Showing posts with label Medical. Show all posts
Showing posts with label Medical. Show all posts

Monday, January 3, 2011

Wipes to 2014

US demand to rise 4.5% annually through 2014
Demand for wipes, both consumer and industrial, is forecast to increase 4.5 percent per annum to $2.3 billion in 2014. Wipes will continue to benefit from features such as ease-of-use, disposability, portability, and reduced risk of crosscontamination. Nevertheless, growth will decelerate from rates achieved during the 2004 to 2009 period due to increasing market maturity and a shift in preferences to more environmentally friendly consumer goods and cleaning methods. In response to the “green” trend, wipes manufacturers will continue to develop more environmentally friendly products, such as those that are biodegradable.

Hand, body wipes to further penetrate consumer market
Convenience, consumer acceptance and innovation will remain driving forces in the consumer market, with household cleaning, hand and body, and a number of other, small volume consumer wipes projected to register the strongest gains. Growth in household care wipes, such as general purpose disinfectant wipes, will be propelled by the appeal of one-step, disposable wipes that provide a quick and convenient format for household cleaning chores. These wipes also offer a fast and easy cleaning alternative for consumers with little free time. Hand and body wipes, such as bathroom hygiene and general purpose bathing, will enjoy increased market penetration. For example, the concept of wet bathroom tissue as part of a standard bathroom routine is gaining acceptance. General purpose bathing wipes are also gaining acceptance among individuals who are bedridden or find it difficult to enter and exit a bathtub. Nevertheless, baby wipes will remain the top selling type of consumer wipe. Demand for baby wipes will continue to suffer due to market maturity, as well as continued replacement by newer, task-specific wipes in non-diaper applications, where baby wipes once enjoyed considerable popularity.

Manufacturing, health care wipes to remain largest industrial wipes segments
After suffering from slower sales during the recession that began in December 2007, the industrial wipes market will benefit from a rebound in manufacturing activity through 2014. As such, wipes geared towards the manufacturing market are projected to achieve the most rapid gains through the forecast period. In addition to a more favorable economic climate, demand for industrial wipes will benefit from new product innovations and expanding applications. Among industrial wipes, manufacturing and health care types will remain the largest segments, with special purpose products such as clean room and surface preparation wipes and personal bathing wipes projected to see the fastest growth.

Surfactants to see fastest gains in chemical materials
Advances for the chemicals that saturate or are deposited into wipes will derive from the increasing diversity of chemical formulations adapted to a wipes format as companies seek to take advantage of the strong consumer interest generated by these convenient, and relatively new, products. Surfactants will experience the fastest gains, resulting from an ongoing shift away from solvent formulations.Furthermore, surfactants offering biocidal properties will drive overall value gains due to increasing concerns regarding bacterial contamination in industrial and consumer applications.

Study coverage
Details on these and other key findings are available in Wipes, a new Freedonia industry study priced at $4900. It presents historical demand data (1999, 2004 and 2009) plus forecasts for 2014 and 2019 by market and raw material. In addition, the study considers market environment factors, evaluates company market share data and profiles 35 industry competitors, including Kimberly-Clark, Nice-Pak and Procter & Gamble.

For more please visit
http://www.bharatbook.com/detail.asp?id=167435&rt=Wipes-to-2014.html

OR Contact us at

Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com

Thursday, December 30, 2010

Cosmetic Surgery Products to 2014

Demand for products used in cosmetic surgery is forecast to increase 6.5 percent per year to $2.8 billion in 2014, when 16.1 million cosmetic procedures are expected to be performed. The economic recession that began in December 2007 impacted the cosmetic surgery industry most profoundly in surgical procedures, which suffered large drops in 2008 and 2009. Likewise, demand for equipment used to perform these surgeries fell more sharply than did that for less expensive, non-invasive nonsurgical procedures. Busy lifestyles and pervasive unemployment rates have led to rapid increases in demand for minimally invasive procedures (such as injections and laser-based procedures). Minimally or non-invasive procedures will continue to take market share from invasive surgeries, although healthy growth will remain in some areas, such as implants, where there are no notable alternatives.

Lasers, other light-based equipment to remain largest, fastest-growing
Equipment has traditionally held the largest share of the cosmetic surgery product market, and in 2009 accounted for over one-third of demand. Purchases of equipment were slowed by the recession and should see a strong rebound. Lasers and other light-based systems will continue to be the largest sector of equipment demand, and will see the fastest growth going forward as new laser-based treatments such as noninvasive liposuction enter the market.

Injectables and implants fastest-growing products
Through 2014, injectables and implants will continue to be the two fastestgrowing product segments. Growth in demand for injectables has boomed since the 1990s when BOTOX (Allergan) first entered the market. Cosmetic injections benefit from increasing societal acceptance as well as high consumer awareness of their ability to provide a quick, noninvasive reduction in wrinkles with no recovery time. With 2009 and 2010 market approvals of competing botulinum toxin-based injectables, BOTOX is seeing its first direct competition, which is expected to have significant impact on the market. Development of newergeneration soft tissue fillers will also continue, with this segment expected to see the fastest gains among injectables. Implants will continue to benefit from silicone’s market re-entry in 2006, as breast implants -- the most common aesthetic surgical procedure -- remain fast-growing. Next-generation implant materials (so-called “gummy bear” implants) are forecast to enter the market once they receive FDA approval following clinical testing. These higher-value implants will drive further value gains.

Study coverage
Cosmetic Surgery Products is a new Freedonia industry study available for $4800. It presents historical demand data (1999, 2004 and 2009) plus forecasts for 2014 and 2019 by procedure, product and raw material. The study also assesses key market environment factors, evaluates company market share and profiles 29 US industry competitors

For more please visit
http://www.bharatbook.com/detail.asp?id=167181&rt=Cosmetic-Surgery-Products-to-2014.html

OR Contact us at

Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com

Wednesday, December 29, 2010

Oncology Market in India to 2017 - Limited Patient Affordability for High Priced Biologics Lowers Market Potential

The leading business intelligence provider, has released its latest research, “Oncology Market in India to 2017 – Limited Patient Affordability for High Priced Biologics Lowers Market Potential”, which provides insights into oncology sales and price forecasts until 2017. The report also examines the Indian oncology treatment usage patterns. In addition, the report also includes insights into the oncology R&D pipeline. The report provides an in-depth analysis of the top five oncology therapeutic indications, which are breast cancer, colorectal cancer, prostate cancer, lung cancer and Non-Hodgkin’s Lymphoma (NHL).

Scope

The report covers:
- Data and analysis on the oncology market in India.
- Annualized market data for the oncology market from 2002 to 2009, with forecasts to 2017.
- Market data on the therapeutic landscape, including market size, market share, annual cost of therapy, sales volume and treatment usage patterns such as disease population and treated population.
- Key drivers and restraints that have had a significant impact on the market and on each indication.
- The competitive landscape of the oncology market includes both Indian players and foreign players.
- Key M&A activities and Licensing Agreements that took place from 2004 to 2010 in the Indian oncology market.

Reasons to buy

The report will assist business development and marketing executives to strategize their product launches, by allowing them to:
- Build effective strategies to launch their pipeline products by identifying potential of the market.
- Exploit in-licensing and out-licensing opportunities by identifying products that might fill their portfolio gaps.
- Develop key strategic initiatives by studying the key strategies of top competitors.
- Develop market-entry and market expansion strategies by identifying each indication’s growth rate.
- Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules which are safer and more efficacious.

Companies Mentioned

Dr. Reddy’s Lab
Piramal Healthcare
Biocon Limited
Cipla Ltd.
Sanofi-Aventis
F. Hoffmann-La Roche Ltd/Genentech, Inc.
AstraZeneca
GlaxoSmithKline

For more please visit
http://www.bharatbook.com/detail.asp?id=167044&rt=Oncology-Market-in-India-to-2017-Limited-Patient-Affordability-for-High-Priced-Biologics-Lowers-Market-Potential.html

OR Contact us at

Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com

Friday, December 24, 2010

Vietnam Mineral Industry

Vietnam: Mineral covers the country's and global mining industry overview, Vietnam economic overview, mineral production including metals, industrial minerals and mineral fuels, and foreign trade of minerals. It also covers the market trends and outlook, government policies and programs in the mining industry, development planning for the mining industry 2003-2010, investment and structure of the industry, plus the profile, comparative matrix and SWOT analysis of the industry leading players: Vietnam National Coal-Minerals Industries Group (Vinacomin), Ha Lam-Tkv Coal Joint Stock Company (Ha Lam), Binh Dinh Minerals Joint Stock Company (BMC), Manganese Minerals JSC, Asian Mineral Resources Ltd and Olympus Pacific Minerals Inc.

Executive Summary

VN Mineral includes an overview of the global mining industry and the Vietnamese mining industry. While agriculture is the primary occupation of the population in Vietnam, the primary export industry is mining. According to the Ministry of Industry, the mining industry will need around USD 56.25 billion for development during the 2006-2010 period, which accounts for around 23.2% of the aggregate social investment capital. Part 1 of the report also contains information and statistics on Vietnam’s production of minerals, trade, and also the important ministries in the industry.

The second part of the report includes government policies and programs in the Vietnamese mining industry, the development planning for the 2003-2010 period, investments in the industry, and also the structure of the industry.

A ranking of the major players in the industry is also provided in the third part of the report. Current leading players in the market include Vietnam National Coal-Mineral Industries Group, Ha Lam-Tkv Coal Joint Stock Company, Binh Ding Minerals Joint Stock Company, Manganese Mineral JSC, Asian Mineral Resources Ltd, and Olympus Pacific Minerals Inc. This part also includes a comparative matrix of the financial highlights of the companies. A SWOT analysis of the companies can also be found in this part of the report.

For more please visit
http://www.bharatbook.com/detail.asp?id=166767&rt=Vietnam-Mineral-Industry-2H10.html

OR Contact us at

Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com

Sunday, July 25, 2010

Conference on Amorphous Pharmaceutical Materials

Amorphous Pharmaceutical Materials
Assessing emerging applications, methodologies, techniques and challenges.
24th - 25th January 2011, BSG Conference Centre, London, UK

Key Speakers:

Ljiljana Harding, Inhalation & Devices Centre of Emphasis, Pfizer,
Franco Sartor, Principal scientist , GlaxoSmithKline,
Sigrid Stokbroekx, Research Fellow, Johnson & Johnson Pharmaceutical R&D,
Dr. Rolf Hilfiker, Vice President Head of Department Solid-State Development, Solvias,
Roger Parker, Senior Scientist, Food Structure and Health Programme, Institute of Food Research,
Dr. Simon Gaisford, Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London
Mark Saunders, Owner, co-founder and Development Director, Kuecept,
Robert Whittock, IP/IT Practice Group, Freshfields Bruckhaus Deringer LLP,
Wouter Pors, Attorney, Bird & Bird,
Michael Gamlen, Managing Director, Pharmaceutical Development Services,
Prof. Graham Buckton, Chief Executive Officer, Pharmaterials,
Dr. Andreas Kordikowski, R&D Director, Activery Biotech,
Dr. Filipe Gaspar, Head of Particle Design, Hovione
Bertrand Gellie, Director of Organic Chemistry, European Patent Office.

Conference Introduction,
Amorphous Pharmaceutical Materials,
24th - 25th January 2011, London, UK.

With the continuous increase in the number of insoluble developmental drug molecules and growing regulatory scrutiny over pharmaceutical solids, the use of amorphous solids is steadily rising in the pharmaceutical companies. This conference combines presentations on the approaches to amorphous detection and quantitation within GSK, and clinical advice and practical tips from Pfizer and Johnson & Johnson. The biopharmaceutical implications for development of amorphous solid solution intermediates will be discussed and strategies to protect and commercialise innovations in amorphous materials will be presented.During the two days you will be exposed to several analytical strategies to protect and commercialise innovations in amorphous materials. Amorphous Pharmaceutical conference will provide an enlightening and thought-provoking forum with a series of case studies ranging from amorphous formulation to novel amorphous microparticle technology.

Reasons to register today:
• Understand the use of isothermal calorimetry to characterise stability of amorphous pharmaceuticals.
• Implement the latest technological developments.
• Discuss the best approaches to control and stabilise amorphous drug forms.
• Examine the quantifi cation of amorphous content.
• Gain a clearer insight on amorphous food materials.
• Seize this opportunity to network with leaders from pharma-biotech, healthcare and regulatory agencies.

Who should attend?

VPs, Directors, Heads and Managers of:
• Stability / Stability testing
• Pre-formulation
• Solid State Chemistry
• Formulation
• Crystallisation • Drug Discovery
• Drug Delivery
• Analytical methods / development
• API Development • Validation
• Pharmacokinetics • Quality Control
• R&D
• Product Submission
• Research and Development • Materials Science
• Technical Operations
• Statistical Sciences
• Manufacturing Science
• Regulatory affairs
• Particle Engineering
• Product Design
• Business Development

Day 1
Amorphous Pharmaceutical Materials,
Monday 24th January 2011, London, UK

09:30 Registration and refreshments,

10:00 Opening address from the chair

10:10 Amorphous content: Quantification in drug substance and drug product.
• Ways to trace amorphous content in crystalline solids.
• Ways to trace amorphous content in formulated products.
• Micronisation and amorphisation.
• Impact on drug substance properties.

Dr Rolf Hilfiker,
Vice President, Head of Department Solid-State Development, Solvias.

10:50 Biopharmaceutical implications for development of amorphous solid solution intermediates.
• Why amorphous solid dispersions / solutions.
• Current in vitro testing strategies.
• Physiology of the gastrointestinal tract and its relevance to oral delivery of poorly soluble compounds.
• Case Study: novel amorphous microparticle technology for targeted drug delivery.

Mark Saunders,
Owner, co-founder and Development Director, Kuecept.

11:30 Morning refreshments

11:50 Approach to amorphous detection and quantitation within GSK,
• Internal strategy, methods and techniques.
• Case study A: detection and quantitation of amorphous for micronised material.
• Case study B: dealing with amorphous formation in a Liquid Deposited Formulation.

Franco Sartor,
Principal scientist, GlaxoSmithKline,

12:30 Amorphous food materials – Some lessons from food research,
• Hot melt extruded flavour encapsulation systems, a vitrified emulsion.
• Small molecules: solvent, plasticiser, both or neither?
• Protein stability in the glass state: physical, chemical and biological.
• Brian Arthur’s “The Nature of Technology”: so what’s new?

Roger Parker,
Senior Scientist, Food Structure and Health Programme, BBSRC Institute of Food Research.

14:30 Stable amorphous dispersions – science, formulation and manufacturing method,
• Methods of manufacture and the importance for stability.
• Relaxation of bulk and surface.
• Intentional and accidental amorphous materials.
• Use of NIR, IGC, and thermal methods.
• The value of Raman mapping.

Prof. Graham Buckton,
Chief Executive Officer, Pharmaterials

15:10 Amorphisation as Tool for Product Life Cycle Management,
• Phases and critical steps in LCM.
• Solid form roles in LCM.
• Activery the amorphisation company.
• Current and future products.
• Amorphous combinations, single drug products and nanoparticles.

Dr. Andreas Kordikowski.
R&D Director, Activery Biotech.

15:30 Afternoon refreshments.

15:50 Patents - amorphous materials & formulations.
• Satisfying patentability requirements.
• Practical advice to drafting strong claims.
• Assessing infringement.
• Reviewing recent case law examples.

Robert Whittock,
IP/IT, Practice Group, Freshfields Bruckhaus Deringer.

16:30 Strategies to protect and commercialise innovations in amorphous materials.
• How to draft for existing active ingredients.
• Create a return on investments and maintain market position.
• Effective enforcement.

Wouter Pors,
Attorney at law, Bird & Bird,

17:10 Closing remarks from the chair.

17:20 Networking drinks.

Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2
Amorphous Pharmaceutical Materials
Tuesday 25th January 2011, London, UK

09:30 Registration and refreshments.

10:00 Opening address from the chair.

10:10 Partially amorphous materials: In-situ monitoring of the recrystallisation process at the nanoscale using heated tip AFM.
• Process-induced disorder and its importance in pharmaceutical industry
• The use of Atomic Force Microscopy (AFM) and related techniques for detection and characterisation of process-induced changes in pharmaceutical materials, incl. several examples from the literature.
• Novel Nano-thermal analysis approach to characterisation of partially amorphous materials at the nanoscale, incl. examples of in-situ monitoring of the recrystallisation process.

Ljiljana Harding
Inhalation & Devices Centre of Emphasis, Pfizer.

10:50 Automated solid dispersion screening: A useful tool to design amorphous systems.
• The approach to automate and miniaturize the search for precipitation inhibitors.
• Preparation of amorphous films.
• Evaluation of amorphous systems.

Sigrid Stokbroekx,
Research Fellow, Johnson & Johnson Pharmaceutical R&D.

11:30 Morning refreshments.

11:50 Stability assessment of amorphous pharmaceuticals with calorimetry.
• Instrument considerations and experimental design.
- Scanning calorimetry and isothermal calorimetry.
• Determination of relaxation rates.
• Examples of applications.
- Measurement of glass transitions with DSC.
- Stability of glassy pharmaceuticals.
- Oral fast-dissolving films.

Dr Simon Gaisford,
Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London.

12:30 Patenting amorphous forms - EPO views.
• What distinguishes amorphous forms from other patentable products?
• How to claim amorphous forms properly?
• How to disclose amorphous forms and support this disclosure properly?
• Case law of interest.

Bertrand Gellie,
Director of Organic Chemistry, European Patent Office.

13:10 Networking lunch.

14:30 Formulating materials to retain amorphous character –ensuring you get what you pay for,
• Amorphous materials are highly active in their nature and need careful processing to ensure they retain their amorphous character.
• Many amorphous materials also have low bulk density and present handling problems.
• Formulation development to ensure the products retain their amorphous character, otherwise the desirable properties will be lost.
• Enabling the small scale manufacture of products containing amorphous materials for use in preclinical and Phase 1 testing while retaining their amorphous character and overcoming bulk density problems.
• Reviewing the possible impact of common pharmaceutical processes on amorphous character.

Michael Gamlen,
Managing Director, Pharmaceutical Development Services.

15:10 Developing solid dispersions by spray drying.
• The role of solid dispersions.
• Methods to produce solids dispersions.
• O Spray drying of solid dispersions.

Dr. Filipe Gaspar
Head of Particle Design, Hovione.

15:40 Afternoon refreshments.
16:10 Process analytical techniques during amorphisation by hot melt extrusion.
• Hot melt extrusion: generation of amorphous and co-crystal forms.
• Process Analytical Technique (PAT) in melt extrusion: Online rheology and NIR measurement.

Prof. Anant Paradkar PhD.
Professor of Pharmaceutical Engineering, Interdisciplinary Chair in Pharmaceutical Engineering Science, University of Bradford.

16:50 Chair’s closing remarks.

17:00 End of Conference.

For more information visit
http://www.bharatbook.com/detail.asp?id=132812&rt=Conference-on-Amorphous-Pharmaceutical-Materials.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com

Conference on Biobanking Americas

Conference on Biobanking Americas ( Conference and Workshop Only )
The future for next generation drug discovery and personalised medicines
To be held at 9th - 11th November 2010, Boston, USA

Key Speakers
• Dr. Marc Allard, Research Microbiologist, Center for Food Safety and Applied Nutrition, FDA
• Dr. Adel Laoui, Director, Healthcare Technologies Aging Therapeutic Strategic Unit, Sanofi-aventis
• Brenda Yanak, West Point IT Site Head and Account Manager, Franchise Biology, siRNA, Imaging, and GeM, Merck
• Jeff Milton, Bioinformatics & Computational Biology, Genentech
• Dr. John G. Baust, UNESCO Chair & Professor, Director, Institute of Biomedical Technology, State University of New York
• Elaine W. Gunter, Founder and President, Specimen Solutions, LLC, National Cancer Institute
• Dr. Hartmut Juhl, CEO, Indivumed
• James Eliason, Director, Stem Cell Commercialization Center
• Dr. Michael Hehenberger, Business Development Executive, Life Sciences, IBM Thomas J. Watson Research Center
• Kristen Rosati, Partner, Coppersmith Schermer & Brockelman
• Dr. Richard J. Maguire, Director of Business Development – LIMS, Ocimum

An estimated $1bn has been invested in the biobanking industry within the last ten years. At least 179 biobanks with 345,000 donors exist in the US, most of which were established in the last 10 years. (Source: Business Insights, March 2009)

TIME Magazine highlighted biobanking as one of "10 Ideas Changing the World Right Now." Biobanking is rapidly growing and thriving to change approaches to target-finding, drug development and patient treatment. It is being viewed as a key driver for next generation biomarker and drug discovery.

The substantial advancement of research on the human genome has led to the creation of biobanks, which has brought a paradigm shift in drug testing and development. Recognizing the potential benefits from biobanks, pharma and biotech across the world are investing in infrastructure and biobank development.

Reasons to register today:
• Learn how to develop the best practices to leverage biospecimen resources
• Analyse major challenges for biorepository management and implementation
• Get the latest updates on the applications on genome sequencing
• Investigate the future of biobanks, regulation, ethics, investment and the humanization of drug discovery in the Americas
• Determine how to implement virtual biorepository
• Understand the importance of quality management in biobanking
• Gain an insight into the bioprospecting of tissues, DNA, protein or genetic information
• Enable confident decision making by benchmarking yourself against other leaders in the field

Who should attend?

VPs, Directors, Heads, Managers of:
• Biobank
• Tissue bank
• Biorepository/BioSample
• Molecular Diagnostics
• Clinical Genetics, Pathology
• Genomics
• Privacy/Protection/Security
• Scientific and Quality
• Laboratory and Inventory
• R&D
• Quality Control
• Strategic Outsourcing
• Clinical Research
• Translational Medicine
• Personalized Medicine
• Bioanalytical Chemistry
• Pharmacogenomics
• Proteomics
• Business development
• Strategic alliances

Others:
Consultants& Academics
Regulatory bodies
Researchers
Biorepository Vendors
Government Officials

Workshop
Pre-conference Workshop, Tuesday 9th November 2010

The role of best and evidence based practice in promoting quality sample and data collection to support biomarker research and development

Led by: Lisa B Miranda, Vice President, Strategic Alliances and International Biobank Relations, Trans-Hit Biomarkers

Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 15:00 Workshop
Timing includes lunch and refreshment breaks

About the workshop:

Many consider biobanks to be the crucial cornerstone of biomedical research through their provision of expertise and procurement of high quality samples and well annotated data to foster research. One’s ability to develop high utility, impactful, yet quality biobanking collections lies in the biospecimen resource’s success in implementing current best practice as well as the foresight to incorporate evidence based practice into daily operations. The role of the biobanker is now expanding to include proactive pipeline planning which incorporates these considerations to ensure successful “proof of concept” in translational research efforts such as biomarker research and development.

This interactive workshop will include discussion of:
• An overview of related best and evidence based practice issues
• The role and current implications of best and evidence based practice in the biobanking workspace that relate to pipeline planning
• Strategies for how to navigate the R&D pathway and build a biomarker discovery pipeline for your biobank that integrates evidence based practice

About your workshop leader

With over 20 years of experience, Ms. Miranda has a vast range of expertise in all aspects of Biospecimen Resource Research Management and Development. After 14 years in research at the University of Pennsylvania, Ms. Miranda attained international prominence as Technical Director of the Tumor Tissue and Biospecimen Bank (TTAB) Core Facility. She served as the prime architect of the centralized biospecimen resource and led TTAB’s collaborative efforts in development of the NCI’s CaTissue Suite inventory management system and a National Mesothelioma Virtual Bank with the University of Pittsburgh and the CDC. In 2006, she was recognized for her development of a Sustainable Cost Recovery Model which was acknowledged as the gold standard by the United States National Cancer Institute’s Office of Biorepositories and Biospecimen Research (NCI OBBR). Since then she has continued to establish and develop best practices for the biobanking community through her role as a NIH Contractor and Consultant for NCI OBBR and the Biospecimen Research for Molecular Medicine Offices, as well as current work on cost recovery for the ISBER Best Practices (2010 version).

In addition to collaborating on development of the Ca Hub, which is aimed at developing a common biorepository infrastructure that promotes resource sharing and team science, in order to facilitate multi-institutional, high throughput genomic and proteomic studies, Ms. Miranda recently authored a new chapter for the NCI Best Practices focusing on Technical Considerations for Management and Operations of Biospecimen Resources. In her role as member of the Ca Hub Acquisition of Normal Tissues Working Group, she collaborated with her ANTWG colleagues on development of an additional best practice document focusing on procurement of post mortem tissues. In 2008, she expanded her consultancy with the incorporation of Biobusiness Consulting Inc., which serves the global biobanking research communities in government, academia, pharmaceuticals, biotech and related industry.

Ms. Miranda is also active in numerous professional societies and committees and has gained recognition as an international speaker and an expert in Biobanking. Her current roles include: Councilor on the ISBER Board of Directors, membership in the global “think tank” known as the “Marble Arch International Working Group on Biobanking for Biomedical Research”, as well as P3G Society (Public Population Project in Genomics), LRIG and the NIH Biospecimens Special Interest Group.

Day 1
Biobanking Americas
Wednesday 10th November 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 NCI's Cancer Human Biobank (caHUB): Raising the level of excellence for research biorepositories
• The vision for caHUB
• Planning process for caHUB
• caHUB as a national reference repository
• Challenges in bioethics and IP
• White papers available on caHUB operations

Elaine W. Gunter
Founder and President
Specimen Solutions, LLC, National Cancer Institute

10:20 The institutional virtual biobank
• Discuss strategies, tools and techniques used for institutional federation and curation of large volumes of disparate data, and present a case-study for a workflow from repositories to data analysis
• Developing a cost-effective workflow to permit computational analysis will become essential to scientific investigations
• High-throughput experimental techniques threaten to dump mountains of new data onto bioinformatics teams already struggling with the diversity, complexity and enormity of existing resources

Jeff Milton
Bioinformatics & Computational Biology
Genentech

11:00 Morning refreshments

11:20 The importance of an Honest Broker function for clinical data associated with biospecimens
• What is an Honest Broker in biobanking?
• Why is it needed for research?
• What types of research does it support?
• How does it work?

James Eliason
Director
Stem Cell Commercialisation Center

12:00 Biobanking in the post-genomic era: methodological challenges

Dr. John G. Baust
UNESCO Chair & Professor, Director
Institute of Biomedical Technology, State University of New York

12:40 Networking lunch

13:40 Science guided biobanking: A prerequisite for the development of individualized cancer therapies
• Tissues are under tremendous biological stress when surgically separated from the body and, subsequently, significantly change gene and protein expression profile and, possibly, also growth regulating factors that might serve as targets or stratification markers for new drugs.
• Several factors have been identified that affect tissue research data, including:
- drug treatment and anesthesia of patients before surgical tissue removal
- intrasurgical ischemia by ligation of main arteries (warm ischemia)
- “cold” ischemia, i.e. the time interval between surgical removal and fixation of tissue
- location of tumor biopsy within a given tumor
- processing of tissue and fixation protocols
• Consequently, biobanks for target discovery and drug development have to be based on fully controlled, well-documented processes that start already presurgery and include rapid and standardized tissue preparation in the surgery unit

Dr. Hartmut Juhl,
CEO, Indivumed and Inostics
Adjunct Professor, Georgetown University
Adjunct Professor, University of Hamburg

14:20 Recent Legal Developments in Biobanking
• The HITECH Act, the HIPAA Privacy Rule amendments, and their impact on biobanking
• The affect of the Genetic Information Nondiscrimination Act on informed consent for biobanking
• And more!

Kristen Rosati
Partner
Coppersmith Schermer & Brockelman

15:00 Afternoon Refreshments

15:20 Sponsor Spotlight Session
Take this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your product/services to the audience.

16:00 Biobanking: A golden cusp for tailor made personalised medicines
• Analysing the opportunities, challenges, approaches
• Discussing recent developments
• Understanding the ethical, legal guidelines

16:40 Closing remarks from the chair

16:50 Networking Drinks
Take your discussions further and build new relationships in a relaxed and informal setting
Day 2
Biobanking Americas
Thursday 11th November 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Case Study: Next Generation sequencing at the FDA center for food safety and applied nutrition. Trace back and testing of foodborne pathogens
• The milestones for this project included: the ability to provide all of the data generated from analysis of Salmonella enterica genomes
• Developed software that will provide full contig assembly of 454 genomic data, annotation of those contigs and then generate lists of genes present in each Salmonella genome based on annotation analysis.
• Recent Next gen experience in building a comparative genomics lab that is directly testing the applications of these methods for foodborne pathogen outbreak detection and analysis

Dr. Marc Allard
Research Microbiologist, Microbiology
FDA-CFSAN-ORS

10:20 Biobanking: changing approaches to target-finding, drug development and patient treatment

Brenda Yanak
West Point IT Site Head and Account Manager, Franchise Biology, siRNA, Imaging, and GeM
Merck

11:00 Morning refreshments

11:20 Integrated Healthcare Technologies Solutions for an Aging Society
• Pharmaceutical company moving towards global healthcare corporation
• Healthcare paradigm shift from traditional inpatient care towards home-based care
• Develop solutions that span from Wellness to Illness care
• Role of Informatics to enable a consumer healthcare business model
• Vision-Gain from a true integrated and diversified healthcare system

Adel Laoui
Director, Healthcare Technologies Aging Therapeutic Strategic Unit
Sanofi-aventis

12:00 Sponsor Spotlight Session
Take this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your product/services to the audience.

12:40 Networking lunch

13:40 IT Solutions to support Biobanking
• Biobanks are essential for the transformation of Healthcare, as we move towards "translational science", preventive care and personalized medicine.
• IT Solutions supporting Biobanks must address privacy and security concerns and should accommodate new data types such as genomic and imaging data
• To provide value to the medical research community, IT solutions must be capable of query and analysis and enable the creation of disease specific repositories
• Examples to be discussed will include Oncology and Neuroscience

Dr. Michael Hehenberger
Business Development Executive, Life Sciences
IBM Thomas J. Watson Research Center

14:20 Panel Discussion- Biobanking in 2010
Panellists will be analysing the recent trends and advancements in sample collection and processing. Focus will be on the challenges and opportunities involved in establishing a biobank.

15:00 Afternoon refreshments

15:20 Biobanking: The Lynchpin for Translational Research
• So, what’s an imperative for the Biobank?
- The Quality of the specimens, diseased and normal, must be absolutely maintained
- The real value of a Biobank, in either context, is the Meta data (patient demographics, diagnosis, cohorts, environmental exposure, behavior (smoker/non-smoker), etc.
- Whether de-identified or anonymized, or with PHI (Patient Health Information), the intrinsic value of biospecimens is in how well and how thoroughly the specimens are annotated
- In the Pharma context, it is also an imperative to validate the biomarker information via SNP Genotyping, Gene Expression, Flow Cytometry or Mass Spectrometry.
- In Medical Research, it essential to track the genealogy of child samples downstream form the Biobank with a referential link to the parent specimen, as that is where the patient Meta data is stored.

Dr. Richard J. Maguire
Director of Business Development – LIMS
Ocimum Biosolutions

16:00 Biobanking: A paradigm shift in drug test and development: Mouse to Man
• Assessing tools in improving drug development
• Overcoming analytical challenges in drug testing
• Implementing effective strategies

16:40 Chair’s closing remarks

16:50 End of Conference


For more information visit
http://www.bharatbook.com/detail.asp?id=140403&rt=Conference-on-Biobanking-Americas-Conference-and-Workshop-Only-.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com

Conference on Anti-Counterfeiting Americas

Conference on Anti-Counterfeiting Americas
Best practices for protecting the pharmaceutical supply chain against counterfeiting and fraud
8th - 9th November 2010, Boston, USA

Increasing efforts are being made to protect the national supply chain for medicines distribution. In the US, the pharmaceutical supply chain involves the daily delivery of approximately 13 million prescription products to pharmacies, hospitals, clinics and other healthcare provider locations (Source: Urch Publishing, July 2009).

Visiongain's Anti-Counterfeiting Americas conference will provide valuable insights, into the latest issues and track and trace packaging technologies shaping the fields of security and supply chain management, with leading experts presenting the best-practices on tackling pharmaceutical counterfeiting and fraud, improving the integrity of distribution channels and relationships between key parties.

By attending the Anti-Counterfeiting Americas conference delegates will gain a comprehensive understanding of this rapidly changing sector, from the complex structure of the supply chain, to the growth in mail order and online pharmacies. The potential for investment in the pharmaceutical logistics market remains high. The FDA has put additional focus on "corporate responsibility" for supply-chain management, and increased vigilance and action is needed due to the rise of counterfeit drugs in the global supply chain. Anti-counterfeiting initiatives discussed include the use of technology-based measures, repackaging, consumer education, and increased collaboration with domestic and international law enforcement agencies.

By attending this conference you will:
• Measure the impact of counterfeit drugs by using a patient centric approach
• Understand the development process necessary to ensure an effective security strategy
• Improve inventory control
• Hear changes in the US FDA and European policies
• Develop global standards to increase patient safety and elevate supply chain integrity
• Learn about leveraging supplier audits throughout a global organization
• Understand the challenges of the global traceability and serialization regulatory environment
• Utilize auto-ID advancements in packaging technologies
• Hear the latest strategies for defending your brand and pursuing offenders
• Develop working relationships with US law enforcement authorities
• Balance the need for tamper-proof packaging with streamlining your supply chain
• Evaluate current methods for the detection of counterfeit medicines
• Be part of a unique networking opportunity

Target Audience:
• Pharmaceutical manufacturing and distributing companies
• Drug wholesalers
• Public health and regulatory bodies
• Legal firms
• Customs and border agencies
• Pharmaceutical packaging and labelling companies
• Anti-counterfeiting technology and service suppliers
• Pharmaceutical specialist couriers
• Anti-counterfeiting organizations
• Contract manufacturing organizations (CMOs)
• Retail pharmacy chains
• Non-governmental healthcare organizations and Academia

Who should attend:

Chief Security Officers, VPs, directors, heads, managers and specialists of:
• Supply chain/ Supply Chain Security/ Supply Chain Systems/ Global Supply Chain
• Anti-counterfeit Projects / Anti-counterfeiting Operations
• Distribution/ Logistics
• Security/ Global Security
• Packaging & Labelling
• Brand Protection
• Legal Counsel
• Regulatory Affairs/ Intellectual Property
• Quality Assurance/ Quality Control
• Compliance
• Information systems


Day 1
Anti-Counterfeiting Americas
Monday 8th November 2010


09:00 Registration and refreshments
09:30 Opening address from the chair
Lorne M Lipkus
Partner
Kestenberg Siegal Lipkus LLP
09:40 The business value of product serialization within the pharmaceutical supply chain
Across the U.S. pharmaceutical supply chain, organizations are aligning themselves to enable more effective product serialization and increased visibility using new standards. With widespread serialization comes tremendous opportunity for pharmaceutical manufactures and their trading partners to leverage new standards for increased efficiency and greater ROI. In this session, the GS1 Healthcare US organization, the US implementation arm of the leading standards-setting body for product identification, illustrates the business value of serialization and pedigree/visibility information.
• GS1 EPCIS standard as a pathway to significant potential business value
• The status of adoption of GLN and GTIN in pharma
• The industry status for using serial data to match product
• How serialization can provide enormous visibility into the supply chain
• Update on the 2015 readiness program (preparing for serialization and pedigree within the US)
Robert Celeste
Director, Healthcare
GS1 US
10:20 Forging strategic partnerships to elevate
product integrity
• Industry trends
• Developing and applying a risk management process
• Assessing qualifications
• Transitioning a qualified vendor into a strategic partner
• Case study
Mike Lewis
Business Development Manager
Sentry BioPharma Services
11:00 Morning refreshments
11:20 Securing pharmaceuticals against counterfeiting: Assessing latest protection technologies
• Latest developments in anti-counterfeiting technologies
• Packaged-bases vs on-product solutions
• Designing a comprehensive anti-counterfeiting strategy
Frank Schurgers
Managing Director
Integris


12:00 Counterfeiting in developing countries: The use of mixed technology
• External control in massive consume products
• The ‘umbrella brand’ concept: The perfect attack
• Internal control in massive consumer products
• The colombia case
• Results and real benefits
Andres Diaz Cote
President
Figurazione
12:40 Networking lunch
13:40 Protecting IP rights
• Trademarks and identity preservation
• History of branding and quality assurance
• Causes of counterfeiting
• Anti-counterfeiting technology and choice
14:20 Track and Trace at the WIP manufacturing level
• Overview for analyzing tradeoffs between brand protection technologies
• Why is information regarding authentication of products and their movement critical?
• “Pre-adaption” of pharmaceutical manufacturers to incorporate brand authentication as an integral part of their existing operations
Jim Williams
Founder & Chief Scientist
Polyonics
15:00 Afternoon refreshments
15:20 Illegal internet pharmacies: A framework for coordinated action and cooperation
• Illegal internet pharmacies: Extent of the problem
• Action against illegal internet pharmacies: What has been done?
• What remains to be done: The need for additional action
16:00 Supporting safe medicines strategies in
developing countries
• Which developed countries are the most susceptible destination markets for counterfeit drugs?
• Assessing the scale and economic cost of counterfeiting
• Discuss the role of drug regulations and law enforcement
• Cooperation with national & international agencies
Tom Woods
President
Woods International
16:40 Closing remarks from the chair

16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.


Day 2
Anti-Counterfeiting Americas
Tuesday 9th November 2010

09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 Cost-effective anti-counterfeiting solutions for the second tier
• Repackaging and counterfeiting
• Technologies
• Evaluate packaging-based and product-based anti-counterfeiting measures by cost, complexity, and effectiveness for second tier products
Sharon Flank
CEO
InfraTrac
10:20 Protecting medicines from diversion and counterfeiting
• A multi-layered approach for brand protection
• Specialty distribution as a tool for combating diversion
• Using smartphones and mobile phones in brand integrity and
loyalty programs
Steve Wood
President & CEO
Covectra
11:00 Morning refreshments
11:20 Combating pharmaceutical anti-counterfeiting from a legal perspective
• Relationship between parallel trade and counterfeiting
• Basic framework for the parallel trade of pharmaceuticals
• Recent and future developments
12:00 Balancing the need for tamper-proof packaging with streamlining your supply chain
• Cost to manufacturers
• Choosing the right tamper-evident packaging for your product
• The smarter supply chain of the future
12:40 Networking lunch

13:40 Detecting pharmaceutical counterfeiting
• Stages of investigation
• Investigation and detection of contamination in pharmaceutical products
• QC and GMP techniques
Philip Payne
Investigative Partner
RSSL
14:20 Case study: Utilizing forensic analysis in support of counterfeit investigations
The presentation will look at various strategies to utilize forensic evidence for carrying out counterfeit investigations
Vaughn Volpi
President
PICA
15:00 Afternoon refreshments
15:20 The global impact of fake medicine
• Overview of the counterfeit drugs: Some examples
• How fake medicines harm patients and public
• Building a Coalition: A call to action
Scott LaGanga
Executive Director
Partnership for Safe Medicines
16.00 Protecting profits and patient safety through implementing new technologies
• Preventative technologies
• Authentication technologies
• Track & Trace technologies
16:40 Chair’s closing remarks
16:50 End of conference


For more information visit
http://www.bharatbook.com/detail.asp?id=141389&rt=Conference-on-Anti-Counterfeiting-Americas-Conference-and-workshop.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com