Hermann Ruckendorfer has more than 30 years of experience in the pharmaceutical and biopharmaceutical industry providing CMC development and regulatory strategy for global product development of small molecules to biologics and advanced therapies. He holds a Ph.D. and Master’s degree in Pharmaceutical Sciences and Analytical Chemistry from University of Graz, Austria.

A previous Vice President at Nycomed Austria, and Director of Pharmaceutical Development at Nycomed Pharma, he provided CMC services to Nycomed/Takeda International Sales Organizations and Licensees in the European Union, USA, and Japan.

When Takeda absorbed Nycomed in 2011, Mr. Ruckendorfer served as the Director of the Quality Division and ISO Certified Medical Device Division at Takeda Austria until his retirement in 2016.

Video: Preclinical Research for DermDefense, Inc. (begins 4:32)

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Michael Danzi holds a BS in Engineering from Cornell University and an MBA from Harvard Business School. He also completed the US Naval Nuclear Power School’s graduate engineering program.

Michael has more than twenty years experience running pharmaceutical companies, producing topical pharmaceuticals used in eye and skin care, buccal surgery healing, and skin cancer treatment.

Over the past 30 years, he has held Founder, CEO, COO, and Board of Director level positions at private and public healthcare companies, including global pharmaceutical companies ICN Pharmaceuticals International and Legacy Pharmaceuticals International, as well as diagnostics companies like BioTek Solutions/Ventana Medical Systems and US Labs.

Video: DermDefense, Inc – Product Development

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David is a partner with Maynard Nexsen, PC, a law firm based in Raleigh, North Carolina.  As part of Maynard Nexsen’s Private Markets group, he provides advice to entrepreneurs and businesses around the world.  Startups to billion-dollar merger partners count on David for guidance and counsel. 

David also works in global compliance and government solutions, where he helps structure cross-border business activities, sometimes involving US Federal contracting.  He helps companies move goods, services, and funds internationally, often highly technical or involving sophisticated transactions. 

In addition to his legal duties, David is the Honorary Consul for Japan in North Carolina and chairs the North Carolina Consular Corps.  He has been to 60 foreign countries and has represented the United States as a member of Team USA at 5 Triathlon World Championships.

David has served as DermDefense’s in-house counsel since its inception in 2021. 

Video: Animal Rule, Priority Review Vouchers (begins 1:13)

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Richard Kristof is an executive with a background in software technology, adult learning, financial services, and business development with over 25 years of experience building massively scalable applications for the learning and financial industries. 

He has twelve acquisitions totaling over $330 million to his credit, along with the startup and operation of several businesses and two bestselling book series with over 1.5 million copies sold.  His work in financial services is a natural extension of his M&A background and history as a Series 6/63 licensed dealer.

Richard also serves as Chief Strategy Officer for Global Verification Network, a background verification company specializing in vetting individuals for financial transactions. His work in business consulting includes a Managing Director role with Authentic Business Intelligence Alliance, a company specializing in consulting services, training, and technology consulting. 

Richard serves on several Boards of Directors and in an advisory capacity with select companies and works with startup companies across a variety of industries.

Videos:

Investor Relations and Business Strategy for DermDefense, Inc.

Strengths of DermDefense, Inc.

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Our Product and Sulfur Mustard – SM-1997

SM-1997 is a unique and natural product that includes amino acids, vitamins, trace minerals, and other nutrients. SM-1997 provides the missing essential nutrients that are needed for repairing and healing.

In the rigid formulation process of SM-1997 high-molecular substances such as proteins, prions or viruses are completely eliminated. SM-1997 contains only low-molecular substances such as amino acids, peptides, and nucleic acid components of less than 10,000 Dalton molecular weight, compared to viruses and prions with molecular weights that usually far exceed 100,000 Dalton.

Raw material controls, in-process controls, and final product quality controls ascertain the purity of SM-1997. Extensive chemical, microbiological and biological tests guarantee high quality, the absence of antigens, pyrogens, microorganisms, and viruses and attest to the efficacy of the active principle and of the SM-1997 products.

SM-1997 comes in an easy-to-use topical spray.

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In 2006 the founders of DermDefense Inc., Neal Andrews and Sandra Chansler, were approached by Dr. John S. Graham, Ph.D. of the US Army Medical Research Institute of Chemical Defense, Aberdeen Proving Ground, MD. after hearing about the SM-1997 Formulation’s ability to heal difficult wounds. This formulation was developed by Sandra Chansler.

Dr. Graham was funded by the National Institute of Health and the Department of Defense to find a treatment program for the Management of Cutaneous Sulfur Mustard Gas Injuries. He was curious about whether the SM-1997 Formulation would work on these types of injuries.

Three years and approximately five million dollars later, the results of this study were published in Toxicology, Vol. 263 Issue 1 Sept 2009. [Graham JS, Stevenson RS, Mitcheltree LW, Hamilton TA, Deckert RR, Lee RB, and Schiavetta AM.  Medical management of cutaneous sulfur mustard injuries. Toxicol.] Fill out our contact form to receive the password to our Studies page.

In conjunction with Dr. Graham’s work, collaboration with Dr. Doug Oliver at the Technology Laboratory, Porton Down, Salisbury United Kingdom helped support his claims. SM-1997 was the most effective product (compared to twenty-two other products tested) and was reviewed by the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD). See our timeline.

Study Results

These results – that SM-1997 promotes wound healing – have been discussed in presentations around the world:

• Bioscience Meeting 2008 – Germany and the Bioscience Meeting 2008 – Baltimore, MD
• XXXIV International Congress of the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) 2014 – Brussels, Belgium
• Academy of Military Medical Science, Medical Unit, Armed Forces, WUXI, Jiangsu Province, China. 
• Also referenced in the Chinese Journal of Traumatology, Mechanism and Treatment of Sulfur Mustard Induced Cutaneous Injury. Author: Tian-Yi Gu, Beijing

DermDefense, Inc. has worked with major universities such as Rutgers University on a corneal mustard-induced injury and SM-1997 proved to be the most effective product to prevent corneal breakdown. Fill out our contact form to receive the password to our Studies page.

DermDefense, Inc. also completed work at KSU University. After the publication in Toxicology (Exhibit A), DermDefense, Inc. was approached by a Director at the Defense Threat Reduction Agency (DTRA), who is now with the SEC US ARMY DEVCOM ECBC at Edgewood. He encouraged DermDefense, Inc. to apply for grant funding to complete the required research for SM-1997 to be approved by the FDA as a drug for the treatment of sulfur mustard injury. (Currently, there is no approved product for this injury).

After a time and cost assessment, it was decided that private funding for the SM-1997 approval process would reduce costs by more than fifty percent and reduce approval time to approximately one year.

A Stellar Team

DermDefense, Inc. has assembled a high-level team of professionals to guide this project through FDA approval and ensure its success. We are well-connected within the chemical and biological communities in the US government and have gained their support for the value and use of the SM-1997 Formulation.

SM-1997 continues to increase its audience of champions because it is effective and affordable, and its easy-to-use spray-on application makes it simple to apply.

DermDefense, Inc. is very confident that our studies will be successful.  The chief scientist conducting the safety and effectiveness studies has the experience and expertise to ensure studies are conducted correctly and professionally.  Our carefully assembled team of qualified contractors, medical partners, manufacturing, and regulatory compliance partners are working closely with our executive team to meticulously guide this life-changing product through approval.

SM-1997 is a sound, effective, predictable, and profitable investment.

The SM-1997 formulation will be the only approved product for the treatment of sulfur mustard gas injuries in the US and within NATO.

DermDefense’s senior management team includes a formulation expert with decades of experience and a disabled army veteran who has worked with and for the benefit of SM-1997 with the following agencies:

• U.S. Army Medical Research Institute of Chemical Defense (USAMRICD)
• U.S. Army Medical Logistics Command (USAMMA) at Fort Detrick
• Defense Threat Reduction Agency (DTRA)
• Battelle Biomedical
• Biomedical Advanced Research and Development Authority (BARDA)
• National Institutes of Health (NIH)
• Counter Act
• Bundeswehr (German Army)
• Institute of Pharmacology and Toxicology in Munich
• Israel Institute for Biological Research (IIBR)

These agencies, along with several more, are eager to harness the benefits of SM-1997 for our nation’s warriors and our allies who have suffered sulfur mustard gas injuries.

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Mustard gas has been used in chemical warfare and was made in large amounts during World Wars I and II. Iraqi President Saddam Hussein reportedly authorized the use of mustard agents during the Iran-Iraq war from 1980-1988 against Iranian soldiers and Kurdish civilians.

Sulfur mustard gas is not presently used in the United States, except for research purposes, and the U.S. Department of Defense was required to destroy all remaining stocks of mustard gas by 2004.

What is Sulfur Mustard?

First used during World War I, mustard agent has been the most commonly produced chemical weapon. The United States, Germany, Russia, and Iraq are all said to have produced mustard agent during the 20th century.

Forms of Mustard Gas

Mustard gas refers to several manufactured chemicals, including sulfur mustard, that do not occur naturally in the environment. Sulfur mustard can be a vapor, an oily-textured liquid, or a solid.

Mustard gas is actually a liquid and is not likely to change into a gas immediately if it is released at ordinary temperatures. As a weapon, it is spread by explosive force, which converts it to a vapor.

What It Looks Like

As a pure liquid, mustard gas is colorless and odorless, but when mixed with other chemicals, it looks brown and can smell like garlic, mustard or onions.

How It Can Be Used

Mustard gas can be delivered via bombs, artillery shells, and land mines. It can also be released into the air or in water.

What It Does

Mustard, known as a blister agent, causes chemical burns at the cellular level. Contact with mustard causes painful, long-lasting blisters on the skin and the mucous membranes. The blister agent reacts with the water in skin cells, and in the lungs, to literally tear apart cellular structures. It can cause severe eye and lung damage and can also cause blindness.

How Lethal Is It?

Exposure to sulfur mustard is usually not fatal. When sulfur mustard was used during World War I, it killed fewer than five percent of those people who were exposed and received medical care, according to the Centers for Disease Control and Prevention.

Persons exposed to significant concentrations without protective equipment are at great risk. Ten milligrams can kill one person. Moreover, mustard-related injuries are so painful and debilitating that several soldiers are required to take care of each casualty, thus reducing the military effectiveness of battlefield forces.

Symptoms of Exposure

Symptoms include itchy skin, irritation, swelling and watering of the eyes, runny nose, sneezing, sinus pain, shortness of breath, and a burning sensation in the lungs. Symptoms can also include abdominal pain, diarrhea, fever, nausea, and vomiting.

Signs and symptoms of exposure typically do not occur immediately. Depending on the severity of the exposure, symptoms may not occur for 2 to 24 hours.

How You Can Protect Yourself

You can prevent exposure by using a gas mask.

If exposed, the best course is to remove the agent from the exposed parts of the body as soon as possible with clean water. Quickly remove any clothing that has been exposed, seal that clothing in a plastic bag and seal that bag into another plastic bag. Eyes should be flushed with water for five to ten minutes and protected with dark glasses or goggles.

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David L. Grange, US Army Major General (Ret), is the President of Osprey Global Solutions, LLC., providing a full range of clinical support to pharmaceutical and biotechnology companies globally. Previously, as CEO and Board Member of PPD, a clinical research organization, he directed clinical and laboratory services and personnel in over 100 countries with 10,500 employees.

Major General Grange spent thirty years in the U.S. Army, retiring as a highly decorated Special Forces qualified Commanding General, Task Force Eagle, and Commanding General of the First Infantry. He commanded the 75th Ranger Regiment, Task Force Green (Special Operating Forces) during Desert Storm, and the I‐503rd Infantry Battalion in Korea.

He is also the President and CEO of McCormick Foundation, one of the largest philanthropic organizations in the US, investing in children, communities, and the country.

Video: Sulfur Mustard Threat

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Sandra Chansler has mastered the skincare industry for more than 30 years, with two decades of experience in cosmetics and laser treatments. She is a certified laser specialist, medical assistant, and licensed aesthetician. She has also played an instrumental role in training physicians on CO2 laser technology and has personally performed 10,000 plus hours of laser procedures.

Ms. Chansler developed the formulation, SM-1997, after discovering its incredible ability to heal difficult wounds. In 2006, she and Co-Founder, Neal Andrews, were approached by Dr. John S. Graham PhD of the US Army Medical Research Institute of Chemical Defense, Aberdeen Proving Ground, MD after hearing about SM-1997.

As the National Sales Director for the American Institute of Esthetics, Ms. Chansler was responsible for all field sales, customer service, product design, and marketing. She also served as President for Esthetician’s Formula Inc., where she was responsible for sales, product development, and customer product training.

Prior to starting DermDefense Inc, Ms. Chansler founded a skincare brand where she still serves as president. She was one of the early skincare pioneers who recognized the amazing benefits of using hyaluronic acid as a cosmetics additive for skin rejuvenation and repair and developed a specialized formula for her brand.

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Michael Day has 20+ years of experience in the pharmaceutical/biopharmaceutical industry. He earned his Ph.D. in Pharmaceutical Sciences and Chemistry from the University of Missouri-Kansas City.

Mr. Day provides both regulatory strategy and chemistry, manufacturing, and controls (CMC) consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced therapies. He previously served as Managing Director of CMC/Global Regulatory Affairs at Cardinal Health Regulatory Sciences.

In addition to his consulting, Michael currently serves as adjunct faculty for the University of Missouri-Kansas City’s School of Pharmacy and as Vice President of the Pharmaceutical Technical Exchange Association.

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