7^th International Conference on Clinical Trials September 24-26, 2018 | Chicago, Illinois, USA
(10 Plenary Forums - 1 Event)

Biography:

Matt Cavallo, MPH is the founder and Chief Empathy Officer of the Patient Activation Network. He is a patient experience thought the leader who has been a keynote speaker for healthcare events across the country. He has been named among The Top 10 Social HealthMakers by WCG and his blog was selected as one of Healthline’s Top Healthcare Blogs. His story of being diagnosed and overcoming the physical and emotional challenges associated with having a chronic disease can be read in his memoir, The Dog Story: A Journey into a New Life with Multiple Sclerosis

 

Abstract:

At twenty-eight years old, Matt Cavallo, MPH was diagnosed with Multiple Sclerosis. Seemingly overnight he went from a fully-functioning, healthy man to someone who was paralyzed from the waist down and unable to walk. His story of being diagnosed and overcoming the physical and emotional challenges associated with having a chronic disease will be presented from the onset of symptoms and hospitalization to the decision to try a black-box therapy. He will discuss the successful outcomes he experienced because of the decision to advocate for himself based on the clinical trial research. Matt will also discuss the emotional and physical toll that it took on him, his wife and their young family. During this lecture, Matt will talk about the importance of participating in clinical trials from the patient perspective. He will discuss the resistance he faced from his care team because of his decision to try a newly approved, but risky therapy option, and how he overcame those objections. Matt has presented on this topic to top researchers and scientists in the field inspiring them with his compelling personal patient experience story. His authenticity and ability to be vulnerable on stage will make this presentation one that your audience will talk about long after the conference has ended. Matt will make your audience laugh, cry, and in the end, inspire hope.

Learning Objectives

The World Health Organization recognizes therapeutic patient education and patient experience as clinical education. Content within the lecture is relevant to healthcare and the designated audiences in the following four areas:

The patient adaptation process including coping with the disease, loss of control, health beliefs and sociocultural perceptions.

Subjective and objective needs of the patient, whether expressed or not, as an integral part of treatment and care

Concerns about the patient’s daily life and psychosocial environment, as well as, the patient’s family and other close relatives and friends.

A disease as a continuous process, which has to be adaptive over the course of the disease and to the patient and patient’s way of life as part of a long-term care of the patient.

Biography:

Tatsuya Takagi has completed his PhD at the age of 32 from Osaka University. At that time, he had been an Assistant Professor of School of Pharmaceutical Sciences, Osaka University for 5 years. Then, since 1993, he had worked for the Genome Information Research Center, Osaka University as an Associate Professor until he became a Professor of Graduate School of Pharmaceutical Sciences, Osaka University in 1998. He has published more than 150 papers in reputed journals and had served as Chairman of Division of Structure-Activity Relationship of the Pharmaceutical Society of Japan for three years (until March 2017).

 

Abstract:

MDM2 (Mouse double minute 2 homolog) is known as a protein which is a significant negative regulator of p53. MDM2 is also considered to be E3 ubiquitin-protein ligase recognizing the N-terminal TAD (Transactivation Domain). Thus, MDM2-p53 interactions are proposed to be a promising therapeutic strategy for tumors. Previously, we reported a part of the FMO (Fragment Molecular Orbital) calculation results of MDM2 and its inhibitors at the 11th China-Japan Joint Symposium on Drug Design and Development. Although we showed a satisfactory result, we also thought the result could be improved using PIEDA (Pair Interaction Energy Decomposition Analysis). In this study, we added some FMO results and tried to obtain a better correlation using data mining methods, such as PLS. First, we selected significant 18 IFIE (Inter Fragment Interaction Energy) values and 45 electrostatic interaction energies as the results of PIEDA from 84 ones. Then we obtained two latent variables as the results of PLS and cross validations. Resulted scatter plot of the two latent variables. In this case, the best-squared correlation coefficient values between observed and calculated pIC50 of MDM2, 0.924, was obtained. FMO calculation results between β-secretase and inhibitors also will be shown.

 

Biography:

Nick Song has completed his PhD from The University of Missouri and his MBA from Purdue University. He is a technical manager of the Science & Technology organization at Abbvie Inc, where he leads the modeling and simulation of drug delivery devices and systems. He previously completed numerous technical consulting projects on drug delivery and medical devices with major medical companies, as a consultant at the world leading simulation solutions company Dassault Systemes (previously ABAQUS Inc.) He has published more than 20 papers in reputed journals and conferences.

Abstract:

Drug delivery devices and drug-device combination products involve complex working mechanisms, nonlinear materials with complex mechanical behaviors, and interactions between fluids and structures. The development and manufacturing of combination products entail the deep understanding of the design, manufacturability, and reliability, where modeling and simulation offer unparalleled capabilities and complement testing based on physical prototypes. This presentation will provide a few case studies of device and combination products modeling at Abbvie. Bio-compatible polymers including thermoplastic polyurethane and thermoplastic elastomer are commonly used in medical devices such as drug delivery tubing and connectors. They provide excellent durability and resistance against oils and chemicals. Their mechanical properties are complex, exhibiting nonlinear large strain nonlinearity, hysteresis, and permanent set under cyclic loading. Hi-fidelity finite element modeling was utilized to study the performance of a delivery system under various conditions. Results showed the high margin of safety. Auto-injector is a combination of drug and device. A syringe pre-filled with a drug is installed into a spring-loaded pen device to achieve automatic subcutaneous drug delivery. Finite element simulations of the firing/activation process provided deep insights into the working mechanism that were not known from prior experiments. An infusion pump is an electro-mechanical device used to deliver the drug into the human body at large volumes and over the long period of time. Simulations showed the working mechanism of the complex device that includes components made from nonlinear silicone rubber and thermoplastic polyurethane materials. Multiphysics modeling of auto-injector provided deep insights into the drug solution fluid flow driven by the device which was not easily measurable.

 

Biography:

Rahul R. Panchal has completed his M.S. (2005) and PhD (2009) in plastics Engineering and Polymer Science from University of Massachusetts, Lowell. He has B.S. in Mechanical Engineering from Gujarat University, India (1998). He has extensive background and expertise in medical device design & manufacturing, polymer injection molding, statistics, multivariate analysis, in-mold sensing technology etc. He is an inventor of the patented in-mold sensor having the capability to measure in-mold shrinkage realtime. He currently works at AbbVie as a Principle Scientist Engineering, Combination Products and transitioning into entrepreneurship. He is also founder and president of Leonine Technologies Inc. which mainly focused on new technology development for injection molding, medical device, as well as training and consultation.

 

Abstract:

Due to the increased health care costs, patients are looking for self-administration drug delivery devices where the drug can be packaged within the device. Because of this many pharmaceutical companies are moving towards drug and device combination for many drugs and reformulating their drugs so they can pack into the delivery device as a combination product like autoinjectors, infusion pumps, nebulizers etc. The delivery device is mainly made of injection molded plastics parts. The self-drug delivery systems have helped the patients a lot without relying on medical practitioners for drug delivery or taking frequent oral doses. However, pharmaceutical companies are still in denial to accept the importance of drug delivery devices as a part of their product portfolio, maybe they are worried about being subjected to medical device regulations which are not their core business. Hence, all major pharmaceutical companies rely on third-party device designers and manufacturers. In general, pharmaceutical companies select the device for a specific drug and conduct the patient survey by showing the device prototype via focus groups or patient experience studies. The risk behind this approach is that the patient creates own bias immediately after looking at the prototype and over 50% of patients do not provide honest feedback. Hence, the majority of patients requirements are not being translated to the device design. Any device failure will lead to patient complaints towards the pharmaceutical company even though the company is making the best drug ever available in the market. Another issue, majority of device developers are mechanical designers with little or no knowledge of plastics product design and manufacturing thus they fail in differentiating between plastics and non-plastics (metal) design concepts. Because of this, the majority of the device available in the market are designed having components with complex features not suitable for plastics materials or with the wrong material selection. This has resulted over a 30% increase in manufacturing cost and time. Therefore, it is very important to understand the importance of customer feedback even before starting the device design as well the science behind plastics product design and manufacturing, related technological innovations.

 

Biography:

Prakash V Diwan obtained his PhD from Postgraduate Institute of Medical Education and Research, Chandigarh, India. Contributed in the areas of Novel Drug Delivery systems & drug discovery. Published over 200 papers in pre-reviewed journals. He delivered guest lectures in India and abroad. He has many awards instituted by Indian Pharmacological Society. He has served as founder Director of NIPER, Hyderabad and fellow of the Royal Society of London, FRSC (London). Presently working as Technical Advisor, Indian Pharmacopeia Commission, Government of India, Director School of Pharmacy, and Hyderabad. Director, CRL, Maratha Mandal Group of Institutions, Belgaum, and Consultant for Indian Institute of Technology, Hyderabad

 

Abstract:

From science fiction to reality: Nano medicine Brings fresh hope to the medical world. Nanomedicine is an offshoot of nanotechnologies. Medical applications, dominate today's market, with sales of $19.1 billion. Emerging nanomedicine technologies could dramatically transform medical science today with their potential to address unmet medical needs and provide targeted therapy. Nanomedicine can offer impressive resolutions for various life-threatening diseases including effective drug delivery systems, drug discovery, and development, medical diagnosis, and devices. The advent of nanomedicine and techniques for the early diagnosis of diseases could usher in a new era of superior prophylactic or preventive medicine. By using preventive medicine, treatment for diseases could be initiated even before preliminary symptoms appear.

Medical Advantages

Nanotechnology has the potential to bring major advances in medicine.

Nanobots could be sent into a patient's arteries to clear away blockages.

Surgeries could become much faster and more accurate.

Injuries could be repaired cell-by-cell.

It may even become possible to heal genetic conditions by fixing the damaged genes. Cancer treatment, drug delivery, drug development, medical tools diagnostic tests, imaging

Novel drug delivery systems of herbal drugs using nanotechnology: Have a potential future

 

Nanomedicine technology faces biggest challenges such as scalability. This perceived difficulty is attributed to the fact that manufacturing standards for nanomaterials and components are yet to evolve. Therefore, there is an urgent need for standardized manufacturing techniques; only then can nanotechnology become ubiquitous in everyday applications. Furthermore, since the characteristics of nanoscale matter are very different owing to their unique nature, there is a need for appropriate quality control measures. Concerns about the potential ill effects of engineered nanomaterials such as nanotubes through inhalation, ingestion, or absorption through the skin are increasing.

Challenges

The exact usage and quality of materials? strategy,

Research is motivated by immediate profits, more concentration on commercial products,

Are nanotechnology inventions required by the society?

What about nanotoxicity? Are products commercially viable?

 

In the longer term, perhaps 10–20 years from today, the earliest molecular machine systems and nanorobots may join the medical armamentarium, finally giving physicians the most potent tools imaginable to conquer human disease, ill-health, and aging.

 

Biography:

Vinod Labhasetwar, PhD, is a Professor of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, both in Cleveland, Ohio, USA. The primary research focus of his laboratory over the past 25+ years has been on nanoparticle-mediated drug delivery in the context of translational and clinical medicine, particularly focusing on disease conditions where no effective treatments yet exist. His team’s specific interests are in developing effective approaches to cancer therapy (against drug resistance and metastasis), cardiovascular diseases (particularly inhibition of restenosis), and facilitating neuromuscular repair mechanisms in stroke and spinal cord injury. Recently, his group’s efforts have been expanding into two new areas: retinitis pigmentosa, with the goal of slowing the progression of photoreceptor degeneration; and transplantation research, with the objective of extending the critical window of time for organ preservation. He has published over 180 peer-reviewed articles and book chapters. He is listed among the 2014 and 2015 Highly Cited Researchers by Thomson Reuters, based on the top 1% of citations during the past 10 years. He has over 25 issued US and international patents and 4 provisional the US patents filed/pending. He is Editor-in-Chief of Drug Delivery and Translational Research, an official journal of the Controlled Release Society.

 

Abstract:

Nanoparticle-based drug delivery systems can potentially overcome several barriers to drug delivery, reduce toxicity to the patient, and thus improve therapeutic outcomes. Over time, nanoparticles have undergone evolution from simple to more complex systems, yet the nanoparticle formulations developed as “nanomedicine” for clinical use remain quite simple. Our laboratory research has shown that simple nanoparticle formulations, developed with a solid rationale, are very effective in treating complex conditions. This overview will describe nanoparticles that are straightforward in design yet effective in treating complex diseases in animal models. One example is a formulation that successfully treats bone metastasis, considered the primary cause of death in many types of cancers but more particularly in prostate and breast cancers. A second example is a formulation that effectively modifies the after-effects of stroke. This presentation will also define the challenges in moving complex nanoparticles through regulatory pathways and the scale-up process toward eventual commercialization.