Thursday, February 25, 2010

Would you like to guest blog from Partnerships in Clinical Trials 2010?

That’s right, we’re offering a few exclusive all-access complimentary passes to 19th Annual Partnerships in Clinical Trials– April 12-14, 2010 in Orlando, and you could attend the conference – on us ($3,000+ value). We’re looking for experienced bloggers who are well-versed in clinical outsourcing and development to begin blogging now and also at this year’s event. In return for your posts, you’ll be able to attend educational sessions and training seminars delivered by industry thought-leaders and Pharma professionals through in-depth case studies featuring the industry experts from leading pharmaceutical companies Shire, Millennium: The Takeda Oncology Company, Pfizer, Endo Pharmaceuticals, Eli Lilly and more.

To apply to be a guest blogger, simply send your name, title, company and a few writing samples (a link to your blog is recommended) to Jennifer Pereira at jpereira@iirusa.com no later than Wednesday, March 24, 2010. We will review the submissions and contact all winners directly with more details. This opportunity doesn’t come often and we encourage you to apply and join us in April in Orlando.

For more information about the event, please follow the links below:

For more on the Partnerships in Clinical Trials event, visit the website:
http://bit.ly/9BJFgd

Download the 19th Annual Partnerships in Clinical Trials Brochure:
http://bit.ly/aeoVVD





Wednesday, February 24, 2010

Who can you meet at the 19th Annual Partnerships in Clinical Trials?

Partnerships in Clinical Trials is the must attend clinical operations and outsourcing and event of the year! The ‘Who’s Who’ in clinical development, operations, and outsourcing, the program delivers the highest-quality content not seen at any other event, alongside unparalleled networking opportunities. Each year nearly 2000 of the world’s most strategic clinical trials executives attend to meet with their outsourcing partners from leading CROs to maximize the return on investment for every clinical research dollar spent.

Industry Participants Already Registered to join us in Orlando April 12-14, 2010 include representatives from :

* Abbott Laboratories * Abbott Vascular * Abraxis Biosciences * Acceleron Pharmaceuticals Inc * Allergan Inc * Amgen Inc * Array BioPharma Inc * Astellas Pharma Global Development * AstraZeneca Pharmaceuticals * Baxter Healthcare Corporation * Bayer Healthcare Pharmaceuticals * Biogen Idec * Biotest AG * Boehringer Ingelheim Pharmaceuticals Inc * Bristol * Myers Squibb Company * Calistoga Pharmaceuticals Inc * Celgene Corporation * Celtic Therapeutics * Cephalon Inc * Cerexa Inc * Cubist Pharmaceuticals Inc * Daiichi Sankyo Pharma * Dainippon Sumitomo Pharma America Inc * Eisai Inc * Elan Pharmaceuticals * Eli Lilly & Company * Endo Pharmaceuticals Inc * Facet Biotech Inc * FibroGen Inc * Forest Laboratories * Genentech Inc * Genzyme Corporation * Gilead Sciences * GlaxoSmithKline * Hoffman La Roche Inc * Incyte * MedImmune Inc * Metabolex Inc * Midas Pharmaceuticals Inc * Millennium Pharmaceuticals * Novartis Pharma AG * Novartis Pharmaceuticals * OSI Pharmaceuticals Inc * Otsuka America Pharmaceuticals Inc * Pfizer * Pharmasset * Purdue Pharma LP * Regeneron Pharmaceuticals Inc * Rigel Inc * Roche * Sanofi Pasteur * Sanofi-Aventis * Satori Pharmaceuticals Inc * Schering Plough * Sepracor Inc * Shire Human Genetic Therapies * Solvay Pharmaceuticals * SuperGen * Tactical Therapeutics Inc * Takeda Pharmaceuticals * Trialytics Inc * UCB Inc * VDDI Pharmaceuticals * Viventia Biotechnologies Inc * Watson Pharmaceuticals * Xanodyne *






Friday, February 19, 2010

Web Seminar: Realizing Multidimensional Performance Metrics for Improved Clinical Trial Management

Next Tuesday, February 23, 2010 2:00 PM - 3:00 PM EST

Sign up here.

Performance metrics need to be reviewed with respect to the end goals of the study they are being measured on. They should be looked at in context with those goals and with an understanding of their effect on other aspects of the study. Status reports should accurately report the Key Performance Metrics and provide insight into their implications if they remain unchanged. This would allow for strategy to be focused on what needs to be done to enhance performance. Status reports with metrics can be a vehicle to consistent communication between upper and lower level management.

What you will learn:
• How to use metrics to enable discussions with upper management
• How to focus results / goals
• Using metrics to guide strategy
• Understand that metrics should not be viewed in a silo

Presented by:
John C. Burnett, PMP
Founder / CEO
JaPa Associates, Inc.

John is a seasoned Clinical Research Professional with nearly 15 years experience working in Clinical Trials, including 8 years in senior level management roles. John has worked for major pharma and biotech companies such as Vivus, Pfizer, Amgen, Scios under Sr. CRA, Clinical Project Manager and Clinical Trial Manager positions.

Sign up for this complimentary web seminar here:
http://bit.ly/7BFIvH




Thursday, February 18, 2010

A Look Back at Partnerships with CROs 2009: Challenges and Opportunities in Biomedical R&D

Over the next few months leading up to 19th Annual Partnerships in Clinical Trials in Orlando, Florida, we will be looking back at some of the presentations from the 2009 event. Today, we have the Keynote Presentation from Dr. Peter Corr, General Partner at Celtic Therapeutics entitled "Challenges and Opportunities in Biomedical R&D". This presentation was featured last year in our live coverage. You can find the write up here.

You can download the PowerPoint PDF here:
http://bit.ly/aFGRtJ

The 19th Annual Partnerships in Clinical Trials features numerous presentations and panels focused on similar high-level concepts including:
*Value Creation Through Strategic Sourcing and New Business Models
*Small is Beautiful: The Virtues (and Vices) of the Virtual Model
*Achieving and Maintaining an Ideal Partnership in Drug Development Outsourcing
*Sourcing to Low Cost Regions: Panacea or Piece of the Puzzle?

To find out more about these sessions and others at the 19th Annual Partnerships in Clinical Trials event taking place this April 12th – 14th in Orlando, Florida, download the brochure here.


To find out what presentations and topics will be at this year's Partnerships in Clinical Trials, visit the webpage here.




Friday, February 5, 2010

Central Labs West: Featured Annual Report: Navigating the Stormy Seas of Pharmaceutical Innovation – Tufts CSdd’s Annual Report on Drug Development

Kenneth I. Kaitin, PhD,
Director and Professor of Medicine, Tufts Center for the Study of Drug Development,
TUFTS UNIVERSITY

Kenneth has been with the Central Labs West conference for six years bringing information collected over the past year and to take a look at the direction the pharmaceutical industry will go through in the current year.

1. Current Environment
Patents are expiring – In the next 4 years the top ten products will total a loss of about 110 billion dollars in market share. Companies are looking to mergers and acquisitions as a way to rethink their model of innovation to avoid patent cliffs.

Marketplace is highly competitive

Market exclusivity periods have dropped – In the 1970’s it was about 10 years and this number has been declining. Time from 1st to 2nd follow ons has also declined steadily from the 1960’s where it was 16 years.

Public support has declined

****Total US healthcare expenditures is only about 10% - converted into 228 billion dollars and their spending growth is 4.9%.

Regulatory regime has changed - FDA has a very busy schedule and no longer has the time to go out there and evaluate the pharmaceutical industry

New drug approvals are not keeping pace with r&d spending. Investors don’t care that about your profits today, they care about your profits tomorrow and they are not confident that those profits will be there.

2. Up to date metrics
  • Consistent declines of approval phases and clinical times are starting to go up again.
  • Biopharmaceutical development times are increasing- avg times to bring these drugs to market is 8 years
  • Why are there diff. among therapeutic classes? Longevity of treatment and how easily they are to measure.
  • Overall clinical approval success rates for NCEs (New Chemical Entities) has dropped to 16%
  • Capitalized cost per approved biotech product is similar to that of pharma
  • Drivers of rising r&d costs – clinical trial size, late stage attrition, pat rec and ret, high cost of disc tech, market oriented studies, reg demands, etc.
  • Business as usual is not sufficient anymore
  • A merging of operational and strategic performance objectives

3. The evolving landscape for innovation – Growth rates in Asia and Latin America make these emerging markets new areas for companies to look to, to save money. The sponsor/cro relationship structures are also changes. The old model was to work with a provider that has transactional services where the new model is to partner with multiple FSPs and Alliances with definite advantages strategically for both parties. Demand for clinical

New R&D Strategies – new integration of operation and strategic industry

  • R&D reorganization – more focused units, diversified functions and targeted medicines
  • Partnerships – Academic institutions, PPPs and Patient Groups; large pharma/small pharma, pharma/pharma and others. Sharing activities and resources to get the best outcome
  • Innovation Networks – FIPNets
Time cost and risk to bring new product to market continue to represent formidable challenges for drug developers – companies need to embrace change and the reorganization of partnerships will be the future of innovation.

Bottom line “Talk about change is no longer sufficient….embrace change and really look at different partnerships as the new outlook for innovation.”




Central Labs West: Rules for Becoming & Remaining a Scientist

Dr. James Watson, Co-Discoverer, DNA Double Helix

The most exciting keynote of the event was Dr. James Watson. The audience watched in awe as this important figure, read about in science books across the world, took the podium. After a standing ovation from the crowd Dr. Watson reflected back on his life and the contributing factors that led him to become an important part of history. He says he wasn’t a genius, which I find hard to believe, but he shared some tips on how he succeeded including:

Preparing to be a Scientist
1. College is for learning how to think
2. Knowing “why” (an idea) is more important than learning “what” (a fact)
3. Think like your teachers
4. Pursue courses where you get top grades
5. Seek out bright as opposed to popular friends
6. Have teachers who like you intellectually
7. Narrow down your intellectual (career) objectives while still in college

He ended his session on a high note with the statement “You can’t guarantee success but you can certainly guarantee failure.”




Central Labs West: Welcome and Opening Remarks

Craig H. Lipset, Director, Molecular Medicine and Member, eHealth Center, PFIZER

Craig welcomes us to the 8th Annual Central Labs West event conference. After 7 years with the event, the Central Labs team has revamped the agenda to include clever formats, and hands on interactive sessions for a re-energized two days. The meeting is at an exciting crossroads – there are new technologies to help bring new medicines to patients and although we’ve come so far, we still have a long way to go.




Wednesday, February 3, 2010

What's New at Partnerships in Clinical Trials 2010?

19th Annual Partnerships in Clinical Trials is taking place this April!

With new attendees come new ideas, solutions and partnering opportunities. Don’t miss out on your chance to make new strategic partnerships for 2010 with over 70% of registered attendees NEW this year.
Over 50 New Sessions and 8 Customized Tracks

*Strategic Sourcing and Financial Outlook
*Spotlight on Strategic Partnerships
*Process Efficiencies, Cost Containment and Quality
*Early Clinical Development
*Investigator Site and Patient Connections
*Alliance Management and Co-Development Deals
*Regulatory and Drug Safety
*Mastering Cost and Contract Management

View Agenda at a Glance here.
Meet Your 2010 Speaking Faculty here.
Visit the Webpage here.


We know that the approval process for attending events has become a challenge so we’ve put together an Easy to Print Agenda, List of past BioPharma Companies in attendance, an Approval Letter template, and 30 Reasons to Attend!






Tuesday, February 2, 2010

DNA Sequencing in Drug Discovery: Market outlook for applications, tools and services, and 40 company profiles

What are the major technologies and services that have emerged in different areas such as microarray, PCR, re-sequencing, high throughput sequencing?

DNA Sequencing in Drug Discovery report answers this question.

This report covers regional markets, products and services while evaluating them over the next five years, and profiles almost 40 companies involved in the DNA sequencing market.

The advent of DNA sequencing technology has had a vast impact on the field of drug development. It has played a key role in the success of the Human Genome Project which has made it an essential tool for genetic analysis. Advanced technological developments in microarrays, bioinformatics and similar tools have increased the scope of applications and services.
The report analyzes the market data (revenues) of DNA sequencing tools and services in North America, Europe, Asia and rest of the world that includes Middle East, Africa, Russia, Latin America and Australia. It covers microarray, DNA sequencing kits, chromatography, mass spectrometry, DNA amplification and many others within the tools market along with their sub segments. The services market includes high throughput sequencing, shot gun sequencing, re-sequencing, sample process and primer walking, single pass analysis and bacterial identification. Find out more information about this report here!