Business of Biosimilars & Generic Drugs Session Spotlight: Outlook and Strategic Impact of U.S. Biosimilar Approval Pathway

After years of waiting, the FDA has finally released its draft guidelines for the development and approval of biosimilars. Now that the industry has a clear path forward, it is essential that you capitalize on the expert commentary of our speakers from Pfizer and Shire in order to best understand how to remain in compliance and reliably push your biosimilar candidates to the market.

Brian Harvey, Pfizer

This September at Business of Biosimilars and Generic Drugs, Brian Harvey, Vice President, U.S. Regulatory Strategy, Pfizer and Carrie Burke, Director of Government Affairs, Shire will be on hand to examine this topic in their presentation "Outlook and Strategic Impact of U.S. BiosimilarApproval Pathway" on Wednesday, September 12.  For more on this presentation and this year's event, download the brochure. If you'd  like to join us in Boston, register and mention code XP1786BLOG to save 25% off the standard rate.

Featured Session: Outlook and Strategic Impact of U.S. Biosimilar Approval Pathway
Featured Speakers: Brian Harvey, Vice President, U.S. Regulatory Strategy, Pfizer
Carrie Burke, Director of Government Affairs, Shire
About the Session: This timely session will focus on the latest updates on the
FDA’s user fee structures for biosimilars as well as their 2012 draft guidelines. The most signifi cant aspects of the biosimilar guidelines will be the allowability of foreign referent products, the assignment of unique non-proprietary names, and the extrapolation of multiple indications through shared MOA. The follow-on industry has its strong opinions on all three of these.

• • Grasp how the new legislation helps you overcome the barriers to market entry
• • Reassess your application and patent defense methods in light of the FDA’s “wall” around innovator data
• • Structure your analytical teams around the comparability methods that regulatory reviewers prefer
• • Frontload your capacity for factor certifi cation, PK studies, and other means to equate point of origin and/or functionality to regulators
• • Overcome additional roadblocks to biosimilar interchangeability at the state level
• • Strategize methods for turning unique name requirements into competitive advantage
• • Protect your budgets from any new studies that may be required if extrapolation of indications is not allowed

Share this article with your social network, just click below to share now!

Share |

Approval for biologics will not come easy with healthcare reform

With the new healthcare reform, there is an option for biosimilars to be approved for US use. However, due to the complexities of making the similar drug, the FDA will be more rigorous with their approval process, assuring that the generics and original drugs genetic structures are the same. Read the full article at Fierce Pharma here.

Share this article with your social network, just click below to share now!

Share |

2nd Annual Value Driven Pharma: New Dates & Venue Announced for 2010

2nd Annual Value-Driven Pharma Conference - SAVE THE DATE!
October 21-22, 2010 Princeton Doubletree • Princeton, NJ

2010 may prove to be the most important year in the history of the pharmaceutical business. With the passage of healthcare reform, the industry must act now to reengineer their market access strategy for future success and sustainable profits. Following the launch of the industry’s premier market access event Value-Driven Pharma in October last year, we are putting the finishing touches on the 2010 agenda.

Value-Driven Pharma 2010 will provide you with the tools to deliver data and information payers want. Explore risk-sharing contracts, the demand for more outcomes data from payers and the requirements around Comparative Effectiveness Research and pave the way for formulary placement from the earliest point possible in the development cycle.

To find out about what's new to this year's event and to sign up for future updates, visit our webpage here.

Share this article with your social network, just click below to share now!

Share |

DDP 2010 Panel: Assessing the Impact of Healthcare Reform on Payment, Reimbursement and Innovation

Moderator: Ian Morrison
Internationally known Futurist, Future of Healthcare and the Changing Business Environment and author, Health Care in the New Millennium: Vision, Values, and Leadership The Second Curve and Future Tense: The Business Realities of the Next Ten Years
Sally C. Pipes, President and Chief Executive Officer, Pacific Research Institute and Author, Miracle Cure: How to Solve America’s Health Care Crisis and Why Canada Isn’t the Answer and The Top Ten Myths of American Health Care: A Citizen’s Guide
Michael J. Ruggiero, Senior Director, Government Policy & External Affairs, Astellas Pharma US, Inc. Peter J. Pitts, President, Center for Medicines in the Public Interest and Advisor, Obama FDA Transition Team

Is health reform dead?
Understanding healthcare is like unraveling an onion, full of layers and tears. The President made a commitment to healthcare reform. He’s increasing the role fo government in the healthcare system, it currently owns 48%. It’s looking to increase it. It isn’t currently dead, according to the panelists, there are lots of things going on behind doors.

Our country’s leaderships doesn’t know if healthcare reform is dead or not. It’s a continuum rather than a series of options. They look to fix the Senate bill and pass it. A bill may be presented, just scaled back. Healthcare is a part of culture, intertwined with the fabric of society. Healthcare policy is not healthcare reform. Some of the biggest issues we have to tackle (infrastructure, value, etc.), have nothing do with actual reform. Innovation in how hospitals are paid, happens regardless no matter what happens to the current passage of the healthcare bill.

How do we achieve quality healthcare? 1) Patient centered solution 2) Increasing Role for government from 48% to nearly 100%. We would move more towards a Canadian healthcare system.

What about multiple tier systems for healthcare?
Canada isn’t the best compression for where the US should get its healthcare from. Holland, France and Germany tend to be the best compression for where US should go. There are rules for the insurance market. Should the US copy Holland? One panelist believes a lot of people look to organize the US healthcare system. As a policy person, it’s difficult to translate the rules. The other panelist believes that all of the systems are undergoing cost control issues. The French system has been facing cost increases, they’re looking at putting people into healthcare education systems. The HMO was making the decision, instead of the patient. However, they’re not making their decision. We need our own healthcare system that suits the needs of America, not the needs of another country. We are world renowned in world for healthcare treatments and devices, we can’t forget that when looking to reform healthcare.

The Drug Delivery industry can help this situation by making it easier to take their medication. That is what they can do to help healthcare reform.

Share this article with your social network, just click below to share now!

Share |

DDP 2010: Explore Insights and Perspectives on Healthcare Reform and its Impact on Innovation and Reimbursement in the Pharmaceutical Industry

Ian Morrison, Internationally known Futurist, Future of Healthcare and the Changing Business Environment and author, Health Care in the New Millennium: Vision, Values, and Leadership The Second Curve and Future Tense: The Business Realities of the Next Ten Years

Every health system in the world is a compromise. They all have flaws. The US has the worst, possibly because we spend twice as much on healthcare than any other nation. Why the difference? The fallacy of excellence – we have great hospitals and technology, but lack in other areas. Can we fix it? Culture is part of the problem. Policy management and the payment system are part of what the problem is in American system.

The average American family cannot afford the average cost of healthcare. The reform to change this is now in jeopardy due to the election of Sen. Brown in Massachusetts. If people are required to buy healthcare, they will be those who cheat the system. The problem with reform is with the stakeholders, most who are onboard with the compromise. Who does the public blame for the problems in the healthcare system? The answers are Pharma and Health insurance.

Extreme right and left feelings have killed reform. Total costs will rise at a slower rate because no coverage expansion subsidized by the government. Rates are going up, no matter what, by 8%. This is without healthcare reform. Could it switch either way? This will result in small businesses getting out priced, just like it has been over the past few decades. There’s no way to balance a budget with a country which has no taxes. The people with the best health plans in America are teachers and firefighters….and those at Goldman Sachs.

Where are we headed? If we stay where we are, generic substitution for drugs will increase. In the 25% of people who are taking injectibles, they don’t take the right amount of medicine due to the current cost. What does this mean for Pharma? Coverage, in Obama’s current plan, would be expanded to cover more drugs. Cost shifting will continue, and it will result in individuals using more generics.

Pharma will have to change the way it does business over the next few years. Value will also have to be demonstrated to the customer at the end.

Share this article with your social network, just click below to share now!

Share |

Do you have a 2010 action plan for your PAP program?

As the nation’s policymakers debate healthcare reform amid rising unemployment rates, more Americans are losing their healthcare insurance and access to essential medications. Now more than ever before, there is a tremendous opportunity for pharmaceutical patient assistance program administrators to leverage, improve, and optimize these programs by increasing access and enrollment.

IIR’s Patient Assistance Programs event is back this October, and the 2009 agenda provides the essential content to guide you through the continued economic and political restructuring. Join us this year as leading industry experts offer fresh insights and approaches for your PAP:
• Receive updates and direction on future industry guidelines and regulations
• Dive into current trends and the shifting landscape
• Implement new technologies and procedures to be more time and cost efficient in this economy
• Gain practical solutions to increase program awareness and infuse new energy into your PAP
• Discover how to build effective partnerships with government and patient groups
• Establish a 2010 action plan for your PAP program

Click here to view the finalized agenda!

Join the Conversation Now:

Join the LinkedIn Group!

Follow us on Twitter!

Share this article with your social network, just click below to share now!

Share |

The effect of healthcare reform on innovation

At Investors.com, Sally Pipes recently voiced her opinion on how health care reform could damage successful innovation in the biotech industry for years to come. Health care reform is important but will have to rely on a variety of places to be successful: hospitals, doctors, insurers and drug companies.

The current favorite place that law markers are looking to reduce costs is the drug makers. While they are the ones with cash, one must remember it takes years and over $1.3 million to make a new medicine. Taking money from the drug makers could have long term effects such as finding cures in the future and experiencing long-term health problems. There are also millions employed in the industry. The number of researchers would have to dwindle, putting stress on already stressed conditions with too few researchers.

What do you think? What are going to be other affects on the biotech industry from healthcare reform?

Share this article with your social network, just click below to share now!

Share |