*Scientific Expert Witness- Helped win my first case at trial (3 days) & working on my 6th case. *Experience working with hemp extracts/CBD/THC liquids/powders & flavor masking. Developed superior tasting products compared with competitors. Invited to be a speaker on CBD in foods at 75th annual IFT Supplier's nite event (Orlando, Feb. 2020). The organizer told me my seminar is SOLD OUT, which is great. Im grateful for all the support Ive received from the cannabis industry, its transformed my life forever! https://www.iftflorida.org/suppliers-night*Advise CEOs/Lab Directors on equipment to purchase to set up lab (granulator, V-blender, tablet presses, capsule filler) and on regulatory/legal/marketing/manufacturing quality issues.*Developed tablet formulations (effervescent) & beverage mixes in multiple flavors (N&A or Natural). Developing CBD skin creams, balms, & nanoemulsions (60-90 nm) for improved oral bioavailability. Working with several companies including ingredient supplier (Stillwater Ingredients/Caliper Foods). Have relationships with testing laboratories and universities. *Have written/edited business plans, investor slide decks, market research, advised entrepreneurs on business strategy.

*Improved lab efficiency by validating QC & testing patient urine samples on same day.*Use Carolina Liquid Chemistries CLC-720 to analyze pain medications & illicit drugs in patient urine samples, generate lab test reports.

Represented Defendant-Selected to work on nutraceutical ingredient importation case. Wrote expert report & was deposed in New York City

Invited to be a scientific contributor on various Cannabis committees to help improve standardization.

Began consulting and was offered f/t job 01/2020. Started up lab & formulating/scaling-up a variety of Cannabis products (THC-free) for pets and consumers. Groovy Waves tests all hemp extracts & finished products for potency, residual solvents, terpenes, pesticides, mycotoxins, bacteria, & heavy metals & issues CoAs.Source raw materials, lab/manufacturing equipment, improve manufacturing processes & formulations, saving company 25% & in some cases 60+%. Advise on marketing, regulatory, & quality issues. Registered company trademarks w/ legal group. Supervise several chemists, provide scientific guidance on making various batches, etc.Products include all-natural tinctures (human/pets), skin creams, balms, bath bombs, capsules, gummies, etc. https://www.groovywaves.com/about-1Responsible for writing 80+ SOPs/Quality Manual, etc. for obtaining GMP Certification (SGS) for company & completing necessary documentation/registration for FDA. Instituted a Quality System within the first 6 months.Finished my 66th publication (on US/Canadian/European regulations for cannabis in foods) for European magazine, Agro FOOD. It will be published 8/2020 & handed out @ Vita Foods Europe. Its posted below.https://www.teknoscienze.com/agro-food-industryCIAN Diagnostics: (www.ciandx.com) Helped CIAN get state contract for COVID PCR testing in nursing homes. Managed 3D printing operation (resin & plastic spool), operating clinical/analytical chemistry equipment (CLC 720 & LC-MS for drug panel screening-pain meds & illicit drugs). Increased lab efficiency by 25% Cannabis totally changed my life & career forever! I'm grateful to the CEOs & MDs that believed in me & enabled me to grow even more as a professional & a leader. I've developed products I never worked on before & I've been having a blast doing it! I will keep working hard 2 move the cannabis industry forward for everyone!Will be receiving IFAHs Top 100 Healthcare Leaders Award in Vegas June 26, 2021

Today’s Deep Thought:You Can’t Spell Healthcare Without THC! Cannabis IS Medicine for the Mind & Body!I was asked by a former UMD classmate if I can write a book chapter on "Medicinal Cannabis: A Review of Dosage Forms and Administration," I said sure & found a pharmacist to collaborate with me. In 2.5 weeks we wrote 40 p d/s with 115 refs. Our chapter has already been through round 1 of edits & re-submitted for review. This book (Introduction to Medical Cannabis for Healthcare Professionals) will have 13 chapters and will be published by Wiley 12/2022 (I always like to be proactive & start my writing early). This is my 3rd book chapter, my other two were on tablets & capsules (appropriate for pharmacy schools) and both book series are sold on Amazon. Ill also put 2 other cannabis articles Ive written here & on my Youtube channel.

It was an honor to receive IFAH's award on stage in Vegas. It was postponed 2x B4 due to COVID. I know they say What happens in Vegas stays in Vegas, but that doesn't apply here!

I was asked to speak @ GWCC! My seminar was postponed to 3/27/2021 on Cannabis/hemp in foods & cosmetics. It went great, organizer told me that he got lots of compliments.

Title: Cannabis/Hemp & Terpenes in Food/Beverage, Cosmetic, & Pharma Products. My first virtual global cannabis science seminar went great & was well received! The link @ left goes to my seminar posted on Youtube (about 40 min.). Enjoy!

My 2/25 seminar on Understanding the R&D Potential of Hemp/CBD in Food & Beverage Products was Sold out! I feel like Beyonce! I thank the organizer Luis Martinez for inviting me & Russ Widger (SoLitSocial.com) for doing a great job adding graphics to my slides. I got lots of positive feedback after my seminar, thanks 2 all that attended!

• Represented defendant (generic) in Paragraph 4 challenge. Wrote report/opined on claims in 2 patents of Plaintiff, compared formula ingredients & manufacturing processes between the 2 litigants & provided scientific justification on why defendant’s drug product does not infringe on the patent claims.

I was a panel speaker on CBD Manufacturing & was also asked to teach a 2 hr. course on CBD: Blending & Formulation. I talked about Cannabinoids & also the different types of products that can be infused with them. Students took an exam at the end & the course which can be used for CE credit. I enjoyed teaching students.

Pharmaceutical trade secrets case, Representing Defendant (generic co.). Wrote expert report and submitted to legal team.

*Received a $5,000 performance bonus from CEO in 2017. *Managed deliverables for multiple US/Intl. client projects for Rx/OTC/Cosmetic products. Demonstrated strong leadership, time management, & technical service skills dealing with 2 large clients. Both increased manufacturing at Ei (Value $2 million +). *Developed skin formulations for clients using a QbD approach. Involved with reverse engineering & technical transfers as products go through scale-up to Commercial scale (1300 gal.) or clinical scale (CTM).*Contributed during Tech. Ops. meetings on process optimization/product quality issues.*Answered FDA QBR CMC questions (Modules 2 & 3) related to client ANDAs/DMFs for drug substance & drug product. Provided CMC information for complete response letters & information requests from FDA in a timely manner. Experience writing ANDA submission.*Trained/Supervised/Managed the work of junior chemists. Physico-chemical characterization: Rheology, API particle size (Malvern), Karl Fischer, Raman, Microscopy, etc.*Quality Documentation: Wrote Bulk/Finished Product/Stability Specifications and master batch records. Wrote QbD/risk assessment documents for drug product, product & process development reports, SUPAC manufacturing site change reports, manufacturing & lab investigation reports (discussed root cause analysis & CAPA), change controls.*Worked on API/OTC projects involving Clobetasol (Solution, Spray, Ointment), Clindamycin, Lidocaine, Desonide, Minocycline, Mupirocin, Nitroglycerin, Ciclopirox, Benzoyl peroxide (BPO), Omeprazole, Erythromycin, Metronidazole, Allantoin, Lidocaine Male Desensitizing Spray, Glycolic acid, & Salicylic acid.

Retained to represent Plaintiff (Rx innovator) in Pharmaceutical Innovator patent litigation (Tablets). Experience with Markman claim interpretation/construction, freedom to operate, patent infringement.

Represented: Defendant; Judge's Ruling: In favor of Defendant, Case Dismissed with Prejudice.*Experience reviewing deposition testimony and writing opinion rebuttal report (76 p.) for CEO Defendant to answer Plaintiff’s expert report (30 p.). Experience successfully giving deposition testimony. Judge admitted me on the record as an expert in formulation/manufacturing issues for chewable & coated tablets & capsules. Successfully explained and defended points from my expert report & during cross-exam on witness stand during trial (3 days). Excellent oral and written communication skills. Judge's ruling on Plaintiff's lawsuit: dismissal with prejudice.Expertise in: tablet/capsule formulation, manufacturing, trade secret infringement, product labeling, patent evaluation.

*Review and provide scientific input on pharmaceutical documentation for tablet/capsule development & manufacturing scale-up (ex. API physico-chemical properties, supplier specs/CoA, R&D reports, drug formulations, microbiological issues, batch records/change controls.*Travel to U.S./International CMO sites to oversee GMP tablet and capsule manufacturing for CTM for Phases 1-2. Tablet operations include roller compaction/milling. Batches produce up to 130,000 coated tablets and up to 20,000 capsules. Capable of resolving pharmaceutical quality issues during production and communicating effectively with production operators and management.*Prepare risk assessment reports during stages of drug development/manufacturing of clinical trial material (CTM). Review and summarize QA CTM investigation reports of root cause analysis.

www.academictechventures.com/technology-specialists*Conduct calls with universities and federal labs on various technologies for myself as well as on behalf of other tech. specialists. Evaluate strength of IP, publications, & technology.*Successfully licensed one technology (Wipe-Rite) and had experience with another technology for e-cigarette design/manufacturing. Drafted licensing agreement & negotiated with university or other corporate entities for mutually agreeable terms. Wrote/edited business plans, financials, investor slide deck, marketing materials, and was involved with documentation for creating a start-up business. *Worked well with other team members, marketing, and website/IT specialists in US & India to update information.Wipe-Rite Technologies, Inc. (start-up) wiperitetech.com/ourteam 08/2015 – 07/2016Chief Scientific Officer *Obtained an exclusive license from Georgia Inst. of Technology to further develop a cleaning wipe product for intravenous & hemodialysis equipment used in hospitals/clinics. Goal is to reduce CLABSIs, a Healthcare-associated infection (HAI). Sought $1 million in funding for 25% equity ($4M valuation).*I wrote/edited business plan & financials through multiple iterations, worked with professor on budget, developed marketing materials and investor slide deck, talked to Angel groups, advised on industry manufacturing partnerships and vendor capabilities. Participated in Keiretsu forum in several cities.

*Wrote 50+ reports on assessment of intellectual property for various U.S./Foreign universities and hospitals: Fields of Specialization: Nutraceutical, Pharmaceutical, Medical device, Biotechnology, Chemistry/Polymer Chemistry, and Materials Science. Hospital Equipment: Magnetic Resonanace Imaging (MRI) contrast agentsDurable functional coating for drug delivery and wound careHighly swellable multi-layer hydrogelsBiologics to treat various forms of cancer and rheumatoid arthritis Medical device for diabetes utilizing NIR spectroscopy Epinephrine nanoparticle formulation in treatment of anaphylaxis Metal-ligand chemistry for targeted drug deliveryLipid-based nanoparticles for oral systained-release drug deliveryTunable silver nanoparticles for biomedical and energy applicationsOpiod drugs – Anti-abuse pharmaceutical formulations (3 technologies)Durable Hydrophobic-Oleophobic CoatingPhoto-activated nanocomposite materials for drug deliveryAntibiotic Therapy *Advise clients on FDA importation regulations for nutraceutical products. Evaluate stage of research, commercialization feasibility, market size/value, competitive position, and prepare list of potential corporate licensing partners. Write marketing documents based on the technologies.

Company is involved in commercializing digital medical device products (tablet with ingestible sensor and patch) at contract manufacturing organizations (CMOs) to improve patient health. Proteus filed the first-ever digital medicine NDA with the FDA, NDA Approved in 2017. *Design/conduct formulation experiments for developing tablet, tablet-in-tablet (core coating), and capsule prototypes containing an embedded FDA-cleared ingestible sensor (moisture-sensitive) medical device. Develop blends to modify disintegration time or improve tablet compactibility, generate compression profiles. *Write R&D development reports and feasibility reports on chemistry/stability for new potential drug products (up to 150 pages/week). Train/Supervise technicians to conduct pharmaceutical QC tests and prepare batches. Experience working in ISO Class 8 clean rooms. *Prepare stability protocols (HDPE bottles and Blister cards) and manage QC testing of stability samples. Analyze results using JMP and report findings on study progress to management.*Conduct Quality-by-Design (QbD) CMC risk assessment of product commercialization work to be done at CMO. Identify/document critical quality attributes of formulations and critical process parameters. Provide advice to manufacturing/operations on other quality/CMC risk assessment (ex. design and process FMEA) documentation.

Plan and organize quarterly meetings on various pertinent pharmaceutical/biotech discussion topics. Liase with other pharma/biotech organizations to increase meeting attendance. Meetings held at USP headquarters in Rockville, MD. Past speakers were from Evonik, Catalent, Millipore, MedImmune, and USP. Affiliated and chartered under AAPS.

Invited to serve as scientific editor for the journal. Edited 60 manuscripts from foreign universities. Edit for content as well as aspects of pharmaceutical chemistry, spectroscopic analysis, and analytical method validation.

Company is involved in patenting and licensing various biotechnology-based innovative technologies for commercialization.ACCOMPLISHMENTS: * Developed coating systems which significantly improved vitamin stability against oxidation as compared against the competitor's technology. Prepared stable o/w nano-emulsions.* Validated process and developed proprietary polymer coating formulation systems which significantly and consistently improved bacterial survival. The long-term success of this work created a new business segment for the company and resulted in a joint research contracts with several Fortune 500 companies.* Received a performance raise after 9 months. DUTIES:*Formulation and Process Development: Develop Nutraceutical (ex. Vitamins, Antioxidants) Encapsulations for Human/Consumer Healthcare.*Developed aqueous and solvent-based polymer coating systems using various plasticizers, lipids, emulsions, and surfactants for a variety of applications. Capable of matching physico-chemical properties of marketed coating formulations. Utilized encapsulation techniques with polymers to protect biological activity. Conducted work independently and also major contributor to inter-disciplinary teams. *Responsible for evaluation/development of Formulation and/or Process Intellectual Property. Write technical reports and informed senior management & project teams on key findings.

*Developed Solid Oral Dosage Forms (Tablets and Capsules) for Adults and Children. Successfully prepared Taste-Masked drug beads of clindamycin & ODTs using a variety of coating polymers. Proficient with Extrusion-spheronization. Publication submitted to J. Pharm. Sci. ---Received FDA Award for Most Innovative Project: Clindamycin ODT *Planned and conducted various Stability Studies including Excipient Compatibility (for Tamiflu - Medical Countermeasures Initiative) using both capsules and blister packages for the Department of Defense (DoD). Presented poster at AAPS 2012.*Independently operated Fluid bed drier (1 kg), DSC, TGA, FTIR, PXRD, HPLC, Surface Area, NIR, UV/VIS, and Raman spectrometers. Proficient with using PCA, PLS, and PCR for Multivariate Analysis in Unscrambler software.*Public health impact: conducted analytical work and chemometrics modeling (NIR/Raman) to analyze for melamine adulteration. Submitted scientific publication to PDA Journal. *PAT Applications: Use Wireless NIR and Focused Beam Reflectance Measurement (FBRM) to monitor granulation particle size and coating processes in the fluid bed drier.*Perform HPLC Analytical Method Validation and analysis (drug potency and release) in accordance with USP parameters.

* Provided scientific and regulatory assessment of a variety of manufacturing plant post-approval change controls and communicated information to stakeholder affiliates in key global markets: US/Canada, Asia, Europe, Middle East, and Central/South America. The affiliates communicated with their health authorities (HA) and I also advised them on the tests and documentation required for products to be marketed in their home countries. Plant changes involved: changing plastic resin and colorant in OTC product bottles, formulation changes, supplier changes, cost savings, re-validation of product manufacture following changes. Example below:*Plant was changing their supplier of PET resins and colorant for bottles of OTC cough syrups. Line trials and stability studies were required in the plant. Communicated with Middle East affiliates: HA required prior approval before shipments allowed. Products were shipped as per schedule. * Author/Reviewed CTD Submission-Ready Components for electronic filing. Managed Renewals and new product registrations in different countries. Obtained CoAs from LIMS. Obtained CEPs for APIs & provide documents for free sales certificate (CPP) from FDA.* Updated SAP, EDMS (Documentum), & Product Dossier Manager (PDM) databases for 130 products to ensure QA compliance. Dual role as Sponsor/Task manager in C-TRAX database (CMC Management tool). Process change controls in C-TRAX to notify global affiliates. Linked mfg. plant documents in PDM under their proper CTD sections for each country.* Reduced stakeholder complaints by 20% by processing change controls efficiently.* Successfully managed & prioritized workload for 20-30 projects.* Provided input to the Raw Materials testing team on which analytical tests are critical to the quality of the finished products. This reduced testing initiative maintains quality & provides cost savings to Pfizer.

Wrote/edited Market Research chapters on Pain Management Therapies. * Rx and OTC drugs- sales/CAGR and clinical aspects * Complementary and alternative medicine * Pain Management Medical Devices (i.e., spinal cord stimulators, TENS, NMES, patient-controlled analgesia devices), and pain management clinics. Summarized clinical trial results. * Familiar with ISO 13485, CE marking, and CFR Part 820 for Medical Devices. Wrote Market Research chapters on Age-related Macular Degeneration (AMD) and Diabetic Retinopathy. Covered clinical aspects, market forecast, and strategic pharmaceutical product analysis.Also wrote market research reports on arthroplasty implants and lab-on-a-chip technologies.

*Managed writing, compiling, and editing of CMC sections for two lyophilized biologics IMPDs (drug substance /drug product (recombinant growth factor and hormone), sNDA (semisolid) to support manufacturing site change (SUPAC), and BLA (interferon). Wrote IND for small molecule (capsules). Interfaced with Regulatory Affairs and Statistics departments in compiling/writing documents and during client tcons. *IMPD: Involved major revisions and substantive writing/editing to transform document into CTD format and gap analysis. Made over 300+ scientific, regulatory, and technical comments.*Handled clinical supply chain management issues (labeling, documents, calculations). Wrote/reviewed label proofs of vials from subcontractor for accuracy. Assisted in resolving shipping issues for oncology/tumor CTM (Sales > $1M). Approved CTM ordering and destruction of expired materials from subcontractor.*Assumed lead CMC role during client telecons; demonstrated ability to problem solve and provide global clients with regulatory strategy. Provided regulatory advice on:residual solvents (USP <467>)analytical method validation and process validation process-related impurities meeting potency specifications during product shelf life.*Managed client project timelines to ensure on-time and on-budget deliverables. Excellent project management skills which resulted in increased client satisfaction.*Wrote two articles: Regulation of Oncology/Cardiology drugs Impact of Biosimilars on CMC information for US/EU

Prepared wet, foam, and MADG granulations of Metformin, Aspirin, APAP, and Atazanavir. Studied differences in particle size, morphology, and surface area. Studied mechanical properties of the different API granulations using Hiestand Indices. Manuscript accepted in Powder Tech. 5/09 (first author).

Developed wet granulation formulations and prepared tablets using Korsch XL-100 & SMI Instrumented Minipress. Characterized properties of drug blends and studied their compressibility using transmitted / ejection force, Heckel analysis, and work.

Start-up Pharmaceutical co. Successfully took Nutraceutical & OTC products from lab concept to manufacturing scale-up. Wrote Master Batch Records, Stability Protocols/Reports, & Nutritional Statements.Managed 4 technicians. Promotions: Senior Manager, 2001Developed sugarless chews (2 flavors) & nutritional bar formulation which were licensed to BMS & launched nationally under Choice DM brand. Company awarded $ 1,800,000 for milestones. Completed Technical Transfer Documentation. Developed/scaled-up rapid-dissolve Dextromethorphan tablet formulations (API encapsulation, Wet Granulation, Compression) for BMS. Wrote Process Validation Protocols/Reports. Effectively taste masked active. Developed taste-masked encapsulations of OTCs/nutraceuticals & chewable APAP tablets (80 mg-325 mg). Scaled-up flavor & sweetener encapsulations to 3000# (sold to International Chewing Gum manufacturers). Developed medicated chewing gums, edible films, & menthol cough drops.Business Development - Wrote Marketing literature, Presented Prototype Products to Various Companies, Filed 2 Provisional Patents.Responsible for all phases of Project Management including cost control and timetables.

Operation/Troubleshooting of Perkin-Elmer HPLC. Used HPLC for Manufacturing QC and competitor blend matching. Also performed ion exchange and size exclusion chromatography.Provided technical assistance on gum formulations to food/pharma clients & salesforce. Extensive experience in formulating and processing a variety of liquid and powdered beverages containing vitamin-mineral premixes and other nutraceuticals (smoothies, protein shakes, sports drinks, energy drinks). Expertise in creating stable beverage flavor micro-emulsions and analytically evaluating during stability testing using a Coulter counter. Set specifications on over 140 blends and conducted a variety of USP/FCC analytical tests. ISO 9001 Lead Auditor. Audited various work areas including manufacturing, laboratory, materials management, purchasing. Wrote over 40 SOPs/work instructions.