Archive for the ‘Drugs’ Category
Wednesday, July 27th, 2011

Strategic Early Development Planning & Management to Avoid High Failure Rates in Innovative Cancer Therapeutics
Conference Dates: 12-13th October, 2011
Venue: Vienna, Austria
When running early clinical trials for experimental new drugs across a range of therapeutic areas, demonstrating “proof of concept” is a critical milestone of the development process, yet one that is very difficult to achieve. It is at this stage where exploratory studies become confirmatory studies and there is a basis for studying the efficacy in a larger population.
Due to the prevalence, diversity and complexity of cancer, oncology clinical trials have evolved along a different path than trials for other therapeutic areas and trial failure rates are amongst the highest amongst all therapy areas. The toxicity ratings, patient recruitment and stratification, and the regulatory and ethical aspects are all challenging considerations specific to oncology trials.
It is widely acknowledged that the current oncology clinical trial system is in desperate need of new breakthroughs as costs are increasing, and the regulatory authorities impose more extensive and complex regulatory guidelines. In recent years, the regulatory bodies have become more receptive to more advanced phase 0 micro-dosing studies, as well as adaptive clinical trials where predetermined modifications can occur in an ongoing study. Challenges in accelerating the proof of concept of oncology drugs include knowing how to integrate multiple disciplines and the latest scientific techniques and weighing the demand made by different stakeholders to make logical decisions earlier with the right information.
This two day event will showcase essential industry, scientific, ethical, academic and regulatory perspectives regarding the latest and most critical issues surrounding early-phase oncology drug development. Experts in the field will talk about their experiences in the pre-clinical, translational and clinical development and how they created a program that satisfies all stakeholders.
Attendees of this event will learn how to utilize resources and the latest science and satisfy major regulations to efficiently translate laboratory theories into clinical practice and achieve proof of concept for innovative oncology therapeutics.
Why Attend?
• Discover the most efficient methods of creating an advanced pre-clinical and translational program to understand disease biology and drug mechanism of action and to obtain approval for FIH studies
• Meet highly experienced experts that are directly involved in anti-cancer agent clinical trial design and implementation.
• Learn about the regulatory requirements in North America and Europe for small and large molecules.
• Work-out the best ways of integrating advanced biomarkers, delivery systems, modelling & simulation, micro-dosing and adaptive trials into your clinical programs.
Who will benefit?
Experienced executives from Pharma, Biotechs and Academia involved in:
oncology drug development
VPs, Professors, Senior Directors and Managers involved in:
biologics, small molecules, discovery, pre-clinical development, exploratory development, early phase clinical development, clinical operations, clinical science, clinical pharmacology, biomarkers, senior scientists, licensing, translational medicine, regulatory affairs, therapy area heads, and R&D.
Agenda request
To request the full agenda please follow the link:
http://www.nextlevelpharma.com/events/view/2nd_annual_translating_oncology_therapies_from_the_lab_to_proof_of_concept
For Booking Information contact:
Erika Vavrovicova
Tel: +421 232 660 382
Fax: +421 2 3301 0331
Email: erika@nextlevelpharma.com
Visit: www.nextlevelpharma.com
Posted in Drug Developmen, Drugs, Health, cancer | No Comments »
Wednesday, July 6th, 2011

Conference Dates: February 1-2nd, 2012
Venue: Vienna, Austria
The roles of medical affairs and liaison have never before been so crucial to the success of pharmaceutical strategic and operational commercial objectives. Medical departments play a vital role in generating quality clinical and real-world data that payers and prescribers need to improve decision making when uncertainty is high. Technologies such as EDC on the trial-sponsor side and e-healthcare on the payer/provider side also offer opportunities to understand and treat disease in diverse patient populations, across all therapeutic areas. The medical affairs department is increasingly becoming central to the coordination of internal stakeholders with the needs of external stakeholders and achieving more client-centric business models. Clearly, the pharmaceutical industry’s traditional sales and marketing models and processes are no longer effective and medical teams are now required to largely fill the void. New ways to engage with tomorrow’s stakeholders are now required.
As payers are increasingly the “gatekeeper” in deciding if a health technology should be reimbursed at all, evidence generation to demonstrate cost-effective health outcomes has never before become so vital. However, best practice approaches have not been defined well and there is still much confusion as to the best way of designing and implementing such studies that can provide relatively unbiased information. Medical teams not only need to develop strong data, but also need to help educate KOLs and payers on the value of that data, especially for complex diseases.
Developing and providing expert medical insight can also deliver strategic direction, increase drug and disease understanding. With particular focus on relationships with payers, KOLs and prescribers, pharmacies and patient advocacy groups, and by working across a range of internal departments on projects there is the real possibility of leveraging this information to create a win-win: increase innovation, patient access and achieve improved budget-effective health outcomes.
Why attend?
• Understand how medical affairs are at the forefront of new pharmaceutical industry commercial models and what needs to be done to maximise success.
• Discover what are the most intelligent ways to engage with KOLs and other prescribers, payers, patient groups, pharmacies and tomorrow’s stakeholders.
• Benchmark with experts to find out what are best practices in late-phase research, especially observational studies, patient registries and investigator initiated studies.
• Discover how medical liaisons, in support of commercial teams, are crucial to the communication of effectiveness, safety and cost-effectiveness.
Who will benefit?
PHARMA:
VPs, directors, managers of Medical Affairs, Medical Science Liaisons, Medical Education, Health Outcomes, & Economics, Medical Marketing, Lifecycle management, Product management, KOL & stakeholder engagement, Late Phase Clinical development, Field Sales, Medical Advisor
Agenda request
To request the full agenda please follow the link:
http://www.nextlevelpharma.com/events/request_agenda/best_practices_in_medical_affairs_management_liaison_to_maximise_value_over_the_product_lifecycle
For Booking Information contact:
Erika Vavrovicova
Tel: +421 232 660 382
Fax: +421 2 3301 0331
Email: erika@nextlevelpharma.com
Visit: www.nextlevelpharma.com
Posted in Drugs, Health Care, Health Management, Medicine | No Comments »
Monday, September 27th, 2010

Phase IV clinical trials are one the fastest growing areas of clinical research. Such post-marketing studies are becoming increasingly important as regulatory agencies demand more long-term data which proves efficacy, safety and quality. Furthermore, a key driver is the demands of health technology assessors and payers and their need for evidence-based economic data, again over the long-term. However, as post-marketing studies tend to be more commercial in nature, successfully planning and implementing them can be a major challenge, especially in terms of motivating investigators and recruiting patients who may already have access to the latest medications.
The event will provide the latest and most valuable, real-life experiences in post-marketing studies, their benefits and challenges. It will be an ideal opportunity for benchmarking and networking with the experts.
Why Attend?
- Gain access to the latest methodologies and real-life cases in the field.
- Explore how market leaders are improving data accuracy.
- Balancing conflicting scientific, regulatory & marketing needs.
- Learn more about comparative studies and their value for drug safety.
- Understand how key figures are affecting future trends and standards.
- Understand regulatory / ethical priorities.
- Find out how phase IV studies & observational research are being outsourced and how industry players are selecting the right partners.
Who will benefit?
Pharmaceutical & Biotech companies Vice Presidents, Directors & Managers of: Medical Affairs, Epidemiology, Clinical Development & Operations, Drug Safety, Pharmacovigilance, Data Management, Regulatory Affairs, Clinical Outsourcing
Solution Providers: CROs, EDC & Data Management, Clinical Software, Market Access & Health Outcomes Consultancies
Academics & Doctors: Epidemiology, Principle Investigators, Primary Care
Government: Ministries of Health, Regulatory & Health Technology Assessment Agencies
Agenda request
To request the full agenda please follow the link:
http://www.nextlevelpharma.com/events/request_agenda/3rd_annual_best_practice_in_phase_iv_clinical_observational_research
For Booking Information contact:
Erika Vavrovicova
Tel: +421 232 660 382
Fax: +421 232 660 397
Email: erika@nextlevelpharma.com
Visit: www.nextlevelpharma.com
Posted in Clinical research, Drugs, Pharmaceutical, Spain | No Comments »
Monday, February 1st, 2010
There is clearly an increasing need for more innovative pricing and reimbursement agreements to help to balance the often conflicting objectives of pharmaceutical and medical technology manufacturers, payers, health technology assessors (HTA), physicians and patients. The industry faces a sustained increase in the cost of healthcare and an ever-increasing range of expensive drugs and technologies available as potential therapies.
Clearly, difficult choices need to be made by payers and HTAs about which products receive funding from increasingly restricted healthcare budgets, especially with often insufficient clinical and real-life evidence available. In terms of innovative agreements, more manufacturers, in more countries, are proposing risk-sharing and value-based schemes more often.
NextLevel Pharma has organized a unique meeting that will be focused purely on risk-sharing and value-based pricing schemes and will provide experts theories and practical case studies of successful models.
Why Attend?
Understand the opportunities, obstacles and challenges in designing and implementing innovative agreements.
Find out when risk-sharing & value-based agreements are required and how they can be designed to satisfy all stakeholders to gain market access.
Understand whether or not the turbulent macroeconomic environment will increase payer motivation for flexible agreements.
Obtain the best and most focused picture of risk-sharing and value-based pricing models today.
Learn how drug effectiveness is being demonstrated in different regions.
Understand the best ways to communicate value and achieve maximum patient and market access.
Hear the perspectives of all stakeholder groups: Payers, regulators, insurers, health economists and the pharmaceutical industry.
Discover how payers are evaluating conditional reimbursement agreements.
Who should attend?
Pharmaceutical companies:
Vice-Presidents, Directors, Managers involved in:
Pricing & Reimbursement,
Market Access,
Health Economics & Outcomes,
Government & Stakeholder Relations,
Regulatory Affairs,
Medical Affairs,
Marketing & Commercial,
Therapy Area Heads,
Country Managers,
Business Unit Heads
Solution providers & consultants:
CEOs,
Business Development,
Senior Consultants,
Regional Heads.
Independent Academics, Health Economists, Senior Doctors, & Patient Representatives.
Agenda request
To request the full agenda please follow the link:
2nd Annual Pharmaceutical Risk-Sharing & Value-Based Pricing & Reimbursement Models
For Booking Information contact:
Erika Vavrovicova
Tel: +421 232 660 382
Fax: +421 232 660 397
Email: erika@nextlevelpharma.com
Visit: www.nextlevelpharma.com
Posted in Austria, Clinical research, Drug Developmen, Drugs, Pharmaceutical, Risk-sharing | No Comments »
Sunday, December 6th, 2009
Conscious Sedation Consulting announces the development of a course to educate non-anesthesia physicians and nurses in the administration of propofol. The company announced that a comprehensive didactic course will be provided internationally for physicians, staff and organizations which wish to add propofol administration to their choice of sedatives. The course covers patient selection, a comprehensive detailed explanation of the pharmacology and pharmacokinetics of propofol, BIS monitoring, computer-controlled infusions, airway management, physiological monitoring, as well as the prevention, recognition and management of adverse events. Also covered are documentation, accreditation standards, patient recovery, discharge, follow up and process improvement. The seminar uses as a foundation, an understanding of a culture of safety as described by the Institute of Medicine in its report To Err is Human.
Propofol (2,6-diisopropyl phenol) is classified as an ultra-short-acting hypnotic agent that provides sedative, amnesic, and hypnotic effects. Propofol rapidly crosses the blood-brain barrier and causes a depression in consciousness that is likely related to potentiation of the g-aminobutyric acid A receptor in the brain.1 Propofol is 98% plasma-protein bound, and it is metabolized primarily in the liver by conjugation to its glucuronide and sulfate to produce water-soluble compounds that are excreted by the kidney. Typically, the time from injection to the onset of sedation is 30 to 60 seconds. Its duration of effect is 4 to 8 minutes. The pharmacokinetic properties do not significantly change in patients with renal failure or moderately severe chronic liver disease. Dose reduction is required in patients with cardiac dysfunction and in the elderly as a result of decreased clearance of the drug. Propofol potentiates the central nervous system effects of analgesics and sedatives such as benzodiazepines, barbiturates, narcotics, and other hypnotic/sedative agents. Therefore, the dose requirements of these agents may be reduced. The cardiovascular effects of propofol include decreases in cardiac output, systemic vascular resistance, and arterial pressure.2 Negative cardiac inotropy and respiratory depression can be seen with the use of propofol. These effects reverse rapidly with dose reduction or interruption of drug infusion3 and rarely require temporary ventilator support.
Controversy surrounds the use of Propofol by non-anesthesia providers. This is in part due to the FDA approved package insert which states that propofol should be administered by individuals trained in the administration of general anesthesia. Additionally some independent practitioners are either unwilling or unable to administer propofol due to local institutional policies or in some cases state regulatory restrictions. In spite of such concerns propofol use has seen a dramatic increase over the last decade. A 2006 study published by the American Journal of Gastroenterolgy reported that 68% of US endoscopists using conventional sedation indicate that they would prefer to administer propofol but are reluctant to do so because of widespread perception of increased complication risks.4 Propofol is more widely used in other countries.
John Hexem, MD, PhD, board certified anesthesiologist and co-founder of Conscious Sedation Consulting, LLC, stated “When used judiciously by physicians with specific training in the administration of propofol, it is a very nice drug. It has very favorable pharmacokinetic properties and patients regain full consciousness quickly, alert and comfortable. I have been administering propofol since 1991 and think it has definite advantages. Dr. Hexem also cautions that “proper monitoring and training that includes advanced airway management skills should be acquired prior to using this drug. Providers using propofol also need a thorough understanding of the continuum of sedation as described by the American Society of Anesthesiologists and national accrediting and safety organizations.
Since 2002 more than 500,000 subjects have received propofol for endoscopic sedation.5
From this data, propofol in appropriate patients with trained personnel has demonstrated an excellent safety record. Transient hypoxia occurs in 3% to 7% of cases and transient hypotension in 4% to 7%. Time to recovery ranged between 14 and 18 minutes. In a retrospective review of Nurse Administered Propofol Sedation (NAPS) in several centers and involving greater than 36,000 endoscopies, the rate of clinical adverse events, defined as apnea or airway compromise that required assisted ventilation via bag-mask, ranged from 0.1% to 0.2%. 6 No patients required intubation, and none had permanent injury or death.
For additional information please visit online at www.SedationConsulting.com
Or call at 1.888.581.4448.
About: Conscious Sedation Consulting LLC, a patient safety advocacy firm that provides continuing education, training and consulting services to non anesthesia health care providers who offer sedation and analgesia services.
Statement of Disclosure: It is the policy of Conscious Sedation Consulting LLC, its principles and any of its employees to disclose any financial interest or other relationship with a commercial interest producing healthcare goods or services that has a direct bearing on the subject matter of any educational activity. A relevant financial interest or other relationship may include such things as grants or research support or a relationship such as an employee, consultant, major stockholder, member of speaker’s bureau, and the like, that has been established for any dollar amount over the past 12 months. We have nothing to disclose.
Conscious Sedation Consulting LLC
27 Forest Lane
Ofallon, MO 63366
1.888.581.4448
www.SedationConsulting.com
1) Trapani G, Altomare C, Liso G, et al. Propofol in anesthesia: mechanism of action, structure-activity relationships, and drug delivery. Curr Med Chem 2007;7:249-71.
2) White PF. Propofol pharmacokinetics and pharmacodynamics. Semin Anesth 1988;7:4-20.
3) Short TG, Plummer JL, Chui PT. Hypnotic and anaesthetic interactions between midazolam, propofol and alfentanil. Br J Anaesth 1992;69: 162-7.
4) Cohen LB, Wecsler JS, Gaetano JN, et al. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol 2006;101:967-74.
5)Cohen LB, Hightower CD, Wood DA, et al. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc 2004;59: 795-803.
6) Rex DK, Heuss LT, Walker JA, Qi R. Trained registered nurses/endoscopy teams can administer propofol safely for endoscopy. Gastroenterology 2005;129:1384-91.
Posted in Drugs, Medicine, Pharmaceutical | Comments Off
Friday, August 7th, 2009

The ability to accurately predict adverse events related to areas like cardiology, nephrology, neurology, haematology and hepatology is extremely exciting. Validated safety biomarkers provide the opportunity for smarter and earlier decision making in R&D, meaning project „kill“ decisions are made quicker, later-stage projects become less risky and hundreds of millions of dollars can be saved.
This webinar will summarise what are the most innovative recent scientific developments and the most promising regulatory initiatives, as well as providing a platform for partnering amongst the pharma, biotech, diagnostics and academic sectors.
Why attend?
- Understand the regulatory requirements to demonstrate safety through biomarkers.
- Make partnerships and alliances with biomarker R&D experts.
- Gain access to the latest successful biomarker development case studies.
- Review multi-stakeholders perspectives: pharma, regulators, research institutes, academia & solution providers.
- Learn how to integrate biomarker knowledge in monitoring safety in drug development to reduce risk.
- Identify and understand better, advanced cardiac, renal, hepatological and neurological risk markers.
- Discover cutting-edge approaches for identification and development of new markers.
Who will benefit:
Pharmaceutical, Biotech, Diagnostic & Academic research organisations:
CEOs / Vice-Presidents / Heads / CSOs / Managers / Professors and Scientists involved in: R&D, drug safety & pharmacovigilance, biomarker discovery/validation, molecular diagnostics, pharmacogenomics/genetics/proteomics, translational medicine, clinical science and development, molecular imaging, pre-clinical development, modeling and simulation, pharmacology, pharmacokinetics/pharmacodynamics
Solution providers & consultants:
CEOs, Business Development, Senior Consultants, Regional Heads
Â
Agenda Request
To request the full agenda please follow the link:
https://www.nextlevelpharma.com/events/request_agenda/safety_biomarkers_in_drug_development
Contact Details:
For Booking Information:
Tel: +421 232 662 621
Fax: +421 232 660 395
Email: erika@nextlevelpharma.com
Visit: www.nextlevelpharma.com
Posted in Bioscience, Drug Developmen, Drugs, biomarkers, webinar | No Comments »
Wednesday, August 5th, 2009
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- Next Generation Sequencing High Throughput Sequencing Platforms: Implementation and Technology Considerations
Sequencing Applications Considerations
- Applying Next-Generation Sequencing to Cancer and Medical Genetics and Discovery Research
- Next Generation Sequencing Technologies and Bioinformatic Analysis Tools
- Data Analysis
- Data Management and Storage Strategies
Oxford Global Conferences is proud to present Next Generation Sequencing (NGS)Congress, which is to be held on the 16th & 17th November 2009 in London. The congress is held in conjunction with qPCR Congress( www.qpcr-congress.com).
Next-generation sequencing technologies are revolutionizing biology by allowing for genome-wide transcription factor binding-site profiling, transcriptome sequencing, and more recently, whole-genome resequencing. These technologies will provide a genome-wide sequence readout as an endpoint to applications ranging from chromatin immunoprecipitation, mutation mapping and polymorphism discovery to noncoding RNA discovery.
Over the 2 days, the conference provides an overview of the current options of next-generation sequencing platforms, technologies, applications and the newest computational tools for the analysis of next-generation sequencing data.
The event will attract over 120 senior-level decision makers working in bioinformatics & data management, next generation sequencing, discovery, RNA profiling, molecular genomics, and clinical & diagnostics development from the UK, Europe and US. This prestigious event provides a forum for practitioners and researchers to learn more about key solutions being provided to their industry, network with their peers, and address key industry concerns through a series of cutting edge conference presentations in a professional yet relaxed environment.
THE EVENT
In keeping with Oxford Global’s highly successful life sciences series, an expert panel of 25 speakers will present a full conference programme covering the following key topics include:
Day 1 – 16th November
Day 2 – 17th November
WHO ATTENDS?
Delegates are pre-qualified dependent on budget, responsibility and seniority. Delegates are senior-level decision makers, from major pharmaceutical, biotech companies and research institutions based in Europe and typically include VPs, Directors, Managers and Heads of:
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Drug Discovery
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High throughput Technologies
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Bioinformatics
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Data Management
|
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Principal Investigation
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Molecular Profiling/Diagnostics
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Clinical Development
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qPCR
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Next Generation Sequencing
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Gene Expression
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Biostatistics
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Genomics
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YOUR NETWORKING OPPORTUNITIES
Meet face-to-face with leading solution providers and senior-level industry peers through a series of formal and informal networking opportunities. Using our online appointment system, you are able to view the full profiles of all solution provides before the event. In addition you have the chance to pre-arrange one-to-one meetings with them, giving you the opportunity to discuss technologies, services and solutions that address your key business needs. Categories of solution providers include:
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Next Generation Sequencing Platforms
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NGS technologies
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Screening Technologies
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High Throughput Sequencing
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Data Management Methods
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Bioinformatics/Biostatistics Solutions
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Special discounts are available by quoting NGSDEL09. For information on sponsorship and registration please email info@oxfordglobal.co.uk or call +44(0) 1865 304925 www.nextgenerationsequencing-congress.com.
Posted in Drug Developmen, Drugs, Pharmaceutical, United Kingdom, biology, database | No Comments »
Sunday, August 2nd, 2009
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- Successful Gene Expression Analysis using real-time PCR
- Profiling technologies: multivariate and multiway expression profiling, temporal expression profiling and spatiotemporal maps
- Other technologies: High resolution melt, Immuno PCR, Methylation sensitive PCR, SNP analysis, microRNA detection and Multiplex technologies
- Development of clinical diagnostics and clinical Development – use in therapeutic areas such as cancer and infectious diseases
- Bioinformatics
- Data management: software applications, data mining, data visualization, biostatistics, multivariate statistics
- Assay optimisation and validation strategies
- New applications of qPCR- High throughput applications, Real-time RT-PCR arrays and Digital PCR
- The discovery of Biomarkers: Disease markers, Tissue specific markers, Cancer markers, Stem cells, Differentiation markers and Cancer stem cells
- The potential and use of qPCR reagents and instrumentation
Oxford Global Conferences is proud to present qPCR Congress 2009 (www.qpcr-congress.com), which is to be held on the 16th & 17th November 2009 in London. The congress is the single most focused event in Europe dedicated to key technological and scientific trends & advances in qPCR in the pharmaceutical and biotech industry, as well as academic institutions. There is also a post conference workshop on Biostatistics on the 18th November.
This conference explores effective strategies, technologies and applications of qPCR in accelerating drug discovery and the development of clinical diagnostics. Over three days, the event will attract over 120 senior-level decision makers working in discovery, biomarkers, gene expression, molecular biology, and clinical & diagnostics development and bioinformatics & data management from the UK, Europe and US. This prestigious event provides a forum for practitioners and researchers to learn more about key solutions being provided to their industry, network with their peers, and address key industry concerns through a series of cutting edge conference presentations in a professional yet relaxed environment.
THE EVENT
In keeping with Oxford Global’s highly successful life sciences series, an expert panel of 45 speakers will present a full conference programme covering the following key topics include:
Day 16th November
Stream 1: qPCR in Diagnostics and Molecular Markers as well as Novel Technical Approaches
Stream 2: Bioinformatics and Data Management
Day 2 17th November
Stream 1: qPCR in Drug Discovery and Development
Stream 2: Next Generation Sequencing High Throughput Sequencing Platforms
Day 3 18th November: Post Conference Workshop – Biostatistics
WHO ATTENDS?
Delegates are pre-qualified dependent on budget, responsibility and seniority. Delegates are senior-level decision makers, from major pharmaceutical, biotech companies and research institutions based in Europe and typically include VPs, Directors, Managers and Heads of:
|
Drug Discovery
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Biomarkers
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Bioinformatics
|
Clinical Diagnostics
|
|
Principal Investigators
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Molecular Profiling
|
Clinical Development
|
qPCR
|
|
Gene Expression
|
|
|
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Toxicology
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Translational Science
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Biochemistry
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Genomics
|
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Biostatistics
|
High throughput Technologies
|
Data Management
|
Cell Biology
|
YOUR NETWORKING OPPORTUNITIES
Meet face-to-face with leading solution providers and senior-level industry peers through a series of formal and informal networking opportunities. Using our online appointment system, you are able to view the full profiles of all solution provides before the event. In addition you have the chance to pre-arrange one-to-one meetings with them, giving you the opportunity to discuss technologies, services and solutions that address your key business needs. Categories of solution providers include:
|
Real-Time PCR Reagents & Instrumentation
|
qPCR technologies
|
Screening Technologies
|
|
Gene Expression Services
|
RNAi Applications
|
Bioinformatics/Biostatistics Solutions
|
|
Molecular & Expression Profiling
|
High Throughput Sequencing
|
Data Management Methods
|
|
Multiplex Technologies
|
Sampling Technologies
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Multimarker Diagnostics
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Special discounts are available by quoting qPCRDEL09. For information on sponsorship and registration please email info@oxfordglobal.co.uk or call +44(0) 1865 304925 www.qpcr-congress.com.
Posted in Bioscience, Drug Developmen, Drugs, Pharmaceutical, United Kingdom | No Comments »
Thursday, July 16th, 2009

This will be a half day webinar for clinical pharmacologists, scientists and pediatricians to discuss overcoming the scientific challenges in designing PK/PD studies to aid developing new pediatric medicines.
NextLevel Pharma’s focused and interactive webinar will look to concentrate on the position that pharmacokinetic and pharmacodynamic modelling and simulations have to answer the questions of how children metabolize drugs differently, how to assess optimal drug dosage levels and optimise the design of pediatric studies.
Experienced industry pharmacologists and pediatricians will join us to discuss recent developments and assess how to better understand drug interaction, determine the optimal dosage and report on efficacy in children.
Why participate?
- Understand the need for pk/pk studies: the when, how and why in the eyes of the regulators.
- Learn what roles pk/pd studies have in the development of pediatric drugs and how they can be used more effectively to determine dosages, measure efficacy and demonstrate value to the pediatric world.
- Hear case study presentations from industry leaders on how to adapt methods used from adult to children and gain fresh perspectives from experienced pharmaceutical companies who have successfully integrated pk/pd into pediatric studies for optimal design.
- Discover which approaches are best to predict dosage, utilize existing (adult) data, and understand the interactions between drug and child.
Who will benefit:
Pharmaceutical & Biotechnology Organisations:
Vice- Presidents, Directors, Managers;
Pediatrics, Pre-Clinical and Clinical Pharmacologists, Modelling and simulation specialists.
Academics;
Pediatricians, pharmacologists and scientists involved in the development of new pediatric medicines
Agenda Request
To request the full agenda please follow the link:
https://www.nextlevelpharma.com/events/request_agenda/pediatric_pharmacology
Contact Details:
For Booking Information:
Tel: +421 232 662 621
Fax: +421 232 662 622
Email: erika@nextlevelpharma.com
Visit: www.nextlevelpharma.com
Â
Posted in Drugs, Pharmaceutical, webinar | 1 Comment »
Tuesday, June 16th, 2009
The ability to accurately predict adverse events related to areas like cardiology, nephrology, neurology, haematology and hepatology is extremely exciting. Validated safety biomarkers provide the opportunity for smarter and earlier decision making in R&D, meaning project „kill“ decisions are made quicker, later-stage projects become less risky and hundreds of millions of dollars can be saved.
This conference will summarise what are the most innovative recent scientific developments and the most promising regulatory initiatives, as well as providing a platform for partnering amongst the pharma, biotech, diagnostics and academic sectors.
Why attend?
- Understand the regulatory requirements to demonstrate safety through biomarkers.
- Make partnerships and alliances with biomarker R&D experts.
- Gain access to the latest successful biomarker development case studies.
- Review multi-stakeholders perspectives: pharma, regulators, research institutes, academia & solution providers.
- Learn how to integrate biomarker knowledge in monitoring safety in drug development to reduce risk.
- Identify and understand better, advanced cardiac, renal, hepatological and neurological risk markers.
- Discover cutting-edge approaches for identification and development of new markers.
Who will benefit:
Pharmaceutical, Biotech, Diagnostic & Academic research organisations:
CEOs / Vice-Presidents / Heads / CSOs / Managers / Professors and Scientists involved in: R&D, drug safety & pharmacovigilance, biomarker discovery/validation, molecular diagnostics, pharmacogenomics/genetics/proteomics, translational medicine, clinical science and development, molecular imaging, pre-clinical development, modeling and simulation, pharmacology, pharmacokinetics/pharmacodynamics
Solution providers & consultants:
CEOs, Business Development, Senior Consultants, Regional Heads
Agenda Request
To request the full agenda please follow the link:
https://www.nextlevelpharma.com/events/request_agenda/safety_biomarkers_in_drug_development
Contact Details:
For Booking Information:
Tel:            +421 232 662 621
Fax: +421 232 660 395
Email: erika@nextlevelpharma.com
Visit: www.nextlevelpharma.com
Posted in Drugs, Pharmaceutical, Slovakia, biomarkers | No Comments »
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