The Minnesota Diet Research Center Gold Standard Trials Claim - - PowerPoint PPT Presentation

The Minnesota Diet Research Center

Gold Standard Trials Claim Substantiation Quality Support

The Minnesota Diet Research Center

Alimentix strives to be the leading clinical research investigative site for food, OTC pharmaceutical and minimally invasive medical device products.

What’s the need?

• Product manufacturers and businesses need to

substantiate health effect and end-user claims for food, drug and medical device products.

• Alimentix provides scientifically sound, “gold

standard” clinical data in order to communicate the authenticity of claims in a truthful and reliable manner

• International regulations and requirements are

evolving rapidly

Our Clients

Alimentix Strengths

• Established comprehensive clinical

investigative center

• Dedicated to conducting clinical trials

for food, food ingredients, dietary supplements, and natural products

• Aimed at substantiating “health

effect” claims through scientifically sound clinical trials

• The ONLY research group of this kind

in the United States

Why Alimentix?

• Poised to fulfill a specialized need in food

research

• Experienced at providing clinical trial services
• Expansive knowledge base
• Established “Gold Standard” service
• Customizable and creative options
• High quality service at low cost
• Collaborative efforts to meet client needs

The Alimentix Difference

AROs Sponsors

• Contracting?
• Pace?
• Intellectual Property?
• Conflict of Interest
• Paid Employees as

Volunteers/Subjects

• Varied Quality
• Objective Data
• Efficient Progress
• Gold Standard Quality

Alimentix History

January 2012

Staff Grew to 8 Full-Time Employees

June 2012

Weight Loss Clinical Trial

November 2013 March 2014

Moved into Clinical Space with Laboratory in Corporate Office Building

October 2013

Founded

Satiety Clinical Trial

February 2014

GRAS Dossier and Panel Meeting

March 2012

Ongoing Medical Device Clinical Trial Developed Safety Surveillance and Reporting System for Client

Meet Our Team!

• Dr. Joy Frestedt PhD, CCTI, RAC, FRAPS, President and CEO
• Matt Harris, Senior Clinical, Regulatory and Quality Manager
• Diedre Ribbens PhD, Technical Writing Specialist
• Kristen Evenson, Technical Writing Specialist
• Kristen Maynard PhD, Clinical Data Analyst
• Rachel Gartner, Regulatory Affairs Specialist
• Shane Hernandez, Executive/Project Assistant

Our Focus Areas

• Finished Foods
• Functional

Ingredients

• Food Supplements
• Medical Devices
• Low risk, non-complex
• Pharmaceuticals
• Low risk, OTC
• GRAS Dossiers
• Weight Management

Studies

• Pain Management

Studies

• Human Use Studies
• Taste/Texture Studies
• Satiety Studies
• Label Comprehension

Clinical Trial Management: Preparation

• Quality Management System (QMS)
• Clinical Trial SOPs in place and functional
• FDA and/or ICH compliance (e.g. ISO 14155)
• Feasibility assessment
• Clinical Evidence Reports
• Literature reviews
• Claim substantiation documentation
• Claim to be supported by clinical trial?
• FOCUS on primary goal

Clinical Trials: Start-Up and Execution

• Select Principal Investigator (PI)
• Designate Site/s and Site Investigator/s
• Oversee Study conduct
• Subject Recruitment
• Diet Analysis/Counseling
• Data Collection
• Monitoring/Auditing
• Query resolution
• Evaluate Site Statistics

Clinical Trials: Study Reporting

• Statistical Analyses
• Clinical Study Report
• Regulatory Considerations
• Federal Trade Commission – claim support
• Regulatory requirements (FDA, EFSA, etc)
• Product Marketing Support
• Publication Support

Protocol Development for Food Trials:

• 1. Establish product claim (e.g.

product X supports weight loss)

• 2. Develop Protocol Synopsis

and document agreement

• 3. Verify appropriate study

designs

• Objectives, Endpoints,

Materials and Methods

• Statistical Analysis Plan (SAP)

including sample size

• 4. Finalize Protocol and

Informed Consent Form (ICF)

• 5. Develop case reports and

database

• Data management plan and

monitoring plan

• 6. Register trial if intending to

publish (www.clinicaltrials.gov)

• 7. Train personnel and

stakeholders

• Manage expectations
• Secondary objectives and

endpoints

• 8. Amend protocol, ICF, CRF,

database as needed

Unique Skills From Start to Finish

• In addition to clinical trials, we can

provide support for:

• Regulatory
• Claim substantiation submissions
• GRAS panel meetings, dossiers
• Dietary ingredient documentation
• Quality Systems
• SOP and WI development
• Forms
• Risk management

Case Study 1: Clinical Trial Management

• Situation: The research center portion of a medical clinic required

assistance conducting and managing a clinical trial to test a combination drug and device product including a novel drug and a novel device.

• Alimentix Approach:
• Enrolled/consented subjects
• Tracked patient health progress
• Collaborated with clinic staff
• Collected and analyzed data
• Results: Alimentix managed the clinical trial over two years. By

collaborating with the research center and integrating into their existing staff, Alimentix developed a lasting partnership with MARC. Alimentix also conducted multiple other drug and device clinical trials while helping identify future avenues for research.

Case Study 2: Safety Reporting

• Situation: A large, global company required post-

market surveillance of safety reports for their new dietary supplement.

• Alimentix Approach:
• Developed a system to track adverse events (AEs)
• Developed a specialized call center to log, categorize, track

and report AE calls

• Used statistical analyses to analyze trends
• Results: Alimentix provided monthly reports and multi-

year comprehensive safety overviews. The client’s corporate team gained expertise in safety oversight and increased their productivity.

Case Study 3: Quality System Support

• Situation: A mid-sized device company was under scrutiny

for their current quality systems and required assistance with their process for medical literature evaluation.

• Alimentix Approach:
• Created SOPs, WIs, Forms, and provided training
• Completed clinical evaluation reports of selected medical

literature

• Evaluated specific claims for company products under review
• Results: The company was enabled to use robust,

comprehensive clinical evaluation processes to review medical literature and support strength of claim substantiation.

Case Study 4: GRAS Panel and Dossier

• Situation: A large, global food product/ingredient

manufacturer had clients requesting a modified ingredient. The company was in need of regulatory guidance to determine if the product could be generally regarded as safe (GRAS).

• Alimentix Approach:
• Reviewed appropriate literature
• Identified and selected expert panelists
• Results: Alimentix conducted and moderated a GRAS panel

for the company’s product. The product was able to be generally regarded as safe and a GRAS dossier document was created, revised, and signed off for approval.

Contact

Alimentix Tel: 952-426-1747 Fax: 952-426-1757 www.alimentix.com info@alimentix.com

• Dr. Joy Frestedt

jf@frestedt.com 612-219-9982