NDDS

Formulation Design

early BIrD DIScountS! FRIDAy 15 JULy 2011 INR 6,300 / US$150

INDIA 2011
Regulation

Scalability

10-12 AUgUST 2011 Holiday Inn Mumbai International Airport Mumbai, India

Commercialisation

gaIn SolutIon-orIenteD guIDance on: hear exeMplary preSentatIonS froM our InternatIonal expertS:
Benefit from the views of Damon Smith on the future direction of innovative drug delivery systems and their growth potential given the multifold increase in the demand of NDDS Capitalise on the growth potential of nanotechnology in the coming years with Mahesh Chaubal and understand quality requirements of an NDDS product developed for the international market Leverage on the various advances made in nanotechnology and evaluate the options to meet formulations and scalability challenges in a case study discussion presented by Shelley A Durazo regulatory Clarifications: Learn the most efficient clinical trial procedures and documentation to achieve smooth and swift approval for NDDS products Innovative Drug Delivery Updates: Explore the new trends in NDDS product demand and align your business strategy with these opportunities Scientific Advances: Leverage the latest developments in existing delivery platforms to improve their efficacy in the most cost-effective way Commercialisation Strategies: Gain techniques to tap new markets and unlock the latent potential to ensure maximum return on your product investment Practical International Showcase: Hear the very latest thinking, trends and innovations surrounding NDDS development taking place across the globe

Damon Smith Senior Vice President Research and Development Labopharm USA

Shelley A Durazo Research Fellow Department of Pharmaceutical Sciences University of Colorado Denver

Mahesh V Chaubal Director Product Development Baxter Healthcare USA

Gautam Ranade Research Fellow Pharmaceutical Development Worldwide Research and Development Pfizer USA

Ensure effective life cycle management of a transdermal patch and understand its technical complexities in the interactive discussion with Gautam Ranade

PRe-CONFeReNCe SemINAR

NeW For 2011

For more details please refer to page 5

INteRNAtIONAL NDDS SHOWCASe

10 AUgUST 2011

outStanDIng preSentatIonS froM:

Subhash C Mandal, Senior Drug Inspector DIReCtORAte OF DRUG CONtROL WeSt BeNGAL Sumedh Gaikwad, Director Medical Services RICHteR tHemIS meDICARe Rahul Gupta, Senior General Manager Corporate Regulatory Affairs PIRAmAL HeALtHCARe Venkata Ramana, Chief Scientific Officer ReLIANCe LIFe SCIeNCeS Komal Shah Bhukhanwala, Director INNOVARIP CONSULtING GROUP Dange Veerapaneni, Managing Director SPARSHA PHARmA INteRNAtIONAL
In Association With

Devaraj Rambhau, Advisor NDDS NAtCO ReSeARCH CeNtRe SP Vyas, Professor, Department of Pharmaceutical Sciences SAGAR UNIVeRSIty, INDIA Dhiraj Khattar, Director Formulations FReSeNIUS KABI ONCOLOGy Kapileshwar Swain, Vice President Product Development mACLeODS PHARmA Sougata Pramanick Director Research and Development (Formulation) EMCuRE PhARMACEutICAlS
Media Partners

Sukhjeet Singh, Senior Vice President Research and Development PANACeA BIOteC Rinti Banerjee, Professor, Department of Biosciences and Bioengineering Centre for Research in Nanotechnology and Science INDIAN INStItUte OF teCHNOLOGy mUmBAI, INDIA Pritam D Kanagale, Manager Product Development JOHNSON & JOHNSON Gaurav Sharma, Senior Manager Business Development and Clinical Research WOCKHARDt

Organised By

To register - Tel: +91 (022) 4046 1466 Fax: +91 (022) 4046 1477 Email: conferences-india@ubm.com

www.ndds-india.com

NDDS
INDIA 2011
Formulation Design Regulation Scalability Commercialisation
Now in its 2nd year, NDDS India 2011 brings you a refreshed, industry-focused, in-depth agenda concentrating on implementable solutions to the challenges you face around NDDS. Focusing on all the key business critical issues including regulatory approvals, product development challenges, and innovative commercialisation strategies, this really is an event not to be missed. Gain the latest facts and updates from national and international speakers through live case studies, stimulating discussions and interactive sessions with the audience. With generic pipelines drying up, this conference will equip you to capitalise upon the vast commercial opportunities available through NDDS.

JUSt SOme OF tHe AtteNDeeS OF NDDS INDIA 2010:

Aarti Drugs Actavis Pharma Manufacturing Advanced Enzyme Technologies Akums Drugs and Pharmaceuticals Aspire Life Sciences Astron Research Bioplus Life Sciences Celon Labs Cipla Concept Pharmaceuticals Dr Reddys Laboratories Emcure Pharmaceuticals Evonik Degussa India Glenmark Pharmaceuticals Indoco Remedies Laila Pharmaceuticals Lincoln Pharmaceuticals Lupin Pharmaceuticals Mascot Engineering Microlabs Millipore (India) Monitor Group MSD Technology Singapore Novartis Healthcare Novo Nordisk Omni Active Health Technologies Panacea Biotec Parry Life Sciences Piramal Healthcare Plethico Pharmaceuticals Roquette India Sanofi Aventis Simpex Pharma Square Pharmaceuticals Strides Arcolab Sun Pharma Advanced Research Company Swati Spentose Richter Themis Medicare Tirupati Medicare Torrent Pharmaceuticals and Research Centre Unichem Laboratories Wanbury Zim Laboratories

7 great reasons To Attend:

Clarify every doubt regarding clinical trials, documentation requirements and approval of NDDS products Leverage IPR to protect and capitalise on your innovative NDDS product Gain technical insights into every delivery platform from benchmark global pharmaceutical companies involved in the development of NDDS Propel your growth to match the global market through key learnings shared in our exclusive interactive seminar led by international NDDS experts Benefit from intensive discussion between senior scientists on future trends and the direction of growth for NDDS Identify and access new markets through innovative marketing strategies establish new partnerships and network with key decision-makers from leading national and international pharmaceutical companies

Promote your Business

Sponsoring or exhibiting at NDDS India 2011 is an excellent way to promote your business to a highly targeted group of key decision-makers with a specific interest in product development, process development and marketing of NDDS products. We have a range of business development, marketing and sales solutions that will be tailored to specifically deliver on your business objectives. To find out more about how you can make the most of your participation at this event, contact Venkat rajan, Sales Manager, at Tel +91 (022) 6612 2689, Mob +91 98195 08779 or Email Venkiteswaran.r@ubm.com
ExHIBITION FLOOR PLAN

What delegates had to say at NDDS India 2010:

The two days of the conference were very effective and helped me get all the current information on NDDS

Good, informative conference, covering almost all issues and technologies of NDDS Excellently handled and very informative

ATM Masud, Senior Manager, Square Pharma, Bangladesh

Coffee & Lunch point

Naresh Harisinghani, Deputy General Manager, Wanbury Limited, India

Nilesh Jaiswal, Senior Manager, Sanofi Aventis, India

Who Should Attend?

Organised by:

This conference has been designed specifically for VPs, Directors, GMs and Heads of R&D, NDDS, Formulations, Analysis and Testing, Product Development, Process Development, Regulations and Business Development from: Innovator Pharma Manufacturers Biopharma Manufacturers Generic Pharma Manufacturers Drug Delivery Platform Providers Medical Equipment Providers Ingredients and Material Suppliers Analytical Laboratories CRAMS

CPhI Conferences is a specialist provider of contentled conferences and seminars aimed at the fast growth segments of the Indian pharmaceutical industry. We monitor markets, identify the most critical trends and provide timely conferences to help you assess and target new business opportunities in India. Each of our events is extensively researched with representatives of both the local and international markets, and designed specifically to bring these audiences together to discuss, debate, network and create profitable new partnerships! Backed by an extensive network of local and international exhibitions, online portals and magazines, our access to senior level decision makers across the Pharmaceutical, Biopharma and Outsourcing industries remains unrivalled!

To register - Tel: +91 (022) 4046 1466 Fax: +91 (022) 4046 1477

CONFeReNCe DAy ONe thurSDay 11 auguSt 2011

08:30 Registration and refreshments 09:00 Opening remarks from the Chair market Overview 09:10 establishing the current picture for NDDS and forecasting domestic and global markets to identify the future direction of growth and encourage investment Examining the size of the global NDDS market and the latest developments to determine the learnings and expertise that can be applied to the Indian market Projecting supply and demand to ensure that India can meet the technological investment and expertise requirements Understanding the competitive advantages and challenges associated with the development of innovative technology platforms and delivery methods Evaluating the various product and marketing strategies of key Indian and global players Adopting a robust R&D process to speed-up regulatory approval and reduce product time to market Determining the quality requirements of international pharmaceutical markets and aligning product development to meet these guidelines and enable entry into new markets Subhash C Mandal, Senior Drug Inspector Directorate of Drug Control, West Bengal Regulatory Landscape 09.40 Updating on the latest government policies and plans currently in place and in development to increase the growth of NDDS in India Recapping on NDDS guidelines for generic and new product approvals Identifying the financial incentives and different initiatives designed to support NDDS development in India Understanding the clinical trials and related documents critical to the successful approval of products and technologies Clarifying guidelines and identifying the various offices and auditing boards for specific NDDS platforms and coordinating with them accordingly to ensure compliance Evaluating the parameters of bioequivalence studies to ensure that clinical trials are focused in the right areas Sumedh Gaikwad, Director Medical Services, Richter themis medicare 12.30 exploring parenteral dispersed systems to identify and overcome their development challenges and maximise their commercial potential Recognising the most appropriate technologies to effectively manage the developmental life cycle of parenteral dispersed systems Understanding the characterisation for various formulations in parenteral suspensions and emulsions to minimise resources involved in clinical trials and time for approval Comparing aseptic and terminal sterlisation techniques employed in parenteral dispersed drug delivery systems to understand their limitations and identify the most suitable methods to improve efficacy and commercial viability Maximising throughput and overcoming scalability issues to cost-effectively produce parenteral dispersed drug delivery systems Sougata Pramanick, Director Research and Development (Formulation) emcure Pharmaceuticals 13:00 Lunch and networking Oral Controlled Drug Delivery Systems 14.10 evaluating and leveraging advances in osmotic oral controlled drug delivery systems to improve efficacy and reduce costs Establishing the class of drugs and plasma profile suitable for oral controlled drug delivery Identifying and developing the specific technologies required to achieve the following release mechanisms and ensure commercial success: - Pulsatile - Gastro retentive - Gastro intestinal therapeutic systems - Other implants using matrix mechanisms Streamlining the processes involved in the manufacturing of oral controlled drug delivery systems to lower investment costs and increase efficiency Maximising the potential and overcoming the technical challenges of SMEDDs to increase solubility and permeability of class IV drugs Developing new distribution channels for oral controlled drug delivery systems to drive commercialisation and enter new markets Pritam D Kanagale, Manager Product Development Johnson & Johnson

nDDS Market

10:50 morning refreshments and networking 11.30 Navigating the complexities of the IPR system in India to promote innovation in NDDS development Mapping out the current IPR scenario in India to establish the importance of IPR and identify the difficulties involved Understanding the current Indian IPR framework and leveraging this to ensure quality within NDDS developments and support future progress Maximising the potential of technology patents in avoiding infringement and protecting competitive advantage Overcoming the roadblocks to IPR protection specific to the various NDDS platforms Identifying and applying global copywriting and trademark policies to protect and maintain brand equity Komal Shah Bhukhanwala, Director, InnovarIP Innovative Drug Delivery Platforms 12:00 Developing effective delivery systems for siRNA based drugs to increase the efficacy of the formulation while maintaining a healthy return on investment Projecting the current market for siRNA based drugs and forecasting its future growth potential to guarantee positive profit margins Understanding the formulation rationale and design challenges of siRNA based drugs to reduce resources involved in the clinical trails Clarifying the regulatory guidelines for the siRNA based drug delivery platform to speed-up the approval procedure Identifying ways to increase scalability in the siRNA based drug delivery platform to sustain commercial viability Formulating robust marketing and commercialisation strategies for siRNA based drug delivery platforms to enter new geographical areas Venkata Ramana, Chief Scientific Officer, Reliance Life Sciences

15:10 Afternoon refreshments and networking 15.20 Overcoming the scalability challenges around various release mechanisms in transdermal delivery systems to ensure commercial success and increase bioavailability Establishing the business case for transdermal patches instead of oral controlled drug delivery systems for the sustained release of drugs Comparing the different types of release mechanism available matrix, osmotic, and geo matrix Determining how different release mechanisms can be effectively used in transdermal patches and if they are commercially viable Effectively managing the costs involved in scaling-up the transdermal delivery system when using different release mechanisms Dange Veerapaneni, Managing Director, Sparsha Pharma International 16.10

Scalability

Ipr

formulation

10.20 examining global regulatory processes and requirements to ensure the smooth and speedy approval of NDDS products and enable entry into international markets Comparing regulatory bodies and guidelines around NDDS in western countries, emerging markets and India Understanding the specific processes involved in the approval of NDDS products to ensure compliance and successful exportation from India Analysing the particularly challenging regulatory requirements of the UK and Japanese markets and developing strategies to overcome these and gain approval Evaluating international regulatory requirements, trends and likely future developments to identify new market opportunities Rahul Gupta, Senior General Manager, Corporate Regulatory Affairs Piramal Healthcare

14.30 Designing pharmacokinetic studies for new oral controlled drug delivery systems to ensure speedy approvals and reduce the challenges of largescale production Understanding the effect of single dose, multiple dose, special dosage and food studies to increase the efficacy of a drug while reducing toxicity Setting the acceptance criteria in pharmacokinetic studies to decrease project resources required and meet the regulatory guidelines Reducing the toxic effects caused by dose dumping in controlled release delivery systems to increase systemic efficacy Identifying the correct procedure for submission and documentation of clinical trial results to address the regulatory requirements and avoid duplication of efforts Sukhjeet Singh, Senior Vice President, Research and Development Panacea Biotec

regulation

global regulation

technologies

Innovations

case study

transdermal Drug Delivery System 14.50 Selecting the most appropriate and innovative materials in the design and formulation process of transdermal delivery patches to increase safety and efficacy Evaluating polymers used for transdermal delivery systems to maximise overall patch performance and ensure external and internal compatibility Examining the challenges regarding adhesives used in transdermal plasters to overcome problems related to pliability, climate-sensitivity and patient convenience Adopting a proactive approach for transdermal patch material selection to ensure quality and regulatory acceptability Gautam Ranade, Research Fellow, Pharmaceutical Sciences, Worldwide Research and Development, Pfizer, USA

case study

exploring new therapeutic applications for transdermal delivery systems to drive development in this area Understanding the current domestic market for transdermals and forecasting the therapeutic areas in which demand is likely to increase in the future Tackling the various technological scalability issues in making transdermals commercially viable for therapeutic application Evaluating cosmeceutical application of transdermal therapeutics to meet evolving consumer and market demands Determining the use of transdermal systems in chronic ailments like diabetes and to overcome BBB and MDR challenges to increase drug delivery through non-invasive techniques Balancing the expense of transdermal systems with the overall medical benefit ensuring new therapeutic applications are commercially viable Damon Smith, Senior Vice President Research and Development Labopharm, USA

16.40 roundtable Discussions: An opportunity to join in with facilitated group discussions around the key issues raised during the course of the day. Come armed with your live challenges and take away practical implementable solutions. 17.30 Close of Conference Day One

Email: conferences-india@ubm.com

applications

CONFeReNCe DAy tWO frIDay 12 auguSt 2011

08:30 Registration and refreshments 09:00 Opening remarks from the Chair Nanotechnology 09.10 evaluating the latest developments in nanotechnology and overcoming the specific formulation challenges to increase efficacy, reduce toxicity and minimise cost Determining the present market demand for nanotechnology and estimating the future size of the industry and the investment required Achieving pharmacodynamic and pharmacokinetic correlation for targeted drug delivery technology Identifying the most appropriate dosage and method of administration for different therapeutic uses to increase efficacy and reduce surrounding cell toxicity Ascertaining the requirements for clinical trials of nanotechnologies to demonstrate bioequivalence and achieve smooth regulatory approval Ensuring reproducibility and minimised costs when scaling-up every specialisation of targeted drug delivery to achieve commercial success Understanding the characterisation for various formulations for faster clinical trial results Mahesh V Chaubal, Director Product Development Baxter Healthcare, USA 13.30 12.20 Lunch and networking Liposomes and microspheres

NDDS
INDIA 2011

Understanding the latest advances in lipid based drug delivery systems to improve absorption and reduce toxicity and ensure their commercial viability Identifying the current market and future requirements of lipid based drug delivery systems in special therapeutic areas Meeting the expertise and investment requirements necessary to commercialising lipid based drug delivery systems as forms of NDDS Overcoming the technical drug loading challenges encountered when using liposomes as a carrier in targeted drug delivery Examining the efficacy of liposomes and microspheres in anti-cancer injectibles Developing processes and techniques to tackle the instability of liposomes as a carrier in nanotechnology Rinti Banerjee, Professor, Department of Biosciences and Bioengineering, Centre for Research in Nanotechnology and Science Indian Institute of technology, mumbai, India Inhalation Drug Delivery Systems

formulation

09.40

examining the various nanocarriers available to ensure the most cost-effective and efficient means of drug delivery Establishing the nanocarriers available for oral and parenteral drug delivery Analysing different polymeric nanocarriers to enhance the performance of drug delivery systems Achieving improved penetration of the drug through membranes using nanocrystals and amorphous nanoparticles Determining how solid lipid nanoparticles contribute to better efficacy and reduced toxicity of tumour surrounding cells Identifying how liposomes help to maximise drug concentration in the targeted area through nanotechnology Developing best practice methods of encapsulation and entrapment of drug molecules into nanocarriers to ensure efficacy at the targeted site Clarifying regulatory guidelines on clinical trial requirements for liposomes and nanoparticles as drug delivery platforms to achieve regulatory clearance Devaraj Rambhau, Advisor NDDS, Natco Research Centre

14.10 Addressing the roadblocks to development in inhalation drug delivery to drive progress and meet growing demand for this platform from specific therapeutic areas Clarifying the regulatory guidelines and clinical trial requirements for nasal sprays Identifying processes to meet particle size requirements and increase deposition ratio Achieving polymorphism to support solubility and permeability in nasal sprays and promote absorption Evaluating various excipient screening processes including high throughput to ensure the best match to the API and increase the efficacy of the delivery device Examining the latest equipment and technology to tackle instability and impurity and reduce toxicity Determining the next steps for inhalation drug delivery to ensure progress and commercial success Kapileshwar Swain, Vice President Product Development macleods Pharma 14:50 Afternoon refreshments and networking Commercialisation in Practice 15.20 Developing effective commercialisation strategies to increase speed to market, maximise return on investment and drive the growth of the Indian NDDS industry Utilising the ultra lean manufacturing process to increase the speed of development from lab to market and ensure the delivery of quality at all stages Adopting the most appropriate clinical trials procedure and using online analytics and controls to reduce investment costs and speed up regulatory approval Leveraging advanced drug delivery approaches to ensure return on investment of NDDS in development Mapping out the potential of new markets including international and rural to increase market share Identifying and meeting the need for developing new distribution channels to support the acceptance of NDDS products in new and existing markets Applying new marketing techniques and strategies to enhance visibility and acceptance of the NDDS product and brand Gaurav Sharma, Senior Manager Business Development and Clinical Research, Wockhardt 16.00 Leveraging packaging as a tool to improve the efficacy of the NDDS product and to communicate and promote the brand identity Identifying and adopting the most suitable packaging materials for different NDDS products depending on their administration characteristics Sourcing packaging materials which support the shelf-life requirements of specific products and ensure safety and efficacy Utilising aesthetics in augmenting acceptance of NDDS products Establishing branding strategies which are communicated through the packaging to protect and increase the brand equity Sponsor led session 16:40 Closing remarks from the Chair and close of conference

10:10 morning refreshments and networking 10.40 Navigating the various sterilisation and filtration challenges encountered when designing a nanotechnology to meet safety requirements Achieving effective sterilisation of nanoparticles through in situ polymerisation Leveraging partial polymerisation of nanoparticles to ensure targeted drug delivery meets safety guidelines Maximising the use of gamma radiation in achieving sterilisation in nanotechnology Evaluating the effectiveness of API sterilisation and its administration to septic areas in maintaining safety levels Examining alternative methods of sterilisation of nanoparticles which minimise cost and increase safety SP Vyas, Professor, Department of Pharmaceutical Sciences Sagar University, India

Sterlisation

11.10 exploring and maximising the potential of nanotechnology drug delivery platforms in new therapeutic and diagnostic areas Understanding the potential use and efficacy of nanotechnology in implanted delivery systems Summarising the advances made in gene therapy through nanotechnology to provide therapeutic options for unmet medical needs Establishing how nanotechnology can best be applied to oncology drugs to increase their efficacy Utilising nanotechnology to overcome MDR and reduce surrounding cell toxicity Applying nanotechnology through oral and patch delivery to chronic therapeutic areas such as diabetes and hypertension Leveraging nanotechnology for diagnostic purposes in scans, MRIs and biomarkers Dhiraj Khattar, Director Formulations, Fresenius Kabi Oncology

applications

11.40 Discussing the critical success factors of commercially launched Abraxanet of Celegene Corporation and utilising albumin nanoparticles to increase efficacy in targeted drug delivery platforms Evaluating the various methods for preparation of albumin nanoparticals to identify the most suitable procedure to increase efficacy and reduce costs Establishing the quality standards of albumin nanoparticles essential for receiving regulatory approvals Comparing the delivery advantages of albumin nanoparticles with other carriers and how they can increase the efficacy of the targeted drug Understanding the role of immunogenicity in the drug to increase the effectiveness of loaded formulation Assessing the patent landscape for albumin nanoparticles to outline the future direction and scope for development Shelley A Durazo, Research Fellow, Department of Pharmaceutical Sciences, University of Colorado, Denver

case study

Solutions

Strategies

Developments

nanocarriers

advances

Q &A Session at NDDS 2010 2011. UBM India Pvt. Ltd. This programme may change due to unforeseen circumstances. UBM India Pvt. Ltd. reserves the right to alter the venue and/or speakers.

www.ndds-india.com

NDDS
INDIA 2011
Dear Colleague,

10-12 AUgUST 2011 Holiday Inn Mumbai International Airport Mumbai, India

Recent reports and forecasts suggest a large opportunity in the Indian NDDS market due to a wide gap between global demand and the rate of local development. With generic pipelines drying up and support from the local pharmaceutical industry and government encouraging further development in NDDS, are you geared-up for this challenge and ready to seize this invaluable opportunity? The 2nd Annual NDDS India 2011 brings you the unique chance to clarify your every doubt on regulatory procedures and capitalise on your innovative NDDS products. Evaluate the formulation and design solutions, find answers to scalability challenges, protect your innovations through IPR, and explore new market avenues to pursue and take advantage of the growing demand for NDDS. The only conference in India to focus on the niche NDDS market, this essential learning forum is based on intensive industry research and will provide you with an in-depth solution-packed agenda designed to meet your India-specific business needs. Attend NDDS India 2011 to: Learn from Baxter Healthcare, USA about new advances in NDDS on a global platform Examine the successfully developed and commercially launched NDDS products with Fresenius Kabi Oncology Explore new opportunities for commercial success of NDDS products with Labopharm USA Hear Sparsha Pharma International share key learnings on how to overcome the scalability challenges of NDDS Benefit from practical guidance provided by Piramal Healthcare on the regulatory requirements for NDDS products when entering new markets Address the roadblocks to development for NDDS products through key insights from macleods Pharma Evaluate the future trends of NDDS with Johnson & Johnson and learn how best to capitalise on these opportunities

Additional speakers from Panacea Biotech, Richter themis medicare, Natco Research Centre and Reliance Life Sciences will also be sharing their exemplary expertise and practical insights. With each day offering a host of exclusive networking opportunities, this is really an event not to be missed. Plus New for 2011! An entire pre-conference seminar dedicated to showcasing the very latest thinking and trends around NDDS from the international pharma community. Let our panel of global NDDS experts take you through all the critical developments and innovations to ensure you are up-to-date and fully equipped to make your mark in the industry and drive real progress in the Indian pharmaceutical market. Book your place now for this unparalleled solution-driven conference and seminar to propel your business to new heights. Just call +91 (022) 4046 1466, or email conferences-india@ubm.com to secure your place. We look forward to meeting you at NDDS India 2011, 10-12 August, Mumbai. yours sincerely,

Ritu Thomas Programme Manager CPhI Conferences P.S. The enclosed brochure contains the full list of in-depth topics and outstanding speaker line-up. To secure your place at a discounted price, please visit www.ndds-india.com, email conferences-india@ubm.com, call us on +91 (022) 4046 1466, or complete and return to us the booking form in the conference brochure.

InternatIonal nDDS ShowcaSe

PRe-CONFeReNCe SemINAR weDneSDay 10 auguSt 2011

Expand your knowledge on the current global NDDS scenario through this dedicated interactive seminar led by top-level experts from Baxter Healthcare, Pfizer and Labopharm USA. Gear-up to take advantage of the potential market opportunities and tackle the expected challenges by gaining key insights into the future trends and direction of the NDDS industry. This is a unique opportunity to benefit from the shared learnings of international industry professionals and academics teaming up on a single platform. Dont miss your chance to hear the very latest thinking, drill-down into the newest innovations and discuss the most up-to-date solutions to all your NDDS development and scalability challenges. Benefit from: The latest facts and figures and growth opportunities in the international NDDS industry Key insights into the specifics of quality requirements for NDDS products in international markets Practical strategies to launch and commercialise NDDS products The technical developments being uncovered in research work currently in progess on various delivery platforms Strategic information on the future course of NDDS products and their commercial viability Essential updates on innovative NDDS products in development and the host of market opportunities these will unearth
15.20 Refreshments and networking 15.50 Updating on the latest developments in nanotechnology to capitalise on the future growth potential Identifying the hot areas of development in nanotechnology to ensure positive return on investment in the next 4-5 years Understanding the quality requirements of nanotechnology drug delivery platforms developed for international markets Overcoming the scalability challenges of nanotechnology in practice to deliver a commercially successful product Mahesh V Chaubal, Director Product Development Baxter Healthcare, USA 17.10 Understanding and navigating the technical challenges of a transdermal delivery system to maximise the return on investments in the coming years with Understanding the technical complexities involved in the development of a transdermal patch to minimise investment costs and increase the efficacy of the delivery system Overcoming bioequivalence challenges in generic transdermal products to ensure speedy regulatory approvals Ensuring effective life cycle management of a transdermal patch through a case study example of a commercially launched product Determining the requirements for quality standards of transdermal products for successful launch in western countries Gautam Ranade,Research Fellow, Pharmaceutical Sciences, Worldwide Research and Development Pfizer, USA 18.20 Closing remarks from the Facilitator and close of seminar

12.30 Registration and refreshments 12.50 Opening remarks from the Facilitator 13.00 Leveraging the latest advances in nanotherapy for back of the eye diseases in ocular therapeutics Examining the current market size of nanotechnology and understanding its future direction Identifying the various nanomaterials being used in ocular nanotherapy to increase the efficacy of targeted drug Overcoming the key formulation challenges for ocular nanotherapeutics Developing nanotherapy as the most suitable mode of administration in back of the eye diseases Discussing a commercially successful NDDS product utilising nanotherapy and analysing the reasons for success Shelley A Durazo, Research Fellow Department of Pharmaceutical Sciences University of Colorado, Denver

14.10 Focusing on innovative drug delivery platforms to propel the growth of the Indian NDDS industry Evaluating different strategies to cost-effectively manage the development life cycle of a delivery platform Discussing the key factors critical to ensuring a greater number of pipeline hits and the commercial success of an NDDS product Mapping out the future direction of geno-medicine to leverage on its commercial potential in coming years Damon Smith, Senior Vice President Research and Development Labopharm, USA

Meet your expertS:

Damon Smith is a Senior Vice President for Research and Development at Labopharm, a Montreal based biopharmaceutical company specialising in pain and CNS products. He has more than 20 years experience in the industry Damon Smith and has presented at various Senior Vice international conferences. Prior to joining Labopharm, Damon President Research and Smith was Senior Director of Development, Research at ConjuChem Inc, a peptide development and delivery Labopharm company. He was also Executive USA Director of Development at Protherics Limited (formerly Therapeutic Antibodies Inc) based in the United Kingdom. Damon Smith holds a PhD in biological chemistry and pharmacology. Shelley A Durazo is pursuing her doctoral degree at the University of Colorado Denver, in the field of ocular nanopharmaceutics. Her undergraduate research was focused on liposomal drug delivery and gold nanoparticle Shelley A actuated release mechanisms. Durazo Shelley Durazo also had the unique opportunity of conducting Research research at the Australian Fellow Department of Institute of Biotechnology and Nanotechnology (AIBN) at the Pharmaceutical University of Queensland, Australia Sciences in Dr Max Lus laboratory. The University basis of this research was focused of Colorado on fabricating and characterising novel layered double hydroxide Denver spherical particles for the delivery of siRNA. mahesh V Chaubal is Gautam Ranade is a Research the Director of Product Fellow in Pharmaceutical Development in Global Research Sciences, Worldwide Research and Development at Baxter and Developments, Pfizer, USA. Healthcare. He has worked in the He has 26 years of scientific field of formulations and drug product development and delivery for more than sixteen managerial experience in years and has published over pharmaceutical research and Mahesh V fifty peer-reviewed articles and Gautam Ranade development. He has 19 US Chaubal industry reports in this field. Research Fellow patents in the areas of novel drug Director Product He was a member of the Pharmaceutical delivery, formulation development Development team that brought GliadelDevelopment and polymeric materials. He the first sustained release has 20 publications in various Baxter Worldwide chemotherapeutic formulation scientific journals in the areas of Healthcare to market. His experience Research and dosage form development, drug USA Development delivery systems and membrane includes novel drug delivery Pfizer research, development of watertransport. He was also on the insoluble drugs, proteins and planning committee for the joint USA gene-based drugs, scale-up and FDA-DIA-AAPS workshop on validation of processes for drug transdermal patch development delivery formulation processes. in 2011.

www.ndds-india.com

NDDS
INDIA 2011
10-12 August 2011 Holiday Inn Mumbai International Airport Mumbai, India

Organised By

Ways to Register
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Credit Card/Debit Card

We accept Visa, MasterCard, Diners Club, American Express, and Maestro cards.To pay by credit card, please tick the box above and return this registration form to us. You will receive an invoice from payments@ubmindia.com with a link where you can pay for your delegate fees securely through our payment portal, CC Avenue. For more information, please contact us at +91 (022) 4046 1466 or by email at conferences-india@ubm.com. We are unable to process credit card payments over the phone.
Payment: Full payment is required within 5 working days from receipt of invoice. Your registration will not be confirmed until full payment is received and may be subject to cancellation. All payments must be made in full before the conference date. All bookings received within 10 working days of the conference can only be paid by credit card. If your payment has not been received or cleared before the first day of the conference, you will be required to provide a credit card guarantee onsite to secure your participation. This will act as a guarantee for a period of 15 days and will only be processed if your official payment has not been received or cleared beyond 15 days post the conference. Conference fees include entrance to the conference sessions, refreshments as per onsite schedule, and the conference papers. Please note that accommodation and travel are not included in the conference fee. Fees are subject to applicable taxes as per government rules and regulations. Pricing and Discounts: To be eligible for an Early Bird discount, the signed booking form must be received by close of business on the relevant deadline date, with full payment received no later than 5 working days following date of invoice. If payment is not received within 5 working days following date of invoice, the discounted rate will no longer apply and the current rate at that time will be applicable. A group booking discount of 5% is applicable to bookings of 3 or more delegates and 10% to 5 or more delegates. Group booking discounts only apply if all delegates in the group book and pay at the same time. Cancellation and Substitutions: Once booked cancellation of delegate places cannot be made, however a substitution can be made at any time. Please email details of the substitute delegate to conferences@ubmindia.com at the earliest opportunity. In the event that UBM cancels an event for any reason, you will receive a refund for 100% of the conference fee paid. In the event that UBM postpones an event for any reason and the delegate is unable or unwilling to attend on the rescheduled date, you will receive a credit note for 100% of the conference fee paid. You may use this credit for another UBM event to be mutually agreed with UBM, which must occur within one year from the date of postponement.

Terms & Conditions:

Except as specified above, no refund or credits will be issued for other forms of cancellation. UBM is not responsible for any loss or damage as a result of a substitution, alteration or cancellation/postponement of an event. UBM shall assume no liability whatsoever in the event this conference is cancelled, rescheduled or postponed due to a fortuitous event, Act of God, unforeseen occurrence or any other event that renders performance of this conference impracticable, illegal or impossible. For purposes of this clause, a fortuitous event shall include, but not be limited to: war, fire, labour strike, extreme weather or other emergency. Accommodation: Please note that accommodation and travel are not included in the conference fee. Orbitz are the officially appointed accommodation agency. Orbitz have secured allocations at conveniently located hotels at discounted event rates. These rates are held for a limited amount of time, so please book early to avoid disappointment. Contact Puneet Sah on +91 (0)93216 53017 or email puneet@orbit-star.com or Rahul at + 91 (0)77388 04884 or email miceindia@orbit-elite.com. Programme Changes: Please note that speakers and topics were confirmed at the time of publishing; however, it may be necessary due to unforeseen circumstances to alter the content, timing, speakers or venue. UBM reserves the right to alter or modify the advertised speakers and/or topics if necessary. Any substitutions or alterations will be updated on the event website as soon as possible. Your Details: By entering your details in the fields above, you agree to allow UBM India Pvt Ltd. and companies associated with the event to contact you (by post, telephone, sms, email or fax) regarding relevant products or services provided. If at any time you do not wish to receive anything from UBM India Pvt Ltd. or carefully selected 3rd parties, please write to Manoj Ambardekar, Database Manager, UBM India Pvt Ltd. Sagar Tech Plaza A, 119, 1st Floor, Andheri Kurla Road, Saki Naka Junction, Andheri East, Mumbai, 400072, India, or email manoj.ambardekar@ubm.com. This contract is subject to Mumbai Jurisdiction law.

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