info@regenerativeoutcomes.com

+1 (855) FDA-RMAT

P.O. Box 40211, Nashville, TN 37204

© 2017 Regenerative Outcomes, LLC.   All Rights Reserved.

Take the next step for approval-to-market

Introduction

Through our Regenerative Medicine Advanced Therapy ("RMAT") Spectrum Services program, we use a specialized, strategic approach that employs a team to do the heavy lifting for a company or provider, helping them confidently and efficiently engage in dialog with regulators to seek fast-track approval to market their therapeutic or device innovations. Although several such efficient pathways to approval exist, FDA’s RMAT designation is the only one developed exclusively for regenerative medicine and gene therapies

Our service competencies (examples with descriptions in bold) offered to clients pursuing an RMAT designation to bring their innovations to market are:

  • Dedicated Team Assignment (Lead Scientist, Clinical Coordinator, Project Manager, and Administrative Support)  

  • Development of Customized Roadmap

  • Strategic Indication Research

  • Assay Support and Referral (e.g. Biomarker, Characterization, Toxicology)

  • 510(k) Predicate Use Cellular Action Evaluation

  • Evaluation of Current Good Manufacturing Practices (cGMP) and Current Good Tissue Practices (cGTP)

  • Contract Manufacturing Organization (CMO) Matching 

  • Certifications and Authorizations

  • Resourcing, Relationship, Referral and Brokering

  • Current HCTP Recovery and Delivery Compliance Review

  • Pre-Clinical and Clinical Studies and Data Quality Assessment

  • Real World Evidence (RWE) and Real World Data (RWD) Evaluation

  • Clinical Trial Phase I/II Design, Including Dosing Escalation

  • Protocol Development

  • Inclusion / Exclusion Criteria

  • Primary and Secondary Endpoints Strategy and Evaluation

  • Investigational New Drug (IND) Planning, Completion, Assembly

  • Synopsis Development

  • Data Management and Monitoring Resource Referral

  • Contract Research Organization (CRO) Resource Referral

  • Investigator Brochure (IB) Development

  • Chemistry, Manufacturing, Controls (CMC)

  • Drug Master File (DMF) Reference

  • Precision Informed Consent Form (ICF)

  • Institutional Review Board (IRB) Matching

  • CBER "INTERACT" and "pre-IND" Regulatory meeting(s)

  • IND Application Preparation,Finalization, Assembly and Validation

  • IND Electronic Common Technical Document (eCTD) Submission

  • RMAT Designation Application and Submission

  • International Technology Transfer Consultation

 

Strategic Indication Research

Regenerative Outcomes' indication research is a strategically focused approach to selecting a best-case indication that aligns with sponsor qualifications, resources, and business plan, and then recommending or confirming target indications a sponsor may consider in order to gain approval for an Investigational New Drug (IND) application that is eligible for the Regenerative Medicine Advanced Therapy ("RMAT") designation for accelerated clinical trials.

Exhaustive literature and clinical research review, current trials conducted worldwide, available real-world evidence, and pre-clinical study meta analysis, as well as other resources allowed for consideration by regulators are collected and evaluated, and then applied to these selected indications.

Strategy is the cornerstone of our clinical pathway roadmap. It provides the information and the framework needed to plan for Speed and prepare for significant Savings of millions of dollars for government fees and clinical trial costs.

 

cGMP & cGTP

Current Good Manufacturing Practice (cGMP) and Current Good Tissue Practice (cGTP) are detailed standards required for processing research and commercial grade biologic products that are safe for use in humans.

 

The right manufacturing conditions, with the right manufacturing equipment and the right standard operating procedures that produce clean, pure, sterile, characterized, potent, and consistent biologic therapeutics at the endpoint are what constitute the first crucial step in gaining approval for any biologic drug, including regenerative medicine therapeutics, devices, or combination products.

Regenerative Outcomes provides support and direct consultation from seasoned subject matter experts to guide a potential sponsor through this important process.

 
 

Precision Informed Consent

Regenerative Outcomes is a leader in introducing the need and calling for a national initiative to personalize and modernize informed consent practices within the field of regenerative medicine.

"Precision Informed Consent", a term coined by Doug Oliver, Founder of Regenerative Outcomes, describes a framework of compiling, aggregating, and curating real time information necessary to develop a robust and principled informed consent process that is evidence-based, all within an industry that is evolving at incredible speed, and for which reliable information for patients is not forthcoming for adequate shared decision making.

 

Using data derived from their own clinical studies, medical records, or outside registries, Regenerative Outcomes can help practitioners and clinical trial sponsors develop informed consent tools and processes that embody a virtue ethic and maximize shared decision-making and transparency between providers and patients.​

IRB Matching

An Institutional Review Board (IRB) is a committee of academics and practitioners with the legal obligation and authority to oversee any and all U.S. medical research on human subjects. Tasked with assessing safety, risk, and ethical factors impacting the human patient, IRB committees collaborate closely with principal investigators, and are empowered to oversee, approve or disapprove protocols and processes within the research project. 

As part of its regulatory services offerings, Regenerative Outcomes helps find well-respected IRB committees that provide a good match for specific in human research and clinical studies.

 

Phase I/II Clinical Trial Design

Emerging biotechnology companies and physician groups often require unique approaches to designing a robust regenerative medicine clinical trial that will not only gain regulatory approval, but do so as quickly and efficiently as possible.

Careful and creative trial and protocol designs using seasoned scientists is crucial to accomplishing accelerated time to market.

 

By identifying sponsor needs as well as their strengths and passions, Regenerative Outcomes provides this caliber of assistance for fledgeling clinical study groups to help them design studies that are nimble, iterative, and flexible.

 

R.M.A.T. Designation

The Regenerative Medicine Advanced Therapy (“RMAT”) designation was established by the 21st Century Cures Act. As described in Section 3033 of the 21st Century Cures Act.

Under the Act, a drug is eligible for the RMAT accelerated pathway if:

  1. The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;

  2. The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and

  3. Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition