PMDD Session Spotlight: Virtual and Global Team Management to Overcome the Distance Hurdle

The 8th Annual Project and Portfolio Management for the Drug and Device Industry, September 20-21st in Boston, Massachusetts, is the only event designed by manufacturers for manufacturers to deliver advanced time saving and silo busting strategies proven to bring drugs and devices to market on time and on budget. Leading up to the event, the Future of Biopharma blog will be spotlighting some of the sessions you can look forward to at the the event.  For more information on the event, download the brochure here.

Featured Session:  Virtual and Global Team Management to Overcome the Distance Hurdle
Featured Speakers:  Debbie Merrill, Senior Project Leader, Project Leadership and Management, MERCK RESEARCH LABS
Michael Stankiewicz, Project Management Director, BAUSCH + LOMB
About the session: Drug development is a global business and clinical trials are being held all over the world. The challenge of managing global clinical trials is exacerbated by time differences, cultural barriers, staffing challenges and regulatory considerations. In this session, attendees receive:
     • Proven tactics to better manage global teams
     • Strategies to overcome challenges with regional companies

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A Special Message from the Cell Based Assays & Bioanalytical Method Development Chairperson

A message from Shan Chung, PhD; Scientist, Bioanalytical Sciences, Genentech; Co-Chair, Cell Based Assays and BioAnalytical Method Development 2011:

Dear Colleague,

We all face similar challenges in designing and validating assays and bioprocesses. Whether trying to secure cell sources that reliably present conditions of interest, determining criteria to identify and eliminate outlier results, or designing assays sensitive enough to track ultra low-abundance proteins, each step involves performance trade-offs that must be carefully considered and accounted for. And ultimately we all seek to design methods with proven transferability and clinical utility.

That is why I would like to invite you to attend IIR’s 7th Annual Cell Based Assays and BioAnalytical Method Development conference, to be held October 3-5, 2011 at the Claremont Hotel Club & Spa in Berkeley, CA. This year’s event will feature nearly 40 speakers, and will continue to offer the small-format discussions and troubleshooting sessions you have come to expect. To learn more, download the latest conference brochure.

Some of the topics we will cover include:
• Strategies for control and assessment of Fc effector functions of therapeutic antibodies
• A rapid approach to developing reporter cell lines for bioassays
• Bioanalytical test elements that facilitate comparability studies for the development of biosimilars
• Virus neutralization assays using multiple image-based technology platforms

For more information, download the event brochure.

Thank you very much, and I look forward to welcoming you to this event in October.

Sincerely,
Shan Chung, PhD
Scientist, Bioanalytical Sciences, Genentech
Co-Chair, Cell Based Assays and BioAnalytical Method Development 2011

As a reader of the Future of Biopharma Blog, register for this event with the special Priority Code XP1668Blog, to receive 25% off the standard rate! If you have any questions about the event, please feel free to contact Jennifer Pereira at jpereira@iirusa.com. Register by emailing register@iirusa.com.

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Patient safety in pathway to biosimilars

In a recent article at the Statesman Journal, John Horton, President of LegitScript in Portland, is the former Associate Deputy Director at the US Office of National Drug Control Policy, shares his opinions on the state of biosimilars and what should come first in the minds of the FDA who is approving these drugs for use.

Some of the things to take into consideration about the safety and cost savings of the drug according to Horton are:

• - This form of drug is just 20-25% cheaper due to the manufacturing process
• - Names of the biologic and biosimilar should be very different in order to differentiate between the two drugs for the consumers
• -Patient safety should be number one - just because the form of the medicine is cheaper, it doesn't mean that it's still cheaper if it doesn't have the same result in terms of treatment

This fall at the Business of Biosimilars and Biobetters, experts will gather for the Compliant Market to Consumer Acceptance which will look at the best practices for naming and labeling biosimilars. For more information, download the brochure here.

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PMDD Session Spotlight: Accelerate Proof Of Concept – Making the transition from project management to portfolio management

The 8th Annual Project and Portfolio Management for the Drug and Device Industry, September 20-21st in Boston, Massachusetts, is the only event designed by manufacturers for manufacturers to deliver advanced time saving and silo busting strategies proven to bring drugs and devices to market on time and on budget. Leading up to the event, the Future of Biopharma blog will be spotlighting some of the sessions you can look forward to at the the event.  For more information on the event, download the brochure here.

Session: Accelerate Proof Of Concept – Making the transition from project management to portfolio management

Featured Speaker: Dee Suberla, Sr. Consultant, Action for Results

About the session: Innovation to accelerate the drug development process is a hot topic in the life science industry.  Speeding up the seemingly standard development plan would mean hundreds of millions in cost savings. While there are ways to get a drug registered in the US and ex-US that don’t require that length of time, PMs aren’t currently taking advantage creative ways to accelerate programs.

In this session you will learn to:
• Design and implement an accelerated drug development strategy
• Conduct portfolio prioritization to enable early decision making
• Implement effective development and scenario planning
• Strategize for early decision making in pharma projects
• Establish interim assessment points and futility assessment points

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How should your biorepository function to enable better drug development?

The design of your sample acquisition and research protocols, and their approval by the IRBs overseeing your access to patients and specimens, must be a focal point of your attention if your biorepository is to function smoothly and enable new drug development.

Ideally your protocols would give you the greatest possible latitude in sample storage and research methods, but in practice some IRB stipulations may get in the way of your normal operational procedures: they may insist that, upon a patient withdrawing their informed consent, you locate and destroy all samples from that patient within 7 days, which could prove to be operationally impossible without extensive and costly outsourcing. Sometimes IRBs may even overrule the wishes of the patients themselves, by placing firm boundaries on the research applications allowed on specimen types. Further complicating the issue is that no two IRBs have exactly the same criteria—and these differences grow even more pronounced when you are attempting to acquire and work on samples from international sources.

If, despite your best efforts at setting up protocols that are as research-friendly as possible, your IRB still insists on a more strict interpretation, you may have to resort to calling in outside experts to appear before the IRB or write letters to it on your behalf in order to explain the validity and urgency of your work.

At Biorepositories 2011, you can learn the best methods for managing and tracking the informed consent status of your samples. There will also be an opportunity learn to plan for the strategic use of outside experts to argue on behalf of your research protocols before the IRB. For more information on the event, which will be taking place as a part of the Clinical Business Expo, download the brochure here.

Exclusive Savings! Our Future BioPharma readers can receive an additional 10% off the current early bird pricing expiring tomorrow, July 8. That’s a savings of up to $600 off the standard registration rate. To redeem, register here. Be sure to include Priority Code XP1698BLDI to receive the discount. This offer expires tomorrow so register early. If you have any questions about the agenda or event, please contact Jennifer Pereira at jpereira@iirusa.com.

Are you writing your research protocols and interacting with your Institutional Review Boards correctly in order to secure the greatest possible amount of exploratory freedom in your research?

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Should biosimilars be required to go through clinical trials?

Biosimilars, while created to lower the cost of biologics, are not exact replicas of their original drugs they were created after. Due to their biological composition, side affects and treatments could be different, unlike the generics created for chemical drugs. This is exactly why the National Hemophilia Foundation is asking that clinical trials be a part of the approval process when clotting factors are involved.  Concerns from this community include the possibility of an infectious pathogen contaminating the cells or culture medium the biosimilars are produced in and potential immunogenicity, the ability to trigger an immune response. For those who have bleeding disorders, it is a great concern to change their medication, because the outcome is not known, and changing inhibitors and possible neutralization that could occur.  Hemaware reports that the patient population is clearly skeptical of potential biosimilars that will come out to treat their conditions.

At the Business of Biosimilars and Biobetters Conference during the full day symposium, there will be a discussion about the need of clinical trials between experts in the field.  To find out more about this session and the full program, download the brochure.  Business of Biosimilars and Biobetters will be taking place September 19-21, 2011, in Boston, MA; as a part of the Clinical Business Expo.

What do you think?  Should biosimilars be required to go through clinical trials before they are brought to market?  Or is there a need to have priorities on which biosimilars should go through clinical trials?

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