Cyber Monday starts early! See details on how you can save on all IIR and IBC Events!

 

To get a head start on the holiday season, as a member of our online community, we’re giving you an extended chance to take advantage of our Cyber Monday sale. Register for the following event and receive 30% off the standard rates. Mention code CYBER2014 when registering for the following:

IBC’s Vaccine Development & Production Summit
December 8-9, 2014 in Boston, MA
Disease and Pandemic Vaccine Research, Discovery and Innovation
More about the event:
Register here.

IBC’s Antibody Engineering & Therapeutics 
December 7-11, 2014 in Huntington Beach, CA
The #1 Forum for Academia and industry to Connect for Scientific Exchange and Networking in Antibody Engineering & Therapeutics, lmmunobiology and Next-Generation Binders
More about the event.
Register here.

IBC’s Commercialization of Cell, Gene & Immunotherapies
December 11-12, 2014 in San Diego, CA
Accelerating the Translation of Commercially Viable Cell, Gene and Immunotherapies Through bioprocess Tools and Technologies
More about the event:
Register here:

IIR’s FDA/CMS Summit for Biopharma Executives
December 11-12, 2014 in Washington, D.C.
Hear about the commercial outlook for biopharma under the new health care exchanges.
More about the event.
Register here.

 IIR’s 19th Annual Drug Delivery Partnerships 
January 29-30, 2015 in Boca Raton, FL.
Accelerating the path to market by leveraging new partnerships, breakthrough innovation and unique business models. Visit the website for full details.
More about the event.
Register here.

IIR’s 12th Annual Medicare Congress
February 3-5, 2015 in New Orleans, LA
Survive the toughest rate environment to date with lessons from top-notch healthcare executives
Visit the website for full details.
Register here.

ePharma **
February 24-26, 2015 in New York, NY
Charge up your marketing campaign with ROI-infused initiatives and embody the newest technologies that bleed success
More about the event.
Register here.

IBC’s Genome Editing Applications
March 18-19, 2015 in Boston, MA
Don't miss out on the only event in the industry focusing on applications of genome editing technologies in research, drug discovery and therapeutic development.
More about the event.
Register here.

IBC’s Biopharmaceutical Development & Production Week (BDP)
IBC’s Single-Use Applications for Biopharmaceutical Manufacturing
IBC’s Flexible Facilities Conference
March 30 – April 1 in Huntington Beach, CA
Create Unique End-to-End Bioprocessing Solutions that Guarantee Reproducible Results and Commercial Manufacturing Success
More about the event.
Register here.

IIR’s 24th Annual Partnerships in Clinical Trials
April 22-24, 2015 in Boston, MA visit the website for full details.
Accelerate speed to market by leveraging new partners, new technologies, and new business models at the must-attend clinical event of the year
More about the event.
Register here.


TIDES
May 3-6, 2015 in San Diego, CA visit the website for full details.
The #1 Industry Forum for CMC, Clinical and Discovery Professionals to Accelerate Oligonucleotide and Peptide Product Development
More about the event.
Register here.

Have any questions? Email Jennifer Pereira.

*This promotion is only valid Wednesday, November 26th 2014 through Monday, December 1st  2014. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IIR approval.
**Cyber Weekend offer only applicable to registrants not utilizing the Buy One Get One offer. Only pharma/biotech/med device companies are eligible for The Buy One Get Offer

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Creating A New FDA/Capitol Hill Legend

Via RPM Report, an FDA/CMS Summit for Biopharma Executives event supporter. The RPM Report provides actionable insight on regulation, policy, FDA and CMS to apply directly to your decision-making.

When FDA managers reflect on their experiences on Capitol Hill, the stories often involve unfair, inflammatory or downright abusive sessions. But Center for Drug Evaluation & Research Director Janet Woodcock has built a different legend this year during the 21st Century Cures initiative of the House Energy & Commerce Committee.

CDER Director, Janet Woodcock has pulled off a Capitol Hill miracle during the 21st Century Cures review of the issues affecting drug and medical device development and commercialization, being the regulator embraced by both sides of the aisle.

From start to finish, Woodcock has basked in praise from Republicans and Democrats. But those notes of praise rose to a crescendo during the final, pre-election session hosted by the E&C/Health Subcommittee on Friday, Sept. 19. During a hearing focused on antibiotic development incentives, Woodcock engaged in a cordial farewell dialogue with the soon-to-retire Rep. Waxman (one of Democrats who traditionally has not been among her supporters), diplomatically handled more calls for FDA-based incentives for the development of antimicrobials and other drugs, and then received congratulations from Rep. John Shimkus (R-Ill.) who applauded Woodcock for staying to listen to the second panel of the hearing.

Incentives Entail Congressional Art, Not Opinions of FDA Scientist/Doctor

Based on her performances, Woodcock has earned the ability to defer opinions on flashpoint issues without looking like she was dodging the issue.

On the topic of incentives for drug developers based on FDA or by conferring exclusivity to a target category or to another drug chosen by the sponsor, Woodcock was able to avoid staking out a stance one way or the other, and instead referred to the criticisms of incentives raised by Waxman and noted that striking that type of balance falls in the realm of Congress and politics and to a physician and scientist.

She had few failures over the five-month period and none that seem to do damage to the agency’s improving reception on Capitol Hill.

Woodcock has so far been unable to see her idea of pushing improvement in drug quality and manufacturing as a jobs issue and a way to stimulate the US economy. That’s a big issue to Woodcock but a small down-note in an otherwise harmonious legislative season for the agency.

 ______________________________________________________________

Do you want the chance to hear from Janet Woodcock, other key regulators from the FDA and CMS, and industry game changers? Join them at the 10th Annual FDA/CMS Summit for Biopharma Executives this December 11-12, in Washington D.C.

At the event, Janet Woodcock will be addressing what the midterm congressional elections mean for the biopharma industry. Do not miss this!

Register here.

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Last Chance to Save $200 for FDA/CMS Summit for BioPharma Executives | Early Bird Rate Ends Friday

What do payors want when it comes to biopharma policy? Come to the FDA/CMS Summit for BioPharma Executives, December 11-12, 2014 in Washington, DC to hear payor perspectives on biosimilars, drug pricing, FDA reforms and drug coverage under Medicare, Medicaid and in the new Affordable Care Act Exchanges.

Take advantage of our Early Bird Rate, a savings of $200 off the standard registration rate. Register now.


Our keynote speakers and panels will take a deep dive into each of these topics, and more. You'll leave better able to make strategic decisions on issues such as:

• The commercial outlook for biopharma under the new health care exchanges

• Updates on the latest drug review statistics from the Office of New Drugs and industry's experience under the new review "Program"

• The future of drug safety at FDA - both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes

• What's in store for the reauthorization of PDUVA VI, and a preview of what's to come as industry and FDA take a second look at BsUFA and GDUFA.

• Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit

• What the mid-term Congressional elections will mean for the biopharma industry.


P.S. Maximize your investment by also attending the co-located FDA/CMS Summit for Payers. If you purchase the All Access Pass you will be able to not only collaborate with biopharm exeuctives, but rub elbows with C-Level health plans executives as well. Register now so you can double the speakers, double the content, and double the value for only an additional $800! Use the code XP1917BLOG when getting your All Access Pass to save $100, making it only an additional $700!

Register Here.

If you have any questions about the event, please reach out to Ryan Geswell at rgeswell@iirusa.com

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Introducing the FDA/CMS Summit for Biopharmaceutical Executives

Join us for the 10th Annual FDA-CMS Summit, for biopharmaceutical executives, December 11-12, 2014 in Washington, DC. Our keynote speakers and panels will take a deep dive into each of these topics, and more. You'll leave better able to make strategic decisions on issues such as:

• The commercial outlook for biopharma under the new health care exchanges

• Updates on the latest drug review statistics from the Office of New Drugs and industry's experience under the new review "Program"

• The future of drug safety at FDA - both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes

• What's in store for the reauthorization of PDUVA VI, and a preview of what's to come as industry and FDA take a second look at BsUFA and GDUFA.

• Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit

• What the mid-term Congressional elections will mean for the biopharma industry.

 
Speakers Include:

o Janet Woodcock, MD, Director, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA)
o John Jenkins, MD, Director, Office of New Drugs, Food and Drug Administration (FDA)
o Leah Christl, Associate Director, Biosimilars Program, Office of New Drugs Food and Drug Administration (FDA)    
o Gerald Dal Pan, MD, Director, Office of Surveillance & Epidemiology, Food and Drug Administration (FDA)
o Jim Robinson, President, Astellas Pharma US    
o Sumant Ramachandra, MD, PhD, MBA, SVP & Chief Scientific Officer, Hospira
o Robert Clark, VP, US Regulatory Affairs, Novo Nordisk    
o Francois Nader, MD, CEO, NPS Pharmaceuticals
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech    
o Chris Garabedian, CEO, Sarepta
o David Beier, Partner, Bay City Capital    
o John McHutchison, MD, Executive Vice President, Clinical Research, Gilead
o Mark McClellan, MD, PhD, Senior Fellow and Director, Health Care Innovation and Value Initiative, Brookings Institution    
o Niall Brennan , Acting Director, Office of Enterprise Management, Centers for Medicare & Medicaid Services (CMS)
o Tamara Syrek Jensen, JD , Deputy Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)    
o Mark McCamish, MD, PhD, Global Head Biopharm.& Oncology Injectables Development, Sandoz International GmbH
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech    
o Chris Garabedian, CEO, Sarepta
o David Mott, General Partner, Biopharmaceutical Investments, New Enterprise Associates (NEA), Former CEO, MedImmune    
o Steven Nissen, MD, MACC, Chairman, Department of Cardiovascular Medicine, The Cleveland Clinic Foundation

Register now for this can't-miss event! 

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