Berry Pharmaceuticals, LLC

Berry Pharmaceuticals, LLC makes offering in Class A2 Units which are $50,000 each with a ROI of $2.333,333 paid in 4 years at Exit Sale of IP new drug RD license to Big Pharma and DoD for new FDA approved new drug. Radiation Dermatitis. This rain forest plant extract is the world's first management to topically cure radiation dermatitis burn in 14 days. USPTO utility patented, managed by experts, 14 years in MD led R&D, and when fully funded will begin FDA IND trial. Investment guarantees first right of refusal to invest in other new drugs of Berry Pharmaceuticals, LLC, Texas based life science company, private and non-profit entity. Made in America by Americans, growing proprietary raw biomass 100% owned in secure, domestic pharmaceutical grade greenhouse in Rio Grande Valley Texas.
Business: Plan Summary:      Berry Pharmaceuticals, LLC (BP) was formed in 2010 was the purpose of developing new pharmaceutical drugs derived from natural botanical extracts found in a South American rain forest plant first discovered  in 2004 by the founder and owner ,Don Wayne Berry, MD, retired Texas heart surgeon.   Five years were spent in DISCOVERY.  This involved complete identification of the plant Genus and species, growing the plant, duplicating extracts, Dermatology supervised self studies on skin diseases, 1st of 7 patentability studies, all successful.  Stage A.    4 1/2 years in Horticultural Science studies about the plant:  24 months at Texas A&M University in a Grant with Berry Pharmaceuticals, LLC.  studying protocols for optimal growing  ans extraction strength with a written monograph by professors at TAMU now our IP,   30 months doing private greenhouse studies confirming all that TAMU stated at maximum growing capacity 12,000 plants in 50,000 sq. ft. harvesting every four months.   Stage B.  Giant Human Field Study for safety and efficacy on human skin for five years 2015 to 2020 confirmed positive in Cosmeceutical skin care company CelSana Beauty and Health, LLC in Anti-Aging Skin Care Series sill in business, www. https://celsanabeauty.com .   Stage C.   Pharmaceutical Development beginning fall 2019 with fund raising in family and friends for $1.5M to do our first FDA IND  trial for the first new drug cure management of Radiation Dermatitis, USPTO patented 2016.   $700,000 is now raised and in escrow to date.  We need to complete $800,000 to fully fund the first IND.    6  pharmaceutical USPTO utility  patents  are issued now in 9 years.   
The following are copied actual investor documents for full detail:   1. V5 Doc 3 1/2 page summary,   2. V5 Business Structure Letter



 1.     DOC 536789 Abbreviated Summary RD Radiant Project

Three and half Page Summary Revision 1 November, 2019

Summary:   This summary highlights certain changes to the proposed Offering Terms for “ X-Rase RD (Radiant) Developmental, LLC “ (2019) , the legal entity conducting the FDA IND Study, with a revised funding approach that seeks to use Grant funding for 2nd Milestone capital raise for Clinical FDA Phase l & ll Trials in lieu of a traditional Class Offering.  Five (5) options exist for RD Grants: CPRIT, RTOG, DoD, BARTA, and Private Offering of Phase l Study (associated with RTOG in Phase ll Study). 

Company:   Berry Pharmaceuticals, LLC, 2010 (The Parent Company), is a Texas-based life science company that manufactures pharmaceutical grade natural botanical biomass through secure, domestic, and continuous greenhouse operations (GA-CP) in the Rio Grande Valley, Texas (Ontogeny Inc, 2012).   The standardized dried GA-CP biomass is extracted/formulated into final products using GMP standards. Utility patents are issued in challenging health care issues. The Business Structure Letter ( FYI ) explains in detail the Radiant RD  FDA  New Drug Project. This summary is FYI for potential investors.

·         Barriers to Entry are well developed

·         Management Team is in place and are very highly experienced professionals 

·         FDA Botanical Guidance Policy as regulatory pathway policy for new drug Radiation Dermatitis (RD), the first new drug: Topical D 02016 RD Drug

·         Each new drug requires a minimum of 3½ years to do FDA R&D for IND, Phase l Clinical Trial (safety), and initiate Phase ll Clinical Trial (efficacy) before EXIT SALE for each new drug

·         Planned EXIT SALE will occur for each new drug during Phase ll Clinical Trial

·         EXIT SALE of $500M is a conservative estimate for new drug RD for management of Radiation Dermatitis thru two separate EXIT SALES (see PROFORMA SECTION  in  Business Structure Letter)

·         There exist no drugs or methods of (RD) management comparable to Berry “RD” new drug

·         Berry RD utilizes unique biotechnology not presently in the marketplace

·        Investors are DDSs, MDs, businessmen, private retired individuals, some still working

Financials:  Assuming an EXIT SALE total of $500M and a CPRIT Grant of $20M, 

$80M of the EXIT SALE proceeds would be repaid to the State of Texas (CPRIT)  in cash only.  The balance of $420M would be allocated in 30% to the holders of Class A Units ($126M).  The Company or its affiliated entity in drug exit sale proceeds will use remaining funds to accomplish 2nd milestone:  FDA Phase I & II Clinical Trials ($20M, $4M for safety, and $16M for efficacy).  Twenty (20) Class B Units sold at $333,333.33 per Unit = $6,666,666.66 which would be a 2:1 Match for CPRIT Grant application of $20M.  ROI is $6,300,000 per Class B Unit (20 x $6.3M = $126M) which is 30% of $420M. 

 The actual amount of CPRIT  Grant funding request may be much less than $20M and as a result much less in 2:1 matching funds needed.  Subsequently, the ROI to the CPRIT State of Texas would only be 4:1 multiple of that lesser amount.

                                                                       

     Class A Private Offering: 1st milestone IND Trial,  Privately funded IND offer of thirty (30) Class A Units for an aggregate of $1,500,000, the first twelve (12) Class A1 Units (COMPLETE & CLOSED) will be offered at a purchase price of Fifty Thousand Dollars ($50,000) per Unit and the remaining second eighteen (18) Class A2 Units (ACTIVE & OPEN) will be offered at a purchase price of  Fifty Thousand dollars ($50,000) per Unit.  All purchasers of Class A Units will participate in proceeds from the sale of the new drug RD or its technology pari passu  with each other.  (See PPM Executive Summary) Investors who purchase initially and buy the Class A1 Units receive the very best value.   ROI Class A is 30% of $420M = $126,000,000. The first 12 holders of Class A1 Units have the very best value  and receive $7,000,000 per Class A1 Unit, which is 140X multiple for Class A1 holders who purchase Class A1 Units at a price of $50,000.    The second group of investors purchasing Class A2 Units for $50,000 receive a lesser value which is  a ROI 46.6X multiple for holders who purchase Class A2 at a price of $50,000.  ROI for Class A2 Unit holders purchase at a price of $50,000 per A2 Unit = $2,333,333.  The Holders who invest in a combination in Units of Class A will be pro-rated in accounting by attorneys.  The attorneys hold in escrow the signed PPM Executive Summaries and Subscriptions.  When the Class A Offering funding is completely gathered, the FDA IND Trial will begin.

Management Team:  HetroGeneity, LLC located in Washington, DC (HG) is a regulatory consulting firm with expertise in botanical drug development.  HG develops the regulatory filings for the US FDA, which will allow the initiation of non- clinical and clinical studies with X-Rase RD in the USA.  A budget will be assigned for the IND, Phase l & ll Clinical studies as we go along to help avoid overruns.  Contingency funds are set aside for potential grant costs.  Freddie Ann Hoffman, MD, HG CEO, and board certified toxicologist Dave Hobson, Ph.D. are very highly experienced individuals, each with more than three decades of experience in US regulatory affairs and  new drug development.  HG assisted the sponsors of the first--and currently only two--botanical new drugs approved by FDA under New Drug Applications (NDAs).  Dr. Hobson has extensive experience in pharmaceutical development and in bringing new drugs to market as outlined in his Curriculum Vitae (see  Hobson’s CV in  Letter of Business Structure).

 

Fourteen years of MD scientific discovery, R&D, laboratory research in both in-vitro and in-vivo studies, two clinical case reports under auspices of attending physicians, five years of large clinical cosmetic commercial field studies in safety and efficacy of botanical extract including  clinical pilot studies by third party professionals, and in associations with four of Texas’ largest and finest institutions:  MD Anderson, Houston, Southwestern Medical School, Dallas, TTUHSC, Lubbock, and Texas A&M University, College Station.  Dr. Hoffman has performed a GAP Analysis of Technology in the total review of the RD new drug “Topical D02016 RD Drug” that includes all the technical studies involved.  She will be happy to discuss her opinions of the RD Radiant Project to potential investors who have unanswered questions.

HOW WILL THE $1,500,000 BE SPENT IN ITEMIZED LISTING?  Explanations are in Business Structure Letter; IND is 18 Months once started.

$1M: 1.)  Dr. Hoffman’s HG group will write an expertise detailed regulatory review of IND and file with  the FDA dovetailing into Clinical (human) Trials. Budgets will be assigned,  2.)  Final Formulation of RD Product (includes GACP GH grown FDA certified biomass, extraction using specific solvents into three separate extracts, by extractor, and GMP formulation of recipe of final formula and outline  of GMP manufacturing process),  3.)  Chemical analysis of final formulated product with gas & liquid chromatography, 4.) Animal Pharmacology & Toxicology studies to test safety levels of product, 5.)  Proof of Concept Clinical (human) Pilot  study in safety and efficacy, 6.) Report of any adverse events, including any previous experience with RD drug in humans and be able to ship across state lines such as to CRO-Certified  Research Organizations who do the testings .  Goal is to reasonably demonstrate to the FDA that  the new drug is safe for human usage .

$500,000 is to 1.) establish new construction of a FDA GACP compatible biomedical pharmaceutical grade Greenhouse in Rio Grande Valley, Texas, long-term lease of land to house GH facility, equipment, materials, labor of a qualified grower, 2.)  usage of a second FDA compatible GACP biomedical pharmaceutical  grade GH for a cash crop to generate a revenue to defray expenses.  GH GACP growing and GMP formulations will occur inside Ontogeny, Inc., (2012) subsidiary of Berry Pharmaceuticals, LLC, 3.) contingency funds set aside for always having a balanced budget.

$4M is in performing Phase l Clinical (human) Safety Trials 18 months once started.

$16M is in performing Phase ll Clinical (human) Efficacy Trials 18 months once started.  

EXIT SALES will begin at end of Phase l Trials and extend into Phase ll. Dave Hobson, Ph.D. is experienced in conducting exit sales working with Big Pharma and DoD both for many years.

Don Wayne Berry , MD    Don Wayne Berry, MD, CEO

BerryPharmaceuticals.com       




2.  Business Structure Letter for potential investors

Houses all IP: USPTOs, LOGOs, Copy Rights, Trade Marks

                                                                                     
                                                          

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                                                                   1 November, 2019

 

 

            This term sheet (“Term Sheet”) summarizes the principal terms of a potential offering (the “Offering”) of membership interests in X-Rase RD Development, LLC (2019), a formed Texas limited liability company (the “Company”) under Berry Pharmaceuticals, LLC.(2010).  This Term Sheet is not intended to create any legally binding obligations and is not intended to be a private offering of equity interests in the Berry Pharmaceuticals, LLC, the Company under the Securities Act of 1933, as amended (the “Act”) or any applicable state securities laws.  Recipients of this Term Sheet are not to construe the contents of this Term Sheet, or any other prior or subsequent communication from the Company, or its representatives, as legal, investment, business or tax advice.  Any formal Offering of equity interests in the Company will be presented to prospective in a, separate Private Placement Memorandum (written November, 2019) accompanied by a Subscription Agreement.  This Term Sheet is intended solely as a basis for further discussion and is not intended to be and does not constitute a legally binding obligation of the parties. No legally binding obligations of the parties will be created, implied, or inferred until definitive agreements are executed regarding the subject matter of this Term Sheet. The performance by any party, before execution of a formal contract, of any of the obligations that may be included in a contract between the parties when negotiations are completed shall not be considered evidence of any intent by any party to be bound by the provisions hereof.  This Term Sheet is being delivered in connection with the execution of that certain Mutual Confidentiality and Non-Disclosure Agreement, a copy of which is attached hereto as Exhibit A.

 

 

Business:                     Berry Pharmaceuticals, LLC, a Texas limited liability company (“BP) was formed in 2010 for the purpose of developing new pharmaceuticals drugs derived from natural botanical extracts found in a true South American rain forest plant.  In 2016, BP received a USPTO RD utility patent issued for this botanical extract and believes that the drugs derived from it will stimulate therapeutics in DNA tissue repair and  APOPTOSIS regeneration and be broadly useful and applicable in the medical fields of dermatology, radiation oncology, internal medicine, neurology and plastic surgery, and burn medicine.  BP owns the utility patents and all of the licenses, intellectual property and royalty rights associated with these botanical extracts, and is currently responsible for all pharmaceutical grant applications with ownership of the deeds to any real pharmaceutical properties.  

 

                                    Prior to any Offering, the Company will be formed in and under applicable Texas law to develop, seek and obtain  approval from the Food and Drug Administration (the “FDA”) and subsequently market and sell a new drug derived from the patented botanical extracts for management of Radiation Dermatitis (the “Radiation Dermatitis Product”).  The X-Rase RD Developmental, LLC Company will receive an exclusive License (as defined below) to develop, market and sell the Radiation Dermatitis Product.  BP currently owns the usage patent for the Radiation Dermatitis Product issued by the USPTO.  The Radiation Dermatitis Product is intended to be a prescription drug for the management  of Radiation Dermatitis and following appropriate approval of the FDA, will be rebranded for sale and development.  The biotechnology for the Radiation Dermatitis Product does not currently exist in medicine for the management of Radiation Dermatitis and current products, such as Aquaphor and  Silvadene, are only used to manage symptomatic relief.   Amifostine (Ethyol® injectable is a FDA – approved as an orphan drug to reduce risk of toxicity due to chemo- or radiation therapy.     Amifostine when used for  RT showed a reduced risk of 77% of  in human trials, but there is a significant  side effect of severe hypotension(62% of patients), GI toxicity, and numerous other side effects.  The Company also believes that the Berry Radiation Dermatitis Product may serve as a countermeasure that the Department of Defense desires to utilize for benefit of the United States Government and Armed Forces. 

 

                                    Hamelia-Pedic, Technology Inc. (2012), a Texas corporation (“HPT”) owns one hundred percent (100%) of the issued and outstanding membership interests of the Company and will dilute and convert its ownership to Class D Units (as hereinafter defined) subject to the terms and conditions of the Offering (the “Class D Members”).

 

License Agreement:  BP will enter into a License Agreement with the X-Rase RD Developmental , LLC (Company), pursuant to which BP will grant an exclusive license to the Company to use its utility patents, licenses, intellectual property and royalty rights for the development, marketing, distribution and sale of the Radiation Dermatitis Product (the “License”).  The initial term of the License will be a minimum of four (4) years and in exchange for the License, the Company will pay to BP a License Fee of no less than Fifty Thousand Dollars ($50,000) a year at seven percent (7%) royalty from the development, production and sale of Radiation Dermatitis  Product (the “License Fee”).  The license fee shall be payable monthly with the first monthly payment due and payable on the one (1) year anniversary of the closing date of the Offering.

 

Management:             Don W. Berry, M.D.: CEO, CV Attached.

 

                                    Dave Hobson, PhD, DABT Toxicology: Consultant, CV Attached.

 

                                    Russell J. Miller, CPA: CFO.

 

                                    Freddie A. Hoffman, M.D., HeteroGeneity, LLC Consultant, Re: FDA Regulations, Bio – information is attached.

                                   Tim Vaughan, Dallas Texas Attorney,  Hallett & Perrin, LLC 

 

                                    The Management Team has a proven track record in developing new pharmaceuticals in the healthcare industry, including the successful development of other FDA approvals.

 

Legal Structure:  BP, LLC will provide a License Agreement to  Hamelia-Pedic Technology, Inc. (HPT) for each NewCo.   HPT will in turn provide each NewCo a License Agreement to perform R&D in FDA Botanical Guidance Pathway.   Legal advantages to multiple layering is a strong liability defense if ever there does occur a legal challenge.

The first NewCo, Radiation Dermatitis, and the second NewCo, Major Thermal Burns, each have two EXIT SALES:  1) Big Pharma for commercialization, and 2) Department of Defense USA for  the USA Military Armed forces  and stockpiling in national defense in event of  a nuclear attack of Americans.  Estimated total sales for each of the first two NewCos is $500 Million for each new drug;  a  Pro-forma  Summary for each NewCo is furnished here below in this document.

All successful companies have viable Successorship Plans.   Successorship Plan  is developed for these following  Berry Health Companies:   (Berry  Pharmaceuticals, LLC, Hamelia – Pedic Technology, Inc (C – class), Ontogeny, Inc. (S – class), all  future NewCo, LLCs housing new FDA drugs, and the Cosmeceutical Company, CelSana Beauty & Health, LLC in the event of Berry demise: either voluntary retirement, or involuntary incapacity, or death.   Dave W. Hobson, Ph.D., project sponsor of all of the same named companies since 2009,  is named and has agreed to serve as  interim CEO.  Upon activation of this Successorship Plan, Dave Hobson and participating Berry Family member (s)receive automatic ownership of common stock in HPT.    Two qualified Berry family members are identified to work with Dr. Dave Hobson.   The Successorship Letter is signed by all Berry family appropriate members and the Successorship Letter is entered into the Minutes of Berry Pharmaceuticals, LLC.   Bennett G. Cooke of Lubbock, Texas is the Berry personal attorney who cares for the Last Will & Testament of Don & Patty Berry.   A second holder of the Successorship Plan is Tim Vaughan, corporate attorney  for Berry Pharmaceuticals, LLC at Hallett & Perrin, LLC, Dallas, Texas.

   All IP is housed inside Berry Pharmaceuticals, LLC, the parent Company and Licencor.    The IP rights of each patented drug respectively housed in BP, LLC will be licensed to HPT  who will in turn license each NewCo.   The NewCos are  designed to specifically domicile each new drug during the FDA R&D; each NewCo will have its own PPM, and Subscription Agreement.   NewCos  continue in the exit sale of that new drug and will be present for the duration of the life of their New Drug.     Purposefully, a triple  layered structure  for maximum liability protection for all participants (investors, owners, stockholders) and the legal structure of the pharmaceutical entities are designed by Securities Attorney, Tim Vaughan of Hallett & Perrin in Dallas, Texas. 

Symbió-Rase, is the internal code name that comprise the standardized  botanical and organically grown pharmaceutical plant extracts of a specific variety of the South American Rain Forest plant  that  are in prototype products  each having undergone Discovery.  As funding becomes present, the prototype of the New Drug formulation will be manufactured at pharmaceutical grade level GMP from dried botanical biomass according to FDA standards of FDA Botanical Guidance Pathway  in Ontogeny, Inc. utilizing GACP (Good Agriculture and Cultivation Practice) private Greenhouse Operations  in the Rio Grande Valley, Texas. 

Hamelia-Pedic Technology, Inc. (HPT) is a privately held biopharmaceutical C-Class corporation developing new pharmaceutical compounds to be marketed to Big  Pharma after each drug’s FDA clinical evaluation and approval.  Each new drug will undergo R&D inside a subsidiary LLC domiciled under HPT.  This first  NewCo entity is named X-RASE RD DEVELOPMENT, LLC (2019), the phenotype model for future corporate entities to domicile new drugs undergoing FDA R&D.  Both Radiation Dermatitis (RD)  and Major Thermal Burns (BN) are DoD designated countermeasures for the national security needs. The first new drug will be topical management of  Radiation Dermatitis; the second new drug will be topical management of Major Thermal Burns. The third new Drug offered is Actinic Keratosis.  Treatment cycle is limited and well defined for definitive markers in the first two New Drugs  There is also an urgency in developing Radiation Dermatitis since there is virtually no efficacy in current RD therapy regimens.  The market is very strong both in current need in private practice and the US Department of Defense, USA Government for stockpile use in National emergency for sudden Radiation exposure i.e.,  Dirty Nuclear Device in a large American metropolis;  25% to 30% of nuclear explosions cause major thermal burns.  We are now in direct communications with Brooke Army Burn Center in San Antonio at Fort Sam Houston regarding R&D of our Berry Burn product.  R&D is to be done at Brooke Army Burn Center in San Antonio, Texas  by Robert J. Christy, Ph.D., head military researcher.  President Trump has written a letter to the FDA requesting the these two new drugs be placed in “FAST TRACK” position to expedite the red tape during FDA Trials.

Ontogeny, Inc. is a privately held biopharmaceutical S-Class corporation developing GACP  Green House growing operations for biomedical pharmaceutical grade biomass and GMP formulation of final  new drug products.  Ontogeny, Inc. will also utilize some of the  Green House growing space to grow biomedical grade cash crops in the Green house for commercial sale for profit.  Revenues will be returned to Ontogeny, Inc.  after expenses are paid.

Ontogeny, Inc. is a privately held biopharmaceutical S-Class corporation developing GACP  Green House growing operations for biomedical pharmaceutical grade biomass and GMP formulation of final  new drug products.  Ontogeny, Inc. will also utilize some of the  Green House growing space to grow biomedical grade cash crops in the Green house for commercial sale for profit.  Revenues will be returned to Ontogeny, Inc.  after expenses are paid. 

Business strategy of HPT is to first obtain funding for each new drug for R&D along FDA botanical guidelines.  Pre-IND studies are done in order to  finish the application to schedule a IND meeting with the FDA.    Each new drug development is then placed into the drug’s own Investigational New Drug FDA (IND) evaluation for approximately 18 months of pre-clinical studies (formulation, toxicology, safety, and pharmaceutical processing).   After FDA-IND approval, each new drug will begin the 1st Clinical Trial (drug safety and 18 months).  Also after each new drug’s IND approval, the newco drug is eligible to be placed into one of four (4) Grant options for RD project:  1)  CPRIT (Cancer Prevention Research in Texas)  GRANT Competition, requiring only 4% ROI to the State of Texas. Radiation Dermatitis is considered to be in the Cancer Area since it is a curative management for radiation injury directly as a result of cancer treatment.  A 2: 1 matching fund is required in CPRIT. 2)  RTOG )radiation Therapist Oncology Group), no matching fund is required,  3)  DoD (Department of Defense), no matching fund is required,  4) BARDA (Biomedical Advanced Research  Development Authority), no match is required, 5) PRIVATELY  funded Phase l Safety Study, no match required.

 At the completion of the  Phase 1 Clinical Trial in approximately 18-20 months, the commercial marketing process of each new drug to big pharma will begin in the EXIT SALE  The IP royalty will then be sold using a 20 % discount of Net Present Value determination of competing products.   Investors are not purchasing equity stock in Berry Pharmaceuticals, LLC., however through the License Agreement process, the investors will participate in ownership material coming from BP, LLC.      If for some reason the drug is not sold at the beginning of FDA Phase ll Clinical Trial   (efficacy) level, the drug project will then  forward  to  complete the  Phase ll Clinical Trial (efficacy) and then be marketed.  The value proposition typically increases tenfold with each Clinical Trial

 

 

Regulation:                 The Radiation Dermatitis Product, as well as any other products that the Company may develop, market or sell from time to time, is likely to be subject to extensive regulation by the FDA, the Federal Trade Commission (the “FTC”) and other domestic and foreign governmental authorities.  The process of obtaining regulatory approvals for trials, manufacturing or marketing of these existing and potential products is costly and time-consuming and is subject to unanticipated delays. If the Company is required to conduct product trials, there can be no assurance as to the length of the trial period required to establish the safety, efficacy, and potency of these products. Accordingly, delays, rejections or unexpected costs may be encountered based on changes in the policies or regulations of the FDA or foreign governmental authorities during the period of product development and regulatory review, which may adversely affect the market for the Company’s products.  Even if regulatory approval of the Radiation Dermatitis Product is obtained, such approval may entail limitations on the indicated uses for which such product may be marketed, which may restrict the use of any product developed and marketed by the Company. In addition, a marketed product is subject to ongoing review by the FDA and other governmental agencies. 

                                    The Company has already made substantial gains in documenting Mechanism of Action and Proof of Concept of the Rain Forest plant extract including non-clinical and two clinical case studies verifying efficacy success which helps documentation to lower risk of investment. 

 

 

 

 

 

 

Offering Price:           The Company intends to privately raise up to $1,500,000 (One Million, Five Hundred Thousand Dollars to fund Class A offering to perform FDA IND (Investigational New Drug) for Radiation Dermatitis (RD) new drug (1st Milestone in FDA Trials in Radiation Dermatitis Product.

 

Use of Funds:             The Company intends to use the funds for the payment of organizational and syndication costs (legal, accounting fees, etc.), the purchase and/or lease of real property and equipment and to fund certain operational expenses and working capital of the Company.   The anticipated operational and working capital expenses related to the development and subsequent approval by the FDA of the Radiation Dermatitis Product include, but are not limited to, (i) the lease from Private land in Rio Grande Valley, Texas for greenhouses to grow the rain forest plants necessary to develop the Radiation Dermatitis Product according to  GACP “Good Agricultural & Cultivation Practice” standards set forth by the FDA; (ii) funding investigational new drug studies and testing; (iii) initial and secondary clinical trials focusing on safety and efficacy, respectively; and (iv) the production, development, marketing and sale of the Radiation Dermatitis Product in the marketplace.  

Offered:                      The Company intends to privately offer one Class A Units of membership interest in the company, each as described below (collectively “Units”) on a best-efforts basis to prospective investors who (i) are at least eighteen (18) years of age and (ii) who qualify as “accredited investors,” as defined in Rule 501(a) of Regulation D under the Act and applicable state securities laws.

 

And Offering Price:              

(i)                 The Company intends to offer a total of thirty (30) Class A Units for an aggregate purchase price of One Million Five Hundred Thousand Dollars ($1,500,000); minimum purchase per investor is one (1) Class A Unit or parts thereof and the maximum purchase per investor is thirty (30) Class A Units.  The first twelve (12) Class A1 Units will be offered at a Purchase Price of Fifty Thousand Dollars ($50,000) per Unit  (COMPLETED & CLOSED) and the remaining eighteen (18) Class A2 Units (ACTIVE & OPEN) will be offered at a Purchase Price of  Fifty Thousand Dollars ($50,000) per Unit. All Purchasers of Class A Units, will participate in proceeds from the sale of the Company or its technology Pari passus with each other.  Grant funding will not be  will not be offered until all Class A Units are fully subscribed.  The Company intends for the proceeds of the Class A Units to be used primarily for preliminary for IND for FDA meeting and to accomplish a IND FDA approval in approximately 18-20 months after funding of Class A Units.  Class A Unit holders possess 30% of common stock in RD new drug in aggregate. 

(ii)                

Initial 12 investors receive the very best ROI.  ROI of Class A1 Units is $7M per Unit, a 140 X multiple increase for Class Al investors, and the second 18 investors receive a lessor amount of ROI.   A ROI of Class A2 Units is $2,333,333 per Unit, a 46.6 X multiple increase for Class A2 investors.  Assume: Exit Sale for $500M, minus $80M to CPRIT ROI calculated by 4X$20M Grant = $80M,  $500M - $80M = $420M,  $420M X 30% =$126M, $126M divided by 30 Units: the first 12 investors receive  $7M per each Class A1 Unit, the next 18 investors receive $2,333,333 per each Class A2 Unit.  See full explanation page 11, Percent of Company offered.

                                    

 

(iii)            The Company plans to seek Grant funding as a non-equity Class member from one of five sources as listed below to capitalize funds for FDA Clinical Phase l (safety) and Phase ll (efficacy) Trials.   Size of capitalization will be in range up to  $4M for Phase l and $16M for Phase ll studies.   The CPRIT Grant does require a 2:1 match; the last four Grants do not require a match.  Investors in the PPM are described as having no Class B Units at present.   Financials of CPRIT are described for benefit of full understanding to investors.  

 

(iv)             CPRIT, State of Texas Grant, requires  matching funds of 2:1 ratio in cash only to be paid before making a formal permanent Grant application to CPRIT.  The three remaining grant sources do not require   a matching fund.

 

(i)                 The purpose for utilizing a Grant funding system is for benefit of the RD  project investors in order to increase the maximum level in the ROI.  

 

(ii)              Grants are competitive by nature requiring excellence in scrutiny at every level of the new drug project.   The Company has done its due diligence in homework to achieve excellence in R&D in Pharmaceutical development, raw commodity Horticultural Science, Legal structure, and Financial offering. The following is explanation of  the RD  new project.

 

 

                                                                                                                                                                           

 

 

                   

                                                                        

 

 

vi)                                EXAMPLE ONLY:   CPRIT Grant Usage:   The Company  may if CPRIT Grant is chosen as Grant of choice offer up to Twenty (20) Class B Units for an aggregate purchase price of Six Million, Six hundred Sixty Six Thousand Dollars ($6,666,666); minimum purchase per investor is one (1) Class B Unit and the maximum purchase per investor is twenty (20) Class B Units.  The Purchase Price per Class B Unit is Three Hundred, Thirty Three, and Thirty Three Dollars ($333,333.33).  Class B Units will only be offered after all Class A Units are fully subscribed and Class C Units  (Grant) will not be offered until all Class B Units are fully subscribed.  The Company intends for the proceeds of the Class B Units to be used primarily for 2:1 matching funds for CPRIT New Drug Development Grant, first time application, to perform Phase l & ll  Clinical Trials.  Grant is for $20,000,000 and a $2: $1 matching grant funds for a three year duration.  Information gained from the FDA approved IND will be used to further the CPRIT GRANT APPLICATION. (CANCER PREVENTION RESEARCH INVESTIGATION IN TEXAS).  Class B funding must be in place prior to submitting a CPRIT GRANT.

                                                ROI of this Class B Unit category is $6,300,000 per Unit (30% of $420M = $126M which is divided by 20 Units = $6.3M per Unit. This $6.3M per Class B Unit is a 18.9X increase from each $333,333.33 Class B Unit cost.

 

                                    (vii)      The Company intends to seek a grant funding from one of the following CPRIT, RTOG, DoD, BARTA. If CPRIT application is approved and the $20M Grant is awarded to the recipient, the State of Texas becomes a non-equity member, and a non-royalty member.  CPRIT will be entitled to receive, in preference to other investors, payment upon exit sale of RD Project of the Company in an amount equal to 4x the amount of grant monies distributed to the grantee by CPRIT (Assuming a grant of $20M, CPRIT would be entitled to receive four (4) times such grant amount or $80M. See the CPRIT Product Development General Contract Term Sheet, available on request.    

 

                                                The Company intends for the proceeds of the CPRIT grant to be used primarily for the Phase I & II Clinical Trials focusing on safety and efficacy, respectively; and the production, development, marketing and sale of the Radiation Dermatitis Product in the marketplace occurring during Phase ll Clinical Trial. 

                                                However, using combinations of other options, the actual cost of Phase l&ll Studies may be much less than the $20 M and include a Class B fund raise of $1.5M.  $IM would be paid to CPRIT in a 2:1 match  to gain back $2M for more testing such as $1M for Phase l study by a private 3rd party (option5)  and $1M to be used to accomplish RTOG doing Phase ll study (option 2).  

 

 

Exit Sale of New Drug:        The Exit Sale of each new drug will occur in FDA Phase ll Clinical Trial to two entities, one is Big Pharma which will probably be a botanical pharmaceutical company who will take over the  FDA Trial and finish studies to NDA, and the second will be to the US Department of Defense.   Dave Hobson, Ph.D. is experienced in making final Exit Sales of new drugs. 

                                                Assume: Exit Sale total of RD new drug to two entities to be $500M (see PROFORMA below).                                              

                                                

Class D Member:       (HPT) Hamelia- Pedic Technologies, LLC will be the Class D Member of the Company and will not own less than Forty Two (42) Class D Units. Berry Investments, LLC, a Texas limited liability company (the “Class D Member”), owns seventy (70%) Class D membership interests at present (each such interest referred to as a “Class D Unit”). The Class D Member will not own less than a seventy percent (70%) Class A ownership interest (assuming this Offering is fully subscribed) and assuming there is no Class B Units sold in the offering.

 

 

Class Distinctions:     As Members of the Company, Class A Members, and the Class D Member will have identical rights and duties except as follows:

 

(i)         Only the Class D Member and the Class A Member will be entitled to elect nominees to the Board of Managers.  See “Company Agreement Terms –Management.”

 

(ii)        Except for certain limited voting rights, including, but not limited to, the right to vote in favor of certain liquidity events, Class A2 Members, and Class C Member (Grant)  will have no voting authority and will be passive members of the Company.

To be Offered:           Maximum up to Thirty Percent (30%) in Class A Units; each whole Class A1 Units(12) twelve and A2 Units (18) eighteen  will represent thirty percent (30%) in the Company assuming the anticipated Offering is fully subscribed.  Assume BP receives $500 M at time of Exit Sale:

                                    $80M is paid to CPRIT at time of sale; $420M is profit to be used in following method:

40% x $420M = $168M to Class D investors:  pay expenses of BPMinimum Offering:  The minimum amount of funds required to be raised for the Company to conduct an initial closing of the Offering and begin implementing the business plan is One Million, five hundred thousand  Dollars ($1,500,000), which represents all the 30 Class A Units (the “Minimum Offering Amount”). Class A members will own 30% in aggregate with 30 Units.  A Separate escrow account will be maintained at the law firm of Hallett & Perrin, P.C.  If any subscriptions are found unacceptable or rejected, or the Company fails to raise the Minimum Offering Amount from prospective investors, all cash received in connection with such subscriptions will be refunded, without interest and without deduction for costs and expenses.

 

Financial Information:  Financial information with respect to Radiation Dermatitis Product and the Company is available on request and will be presented separately from this Business  Structure Letter  but will be made a part of any Offering. Founder and CEO of Berry Pharmaceuticals, LLC, Don Wayne Berry, MD, has personally invested the funds itemized below in Discovery, and R&D of the new drug project during the 14 years of tenure. 

 

a.       Consultations: $200,000 (2010-2019)

b.      Legal: $100,000 2009-2019

c.       SRA at TAMU 24 months 2011-2013:  $258,000 

d.      Nursery: 2014 6 months pilot study in private Greenhouse: $30,000

e.       Freeze Drying Dehydration Expenses 2014-2015: $50,000

f.        USPTO patent fees 2009-2019:  $100,000

g.       Extraction/Formulations: $150,000

PROFORMA in two new drugs

Third degree thermal burns are the most severe form of thermal burn injury.  Third degree involves all layers of skin compared to superficial sunburns such as  first degree thermal burn (sunburn) and second degree thermal burns which is a partial burn but does not include full thickness injury. 

There are 50,000 new third degree thermal burn cases in the USA yearly.   These type of patients are treated in Burn Centers or Burn Hospitals such as Shriners Children Hospital in Galveston, a part of University of Texas Medical Branch at Galveston, Texas.    The Parkland  Burn Unit at Southwestern Medical School in Dallas, Texas was the very first Burn Unit in the nation.

American Burn Association states that 40,000 of these serious burns are admitted each year to 128 Burn Centers  ( each burn unit averages 200 cases yearly).  25,600 cases each year are life threatening conditions.  $500,000,000 divided by 25,600 cases equals average of $20,000 per case cost.  The most severe burns undergo surgical procedures called escharectomy debridement of the necrosis and unviable burned full thickness tissue down to the viable tissue layers.  The loss of skin covering exposes the patient to outside infections such as bacteria that secondarily invades the open wounds.  Autogenous skin grafting, cadaver skin grafting, and allografts of even such things as Tilapia skin of fish are used to temporarily attempt wound protection.  Much hospitalization cost is associated with the severe burn injury that may last many days, weeks, even years, much more than $20,000 per third degree Major Burn.

In a perfect world, treatment would consist of near immediate relief through stimulation of the patients own autogenous granulation tissue coverage.  Simultaneously the treatment would consist of  topical treatment using  anti-bacterial substances to control the infection.  Another third modality needed is pain relief in an open area skin wound.  

New and unique biotechnology does exist in the new drug  Berry (BN) Prototype containing South American Symbió-Rase Rain Forest  Botanical Extract. A utility patented  ( USPTO  issued in 2019)  standardized  topical cream is applied initially following the escharectomy in preference to immediate skin-grafting, a traditional form of standard care following escharotomies.  The botanical new drug immediately stimulates the patient’s own autogenous granulation tissue growth that covers the wound in 24-36 hours, relieves pain and fights off invading bacteria.  Three specific bacteria are common in  Burn Center colonization of wounds: Escherichia coli, Methicillin Resistant Staphylococcus aureus, and Pseudomonas aeruginosa.   All three bacteria respond to the natural botanical extract’s small compounds without the use of expensive systemic antibiotics.   Burn wound sepsis is a life threatening condition that requires immediate medical attention and represents a major tenant of care in major third degree burns.  

Symbió-Rase BN is a block buster of a new drug that treats all three parameters in  natural concomitant fashion:  1.) natural analgesia completely relieves pain, 2.) immediately  natural botanical stimulation the body’s own autogenous granulation tissue to grow and populate the burn wound surface, and 3.) successfully fights bacterial colonization  naturally avoiding infectious colonization of the wound surface.  Symbió-Rase does away with the need for surgical skin grafting, need for powerful and expensive intravenous antibiotics and addicting pain medicines.  Clinical  tests  have shown complete epithelization wound closure in 2-3 weeks treatment time with daily dressing changes BID.  Primary healing of escharectomy burn wounds, no infection, no skin grafting , and no more morphine drips for pain will revolutionize Burn Medicine. 

Case File:   Wayne Newby 18 year old male , patient of Parkland Memorial Hospital Burn Center in Dallas, Texas was a 90% 3rd degree burn victim; Wayne was dismissed home after 5 years of attempted traditional skin grafting procedures, all of which failed on 4 large open burn wound escharectomy sites.  Our Topical BN Prototype successfully managed  all four wounds in a home setting in a three week time frame without any more skin grafting.  All four wounds have remained healed the past three years despite normal routine activities such as riding horses. 

If each third degree burn patient treatment cost on the average is just $20,000 ($500,000,000 divided by 25,600 = $20,000),  this new biotechnology will safe $10,000  per patient care cost, shorten treatment times, avoid surgical invasive skin grafting, relieve pain and avoid the most dreaded of burn wound complication of ongoing burn wound sepsis.  The sepsis issue is immediately combated using Symbió-Rase by growing granulation tissue which is defensive itself in healing open wounds and also the Symbió-Rase is naturally anti-bacterial, anti-viral, and anti-fungal.  All three bacteria most commonly infecting  open Burn Wound Center patients  are the very same three shown in the Laboratory Research to be responsive to topical Symbió-Rase.   At creation, God designed the botanical  extract needed in a true South American  botanical seed bearing rain forest plant for present day management of severe burn wounds in an exciting unique Blockbuster new biotechnology. This specific new drug most perfectly suits the unmet needs of third degree burn patients. 

 Summary of the Company Agreement

 

Management:             The Board of Managers will have the sole right to manage the Company’s business.  The Board of Managers will be composed of three (3) managers and the Class D Member will have the right to nominate two managers and the Class A Members will have the right to nominate one (1) manager.  The initial managers will be Don W. Berry, M.D., Dave Hobson, PhD, and a third to be nominated by the Class A Members pursuant to the terms and conditions of the PPM Offering.  The number of Managers may only be increased or decreased by amendment to the Company Agreement of the Company (the “Company Agreement”).  

 

Distributions:             The Board of Managers is required to determine the amount of cash,  available for distribution no less often than annually.  Any distributions of cash will be distributed pro-rata among the Members.  In addition to distributions of available cash, if any, the Board of Managers will make annual tax distributions as described in the Company Agreement.

 

 

Taxable Income:        Taxable income , if any, from operations will generally be allocated among the Members in such a manner so that the capital account balances of the Members equal their respective rights to Company distributions.  

 

Transferability:         Except for certain permitted transfers to affiliates, a Member may transfer its interests only if approved in advance by the Board of Managers, which may be withheld at the Board of Managers’ sole discretion, and only after complying with the right of first refusal described below.

 

 

 

Refusal:                      If a Member shall propose to transfer an interest to a third party, the Company shall have a right to purchase such Interest on terms identical to the terms of the proposed transfer to the third party.  If the Company does not exercise its right to purchase all of such Interest, the other Members shall have the right to purchase the portion of the Interest not purchased by the Company on terms identical to the terms of the proposed transfer to the third party.

 

Drag-Along:               If any Member or any group of Members (collectively, a “Dragging Member”) desires to transfer to a third party purchaser membership interests in the Company representing more than fifty percent (50%) of all the outstanding membership interests in the Company, then the Dragging Member shall have the right to require the other Members to sell to such purchaser, on the same terms and conditions as the Dragging Member, that percentage of such other Members’ membership interests in the Company as is equal to the percentage of the membership interests owned by the Dragging Member that the Dragging Member proposes to sell to such purchaser.

 

of Managers:              Members of the Board of Managers who are made a party, or are threatened to be made a party, to or are involved in any threatened, pending or completed proceeding, by reason of the fact that such Manager is or was a Manager or an officer of the Company shall be indemnified by the Company to the fullest extent permitted by Texas law; provided, however, that no person shall be entitled to indemnification if the acts or omissions of such person constitute an intentional breach of the Company Agreement or gross negligence or willful misconduct on the part of such person.

 

Governing Law:        All documents will be governed by the laws of the State of Texas.

 

 

 

Management Accomplishments:  Freddie Ann Hoffman, MD,  CEO of HeteroGeneity, LLC has completed a  detailed technical  review  of the RD Radiant Project called a GAP Analysis.    Fund raising is active currently to fully fund the  FDA RD IND  project.   To date $600,000 has been raised.   $900, 000 is remaining to be raised.   

                                    When funding is completed Dr. Hoffman and staff at HeteroGeneity, LLC will write an expertise detailed summary of the FDA IND study as it relates to the Clinical Trials.  She will then file the   IND Review Document  with the FDA.   During the IND study, a decision will be made of the Grant approach strategy.  

                                    As soon as the RD FDA IND Funding is accomplished, work on the Berry Burn  FDA IND fund raising will begin.     The Company can conduct two (2) INDs at one time simultaneously.      

 

See Attached; 3 page NDA of the Company Berry Pharmaceuticals, LLC, NDA is to be signed in event an investor wishes to proceed with committing to invest in the project. 

 

Berry Pharmaceuticals, L.L.C.

624 Rio Grande Loop

Georgetown, TX 78633

 

 

Date                                        

 

 

__________________

                                    

                                    

 

 

Attention:                                 

 

Gentlemen:

 

This will confirm that Berry Pharmaceuticals, L.L.C., a Texas limited liability company ("BP"), on behalf of itself and certain other entities or persons with whom which BP or its affiliates may have relationships (collectively, the “BP Group”), intends to enter into certain business discussions with                                ("Recipient”), concerning a possible relationship between members of the BP Group and Recipient (a “Transaction”).  In connection with such discussions and in order to assist Recipient in evaluating a Transaction, BP may disclose certain confidential and proprietary information to Recipient.  Such confidential information (collectively, the "Information") may include, but is not limited to descriptive, source, background, chemical and technical information, data and materials relating to active ingredients, scientific research methodologies, and results of scientific research and tests, financial statements, theories, research methods, procedures and results, business plans and budgets, marketing plans, cost and expense data, and other business or trade information concerning BP or other members of the BP Group that BP regards as confidential, specifically including, without limitation, all information and data contained in that  Hamelia-Pedic Technology, Inc, Ontogeny, Inc.,  CelSana, Beauty & Health LLC, X-Rase RD Developmental, LLC and other future Series LLC for R&D of new  pharmaceutical drugs.  Business Plan Summary, dated,  2013, and in all amendments, modifications and supplements to such Business Plan Summary, if any.

 

In consideration of BP disclosing or revealing the Information to Recipient, Recipient agrees as follows:

 

1.         Recipient shall treat the Information as confidential, and neither Recipient nor any affiliates, stockholders, partners, principals, members, managers, employees, agents or representatives of Recipient (collectively "Representatives") shall disclose the Information to third parties, nor use the Information for any purpose unrelated to such evaluation or advice, except as to any Information contained therein: (a) which Recipient can show was in its possession or was known to the public or in the published literature prior to BP’s disclosure or making available of such Information to Recipient hereunder; (b) which subsequent to the time of BP’s disclosure or making available of such Information to Recipient, becomes known to the public or appears in the published literature through no fault of Recipient; or (c) is lawfully acquired by Recipient from a third party who is not in breach of any confidentiality agreement with BP with respect to such Information. 

 

2.         Recipient shall restrict access to the Information to those of its Representatives directly involved in evaluating BP or the other members of the BP Group (who may include attorneys, accountants and other consultants employed by Recipient in connection with such evaluation and advice), it being understood that they shall be informed by Recipient of the confidential nature of the Information and shall acknowledge that by receiving the Information they are agreeing to be bound by the terms and conditions of this Agreement.  Recipient shall, if requested by BP, require all of its Representatives who may obtain access to the Information to sign individual confidentiality agreements with BP or the other members of the BP Group respecting the business of BP or the other members of the BP Group.

 

3.         All Information shall remain the property of BP or the other members of the BP Group, as the case may be, and all written Information, with all copies and extracts thereof, shall forthwith be delivered to BP, and all memoranda, notes and other writings prepared by Recipient or its Representatives based on the Information shall be destroyed upon BP's request, or upon termination of such exploratory discussions for any reason.

 

4.         In the event Recipient or its Representatives are requested in any legal proceeding to disclose any Information, Recipient will give BP prompt notice of such request so that BP may seek an appropriate protective order.  Such notice shall, in no event, be more than two (2) business days following the receipt by Recipient or its Representatives of such request to disclose the Information in a legal proceeding.  If, in the absence of a protective order, Recipient is nonetheless compelled to disclose the Information, by a court or governmental body having the apparent authority to order such disclosure, Recipient may disclose the Information without liability hereunder; provided however, that Recipient gives BP written notice of the Information to be disclosed as far in advance of its disclosure as is practicable and, upon BP’s request, Recipient uses its best efforts to obtain assurances that confidential treatment will be accorded to the Information.

 

5.         Except for the obligations of confidentiality and restricted use set forth in this Agreement, neither Recipient, on the one hand, nor BP or the other members of the BP Group, on the other hand, shall be committed in any way with respect to the matters to be discussed.

 

6.         Subject to the requirements of confidentiality and restricted use set forth in this Agreement, nothing contained herein shall be construed to obligate either party to refrain from engaging at any time in any other business in which the other party is now or hereafter engaged, or to refrain from entering into negotiations and/or agreements with any third party.

 

7.         Recipient and BP hereby each confirm that any Information that BP has disclosed to Recipient prior to the date of this Agreement was disclosed on the basis set forth in and shall be subject to the provisions of this Agreement.

 

8.         From the date of this Agreement, neither Recipient nor any of its Representatives will, without the prior written consent of BP, make any statement, or any public announcement, or any release to trade publications or to the press, or make any statement to any competitor, customer, or other third party, with respect to such discussions, except as may be necessary, in the opinion of counsel, to comply with the requirements of any law, governmental order or regulation.

 

9.         Recipient agrees that money damages would not be a sufficient remedy for any breach of this Agreement by Recipient or any of its Representatives, and that, in addition to all other remedies, BP and the other members of the BP Group shall be entitled to specific performance and injunctive or other equitable relief as a remedy for any such breach.  Recipient further agrees to waive, and to use its best efforts to cause its Representatives to waive, any requirement for the securing or posting of any bond in connection with such remedy.

 

10.       The above obligations of confidentiality and restricted use shall expire three (3) years following the date of this Agreement.

 

11.       This Agreement shall be governed and construed in accordance with the laws of the State of Texas, without giving effect to its conflict of laws, principles or rules.

 

Please indicate your agreement with respect to the above terms and conditions by signing the enclosed copy of this Agreement at the place indicated below and returning such copy to my attention. 

 

                                                                                    Very truly yours,

 

                                                                                    Berry Pharmaceuticals, L.L.C.

                                                                                                

                                                                                    

                                                                                    By:   DonWayneBerry, MD

                                                                                    Name:  Don Wayne Berry, M.D.

                                                                                    Title:    CEO, Founder

Accepted and agreed to:

 

___________________

                                                                                                                                                                                 
CURRICULUM VITAE 2019

624  Rio Grande Loop                                   P. 0. Box 361

Georgetown, TX  78633                               0960 Rio Grande Club Trail

                                                                 South Fork, Colorado 81154

 

University

 

West Texas A & M University, Canyon, Texas, B.S. 1960-1963

•          Dean's List, Summa Cum Laude

•          Mary E. Hudspeth Honor Society

•          Alpha Chi Honor Society

•          Who's Who in American Colleges and Universities

•          Most Outstanding ROTC Cadet Award

•          Chicago Tribune Award

•          President, Buffalo Bills (Social Service Organization)

•          Laboratory Instructor - Chemistry

 

Medical School

 

University of Texas Southwestern Medical School, Dallas, Texas 1963-1967

•          Eben J. Carey Award (highest scholastic achievement in Gross Anatomy) 1964

•          Phi Chi Medical Fraternity

•          Student American Medical Association

•          Awarded Top-of-Texas County Medical Society Scholarship 1965

•          Student Research

Department of Surge1y, Drug Studies, Dr. Charles R. Baxter Division of Urology, Cancer of Prostate, Dr. Paul Peters

•          Surgical Assistant, St. Paul's Hospital, Dallas

•          Surgical Externship, Highland General Hospital, Pampa, Texas

 

Postgraduate Training

 

INTERNSHIP - 1967-1968

•          Rotating Internship, Parkland Memorial Hospital, Dallas, Texas RESIDENCY - 1968-1972

•          General Surgery, University of Mississippi Medical Center, Jackson, Mississippi

•          Awarded Southern Medical Association Residency Training Grant for Surgical Research in Arterial Trauma 1971-1972

FELLOWSHIP - January- December, 1978

•          Peripheral Vascular Fellowship, Baylor Medical Center, Houston, Texas under Michael DeBakey, MD

 

 

RESIDENCY - 1985-1986

•          Cardio-Thoracic Residency, Ochsner Foundation Hospital, New Orleans, Louisiana

Private Practice

 

 | 1987-2001 | Cardiac, Thoracic, Peripheral Vascular Surgery, Lubbock, Texas
 | (1985-1986) | (Cardio-Thoracic Residency)
 | 1977-1987 | Peripheral Vascular and General Surgery, Hendrick Medical Center and Humana Hospital, Abilene, Texas,

(1978)                         (Peripheral Vascular Fellowship)   

1972-1977                   General Surgery, Private Group Practice, Hillsboro, Texas

 

Appointments

 

 | 1996-1999 | Medical Director, St. Mary Mobile Cardiovascular Ultrasound
 | 1993-1994 | Chief of Staff, Department of Cardiovascular Surgery, St Mary of
 |   | Plains, Hospital, and Methodist Hospital, Lubbock
 | 1988-2001 | Clinical Assistant Professor, Texas Tech University Health
 |   | Sciences Center School of Medicine, Lubbock
 | 1973-1984 | Clinical Assistant Professor, University of Texas Southwestern
 |   | Medical, Dallas
 | 1971-1972 | Chief Administrative Surgical Resident September and October, University of Mississippi Medical School, Jackson
 | 1969-1972 | Assistant Instructor, Department of Surgery, University of

Mississippi Medical School

 

Certifications

 

•         Board Certified, General Surgery, American Board of Surgery, Cert. #20122 April, 1974. Valid in perpetuity

•         Board Certified, General Vascular Surgery, American Board of Surgery, Cert. #46 November, 1983, Recertified October, 1992. (Valid through 2004).

•         Board Certified, Thoracic and Cardiovascular Surgery, American Board of Thoracic Surgery, Ce1t. #4641, May, 1988, Recertified 1996 (Valid through 2008).

•         Certified, Registered Vascular Technologist, The American Registry of Diagnostic Medical Sonographers. Registry #56082, 1997.

 

Medical Licenses and Permits

 

•         Texas State Board of Medical Examiners, No. D-4602 (1968-present) - Texas Medical License - active

•         Texas Department of Public Safety, No. P0005580

•         Drug Enforcement Administration, No. AB527523 (expires July 31).

•         Malpractice Insurance, Medical Protective Company, No. 517055 (expires December 15).

•         NPI: 1902130701

 

Associations

 

•         Lubbock-Crosby-Garza County Medical Society

•         Texas Medical Association

•         Texas Society for Gastrointestinal Endoscopy, 1980

•         Southern Medical Society

•         Diplomate of National Board of Medical Examiners

•         Alton Ochsner Surgical Society

•         Michael DeBakey International Cardiovascular Society

•         American Society for Gastrointestinal Endoscopy, Cert. 1979

•         American College of Surgeons, 1975

•         Committee on Trauma, American College of Surgeons

•         Texas Surgical Society, October, 1983

•         International Society for Cardiovascular Surgery, 1982

•         James D. Hardy Society, 1992

 

Presentations

 

1.      Berry, D. W.: American College of Surgeons, North Texas Chapter, Spring Meeting, Dallas, Texas. Celiac Artery Stenosis - Arcuate Ligament Syndrome. May, 1979.

 

2.      Berry, D. W.: American College of Surgeons, North Texas Chapter, Spring Meeting, Dallas, Texas. Splenic Vein Thrombosis - A Curable Form of Portal Hypertension. May, 1982.

 

3.      Berry, D. W.: Diabetes Update, Aspen, Colorado. Cerebrovascular Insufficiency, March, 1984.

 

4.      Berry, D. W.: Texas Surgical Society, Spring Meeting, Lubbock, Texas. Bleeding and Clotting Problems in Surgical Patients. April, 1984.

 

5.      Berry, D. W.: Concomitant Myocardial Revascularization with Left Ventricular Aneurysm Repair. International Society for Cardiovascular Surgery, XVIII World Congress, Sydney, Australia, September 20-25, 1987.

 

Military

 

Obligation completed. Active Ready Reserve U. S. Navy, Dallas Naval Air Station, September, 1972 - September, 1975. Rank at Discharge: LCDR

 

Retirement Retired July 1, 2001

 

Publications

 

1.     Neely, W.A.; Berry, D.W.; Hardy, J.D.; and Rushton, P.R.: Septic Shock: Clinical Physiological and Pathological Survey of244 Patients. Presented at Southern Surgical Association, December, 1969, Boca Raton, Florida. Ann. Surg., 1971.

 

2.      Hardy, J.D.; Raju, S.; Neely, W.A.; and Berry, D.W.: Arteries and other Arterial Injuries. Ann. Surg., 181: 640, 1975.

 

3.      Vauthey, N.; Berry, D.W.; and Ochsner, J.: "Surgical Repair of Left Ventricular Aneurysms with Concomitant Myocardial Revascularization in 244 Consecutive Cases." Ann. Thoracic Surg., 46:29-35, July, 1988.

 

4.      Berry, D.W.; Vauthey, N.; Ochsner, J.; and Mills, N.: "Difficult Cases of Left Ventricular Aneurysm Repair." Journal of Cardiovascular Surgery, In Press, 1988.

 |
 |   |

 

 

Married April 14, 1968, to Patty Lynn Columbus through present, 50 years anniversary Four children, Ten grandchildren

Grew up in Pampa, Texas

Born May 2, 1942, in Pampa, Texas to Mr. and Mrs. Albert E. Berry of Pampa, Texas Religion: Church of Christ

 

Businesses

 

Berry Farms LTD - Texas Based Family Partnership with family as Limited Partners in multiple holdings

 

Berry Oil & Gas, LLC - Non-passive Income with oil holdings, Texas, Kansas

 

Berry Pharmaceuticals, LLC - CEO and Founder, Organized 2010 to initiate IP application in two "C" and "S" class Corporations for development of IP

1.      USPTO Patent Approval Nov. 2013 appl. No. 12/661,567, Issued 18 February, 2014 8,652,534 Actinic Keratosis: Compositions and Methods for Treatment of Mammalian Skin, Inventor: Don Wayne Berry, M.D.

Ontogeny, Inc. - "S" Class, Organized July, 2012, as private commercial botanical biomass greenhouse growing, harvesting, manufacturing, creating botanical extract multiple product business in Series LLC for each new drug

 

Hamelia-Pedic Technology, Inc. - "C" Class, Organized July, 2012, as Subsidiary Corporation to do R&D to develop IP for new innovative life science technology of five innovative new pharmaceutical drugs

 

CeISana, LLC - Organized 2015 to do commercial cosmeceutical testing skin care products in marketplace, dissolved into CelSana Beauty & Health, LLC in 2017

 

CelSana Beauty & Health, LLC - Organized 2017 for marketing of cosmeceutical skin care products, and on 1 November, 2018 became an Internet Store

 

Sun-Rase AK Developmental, LLC 2015 for R&D of new pharmaceutical Drug as first of a Series LLC for each new drug; a prototype for future LLC formations

 X-Rase RD Developmental , LLC   2019 for R&D of new pharmaceutical new drug Radiation Dermatitis RD  

 

           

 

 
CURRICULUM VITAE

613 Pleasant Valley Drive Boerne, TX 78006

Office:(210) 269-6169

 

 

 | 1982 | Doctor of Philosophy - Toxicology, Texas A&M University.
 | 1978 | Master of Science -Zoology (Marine Environmental Toxicology), Texas A&M University.
 | 1975 | Bachelor of Science - Zoology, (Chemistry minor) University of Nebraska.

American Board of Toxicology- Certified 1985, Recertifications 1990, 1995, 2000, 2005, 2010

 

EXPERIENCE
2008 - Present 

2005 - Present

2001-2008

President of Lone Star PharmTox LLC a pharmadevelopment and medical device consulting firm that provides support and advice to government and industry on product and technology development issues primarily for dermatologic, ocular, wound healing and tissue repair therapeutics and devices including nanotechnology drug and diagnostic products.

 

Chief Scientific Officer (acting), NanoTox Inc., Austin, Texas and NanoTox BV, Maastricht, The Netherlands. Establishment and management of laboratory  and research operations for the first private international nanotechnology products safety and risk assessment firm. Work includes toxicology evaluations, design consultations, product discovery and development support, intellectual property safety evaluations,  preparation  of safety and risk assessments for key clients. Formally, this is a consulting contractual  relationship in an "acting" capacity to assist the growth of a U.S. based, international  startup company needed to facilitate  the safe discovery and development of emerging nanotechnology products.

 

Senior Partner, H&H Scientific Services, LLP., a toxicology/pharmaco]ogy consulting partnership specializing in pharmaceutical development with emphasis on topical dosage forms including medical devices, small molecules, peptides, biopharmaceuticals and veterinary  pharmaceutics. Partnership specializations also included  occupational health,

environmental impact and risk assessment The client base included, government, industry, private research institutions and legal firms. In 2008, the company divided into two entities for business growth and efficiency reasons, one handling environmental impact and risk assessments primarily for the U.S. Environmental Protection Agency and Lone Star Pharm-*Tox LLC becoming the pharmaceutical and medical device client supporting entity.ice President, Research & Development, Chrysalis Biotechnology, Inc. One of three principals responsible for the oversight of a multimillion-dollar proteomic research and development program that included novel  tissue repair  therapeutic  peptides. Projects included discovery through NDA research studies on bone, cartilage, cardiovascular, nerve, muscle and epithelial tissues. Prepared  and  presented four IND filings in different divisions of the FDA for synthetic peptides. Also, prepared  pharmacology/toxicology and CMC sections for licensee filings. Established strategic collaborations with academic, government and industry R&D partners. Directed the manufacturing of  and the formulation and manufacturing of novel dosage forms including a novel microsphere-based, multicomponent delivery system for orthopedic applications. Participated in the design  of clinical  programs for chronic wound healing, cardiovascular and dental indications. Established mission and vision statements for the company. The company received the Frost & Sullivau Technology Innovation Market Engineering Award for 2001 and Deloitte & Touche Technology Fast 500 Award for 2002. The company remained financially strong and privately held during tough economic times and the strategic plan to increase the technology value, without venture capital, and to position for acquisition was advanced as therapeutics moved to NDA filing.

In 2004, Chrysalis Biotechnology Inc., a private entity, was successfully acquired by a public company.

 

Vice President, Medical Product Research and Development, DFB Pharmaceuticals, Inc. and Healthpoint, Ltd., Responsible for coordinating the activities of senior scientists directing the development and technical activities for product development pipelines leading to new infection control, wound healing and dermatological products. Develop and coordinate all product safety testing and clinical studies. Evaluate and introduce new technologies for infection control, wound healing and dermatology. Review and participate in FDA submission activities to include IND, NDA, ANDA, and chemical germicide submissions and review of OTC product development. Responsible for oversight of product safety and preclinical development programs for Healthpoint, DFB Pharmaceuticals and DPT Laboratories including adverse reaction response and reporting, preparation of Material Safety Data Sheets, CMC sections, preparation of toxicology evaluations for new technologies, conduct of preclinical safety studies in support of 510(k), ANDA, IND, PMA and NDA submissions, product label preparation and review. Perform toxicologic reviews of cleaning procedures used and data obtained in contract manufacturing operations engaged in manufacturing over 100 different topical and oral products. Developed several key intellectual properties that have resulted in currently marketed products and patents for novel formulations.

 

 

Director, Pharmaceutical Sciences, Dermatological Products of Texas (DPT) Laboratories (now an operating division of DPT  Pharmaceuticals). Responsibilities  include  coordination of pharmaceutical discovery and development group research and development activities including toxicology and pharmacology study design and oversight, microbiological testing, formulation chemistry and analytical chemistry. Work involved the oversight of in-house and extramural research and development projects, including toxicological studies and CMC sections required for the preparation of IND, NDA, ANDA, 510k and chemical germicide submissions.

Vice President, Medical Research and Development, and Manager Medical Research and Evaluation Facility (MREF), Battelle Memorial Institute, Columbus, Ohio. Responsible for the operation of Battelle's principle pharmaceutical discovery support laboratory and the design, construction and operation of its first biosafety (BSL-3&4) facility with an annual research budget totaling over $20M and a total staff population of 60 individuals (18 Ph.D., D.V.M., MBA, and M.S. level professionals, 38 technical/clerical, and 4 facility maintenance/support). Work involved developing novel pre-clinical pharmacologic and

toxicologic test procedures, pre-clinical pharmacokinetic ADME studies, clinical pharmacokinetic studies and the screening of new pharmaceuticals using both in vivo and in vitro toxicology and pharmacology models for discovery evaluations and new drug submissions (NDAs). This facility has grown to over 250 employees and continues to be a premier and exemplary research operation for both Battelle and the U.S. government.

 

Research Leader, Medical Research and Evaluation Facility (MREF), Battelle Memorial Institute, Columbus, Ohio. Directed Battelle's principal pharmaceutical discovery support research program.  Also served as Co-Director of the Battelle-North Carolina State University Cutaneous Toxicology Research Center. This work involved the development of

in vitro and in vivo pharmacologic and toxicologic models (including chemical and

biochemical analytical methods) to screen and evaluate new therapeutic agents in the drug discovery mode and to support pre-clinical regulatory submissions. Developed new skin equivalent models and served as a technical advisor to companies involved in the commercial development of vatious skin equivalent, transdermal drug delivery and wound healing technologies.

 

Associate Manager, Biomedical Sciences Section, Battelle Memorial Institute, Columbus, Ohio. Assisted in the direction of research activities of 9 professional and 28 technical staff members with a total annual volume of approximately $5M in government and industrial contract work. Research studies involved pharmaceutical discove1-y, evaluation and

development (GLP studies for FDA submissions, in vitro and in vivo screening,

pharmacokinetics, etc.). Projects of personal interest involved development of advanced, cell and organ culture-based skin toxicity test procedures, assisting our Washington D.C. and North Cm·olina offices with required toxicology input for human health risk assessments and environmental impact statements, development of a humane in vivo dermal wound model for drug assessment and, establishment of an in-house capability for construction  and validation of physiologically-based pharmacokinetic models for dose route and interspecies extrapolation.

 

Principal Research Scientist. Medical and Chemical Sciences Department, Battelle Memorial Institute. Directed and participated in the conduct of GLP toxicology, pharmaceutical

efficacy and pharmacokinetic studies involving the use of various laboratory animal species (rabbits, swine, sheep, non-human primates). Developed novel in vitro and in vivo procedures for the screening and development of various pharmaceutical agents that were under consideration as new drugs by the U.S. Food and Drug Administration (NDA).

 

Principal Investigator and Head of the Applied Toxicology Section, Naval Medical Research Institute, Toxicology Detachment, Wright-Patterson AFB, OH. Performed toxicologic and pharmacologic evaluations of chemicals, pharmaceuticals and mixtures of interest to the Department of Defense for medical, occupational health, materials development and drug abuse assessment purposes. Studies conducted included inhalation, dermal, behavioral, reproductive and combustion toxicology studies. Established the Navy's first in vitro

toxicology laboratory and combustion toxicology research facility. Developed clinical chemical methods to detect pharmacologic and toxicologic changes in serum, urine, pulmonary lavage and seminal fluids of laboratory animals. Served as Navy liaison to the Americau Petroleum Institute and Petrochemical Industry for fuel matters and the evaluation of toxicity of unleaded gasoline.

 

Research Associate and Laboratory Instructor. Veterinary Physiology & Pharmacology Department, Texas A&M University. Developed nuclear medical procedures and radiopharmaceuticals used in various veterinary medical research projects including toxicology and pharmacology studies. Taught laboratory courses in Nuclear Medicine and Physiology for Bioengineers at the Veterinary School.

 

Research Associate and Laboratory Instructor. Biology Department, Texas A&M University. Taught laboratories and lecture portions, for General Biology and Comparative Animal Physiology courses. Conducted contract research studies for various government and industry sponsors concerned with the toxicity of various crude oils and crude oil fractions to various marine and estuarine animals (vertebrates and invertebrates),

 

Analytical Chemist (Nuclear). Center for Trace Characterization, Chemistry Department, Texas A&M University. Utilizing state of the art nuclear analytical methods, established and operated computer-assisted neutron activation analysis systems and performed trace element analysis of various materials (i.e., Apollo program moon rocks, meteorites, deep ocean sediments, etc.) using radiochemical procedures at the university's TRIGA Mark ill (1 MW) nuclear reactor research facility. Analyses of trace elements in samples of various compositions from various contracting agencies including NASA, BLM, NIOSH and EPA as well as several major companies were performed to provide data necessary to solve applied scientific problems. Additional trace analytical and preparative modalities used included proton induced x-ray emission (PIXE), x-ray fluorescence, atomic absorption aud HPLC methods.

 

Research Assistant/Residence Advisor. University of Nebraska, Lincoln. Developed uovel neutron activation analysis procedures for the routine determination of trace aluminum and iodine in clinical at the Veteran's Administration Hospital TRIGA Mark I (250KW) nuclear reactor research facility in Omaha. Trace aluminum work was focussed ou examining toxicologic hypotheses for trace metal pathogenesis of senile dementias and bone disorders. Concurrently worked as a personal and academic counselor to students in a men's residence hall.

 

(Peer Reviewed Publications= 51; Book Chapters 16; I Book)

 

Hobson DW, Nanotechnology, Comprehensive Biotechnology, Moo-Young et al. eds., Elsevier, July 2011, 5320 pp.

 

Hobson DW, Basic Toxicological Issues in Product Safety Evaluations, Ballentyne, et al., eds. General and Applied Toxicology. 2010 Hobson, D.W. Commercialization of Nanotechnology, Nanomedicine. 2009

Hobson DW and Hobson VL. Normal and Abnormal Intestinal Absorption in Humans, Chapter 11 in S. Gad ed.. Toxicology of the Gastrointestinal Tract, CRC Press, Boca Raton, FL. 2007.

 

Hobson DW and Seal LA, Brushless Surgical Handwashing, Chapter 15, pp 221-240 in: D. Paulson ed., Handbook of Topical Antimicrobials: Industrial Applications in Consumer Products and Pharmaceuticals, Marcel Dekker, NY, NY, 2003, 452 p.

 

Hobson DW and Seal LA, Antimicrobial Body Washes, Chapter l l, pp 167-180 in: D. Paulson ed., Handbook of Topical Antimicrobials: Industrial Applications in Consumer Products and Pharmaceuticals, Marcel Dekker, NY, NY, 2003, 452 p.

 

Hobson DW and Boisen K, Methods of Testing Oral and Topical Antiseptics and Antimicrobials. Chapter 69, pp 1329-1360 in: Disinfection, Sterilization and Preservation, 5th ed. Seymour S. Block Lippincott, Williams & Wilkins, Philadelphia, PA. 2001.

 

Hobson, D.W. Toxicology of Wound Healing Product Development, Consent  Advances in Dermatoxicology. H. Maibach, ed., Taylor and Francis, Philadelphia, 2000

 

Hobson, D.W. and Seal, L.A. 2000. Evaluation of a Novel, rapid-acting, stylizing solution at room temperature. American J. Infection Control, 28, 370-5.

 

Hobson, D.W. and Seal L.A. 1999. Handwashing: Technology Advancements for a New Millennium. Infect. Control Today. May: 22- 32.

 

Hobson, D.W., Woller, W., Anderson, L. and E. Guthery, 1998. Development and Evaluation of a New Alcohol-Based Surgical Hand Scrub Formulation with Persistent Antimicrobial Characteristics and Brushless Application, Am. J. Infect. Control, 26: 507-12.

 

Hobson, D.W. 1998 Surgical Hand Washing: New Products for the Next Millennium. Surgical Services Management,1(1), 36-43.

 

Hobson, D.W. General Overview of In Vitro and Other Alternatives to Skin Toxicity Evaluation, Chapter 15 (pp. 131-144), in Salem,

H. ed., Animal Test Alternatives: Refinement, Reduction. Replacement, Marcel Dekker, Inc., New York, 1995.

 

Hobson, D.W. Sub chronic Dermal Exposure Studies With Industrial Chemicals, Chapter 14 (pp. 201-216), in Wang, R. G. M., Knaak,

J.B. and H.I. Maibach, eds, Health Risk Assessment Through Dermal and Inhalation Exposure and Absorption ofToxicants, CRC Press, Inc., Boca Raton, 1993

 

Hobson, D.W., ed., Dermal and Ocular Toxicology: Fundamentals and Methods, 647 pp., CRC Press, Inc., Boca Raton, 1991.

 

Scientific Presentations 125

Hobson DW. Nanotechnology Enabled Device Design and Safety Assessment - Symposium I. Evolving Issues and Approaches to Regulatory Biocompatability Assessment in the Development of Medical Devices. An1erican College of Toxicology, Annual Meeting, Scottdale, AZ, November 2011.

 

Phi Sigma - Biological Sciences

Amedcan College of Toxicology- Distinguished Service Award Wound Healing Society- Certificate of Appreciation

 

American College of Toxicology (ACT) Southwestern Association of Toxicologists Society of Toxicology

Wound Healing Society

 

Radiation Biology/Biophysics - 2002 to present,, Nuclear Medicine Department, University of the Incarnate Word, San Antonio, TX

Nuclear pharmacy, Radiochemistry, and Radioimmunoassay. - 2001 to present,, Nuclear Medicine Department, University of the Incarnate Word, San Antonio, TX

Bionucleonics-Spring 1982, Veterinary Physiology and Pharmacology Department, Texas A&M University, College Station, TX

Physiology for Bioengineers-Fall 1981, Veterinary Physiology and Pharmacology Department, Texas A&M University, College Station, TX

General Biology- Fall 1978, Department of Biology, Texas A&M University, College Station, TX

 

Vice President-Roundtable of Toxicology Consultants-2011 -present

Councilor - Society of Toxicology - Nanotoxicology Specialty Section - 2011 - present

Co-Chair - Symposium 1. Evolving Issues and Approaches to Regulatory Biocompatibility Assessment in the Development of Medical Devices. American College of Toxicology, Annual Meeting, Scottdale, AZ, November 2011.

Secretary-Roundtable of Toxicology Consultants - 2009 - 2011.

President-Dermatoxicology Specialty Section of the Society of Toxicology, 2007 - 2008 Membership committee Chairman - Wound Healing Society, 2004 to 2009

Research Task Force -Association for Advanced Wound Care, 2004 to 2006.

Reviewer, American Institute for Biological Sciences, 2001 to present. Review wound healing and infection control grants and projects. Served as the review Team Leader for a recent evaluation of the overall U.S. Anny wound and burn healing research program. Other participants included experienced and well-recognized burn physicians and plastic surgeons.

Editorial Advisory Board, International Journal of Toxicology, 2001-present

Dermal Toxicology Section Editor, International Journal of Toxicology, 1994-Present Past-President-American College of Toxicology, - 1998-1999

Annual Meeting Program Chair -American College of Toxicology - 1998 President-Elect, American College of Toxicology, 1998

Vice President, American College of Toxicology, 1997

Reviewer- (Dermal Toxicology) - Journal toxic/ogic Pathology - 1997-98

Co-Editor, Journal of the American College of Toxicology, Special Issue on Chemical Defense Toxicology, Volume 15, Supplement 2, 1996.

Co-Chair, Symposium XIII: Toxicokinetic in Practice with Drug and Device Safety Assessment. 17'" Annual Meeting of the American College of Toxicology, King of Prussia, PA, 10-13 November 1996

Chair, Education Committee, American College of Toxicology, 1995

Session Chair, "Skin: In Vitro Systems", Society of Toxicology, 33"' Annual Meeting, Dallas, TX. 13-17 March 1994.

Chair, Symposium XI, "Current Issues in Pharmaceutical Development", 14th Annual Meeting of the American College of Toxicology, New Orleans, LA, 3-6 October 1993.

Board of Directors, Ohio Alliance for the Environment elected for service from 1993 to 1997. Member, Animals in Research Committee, American College of Toxicology, 1993 - 1995.

Member, Animals in Research Committee, American College of Toxicology, 1993 - 1995.

 

Councilor (1993 to 1995), American College of Toxicology.

Board of Advisors, Advanced Tissue Sciences, Inc., La Jolla, CA. (1988 - 1994),

Senior Technical Advisory Council, Health and Environment Group, Battelle Memorial Institute (1990-1992),

Commanding Officer, U.S. Navy Medical Detachment Hof the 4th Marine Division (1990-1994). Awarded the best trained unit

Board of Advisors, Defense Fire Protection Association (1989 - 1991)

Executive Officer, Naval Reserve Fleet Hospital CBTZ 18 Det. D, Columbus, OH. (1988-1990).

 

Methods of therapy using pharmaceutical composition for thrombin peptide derivatives.U.S. Patent 7,875,588, DW Hobson, Assignee: Orthologic Corp., January 25,201I.

 

Organic peroxyacid precursors, U.S. Patent 7,615,187, D.W. Hobson, Assignee: DH Technologies LLP, November 10, 2009

 

Pharmaceutical composition for thrombin peptide derivatives, U.S Patent 7,291,596, D.W. Hobson, Assignee: O11hologic Corp., November 6, 2007

 

Organic peroxyacid precursors, U.S. Patent 7,307,191, D.W. Hobson, Assignee: DH Technologies LLP, December 11, 2007

 

Mold remediation system and method, U.S. Patent No. 7,144,551 D.W. Hobson, Assignee DH Technologies LLP, Boerne, TX, December 5, 2006.

 

Peracid precursors for antimicrobial use, U.S. Patent No. 7,005,549, D.W. Hobson, Assignee, DH Technologies LLP, San Antonio, TX, February 28, 2006

Stable enzymatic wound debrider, U.S. Patent No. 6,548,556 D.W. Hobson, Assignee, Healthpoint Ltd., Ft. Worth, TX, April 15, 2003

Elegant hydrogenated castor oil ointments, U.S. Patent No. 6,479,060 D.W. Hobson, Assignee, Healthpoint Ltd., Ft. W011h, TX, November 12, 2002

Anhydrous, hydrophilic absorbent wound dressing (tube) with antimicrobials or other pharmaceutically active agents, U.S. Patent No. 6,399,092, D. W. Hobson, Assignee: Healthpoint Ltd., Ft. Worth, TX, June 4, 2002

Quick Acting Chemical Sterilant, U.S. Patent No. 6,096,348 D.W. Hobson, Assignee: Healthpoint Ltd., San Antonio, TX., August 1, 2000.

Quick Acting Chemical Sterilant. U.S. Patent No. 5,827,542 ., D.W. Hobson, Assignee: Healthpoint Ltd., San Antonio, TX., October, 27, 1998.

A Flow Through Device for Determination of the Penetration Rate of Chemicals Across Biological Membranes In Vitro. U.S. patent No. 4,667,504n. D.W. Hobson, Assignee: The United States of America as represented by the Secretary of the Air Force. May 26, 1987.

 

NDA Drugs ( 7 approvals; 9 NDAs in progress; IO INDs active)

ANDA Drugs ( 5 approvals); 2 in progress

Medical Devices ( 3 PMAs ; 8 510k approvals; I PMA and 2 510ks in progress)

OTC Monograph ( 5 OTC monograph products)

Other (3 pharmaceutical manufacturing site transfers; 2 dietary supplements; I homeopathic designation; 5 excipient / additives)

 

Born: Loma Linda, California Married: since 1976

Children:  two daughters, two grandchildren Hobbies: outdoor sports, playing and writing music.

 

 Freddie Ann Hoffman, MD CEO and Founding Member
HeteroGeneity, LLC
5611 16th Street, NW Washington, DC 20011-6809 USA  www.heterogeneity-LLC.com
Dr. Hoffman received a Bachelor of Science in Chemistry from UCLA and a Medical Doctorate from the University of California at Davis. She completed a fellowship in pediatric hematology-oncology at the United States National Cancer Institute (NCI), where she spent nearly a decade conducting laboratory and clinical research in cancer and nutrition. At the NCI, she held positions as Section Chief for Nutrition and Supportive Care in the Clinical Investigations Branch, and Director of Extramural Clinical Trials for the Biologic Response Modifiers Program in the Division of Cancer Treatment.
In 1986, she joined the United States Food and Drug Administration (FDA) serving as Chief of the Cytokines, Growth Factors, and Oncologic Products Branch in the Center for Biologics Evaluation and Research. In this role she was a member of the product licensing (approval) teams for 15 biologic drugs for cancer and other serious and life-threatening conditions. In 1989, she joined the FDA Office of the Commissioner, where she served as Deputy Director of the Medicine Staff for more than a decade. There she developed regulatory policies for drugs for serious and life-threatening conditions, nutritional supplements, and medical devices, and complex (botanical) drugs, serving on numerous task forces and working groups. Some of her duties included chairing the Agency’s Institutional Review Board (IRB), and serving as the FDA liaison to various federal departments and agencies, such as the National Institutes of Health (NIH) programs in complementary and alternative medicine, as well as non-government agencies, such as the American Cancer Society. Dr. Hoffman formed and chaired internal FDA working groups on homeopathic drugs, acupuncture needles and botanicals. Based on these efforts, acupuncture needles are now legally sold in the US, and FDA published the FDA Guidance for Industry on Botanical Drug Products.
She retired from the US government as a Captain in the US Public Health Service. She then joined Warner-Lambert-Pfizer Consumer Healthcare (Morris Plains, New Jersey) in 1999 as Senior Medical Director for New Product Development, serving on the New Technology Search and New Product Development teams. In August 2003, she returned to Washington, DC to start her own consulting firm, HeteroGeneity, LLC (HG). HG focuses on development strategies for natural and complex products. HG has guided sponsors to achieve the first two botanical “new” drugs approved by FDA, both as prescription drugs.
Dr. Hoffman currently serves as a scientific advisor to the American Botanical Council, as an expert to the NIH Office of Dietary Supplements, and to the federal Plant Conservation Alliance. She was an invited speaker at the 18th White House Commission for the Study of Bioethics Issues concerning the “Brain Research through Advancing Innovative Neurotechnologies” (BRAIN) initiative, and at the US Federal Trade Commission Workshop on Homeopathic Medicines Advertising (2015). She is a member of the American Society for Pharmacognosy and has written dozens of articles on natural health product development and regulation and is first author of the chapter on FDA regulation in the American College of Legal Medicine’s Textbook on Legal Medicine.