L Intérêt du Projet CTI

Size: px
Start display at page:

Download "L Intérêt du Projet CTI"

Transcription

1 L Intérêt du Projet CTI Prof. Yogeshvar N. Kalia Molecular Therapeutics Delivery Group Section des sciences pharmaceutiques CMU, 1 Rue Michel Servet, Genève yogi.kalia@unige.ch REUSSIR VOS PROJETS CTI Université de Genève / Faculté des sciences Mercredi 8 février 2017

2 My group s research interests and expertise NEW ACTIVITIES CREATED THROUGH CTI PROJECTS DRUG DELIVERY ACROSS BIOLOGICAL BARRIERS Transdermal, Ocular, Buccal & Intestinal absorption PRODRUG DESIGN Synthesis & Characterisation THERAPEUTICS Small Molecules, Peptides, Proteins and Antibodies DRUG VISUALISATION UNIGE Bioimaging Platform QUANTIFICATION AND DETERMINATION OF DRUG BIODISTRIBUTION HPLC + UHPLC with UV, Fluorescence & MS/MS, ELISA, Activity Assays DRUG FORMULATION Micelles, Microparticles, Nanoparticles, Semi-solids, Films & Patches DRUG DELIVERY TECHNOLOGIES Polymer Systems, Iontophoresis, Fractional Laser Ablation 2

3 Industrial collaborations and CTI projects FUNDING? DIRECT CTI YN Kalia UNIGE, 2017 PERSONNEL 3

4 Different projects different activities and goals Project Title # # # Novel approaches for minimally invasive intraepidermal drug delivery (PI) Development of a new alcohol-free gel product for the controlled transdermal delivery of testosterone to treat sexual dysfunction (PI) Peptides based on animal venom constituents as new active ingredients for cosmetic products (Co-I) # # # Development of novel hydrocolloid patches for use with P.L.E.A.S.E. fractional laser ablation system for the intraepidermal needle-less delivery of biotechnology therapeutics (PI) Development of a physiological model for drug permeation in the gastrointestinal tract using porcine intestinal mucosa: A new efficient method for drug screening and identification of lead candidates (PI) Spironolactone-ApidSOL formulation for delayed healing of minor wounds in glucocorticoid treated patients (PI) 4

5 Device projects (Pantec Biosolutions) Novel approaches for minimally invasive intraepidermal drug delivery (PI) Development of novel hydrocolloid patches for use with P.L.E.A.S.E. fractional laser ablation system for the intraepidermal needle-less delivery of biotechnology therapeutics (PI) PLEASE PROFESSIONAL Launched BioPharm America Sep 2011 AIMS Development and evaluation of new transdermal systems for minimally invasive drug delivery to provide a safe, efficient alternative to parenteral administration ACHIEVEMENTS & REWARDS Acquired new skills and know-how wrt molecules, created new drug delivery technology; first report of needle-free local antibody delivery Clinical trials initiated 5

6 Sometimes possible to publish

7 Making better formulations: PharmaCo X, Activen, Apidel Development of a new alcohol-free gel product for the controlled transdermal delivery of testosterone to treat sexual dysfunction (PI) Peptides based on animal venom constituents as new active ingredients for cosmetic products (Co-I) Spironolactone-ApidSOL formulation for delayed healing of minor wounds in glucocorticoid treated patients (PI) YN Kalia UNIGE, 2017 AIMS Develop new, more efficient formulations for topical or transdermal delivery ACHIEVEMENTS & REWARDS Successful development of new formulations with possibility of entering clinical trials New research opportunities and activities created Possibilities for future collaboration Experience of industrial product development and requirements/rigour 7

8 Developing a new preclinical model: Debiopharm International Development of a physiological model for drug permeation in the gastrointestinal tract using porcine intestinal mucosa: A new efficient method for drug screening and identification of lead candidates (PI) AIMS Develop new, preclinical model ACHIEVEMENTS & REWARDS Successful development of model New research axis Collaboration opportunities created 8

9 Conclusions: Take home message SCIENTIFIC OPPORTUNITIES Create new research activities innovation. Acquire new skills and capabilities. Learn new applications of routine techniques. NETWORKING / COLLABORATION OPPORTUNITIES Mechanism to create collaborations and expand network. Build awareness, credibility this leads to further collaborations. Improve employment opportunities for group members (postdocs). DIFFERENT APPROACH Must understand the needs and requirements of the industrial partner. Precise, clear objectives required goal-oriented. Results must be delivered within the required timeframe. SOCIAL RESPONSABILITY Public-Private Partnerships - build closer links to companies in the Lemanic region and Switzerland. 9

IIS INNOVATIVE INJECTION SYSTEMS NEW PERSPECTIVES, MORE POSSIBILITIES

IIS INNOVATIVE INJECTION SYSTEMS NEW PERSPECTIVES, MORE POSSIBILITIES IIS INNOVATIVE INJECTION SYSTEMS NEW PERSPECTIVES, MORE POSSIBILITIES IIS REVOLUTIONARY ADMINISTRATION TECHNIQUES MORE EFFICIENCY AND SAFETY IIS researches and develops innovative injection systems. Within

More information

Transdermal Drug in Adhesive Delivery Patch

Transdermal Drug in Adhesive Delivery Patch Transdermal Drug in Adhesive Delivery Patch A Technology Outline CC Lee M.Sc.,B.Sc.(Hons) CEO, Director of Technology Transdermal Drug Delivery Offers the Best of IV and Oral Administration IV Oral TDD

More information

The 13th ICDRA (16-19 September) Regulatory Approaches to proving Interchangeability. WHO Biowaiver Guideline in Regulatory Practice

The 13th ICDRA (16-19 September) Regulatory Approaches to proving Interchangeability. WHO Biowaiver Guideline in Regulatory Practice The 13th ICDRA (16-19 September) Regulatory Approaches to proving Interchangeability WHO Biowaiver Guideline in Regulatory Practice Dr Kamel IDDIR General Director Medicines and Pharmacy Directorate Berne

More information

Innovative drug delivery solutions for exceptional therapeutics APIDEL2017. ALL RIGHTS RESERVED.

Innovative drug delivery solutions for exceptional therapeutics APIDEL2017. ALL RIGHTS RESERVED. Innovative drug delivery solutions for exceptional therapeutics Apidel at a glance Apidel develops pharmaceutical products and provides innovative and more effective drug delivery solutions. Based on our

More information

We make drugs smarter

We make drugs smarter We make drugs smarter Brookwood Pharmaceutical Services WE MAKE DRUGS SMARTER Using our 40 years of experience, our state of the art facilities and our IP protected technologies, we leverage existing capabilities

More information

Evonik Birmingham Laboratories

Evonik Birmingham Laboratories Evonik Birmingham Laboratories An integrated CDMO for advanced parenterals with a portfolio of delivery technologies, formulation development services and GMP manufacturing Evonik Birmingham Laboratories

More information

NOVEL DRUG DELIVERY SYSTEMS II

NOVEL DRUG DELIVERY SYSTEMS II NOVEL DRUG DELIVERY SYSTEMS II Polymer Science 1. Define Polymer. Describe its properties. 2. Classify polymers based on various criteria. 3. What are the ideal characteristics of biodegradable polymers?

More information

Applications of self-assembling peptides in controlled drug delivery

Applications of self-assembling peptides in controlled drug delivery Applications of self-assembling peptides in controlled drug delivery Sotirios Koutsopoulos, Ph.D. Problems associated with drug administration Drug concentration in blood C toxic C effective Time 1 The

More information

FORMULATING FOR MICRONEEDLE DELIVERY. Professor Finn Bauer

FORMULATING FOR MICRONEEDLE DELIVERY. Professor Finn Bauer FORMULATING FOR MICRONEEDLE DELIVERY Professor Finn Bauer OVERVIEW Conventional microneedle strategies Change of mind set to consider systemic delivery of therapeutic agents Design & manufacture considerations

More information

CHAPTER INTRODUCTION 1.1 ORAL DRUG DELIVERY: SCOPE AND ADVANTAGES

CHAPTER INTRODUCTION 1.1 ORAL DRUG DELIVERY: SCOPE AND ADVANTAGES 1.0 INTRODUCTION 1.1 ORAL DRUG DELIVERY: SCOPE AND ADVANTAGES Oral ingestion is the preferred route for administration of therapeutic agents, providing a convenient method of effectively achieving both

More information

In vivo predictive biopharmaceutics tools for oral drug delivery

In vivo predictive biopharmaceutics tools for oral drug delivery In vivo predictive biopharmaceutics tools for oral drug delivery Bertil Abrahamsson, AstraZeneca and Mark McAllister, Pfizer Background non-absorbable drug complex complex formation drug in solid dosage

More information

SYMBIOTIC HEALTH. Targeted GI Delivery of Orally Administered Cells and Proteins for Microbiome-Based Therapeutics

SYMBIOTIC HEALTH. Targeted GI Delivery of Orally Administered Cells and Proteins for Microbiome-Based Therapeutics SYMBIOTIC HEALTH Targeted GI Delivery of Orally Administered Cells and Proteins for Microbiome-Based Therapeutics Contact: Gerard Honig PhD, Director ghonig@symbioticbio.com Overview Biotechnology startup

More information

5 key characteristics

5 key characteristics Biosimilars 5 key characteristics Biologics are medicinal products derived from living organisms. 1 Their use has impacted the treatment of a variety of diseases. 1 Patents for many biologics will soon

More information

Centre for Bioactive Molecules and Drug Delivery (BMDD)

Centre for Bioactive Molecules and Drug Delivery (BMDD) Centre for Bioactive Molecules and Drug Delivery (BMDD) Foreword by Prof Mak Joon Wah Professor, Dean, Postgraduate Studies & Research cum Vice-President, Research, School of Postgraduate Studies & Research

More information

Your bridge to. better medicines

Your bridge to. better medicines Your bridge to better medicines At a Glance Anapharm Bioanalytics is a client-oriented, GLP-certified, FDA-inspected, GCP-compliant and ANVISA-certified bioanalytical contract research organization (CRO)

More information

Introduction of Development Center for Biotechnology TAIWAN

Introduction of Development Center for Biotechnology TAIWAN Introduction of Development Center for Biotechnology TAIWAN DCB Nonprofit Organization Founded in 1984 Funded Mainly by Ministry of Economic Affairs (MOEA), National Science Council and the Industry 394

More information

Applying Affimers. Dr Amanda Nicholl at Avacta Life Sciences. Improving Antibody PK Assay Development

Applying Affimers. Dr Amanda Nicholl at Avacta Life Sciences. Improving Antibody PK Assay Development Improving Pharmacokinetic Assays in a Regulatory Bioanalysis Setting Applying Affimers With an increasing number of antibody-based therapeutics entering the clinic, the need for validated anti-idiotypic

More information

MASTER IN PHARMACEUTICAL SCIENCES (Thesis Track)

MASTER IN PHARMACEUTICAL SCIENCES (Thesis Track) MASTER IN PHARMACEUTICAL SCIENCES (Thesis Track) I. GENERAL RULES CONDITIONS: Plan Number 1 \ 12 70 2005 T 1. This plan conforms to the valid regulations of the programs of graduate studies. 2. Areas of

More information

Applied Protein Services

Applied Protein Services Applied Protein Services Applied Protein Services A Window into the Future Development risk and attrition rates remain two of the greatest challenges to a successful biopharmaceutical pipeline. To help

More information

Primiano Pio Di Mauro, Biomedical Engineer, PhD in Bioengineering

Primiano Pio Di Mauro, Biomedical Engineer, PhD in Bioengineering Primiano Pio Di Mauro, Biomedical Engineer, PhD in Bioengineering pri.dimauro@gmail.com Mobile: 0034 689326511 Carrer de la Diputació 478 1º2ª, 08013, Barcelona, Spain https://www.linkedin.com/in/pridimauro/

More information

Bayer Pharma s High Tech Platform integrates technology experts worldwide establishing one of the leading drug discovery research platforms

Bayer Pharma s High Tech Platform integrates technology experts worldwide establishing one of the leading drug discovery research platforms Bayer Pharma s High Tech Platform integrates technology experts worldwide establishing one of the leading drug discovery research platforms Genomics Bioinformatics HTS Combinatorial chemistry Protein drugs

More information

AdaptDose, an innovative platform that reduces product development time and costs by 30% or more

AdaptDose, an innovative platform that reduces product development time and costs by 30% or more WHITE PAPER January 2017 AdaptDose, an innovative platform that reduces product development time and costs by 30% or more Frontida BioPharm, Inc. Ron Connolly 01.01.2017 CONTENTS ABSTRACT INTRODUCTION

More information

LUPAS Luminescent Polymers for in vivo Imaging of Amyloid Signatures

LUPAS Luminescent Polymers for in vivo Imaging of Amyloid Signatures LUPAS Luminescent Polymers for in vivo Imaging of Amyloid Signatures A research project for innovative diagnostics for neurodegenerative disorders Funded by the European Union under the 7 th Framework

More information

PROF. DR. ASMAA HUSSEIN DIRECTOR OF THE MOLECULAR BIOLOGY RESEARCH UNIT

PROF. DR. ASMAA HUSSEIN DIRECTOR OF THE MOLECULAR BIOLOGY RESEARCH UNIT BY PROF. DR. ASMAA HUSSEIN DIRECTOR OF THE MOLECULAR BIOLOGY RESEARCH UNIT Immunoassay are based on the strong and highly specific interaction occurring between antigens (Ag)) and antibodies (Ab). Ag Ab

More information

Molecular imaging in vitro and in vivo

Molecular imaging in vitro and in vivo Molecular imaging in vitro and in vivo Tony Lahoutte, MD PhD Free University Brussels Technology Day 18/09/2008, Brussels Molecular Imaging Definition: Molecular imaging is the visualization, the characterization

More information

Strategic Overview of the Biotechnology Industry

Strategic Overview of the Biotechnology Industry Strategic Overview of the Biotechnology Industry Cavan Redmond Executive Vice President General Manager Wyeth BioPharma Business Unit June 15, 2004 2003Wyeth. Risk and Innovation Create Opportunity Biotech

More information

PHARMACEUTICAL TESTING

PHARMACEUTICAL TESTING WHITEHOUSE, NJ PHARMACEUTICAL TESTING Pharmaceutical Expertise for GMP & CMC Testing Our Pharmaceutical Expertise With more than 20 years of experience in a variety of industries, our Whitehouse, New Jersey

More information

Foresee Pharmaceuticals, Inc.

Foresee Pharmaceuticals, Inc. Foresee Pharmaceuticals, Inc. Rapid Development and Commercialization of a Proprietary Sustained-release Depot Formulation of Leuprolide for the Treatment of Advanced Prostate Cancer PNWBIO Meeting 10

More information

Introduction to Drug Design and Discovery

Introduction to Drug Design and Discovery Introduction to Drug Design and Discovery Course: Drug Design Course code: 0510412 Dr. Balakumar Chandrasekaran Dr. Bilal Al-Jaidi Assistant Professors, Pharmaceutical Medicinal Chemistry, Faculty of Pharmacy,

More information

DIFFERENT APPROACHES FOR IMPROVING SKIN ACCUMULATION OF CLOBETASOL-17-PROPIONATE

DIFFERENT APPROACHES FOR IMPROVING SKIN ACCUMULATION OF CLOBETASOL-17-PROPIONATE DIFFERENT APPROACHES FOR IMPROVING SKIN ACCUMULATION OF CLOBETASOL-17-PROPIONATE Taner ŞENYİĞİT*, Cristina PADULA**, Özgen ÖZER*, Patrizia SANTI** *Ege University, Faculty of Pharmacy, Department of Pharmaceutical

More information

Career Growth Areas in Physiology / Pharmacology

Career Growth Areas in Physiology / Pharmacology Career Growth Areas in Physiology / Pharmacology Magdalena Alonso-Galicia, PhD Pharmacology Department Forest Research Institute, Inc. Jersey City, NJ 1 Career Growth Areas in BioPharma n Pharmaceutical

More information

At LATITUDE, we only do one thing, and we do it very well.

At LATITUDE, we only do one thing, and we do it very well. Formulation Experts for Insoluble Compounds At LATITUDE, we only do one thing, and we do it very well. LATITUDE Pharmaceuticals Inc. has been tackling the most difficult drug formulation challenges for

More information

Healthcare. Healthcare. The Centre for Process Innovation. From innovation to commercialisation

Healthcare. Healthcare. The Centre for Process Innovation. From innovation to commercialisation Healthcare Healthcare The Centre for Process Innovation From innovation to commercialisation The Centre for Process Innovation From innovation to commercialisation The Centre for Process Innovation (CPI)

More information

From Bench to Bedside. Russ H. Read June 23, 2014

From Bench to Bedside. Russ H. Read June 23, 2014 From Bench to Bedside Russ H. Read June 23, 2014 Talent Required Scientists, clinicians, technicians, chemists, biologists, pharmacologists, toxicologists, research associates, regulatory experts, manufacturing

More information

EXPERT COLLECTION. Explore our leading medical review series

EXPERT COLLECTION. Explore our leading medical review series EXPERT COLLECTION Explore our leading medical review series Introducing the EXPERT COLLECTION The Taylor & Francis Expert Collection is the world s largest series of review journals in research, development,

More information

Food and Drug Administration (FDA) 101

Food and Drug Administration (FDA) 101 Food and Drug Administration (FDA) 101 What is the Food and Drug Administration (FDA)? The FDA is an agency within the U.S. Department of Health and Human Services that is responsible for protecting the

More information

Chapter 1. Introduction

Chapter 1. Introduction Chapter 1 Introduction Controlled drug delivery systems, which are intended to deliver drugs at predetermined rates for predefined periods of time, have been used to overcome the shortcomings of conventional

More information

T ransdermal Drug Delivery Systems

T ransdermal Drug Delivery Systems Register by January 1 st and receive a $300 Discount! PharmaED s T ransdermal Drug Delivery Systems E x a m i n e R e c e n t D e v e l o p m e n t s i n Tra n s d e r m a l D r u g D e l i v e r y FEBRUARY

More information

Specialty Lab Services. Deep science at scale

Specialty Lab Services. Deep science at scale Specialty Lab Services Deep science at scale Advancing biomarker research Our broad expertise and global laboratory footprint deliver deep science at scale Specialty assays drive insight into preclinical

More information

Scientific and Regulatory Perspectives on Measuring Protein Aggregation of Biotechnology Products

Scientific and Regulatory Perspectives on Measuring Protein Aggregation of Biotechnology Products Scientific and Regulatory Perspectives on Measuring Protein Aggregation of Biotechnology Products Ashutosh Rao, Ph.D. Chief, Laboratory of Applied Biochemistry Division of Biotechnology Review and Research

More information

DISCOVERY AND VALIDATION OF TARGETS AND BIOMARKERS BY MASS SPECTROMETRY-BASED PROTEOMICS. September, 2011

DISCOVERY AND VALIDATION OF TARGETS AND BIOMARKERS BY MASS SPECTROMETRY-BASED PROTEOMICS. September, 2011 DISCOVERY AND VALIDATION OF TARGETS AND BIOMARKERS BY MASS SPECTROMETRY-BASED PROTEOMICS September, 2011 1 CAPRION PROTEOMICS Leading proteomics-based service provider - Biomarker and target discovery

More information

NanoAssemblr Benchtop. Develop Future Nanomedicines

NanoAssemblr Benchtop. Develop Future Nanomedicines NanoAssemblr Benchtop Develop Future Nanomedicines Develop the Future of Medicine Overcome key challenges in advancing nanomedicines: Challenges with conventional production methods Solutions with the

More information

Detection of toxicity to reproduction for human pharmaceuticals. Explanatory slides agreed by EWG members

Detection of toxicity to reproduction for human pharmaceuticals. Explanatory slides agreed by EWG members Detection of toxicity to reproduction for human pharmaceuticals Explanatory slides agreed by EWG members 2 October 2017 International Council for Harmonisation of Technical Requirements for Pharmaceuticals

More information

Duncan Holmes European Head Discovery Partnerships with Academia GlaxoSmithKline

Duncan Holmes European Head Discovery Partnerships with Academia GlaxoSmithKline R&D Strategy Bridging g the academia-industry industry yg gap Duncan Holmes European Head Discovery Partnerships with Academia GlaxoSmithKline GSK at a glance Who we are We are a science-led global healthcare

More information

Toxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development

Toxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development Toxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development No. 1 of 10 1. regulates all the drugs products manufactured and sold in the USA. (A) EMEA (B) IND (C) FDA (D) NDA (E) OSHA

More information

Priority Research Programme

Priority Research Programme Priority Research Programme Science of Food Distinguished Professor Harjinder Singh Riddet Institute, Massey University Science of Food - Goals 1. Establish a cluster of expertise in developing prototype

More information

Advanced Biomaterials and Nanotechnologies in Drug Delivery

Advanced Biomaterials and Nanotechnologies in Drug Delivery NANOTECHNOLOGY & ADVANCED MATERIALS SYMPOSIUM Advanced Biomaterials and Nanotechnologies in Drug Delivery Date : 25 September 2015 (Friday) Time : 2:00pm 5:00pm (Registration starts at 1:45pm) Venue :

More information

the PLATFORM Pipeline in Lyon AREA

the PLATFORM Pipeline in Lyon AREA the PLATFORM Pipeline in Lyon AREA Do you have development or partnership projects in Life Sciences? Are you interested in developing your business in France? This overview is designed to give you an idea

More information

COMPANY PROFILE. Dishman offers innovation, security of supply and value for money. Dishman Group. Research EARLY STAGE API. Preclinical.

COMPANY PROFILE. Dishman offers innovation, security of supply and value for money. Dishman Group. Research EARLY STAGE API. Preclinical. COMPANY PROFILE Dishman is a global outsourcing partner for the pharmaceutical industry offering a portfolio of development, scale-up and services. Dishman improves its customers businesses by providing

More information

NIH-RAID: A ROADMAP Program

NIH-RAID: A ROADMAP Program NIH-RAID: A ROADMAP Program (Rapid Access to Interventional Development} A Program designed to facilitate the development of new therapeutics The NIH-RAID Pilot Program is intended to reduce some of the

More information

Appropriate Control Strategies Eliminate the Need for Redundant Testing of Pharmaceutical Products

Appropriate Control Strategies Eliminate the Need for Redundant Testing of Pharmaceutical Products Date: April 23, 2012 Appropriate Control Strategies Eliminate the Need for Redundant Testing of Pharmaceutical Products Key Messages Importation quality control testing for pharmaceutical, biological/biotechnology

More information

ASCENDIA PHARMACEUTICALS Aspiring for Better Medicine

ASCENDIA PHARMACEUTICALS Aspiring for Better Medicine ASCENDIA PHARMACEUTICALS Aspiring for Better Medicine Ascendia Pharmaceuticals, founded in 2012, is a privately-owned, speciality pharmaceutical company dedicated to developing enhanced formulations of

More information

How Targets Are Chosen. Chris Wayman 12 th April 2012

How Targets Are Chosen. Chris Wayman 12 th April 2012 How Targets Are Chosen Chris Wayman 12 th April 2012 A few questions How many ideas does it take to make a medicine? 10 20 20-50 50-100 A few questions How long does it take to bring a product from bench

More information

Course Curriculum for Master Degree in Pharmaceutical Technology

Course Curriculum for Master Degree in Pharmaceutical Technology Course Curriculum for Master Degree in Pharmaceutical Technology The Master Degree in Pharmaceutical Technology is awarded by the Faculty of Graduate studies at Jordan University of Science and Technology

More information

Vetter Development Service

Vetter Development Service A unique blend of expertise for clinical manufacturing Vetter Development Service Supporting your compound s success Answers that work 1 Your molecule s future starts here. By the time your new injectable

More information

Stem cell and cell therapeutics research in Lithuania. Bernardas Morkunas Head of Business Development

Stem cell and cell therapeutics research in Lithuania. Bernardas Morkunas Head of Business Development Stem cell and cell therapeutics research in Lithuania Bernardas Morkunas Head of Business Development Lithuanian biotech Biotechnology is considered as one of 2014-2020 Smart Specialisation priority fields

More information

Innovative Pharmaceutical Solutions for Discovery Chemistry, Biology and cgmp Manufacturing

Innovative Pharmaceutical Solutions for Discovery Chemistry, Biology and cgmp Manufacturing Innovative Pharmaceutical Solutions for Discovery Chemistry, Biology and cgmp Manufacturing Overview Serving biotech and pharma community since 1998 Proven track record of advancing small molecules from

More information

Advancing Life Sciences

Advancing Life Sciences Advancing Life Sciences Sweden s largest center for life sciences A national resource SciLifeLab, Science for Life Laboratory, is a Swedish national center for molecular biosciences, with the mission to

More information

Formulation Aspects in Biosimilar Development. Kedar S. Gokhale, PhD. Lupin Ltd. (Biotech)

Formulation Aspects in Biosimilar Development. Kedar S. Gokhale, PhD. Lupin Ltd. (Biotech) Formulation Aspects in Biosimilar Development Kedar S. Gokhale, PhD. Lupin Ltd. (Biotech) Typical Protein Formulation Components of a protein formulation Active Ingredient Buffer Tonicity modifier Stabilizer

More information

Microelectromechanical Drug Delivery Systems. Sarah Smith & Jurek Smolen

Microelectromechanical Drug Delivery Systems. Sarah Smith & Jurek Smolen Microelectromechanical Drug Delivery Systems Sarah Smith & Jurek Smolen Current Drug Delivery Systems Common Administration Methods Problems Oral Intravenous Intramuscular Transdermal Difficult to control

More information

Regulatory Issues and Drug Product Approval for Biopharmaceuticals

Regulatory Issues and Drug Product Approval for Biopharmaceuticals Regulatory Issues and Drug Product Approval for Biopharmaceuticals Vinod P. Shah, Ph. D. FIP Scientific Secretary Biotech 2007 Southern African Regional and International Regulatory Biotechnology Workshop

More information

Transdermal Drug Delivery System Regulatory Requirements (USA)

Transdermal Drug Delivery System Regulatory Requirements (USA) Transdermal Drug Delivery System Regulatory Requirements (USA) Vinod P. Shah, Ph. D., FIP Scientific Secretary Conference on To and Thru the Skin IPA AAPS FIP - APSTJ Mumbai, India, February 20-21, 2009

More information

Cancer Research UK; $500m annual research spend on basic research, drug discovery and clinical development

Cancer Research UK; $500m annual research spend on basic research, drug discovery and clinical development Cancer Research UK; $500m annual research spend on basic research, drug discovery and clinical development Phil L Huillier Director Cancer Research Technology Ltd London, UK Who we are Cancer Research

More information

Innovative Partnerships in Biotechnology A Biotech Perspective on Past, Present & Future

Innovative Partnerships in Biotechnology A Biotech Perspective on Past, Present & Future Innovative Partnerships in Biotechnology A Biotech Perspective on Past, Present & Future Donald Olds Chief Operating Officer & CFO Aegera Therapeutics Inc. June 8, 2010 1 Discussion Points Why do biotech

More information

IK4 BIOTECHNOLOGY & BIOMATERIALS. Research Alliance.

IK4 BIOTECHNOLOGY & BIOMATERIALS. Research Alliance. IK4 Research Alliance BIOTECHNOLOGY & BIOMATERIALS www.ik4.es BIOTECHNOLOGY AND BIOMATERIALS, CROSS-CUTTING TECHNOLOGIES The biotechnology and biomaterials fields are characterised by the fact that they

More information

Capabilities & Services

Capabilities & Services Capabilities & Services Accelerating Research & Development Table of Contents Introduction to DHMRI 3 Services and Capabilites: Genomics 4 Proteomics & Protein Characterization 5 Metabolomics 6 In Vitro

More information

Highlight Product : QuickSwitch Custom Tetramer Kits. Featured Product : PCSK9 ELISA Kit & PCSK9-LDLR in vitro Binding Assay Kit

Highlight Product : QuickSwitch Custom Tetramer Kits. Featured Product : PCSK9 ELISA Kit & PCSK9-LDLR in vitro Binding Assay Kit vol.1 Sep. 2017 Highlight Product : QuickSwitch Custom Tetramer Kits Featured Product : PCSK9 ELISA Kit & PCSK9-LDLR in vitro Binding Assay Kit Attended The 8th International Symposium on Autophagy Hi,

More information

SPEED UP YOUR TIME TO MARKET

SPEED UP YOUR TIME TO MARKET SPEED UP YOUR TIME TO MARKET #Pre-clinical #Biologics #Small molecules Welcome to Accelera. As a Contract Research Organization (CRO) serving since more than 30 years pharmaceutical and biotechnology companies

More information

TECHNOLOGIES & SERVICES FOR THERAPEUTIC ANTIBODY DEVELOPMENT

TECHNOLOGIES & SERVICES FOR THERAPEUTIC ANTIBODY DEVELOPMENT Specialist in tissue analysis by Histology, Immunohistochemistry and In Situ Hybridization TECHNOLOGIES & SERVICES FOR THERAPEUTIC ANTIBODY DEVELOPMENT CONTENTS Histalim: who we are Our areas of expertise

More information

DRUG SOLUBILITY EXECUTIVE SUMMARY

DRUG SOLUBILITY EXECUTIVE SUMMARY DRUG SOLUBILITY Utilising a high throughput screening platform to determine the optimum pharmaceutical excipients in the development of liquid formulations EXECUTIVE SUMMARY Drugs are small molecules or

More information

Intertek Melbourn Company Presentation. MIBio 2016

Intertek Melbourn Company Presentation. MIBio 2016 Intertek Melbourn Company Presentation MIBio 2016 November 2016 Global Leader in quality solutions across all industries Innovative and bespoke quality solutions for our clients 24/7 FTSE 100 company in

More information

Phylogica. Harnessing Biodiversity for Peptide Therapies. Life Sciences Showcase, 23 August 2011 Nick Woolf: CFO & VP Corporate Development

Phylogica. Harnessing Biodiversity for Peptide Therapies. Life Sciences Showcase, 23 August 2011 Nick Woolf: CFO & VP Corporate Development Phylogica Harnessing Biodiversity for Peptide Therapies Life Sciences Showcase, 23 August 2011 Nick Woolf: CFO & VP Corporate Development Introduction Biotech company offering leading peptide drug discovery

More information

SKIN BIOLOGY A VALUABLE TOOL FOR THE INNOVATION AND DEVELOPMENT OF NOVEL THERAPEUTIC ALTERNATIVES IN DERMATOLOGY

SKIN BIOLOGY A VALUABLE TOOL FOR THE INNOVATION AND DEVELOPMENT OF NOVEL THERAPEUTIC ALTERNATIVES IN DERMATOLOGY SKIN BIOLOGY A VALUABLE TOOL FOR THE INNOVATION AND DEVELOPMENT OF NOVEL THERAPEUTIC ALTERNATIVES IN DERMATOLOGY COMPANY BACKGROUND Specializes in liquid and semi-solid topical products Rx, OTC & Therapeutic

More information

ALLERGAN ENTERS STRATEGIC R&D ALLIANCE WITH EDITAS MEDICINE TO DISCOVER AND DEVELOP CRISPR GENE EDITING PROGRAMS FOR OCULAR DISEASES

ALLERGAN ENTERS STRATEGIC R&D ALLIANCE WITH EDITAS MEDICINE TO DISCOVER AND DEVELOP CRISPR GENE EDITING PROGRAMS FOR OCULAR DISEASES ALLERGAN ENTERS STRATEGIC R&D ALLIANCE WITH EDITAS MEDICINE TO DISCOVER AND DEVELOP CRISPR GENE EDITING PROGRAMS FOR OCULAR DISEASES Novel Development Programs for Potential Treatments of Serious Ocular

More information

Risk-based testing for anti-drug neutralizing antibodies during development of biological therapeutics

Risk-based testing for anti-drug neutralizing antibodies during development of biological therapeutics Risk-based testing for anti-drug neutralizing antibodies during development of biological therapeutics April 18 th, 2016 AAPS National Biotechnology Conference, Boston, MA Shalini Gupta, PhD Amgen Inc.

More information

PMDA Perspective on Specifications for Biotechnological Products

PMDA Perspective on Specifications for Biotechnological Products WCBP 2016, January 26 28, 2016, The Mayflower Hotel, Washington, DC, USA PMDA Perspective on Specifications for Biotechnological Products Yasuhiro Kishioka, Ph.D. Principal Reviewer Office of Cellular

More information

INNOVATIVE SOLUTIONS IN THE PHARMACEUTICAL INDUSTRY

INNOVATIVE SOLUTIONS IN THE PHARMACEUTICAL INDUSTRY INNOVATIVE SOLUTIONS IN THE PHARMACEUTICAL INDUSTRY Soula Kyriacos, B.Pharm, PhD Head R&D, Pharmaline May 2017 Next-generation patients demand next-generation innovation Patient expectations rise We are

More information

Company Profile. German-Taiwan Biotech Seminar 6 November 2017

Company Profile. German-Taiwan Biotech Seminar 6 November 2017 Company Profile German-Taiwan Biotech Seminar 6 November 2017 Our Mission Bayer: Science For A Better Life A growing and aging world population requires an adequate supply of food and improved medical

More information

The Leader in AAV Gene Therapy. A Guide to AAV Gene Therapy for MPS I and II

The Leader in AAV Gene Therapy. A Guide to AAV Gene Therapy for MPS I and II The Leader in AAV Gene Therapy A Guide to AAV Gene Therapy for MPS I and II REGENXBIO seeks to understand the diverse perspectives of patients, caregivers and families, and to learn from their experiences

More information

Performance Testing of Novel Dosage Forms

Performance Testing of Novel Dosage Forms RQA Ireland Regional Forum - Athlone, May 2016 Quality Considerations Pharma and Biopharma Performance Testing of Novel Dosage Forms Terry Way BPharm MAPS Dissolution Science Consultant Glasside Technologies

More information

Shareholder Update Frequently Asked Questions

Shareholder Update Frequently Asked Questions 22 nd November 2018 Shareholder Update Frequently Asked Questions Dear Shareholders Since last week s announcement we have received a number of questions about the results of the Company s Phase 2 VF00102

More information

Advancing minimally invasive. therapeutics through novel device. development. Minima y Invasive New Technologies T H E L E O N A M. A N D H A R R Y B.

Advancing minimally invasive. therapeutics through novel device. development. Minima y Invasive New Technologies T H E L E O N A M. A N D H A R R Y B. MIN T Minima y Invasive New Technologies Advancing minimally invasive therapeutics through novel device development T H E L E O N A M. A N D H A R R Y B. C H A R I T A B L E T R U S T he Minimally Invasive

More information

NON-CLINICAL LOCAL TOLERANCE TESTING OF MEDICINAL PRODUCTS

NON-CLINICAL LOCAL TOLERANCE TESTING OF MEDICINAL PRODUCTS NON-CLINICAL LOCAL TOLERANCE TESTING OF MEDICINAL PRODUCTS Guideline Title Non-clinical Local Tolerance Testing of Medicinal Products Legislative basis Directive 75/318/EEC as amended Date of first adoption

More information

Future Areas of Technology Convergence

Future Areas of Technology Convergence Future Areas of Technology Convergence Dr J Malcolm Wilkinson Managing Director Technology For Industry Ltd Cambridgeshire, UK Medilink Yorkshire & Humberside, 8 December 2005 1 Technology For Industry

More information

Affigenix Biosolutions Private Ltd, 265/ 1F, KSSIDC Industrial Area Bangalore, Karnataka,India

Affigenix Biosolutions Private Ltd, 265/ 1F, KSSIDC Industrial Area Bangalore, Karnataka,India Host Cell Protein & Other Impurity Clearance Assays for Biosimilar Development Omics Biowaivers, Biologics & Biosimilars- Oct 29, 2014 Affigenix Biosolutions Private Ltd, 265/ 1F, KSSIDC Industrial Area

More information

KRISANI BIO SCIENCES PVT. LTD.

KRISANI BIO SCIENCES PVT. LTD. KRISANI BIO SCIENCES PVT. LTD. Flat B2, 2 nd Floor, Suryateja Apartments, Hindi Nagar, Punjagutta, Hyderabad, Telangana 500078. Email: kkr@krisanibio.com. URL: www.krisanibio.com Contact Number: +91 98494

More information

Quarterly Report for the Period Ended 31 March 2018

Quarterly Report for the Period Ended 31 March 2018 Quarterly Report for the Period Ended 31 March 2018 Highlights Cash receipts of $617,440 received during the March quarter. Main royalty contributors were the SK-II Power Booster (throughout Asia) and

More information

We offer integral tailor-made solutions, providing our expertise, flexibility and capability from early stages to launch.

We offer integral tailor-made solutions, providing our expertise, flexibility and capability from early stages to launch. Reig Jofre www.reigjofre.com Reig Jofre is a pharma company focused on the research, development, manufacture and marketing of pharmaceutical products and nutritional supplements, as well as on contract

More information

European Medicines Agency Evaluation of Medicines for Human Use COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT

European Medicines Agency Evaluation of Medicines for Human Use COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT European Medicines Agency Evaluation of Medicines for Human Use London, 27 July 2005 EMEA/CHMP/89249/2004 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT Guideline on the Clinical Investigation

More information

Empowering innovation.

Empowering innovation. Empowering innovation. RESOMER is a synonym for innovation and vision, enabling both pharma and medical device companies to shape and design a better future. 30 years of RESOMER The history of RESOMER

More information

Types of Complex Formulations

Types of Complex Formulations Types of Complex Formulations Johannes Stanta on behalf of the EBF EBF Focus Workshop New Modalities and Novel Concepts in Bioanalysis Altis Grand Hotel, Lisbon - 15 to 16 May 2018 http://www.europeanbioanalysisforum.eu

More information

LAB EXPERTS AT YOUR SIDE Over twenty years of experience

LAB EXPERTS AT YOUR SIDE Over twenty years of experience LAB EXPERTS AT YOUR SIDE Over twenty years of experience About us SYNLAB Pharma offers a broad range of laboratory services to the biotechnology, pharmaceutical and cosmetic industries as well as to manufacturers

More information

Challenges in receptor occupancy determination assays by flow cytometry in drug development

Challenges in receptor occupancy determination assays by flow cytometry in drug development Challenges in receptor occupancy determination assays by flow cytometry in drug development DATE 17 November 2016 PRESENTED BY Martine Broekema, Ph.D. Associated Director of Bioanalytical Sciences Large

More information

Handbook Controlled Release Of Drugs Polymers And Aggregate Systems

Handbook Controlled Release Of Drugs Polymers And Aggregate Systems Handbook Controlled Release Of Drugs Polymers And Aggregate Systems (1) The development of controlled release drug delivery system has long been a major area of bipinnata, which is used as release retardant

More information

Synthetic vaccine research and development. Comprehensive and innovative synthetic biology solutions and technologies

Synthetic vaccine research and development. Comprehensive and innovative synthetic biology solutions and technologies Synthetic vaccine research and development Comprehensive and innovative synthetic biology solutions and technologies From plan to product, Thermo Fisher Scientific supports your synthetic vaccine goals

More information

Assembly Biosciences Jefferies 2015 Microbiome Summit. December 16, 2015

Assembly Biosciences Jefferies 2015 Microbiome Summit. December 16, 2015 Assembly Biosciences Jefferies 2015 Microbiome Summit December 16, 2015 Forward-Looking Statements This presentation contains forward-looking statements regarding future events. Forward-looking statements

More information

P08 P14 P19 TRANSDERMAL DELIVERY & MICRONEEDLES TRANSDERMAL DELIVERY USING NATURAL MOISTURISING FACTOR COMPONENTS

P08 P14 P19 TRANSDERMAL DELIVERY & MICRONEEDLES TRANSDERMAL DELIVERY USING NATURAL MOISTURISING FACTOR COMPONENTS P08 P14 P19 TRANSDERMAL DELIVERY USING NATURAL MOISTURISING FACTOR COMPONENTS HIGHLY CUSTOMISABLE HOLLOW POLYMER MICRONEEDLE SOLUTIONS SUCCESSFUL MASS PRODUCTION OF DISSOLVABLE MICRONEEDLE TECHNOLOGY TRANSDERMAL

More information

Panama City, Panama April, 12-15, Marcelo Mario Matos Moreira. The Brazilian Health Surveillance Agency (ANVISA)

Panama City, Panama April, 12-15, Marcelo Mario Matos Moreira. The Brazilian Health Surveillance Agency (ANVISA) DIA Latin American Regulatory Conference Panama City, Panama April, 12-15, 2011 Biosimilars/Biotechnology Marcelo Mario Matos Moreira Coordinator Office of Biological Products The Brazilian Health Surveillance

More information

MARKETS & CUSTOMERS. Progressing globalization. Evolving markets

MARKETS & CUSTOMERS. Progressing globalization. Evolving markets Peptides are used worldwide in medical research. They contribute immensely to the understanding of diseases and have proven to be effective in medicinal products. Today, peptides can be produced at low

More information

Investor Presentation. September 2018

Investor Presentation. September 2018 Investor Presentation September 2018 Safe Harbour Certain statements in this release concerning our future growth prospects are forward-looking statements, which are subject to a number of risks, uncertainties

More information