Cheah (Charles) Oo

Preclinical DMPK & Clinical Development

About

As a nonclinical & clinical development/clinical pharmacology drug developer familiar with all phases of drug development, my primary objective is to optimize drug development programs and secure regulatory approvals in both the USA and global markets. With 30 years of hands-on experience, I apply scientific principles and model-based drug development methods to design, execute, and interpret clinical trials for biologics, small molecules, and combination drugs. These trials involve navigating the 505(b)(1, 2, or j) and 351(a or k) approval processes, as well as expedited development and review pathways, including orphan drug designations. My mission extends beyond the lab: I aim to advance the practice of science and facilitate translation of innovative therapies to patients. In addition to my expertise in drug development, I am well-versed in developing and evaluating prescription digital therapeutics—software-based interventions that deliver personalized, evidence-based treatment for various conditions. My experience in team leadership. project resources, and portfolio management enables me to empower team members, align with project missions, and prioritize assets while identifying strengths and weaknesses to enhance market competitiveness. As a registered pharmacist, a diplomate of the American Board of Clinical Pharmacology (Applied), and a fellow of the American College of Clinical Pharmacology, I have track records on my contribution. My role on 3 editorial review boards and my published articles on various drug development topics testify passionate commitment to advancing pharmacotherapies.

Country

United States

City

Morris Plains

Industry

Biotechnology

Skill

Clinical Development, Clinical Pharmacology, Translational Medicine, Drug Development, Clinical Research, Pharmaceutical Research, Biomarkers, Pharmacology, Clinical Trials, Pharmacokinetics, Drug Discovery, IND, Drug Metabolism, CRO, Oncology, Pharmacodynamics, FDA, Pharmaceutical Industry, Pharmaceutics, U.S. Food and Drug Administration (FDA)

Experience

Preclinical DMPK & Clinical Development

SunLife Biopharma LLC

2015 - Present · 11 yrs

FTE/part-time; Strategize drug development in nonclinical (discovery to IND enabling studies), & clinical (Phases 1 to 4 & launching) of small molecules, biologics (peptides, mAbs, multi-specific antibodies, antisense oligonucleotides, ssDNA/RNA, siRNA & cell therapies); optimize dosing of special population; model & simulation. • Major projects: solid & hematological tumors, multispecific mAbs, orphan drugs & neurodegenerative diseases. • Supported companies in US & China for drug development; performed gap analysis of development plans. • Clinical development of digital health and digital therapeutics.

Senior Consultant

Nuventra Pharma Sciences

2019 - 2019

Adjunct Professor

Fairleigh Dickinson University

2018-7 - 2018-12 · 6 mos

Greater New York City Area

Scientific Director, Janssen China (Full Time)

Johnson & Johnson Innovative Medicine

2017-4 - 2018-6 · 1 yr 3 mos

Shanghai, China

Scientific overview of all projects; clinical pharmacology lead; mentor junior staff

Senior Director (Full Time)

Asubio Pharma Co., Ltd.

2004-8 - 2015-2 · 10 yrs 7 mos

Edison, NJ

Early transition development in the 1st-in-human, 1st-in-class, and best-in-class medications in a small and fast-paced biopharmaceutical entity: • Provided hands-on medical, scientific and regulatory expertise in drug development; • Prepared IND documents for submission, developed project plan, budget & timelines; • Consulted KOLs, & managed CROs for assay laboratories & report writings;

Associate Director (Full Time)

Sanofi

2002-8 - 2004-8 · 2 yrs 1 mo

Bridgewater, NJ

Enhanced pharmacokinetic-pharmacodynamics roles in clinical development; design & coordination of dose regimen & drug interaction studies in a multinational company: • Used biomarkers to guide transition to clinical drug development; • Led a DMPK matrix team for transition from nonclinical phase & conduct of studies; • Contributed to the development of Aubagio® for the relapsing forms of multiple sclerosis.

Associate Director, Hoffmann La Roche Inc. (Full Time)

Roche

1999 - 2002 · 3 yrs

Nutley, NJ

Collaboration with international sites (Palo Alto, UK Welwyn Garden City, & Basel); participation of submission of CTDs for NDA/MAA, label negotiations, launching of Tamiflu®: • Represented clinical pharmacology in Life Cycle & in FDA, EMA, MHLW interactions; • Led clinical pharmacology teams in Phases II, III, & IV projects; • Assisted in successful registration of Tamiflu® for adult & pediatric indications.

Clinical Science Manager, Medical Affairs, Roche laboratory, Inc.

Roche

1996 - 1999 · 3 yrs

Nutley, NJ

Phases III-IV clinical investigations (new formulations, new indications, dosing frequency,drug-drug interaction, dose finding, & ADME studies) for business rationales, market differentiation and regulatory submissions: • identified clinical sites, managed operation, located laboratory/assay CROs; • Wrote clinical protocols, conducted data analyses, & wrote clinical reports; • sNDAs/NDAs (Accutane®, Versed®, Rocaltrol®, Fortovase®, Rocephin®, & Klonopin®); • Reported/presented study results, & involved in marketing activities.