCT05163886?term=NCT05163886&rank=1 ).
Wrote and obtained US and European Orphan drug status for apilimod dimesylate for ALS
Small molecule discovery and research directed at kinases (PIKfyve, BTK, mTOR) and epigenetic (HDACs, BET proteins) targets
Discovery and validation of PD biomarkers to support clinical trials.
Design and conduct of Phase I clinical trial of HSP90 inhibitor for AML (LAM-003: NCT03426605; https://clinicaltrials.gov/study/NCT03426605?intr=LAM-003&rank=1).
Support of Phase 2 clinical study of PIKfyve inhibitor in Non-Hodgkin’s lymphoma (LAM-002A: NCT02594384; https://clinicaltrials.gov/study/NCT02594384?intr=LAM-002A&rank=2
Measurement of HDAC inhibitor target engagement biomarkers in Phase I studies to support dose selection (abexinostat: NCT00473577; https://clinicaltrials.gov/study/NCT00473577?term=CRA-024781&rank=1)
Ibrutinib/Imbruvica for hematopoietic cancers (approved for MCL, SLL/CLL, WM, MZL cancer)
Small molecule programs targeting cytokines/chemokines (IL-1, IL-5, IL-8), kinases (p38MAPK, BTK), epigenetics (BET) and proteases (cathepsin S)
Identification and implementation of clinical biomarkers.
Measurement of cathepsin S inhibitor (CRA-028129) target engagement biomarkers in Phase I study to support dose selection
Mepolizumab/Nucala for severe asthma and eosinophilic granulomatosis.
Programs targeting EPO, TPO and G-CSF mimetics (small molecule, peptide and/or agonist antibody).
Translational studies to support clinical programs (peginesatide, Phase 3; NCT00372489)
Eltrombopag (Promacta); Peginesatide (Omontys).
Programs to identify and/or evaluate small molecules targeting COVID-19 (PIKfyve) and Hepatitis C (Reverse transcriptase, protease, N5A).
Design and conduct of POC Phase 2 trial of PIKfyve inhibitor for COVID-19 (LAM-002A: NCT04446377; https://clinicaltrials.gov/study/NCT04446377?intr=LAM-002A&rank=3
Young PR, Landrette S, Spirli C, Fandrick K, Gunel M. “Antiviral Compositions and Methods.” US20240189317
Programs in dyslipidemia and atherosclerosis targeting PPARalpha, FXR, BET, ACC and DGAT.
Preclinical studies to support clinical program in atherosclerosis (apabetalone (RVX-208); BET inhibitor) and role of cytokines in stroke.
Discovery of mTOR/DRR pathway that led to multiple uses including pulmonary applications
Program to discover Monoclonal Antibody to IL-5 for treating asthma
Design and implementation of translational measures to support clinical studies in peripheral hypertension and bronchiolitis obliterans of inhaled mTOR inhibitor (sirolimus)
Wrote and obtained orphan drug application for inhaled mTOR inhibitor in select lung diseases
Mepolizumab/Nucala for severe asthma
Discovered and/or characterized multiple novel genes and gene products (examples include cytokines, cytokine receptors, protein kinases, protein phosphatases, transcription factors, epigenetic regulators, proteases, DNA binders)..
Discovered, tested and implemented multiple biomarkers in preclinical animal models and clinical trials for target engagement, proof of mechanism and efficacy (examples include HDAC inhibitor, Cathepsin S inhibitor, BET inhibitor, PIKfyve inhibitor)
Peer Reviewed Literature
Patents
Patent Applications
Peer Reviewed Literature
Patents
Peer Reviewed Literature
Reviews
Patents
Peer Reviewed Literature
Patents
Peer Reviewed Literature
Reviews
Peer Reviewed Literature
Patent
Peer Reviewed Literature
Reviews
Patents
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Short Hills, New Jersey, United States
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