The Scope of Nano Medicines and The Expected Value of The Market


Yashwant V Pathak
M Pharm, Executive MBA, MSCM, PhD
Professor  and Associate Dean for Faculty Affairs, College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd, MDC 030 , Tampa FL 33612, USA

 

The recent burst of innovation and creativity in pharmaceutical industry led to over 4500 active technologies which can be utilized to deliver a drug in the body by many different routes of administration. The new technologies are giving technological advantages to the industry and also helping to reposition the FDA approved drugs which are already in the market. New products using these technologies also help the industry to explore new therapeutic indications. Due to the advent of nanotechnology in drug delivery, interestingly more than 2400 injectable have been developed in recent years followed by 935 which are orally delivered. Nanomedicine use in cancer beats all other indications with 758 products which are mostly nanotechnology based while immediate next area is endocrine diseases and followed by infectious diseases. This presentation discusses about the US FDA approach towards the nano medicine. FDA is maintaining the product focused and science based regulatory policy towards nano medicines.  FDA also expects the industry to be responsible for the development of the Nano medicines. The presentation will also discuss the trends of nano medicine development and the market potential of Nanomedicine worldwide.

Learning objectives:

  1. To understand what are the nano medicines
  2. To understand what are the characteristics of nano medicines
  3. To understand the FDA requirement and approach towards the Nano medicines
  4. To understand the impact and growth of nano medicine market in terms of dollar value as well as the intellectual property value
  5. To understand the focus of nano medicine and its impact on healthcare delivery especially in specific disease groups.

Advances and Challenges of Nanomedicine
Alekha K. Dash, R.Ph., Ph.D.
Department of Pharmacy Sciences, School of Pharmacy and Health Professions
Creighton University, Omaha, NE 68178, USA

The application of nanotechnology in medicine for addressing medical and health-related issues has shown tremendous progress over the last few decades. Because of their unique small size, nanomaterials exhibit novel chemical, physical, and biological properties that are distinct from bulk materials. Nanomedicine is not limited to pharmaceutical formulation. It has applications that span a multitude of areas including drug delivery, diagnosis and imaging, wearable devices, implants, personalized medicine, and high-throughput screening platforms. Nanomedicine is an interdisciplinary field which includes collaboration between nanoscience, nanoengineering, nanotechnology, and the life sciences. It is expected that this multidisciplinary approach will lead to the development of drugs, devices, and applications for the early diagnosis and treatment of many disease conditions. Two-thirds of nanomedicine research is dedicated to oncology-based therapeutics. Liposomal doxorubicin (DoxilTM) was the first anti-cancer nanomedicine approved in 1996. Since then, many additional drugs have been approved and are at various stages of their development. Aside from all of these developments, nanomedicine challenges still exist due to the lack of our understanding of nano-bio interactions, their toxicity, the heterogeneity of tumor biology, and challenges in the manufacturing, chemistry and quality control requirements for clinical translation and commercialization. Even with all these challenges, the field of nanomedicine will provide multiple avenues and products for the diagnosis and treatment of diseases in the coming decades. Our experiences with nanomedicine are in three distinct areas, which include solid-lipid nanoparticles, stealth liposomes, and localized near-infrared light-induced drug release from liposomes will be presented.

 

Objectives
After completion of this seminar the attendees should learn:

  1. The meaning of the terms: nanoscience, nanotechnology, nanomedicine and cancer nanomedicine
  2. The various areas of major developments in cancer nanomedicine
  3. The various advantages of nanomedicine in cancer treatment
  4. The various challenges of nanomedicine in cancer treatment
  5. Why there is a gap between in vivo data and translational outcome?
  6. Various areas of our works with nanomedicine

Requirements for building a nano research laboratory
Yashwant V Pathak
M Pharm, Executive MBA, MSCM, PhD
Professor  and Associate Dean for Faculty Affairs, College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd, MDC 030 , Tampa FL 33612, USA

Majority of the leading Universities worldwide have established their research centres while the field of research in nanotechnology was growing in last two decades. Building a nano centre we need to ask three questions

  1. Why do we want to establish the nano center?
  2. What do we want to achieve?
  3. Why do we think it is important for UWI?

The major constituents needed when we discuss about the requirements of the nano research laboratory include focus, people, passion, translational applications, intellectual property and facilities. Nano research laboratories need to have a very specific focus and area of applications. The nanotechnology field is so vast that unless such specific focus is there the success of the center cannot be ensured. In the health care institutions, the center can have specific disease treatment focus (cancer treatment, Lung diseases and so on) or specific drug delivery system based such as Liposomes, nanoparticle development or the third one is center focusing on developing intellectual property based on repositioning of the existing FDA approved drugs. This presentation discusses the profiles of interesting scientists who have very specific focus in their research in this area. Some suggestions will be provided for the development of nanotechnology based centers and requirements needed to establish the center in University scenario.

Learning Objectives:

  1. To understand the need for nano center for the academic institution to be competitive in global world
  2. To understand why it is necessary to establish the nano research center
  3. To understand what we would lik to achieve by establishing the nano center
  4. To understand important factors needed to establish and ensure the success of the nano center
  5. To Share some profiles of nano experts and possibilities for the new nano center

Nanofillers in Restorative Dentistry: What are the implications?
Dr. Shivaugh Marchand
Senior Lecture
School of Dentistry
The University of the West Indies, St. Augustine Campus

The incorporation of nanotechnology in dentistry has varied significantly from its application in medicine and pharmaceuticals. Nanosized fillers have been used in the development and improvement of aesthetic dental composite restorative materials, from an engineering perspective.  This lecture will focus on the material improvements of dental composites as a result of the incorporation of nanosized fillers and the translation of these into clinical improvements with respect to material handling and longevity.

  1. To describe and explain what  are  nano sized filler.
  2. Explain how nano size fillers improve clinical outcomes

Key research areas in nanomedicines and status on the innovation lifecycle
Sureshwar Pandey
Professor
School of Pharmacy
The University of the West Indies, St. Augustine Campus

Nanomedicine is a relatively new and rapidly evolving field combining nanotechnology with the biomedical and pharmaceutical sciences. Nanoparticles (NPs) can impart many pharmacokinetic, efficacy, safety, and targeting benefits when they are included in drug formulations. Many nanodrugs have entered clinical practice, and even more are being investigated in clinical trials for a wide variety of indications. However, nanopharmaceuticals also face challenges, such as the need for better characterization, possible toxicity issues, a lack of specific regulatory guidelines, cost–benefit considerations, and waning enthusiasm among some health care professionals. For these reasons, expectations regarding nanodrugs that are in early stages of development or clinical trials need to remain realistic.

Learning Outcomes:

At the end of this lecture, the participants will be:

  1. Able to recognize the USFDA approved nanomedicines.
  2. Able to recognize the thrust area in nanotechnology research by visualizing the Nanomedicine which are presently under clinical trials.
  3. Update the knowledge of application of nanotechnology in designing nanomedicines.

References

  1. Bobo D, Robinson KJ, Islam J, et al. Nanoparticle-based medicines: a review of FDA- approved materials and clinical trials to date. Pharm Res. 2016;33(10):2373–2387.
  2. Caster JM, Patel AN, Zhang T, Wang A. Investigational nanomedicines in 2016: a review of nanotherapeutics currently undergoing clinical trials. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2017;9(1)
  3. Ventola CL. The nanomedicine revolution: part 1: emerging concepts. P T. 2012;37(9):512– 525.
  4. Havel HA. Where are the nanodrugs? An industry perspective on development of drug products containing nanomaterials. AAPS J. 2016;18(6):1351–1353.
  5. Havel H, Finch G, Strode P, et al. Nanomedicines: from bench to bedside and beyond. AAPS J. 2016;18(6):1373–1378.