Archive for the ‘Clinical research’ Category

3rd Annual Best Practice in Phase IV Clinical & Observational Research

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

2nd Annual Pharmaceutical Risk-Sharing & Value-Based Pricing & Reimbursement Models

Monday, February 1st, 2010

Pharmaceutical Risk Sharing

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

    Enhancing Performance of Early Phase Drug Development Projects

    Monday, February 1st, 2010

    Early Phase Drug

    The pharmaceutical industry is constantly facing increasing demands for efficiency and cost effectiveness, making the development of project management skills and tools combined with their flawless application critical to deliver the best chance of success for a new compound. A well planned and executed project is vital in ensuring the speedy collection of critical data to judge efficacy, safety and the value of progressing the drug candidate to the next level.

    However, in drug development it’s a constant challenge to identify early on the best candidates and strategic approaches to achieve proof-of-concept and minimize attrition likelihood in p.III. As drug development becomes increasingly globalised, unexpected delays combined with requests for further studies and communication failure can prevent the timely completion of a project.

    Enhancing Performance of Early Phase Drug Development” will look to examine the current state of project management approaches during pre-clinical to phase II and the improvements that can be made in planning, implementing, and controlling pharma project components. By developing these areas biopharma companies and project teams will be able to minimize the risks associated with a new drug’s development, and better reach go/ no go decisions in both small and large molecule drugs.

    Why Attend?

    This conference will cover how to decide upon early phase research strategies, and the operational project management tools and techniques to be best used:

  • Improve strategic decision making to enable multiple project successes.
  • Minimise risks generated by advancing a compound’s development
  • Learn how to execute projects involving varied early phase & remote stakeholders, both internally and externally.
  • Clarify project scope & team responsibilities to enable optimum allocation of resources.
  • Define project management tools and techniques to better leverage early stage research
  • Build effective project teams involving both internal and external resources.
  • Who will benefit?
    Project Managers and those individuals with project responsibilities in early phase Development
    VPs, Senior Directors and Managers of:
    o Discovery,
    o pre-clinical development,
    o exploratory development,
    o early phase clinical development,
    o clinical science,
    o clinical operations,
    o clinical pharmacology & PK/ PD, drug safety,
    o biomarkers,
    o translational medicine,
    o adaptive research,
    o regulatory affairs,
    o therapy area heads & specialists,

    Agenda request
    To request the full agenda please follow the link:

    www.nextlevelpharma.com/events/request_agenda/enhancing_performance_of_early_phase_drug_development_projects
    For Booking Information contact:
    Erika Vavrovicova

    Tel: +421 232 660 382
    Fax: +421 232 660 397
    Email: erika@nextlevelpharma.com
    Visit: www.nextlevelpharma.com

    Advancing Biologics from the Lab to the Clinic

    Thursday, August 20th, 2009

    Advancing Biologics

    This event will provide essential perspectives from both industry, regulatory and scientific perspectives in terms of what are the factors preventing biologics from progressing further in development and the vital elements of a successful early stage strategy for biologic studies.

    Attendees will achieve an advanced understanding of how to incorporate the specific biologic requirements into the strategic & operational planning for an early phase clinical trial that provides the best opportunity to save time, reduce risk, reduce costs and maximise product value.

    Why attend?

    * Meet experts directly involved in biologic trial design and implementation
    * Learn about the specific regulatory guidance and level of proof required to satisfy the governing bodies.
    * Understand the perspectives of all stakeholder involved, i.e. regulators, sponsors, CROs, SMOs, central labs and experienced biologic investigators.
    * Come to benchmark, share experience and help to develop a best-practice approach to biologic clinical development.
    * Build stronger relationships upon a better understanding of the challenges faced by each group, who are all vital to the planning and implementation of the study

    Who will benefit

    * Experienced executives from Pharma and Biotechs involved in Biologic development
    * VPs, Professors, Senior Directors and Managers
    * Discovery
    * Pre-Clinical Development
    * Exploratory development
    * Early phase clinical development
    * Clinical science
    * Clinical Operations
    * Clinical pharmacology
    * PK & PD
    * Drug safety & biomarkers
    * Translational medicine
    * Regulatory affairs

    Agenda Request

    To request the full agenda please follow the link:

    https://www.nextlevelpharma.com/events/request_agenda/advanced_biologics_from_the_lab_to_the_clinic

    Contact Details:

    For Booking Information:

    Tel: +421 232 662 621

    Fax: +421 232 662 622

    Email: erika@nextlevelpharma.com

    Visit: www.nextlevelpharma.com

    Best Practic in Phase IV Clinical & Observational Research

    Thursday, August 20th, 2009

    Phase IV Clinical & Observational Research

    href=”http://www.goingtomeet.com/conventions/details/54730″>Phase IV clinical trials are 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.

    This event will be looking moving towards „best-practice“approaches to designing and implementing post-marketing studies. Essential topics to be discussed will include:

    * Study design considerations and implications
    * Comparative studies
    * Balancing the complex requirements of key stakeholders: marketing, clinical, regulatory, safety, KOLs and investigators
    * Overcoming patient recruitment and retention challenges, when the product is commercially available
    * Motivating academically –focused investigators for commercially-focused studies
    * Finding and performance managing the right CRO
    * Leveraging phase IV clinical research to maximise product life cycles
    * Best practice approaches in phase IV clinical operations and implementation
    * Outsourcing phase IV & observational studies

    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
    * Meet ethics committees to retrieve the full regulatory / ethical picture
    * 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

    To request the full agenda please follow the link:

    https://www.nextlevelpharma.com/events/request_agenda/best_practice_in_phase_iv_clinical_observational_research

    For Booking Information:

    Tel: +421 232 660 382

    Fax: +421 232 660 397
    Email: erika@nextlevelpharma.com

    2nd Annual Proteins Congress 2009 to be held in Berlin, Germany

    Tuesday, July 28th, 2009

    Oxford Global Conferences is proud to present the 2nd Annual Proteins Congress 2009, which is to be held on the 29th & 30th October in Berlin. The congress is the single most focused event in Europe dedicated to key technological and scientific trends in Proteins in the pharmaceutical and biotech industry, as well as academic institutions. It will also be co-located with our GPCR Congress

    With the ever-expanding protein therapeutic market, there is a need for the bio/pharma industry to reassess the technology, discovery and delivery trends.  Protein expression & characterisation systems are rapidly evolving, and there is more pressure to harvest larger, purer quantities of product to support research pipelines. More efficient methods are also needed to identify and analyse proteins involved in disease populations with the aim to discover novel diagnostic tools and treatments. The conference also looks at effective strategies in protein assays and microarrays and data mining in discovery.

    Over two days, the 2 events will attract over 150 senior-level decision makers working in Proteins development from the UK, Europe and US.  This prestigious event provides a forum for practitioners and prominent innovators 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, during a 2 day conference programme.

    Day One

    Protein Expression, Purification and Characterization: Examines different expression systems including Bacman technology in mammalian cells through the use of Baculovirus, as well as purification and characterization processes, new cell line development, and how to overcome immunogencity problems

    Vaccines, Novel Technologies & IP and Outsourcing Issues: Explores various techniques and technologies involved with Proteins and Vaccines and also a strategic overview of various IP & outsourcing issues.

    Day Two

    Biotherapeutics: Protein engineering technologies for next generation biotherapeutics including focus on increasing half life, alternative scaffolds and biosimilars

    Protein Structure & Production: Analysis of protein structure from a structural biology angle as well as focus on Protein Production solutions and techniques

     

    Who you will meet

    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:

     

    Proteins   Protein Engineering  Structural Chemistry  Crystallography  Molecular Research

    Proteomics Protein Science  Structural Biology    Bioformulations  Biopharmaceutical Development

    Discovery Protein Production  Bioinformatics Biomarkers  Biologics Research

    Biotherapeutics  Medical Science Biochemistry  Expression Systems  Technology Development

     

    THE NEW EVENT FORMAT: NETWORKING AND BUSINESS MEETING 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:

     

    Protein Analysis  Expression Vectors  Protein Engineering Solutions  Protein Chip & Microarrays

    Lyopllization  Phage Display  Protein & Antibody Labelling High Throughput Applications / Platforms

    Purification Sequencing Plasma Protein Profiles  Protein Expression Systems

    Sequencing  Immunogenicity  Diagnostics   Protein Protein Interactions

    Transcription Regulation Protein DetectionCell Signalling  Parallel Quantitative Biology

     

    THE ORGANISERS

    Oxford Global Conferences, produce cutting edge congresses and summits in the Life Sciences sector. Focusing on summits,

    Conferences and unique congress formats, our success is unrivalled in the production of high calibre events that offer tailored

    knowledge-sharing, industry solutions and networking opportunities. A list of upcoming events is below:-

    2nd Annual Proteins Congress, October 29th-30th 2009, Berlin Germany

    GPCR Congress, October 29th-30th 2009, Berlin Germany

    QPCR Congress, 16-17 November 2009, London

    5th Annual Biomarkers Congress, February , 2010, Midland Hotel, Manchester, UK

    2nd Annual Drug Development Summit, April 2010,One America Square, London, UK

    11th Annual Drug Discovery Leaders Summit, June 2010

    8th Annual Pharma Technology and IT Summit, June 2010

    Special discounts are available by quoting “PCDEL09�. For information on sponsorship and registration please email info@oxfordglobal.co.uk or call +44(0) 1865 304925 www.proteins-congress.com.

     

    4th Annual Clinical Site Partnerships in Central & Eastern Europe

    Tuesday, June 16th, 2009

     

    Central & Easter n Europe continues to be one of the most attractive regions globally for running clinical trials. With its substantial pool of patients, centralized healthcare system and highly motivated investigators it still offers time, cost and quality advantages over other territories.

    This event will build upon our previous meetings by examining in detail the current clinical landscape impacting clinical trials in the CEE & CI S region, dealing with longstanding regulatory obstacles, site selection and performance hurdles, approaches to ensure the quality and integrity of data and improving understanding of clinical trials amongst the region’s population. Particular attention will also be given to the continuing barriers to improvements in EU member states as well as Russia, Ukraine and the Balkan regions via focused conference sessions.

    NextLevel Pharma’s “Clinical Site Partnerships in Central & Easter n Europe” event is the only meeting which provides the opportunity to participate in 1 on 1 partnering sessions enabling trial sponsor companies, CROs, clinical solution providers, and sites themselves to meet with one another to discuss potential partnerships.

    Why attend?

    • Learn how CEE can consolidate its position as a highly productive region for clinical research.
    • Hear fresh perspectives from Ministries of Health, ethics committees, clinical research associations, patient organisations and sites as well as sponsor companies on how to improve the region’s clinical research infrastructure.
    • Gain vital local knowledge and improve relationships by hearing from sites directly via presentations and partnering meetings.
    • Develop your approach to train, motivate and support clinical teams in these specific regions.
    • Case study presentations from experts with focus also given to Russia, Ukraine, Turkey and the Balkans.
    • Lear n and implement the most efficient partnership model in CEE to maximise the performance of your clinical partners.
    • Partner with the leading clinical solution providers operating in CEE/CIS in our exclusive 1-on-1 partnering sessions
    • Network and build the contacts & relationships you need at NextLevel Pharma ’s very popular & entertaining networking dinner.

    Who will benefit:

    Pharmaceutical & Biotechnology Organisations:

    Global / European / Regional / Country Heads of Outsourcing, Business Development, Clinical Operations, Clinical Development, Contract Management, Risk Management, R&D Sourcing, Vendor Relationship and Purchasing

    CROs & Clinical Solution Providers:

    CEOs, Business Development Directors, Product Managers, Marketing Managers and Country Managers from the region

    Clinical Sites:

    Principal Investigators, Co-Investigators, Study Co-Coordinators, Study Nurses and others involved in Clinical Research

    Agenda Request

    To request the full agenda please follow the link:

    https://www.nextlevelpharma.com/events/request_agenda/4th_annual_clinical_site_partnerships_in_central_eastern_europe

    Contact Details:

    For Booking Information:

    Tel: +421 232 662 621

    Fax: +421 232 662 622

    Email: erika@nextlevelpharma.com

    Visit: www.nextlevelpharma.com

     

    EMERGING SUPERPOWERS OF CLINICAL RESEARCH Russia, India, China

    Thursday, March 26th, 2009

    How essential is it for you to gain update and vital knowledge on the nuances of healthcare and challenging clinical regulations in Russia, India and China?

    NextLevel Pharma is organising the high level meeting which will examine in detail the opportunities in the unique markets: Russia, India and China which present the fastest global growth in clinical trials for timely, high-quality and cost-effective clinical development.

    Unlocking the true recruitment potential of exciting and complex mega-markets

    28th-29th May, 2009; Amsterdam, Netherlands

    By attending this event you will:

    • Understand the nuances of healthcare in Russia, India and China before conducting clinical trials in these relatively new locations.
    • Learn how to overcome challenges like unethical trials, delays in trial approval, inappropriate protection of clinical data, lack of GCP, etc.
    • Hear fresh perspectives from sponsor companies who have run clinical trials in the “clinical trial paradiseâ€? and benefit from their experience.
    • Gain vital local knowledge by hearing updates on challenging clinical regulations.
    • Hear case study presentations from experts active in the Russian Federation, India and China.
    • Implement the most efficient partnership model in the clinical development to maximise the performance of your CRO and clinical partners.
    • Network and build the contacts & relationships you need at NextLevel Pharma’s very popular & entertaining networking dinner

    Who will benefit:

    Pharmaceutical & Biotechnology Organisations:
    Global / Regional / Country Heads / VPs/ Directors / Managers of Clinical Development, Clinical Research, Clinical Operations, Patient Recruitment, Medical Affairs, Outsourcing, Contract Management, Risk Management, R&D Sourcing, Vendor Relationship and Purchasing, Clinical Study Managers, Senior CRAs

    CROs, SMOs & Clinical Solution providers:
    CEOs, Business Development Directors, Product Managers, Marketing Managers and Country Managers from the region

    Clinical Site:

    Professors, Investigators, Study Nurses
    Industry

    • Bristol Myers Squibb- Executive Director Regional Clinical Operations Asia Pacific and EMEA, Global Development and Medical Affairs
    • AstraZeneca- Vice President Clinical Development MC
    • Pfizer, India- Head Specialist Medical Affairs & Research
    • Amgen, India- Clinical Operations Manager
    • Ranbaxy Laboratories, India- Director Medical Affairs and Clinical Research
    • LifeScan- Clinical Affairs Manager EMEA
    • Johnson & Johnson Medical, China- Director of Clinical Operations
    • Eli Lilly, Russia- Clinical Operations Manager
    • Lundbeck A/S- Regional Director Clinical Operations CEE
    • Novartis, Switzerland- Head of Emerging Regions – TBC

    Clinical Site

    • Nanjing University School of Medicine- Department of Neurology, Jinling Hospital
    • Christian Medical College, India- Asst Professor, Radiation Oncology Unit 1

    Regulator

    • Roszdravnadzor Russian Federation- Deputy Head of Department of Registration (drugs) TBC
    • Federal Ethic Committee of Russian Federation- Member
    • Good Clinical Practice Alliance – Europe- Executive Director
    • US Office for Human Research Protections, DHHS- Deputy Director

    Solution Provider

    • Astrom Research- CEO – TBC

    Together, they will deliver knowledge, expertise, insights, opinions, facts and data that can add strategic intelligence and real-value to your business.

    Agenda Request:
    To request the agenda, registration form and to learn more about this event, please follow the link:

    http://www.nextlevelpharma.com/events/request_agenda/25
    In case you have any problems with link, please contact me directly and I will send the agenda to you immediately.

      • PS:  Take advantage of EARLY BIRD DISCOUNT available until 28th March, 2009!!!!
      •  

    Contact:

    Erika Vavrovicova

    NextLevel Pharma

    ph: +421 2 3266 2621

    fax: +421 2 3266 0395

    erika@nextlevelpharma.com