17th Annual Summit on

Bioavailability and Bioequivalence

Scientific Program

Keynote Session:

Meetings International -  Conference Keynote Speaker Kateryna Zupanets photo

Kateryna Zupanets

National University of Pharmacy, Ukraine

Title: Biopharmaceutical differences of herbal drugs and their phytosimilars

Biography:

Kateryna Zupanets as a clinical pharmacist completed her PhD at the age of 27 years from National University of Pharmacy (Kharkiv, Ukraine) and last year she finished her post-doctoral studies at Clinical and Diagnostics Center of the National University of Pharmacy. She is the author of more than 50 papers in reputed journals (6 articles for SCOPUS journals). Dr. Zupanets has been working as a Co-Investigator in more than 50 trials of Bioequivalence studies and Phase I (Clinical and Diagnostics Center of the National University of Pharmacy).

Abstract:

In the epoch of antibiotic resistance and drug-dependent side effects the herbal drugs become more and more popular. According to the evidence level (EPOS 2012) herbal drugs hold Ib rate with the corresponding Grade A recommendation. The present parameters are the same as for Paracetamol. This fact is extremely reliable cause in terms of their potential herbal drugs can definitely be used to treat colds. As far as herbal medicines are as old as human kind they are well-studied and form the basis of modern pharmaceutics. Despite a huge variety of plant-based medicines and healing activities of natural substances they are still yielding surprising insights. For example, anti-inflammatory activity is not determined by one or other compound alone, it’s a result of correct composition. But it doesn’t mean that all herbal drugs with the similar content possess the same pharmacological activity. According to our in-depth studies of herbal medicine pharmacological activities we came up with an idea that there are no generics among herbal drugs. When studying a number of plant-based medicines such as novel dry extract BNO 1011 (Sinupret® extract), BNO 1045 (Canephron® N), micronized purified flavonoid fraction (Detralex®), significant biopharmaceutical differences were found in comparison with their copies, more precisely with phytosimilars. Although different manufactures can copy the ingredients and doses of raw material of well-known brands but it doesn’t maintain the same safety and efficacy. We have found out that phytoneering herbal drugs prove to be as effective as standard therapy due to the unique high-tech approach. Thus, standardized herbal drugs with scientifically determined efficacy are setting new reliable benchmarks which may help to treat diseases in a targeted and effective fashion.

Meetings International -  Conference Keynote Speaker InWook Choi photo

InWook Choi

Korea Food Research Institute, Republic of Korea

Title: Effect of catechol o-methyl transferase inhibitor on anti-inflammatory activity of luteolin metabolites

Biography:

Dr. Choi has worked with great enthusiasm and endeavor for developing functional foods or pharmaceutical ingredients from animal and plant resources and commercializing them. Currently, He is interested in developing the system inferring functional properties of natural extracts (Bio-FINE).  The system is based on bio-information that can be extracted by comparing differently expressing genes between normal and natural extracts fed animals.  Through the system, various functional properties of single as well as combinatorial natural extracts can be ranked and further utilized for commercialization.

Abstract:

Although luteolin is known to have potent anti-inflammatory activities, much less information has been provided on such activities of its hepatic metabolites. Luteolin was subjected to hepatic metabolism in HepG2 cells either without or with catechol O-methyl transferase (COMT) inhibitor. To identify hepatic metabolites of luteolin without (LMs) or with COMT inhibitor (LMs+CI), metabolites were treated by ß-glucuronidase and sulfatase, and found that they were composed of glucuronide and sulfate conjugates of diosmetin in LMs or these conjugates of luteolin in LMs+CI. LMs and LMs+CI were examined for their anti-inflammatory activities on LPS stimulated Raw 264.7 cells. Expression of iNOS and production of nitric oxide and pro-inflammatory cytokines such as TNF-α, IL-1ß and IL-6 were suppressed more effectively by the treatment with LMs+CI than LMs. Our data provide a new insight on possible improvement in functional properties of luteolin on target cells by modifying their metabolic pathway in hepatocytes

Meetings International -  Conference Keynote Speaker Yuan Chen photo

Yuan Chen

Genentech, USA

Title: E-BABE- Understanding of Pirfenidone pharmacokinetics in bioequivalence study using PBPK approach

Biography:

Yuan Chen is a Principal Scientist in the Department of Drug Metabolism and Pharmacokinetics at Genentech. Yuan has nearly 20 years of experience in the drug metabolism and pharmacokinetics discipline working at Roche and Genentech. She has been DMPK project lead for many drug discovery and development projects, and contributed to many clinical candidate nomination and filing of IND to the regulatory authorities. Yuan’s current research focus is on physiologically-based pharmacokinetic (PBPK) modeling for the prediction of human PK, absorption, and CYP-and transporter-mediated drug-drug interactions. She leads PBPK effort at Genentech and has been active member on IQ PBPK expert working groups.

Abstract:

Pirfenidone is the first treatment approved to treat Idiopathic Pulmonary Fibrosis (IPF). Film-coated tablets were developed to offer an alternative to the marketed capsule formulation, and the bioequivalence (BE) study of pirfenidone after single-dose of tablet and capsules under fasted and fed states were assessed.  A physiologically-based pharmacokinetic (PBPK) model was developed to describe pharmacokinetic (PK) for pirfenidone under fasted and fed conditions. The mechanistic absorption model simulation captured the observed BE study data and explained the phenomenon of Cmax slightly exceeding the BE criteria based on the hypothesis of slower disintegration with capsule under fed condition. The PBPK simulation result further supports the conclusion that the small difference in Cmax between the tablet and the capsules observed in the fed state is not expected to have clinically meaningful impact on the benefit-risk profile of pirfenidone.

Meetings International -  Conference Keynote Speaker Bjorn Margeirsson photo

Bjorn Margeirsson

University of Iceland, Iceland

Title: Structural and heat transfer modelling of lighter expanded polystyrene boxes

Biography:

Bjorn Margeirsson is a mechanical engineer holding an MSc degree from Chalmers University of Technology in Gothenburg, Sweden and a PhD from University of Iceland since 2012. He serves as Assistant Professor at the University of Iceland since 2016 and Research Manager at the plastic manufacturers RPC-Saeplast and RPC-Tempra in Iceland since 2013. He has been involved in research, development and teaching within the field of heat transfer modelling, fresh fish processing, packaging and transport for 10 years.

Abstract:

Discussion about the environmental impact of single use plastic packaging has increased during recent years. Due to its high insulation value and strength to weight ratio, expanded polystyrene (EPS) boxes are the industry standard for packing fresh fish and the recommended choice worldwide, especially in case of poor temperature control during distribution. EPS boxes are available in different size ranges but the most common ones are designed for 3 to 25 kg of fish. For packing fresh, whole salmon, typically 20-22 kg of fish is packed with 4-5 kg of ice or ice packs on top in an EPS box with volume capacity of around 40 L and weight of around 650-900 g. The aim of the project Lighter salmon box is to integrate the methods of computational heat transfer modelling, structural analysis and laboratory experiments and in the real supply chain in order to improve the design of expanded polystyrene boxes used for export of fresh, farmed fish. The effects of decreased EPS density on strength and insulation are also studied. The cooperative partners are University of Iceland, the largest fresh fish box manufacturer in Iceland, Tempra ltd., and the largest farmed fish exporter in Iceland, Arnarlax ltd. The higher order objective is to decrease the environmental impact of fresh fish packaging.

Meetings International -  Conference Keynote Speaker Elena Horska photo

Elena Horska

Slovak University of Agriculture, Slovakia

Title: Qualitative factors affecting the production and consumption of milk and cheese

Biography:

Elena Horska research activities are focused on food marketing and internationalization, intercultural studies in consumer behavior, food trend perception and changes in market environment. The workshop is supported by principal investigators of research project of the Slovak Research and Development Agency Nr. APVV-16-0244.

Abstract:

The increase of milk and cheeses consumption belongs to the key problems of food and nutrition policy worldwide, because the consumption of these products has the irreplaceable health benefit. The main aim of the workshop is to discuss the possibility of increasing the consumption of milk and cheeses with special attention paid to the consumers in order to find products which are for them in every way satisfactory in the market. To increase consumption and popularity of milk and milk products we have to know and understand socio-economic and qualitative factors affecting the production and consumption of milk and cheese. There is a place to discuss microbiological and sensory aspects of milk quality as well as all external product and marketing features. Experiences from using various research techniques will be discussed and compared to in order to show how they contribute to discovering rational and emotional feelings and reactions of consumer, all together leading to understanding purchasing and consumer behaviour on milk and milk products market. Partial attention will be devoted to intercultural studies and perception of symbols as external product features.