Biorepositories Podcast: Lisa Miranda, Biobusiness Consulting

Download the pre-event Podcast from biobanking expert Lisa Miranda, President of Biobusiness Consulting, who will be speaking at the 4th Annual Biorepositories event. She will be speaking on at Biorepositories 2011 participating in both: “Manage Your Biorepository to Guarantee Full Life-Cycle Specimen Quality - Learn how to do more with less!” and “Integrating Technology Transfer Offices for Strategic Breakthroughs in IP and Data Management”.

Download her podcast here.

In addition to Lisa Miranda, our speaking faculty includes industry thought leaders from Merck, Pfizer, Genentech, Biogen Idec, Infinity, Astrazeneca, Roche, Dow Agrosciences, Centocor, Boston University, Rutgers University, and Harvard Partners Healthcare, plus a not-to-be-missed regulatory keynote from Dr. Helen Moore of NIH’s Office of Biorepositories and Biospecimen Research. To learn more, download the conference brochure.

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Exclusive Biorepositories Video from Genentech

As a valued reader of the Future of Biopharma blog, we would like to offer you a free sneak preview of the learning opportunities available at the upcoming Biorepositories Event with an exclusive video from Genentech’s Jamieson Sheffield, Head of the SSF Sample Repository.

In this installment of our Biorepositories Video Series, Jamieson shares his insights into biobanking and the value of centralized sample collection, transport, and protection.

For your first chance to download the video before everyone else, please visit the website.

The Fourth Annual Biorepositories Event will be taking place this September 19-21, 2011, in Boston, MA with the Clinical Business Expo.  For more information on the speakers and sessions at this year's event, 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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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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Save the Date for the 4th Annual Biorepositories Event!

Save the date for the 4th Annual Biorepositories conference, taking place September 19-21 in Boston at the Sheraton Hotel and World Trade Center. Learn advanced strategies to take your biorepository from operational to profitable.

You will gain crucial insights into how to:

• -Guarantee full life-cycle specimen quality control
• -Uncover the balance between on-site and outsourced operations ideal for your business model
• -Master state-of-the-art techniques in specimen storage, management, and transportation
• -Implement surefire added value strategies for your collection
• -Maximize biospecimen renewability and stability
• -Develop and comprehensively track the most useful informed consent
• -Harmonize biospecimen research techniques with input from the physician and patient communities to improve treatment outcomes
• -Target opportunities and avoid obstacles in domestic and international partnerships and expansions

Find out more about the 2011 Biorepositories Event.

Are you interested in speaking? We currently have a limited number of speaking spots available. To learn more, please contact Matthew Greenbaum at MGreenbaum@iirusa.com.

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Save the Date for the 2011 Cell Therapy Commercialization Summit!

The Cell Therapy Commercialization Summit is the only event where business executives, along with clinical operations stakeholders, learn cutting-edge strategies towards production and commercialization of viable therapeutic products, enabling you to turn scientific business challenges into money-making solutions.

Highlights of the Summit include:
Operational Strategies
• Identify Therapeutic Opportunities to Develop the Most Robust Pipelines.
• Manage Big Pharma Alliances To Ensure Effective Partnering of Cell Therapy Platforms
• Implement Your Partnership to Meet Pipeline Development Goals
• Determine What Pipelines Will Attract Investors in an Unstable Economy
• Ensure your Investments Have Enforceable Intellectual Property
• Outsourcing Your Clinical Trials to Minimize Cost and Streamline the Clinical Process
• Maintaining Quality & Maximizing Efficiencies in Post-Production Logistics
• Sail Through the Murky Waters of Reimbursement For Cell Therapies

Business Strategies
• Choose the Right Design Parameters for Trial Efficiency and Sustainability
• Minimize Waste, Maximize Efficiencies, and Speed Up Timelines During the Clinical Trial Transition
• Maintain the Quality of Cell Therapy Products and Ancillary Materials
• Overcome Cold Chain Inefficiencies to Deliver a Fully Potent, Commercially Viable Cell Therapy Product
• Identify and Establish Optimal Delivery Systems for Your Cell Therapy Product
• Running a Bioprocessing Mechanism that Will Give You a Viable Cost to Goods Model

Visit the Cell Therapy Commercialization Summit webpage.

Collocated alongside 5 industry events at the Clinical Business Expo, it is the one cell therapy conference where you will meet 200+ experts, 600+ attendees, 50+ exhibitors and have 10+ hours of incomparable networking time with invested peers in all areas of clinical development. Find out more about the Clinical Business Expo.

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