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Market Share in Nanotechnology and Nanomedicine for Treatment of Viral Infections Could Reach Tens of Billion Dollars – P&T Community

PALM BEACH, Florida, Oct. 29, 2019 /PRNewswire/ -- There is much activity in the nanotechnology & nanomedicine markets as new treatments and human clinical trials are growing at a record pace. And these new treatment are hope they could be key to combating viral infections such as, bacteria, viruses, fungi,HBV, hepatitis C, Influenza, HSV, Human papillomavirus and parasites account for approximately 15million deaths worldwide, with acute respiratory infections and human immunodeficiency virus (HIV) being the leading causes. The National Institutes for Health NCBI Center for Biotechnology Information (NCBI) reports: "Infectious diseases are the leading cause of mortality worldwide, with viruses in particular making global impact on healthcare and socioeconomic development. In addition, the rapid development of drug resistance to currently available therapies and adverse side effects due to prolonged use is a serious public health concern. The development of novel treatment strategies is therefore required. The interaction of nanostructures with microorganisms is fast-revolutionizing the biomedical field by offering advantages in both diagnostic and therapeutic applications. Nanoparticles offer unique physical properties that have associated benefits for drug delivery." Mentioned in today's commentary includes: TG Therapeutics, Inc. (NASDAQ: TGTX), NanoViricides, Inc. (NYSE: NNVC), Matinas BioPharma Holdings, Inc. (NYSE: MTNB), Clovis Oncology, Inc. (NASDAQ: CLVS), Pfizer Inc. (NYSE: PFE).

Nanoparticle-based delivery systems present new opportunities to overcome challenges associated with conventional drug therapies and have therefore attracted enormous interest in the treatment of viral infections. Nanomaterials can be engineered to incorporate conventional antiviral properties with those modifications that are unique to nanosystems (ultra small and controllable size, large surface area to volume ratio, and the ability to tailor the surface with the possibility of multi-functionalization). This is undoubtedly a promising tool for biomedical research and clinical use.

One of the more active companies in the industry includes NanoViricides, Inc. (NYSE American: NNVC). NanoViricides,a leader in nanomedicines with novel platform technology to treat difficult and life-threatening viral diseases, on October 9, 2019 announced that it has initiated bio-analytical studies as part of the required IND-enabling preclinical safety and toxicology studies of NV-HHV-101, moving towards human clinical trials.

The Company has contracted NorthEast BioLab, Hamden CT, to conduct the bio-analytical studies and facilitate the toxicokinetic analyses. These studies and analyses are part of the required general safety and toxicology studies that will go into an Investigational New Drug (IND) Application to the US FDA.

NorthEast BioLab has already performed the bio-analytical assay development and validation and is in the process of determining the concentrations of NV-HHV-101 in blood samples from the general safety and toxicology studies that are required for IND.

The company feels that the market size for its immediate target drugs in the HerpeCide program is variously estimated into Billions to tens of Billions of Dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.

NanoViricidesalso released a report this past August that its first drug candidate, NV-HHV-101, is on track with required preclinical GLP Safety and Toxicology studies moving towards human clinical trials. The Company reports that NV-HHV-101 has been found to be safe and well tolerated in the clinical observation portion of the GLP Safety/Toxicology study of NV-HHV-101 as a dermal treatment.

The Company has previously found that NV-HHV-101 was safe and well tolerated in non-GLP safety/toxicology studies. The GLP studies are an expanded version of the non-GLP studies, with extended treatment, larger number of subjects, and stringent operational requirements as specified by the current Good Laboratory Practices guidelines for such studies.

Additional studies required for the Safety and Toxicology datasets for filing an IND are in progress.

The Company anticipates advancing NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication, assuming that these studies are successful. The Company also continues to evaluate this broad-spectrum drug candidate as well as certain variations based on the same candidate, for the treatment of other herpesviruses, namely HSV-1 cold sores and HSV-2 genital herpes. The market size for its immediate target drugs in the HerpeCide program is variously estimated into billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.

In addition, the Company also recently announced that its first clinical drug candidate, NV-HHV-101, for the treatment of the Shingles virus (aka VZV), is on track with required preclinical GLP Safety and Toxicology studies moving towards human clinical trials. The Company has reported that NV-HHV-101 has been found to be safe and well tolerated in the clinical observation portion of the GLP Safety/Toxicology study of NV-HHV-101 as a dermal treatment.

NanoViricides' current programs target a potential market opportunity of over $20 Billion. Investors are urged to view an informative video interview with Anil R. Diwan, PhD, President and Executive Chairman, who was interviewed by broadcast journalist Christine Corrado of Proactive Investors, a leading multi-media news organization, investor portal and events management business with offices in New York, Sydney, Toronto, Frankfurt, and London. Click here to access the video interview.

In other biotech news in the markets this week:

TG Therapeutics, Inc.(NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, announced that the follicular lymphoma (FL) cohort of the UNITY-NHL Phase 2b pivotal trial evaluating single agent umbralisib, the Company's novel, once daily, PI3K delta inhibitor, met the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) for all treated patients (n=118) who have received at least two prior lines of therapy including an anti-CD20 monoclonal antibody and an alkylating agent. The results met the Company's prespecified ORR target of 40-50%. Importantly, umbralisib monotherapy appeared to be well tolerated with a safety profile consistent with previous reports.

The Company plans to present the data at a future medical conference as well as discuss the data with the U.S. Food and Drug Administration (FDA).

Matinas BioPharma Holdings, Inc.(NYSE AMER: MTNB), a clinical stage biopharmaceutical company, this month announced that it has initiated its Phase 2 EnACT clinical study, which will explore the use of MAT2203 for both induction and maintenance therapy in HIV-patients with cryptococcal meningitis, a life-threatening fungal infection most commonly observed in immunocompromised individuals.

"We are extremely pleased to advance clinical development of MAT2203 for the treatment of cryptococcal meningitis," commented Theresa Matkovits, Ph.D., Chief Development Officer of Matinas.

Clovis Oncology, Inc.(NASDAQ: CLVS) this month announced that the National Institute for Health and Care Excellence (NICE) has recommended that women with relapsed ovarian cancer in England have access to rucaparib through the Cancer Drugs Fund (CDF).1 Rucaparib is available for use within the CDF as an option for the maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, based on the conditions outlined in the managed access agreement.

"Ovacome welcomes the availability of rucaparib via the CDF as an option for maintenance treatment of platinum-sensitive relapsed high grade serous epithelial ovarian cancer regardless of BRCA status or line of treatment in the relapsed maintenance setting," said Victoria Clare, CEO of Ovacome, a United Kingdom ovarian cancer charity focused on providing support to anyone affected by ovarian cancer.

Pfizer Inc. (NYSE: PFE) reported financial results for third-quarter 2019 and updated certain components of its 2019 financial guidance.Third-Quarter 2019 Revenues of $12.7 Billion, Reflecting 3% Operational Decline; Excluding the Impact from Consumer Healthcare, Third-Quarter 2019 Revenues were Flat Operationally - See the full financial reporting at: https://finance.yahoo.com/news/pfizer-reports-third-quarter-2019-104500229.html

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Market Share in Nanotechnology and Nanomedicine for Treatment of Viral Infections Could Reach Tens of Billion Dollars - P&T Community

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What is Nanobots & Its Biggest Contribution in The Medical Industry – Robots.net

Afraid of nanobots rising up and taking over the world? Dont be, that only happens in movies. In the real world, there are types of robots that save the human race, nanorobots to be exact. Experts and professionals are continuously doing extensive research and advanced development in nanotechnology. Research in finding the best uses of nanorobots and nanomachines into the medical industry.

In the field of medicine, theres only a tiny room for error. To be more precise, everything has to be perfect. Of course, professional doctors are highly skilled and knowledgeable to do various surgeries and other treatments to patients. But there are some procedures that require extreme precision that even world-class doctors arent capable of doing.

Imagine a doctor pinpointing cancer cells, or a doctor eliminating the defected parts in someones DNA structure. Those are tasks that are almost impossible to do. But lucky for us, nanorobots and nanomachines exist in our world today. What it does is a guarantee to provide patients with the treatment they need. Hence, giving them a chance to live their lives better and longer.

In this article, well take a deeper look and have a further understanding of what nanobots truly are. We analyze thoroughly from its components, types, to their uses in the medical industry.

Nanorobotics falls under the field of nanotechnology. They deal with the design and development of devices at an atomic, molecular or cellular level. These hypothetical nanorobots are superbly tiny, ranging from 0.1-10 micrometers, capable of traveling inside the human blood. In general, almost all nanorobots have specialized sensors that are able to target molecules. Therefore, it can be programmed to determine and treat targeted diseases.

A nanorobot, also known as nanobot, nanomachines or nanomites, can be made out of different mechanical components. It can be gears or motors using a variety of elements like hydrogen, sulfur, oxygen, nitrogen, silicon and such. On the other hand, the exterior of a nanobot can be created using a diamondoid element due to its dormant characteristics, high thermal conductivity, and durability. They feature extremely smooth surfaces, lessening the possibilities of triggering the bodys immune system.

While an excellent property that nanorobots have is the ability to correlate to each other. Hence, developing a structure with decentralization. Another point is nanobots can do a self-replication process. In which they will create duplicates of themselves and replacing all the non-working units at the same time.

If youre wondering if its possible to communicate with nanorobots, the answer is, yes. All it needs is by encoding messages to acoustic signals at a wave frequency ranging from 1-100 MHz. When the task is completed, these nanorobots can be retrieved through the usual human excretory channels or active scavenger systems can be used.

In constructing nanorobots, there are two main approaches. They are the Positional assembly and the Self-assembly.

In the self-assembly, the nanomachines robotic arm thats used to pick and assemble the molecules are controlled manually by an operator while on the positional assembly, billion of molecules are put together and the nanobots can automatically assemble them into their natural configuration.

Also, nanobots are provided with swarm intelligence for decentralization activity, a technique that was inspired by the behaviors of social animals like ants, bees, etc that can work collaboratively naturally. But in order for the nanobots to function perfectly, they must have these specific components and substructures:

The section where the nanobot holds and releases a small dose of drug/medicine.

The nanorobot may include a miniature camera. The operator can steer the nanorobot when navigating through the body manually

The electrode mounted on the nanorobot could form the battery using the electrolytes in the blood.

These lasers could burn the harmful material like arterial plaque, blood clots or cancer cells.

Use when the nanorobots target and destroy kidney stones.

The nanorobot will need a means of propulsion to get into the body as they travel against the flow of blood in the body.

According to Robert A. Freitas Jr., who has pioneered the study and communication of the benefits to be obtained from advanced nanorobotics and biotechnology, classified nanorobots into three types; Respirocytes, Microbivores, and Clottocytes. He is also responsible for the term Nanomedicine that is commonly used in the field of science today. Lets check out how these three nanobots differ from one another.

First up on our list is the Respirocytes and no, its not the Death Star from Star Wars. Respirocytes are the nanorobots that intend to act as artificial mechanical red blood cells. Its characteristics are the following. First, they are in a spherical blood-borne shape that has 1 micrometer in diameter. Second, it composes of a diamondoid 1000 atm pressure container, the exterior casing. Third, it has reversible molecule-selective pumps.

Respirocytes transport oxygen and carbon dioxide molecules throughout the body. Finally, the respirocyte is a construction of 18 billion atoms. All are accurately arranged in diamondoid pressure tanks. These tanks are capable of storing up to 3 billion oxygen and carbon dioxide molecules. Compared to natural red blood cells, the respirocyte would deliver 236 times more oxygen to the body tissues.

Gas concentration sensors and an onboard nanocomputer can control the respirocyte. Moreover, it manages the carbonic acidity. The stored gases will discharge from the tank in a controlled behavior into the molecular pumps. The respirocytes exchange gases via molecular rotors that have special tips for a particular type of molecule.

Next on our list is the Microbivores. Unlike the Respirocytes, it is an artificial white blood cell that is also known as Nanorobotic Phagocytes.

Microbivores are the nanorobot. It functions as artificial white blood cells and also known as nanorobotic phagocytes. However, this particular nanobot is a spheroid device that consists of a diamond and sapphire. The Microbivers measures 3.4 micrometers in diameter along its major axis and 2.0 micrometers diameter along the minor axis. There are 610 billion of arranged structural atoms are inside the nanobot.

What it does is it traps in the pathogens existing in the bloodstream then breaks down into smaller molecules. While the Microbivores main purpose is to absorb and digest the pathogens in the bloodstream by using the process of phagocytosis. There are four fundamental components of microbivore:

For only 30 seconds, an entire cycle of microbivores phagocytosis will complete. There are no possibilities of septic shock since it has internalized bacterial elements. Also, it digested into non-antigenic biomolecules. The microbivore is 1000 times quicker than antibiotic aided white blood cells. The pathogen also stands no chance of multiple drug resistance.

Taking the third and final spot on our list is the Clottocytes. These nanorobots described as artificial mechanical platelet, designed for Hemostasis. Whats Hemostasis, you say? Let us explain, Hemostasis is the process of blood clotting when theres damage to the endothelium cells of blood vessels by platelets. These platelets will activate by the collision of exposed collagen from damaged blood vessels to the platelets. It will take around 2-5 minutes for the whole process of natural blood clotting.

Clottocytes, on the other hand, can complete the whole process in 1 second approximately. This nanorobot in spherical form is powered by serum-exyglucose. It is about 2 micrometers in diameter and it contains a fiber mesh thats neatly folded inside. When released, the fiber mesh would be biodegradable, a film-like layer of the mesh would disappear in contact with the plasma to reveal the sticky mesh. When compared to the natural hemostatic system, Clottocytes are 100 times if not, 1000 times faster than natural healing.

Nanomites are specifically designed for drug transport called Pharmacytes. The dosage of the drug will load into the payload of the Pharmacyte. And they can precisely transport and target the drug to specific cellular points.

By using nanobots, the patients vitals can be continuously monitored. However, it will lead to a quantum leap in diagnostics.

Dentifrobots are nanorobots that intend for dental treatment. These types of nanomachines can induce oral analgesia, desensitize teeth, manipulate the tissues. Besides, it also uses to realign and straighten irregular sets of teeth.

Nanobot is a program to be self-sufficient onsite surgeons inside the body. Plus, they can do multiple functions. These functions include detecting pathology, diagnosing, correcting lesions. Function coordinated By nano-manipulation by an on-board computer.

Nanorobots are made with a mixture of a polymer. Its transferrin is capable of detecting tumor cells. They feature embedded chemical biosensors, primarily used for detecting tumors

Nanobots carry out glucose molecules into the bloodstream. In order to maintain human metabolism. They use a Chemosensor in which they can modulate the hSGLT3 protein glucose-sensor activity.

Due to the fact that nanorobots can provide better access to the required area, thus it performs micro-surgeries. Moreover, it has extreme precision, they can perform certain surgeries that doctors are not capable of doing.

By medical nanomites, it can treat genetic diseases. Besides, this is by analyzing the molecular composition of DNA and proteins found in the cell. The best part, by using Chromallocytes it can perform Chromosome replacement therapy too.

If nanorobots are really the future of medicine, we are all ready for it. Their precise and efficient performance is definitely something we can rely on. The successful development of Nanobots can unveil new approaches to medical treatment. Hence, resulting in revolutionizing traditional medical treatment that is faster, concise & error-free treatment.

With the constant development and innovation of nanotechnology and nanomedicine, inevitably, more and more of these micrometer nanomachines be developed. Hence, treating more diseases and doing more surgeries, saving more patients in the years to come.

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Richard Young, Ph.D., Founder of CAMP4 Therapeutics, Elected to National Academy of Medicine – Business Wire

CAMBRIDGE, Mass.--(BUSINESS WIRE)--CAMP4 Therapeutics, a biotechnology company unraveling transcriptional machinery and the network of signaling pathways to accelerate drug discovery and development across therapeutic areas, announced that Richard Young, Ph.D., one of the companys founders, has been elected to the National Academy of Medicine (NAM). Dr. Young, a Member of the Whitehead Institute and Professor of Biology at the Massachusetts Institute of Technology (MIT), was one of 90 regular members and 10 international members elected to NAM earlier this week. Election to NAM is considered one of the highest honors in the fields of health and medicine, recognizing individuals who have made major contributions to the advancement of the medical sciences, health care and public health. Dr. Young was elected to the National Academy of Sciences in 2012 as well.

Dr. Youngs research focuses on mapping the regulatory circuitry that controls cell state and differentiationusing experimental and computational technologies to determine how signaling pathways, transcription factors, chromatin regulators, and small RNAs control gene expression.

CAMP4 was founded based on the seminal discoveries made by Dr. Young, along with Leonard Zon, M.D., Grousbeck Professor of Pediatric Medicine at Harvard Medical School, Investigator at Howard Hughes Medical Institute, and Director of the Stem Cell Program at Boston Childrens Hospital.

Based on Drs. Young and Zons discoveries, CAMP4 has built its proprietary Gene Circuitry Platform, with which it is pioneering a systematic and scalable approach to discover new, druggable targets to control gene expression to treat diseases across all therapeutic areas.

On behalf of the entire CAMP4 team, I want to congratulate Rick on this tremendous and well-deserved honor, said Josh Mandel-Brehm, President and Chief Executive Officer of CAMP4. In addition to all of his remarkable scientific accomplishments that have the potential to impact peoples lives around the world, and the numerous resulting accolades bestowed on him, I am continually struck by Ricks incredible humility and humanity. We are grateful to have the opportunity to work with and advance Ricks science and vision.

Dr. Young received his Ph.D. in Molecular Biophysics and Biochemistry at Yale University, conducted postdoctoral research at Stanford University and joined Whitehead Institute and MIT in 1984. He has served as an advisor to the National Institutes of Health, the World Health Organization, the Vatican and numerous scientific societies and journals. Dr. Young has founded and advised companies in the biotechnology and pharmaceutical industry and is currently a member of the Board of Directors of CAMP4, Syros Pharmaceuticals and Omega Therapeutics. His honors include Membership in the National Academy of Sciences, the Chiron Corporation Biotechnology Research Award, Yales Wilbur Cross Medal, and in 2006 Scientific American recognized him as one of the top 50 leaders in science, technology and business.

The National Academy of Medicine, established in 1970 as the Institute of Medicine, is an independent organization of eminent professionals from diverse fields including health and medicine; the natural, social, and behavioral sciences; and beyond. It serves alongside the National Academy of Sciences and the National Academy of Engineering as an adviser to the nation and the international community. Through its domestic and global initiatives, the NAM works to address critical issues in health, medicine, and related policy and inspire positive action across sectors. The NAM collaborates closely with its peer academies and other divisions within the National Academies of Sciences, Engineering, and Medicine.

View the Whitehead Institutes statement on Dr. Youngs election to NAM.

About CAMP4 Therapeutics

At CAMP4 Therapeutics, we are revolutionizing drug discovery and development to be faster, smarter and better. With our Gene Circuitry Platform, we have discovered how to dial up or dial down the expression of any gene. Using the foundational insights enabled by our platform, we are pioneering a systematic and scalable approach to discover new, druggable targets to control gene expression to treat diseases across all therapeutic areas. This approach involves creating tissue-specific Gene Circuitry Maps that comprehensively reveal the transcriptional machinery and its connected network of signaling pathways governing gene expression. Each map serves as its own therapeutic area discovery engine, revealing dozens, sometimes even hundreds of disease-solving opportunities. Our goal is to decipher the transcriptional machinery and signaling networks controlling gene expression for all cell types central to disease, ultimately delivering druggable targets for a multitude of undruggable diseases. Our vision is to create a world where a treatment for every disease is possible. Learn more about us at http://www.camp4tx.com.

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Richard Young, Ph.D., Founder of CAMP4 Therapeutics, Elected to National Academy of Medicine - Business Wire

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Your Brain Cells Could Be Reprogrammed to Fight Parkinson’s Disease – Futurism

Support Cells Turned Super Cells

Parkinsons disease is one of the worlds most common neurodegenerative ailments. It causes patients with Parkinsons to lose dopamine neurons, which are important for the motor control centers of the brain. According to statistics from the Parkinsons Disease Foundation, there are over 10 million people worldwide whosuffer from it, with about 60,000 diagnosed cases in the United States alone.

Researchers from the the Karolinska Institute in Stockholm developed a stem cell-based treatment that doesnt rely on embryonic or adult stem cells, which are often too difficult to harness and transplant into the brain. Instead, they found a way to reprogram the brains astrocytes support cells forneurons into dopamine neurons.

You can directly reprogram a cell that is already inside the brain and change the function in such a way that you can improve neurological symptoms, senior author Ernest Arenas explained to the Scientific American.

The trick was adding a cocktail of three genes and a small RNAmolecule to force astrocytes into becoming dopamine neurons. The treatment was tested on mice whose dopamine neurons in brain were destroyed to simulate Parkinsons disease. Within five weeks of being injected with this gene cocktail, the mice showed improved and more coordinated movement. These results were published in the journal Nature Biotechnology.

While this stem cell approach wont cure Parkinsons, it can certainly improve current standard treatments for it. For one, astrocytes are already present in the brains of Parkinsons patients. Reprogramming these would eliminate the need for donor cells, which run the usual incompatibility risks associated with transplants. Second, the proteins produced in the treatment are involved in normal cellular processes, limiting potential side effects thatcurrent drug-based therapies often carry.

This is like stem cell 2.0. Its the next-generation approach to stem cell treatments and regenerative medicine, said James Beck, VP and chief scientific officer for the Parkinsons Disease Foundation, a nonprofit organization that was not involved with the research.

Still, theres a long way to go before an actual cure can be developed. Motor improvement is only half the battle, Beck said to Scientific American. But winning half the battle is still significant. This new approach, he noted, could ease the management of motor symptoms in potentially millions of Parkinsons patients. It might also make keeping up with medications simpler for them, potentially reducing the eight or more pills that patients with advanced Parkinsons often take.

Further research is needed to make sure thatthis reprogramming method doesnt change other cells in the brain. Only then would it be ready for human clinical trials. But Beck is hopeful that this study will spur new Parkinsons treatments down the road. This is an insight into what the future of Parkinsons treatment holds, Beck noted.

Stem cell therapies are revolutionizing Parkinsons disease treatment, as well as a host of other medical conditions. Many believe that the ability to reprogram cells is a glimpse of the future, not just of Parkinsons treatment, but of the entire field of medical research.

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Your Brain Cells Could Be Reprogrammed to Fight Parkinson's Disease - Futurism

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Nanotechnology: What it can do for drug delivery

J Control Release. Author manuscript; available in PMC 2008 Jul 16.

Published in final edited form as:

PMCID: PMC1949907

NIHMSID: NIHMS26595

Kinam Park, Weldon School of Biomedical Engineering and Department of Pharmaceutics, Purdue University, West Lafayette, IN 47907, Perspective for Journal of Controlled Release;

Every so often, a new term comes along that represents an emerging scientific trend. Biotechnology, genetic engineering, tissue engineering, gene therapy, combinatorial chemistry, high throughput screening, and stem cells are some examples of past terms. Recently, nanotechnology has become a popular term representing the main efforts of the current science and technology. Nanotechnology, which is still not a mature technology and thus, more appropriately called nanoscience, usually refers to research at the scale of 100 nm or less. Nanotechnology is unique in that it represents not just one specific area, but a vast variety of disciplines ranging from basic material science to personal care applications. One of the important areas of nanotechnology is nanomedicine, which, according to the National Institute of Health (NIH) Nanomedicine Roadmap Initiative, refers to highly specific medical intervention at the molecular scale for diagnosis, prevention and treatment of diseases [1].

Nanomedicine, like other technologies that have come before it, has incredible potential for revolutionizing the therapeutics and diagnostics under the premise of developing ingenious nanodevices. Drug delivery nanosystems constitute a significant portion of nanomedicine. In drug delivery, however, describing nanotechnology based on a size limit is pointless because the efficiency and usefulness of drug delivery systems are not based only on their sizes. Useful drug delivery systems range from truly nanosystems (e.g., drug-polymer conjugates and polymer micelles) to microparticles in the range of 100 m. Both nano- and micro scale systems have been extremely important in developing various clinically useful drug delivery systems. For practical reasons, in this perspective, nanotechnology includes microtechnology, and nanofabrication or nanomanufacturing and its micro counterparts.

Nanotechnology received a lot of attention with the never-seen-before enthusiasm because of its future potential that can literally revolutionize each field in which it is being exploited. In drug delivery, nanotechnology is just beginning to make an impact. Many of the current nano drug delivery systems, however, are remnants of conventional drug delivery systems that happen to be in the nanometer range, such as liposomes, polymeric micelles, nanoparticles, dendrimers, and nanocrystals. Liposomes and polymer micelles were first prepared in 1960s, and nanoparticles and dendrimers in 1970s. Colloidal gold particles in nanometer sizes were first prepared by Michael Faraday more than 150 years ago, but were never referred to or associated with nanoparticles or nanotechnology until recently. About three decades ago, colloidal gold particles were conjugated with antibody for target specific staining, known as immunogold staining [2]. Such an application may be considered as a precursor of recent explosive applications of gold particles in nanotechnology. The importance of nanotechnology in drug delivery is in the concept and ability to manipulate molecules and supramolecular structures for producing devices with programmed functions. Conventional liposomes, polymeric micelles, and nanoparticles are now called nanovehicles, and this, strictly speaking, is correct only in the size scale. Those conventional drug delivery systems would have evolved to the present state regardless of the current nanotechnology revolution. To appreciate the true meaning of nanotechnology in drug delivery, it may be beneficial to classify drug delivery systems based on the time period representing before and after the nanotechnology revolution.

As shown in , the drug delivery technologies in relation to the current nanotechnology revolution can be classified into three categories: before nanotechnology revolution (past); current transition period (present); and mature nanotechnology (future). The examples of drug delivery systems of the past (prior to the current nanotechnology revolution) are liposomes, polymeric micelles, nanoparticles, dendrimers, and nanocrystals, as mentioned above. The current drug delivery systems include microchips, microneedle-based transdermal therapeutic systems, layer-by-layer assembled systems, and various microparticles produced by ink-jet technology. These efforts are just beginning and many fabrication methods have been developed. The future of drug delivery systems, as far as nanotechnology is concerned, is to develop nano/micro manufacturing processes that can churn out nano/micro drug delivery systems. The current technology of fabrication and manufacturing of engineering materials at the nano/micro scale is advanced enough to develop nano/micro scale processes for producing products other than semiconductors [3]. Imagine that the current soft gelatin capsules, which are in the centimeter scale, are manufactured at the nano/micro scale.

Examples of drug delivery technologies in relation to the current nanotechnology revolution.

It is a fair and important question to ask whether nanotechnology will realistically bring clinically useful drug delivery systems. The answer is yes; making the more appropriate question when. Theoretically, it should have happened already, as scientists fabricating nanodevices could have teamed up with those heavily engaged in drug delivery systems to manufacture clinically useful nano/micro drug formulations. However, it has not happened yet. One of the reasons for this is the overwhelming obsession with nano scale, which caused the scientists to pass over the micro scale drug delivery systems. Clinically useful drug delivery systems need to deliver a certain amount of a drug that can be therapeutically effective, and often over an extended period of time. Such requirements can be met by the micro scale drug delivery systems manufactured by nanotechnology. In addition, little attention has been paid to the fact that the systems have to be introduced into the human body, requiring approval from the Food and Drug Administration (FDA).

To describe what nanotechnology can do to manufacture nano/micro drug delivery systems, one can use manufacturing of nano/micro particles (or capsules) as an example. The current methods of preparing nano/micro particles are mainly based on double emulsion methods or solvent exchange technique [4]. The main problems with the current methods are the low drug loading capacity, low loading efficiency, and poor ability to control the size distribution. Utilizing nanotechnologies, such as nanopatterning, could allow manufacturing of nano/micro particles with high loading efficiency and highly homogeneous particle sizes.

One of the themes of the NIH Nanomedicine Roadmap Initiative is re-engineering of the clinical research enterprise through translational research facilitating translation of basic discoveries to clinical studies [1]. The ultimate application goal of nano drug delivery systems is to develop clinically useful formulations for treating diseases in patients. Clinical applications require approval from FDA. The pharmaceutical industry has been slow to utilize the new drug delivery systems if they include components (also called excipients) that are not generally regarded as safe. Going through clinical studies for FDA approval of a new chemical entity is a long and costly process; there is resistance in the industry to adding any untested materials that may require seeking approval. To overcome this reluctant attitude by the industry, scientists need to develop new delivery systems that are substantially better than the existing delivery systems. Only marginal increase in functions will not make seeking the required approval worthwhile. Nanotechnology has a potential just to do that: increase in efficacy by orders of magnitude. For instance, nano/micro devices can be developed for both diagnosis and therapy (theragnosis) using the same device, and such theragnosis devices hold great promises in personalized medicine [5].

Nanotechnology has a great potential in revolutionizing the drug delivery field, but realizing such a potential requires harmonized efforts among scientists in different disciplines and continued support by funding agencies. As shown in , the future of nanotechnology-based drug delivery systems depends on the ability of scale-up production by nano/micro manufacturing. This requires design of the simplest possible delivery systems, and this will be possible only through intimate communication between nanofabrication engineers and drug delivery scientists. Nanotechnology for drug delivery will mature faster and become more useful if we appreciate that the real potential of nanotechnology in drug delivery is based on utilization of nano/micro fabrication and manufacturing, rather than on dealing with delivery systems in the nano/micro scale.

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3. Jackson MJ. Microfabrication and Nanomanufacturing. Taylor & Francis; Boca Raton: 2006.

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Nanotechnology: What it can do for drug delivery

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Bioengineering – University of Washington

Department Overview

N107 William H. Foege Building

Bioengineering encompasses a wide range of activities in which the disciplines of engineering and biological or medical science intersect. Such multidisciplinary endeavors are yielding new discoveries and major advances that are revolutionizing the healthcare system. The Department of Bioengineering, housed jointly in the School of Medicine and the College of Engineering, provides a comprehensive, multidisciplinary program of education and research and is recognized as a leading bioengineering program in the world. Major areas of research and education include biomaterials and regenerative medicine, molecular and cellular engineering, technology for expanding access to healthcare, instrumentation, imaging and image-guided therapy, and systems, synthetic, and quantitative biology.

Adviser N107 William H. Foege Building, Box 355061 (206) 685-2000 bioeng@uw.edu depts.washington.edu/bioe/programs/bachelors/bs.html

The Bioengineering program offers the following programs of study:

Suggested First- and Second-Year College Courses: CHEM 142, CHEM 152, and CHEM 162; CSE 142, English composition, MATH 124, MATH 125, MATH 126, PHYS 121.

Admission is competitive. Students may be admitted at three different points. Consult the department's website for more information.

Nanoscience and Molecular Engineering Option (NME): Admission to the NME option for bioengineering majors is by self-selection and normally occurs in winter quarter of the junior year, upon completion of all bioengineering prerequisites and formal admission to the BS bioengineering major. Students applying for the NME option should indicate that interest on their bioengineering major application and discuss their interests/background in their application personal statement.

Students follow requirements in effect at time of entry into the department. 180 credits as follows:

General Education Requirements (105 credits):

Major Requirements (75 credits):

Nanoscience and Molecular Engineering Option Requirements (77 credits):

Of Special Note: Courses on technology commercialization are available to seniors.

Graduate Program Coordinator N107 William H. Foege Building, Box 355061 (206) 685-2000 bioeng@uw.edu

The Department of Bioengineering offers programs of study which lead to the Master of Science (MS), the Master of Pharmaceutical Bioengineering (PHARBE), and Doctor of Philosophy (PhD) degrees.

The Master of Science degree program provides breadth of knowledge of engineering, biology, and medicine, and depth of knowledge in a particular research area. The degree prepares students for careers in academic, industrial, or hospital environments.

All application materials must be received in the appropriate office by the deadline. International applications are due by December 1; domestic applications are due by December 15. Late and/or incomplete applications are not reviewed. Required application items include:

More information about the application is online at depts.washington.edu/bioe/education/prospective/educ_prospective.html. Materials sent in addition to those listed above are considered non-essential and do not enhance the application.

Applicants are expected to have the following courses as part of their undergraduate education: ordinary differential equations, linear algebra, signal analysis, probability theory and statistics, programming, electrical engineering and physics, chemistry, materials science, rate processes and mathematics, and cell and molecular biology. Admitted students must be knowledgeable of these topics prior to entrance to the MS program.

Course requirements for the MS in Bioengineering are detailed below. All core and elective courses must be taken for a numerical grade. Students must complete a one-quarter teaching assistantship. The timing of the teaching assistantship is decided in consultation with the department and the faculty adviser.

Note: A single course may not count for two separate requirements.

36 credits as follows:

The Master of Pharmaceutical Bioengineering (PHARBE) program is an evening degree program designed to enable working local engineers, scientists, researchers, and professionals in the biotechnology, pharmaceutical, and related industries to explore advanced education in the areas of molecular and cellular biology, drug discovery and design, pharmaceutics, and translational pharmaceutics. Professionals may also complete three certificate programs without applying for degree status.

Minimum 40 credits, with a minimum 3.00 cumulative GPA, as follows:

The objective of the PhD program is to train individuals for careers in bioengineering research and teaching. The program has three major objectives: (1) breadth of knowledge about engineering, biology, medicine, and the interdisciplinary interface between these different fields; (2) depth of knowledge and expertise in a particular scientific specialty; (3) demonstrated independence as a bioengineering researcher. These objectives are fulfilled through a combination of educational and research experiences. The program is rigorous but maintains flexibility to accommodate qualified students from diverse academic backgrounds. Entrance to the PhD program does not require prior completion of the MS degree and may be made directly after the BS An optional dual PhD degree in bioengineering and nanotechnology is available; see http://www.nano.washington.edu for more information.

See the application process detailed in the MS section.

While it is not required to complete an MS degree before beginning the PhD, every graduate student is expected to have the following courses as part of her or his undergraduate education: ordinary differential equations, linear algebra, signal analysis, probability theory and statistics, programming, electrical engineering and physics, chemistry, materials science, processes and mathematics, and cell and molecular biology. Admitted students must be knowledgeable of these topics prior to entrance to the PhD program.

90 credits, to include:

Students must complete a one-quarter teaching assistantship. The timing of the teaching assistantship is decided in consultation with the department and the faculty adviser.

All core and elective courses must be taken for a numerical grade. A single course may not count for two separate requirements. Required courses include:

Ordinarily, a student progressing well follows this schedule:

A Medical Scientist Training Program (MSTP) exists for the support of individuals interested in coordinated graduate school/medical school study leading to both the MD and PhD degrees. Students entering this highly competitive program are given an opportunity to pursue a flexible, combined course of study and research. Early inquiry is essential for this option. Contact the MSTP office at (206) 685-0762.

As the department is established within the College of Engineering and the School of Medicine, bioengineering students have access to all engineering and health science departments and facilities. A wide range of technologies and virtually all aspects of biomedical research tools are available.

Financial support is available to qualified graduate students in the form of traineeships, fellowships, and teaching and research assistantships. Funding is derived from federal research and training programs, the Graduate School Fund for Excellence and Innovation, and programs sponsored by private agencies. Questions regarding financial support may be directed to the adviser.

Department Overview

Undergraduate Program

Graduate Program

Time Schedule

Academic Planning Worksheet

Departmental Web Page

Departmental Faculty

Course Descriptions

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Bioengineering - University of Washington

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