Rapid Microbiology Consulting and Training

Are you considering implementing rapid micro methods but don't have the in-house expertise to champion these efforts? Are you designing a new RMM technology and want to develop a robust strategy for commercialization? Concerned about regulatory impact and return on investment? Our RMM expert can provide guidance and support in all of these areas, whether you are a supplier of new microbiology technologies or an end-user.

Consulting with End-Users

Dr. Miller teams with RMM customers to coordinate the initial assessment of rapid micro methods, recommends the best technology, and creates feasibility and validation test plans, comparability protocols and Quality Expert Reports. He has developed extensive return on investment (ROI) models for rapid micro methods and will work with your senior management and finance groups to gain approval for RMM implementation. Dr. Miller provides an in-depth understanding of FDA and EMEA regulatory expectations for RMM validation and implementation, and can act as your liaison when meeting with regulatory agencies and competent authorities.

  • Create a corporate rapid method strategy and communicate to senior management
  • Review current conventional methods and identify appropriate RMM technologies as alternatives
  • Develop and manage feasibility studies (in-house or with the technology vendor)
  • Prepare and support the execution of a comprehensive validation plan, including DQ, IQ, OQ, PQ and equivalency studies that are aligned with USP <1223>, Ph. Eur. 5.1.6 and PDA Technical Report #33
  • Formulate regulatory acceptance strategies and discuss with your Regulatory Affairs department
  • Establish a relationship with relevant Regulatory Agencies and set up initial strategy meetings
  • Develop Return on Investment (ROI) and business justification models
  • Compose FDA comparability protocols and EMA Expert Reports
  • Construct and deliver a comprehensive and holistic in-house training program

Consulting with Suppliers of RMM Technologies

Working directly with RMM innovators, start-up companies and global RMM suppliers, Dr. Miller provides technical, regulatory, marketing, sales, business and strategic direction during the design and commercialization of next generation microbiology technologies.

  • Support the development of strategic, business and commercialization plans
  • Conduct due diligence activities for new technologies or potential mergers, acquisitions or investments
  • Create industry focus groups and moderate discussions
  • Prepare validation plans that are aligned with USP <1223>, Ph. Eur. 5.1.6 and PDA Technical Report #33
  • Oversee contract laboratory testing and in-house microbiology studies
  • Develop regulatory strategies and establish your company with key global Regulatory Agencies
  • Support the development and submission of FDA Drug Master Files (DMF)
  • Develop Return on Investment (ROI) and business justification models that can be used with potential customers
  • Consult with your customer base on validation, regulatory and implementation strategies
  • Construct and deliver a comprehensive and holistic in-house training program

Consulting with Venture Capital Firms

Venture Capital firms interested in early-stage, high-potential companies often look toward experts with technology backgrounds, business training and deep industry experience to help guide them in understanding the long-term potential for their investments. Dr. Miller has experience in assisting a number of VC firms in providing commercialization, strategic and technical direction when considering investing in rapid microbiology opportunities.

In-House Rapid Methods Training Course

Companies find that in-house training is the most cost-effective means to improve the skills and capabilities of their employees. Dr. Miller routinely delivers his RMM training course at global microbiology and manufacturing conferences. Now you can have him teach his course in your own facility without the fear of asking confidential questions regarding your products or processes.

A comprehensive, intensive and interactive two or one-day training course can be tailored to your company's needs. An example two-day syllabus is provided below:

Introduction

  • History of microbiology methods and the need for change
  • RMM technical benefits when compared with traditional methods
  • Opportunities for use and areas of application including microbial detection, quantification and identification
  • Understanding how to match the right RMM with the intended application

Technology Review

  • Growth-based technologies that rely on the measurement of biochemical or physiological parameters that reflect the replication and proliferation of microorganisms
  • Viability-based systems that utilize viability stains and/or cellular markers for the detection and quantification of microorganisms without the need for cellular growth
  • Artifact-based technologies that rely on the analysis of cellular components or the use of probes that are specific for microbial target sites of interest
  • Nucleic acid RMMs including PCR-DNA amplification, RNA-based transcription-mediated amplification, 16S rRNA typing and gene sequencing
  • Spectroscopic methods that use of light scattering and other optical techniques to detect, enumerate and identify microorganisms
  • Introduction to Micro-Electro-Mechanical Systems (MEMS), such as microarrays, biosensors and Lab-On-A-Chip technologies

Validation Strategies

  • Guidance from USP <1223>, Ph. Eur. 5.1.6 and PDA Technical Report #33
  • New guidance on rapid sterility testing and alternative sampling strategies
  • Insights on how to develop a meaningful DQ, IQ, OQ and PQ program
  • Software and hardware qualification
  • Acceptance criteria and the use of statistics
  • Vendor expectations and audits

Regulatory Perspectives

  • US FDA and EMA expectations for validation
  • Submission strategies, comparability protocols and research exemptions
  • Changing acceptance levels and specifications
  • The role of process analytical technology initiatives (PAT)
  • Recent policy changes for ATMPs, gene and cell therapy products

Developing a Business Case for RMMs

  • The need for creating a business case to economically justify RMM implementation
  • Understand how to develop return on investment (ROI) and payback period models
  • Review an actual RMM ROI case study
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