Learn Silo-Busting Strategies Proven to Bring Drugs and Devices to Market on Time and on Budget

Are you looking for proven strategies to deliver advanced time saving and silo busting strategies to bring drugs and devices to market on time and on budget?

Then the Project and Portfolio Management for the Drug and Device industry event is a can’t miss for you and your company.

In two days you will hear from industry leaders who will share tried and true methods for managing their projects and portfolios. These leaders include:

• • Anthony Cangialosi , Johnson and Johnson
• • Randy Krauss, Genzyme Corporation
• • Kathy Crankshaw, Alexza Pharmaceuticals
• • Dr. Miriam Halperin Wernli, Actelion Pharmaceuticals

To find out more about their presentations and the full program, download the brochure.

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South Korea could be the first country to approve stem cell therapy

The Korea Food and Drug Administration (KFDA) could be the first in the world to approve stem cell therapy as a medicine in the world.  According to the Yonhap News Agency, the therapy would treat acute myocardial infarction.  The stem cells are harvested from the person's body then treated and injected back into the heart. It has passed the safety and validity tests needed for approval.

This September, The Cell Therapy Commercialization Summit will be join by AON Insurance, Argenta Advisors and others to identify how companies can ensure reimbursement for cell therapy treatments long before they are approved by the US FDA. For more about the Cell Therapy Commercialization Summit, download the brochure.

What could approval of a stem cell therapy in South Korea mean for other pending approvals across the world?

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Is Enoxaparin a biosimilar?

Nearly a year ago, the FDA approved their first biosimilar, Enoxaparin.  However, since the approval there are still questions as to whether or not this biosimilar is actually a biosimilar.  The Generic and Biosimilars Initiative  points out that that it is not a therapeutic protien, Lovenox was not approved as a biologic, and the BCPI Act was not in place when the approval process was initiated.  If the FDA would release guidelines as to what they view as actual biosimilars and what comprised of them, this would not be a debate.

Join the debate at the Business of Biosimilars & Biobetters event as Bruce Leicher (Momenta Pharmaceuticals), Brian Harvey (Sanofi-Aventis) and Steven Goldberg (Express Scripts) discuss the usefulness of the Abbreviated Pathway on September 20 at 2:30.

What would the FDA need to offer to make the pathway worthwhile?

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Download the 2011 Project and Portfolio Management for the Drug and Device Industry Agenda

The Project and Portfolio Management for the Drug and Device Industry conference is where project leads go to achieve more with less in a global marketplace. It is taking place September 19-21, 2011 in Boston, MA as a part of the Clinical Business Expo.

You will have the opportunity to learn to build strategies to communicate with and manage global or virtual teams, learn to effectively transition from PM to portfolio manager, influence and obtain buy-in from senior management and more.

Download the agenda today and see why is the can’t-miss event of the year.

What can you do after you join us this year?

1. 1. Build Strategies to Communicate with and Manage Global or Virtual Teams
2. 2. Learn to Effectively Transition from PM to Portfolio Manager
3. 3. Influence and Obtain Buy-In from Senior Management
4. 4. Learn Design and Implementation of Accelerated Drug Development Strategies
5. 5. Streamline the PM Process, Leveraging Efficiencies for Faster Communication and Time Saving Template Standardization
6. 6. Increase the Flexibility of Your Budgets, Timelines and Resources to Attract and Retain Qualified Managers and Team Members
7. 7. Create an Implementable Project Plan for Preparation and Distribution of Your Clinical Supplies

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Stem cells have potential for Type I Diabetes

ViaCyte has released news indicating that preliminary studies have shown that mice with Type I Diabetes have been cured when islet cells were injected into the mices' skin to function as pancreatic cells. According to the LA Times, Type I Diabetes is ideal for this type of treatment because it only needs to have one type of cell replaced. By inserting the pancreatic cells into the skin, the cells function as a new pancreas, thereby potentially curing the disease. Funding from the California Institute of Regenerative Medicine made this study possible.

At the Cell Therapy Commercialization Summit, Chad Green, Associate Director for Device Engineering & Manufacturing will be presenting the session, “Identify and Establish Optimal Delivery Systems for Your Cell Therapy Product.” In this session, hear about how Viacyte is pioneering delivery systems for cell therapies such as their Type 1 Diabetes study that has the potential to revolutionize the treatment of diabetes.  Download the brochure to find out more about this session and this year's agenda.

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Cell Therapy Commercialization Summit Brochure available for download

The Cell Therapy Commercialization Summit is the only multi-stakeholder event that delivers a comprehensive tool kit for taking your cell therapy product from preclinical all the way to commercialization – in only three days.

At the Summit, join over 15 sessions are devoted to the complete clinical development life-cycle, including:

• → Testing: Use Stem Cell Derived Models for Development Toxicity to Ensure Product Progress
• → Partnering: Manage Big Pharma Alliances to Ensure Effective Cell Therapy Partnerships
• → Financing: Manage Costs to Control the Spending Burn and Remain Self-Sustaining
• → Designing: Choose the Right Design Parameters for Trial Efficiency and Sustainability
• → Ensuring Quality: Incorporating the Concepts of Pharmaceutical Quality Systems into Cell Therapy Product Development
• → Manufacturing: Run a Bioprocessing Mechanism that Will Give you a Viable Cost to Goods Model
• → Storing: Maintain Quality and Maximize Efficiencies in Post-Production Logistics
• → Delivering: Overcome Cold Chain Inefficiencies to Deliver a Fully Potent, Commercially Viable Product

Download the brochure today.

The Cell Therapy Commercialization Summit is a part of the Clinical Business Expo, the host location and home to 6 exclusive and successful conferences all related to clinical business to deliver the latest technical, operational and scientific approaches for clinical development continuum.  Find out more about CBE, taking place September 19-21, 2011 in Boston, MA here.

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