Join Medicilon at the Applied Pharmaceutical Analysis (APA) 2024

Applied Pharmaceutical Analysis (APA) 2024

We are excited to announce that Medicilon will exhibit at the Applied Pharmaceutical Analysis (APA) 2024 in Cambridge, MA. We are happy to meet you in person to discuss how our services and capabilities can support your research and expedite your drug discovery and development activities.

Dr. Peggy Teng, Executive Director BD Operations of MEDICILON USA CORP., will give be a speaking at 2:25 - 3:05 local time on October 8. We sincerely invite you to visit us at booth #3!

Date: October 7-9, 2024

Location: Bristol Myers Squibb, Cambridge, MA

Medicilon Booth #3

About Applied Pharmaceutical Analysis (APA)

Applied Pharmaceutical Analysis (APA) was formed in 2004 by The Boston Society (a 501(c)3 non-profit) as an industrially-focused and highly interactive forum on Bioanalysis in Drug Discovery, Biotransformation and Regulated Bioanalysis which meets annually in September. Each year different scientific leaders meet regularly to help plan a solid agenda based on cutting edge technologies and best practices of Bioanalysis and Biotransformation of Drug Discovery and Development. This group is open to all interested scientists.

APA 2024 Sessions

❖Regulated Bioanalysis Workshop

Session I: Regulatory and Industry Perspectives on M10 Implementation

Session II: Advances in Sampling Strategies and Drug Delivery Innovations

Session III: Advances in Drug Modalities and Emerging Technologies for Characterization

Session IV: Innovation Junction - Bridging Science and Solutions in Pharma

❖Discovery Bioanalysis and New Technologies Workshop

Session I: Emerging Analytical and Bioanalytical Platform Technology

Session II: Novel Strategies to Advance Biotherapeutic Development

Session III: Innovation Junction - Bridging Science and Solutions in Pharma

Session IV: Recent Case Studies to Support New Modalities

❖Mechanistic ADME Workshop

Session I: Role of NonCYP enzymes in DDI

Session II: PK/PD Challenges of New Modalities: ADCs, in vivo Gene Therapies, and PROTACs

Session III: The importance of tracking missing metabolites/new technologies (covalent drugs)

Session IV: New Approaches to in Vitro ADME Assays for Improved Drug-Drug-Interaction and Clearance Predictions

Medicilon DMPK & Bioanalysis Services

DMPK (Drug Metabolism and Pharmacokinetics) considers how the drug is metabolized and processed by the body. DMPK services help support drug developers in understanding the Absorption, Distribution, Metabolism, and Excretion (ADME) processes of compounds or drugs. Pharmacokinetics (PK) is the study of the time course of the ADME of a drug, compound or new chemical entity (NCE) after its administration to the body. ADME test results can be used to predict how the drug will behave in the body and to assess its potential for drug-drug interactions (DDIs) with other drugs. Bioanalytical support plays a vital role during the lead optimization stages. Bioanalytical tools can play a significant role and impact the progress in drug discovery and development. Dramatic increases in investments in new modalities beyond traditional small and large molecule drugs, such as peptides, oligonucleotides, cell and gene therapy, mRNA, PROTAC and XDC, necessitated further innovations in bioanalytical and experimental tools for the characterization of their ADME and PK properties.

Gain access to an integrated network of facilities, including DMPK R&D centers across China and the United States. Medicilon’s DMPK&BA department offers a full range of discovery screening, IND-enabling and clinical drug metabolism, pharmacokinetic platforms and services in the following areas: in vitro ADMET, in vivo PK, MetID, Radiolabeled DMPK/ADME, BA, and non-GLP Tox services for both small, large molecule and new modality drugs such as proteins, antibodies, peptides, oligonucleotides, cell and gene therapy, mRNA, PROTAC and XDC. We have all common laboratory animal species such as non-human primates, dogs, minipigs, mice, rats, and rabbits available.

Additionally, Medicilon boasts extensive experience in PK studies of ophthalmic drugs and inhaled drug delivery systems, encompassing a range of animal species such as rodents, rabbits, dogs, and monkeys. We offer a variety of delivery methods to accommodate the diverse requirements of drug studies during the preclinical phase.

In vitro ADMET

❖Liver microsome / S9 / Hepatocyte stability

❖CYP450 enzyme inhibition & TDI

❖CYP450 enzyme induction

❖Enzyme phenotype analysis

❖Plasma protein binding

❖Plasma (serum) stability

❖In vitro MetID and metabolic pathways

❖GSH-trapping

❖Whole blood / plasma distribution

❖Permeability and efflux

❖Transporters

❖(Pgp/BCRP/OATs/OCTs/OATPs/MATEs/BSEP)

❖BBB penetration,Kp,uu

❖hERG

❖Mini-Ames

In Vivo PK & Non-GLP Tox              

❖Species：Mouse (ICR, C57, balb/c, SCID, Nude mouse), Rat (SD, Wistar), Guinea pig, Mini-pig, Rabbit, Canine (beagle dog), Cynomolgus monkey

❖Administration Routes: Intravenous (IV), Oral (PO), Subcutaneous (SC), Intramuscular (IM), Intraperitoneal (IP), Topical, Transdermal, IT et

❖Dose Strategies: Single, multiple and cassette dosing

❖Serial blood microsampling

❖In vivo metabolite identification and quantitation

❖Tissue distribution

❖Mass balance with excretion

❖Pre-formulation screening

❖PK/PD & human PK modeling

❖Tox, MTD, DRF

❖¹²⁵I/¹⁴C/³H labeled isotope drug metabolism and mass balance studies

❖Surgical techniques: Venous cannulation, biliary cannulation, infusion pump, liver/muscle biopsy and implantation

#APA2024 #ADME #PK #DMPK #Bioanalysis

Meet with Medicilon

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