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Read our FAQ below.

How is the FDA regulatory landscape for X evolving? How does X compare to Y from a regulatory point of view?

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How does the FDA regulate algorithms and algorithm-based tools that help select the right therapy?

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How should phase 1 and 2 studies be conducted to satisfy regulatory expectations and enable the stratification of the patient population using genetic biomarkers? How does it impact reimbursement?

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Which regulatory pathway is appropriate to accelerate my product development (e.g. breakthrough dedication, voluntary submission, pre-Subs, and others)? How do I apply for it?

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Is a health economic and outcomes research (HEOR) study needed to convince payers about the value of the product? How should this study be designed and where can it be conducted?

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What is in the pipeline for indication X? Can I competitively position my product, e.g. using a biomarker?

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What milestones can I use to create a logical development plan for my personalized medicine product and how can it be integrated in our corporate goals (e.g. financing strategy)?

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Will a genetic test be required for approval, under what circumstances, and what are the consequences?

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.

How can I align the development of a diagnostic with my drug development so that they are strategically aligned and regulatory submissions for both the drug and the diagnostic are coordinated?

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.

What are the challenges aligning the development of a diagnostic with the much longer, more complex development of a new drug therapy?

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Will reimbursement of the companion diagnostic test automatically follow reimbursement of the drug? Is it advisable to develop a companion diagnostic and what are potential other options?

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Which Center at the FDA should I address for companion diagnostic development information?

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.

How do I design my clinical trial if I want to incorporate a biomarker? Do I need to prospectively select patients based on biomarker data or can I evaluate this information retrospectively?

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How does the FDA regulate next-generations sequencing (NGS)-based products?

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Does my pivotal trial, designed for regulatory purposes also provide useful information for payers? If not, how can I integrate/generate data that is of interest to payers?

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.

I’m starting a new business. How can I align my product development milestones with my business strategy?

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Do I need to submit my product to the FDA for review or should I use an alternative (e.g. a laboratory-developed test, LDT) approach? What are the pros and cons of each approach?

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How does the laboratory/diagnostic market evolve for my product? Should I invest in this market?

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Examples of Completed Assignments

Some examples text below goes here.

  • Regulatory strategy for oncology drug development requiring companion diagnostic
  • Alignment strategy, trial design drug-test co-development effort in inflammatory-bowel syndrome
  • Due-diligence of various investment opportunities (start-up and early stage) for VC firm
  • Support of (pre-)IDE submission and representation of diagnostic company at FDA
  • Analysis of US reimbursement opportunities for Crohn’s Disease, NASH and NAFLD diagnostics
  • Feasibility evaluation for creating new HEOR unit within global consulting firm
  • Phase 2 and phase 3 clinical trial design for oncologic drug development effort
  • Due-diligence of next-gen sequencing support and market access strategy for reagent supplier
  • Health economic evaluation and payer strategy of novel renal therapy
  • Identification of market access strategy for new diagnostic via integrated health systems
  • Strategic plan to integrate big-data analytics in personalized medicine functional area (pharma client)
  • Development and conduct of professional surveys and questionnaires for big pharma company
  • Laboratory strategy, including LDT, CLIA versus 510(k), PMA kit development
  • Development of online education (multi-module course) for personalized health care
  • Advisory committee and expert testimony at senior management and strategy retreats
  • Board memberships and advisory functions at diagnostic and pharmaceutical companies
  • Lectures and courses/workshops at national and international conferences and workshops
  • Product positioning for new microbiome company
  • Development of company-wide strategy to incorporate DNA collection in all clinical trials (pharma client)
  • Regulatory strategy for systems biology data and regulatory submissions for large tobacco company
  • Long-range planning for pharma client to assess new market options (e.g. digital health, wearables)
  • Population-based screening for pharmacogenetic applications, integration into national health care
  • Identification of business partner for microbiome-focused joint venture, design of joint venture
  • Full business plan for NGS-based oncology diagnostic new company, incl. market and financial analyses
  • Evaluation and strategic planning for creation of “in silico tumor board application” for Health IT company
  • Strategic planning and change management to integrate precision medicine strategy at big pharma client
  • Evaluation of new platform technology (3D printing) at big pharma client