Biography:

Hye Jin Jung is an associate professor at the Department of Pharmaceutical Engineering & Biotechnology, Sun Moon University from 2014. She received her PhD in Bioscience and Biotechnology from Sejong University in 2006. She started her postdoctoral studies at Yonsei University in the area of chemical biology. In 2008, she was appointed as a research professor of Yonsei Biomolecule Research Initiative (YBRI). She was a senior fellow at the Institute for Refractory Cancer Research (IRCR), Samsung Medical Center from 2012 to 2014. She is currently working on discovering novel bioactive small molecules from natural products and deciphering their molecular action mechanisms.

Abstract:

Glioblastoma stem cells (GSCs) have been proposed as central drivers of tumor progression, treatment resistance and tumor recurrence. Although several molecular markers, such as Wnt, Hedgehog, Notch, TGF-β and EGFR, are known to be useful for targeted therapy in GSCs, exploring novel therapeutic targets and agents to eradicate GSCs can provide a promising treatment strategy that significantly improves glioblastoma patient survival and quality of life. We recently demonstrated that downregulation of mitochondrial ubiquinol−cytochrome c reductase binding protein (UQCRB) and Ca²⁺/calmodulin-dependent protein kinase II (CaMKII) inhibits cancer stem cell-like properties in glioblastoma. The treatment with specific inhibitors and siRNAs against the molecular targets significantly inhibited not only the self-renewal capacity, such as cell growth and neurosphere formation, but also the metastasis-promoting ability, such as migration and invasion of GSCs. Notably, the inhibition of stem-like features of glioblastoma cells was associated with the downregulation of mitochondrial ROS/HIF-1a/c-Met and calmodulin/CaMKII/c-Met pathways, resulting in reduction of the expression levels of GSC markers, such as CD133, Nanog, Sox2 and Oct4. These findings suggest that UQCRB and CaMKII could be new therapeutic targets and thus their inhibitors might be utilized as lead compounds for eliminating cancer stem cells in glioblastoma.

Biography:

Professor Raid Alany is a registered New Zealand Pharmacist with a PhD from the University of Otago, Dunedin, New Zealand. He is the Inaugural Head of School of Life Sciences, Pharmacy and Chemistry at Kingston University London, UK; holds an honorary professorship at the University of Auckland, New Zealand. He is the Editor-in-Chief of Pharmaceutical Development and Technology (Taylor and Francis) and Immediate Past President of the New Zealand Chapter of the Controlled Release Society. Raid’s research is on ophthalmic drug delivery, lipid and surfactant-based systems, in-situ gels and animal health. He holds international patents that have been commercialized in New Zealand and Australia where he consults for animal health companies, regulatory bodies and IP-specialized law firms. His ResearchGate score is 35.72 and his h-index is 21 (google scholar).

Abstract:

Oxford dictionary defines research as ‘’the systematic investigation into and study of materials and sources in order to establish facts and reach new conclusions’’. Merriam-Webster dictionary defines research as ‘’studious inquiry or examination; especially: investigation or experimentation aimed at the discovery and interpretation of facts, revision of accepted theories or laws in the light of new facts, or practical application of such new or revised theories or laws’’.

Academic institutes worldwide consider research a key academic domain and would expect all their academic staff to conduct and engage in research unless they are on a non-traditional contract (teaching fellow, teaching practitioner, demonstrator, hourly paid lecturers etc.). Career progression and promotion in academic institutes involves a thorough and comprehensive review and critique of research outputs. The contribution of a particular academic staff member is assessed; the quality and quantity of journal articles published are scrutinized. Successful publication of scientific outputs is a demanding exercise especially when the target publication medium is a reputable and well established journal.

The aim of this keynote presentation is to shed light on the editorial process involved in reviewing and making editorial  decisions on scientific manuscripts submitted for publication in ‘’Pharmaceutical Development and Technology’’ ; a Taylor and Francis journal that has been in publication for 22 years and has an impact factor of 1.86. An overview of the various metrics used in ranking journals and individual scientific outputs will be covered. Tips on how to prepare a manuscript; to improve chances of success with manuscript submission for publication in leading journals will be given. 

Biography:

Young Bong Kim has received his Doctorate from Sogang University in Korea and trained at the NIAID/NIH and CWRU in United States. Since his appointment as a Professor at Konkuk University in 2003, he has been working on several vaccines against pathogenic viruses such as HIV, MERS-CoV and ZIKA virus.

Abstract:

Middle east respiratory syndrome coronavirus (MERS-CoV) is a novel betacoronavirus that has been an emerging infectious disease in human. In 2015, the MERS-CoV outbreak has been occurred in the Republic of Korea. In order to aid prophylactic strategies and control of MERS-CoV outbreak in future, we have developed a MERS-CoV DNA vaccine using baculoviral delivery system. For enhancing cellular delivery, we constructed a non-replicating recombinant baculovirus coated with human endogenous retrovirus envelope (AcHERV). First, we constructed a recombinant baculovirus encoding each of S, S1, RBD genes under the control of the AcHERV system. We confirmed MERS-CoV S, S1 and RBD genes expression levels by western blot in Huh7 cell. To investigate the efficacy of vaccine, we immunized with each of recombinant baculoviruses in Balb/c mice. We found that all three recombinant baculoviruses delivering each of MERS-CoV S, S1 and RBD genes elicited high level of IgG, neutralizing antibody, and IFN-r. Of these three constructs, S1 showed the highest humoral and cellular immune response. In conclusions, AcHERV baculoviruse could be a potential prophylactic vaccine against MERS-CoV.

Biography:

Dr. Lalit Baregama has completed his Master in Organic Chemistry and PhD in Medicinal Chemistry from Mohan Lal Sukhadia University, Udaipur. He has 28 patents and 14 Research articles in his credit. He has worked with many reputed companies in India and abroad like Ranbaxy, Hikal, Vimta, Wuxiapptech and currently associated with Cadila Pharmaceutical Ahmedabad as a General Manager-International Business Development. He has contributed from Drug Discovery to commercialization of drugs and specialty chemicals. He has presented in about 18 international conferences worldwide as an invited speaker.

Abstract:

Pharmaceutical market is already crossed the USD one trillion mark and growing further. Business strategies are changing to meet the market demand where formulation development and drug delivery system plays an important role. All big pharmaceutical companies are changing the R&D execution strategy and outsourcing full/partly development to CRO/CDMO.

Outsourcing: current scenario

• Transformational shifts of Pharma industry
• Reshaping of development strategy
• Core sectors become the growth strategy
• Essential elements for successful partnership

• Strategic intent of outsourcing
• Nature of business, risk tolerance
• Mode of partnership: single transduction or long term

Advantages, Challenges and Limitations

• Partner selection: Location, opportunities, risk and cost
• Preference advantages
• Challenges and Limitations: competition, policies, pricing, EHS

Future perspective

Biography:

Syed Abid Hassan has completed his D. Pharma from RLSY college, Master of Science in Chemistry from VM University, Master of Business Administration (in International Business) from EILM- India. Mr. Abid is doing his Ph.D in Chemistry from SSSUTM from India.

Mr. Abid is Certified Lead Auditor for ISO13485 (Medical Device) from the following well recognized centres:

BSI (British Standard Institute) UK

IRCA (International Register of Certificated Auditors) UK

Abstract:

The Regulatory Affairs is one of the key department in an organization and for those who are involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. It helps to.

Regulatory submission team:

Regulator submission team taking care of the preparation and submission of dossiers in different countries as per the national regional requirements and template.

Regulatory compliance team:

Regulatory compliance team is responsible to see the regulatory compliance in the initial product evaluation, product development at research and development unit; plant regulatory compliance, impact analysis of changes (Variation), Change control system,  CAPP (Corrective action and preventive measure), cGxP (GDP, GLP, GMP) at Manufacturing unit, Post marketing surveillance/complain, Vendor qualification as per regulatory compliance.

Regulatory Affairs department is governed by the in-built SOPs and system, which is based on the cGDP.

Regulatory affairs department ensures that the company adheres to Regulatory requirements as per rules/regulations and laws imposed to protect public health.

Since Regulations are set and changed by the leading regulatory bodies such, as ICH, WHO, FDA and EMA etc., and consequently by local and regional regulatory bodies (SFDA, GCC, JFDA, NHRA, TFDA  etc.) too, we are operating in, hence the Compliance has been an unavoidable mandatory factor for adherence to laws, regulations in accordance with the guidelines. And failing to the compliance, results in delays, rejection of approval -- even refusal at initial submission sometimes. Not only this, violating of it may result to legal punishment, including from warning letter, federal penalties to the extent of locking the firm, as it has befallen few companies, we have come across.

Hence Pharma companies across the globe are compelled to alter their practices to conform to day-to-day changes in regulations and stringent laws, so as a result of evolvement these days a dedicated section/dept. called Plant Regulatory is in vogue to ensure the adequacy of the following major basic parts (comprises all the technical items/modules) of a dossier before application/compilation/submission:

• Different Task: Development of the Vendor for compliant of API and the relevant docs

Wherein in order to raise, meet, demonstrate and maintain the standard of the dossier, many manufacturers were/are developed by educating and guiding them through series of e_mails, telephonic discussions and video conferencing etc. to bring their standard to the level of compliance to the regulatory requirements to expedite registration, renewal or variation approval by avoiding and/or minimizing the queries. 

So, a holistic approach is required to ensure that the proper steps are taken to meet global regulatory compliance from the beginning to ensure the origination of correct documents for regulatory filling and to set the system to increase the productivity with high quality and expedition, because if any step is skipped/missed, and thus right practices are NOT implemented correctly on/in time, then reverse effort to meet regulations and policies later, is likely to add cost dearly, and even may fail sometime to repair/meet.

Biography:

Laura Sánchez García is a PhD student at the Universitat Autònoma de Barcelona. She is doing her research in the Nanobiotechnology group, which is working in the development of targeted protein-only nanoparticles against cancer stem cells. She has studied a degree in Microbiology and a masters in Applied Microbiology. She has published 13 papers in reputed journals and has received an EMBO Fellowship to perform a 3-month internship in Slovenia.

Abstract:

Nowadays, conventional cancer treatments present high systemic toxicity, leading to side effects on healthy tissues. For that reason, it is of great relevance to develop targeted drugs that can increase the local drug concentration, minimize toxic effects on off-target tissues and reduce the dose administered. Moreover, loading capacity and drug leakage from vehicles during circulation in blood is a major concern when developing nanoparticle-based cell-targeted cytotoxics. To circumvent this potential issue it would be convenient the engineering of drugs as self-delivered nanoscale entities, devoid of any heterologous carriers. In this context, we have engineered potent protein toxins, using the active fragments of the diphtheria toxin and the Pseudomonas aeruginosa exotoxin, as self-assembling, self-delivered therapeutic materials targeted to CXCR4⁺ cancer stem cells. CXCR4 receptor is overexpressed in a variety of human cancers and plays a critical role in metastatic process. For this reason, we have fused T22 to the toxic domains (T22-TOXIN-H6), as it is a CXCR4 ligand able to bind specifically and internalize into the target cells.

The systemic administration of both nanostructured drugs in a colorectal cancer xenograft mouse model promotes efficient and specific local destruction of target tumor tissues and a significant reduction of the tumor volume. This observation strongly supports the concept of intrinsically functional protein nanoparticles, which having a dual role as drug and carrier, are designed to be administered without the assistance of heterologous vehicles. The promising results obtained have allowed the development of a new patent (EP17169722) that has been licensed to NANOLIGENT SL.

Biography:

Gulay Yelken Demirel has a degree in Department of Chemistry from University of Gazi (Ankara, Turkey) followed by a master degree in Medicinal and Pharmaceutical Chemistry (faculty of pharmacy) from the same university and studied Executive Master of Business Administration at Istanbul University. Currently, She has an ongoing PhD in Medicinal and Pharmaceutical Chemistry(faculty of pharmacy) at Yeditepe University. She is also a Turkish Patent Attorney. She has eleven years experience in R&D department of generic pharmaceutical companies. She worked as formulation scientist at the Pharmaceutical Technology Department of Nobel Pharmaceuticals. Presently, She owns the R&D Project Group Executive position at Sanovel Pharmaceuticals. She has several published papers in the academic areas and over 100 patents&patent applications in the industrial areas on pharmaceutical dosage forms

Abstract:

Biography:

Syed Abid Hassan has completed his D. Pharma from RLSY college, Master of Science in Chemistry from VM University, Master of Business Administration (in International Business) from EILM- India. Mr. Abid is doing his Ph.D in Chemistry from SSSUTM from India.

Mr. Abid is Certified Lead Auditor for ISO13485 (Medical Device) from the following well recognized centres:

BSI (British Standard Institute) UK

IRCA (International Register of Certificated Auditors) UK

Abstract:

Medical device is an instrument, appliance, apparatus, implement, machine, software, calibrator, contrivance, implant, In-vitro reagent, or other similar or related article, along or in combination, including a component part, or accessory or other article which is intended for the following :

• Diagnosis, prevention, monitoring, treatment, mitigation, cure or alleviation of disease,
• Investigation, replacement, or modification of the anatomy or of a physiological process
• Supporting or sustaining life
• Providing information for medical or diagnostic purposes by means of In-vitro examination of specimens derived from the human body
• To affect the structure or any function of the body of man or other animals, and/but does NOT achieve any of its primary intended purposes through its chemical action (within or on the body)
• A medical device should not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.

Medical device Classification determinations should be based on a device’s potential to harm a patient, its intended use and also the technology it uses:

Manufacturers should document their justifications for assigning their devices to Class A, B, C or D

RAs should establish a device classification system consisting of four classes where Class A represents the lowest hazard, and Class D the highest hazard.

Principle of Medical Device Classification by GHTF through doc number GHTF/SG1/N77:2012 was developed and intended for use by RAs (Regulatory Authorities), CABs (Conformity & Assessment Bodies) and Industry.

21. Regulatory Authority (RA): A government body or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and that may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements.
21. Conformity Assessment Body (CAB): A body, other than a Regulatory Authority, engaged in determining whether the relevant requirements in technical regulations or standards are fulfilled.

The actual classification of each device depends on the claims made by the manufacturer for its intended use and the technologies. As an aid to interpreting the purpose of each rule, illustrative examples of medical devices that should conform to the rule have been provided in the table of previous slide. However, it must be emphasized that a manufacturer of the medical device should NOT rely on its appearing as an example, but should instead make an independent decision on classification taking account of its particular design and intended use:

21. Manufacturers of Class A devices should implement and maintain the basic elements of a QMS, but have the option of excluding design and development controls from it. The QMS is normally not subject to premarket on-site audit by the RA or CAB, except where assurance of sterility or of a measuring function is required.
21. Manufacturers of Class B devices should implement and maintain an effective QMS, but may have the option of excluding design and development controls from it.
21. Manufacturers of Class C and D devices should implement and maintain an effective QMS that includes design and development controls, and complies with GHTF SG3 guidance documents.
21. For Class B, C, and D devices, the RA or CAB needs to have confidence that the manufacturer has an appropriate and effective QMS in place.

Biography:

Pranav Shah has completed his Ph D at the age of 27 years from The Maharaja  Sayajirao University of Baroda, India. He is working as an Professor in Pharmaceutics at Maliba Pharmacy College, Gujarat, India. He has published 20 papers in reputed journals, 2 book chapters and 1 book. He has presented several papers in national and international conferences.          

Abstract:

   Rivaroxaban is a potent selective oral direct factor Xa inhibitor, Rivaroxaban belongs to BCS Class II. Liquisolid system involves dissolving water insoluble drugs in non-volatile solvents and then converting them into dry, nonadherent, free- flowing and compressible powder mixtures by blending with selected carriers and coating materials. Liquisolid compacts (LSC) of poorly water soluble drug Rivaroxaban were prepared to enhance its dissolution rate and bioavailability. Liquisolid tablets were prepared using Polyethylene Glycol (PEG-400) as the non-volatile solvent with selected carriers and coating materials. The prepared liquisolid (LS) systems were evaluated for the flow properties.The physico–chemical properties of liquisolid systems were evaluated by Infrared spectra analysis (IR), Differential scanning calorimetry (DSC) and X- ray diffraction (XRD) and Scanning electron microscopy(SEM). DSC studies revealed that there was no interaction between the drug and carrier. XRD studies demonstrated that there was a loss in crystallinity of pure drug present in LS system. SEM indicating that the drug existed in a solid dosage form, it is held within the powder substrate in a solubilized, almost molecularly dispersed state, which contributed to the enhanced drug dissolution properties. And it is  also complies with the results of XRD and DSC that the drug is in the liquisolid system. The liquisolid tablets were evaluated for Weight variation, Hardness, Drug content, Disintegration time and Dissolution rate. Liquisolid compact exhibited higher dissolution rate as compared to marketed tablet. This enhanced dissolution rate might be due to increased wetting properties and surface area of drug available for dissolution.

Biography:

My self Pradeep Kumar, Ph.D. Scholar at Amity Institute Of microbial Technology, Amity University Rajasthan under the supervision of Prof. (Dr.) G.K. Aseri. I have 12-month Experience of Work on Synthesis of dendrimer and its utilization in pharmaceutical application from the national institute of Immunology, JNU Campus, New Delhi

Abstract:

Leishmaniasis: a vector-borne disease has a worldwide existence. It presents mainly in four forms: visceral leishmaniasis, Cutaneous Leishmaniasis, Mucocutaneous Leishmaniasis and Post Kala-Azar Dermal leishmaniasis (PKDL).In India Visceral leishmaniasis is the most existence type of leishmaniasis. Visceral leishmaniasis is also known as Kala-Azar, Black Fever, Dumdum Fever, Bardwan Fever, Sarkari Bimari etc. Visceral Leishmaniasis is caused by protozoa species haemoflagellate leishmaniasis Donovan and transmitted by the bite of sand flies of Phlebotomus genus. Visceral leishmaniasis affects various age groups. Approximate 10k morbidity with 1k mortality occurs annually due to visceral leishmaniasis in India. Fast urbanization, poverty, improper sanitation, lack of knowledge about prevention and individual risk factors like HIV, malnutrition and genetic susceptibility is the major source of visceral leishmaniasis existence in India. Approximate 90% cases of Indian visceral leishmaniasis come from Bihar. Available treatment modalities have limitations like serious side effects, nonoral solubility, high cost and long hospitalization due to this a favorable treatment option for visceral leishmaniasis is still out of range of a common man. A dendrimer is a new generation of artificial polymeric macromolecules constructed in a step-by-step fashion using repetitive chemistry. Dendrimer has a number of applications in several pharmaceutical fields such as enhancing the solubility of the poorly soluble drug, enhancing the delivery of DNA, and as a carrier for the development of novel drug delivery systems. The present research emphasizes the development of a conjugate of Dendrimer with the nonoral soluble drug for the purpose of oral solubility enhancement and then use for the treatment of visceral leishmaniasis.