CLINICAL PHARMACOLOGY CONSULT COMPANY

Offering Professional Assistance for Your Drug Development Needs

CLINICAL PHARMACOLOGY CONSULT COMPANY

Offering Professional Assistance for Your Drug Development Needs

Welcome to XP Pharma Consulting

XP Pharma Consulting is a service provider that specializes in the design and implementation of clinical pharmacology-guided drug development strategies across various therapeutic areas, from early to late development and through registration.

XP Pharma Consulting uses pharmacokinetics (PK), pharmacodynamics (PD), and PK/PD modeling and simulation techniques to advance the understanding of drug properties, enhancing informed decision-making by the client at each stage of drug development.

Welcome to XP Pharma Consulting

How Can We Help?

Clinical Pharmacology integrated Drug Development

Clinical Study Strategy and Design

Clinical pharmacology development strategy
Study design and protocol development
Dose rationale and dose administration
PK and PD sampling schedule
Inclusion/exclusion criteria
Robust PK and PD analysis
Medical/Clinical monitoring
Clinical study report (CSR) and/or standalone PK report
Documents that are eCTD-publishing ready
Post-study update (if necessary) to clinical pharmacology strategy
Contribution to Pre-IND, Briefing document, IND/NDA modules’ writing
IB, Label and Safety update

Clinical Pharmacology Studies

First-In-Human (FIH), Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)
Proof of Concept and Larger Dose Ranging
Thorough QT/QTc (TQT), including C-QT analysis/modeling
Relative Bioavailability and Pivotal Bioequivalence
Drug-Drug Interaction (DDI)
Food Effect
Large Registrational Safety and Efficacy, to establish population PK and exposure-response (PK/PD)
Renal Impairment and Hepatic Impairment
Pediatric and Elderly
Site of Absorption
Radio-Labeled Mass Balance

Development and Regulatory Strategy

Regulatory strategy and integrated drug development across all phases, therapeutic areas, and patient populations (including pediatrics)
Regulatory strategy for multiple therapeutic modalities (small molecules, biologics, oligonucleotides, cell and gene therapy)
Dose justification, candidate selection, first-in-human, proof of concept, dose-ranging safety and efficacy studies, registration, and lifecycle management
Due diligence (asset evaluation) and gap analysis
Full-service Pre-IND, IND, NDA, BLA, and ANDA support
Interpretation of pre-clinical data as a guide for next steps in clinical pharmacology programs
Drug-drug interaction (DDI) waiver justifications
In vitro/in vivo transporter and DDI study guidance
Proactive risk management planning to identify and minimize development challenges
Review of clinical pharmacology data/decisions that impact late phase studies
Strategic planning for regulatory interactions associated with and without clinical pharmacology data
Interpretation of industry guidance documents for individual clinical pharmacology development programs

Regulatory Representation, Writing, and Submissions

Authoring clinical pharmacology modeling simulation sections in IND/NDA/BLA submissions (all modules), CTAs, PIP/PSPs, briefing documents, product labeling, information requests, PMR, PMC, etc.,
Participation in agency meetings (e.g., Pre-IND, EOP2)
CTD m.2.7.1, m.2.7.2 and key contributor to m2.5 (biopharmaceutics, clinical pharmacology, dose justification) and certain sections of m2.7.3 and m2.7.4
Investigator Brochure (IB) authoring and updates
Briefing documents
Clinical trial/clinical pharmacology study protocols and Clinical study reports (CSRs)
PK/PD, TK, and population PK reports

Scientific/Technical Writing, Manuscripts, and Communications

Model Informed Drug Development (MIDD)

Dose Translation, Rationale, and Justification

Calculating the clinical dose to inform:
- candidate selection, product profile, therapeutic index, formulation selection, drug supply, cost of goods, dose range for toxicology studies, assay development, and drug-drug interaction potential
Translating in vitro, non-clinical PK/PD data, and published controlled clinical study results to clinical dose strategies
- i.e., starting dose, dose escalations, dose cohorts, proof of concept and dose-ranging study designs, drug-drug interaction studies, etc.
Optimizing dose and dose frequency for specific populations
- infants, children, pregnant and breast-feeding women, elderly, patients with renal or hepatic impairment, and more
Providing comprehensive justification of the clinical dose(s) for indications, diverse patient characteristics, and various clinical scenarios for regulatory authority review

Pediatric Drug Development

Extrapolation to scale the previously established model describing the adult data to children based on body size, physiological differences, ADME, and disease features, as appropriate.
Using modeling and simulation to inform more efficient (i.e., parallel, fewer and/or shorter) pediatric studies by optimizing sampling and maximizing the information collected on a drug’s PK and PD in this population.

Bridging and Extrapolation Approaches

Modeling and Simulation

Pharmacometrics, Pharmacokinetics & Pharmacodynamics (PK/PD)

Data Management, Programming, and CDISC Dataset Creation

Bioequivalence/Bioavailability
Clinical Research Monitor Training for PK/PD Issues
Concentration-QT Dataset Generation
CRF and Database Structure Review for PK/PD Data
Dose Proportionality Assessment
Exposure-Response Dataset Generation
Interim PK/PD Data Review
PK Sampling Schedule Review
PK/PD Data Review Tactics
Population PK/PD Dataset Generation
Protocol and Study Design Review
Review of Electronic Edit-Checks for PK/PD Data

Noncompartmental PK Analysis (NCA)

Population Pharmacokinetics (popPK)

Population PK study design, including protocol and analysis plan development
NONMEM datasets preparation
Population PK model generation, development, and refinement
Identification & confirmation of predictive covariates
Modeling & simulation to support population PK/PD
Dose selection and justification
Exposure-response analysis
Concentration QT (cQT) modeling
Submission-ready population PK report writing

DMPK and Translational Drug Development

Drug-Drug Interaction (DDI) Strategy

Nonclinical PK, TK, and PD Analyses

Nonclinical Strategy, Study Design, and Analysis

Why Partner with XP Pharma Consulting?

XP Pharma Consulting supported multiple pharmaceutical companies. Our experiences and competency have been recognized by Record of Success, Publications, and Case Studies. You may check Testimonials provided by our clients.

XP Pharma provides you with quality services. Our consultants have more than two decades of experience and hold advanced degrees in their respective fields.

We are your trusted partner to help guide and support you during your drug development process. No matter what stage of the process is slowing you down, you can count on XP Pharma Consulting for accurate and dependable strategies.

Let XP Pharma Consulting be your go-to clinical pharmacology consulting company. Contact us today to learn more about our experiences and what we can do for you.

Testimonials

Clinical Pharmacology Strategy and Writing: “I enjoy working with XP Pharma Consulting. They can manage all aspects of clinical pharmacology projects. For example, XP Pharma supported us in the assessment of drug-drug interactions, integrated non-clinical and clinical evaluation of QT prolongation potential, application for a thorough QT study waiver, design of clinical pharmacology studies, interpretation of population PK and PK/PD modeling results, and scientific writing for regulatory documents”.

Senior Director-Clinical Pharmacology, Pharma Client

Population PK/PD Modeling &Simulation: “XP Pharma has played a significant role in supporting the early clinical development programs of two of our novel molecules. XP Pharma’s PK assessments and modeling have provided us with important information that has helped us to determine safe and optimal dosing and dosing regimens for our Phase 1 and 2 clinical trials”.

Executive Director ‐ Clinical Development, Pharma Client

Clinical Pharmacology Studies: “XP Pharma Consulting’s knowledge of FDA requirements around clinical pharmacology (drug‐drug interaction studies, CYP450 interaction studies) has helped us to design our Clinical Development plans more accurately by allowing us to incorporate these NDA required studies optimally”.

Executive Director ‐ Clinical Development, Pharma Client

Timely and Detailed Analysis. “XP Pharma is available on short notice and provides timely and detailed analyses. We continue to work closely with XP Pharma as our clinical development programs move forward”.

Executive Director ‐ Clinical Development, Pharma Client

Leading Edge Clinical Pharmacology Support: “XP Pharma Consulting provided leading edge clinical pharmacology and development advice and services that led to several successful IND approvals and the implementation of several clinical development programs. They have also assisted us on translational research programs at pre-IND to IND stage using state-of-the-art modeling and simulation tools”.

Director. Clinical Development, Pharma Client

“High Quality and High Science Plans: Dr. Zhang and her team engaged early and provided rapid, high quality, high science plans and analyses. We really appreciate all of their hard work and advice to our development program. We look forward to continued collaboration and hopefully more regulatory IND and NDA approvals in the months and years to come”.