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INTERview








Improving Pipeline for Drug Development Companies by Deploying Nanotechnology at Preclinical Formulation Development


Dr. Kay Olmstead

Co-founder and CEO


Nano PharmaSolutions, Inc.

www.nanopharmasolutions.com


Contact:

Kay Olmstead

858-900-2155

kay@nanopharmasolutions.com


Interview conducted by:

Lynn Fosse, Senior Editor

CEOCFO Magazine

Published – January 11, 2021


CEOCFO: Dr. Olmstead, what is the concept for Nano PharmaSolutions, Inc?  

Dr. Olmstead: We provide drug development companies a cutting-edge nanoformulation technology to enhance their therapeutic candidates. About eighty percent of the new drug candidates today are poorly soluble or completely insoluble in water, which is a huge problem for drug companies as they develop safe and efficacious drugs. Therefore, solubilizing their drug candidates is the number one concern in early-stage development. Although there are many solubilization technologies, our nanoformulation platform is the only one that uniformly deposits solidified active pharmaceutical ingredients in a purely physical way without using any chemicals or solvent. The market opportunity is huge: nanotechnology is a $150 billion market in 2019 figure and growing at a 20% annual rate.      


CEOCFO: Why is it so difficult for a drug to be soluble?

Dr. Olmstead: It is because recent advances in combinatorial chemistry, computational molecular modeling and high throughput screening in drug discovery have significantly increased the number of poorly soluble drugs. Often candidates identified from the R&D search are not soluble. They are usually selected via binding affinity to a target, but not solubility. Therefore, these candidates work on a cellular level, but not on a physiological level. This stage is what they call the “valley of death”—the drug development process from the laboratory bench to an approved drug—which has only about a 0.2% success rate.  


CEOCFO: What do you understand about creating solubility that others do not?

Dr. Olmstead: Other nanotechnologies use chemicals and excipients, and we generate drug nanoparticles in a purely physical way, with nothing added on. If you make the drug soluble by using other chemicals, these chemicals cannot be taken out, so they become part of your drug, potentially affecting the safety and efficacy of the medication. We achieve increased bioavailability in poorly soluble drugs using our nanotechnology platform without the addition of undesirable chemicals and other potential adulterants.    


CEOCFO: What are the challenges in getting the right people to know what you can do at Nano Pharma?

Dr. Olmstead: Nano PharmaSolutions, Inc. was founded less than two years ago. People challenge us by asking if we can maintain the integrity of the drug in our process. We use a micro-vacuum system so the drug powder can be vaporized without any thermal degradation, then capture the vapor as nano particles. That is the essence of our technology. The secret is how to vaporize solid-state drug into vapor-state and capture it back as nanoparticles without changing the nature of the drug. That is the “secret sauce” of our proprietary technology.    


CEOCFO: What can you tell us about how you do it and how the technology was developed?

Dr. Olmstead: About 10 years ago, NASA developed what is called Plasma-PVD (Physical Vapor Deposition) technology to make a very thin film of ceramics for spaceships. It’s very hard stuff. Metals and ceramics are much harder than organic drugs, and yet they figured out a way to vaporize them with strong energy like plasma. We utilize the same concept t to vaporize drugs but with far less energy. Since we create the nanodrugs in a vacuum there is no water or oxygen that can react with the drug while it’s being nanosized. Some of the drugs, like ibuprofen, evaporate at seventy degrees in our system. This is really safe. Our technology is gentle and does not degrade the drug during the manufacturing process.


CEOCFO: How are you getting the word out?

Dr. Olmstead: We’ve been having robust traffic to our website (www.nanopharmasolutions.com), and we use LinkedIn as a social marketing tool. It has been tough to get the word out in 2020 because of COVID. Normally, companies with new technologies like ours go to industry conferences and conventions to meet stakeholders in “one on one” meeting. However, because of the pandemic all conferences and meetings were either cancelled or went virtual, so we have not been getting our message out as much as we otherwise would. We will be more proactive in 2021 and publish our data in peer reviewed journals and/or white papers.


CEOCFO: Do potential customers understand? Are they skeptical? How can you show people that it really works?   

Dr. Olmstead: It is all in the data. We are scientists and we are talking to our customers, who are scientists. If we show them the dissolution data of our nanoformulation of a drug vs its native state, the data will sell itself. We also perform pharmacokinetics studies, which show bioavailability differences between the nanodrug and its native forms in animal models. We can also compare in-vitro and in-vivo data from our nanodrugs to native drugs.  


CEOCFO: Where does cost come into play? Although it should not for something that is really effective.

Dr. Olmstead: Right. Nanotechnology in general is very expensive, because other chemical nanotechnologies go through several iterations to reach the best formulation. However, since we do not use any chemicals our trials are very fast. We measure the triple point of a drug in our NanoTransformer™ in just one trial with our online video camera. If the triple point is seventy-five degrees, for example, that is a unique characteristic for that drug, and the key formulation parameter we use. Our customers save on materials as this can be measured in one day using less than a gram. The rest is scaling up so we can deliver the drug nanoformulation to our client in very short period.


We came up with this offer to the drug industry: Give us just seven grams of drug and in seven weeks we can deliver the nanosized formulations for the fee of seventy thousand dollars. Compared to our competitors, the required quantity of drug, time and fee structure is about one third. Therefore, we make this service accessible to early-stage development when a company may have only very small amounts of a drug candidate. At the preclinical stage, these savings are essential, as companies do not have tons of drug material to play with or time to develop an formulation for animal toxicology trials. The speed of the drug development, size of the drug sample needed, as well as the low fee allows almost anyone to try out our nanotechnology. Drug companies routinely employ polymorph and salt screening in order to increase the solubility of a drug, which can take up to $200,000 and >6 months, and 50 grams of drug. We ask these companies to try us out before they go through this solid-state screening program. To repeat: it only takes seven grams, seven weeks and seventy thousand dollars to see if our nanoformulation can drastically improve the solubility without going through lengthy salt screening studies. It is a fraction of materials, a fraction of time, a fraction of the money compared to other formulation development platforms.


CEOCFO: Are you seeking funding, partnerships or investment?

Dr. Olmstead: We are a hardtech pharmaceutical-enabling company with manufacturing and analytical testing facility in-house. We are raising $5 million in a Series A in 2021.This funding is to support our near-term goal to manufacture human clinical trial materials for our clients and fuel our revenue growth. We can currently manufacture material for animal models in toxicology studies for our customers. After successful preclinical studies, our partner companies will look to us to prepare drugs for human clinical trials. We are poised to move our platform to the next level and support human trials with our raise in 2021.  


CEOCFO: What has been the interest from the investment community or do they not really know what you are doing yet?

Dr. Olmstead: We are in the early stages of raising capital and have not finalized our messaging. JP Morgan is in January and we will be participating. Likewise, we plan to present at the BIO conference for CEOs and investors in February.     


We are hoping that will get our story out to the investment community. Therefore, 2021 will be a transformative year for us. We were mentioned in a Forbes article in December as one of the companies that pivoted due to COVID and were mentioned as a resilient company.


CEOCFO: What, if anything, might someone miss when they take a look at Nano Pharma Solutions, either from the investment perspective or from the scientific perspective?

Dr. Olmstead: Nano PharmaSolutons is a young company with a small team. An outsider might say that we do not yet have a critical mass, but all our team members believe in our technology and are highly dedicated. With the necessary funding, we will continue to build our team and intellectual property portfolio. Ultimately, we will be a leader in solubilizing nanotechnologies that enable our pharmaceutical customers to develop better drugs faster. This will in turn give patients access to a wider variety of efficacious, life-saving therapies.


Nano PharmaSolutions, Inc., Dr. Kay Olmstead, Nano Spray Coating, Nanotechnology For Drug Delivery Design and Discovery, Improving Pipeline for Drug Development Companies by Deploying Nanotechnology at Preclinical Formulation Development, CEO Interviews 2021, Medical Companies, Nanotechnology Drug Delivery Platform, Nanotechnology for spray-coated pulmonary drug products, Nanotechnology for Drug Development Companies, Enhancing Bioavailability for Insoluble Drugs, Enhancing the bioavailability of insoluble drugs using nanoformulation technology, prepare soluble preparations of API using a phase-transition nano-formulation technology, Nano PharmaSolutions, Inc. Press Releases, News

“Although there are many solubilization technologies, our nanoformulation platform is the only one that uniformly deposits solidified active pharmaceutical ingredients in a purely physical way without using any chemicals or solvent.” Dr. Kay Olmstead


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