Madd Ox Consulting

Madd Ox Consulting LLC · CMC · Cell & Gene Therapy · Biologics

Tailored. Balanced. Together.

Independent CMC consultant supporting developers of cell & gene therapies, biologics, and other pharmaceutical products, from preclinical through commercial.

Get in Touch Explore Services

Madd Ox Consulting specializes in 4 core areas of CMC development:

Services

How Madd Ox Consulting Can Serve You

Four core areas of service to support you throughout your product’s lifecycle.

01

Technical/Scientific Development Services
  • Analytical method development, qualification, and validation
  • Process development, qualification, and validation
  • Process and materials control strategy development
  • Formulation development
  • Product specification development and Justification of Specifications
  • Analytical comparability
  • Extractables and leachables (process train and container/closure systems)
  • Viral clearance evaluation and validation
  • Raw material qualification and adventitious agents risk assessments
  • In-use stability and compatibility
  • Forced degradation and stability
  • Biophysical, physicochemical, and structural characterization
  • Impurity characterization and qualification
  • Container/closure integrity
  • Sterile filter validation
  • Disinfection and sterilization method qualification and validation
  • Aseptic process qualification
  • Shipping validation
  • Technical writing (protocols, reports)
02

Technical Operations Services
  • Requests for proposals from prospective vendors
  • Evaluation and selection of prospective vendors
  • Contract/QTA review
  • Project management and oversight of outsourced activities
  • Direct and execute CMC development strategies at outsourced vendors
  • Supply chain maps and supply chain management
03

CMC Regulatory Affairs Services
  • Manage regulatory filings and submissions
  • Develop, implement, and direct CMC regulatory strategies
  • Health authority interactions (Type A/B/C/D meetings with FDA; Scientific Advice)
  • Module 2.3 and Module 3 authoring, preparation, and compilation
  • Original applications (INDs, CTAs, DMFs and other master files, NDAs, BLAs, MAAs, NDSs)
  • Responses to Requests for Information (RFIs) or Information Requests (IRs)
  • CMC Information Amendments
04

cGMP Compliance & Quality Services
  • On-site vendor audits/inspections
  • Batch record review and product disposition
  • Product complaint, deviation, and out-of-specification investigations
  • Compliance action remediation support (e.g., 483 observations, Warning Letters, Consent Decrees, etc.)
  • Quality Management System build out and SOP authoring
  • Due diligence and compliance gap assessments
  • cGMP and Quality Systems requirements for:
    • US (21 CFR Part 11, 210, 211, 600, 610, 820)
    • EU (EudraLex Volume 4, Regulation (EU) 2017/745)
    • Canada (Part C, Division 2; GUI-0001, GUI-0014)
    • Other international guidelines and standards (e.g., ICH Q7/9/10, ISO 13485)

About

Meet Jaymeth

Jaymeth Maddox, principal consultant at Madd Ox Consulting
Jaymeth Maddox · Principal Consultant

A seasoned consultant with 16+ years of experience formulating, executing, and directing CMC development, operations, and regulatory strategies to support product development from the preclinical through to successful marketing authorization and postapproval lifecycle management. I have broad experience developing drugs, biologics, cell and gene therapies, other advanced therapies, medical devices, and combination products across many of the major global markets (US, EU, Canada, RoW).

Focus
CMC, Cell & Gene Therapy, Biologics
Experience
16+ years, all phases of development, numerous product classes
Regions
US, EU, Canada, and RoW

The Madd Ox Approach

How I Work

Tailored

Each team has its own unique mix of resources, goals, ambitions, and needs, let alone the unique challenges presented by the complex products you are developing. Add in that these factors are continuously changing as the industry and regulatory authorities evolve. There is no one size fits all solution to product development. I use my extensive experience, from working on teams of all shapes and sizes, and products across a wide range of modalities, routes of administration, indications, and complexities, to tailor product development strategies and solutions that are the perfect fit for you.

Balanced

Product development requires a constant balancing act between expenditure of resources (time, money, human capital) while ensuring that you will meet the necessary quality and regulatory standards. Some decisions in product development are black and white, but the vast majority lie in shades of gray. I work closely with you and your teams to assess your goals, resources, and risk tolerance. Then, I chart the most efficient path to success, that balances complying with quality and regulatory expectations without wasting your precious resources.

Together

I am a firm believer that it takes a team, and the whole team, to accomplish great things. Considering and building upon diverse and divergent perspectives is the best way to drive the creative solutions necessary to overcome the challenges we’ll face together. Once the rubber meets the road, we must act as a unified front to tackle these challenges. I listen carefully, debate vigorously, and once decisions are made, act together as one Team.

Expertise & Track Record

Areas of Expertise

Product Classes
  • Advanced therapies
  • Cell and gene therapies
  • AAV gene therapies
  • Somatic cell therapies
  • Microbial vector gene therapies
  • Tissue-engineered medicinal products
  • Exosome and secretome products
  • Live-attenuated viruses
  • Oncolytic viruses
  • Virus-like particles
  • Live biological products
  • Anti-body drug conjugates
  • Recombinant therapeutic proteins
  • Synthetic peptides
  • Oligonucleotide products
  • A variety of small molecule product classes

Dosage Forms
  • Solutions and suspensions (sterile and non-sterile)
  • Lyophilized (sterile and non-sterile)
  • Ophthalmic
  • Topical gels/creams/emulsions
  • Solid oral, including modified-release, delayed-release, sustained-release, and immediate-release

Routes of Administration
  • Parenteral
  • Intraventricular
  • Intraparenchymal
  • Intrathecal
  • Various ocular/ophthalmic
  • Intranasal
  • Inhalation
  • Interstitial
  • Intratumoral
  • Topical
  • Transdermal
  • Oral
  • Various others

Combination Products
  • Drug-drug
  • Drug-device
  • Single-entity
  • Co-packaged
  • Cross-labeled
  • Pre-filled syringe
  • Topical ophthalmic delivery systems
  • Nasal/inhalation administration systems
  • Transdermal administration systems
  • Imaging/visualization systems
  • Light/sound-based “activation” systems

By the Numbers

  • 6New Drug Applications (NDAs) approved in US
  • 2Biologics License Applications (BLAs) approved in US
  • 3Marketing Authorization Applications (MAAs) approved in EU
  • 3New Drug Submissions (NDS) in Canada
  • 30+Meetings with regulatory authorities in the US and EU
  • 25+Original Investigational New Drug Applications (INDs) cleared in US
  • 15+Original Clinical Trial Applications (CTAs) approved in the EU and Canada
  • 50+Establishment inspections/assessments performed (e.g., vendor qualification, mock-regulatory authority, due diligence)

Contact

Contact Me

Interested in working together? Complete the form below or reach out to me directly and I will respond within 1-2 business days.

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