8^th World Congress on Bioavailability & Bioequivalence: Pharmaceutical R & D Summit June 26-27, 2017 San Diego, California, USA

Biography:

Sudheendra K has his expertise in managing the GCP Quality Management Systems at Syngene Clinical Development in the conduct of Phase I, Bioequivalence, Bioavailability studies. He has hosted many international regulatory inspections such as US FDA, EMA, ANVISA, Thailand GLP at Syngene Clinical Development. He is a trained biochemist and has been associated with GCP QMS management for the last 14+ years. He has also audited many vendors and service providers who provide support for the contract research organizations for the conduct of early phase studies. He has also audited many complex clinical trials Phase II and Phase III trials have been conducted at different hospital sites.

                                                                                                                               Email: sudheendra.kulkarni@syngeneintl.com

Abstract:

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Abstract:

Clinical Research Organizations and Industry have seen a paradigm shift towards the regulatory inspection scenario and data integrity standards that have taken the primary focus on the rights, safety and well-being of the trial subjects. The DI standards have become one of the key attention area for the regulatory inspections, not that the inspectors are looking for fraud and maleficence. The systems used in the research industry have become more complex in terms of metadata that is being generated across the companies. The metadata that is created in a clinical trial is enormous and the inspectors are very aware of the possible DI issues that occur from time-to-time. The functions such as User Access, Data Backup Policies, Audit Trail, etc. have become the focus of attention.  ALCOA principle is applicable to both paper and electronic data, thereby to ensure that the DI standards are followed all the time by all the personnel involved who generate the clinical trial data. To ensure that the DI standards are maintained across the life cycle of the clinical trial, Quality Systems should be in place and the rigor of sustaining the checks be on a continual mode. This will ensure that the clinical trial data generated will meet all the applicable regulatory requirements. No doubt, in the coming days, the DI requirements shall be more demanding and key focus in clinical research.

Biography:

Sudheendra K has his expertise in managing the GCP Quality Management Systems at Syngene Clinical Development in the conduct of Phase I, Bioequivalence, Bioavailability studies. He has hosted many international regulatory inspections such as US FDA, EMA, ANVISA, Thailand GLP at Syngene Clinical Development. He is a trained biochemist and has been associated with GCP QMS management for the last 14+ years. He has also audited many vendors and service providers who provide support for the contract research organizations for the conduct of early phase studies. He has also audited many complex clinical trials Phase II and Phase III trials have been conducted at different hospital sites.

Abstract:

Clinical Research Organizations and Industry have seen a paradigm shift towards the regulatory inspection scenario and data integrity standards that have taken the primary focus on the rights, safety and well-being of the trial subjects. The DI standards have become one of the key attention area for the regulatory inspections, not that the inspectors are looking for fraud and maleficence. The systems used in the research industry have become more complex in terms of metadata that is being generated across the companies. The metadata that is created in a clinical trial is enormous and the inspectors are very aware of the possible DI issues that occur from time-to-time. The functions such as User Access, Data Backup Policies, Audit Trail, etc. have become the focus of attention.  ALCOA principle is applicable to both paper and electronic data, thereby to ensure that the DI standards are followed all the time by all the personnel involved who generate the clinical trial data. To ensure that the DI standards are maintained across the life cycle of the clinical trial, Quality Systems should be in place and the rigor of sustaining the checks be on a continual mode. This will ensure that the clinical trial data generated will meet all the applicable regulatory requirements. No doubt, in the coming days, the DI requirements shall be more demanding and key focus in clinical research.

Biography:

Ashish Mungantiwar a PhD pharmacologist by profession. He is working as President Medical Services in Macleod’s Pharmaceuticals Limited. He heads various departments like Bioequivalence, Clinical trial and Pharmacovigilance. As Head of Bioequivalence he is served as Study Director for more than 2000 Bioequivalence studies. He has successfully handled more than 25 inspections from USFDA, WHO, EU and ANVISA.  He has attended meeting with regulators of WHO and EU during approval process of the product. In order to keep his academic temperament alive he works as PhD guide in industry and has already guided 5 PhD students. He is invited speaker in various international conferences.

Abstract:

Statement of the Problem: Bioequivalence study is conducted on healthy volunteer/patient to compare pharmacokinetic parameter of test product and reference product. Generic company conducting/sponsoring the study should be aware of risks of rejection and non-compliance.

Methodology & Theoretical Orientation: Current topic will cover list of inspection findings from various regulatory agencies like US, EU and WHO and How to be ready for unannounced inspection, Presentation will discuss current inspection trends and queries asked during dossier assessment.

Conclusion & Significance: This presentation will critically review inspector and assessors expectation on Bioequivalence studies. Understanding such expectation will help for early and successful approval of the product.

Biography:

Dr. Muneesh Garg has completed his MD (Physician) from Dagestan State Medical Academy, Russia and MD (Pharmacology) from Goverment Medical College, Patiala, Punjab, India. He has more than 18 years of experience in academia, and clinical research. He is the principal investigator of Sitec Labs Pvt Ltd., Navi Mumbai, India, for more than 11 years and has completed about 1000 BA/BE studies. He has published many research papers in reputed journals.

Abstract:

Salmeterol xinafoate and fluticasone propionate has been shown to be effective and well tolerated in the treatment of asthma. Our research aimed to determine the bioequivalence between two formulations (test and reference) of salmeterol xinafoate/fluticasone propionate HFA pMDI 25/250 mcg per actuation with and without charcoal blockade. Study-1 was a single dose, randomized, 4-period, 2-sequence, laboratory-blinded, crossover replicate design conducted in 42 healthy volunteers under fasting conditions with concurrent oral charcoal administration (to block gastrointestinal absorption). Study-2 was a single dose, randomized, 2-period, 2-sequence, laboratory-blinded, crossover design conducted in 74 healthy volunteers under fasting conditions without concurrent oral charcoal administration. Both the studies had a minimum washout period of 14 days.  Blood samples were collected up to 18 hours post-dose and 36 hours post-dose for pharmacokinetic profiling for study-1 and 2 respectively. Safety evaluations included monitoring adverse events and vital signs as well as clinical laboratory assessments. Plasma concentrations of salmeterol xinafoate and fluticasone propionate were determined using a validated LC-MS/MS method. The 90% CI of the difference between the test and reference for salmeterol xinafoate was 94.10-113.20, and 96.44-116.69 for Cmax, and AUC0-t respectively in study-1. The 90% CI of the difference between the test and reference for salmeterol xinafoate was 83.44-100.29 and 104.08-120.08 and for fluticasone propionate was 91.08-105.07, and 99.86-115.61 for Cmax and AUC0-t respectively in study-2. Since the 90% CI for Cmax and AUC0-t was within the 80–125% interval in both the studies, it was concluded that test and reference formulations of salmeterol xinafoate/fluticasone propionate HFA pMDI 25/250 mcg per actuation are bioequivalent in their rate and extent of absorption with and without charcoal blockade.

Biography:

Dr. Nadin Almosnid is working as Associate professor. She has been published 12 International Journals, 22 National Journals and attended 23 conferences. She belongs to Pharmaceutics and Pharmaceutical Technology specialization.

Abstract:

Cancer is the second cause of death due to the limited treatment options.  Because of the side effects and drug resistance of the current chemotherapy, there is an urgent need to develop new chemotherapeutic agents. Based on an ethno pharmacological survey, sixteen plant species widely used in the Medicines of Yao ethnic group in China, which is a special branch of traditional Chinese medicine (TCM), were collected and 64 plant extracts were prepared from these plants. An in vitro cytotoxicity screening was conducted with a panel of four human cancer cell lines namely, lung cancer A549, breast cancer BT20 and MCF-7, bone cancer U2OS. Besides, their possible toxicity was evaluated using two normal human cell lines, lung HPL1A and breast HMEC. A potent activity (IC50 < 5 µg/mL) was observed for ethanol extract from Melaleuca leucadendra Linnagainst against U2OS cells. The most potent extract was acetate extract from Elephantopus scaber against all tested cancer cells (BT20, A549, U2S, and MCF7) with IC50 range between 3.1-24 µg/mL. However, most of the antitumor behaviours were against U2OS cell with IC50 49.3-4 µg/ml.  The selectivity index of the active samples varied from 0 to > 100. Additionally, extracts that showed the anti-proliferation activity exhibited the ability of inducing apoptosis in U2OS cells. This study provides in vitro evidence for the traditional use of these ethno medicinal plants, and validates the safety of these plant extracts.

Biography:

Present position: Retired from Senior Research Associate position from the University of Pannonia, Georgikon Faculty, Department of the Animal Sciences & Animal Breeding,

Diploma: Geneticist – biologist & Teacher Certification for High School, 234/1964

PhD: Committee for Doctoral Awards of the Hungarian Academy of Sciences, October 7, 1974, Budapest, Hungary; PhD: Candidate of Biological Sciences; (No. 6.162).

Biological Doctor’s Degree: D-1674/1974, Eötvös Loránd University, Budapest, Hungary, December 3, 1974.

Habilitation: Habilitation Committee of the Eötvös Loránd University, Budapest, Hungary, December 13, 2000, Budapest, Hungary.

Széchenyi Professorship Award: March 19, 1999, Hungarian Ministry of Education

Fulbright Research Grant, a Fulbright Grant Biological Science Grant (1214102) and funds from Valent Biosciences, both awarded to András Fodor to conduct research in the lab of Heidi Goodrich-Blair at the University of Wisconsin-Madison, USA, 2015.

Abstract:

The emergence of antibiotic resistance proves an increasing challenge n prevention and control in microbial (zoonic) pathogens in foods. The aim of this work is to establish a suitable experimental system for genetic analysis of antimicrobial peptide-resistance in a genetically well-characterized Gram-negative target, and found Agrobacterium tumefaciens.  Intentionally, not a single but a multiple antimicrobial peptide-complex (EMA_PF2, isolated from Xenorhabdus budapestensis, with a reproducible MALDI profile), was chosen as a model to be bio-assayed in liquid cultures. Antimicrobial activity of EMA_PF2 is demonstrated on t   Gram-positive Rhodococcus equi, Erysipelothrix rhusiopathiae, Staphylococcus aureus, Streptococcus equi, Corynebacterium pseudotuberculosis, and Listeria monocytogenes) and Gram negative Salmonella Gallinarum, Salmonella Derby, Bordetella bronchiseptica, Escherichia coli, Pasteurella multocida, Aeromonas hydrophila strains including multi-resistant ones.  A. tumefaciens A281 strain with C58 chromosome (originated from a nopaline-catabolizing strain) and intact (transfer-DNA, T-DNA carrying) pTiBo542 plasmid (with agropine (L, L, -succinamopine) catabolizing genes) proved fully resistant to EMA_PF2; while the studied disarmed (transfer-DNA-deleted, del-T-DNA) plasmid-harboring derivatives (AGL1; EHA105 and A4T) were fully sensitive. By contrast, all 5 examined pTi58-plasmid-cured derivatives of C58 nopaline-catabolizing strains proved resistant to EMA_PF2. Two octopine-catabolizing strains behaved differently. Agrobacterium strains sensitive to EMA_PF2, harboring disarmed pTiBo542 provide a system for genetic complementation analysis of resistance to antimicrobial peptides using complementary sequences from resistant strains.

Biography:

Alejandro Saul Padron Yaquis has completed his PhD from Habana University. He has graduated from Dmitry Mendeleev University of Chemical Technology of Russia. He is the General Director of the Center for Pharmaceuticals Research and Development at BioCubaFarma Organization. He has published more than 25 papers in reputed journals and has been serving as the Director of a Bioequivalence Unit. He has provided training and support for the conduction of BE study in other countries.

Abstract:

Introduction: The implementation of generic drug development programs constitutes a basic component of global health policy. The aim of this work is to determine the existence of bioequivalence between two prolonged release diclofenac sodium formulations in healthy volunteers.

Materials and methods: A phase I, randomized, crossover, double-blind clinical trial was conducted where Voltaren Retard® (Novartis, Switzerland) and a prolonged release Cuban diclofenac sodium formulation (CIDEM, Havana, Cuba) were compared. The sampling period was 40 hours, with a washout time of 15 days between each period. Thirty-six healthy volunteers of both sexes, aged between 18 and 50, were included. All subjects received orally a single dose of 100 mg (one tablet) of the corresponding formulation in each period.

Results: The quantification of diclofenac sodium in plasma by HPLC demonstrated that both formulations could be considered as bioequivalent. Mean values of the key pharmacokinetic parameters were: AUC (4924.25 vs. 4928.32 μg/mL), Cmax (1046.97 vs. 1042.19 μg/mL); median Tmax was 2 hours for both formulations. The confidence intervals for AUC and Cmax were 98.3-101.7 and 98.75-101.2, respectively. The most frequent adverse events, with both formulations, were headache (11.1%), increase in transaminases values (11.1%), increase in urea (11.1%) and hypertension (8.3%), all of them mild.

Conclusions: Cuban prolonged release diclofenac sodium formulation was bioequivalent with the international leader formulation Voltaren Retard®.

Biography:

Dr. Barkat Ali Khan: Was born on 20 September 1982 in, Bannu, Khyber Pakhtunkhwa, Pakistan. He completed his B. Pharm. in 2005 from Gomal University D.I Khan, M. Phil. And PhD (Pharmaceutics) in 2010 and 2013 respectively from the Islamia University of Bahawalpur under the supervision of renowned professor Dr. Navid Akhtar. He is serving as a Lecturer in the department of Pharmaceutics at faculty of Pharmacy, Gomal University D.I Khan, Pakistan, since January 2012. He also served the school of pharmacy, Kampala international university Uganda; east Africa for one year. He has more than 100 publications in national and international journals. His research interest is in the area of cosmetics, skin preparations, novel drug delivery systems such as nanoparticles, microparticles and liposomes and their design, preparation optimization and evaluation. He is the chief editor of journal of pharmaceutical and cosmetics sciences. He is serving as Editorial Board Member and reviewer for many reputed journals. He received scholarship for his master and PhD studies from the higher education commission (HEC) of Pakistan. He was granted travel expenses to present his research papers at Thailand and Turkey by HEC.

Abstract:

Aims: This study was conducted to prepare modified release Diclofenac potassium loaded ethyl cellulose micro particles.

Methods: 13 trail formulations were studied to form an optimized formulation. Non-solvent addition coacervation method was used for the preparation. Response Surface Methodology (RSM) was applied for modified release formulation optimization. Solid state study was conducted for optimized formulation both qualitatively and quantitatively.

 Results: As the polymer concentration (X1) and stirring speed (X2) increases Entrapment efficiency (Y3) also increases. Stirring speed (X2) has great effect over particles size (Y4). As polymer concentration (X1) and stirring speed (X2) increases compressibility index (CI:Y5) also increases. Optimized formulation was selected from 30 predicted values. Polymer concentration (X1) for optimized formulation was 1.96gm and stirring speed was 602rpm. Characterization study of modified formulation of Diclofenac potassium were given as; %DR after 1^st hour (Y1) was 29.793%,  % DR after 7^th hr (Y2), E.E(Y3) was 94.511%, particle size was 343.70µm and CI (Y5) was 13.46%. In vitro dissolution study showed sustained release for 12 hrs. Kinetic study showed high R² values for zero order (0.9318) and Higuchi model (0.9962). Both qualitative and quantitative analysis proved the stability of optimized micro particles.

Conclusion: SEM showed that particles of optimized formulation were nearly spherical, light yellowish in colour, and having porous and rough surface entrapping drug crystals. Fourier transform spectrophotometry showed that drug is stable in polymer and having no interactions, X-rays powder diffraction (XRD) showed decrease in crystallinity of Diclofenac Potassium in optimized formulation and differential scanning calorimetry (DSC) proved the thermal stability of formulation.

Biography:

Alejandro Saul Padron Yaquis has completed his PhD at the age of 33 years from Habana University. He graduated from Russian University of Chemistry D. I. Mendeleiev. He is the Director of the Center for Pharmaceuticals Research and Development, one of the enterprises of BioCubaFarma Organization. He has published more than 25 papers in reputed journals and has been serving as Director of a Bioequivalence Unit. He has provided training and support for the conduction of BE study in other countries.

Abstract:

Biography:

Present position: Retired from Senior Research Associate position from the University of Pannonia, Georgikon Faculty, Department of the Animal Sciences & Animal Breeding,

Diploma: Geneticist – biologist & Teacher Certification for High School, 234/1964

PhD: Committee for Doctoral Awards of the Hungarian Academy of Sciences, October 7, 1974, Budapest, Hungary; PhD: Candidate of Biological Sciences; (No. 6.162).

Biological Doctor’s Degree: D-1674/1974, Eötvös Loránd University, Budapest, Hungary, December 3, 1974.

Habilitation: Habilitation Committee of the Eötvös Loránd University, Budapest, Hungary, December 13, 2000, Budapest, Hungary.

Széchenyi Professorship Award: March 19, 1999, Hungarian Ministry of Education.

Fulbright Research Grant, a Fulbright Grant Biological Science Grant (1214102) and funds from Valent Biosciences, both awarded to András Fodor to conduct research in the lab of Heidi Goodrich-Blair at the University of Wisconsin-Madison, USA, 2015.

Abstract:

The emergence of antibiotic resistance proves an increasing challenge n prevention and control in microbial (zoonic) pathogens in foods. The aim of this work is to establish a suitable experimental system for genetic analysis of antimicrobial peptide-resistance in a genetically well-characterized Gram-negative target, and found Agrobacterium tumefaciens.  Intentionally, not a single but a multiple antimicrobial peptide-complex (EMA_PF2, isolated from Xenorhabdus budapestensis, with a reproducible MALDI profile), was chosen as a model to be bio-assayed in liquid cultures. Antimicrobial activity of EMA_PF2 is demonstrated on t   Gram-positive Rhodococcus equi, Erysipelothrix rhusiopathiae, Staphylococcus aureus, Streptococcus equi, Corynebacterium pseudotuberculosis, and Listeria monocytogenes) and Gram negative Salmonella Gallinarum, Salmonella Derby, Bordetella bronchiseptica, Escherichia coli, Pasteurella multocida, Aeromonas hydrophila strains including multi-resistant ones.  A. tumefaciens A281 strain with C58 chromosome (originated from a nopaline-catabolizing strain) and intact (transfer-DNA, T-DNA carrying) pTiBo542 plasmid (with agropine (L, L, -succinamopine) catabolizing genes) proved fully resistant to EMA_PF2; while the studied disarmed (transfer-DNA-deleted, del-T-DNA) plasmid-harboring derivatives (AGL1; EHA105 and A4T) were fully sensitive. By contrast, all 5 examined pTi58-plasmid-cured derivatives of C58 nopaline-catabolizing strains proved resistant to EMA_PF2. Two octopine-catabolizing strains behaved differently. Agrobacterium strains sensitive to EMA_PF2, harboring disarmed pTiBo542 provide a system for genetic complementation analysis of resistance to antimicrobial peptides using complementary sequences from resistant strains.

Biography:

Ashish Mungantiwar PhD, pharmacologist by profession. He is working as President Medical Services in Macleods Pharmaceuticals Limited. He heads various departments like Bioequivalence, Clinical trial and Pharmacovigilance. As Head of Bioequivalence he has served as Study Director for more than 2000 Bioequivalence studies. He has successfully handled more than 25 regulatory inspections from USFDA, WHO, EU and ANVISA. He has attended meeting with regulators of WHO and EU during approval process of the product. His passion for respiratory drug is seen from the fact that he has been awarded patent on device of Dry powder inhaler. In order to keep his academic temperament alive he works as PhD guide in industry and has already guided five PhD students. He is invited speaker in various international conferences.

Abstract:

Statement of the Problem: Respiratory dosage forms are at the forefront of asthma and chronic obstructive pulmonary disease treatments, two diseases that afflict worldwide populations. The global sales data estimates for asthma is approximately $15.9 billion. The US itself contributes 64% of the sales mainly due to much higher prices and lack of generic inhalers in the market. Introduction of generics is essential as pricing is barrier to patient care. However, regulatory approvals of these products by different agencies are demanding and are not harmonized.

Methodology & Theoretical Orientation: Current topic will cover US and EU requirement of bioequivalence and in-vitro performance studies. Understanding various study designs and challenges. Presentation will also cover current practice and precautions to be taken during the conduct of bioequivalence studies.

Conclusion & Significance: This presentation will critically review requirement and present future directions for clinicians, scientists, and regulators to consider optimizing the development and approval of drug products for respiratory dosage forms.

Biography:

Sudheendra K has his expertise in managing the GCP Quality Management Systems at Syngene Clinical Development in the conduct of Phase I, Bioequivalence, Bioavailability studies. He has hosted many international regulatory inspections such as US FDA, EMA, ANVISA, Thailand GLP at Syngene Clinical Development. He is a trained biochemist and has been associated with GCP QMS management for the last 14+ years. He has also audited many vendors and service providers who provide support for the contract research organizations for the conduct of early phase studies. He has also audited many complex clinical trials Phase II and Phase III trials have been conducted at different hospital sites. 

Abstract:

Clinical Research Organizations (CRO) supporting the biopharmaceutical and pharmaceutical Industry have seen a paradigm shift in how regulatory inspections are conducted.  The current expectations is that the CRO has to demonstrate Quality and data integrity (DI) in order to gain the trust of the regulatory investigators.  Adherence to DI standards have become one of the key areas of focus during regulatory inspections. The systems used in the research industry have become more complex in terms of metadata that is being generated across the companies. Metadata that is created in a clinical trial is quite voluminous and the inspectors are aware of the possible DI issues that can arise from time-to-time. The functions such as User Access, Delete Features Data Backup Policies, Audit Trail, role of the System Administrator etc. have become the focus of attention during inspections. ALCOA principles is applicable to both paper and electronic data, thereby to ensure that the DI standards as part of Good Documentation Practices (GDP) are followed uniformly by all personnel who generate clinical trial data. To ensure that the DI standards are maintained across the life cycle of the clinical trial, Quality Systems should be integrated and omnipresent in the operation to ensure the protocol, regulations and procedures are followed. Adherence to these standards will ensure that the clinical trial data generated will meet the applicable regulatory requirements. The current climate is such that, the DI requirements shall be more demanding and a primary focal point in clinical research. The focus of this presentation will highlight how we prepared the teams on the current global requirements to ensure a successful regulatory inspection. 

Biography:

Dr Muneesh Garg has completed his MD (Physician) from Dagestan State Medical Academy, Russia and MD (Pharmacology) from Goverment Medical College, Patiala, Punjab, India. He has more than 18 years of experience in academia, and clinical research. He is the principal investigator of Sitec Labs Pvt Ltd., Navi Mumbai, India, for more than 11 years and has completed about 1000 BA/BE studies. He has published many research papers in reputed journals.

Abstract:

Fluticasone propionate (FP), a topically active corticosteroid shows little or no systemic activity after oral administration is indicated for the prophylactic management of asthma of all severities. The aim of these studies was to determine the bioequivalence of test and reference formulations of fluticasone propionate HFA pMDI 250 mcg per actuation with and without a spacer device. Study-1 was a single dose, randomized, 4-period, 2-sequence, laboratory-blinded, crossover replicate design conducted in 32 healthy volunteers under fasting conditions without volumatic spacer. Study-2 was a single dose, randomized, 2-period, 2-sequence, laboratory-blinded, crossover design conducted in 28 healthy volunteers under fasting conditions with volumatic spacer. Both the studies had a washout period of 14 days. Blood samples were collected up to 36 hours post-dose for pharmacokinetic profiling. Safety evaluations included monitoring adverse events and vital signs as well as clinical laboratory assessments. Plasma concentrations of fluticasone propionate were determined using a validated LC-MS/MS method. The 90% CI of the difference between the test and reference for fluticasone propionate was 97.46-112.34 and 98.55-113.06 for C_max, and AUC_0-t respectively in study-1. The 90% CI of the difference between the test and reference for fluticasone propionate was 88.13-104.88, and 96.21-111.22 for C_max, and AUC_0-t respectively in study-2. Since the 90% CI of fluticasone propionate for C_max and AUC_0-t were within the 80–125% interval in both the studies, it was concluded that test and reference formulations of fluticasone propionate HFA pMDI 250 mcg per actuation are bioequivalent in their rate and extent of absorption with and without a spacer device.

Biography:

Dr Raja Mohamed has completed his PhD from Indian Institute of Technology (IIT) Delhi & Technical University, Dresden, Germany & a Post-Doctoral Fellowship. He worked as technical lead in Dept. of Science & Technology; Govt of India sponsored Research Project to Orchid Healthcare & IIT Chennai. He had been awarded prestigious DAAD fellowship to carryout research work in Germany. Currently he is heading Bio strategy Team @ Orchid Healthcare Ltd. He has guided several M. Pharm, B. Pharm & B. Tech graduates. He has published many research papers in reputed international and national journals.

Abstract:

Cancer is second most common cause of death in US & millions die world wide due to different types of cancers. Cancer is an uncontrolled division of abnormal cells and spreading of the same into surrounding tissues.  This phenomenon interferes with digestive, nervous, circulatory systems and alters the body function.  In many ways cancer cells are different from normal cells. Normal cells mature into very distinct cell types with specific functions, whereas cancer cells don’t. Cancer cells don’t follow the apoptosis process (programmed cell death), thus continue to divide into multiples. Cancer cells influence microenvironment, for example formation of blood vessels, over expression of certain receptors to have access to nutrients necessary for the growth. Predominantly anti cancer drugs are being used for the treatment of cancers. However, they do have dose-related cardio and neuro toxicities. Further they are mostly non specific to cancer cells. It means they not only kill the cancer cells but also the normal cells. These issues make the treatment difficult. Recently, researchers are employing different methods to maximize the drugs efficiency at the same time trying to reduce the adverse events caused by them. Classically drugs are being delivered to the tumors locally or targeted to the cancer cells. However, regulatory approval of such delivery systems becomes more stringent due to inherent toxicity raised from the drug delivery systems. Current study explains the different ways of targeting cancer cells using biodegradable/biocompatible delivery system to maximize the drug’s efficiency. In this study, hydrogels of biocompatible nature are being employed to deliver the drugs.