Natural Products: New Product Development, Formulation and Regulatory Expert

Expertise

• Natural product development and formulation; vet new product opportunities: Navigating IP infringement avoidance, scientific validation, efficacy, dosage, market viability, and regulatory compliance.
• Natural product ingredient assessments, technical review, and scientific approval.
• Provide marketing content, direction and guidance for new product launch.
• New product positioning and marketing strategy, product naming and tag line creation.
• Natural product: Product quality and marketing integrity: IP protection, regulatory compliance and quality assurance.
• Oversee all business and legal aspects of natural products development and launch; legal for reviews of trademark, patent, or other IP issues.
• Research and development of ingredients and functional food initiatives.
• Build and oversee scientific affairs, quality assurance, quality control, regulatory compliance, product development, and research and development departments: oversee and direct contract manufacturing.

Experience

Undisclosed Company, Owner and Founder, 2019 - Present

• Consultant to the natural products industry, including dietary supplements and natural/functional
  foods and beverages;
• Product development and R&D, from concept through prototype development and full scale GMP manufacturing, all dosage forms, including capsules, tablets, softgels, powders, gummies, and liquids;
• Quality Management System planning, development, and implementation; scientific and technical services, including ingredient research and vetting;
• Product claims substantiation and regulatory compliance, and product safety/efficacy dossier
  development;
• Consumer complaint handling/responding and AE/SAE reporting and recordkeeping;
• Develop compliant label copy.
• Develop and/or revise formulas, run benchtop trials, and create prototypes for new and existing
  brand owners
• Research, source, and vet raw materials
• Source appropriate contract manufacturers, co-packers, and contract labs for brand owners
• Write/develop complete SOP books
• Create finished product testing strategies
• Develop finished product and raw material specifications
• Research and create product claims substantiation dossier

Ideal Living Management, Sherman Oaks, CA, Chief Science Officer,                                          2017 - 2019

• Accountable to build and implement the Quality Management System;
• Develop and revise company SOPs;
• Oversee, audit, and direct contract manufacturing;
• Distinguish and address gaps in GMP compliance;
• Manage AE/SAE reporting and compliance;
• Source and vet new ingredients;
• Create/develop new products from concept through manufacturing;
• Troubleshoot and reformulate existing products;
• Develop, manage, and run R&D trials of new or reformulated products.
• Create/develop finished product specifications and raw material specifications for new and
  existing products
• Create and implement finished product stability strategies and protocols
• Oversee international regulatory projects and initiatives
• Develop and review GMP compliant labels for new and existing products

Creator/Innovator of new and upgraded Therabotanics products:

• Dr. Ho Cleanse™ Herbal Detox (reformulation)
• Grown American Superfood Ultra
• BeFlexible™ (participated as talent in 30-minute infomercial as product inventor/expert

Golo, LLC, Newark, DE,  Chief Science Officer, 2016 - 2017

• Accountable to build and oversee scientific affairs, quality assurance, quality control, regulatory compliance, product development, and research and development departments, overseeing and directing:
• Contract manufacturing; source and vet new raw materials; develop vendor relationships and negotiate supply agreements;
• Develop SOPs and protocols for GMP compliance; conduct GMP audits;
• Develop ingredient specifications and create finished product spec packets;
• Develop new products and revise existing formulas;
• Oversee new ingredient qualification and finished product testing;
• Create claims substantiation dossiers and white papers;
• Contribute to clinical trial design; oversee product licensing with Health Canada.
• Build scientific affairs, QA/QC, (Quality Assurance and Quality Compliance) regulatory affairs, product development and research and development from the ground up.
• Champion full GMP compliance through developing SOPs for all departments.
• Innovate, design and develop new product launches from ideation through manufacturing.
• Develop GMP compliant labels for new and existing products.
• Intellectual property development, including patented formulas and trademark names.
• Provide leadership and direction around product claims substantiation.

Creator and Developer (new and upgraded) firm's brand products:

• Release™
• GI Health Formula
• Mood Balance Formula

Progressive Laboratories, Irving, TX, Director of Product Innovation, 2013 - 2015

• Accountable for innovation in new product development and formulation; brand identity distinction and development; seek out exclusive opportunities to launch unique new products and or delivery systems.
• Develop and implement new raw material qualification protocols; provide leadership around quality assurance and regulatory compliance throughout product development process.
• Oversee project management from ideation through manufacturing; vet new product opportunities through scientific, technical, safety, and legal review.
• Develop marketing, sales, and educational materials for new product launch; speak at trade shows and conventions.
• Innovate, design, and develop new product launches from ideation through manufacturing.
• Guide executive management in marketing strategy, product positioning, claim substantiation, and brand identity development.
• Direct purchasing department regarding new product launch forecasting and initial PO estimation.
• Label development and review.
• Intellectual property development and protection.
• Product naming and tag line creation.
• Develop and deliver educational webinars for licensed health care professionals.

Creator and Developer:

• Resilience® line of Progressive Labs products
• Daily Resilience® (encapsulated and stick pack versions)
• Cognitive Resilience®
• Adrenal Resilience®
• Antioxidant Resilience®
• Hair, Skin, and Nail Resilience®
• Men's Resilience®
• Women's Resilience®
• Liver Resilience®
• Cardio Fit™
• Opti-Pedi™Multi-Vitamin

Life Extension, Fort Lauderdale, FL, Senior Research and Development Scientist, 2010 - 2013

• New product development and formulation; vet new product opportunities.
• Product navigating IP infringement avoidance, scientific validation, efficacy, dosage, market viability, and regulatory compliance.
• New ingredient assessment, technical review, and scientific approval.
• Provide marketing content, direction and guidance for new product launch magazine articles and ads.
• Oversee all business and legal aspects of product development and launch; partner with legal for reviews of trademark, patent, or other IP issues.
• Collaborate with quality assurance around raw material testing strategy and qualification.
• Innovate, design, and develop new product launches from ideation to manufacturing.
• Guide and oversee research and development for ingredient research and functional food initiatives at universities.
• Guide and oversee ingredient and product clinical research and claim substantiation.
• Direct purchasing group regarding new product launch forecasting and initial PO estimation.
• Direct magazine Chief Editor regarding new product positioning and marketing strategy.
• Product naming and tag line creation.

New Product Development

• Liver Efficiency Formula
• Advanced Natural Sex for Women®
• Advanced Natural Sex for Women® 50+
• Adrenal Energy Formula
• Bio-Collagen with Patented UC-II®
• Cardio Peak™ with Standardized Hawthorn and Arjuna
• Extraordinary Enzymes
• Black Cumin Seed Oil
• Black Cumin Seed Oil with Bio-Curcumin®
• Immune Modulator with Tinofend®
• GlycemicPro™ Transglucosidase

Pure Essence Labs, Las Vegas, NV, Director of Product and Trainer, 2009 - 2010

• Accountable for innovating, developing and delivering new products including material and manufacturing sourcing, marketing collateral, technical literature and documentation.
• Provide delivery chain support; training and education for health care practitioners, inside and outside sales, customer service representatives, retail sales force and consumers.
• Manage Quality Assurance and Regulatory Compliance.
• Innovate, design and manage new product launch from concept through cGMP manufacturing.
• Spearhead initiative to create complete technical product formula bibliographies.
• Initiate, direct and deliver an ingredient library specific to consumer and retailer inquires.
• Design and direct label information, marketing and web copy audits. Institute corrections through policy and procedure development as necessary.
• Increase Prop 65 product compliance through special project initiative.
• Direct and manage product audits; initiate purity changes to align with intended formulation
• Contribute to the formulation, development and launch of 4 new products over six months.
• From concept, create over 20 product training presentations.

Vaxa International, Tampa, FL, Chief Medical Officer and Chief Science Officer, 2008 - 2009

• Accountable for product education and training, technical support: practitioners, inside - outside sales force, and customer service.
• Company spokesperson; national and local radio program guest; write technical copy and feature articles for website and marketing pieces.
• Manage Quality Assurance and Regulatory Compliance: Design; develop and build an in-house library of CofAs for all product ingredients.
• Initiate a technical specification library for all products and ingredients.
• Provide accurate, and relevant scientific rationale and validation for nutraceutical ingredients.
• Research Materia Medica: Deliver accurate and relevant rationale for homeopathic and nutracetucial ingredients.
• Direct and manage product audits; correct stability issues with existing products.
• Design and direct labeling, marketing and web copy audits.
• Institute corrections through policy and procedure development.
• Provide guidance in effectively responding to FDA audits; provide accurate and relevant information to correct label discrepancies.
• Led over 40 training sessions per month for health care practitioners, inside and outside sales, customer service and retail sales representatives, training over 500 people.
• Conceive, design and deliver a product training manual library.
• Regular guest on WHNZ Consumer Education Network radio program, Tampa, FL and on Community Talk AM KTLR.

Sea Change New York, Manhattan, NY,Naturopathic Physician, 2006 - 2007

• Private practice

The Chopra Center for Wellbeing, Carlsbad, CA, Naturopathic Doctor and Director, 2004 - 2006

• Accountable for patient consulting, launch and directing of the Practitioner Affiliate Program providing Ayurvedic training for health care practitioners.
• Center spokesperson responsible for public relations in person, marketing and web copy.
• Lecturing to Chopra Center and La Costa Resort guests.

Natural Alternatives International, San Marcos, CA, Research Scientist, 2002 - 2005

• Accountable for innovating, developing and delivering new products.
• Material sourcing, marketing collateral, technical and scientific literature and documentation.
• Delivery chain support; training and development of inside and outside sales, customer service representatives, and retail sales force.
• Research and develop formulas, structure and function claims, scientific validation, develop label copy and bibliography materials.
• Manage product piloting and post formulation production process.
• Lead formulator for "Chopra Center Essentials" nutritional supplements.
• Medical writer and managing editor for the "Chopra Center Essentials" magalog.
• Project manager and call center staff trainer for the Chopra Center and Jennifer O'Neill brand products.
• International corporate speaker for Nikken nutritional supplements.

Honors & Publications

Credentials

• Health Care Practitioner Trainer
• Excellerated Business Schools, San Diego, CA (Money)
• Mission Control Productivity and Accomplishment graduate
• Instructor: Curriculum for Living, Communication Courses

Education

• N.D. Naturopathic Medicine, National College-Naturopathic Medicine, Portland, OR
• B.G.S. Biomedical Graduate Studies, University: Pittsburg State University, Pittsburg, KS