Celebrate Cyber Monday with 25% Off IIR and IBC Pharma and Life Sciences Events

Use code CYBER25 for 25% off the current rate TODAY ONLY. For this exclusive savings use code CYBER25 to register today, November 30th for all the below IIR and IBC Life Sciences pharmaceutical and life sciences conferences:

Antibody Engineering & Therapeutics

December 7-10, 2015

San Diego Convention Center

San Diego, CA

Discount code: CYBER25

Download the brochure: http://bit.ly/1MZnpHL

Register: http://bit.ly/1MZnmf3

RIM

Regulatory Information Management Summit

December 14-15, 2015

Ritz Cartlon

Washington DC

Discount code: CYBER25

Download the brochure: http://bit.ly/1lU3rYj

Register: http://bit.ly/1NinS7j

FDA/CMS Summit

December 14-15, 2015

Washington DC

Discount code: CYBER25

View the agenda: http://bit.ly/1lpMvs8

Register: http://bit.ly/1lpMrIN

Drug Delivery Partnerships
January 20-22, 2015

PGA National Resort & Spa

Palm Beach Gardens, FL

Discount code: CYBER25

Download the brochure: http://bit.ly/1QPkxU0

Register: http://bit.ly/1NDAXye

Asia TIDES

February 24-26, 2016

Westin Miyako Kyoto

Kyoto, Japan

Discount code: CYBER25

Download the brochure: http://bit.ly/1lU53S2

Register: http://bit.ly/1IjGIyR

ePharma

February 29-March 2, 2016

Sheraton Times Square

New York, NY

Discount code: CYBER25

Download the brochure: http://bit.ly/1YD9hLV

Register: http://bit.ly/1YD9gaA

BioProcess International Conference & Exposition West

March 14-17, 2016

Oakland Marriott City Center

Oakland, CA

Discount code: CYBER25

View the preliminary agenda: http://bit.ly/1OzE7A6

Register: http://bit.ly/1HzTgSP

TIDES

May 9-12, 2016

Long Beach Convention Center and Entertainment Center

Long Beach, CA

Discount code: CYBER25

Download the brochure: http://bit.ly/1OqjtEp

Register: http://bit.ly/1HzTwkH

We hope to see you at our 2015-16 events!

*All registrations are subject to approval. Discounts cannot be retroactively applied*

Cheers,

The IIR and IBC Life Sciences Teams

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Why You Should Attend IN3 Medical Device 360 Summit This Fall

IN3 brings together buy side strategics, VCs, and medtech innovators to build the necessary connections to expand portfolios, secure funding, and drive medical device progress. This event not only provides you with insights from experienced strategics and investors, it also provides you with a state-of-the art partnering tool to maximizes your networking capabilities.

Top Reasons to Attend IN3:

Know What Investors Look For. Crafting the right narrative and showcasing the best value metrics are essential to selling your technology. Discover exactly what criteria Strategics and VCs use to evaluate potential acquisitions. Download the agenda: http://bit.ly/1OCI0nd

Pitch to Put Your Technology on the Map. Competition is fierce in the medtech sector. Do what it takes to rise above your rivals -- pitch your technology to a global audience of top-tier investors. Secure Your Spot before Your Rivals Take it. Apply Now: http://bit.ly/1izpUbE

Find Your Next Partner. Introducing partneringONE®, the perfect platform for meeting exactly the right person at exactly the right time. Leverage partneringONE® to pre-arrange one-on-one meetings with the high-level decision makers you’ve been searching for. Move beyond chance encounters and conduct more quality meetings in two days than most companies do throughout the entire year.  Explore how it works: http://bit.ly/1KcxBPp

Also, here’s the event’s keynote lineup:

• Chris King, VP, Business Development and Strategic Partnering, Medtronic
• Bill Roskopf, VP, Business Development and Strategic Planning, Stryker
• Sherrie Perkins, VP, Business Development, Sorin Group
• Evelyn Douglas, VP, Corporate Strategy & Development, BD
• Jeff Karan, Managing Partner, Mavericks Capital
• Gil Kliman, Managing Director, InterWest Partners
• Ted Driscoll, Partner, Digital Healthcare Lead, Claremont Creek Ventures
• John Ryan, Partner, ONSET Ventures
• David Allison, Investment Professional, Versant Ventures
• Andrew Baldwin, Principal, Western Technology Investment
• Arthur Pappas, Managing Partner, Pappas Ventures
• Ittai Harel, General Partner, Pitango Venture Capital
• Gregory Grunberg, Managing Director, Longitude Capital
• Zack Scott, Managing Partner, Leerink Revelation Partners
• Bill Starling, Managing Director, Synergy Life Science Partners
• Jeffery T. Barnes, Managing Director, BioVentures Investors
• Greg Grunberg, Managing Director, Longitude Capital

As a valued reader of our blog, you get an exclusive $100 off the current rate when you use code IN315BL to register: http://bit.ly/1OCI0nd

We hope to see you in San Francisco this Fall!

Cheers,

The IN3 Team

@FutureofBioPharma

#IN3SF

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Unlock the Key to Advancing Immuno-Oncology

As innovations and discoveries in cancer immunotherapies progress at lightning speed, it is critical to understand the successes and challenges with current immunotherapies to separate the hype from the real opportunities. IBC's Immuno-Oncology event develops tactics for improving the efficacy and response rates with first generation immunotherapies and builds a strategy for utilizing combination therapies, t-cell therapies, and checkpoint inhibitors to propel the next wave of cancer immunotherapies.

Download the Immuno-Oncology brochure now to create your pathway for an answer to cancer: http://bit.ly/1O6tbIZ

Immuno-Oncology

Advancing the Next Generation of Cancer Immunotherapies

September 30 – October 1, 2015

Hilton Alexandria Mark Center, Alexandria, VA

Register today and explore the latest advances in Immuno-Oncology to:

Develop next generation immunotherapies by understanding recent advances made with CAR-T and T-Cell therapies, checkpoint inhibitors, cancer vaccines, and agnostic antibodies

Create a successful combination therapy strategy by gaining insights from global leaders on effective combinations

Optimize the discovery and development of your promising immunotherapies by hearing best practices and lessons learned from the first wave of cancer immunotherapies

Download the brochure for full program details: http://bit.ly/1O6tbIZ

Reserve your seat now. Use code IMMUNO15BL to get $100 off the current rate. Register today: http://bit.ly/1O6tbIZ

Best,

The Immuno-Oncology Team 2015

@ibcusa

#Immuno15

Related articles

• New Drug Combination Boosts Immune System and Manipulates Gene Activity To Slow Leukemia
• Researchers develop method to increase T cells in melanoma patients

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How to improve your monoclonal antibody harvest step using flocculation with smart polymers

In my last post (Might the sun be setting on process-scale chromatography for the purification of biopharmaceuticals?) I discussed how the trend of increasing bioreactor productivity at a near exponential rate has outstripped developments in packed-bed chromatography leading to bottlenecks in downstream processing.

Addressing the need for purification methods with higher throughputs will be the subject of presentations at the BioProcess International 2015 conference, however, seeking ways to eliminate chromatography steps is not necessarily the only solution to the problem of throughput-constraints in purification.  

Flocculation and cell culture harvests

Ken Kang from Eli Lilly and Company is scheduled to present on “Monoclonal flocculation with smart polymers for efficient clarification of high titer cell cultures and improved removal of impurities”. In 2013, Kang and collaborators from both Eli Lilly and Company and EMD Millipore published an article in the journal ‘Biotechnology and Bioengineering, 2013;110:2928-2937’ describing an alternative harvest process for monoclonal antibodies (mAbs) using the stimulus responsive polymer, benzylated poly(allylamine) as a flocculent followed by depth filtration.

Highly productive bioreactor processes also typically generate both high cell densities and levels of impurities that put additional pressure on purification trains. Although a relatively low resolution purification technique, flocculation can be used to remove considerable amounts of cells, host cell proteins and DNA in a quickly and cheaply. This decreases the burden on chromatography columns allowing a reduction in the number of cycles that must be performed and increasing the usable lifetime of resins. An additional benefit is that flocculation process are relatively easy to fit into existing equipment configurations without having to perform a whole-scale redesign of manufacturing facilities.

Residual levels of impurities in Protein A chromatography eluates

The process described in the article was not only high yielding and improved the clearance of cell debris but  also reduced aggregated product, HCP and Nucleic Acids. The burden on polishing chromatography steps was considerably reduced as the investigators were able to show that once the clarified cell culture filtrate was purified by Protein A chromatography the impurities in the eluate were so low they potentially met drug substance requirements. Crucially the team were able to demonstrate the clearance of residual polymer using fluorescence tagging.

Could flocculation improve your antibody harvest step?

The results from studies on flocculation such as this one seem both to present a path forward to reduce the impact of downstream bottlenecks while also being readily implementable. Flocculation processes seem relatively easy to develop, scale and operate without requiring sophisticated or expensive new equipment. What do you see as the benefits and challenges associated with this bioprocessing technique?

About the Author: Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

https://uk.linkedin.com/pub/dr-nick-hutchinson/0/b38/37 

Join me at #BPIconf

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Mark McClellan, Carolyn Clancy, and Jim Greenwood to Keynote

Impending legislation coupled with new FDA initiatives, leave many companies wondering what to expect as we head into 2010. Join the Biopharm Regulatory Reform Summit as Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA discusses the challenges in establishing a regulatory pathway for biosimilars. Quality, patient safety, and efficacy are all primary issues the FDA must focus upon in the review and approvals for these complex biologics. Dr. Kozlowski addresses these issues in addition to comparative effectiveness and factors to consider for drug development plans for products in the pipeline. Bring home regulatory insights to challenges with defining “biosimilars” and their scope, biosimilars’ regulatory pathway, and the latest on comparative effectiveness.

Don’t miss the keynote presentations from Mark McClellan, Senior Fellow, Director of the Engleberg Center for Healthcare Reform, Carolyn Clancy, MD, Director, AHRQ, and Jim Greenwood, CEO, BIO.

Join the Meet and Greet session with Jacquelyn White, Director, Office of Strategic Operations and Regulatory Affairs, CMS

In an era of personalized medicine, IIR’s Biopharm Regulatory Reform Summit provides a unique opportunity to interact with industry thought leaders focusing exclusively on the true downstream effects of reform on how biopharm does business. Join senior leadership for two days to create actionable strategies to respond to reform, protect profitability, and deliver patient driven care for pharmaceutical, biotech and medical device executives.

2009 Faculty Highlights
• Dr. Mark B. McClellan, Senior Fellow, Director of the ENGELBERG CENTER FOR HEALTHCARE REFORM
• Carolyn Clancy, MD, Director, AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)
• Jim Greenwood, CEO, BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO)
• Joseph Antos, Health Adviser to the Congressional Budget Office, AMERICAN ENTERPRISE INSTITUTE FOR PUBLIC POLICY RESEARCH
• D. Bruce Burlington, MD, Pharmaceutical Product Development and Regulatory Affairs, Independent Consultant, former Executive Vice President Business Practices and Compliance, WYETH
• Jane Galvin, Managing Director, Regulatory Affairs, BLUE CROSS BLUE SHIELD (BCBS)
• Julie K. Letwat, JD, MPH, Government and External Affairs, TAKEDA PHARMACEUTICALS AMERICA
• Amy Miller, PhD, Director, Public Policy, PERSONALIZED MEDICINE COALITION
• Les Paul, MD, Vice President, Clinical and Scientific Affairs, NATIONAL PHARMACEUTICAL COUNCIL (NPC)
• Ian D. Spatz, Principal, ROCK CREEK POLICY GROUP and Senior Advisor, MANNATT HEALTH SOLUTIONS, formerly, Vice President, Global Health Policy, MERCK
• Dan Todd, Executive Director, Health Policy, EMD SERONO
• Myrl Weinberg, President, NATIONAL HEALTH COUNCIL
• Jacquelyn White, Director, OFFICE OF STRATEGIC OPERATIONS AND REGULATORY AFFAIRS, CMS

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IIR's Genotoxic Impurities Brochure Ready to Download

IIR’s Genotoxic Impurities is the US event presenting New Toxicology and Analytical Chemistry Approaches for Managing Genotoxic Impurities (GTIs) in Compliance with EU and FDA Guidance. Click here to download the conference brochure.

IIR’s Genotoxic Impurities event is the only US intensive day and a half event that brings together industry thought leaders, white paper and FDA guidance authors to define regulatory concerns to build industry best practices to reduce the need for individual judgment calls. This intensive format designed to deliver everything you need to know about GTIs through regulatory case studies, interactive panel discussions and in depth round tables to build industry best practices.

Answers to Your Current GTI Questions

• Identify what constitutes an Serious Adverse Reaction (SAR) alert
  
• Strategies to assessing and handling degradation products
• Discover sensitive analytical techniques that can provide accurate measurements of the genotoxic impurities in presence of the difficult matrices (API, lipid formulations and etc.)
• Understand how other companies are handling issues such as related substances and degradation products
• Define the appropriate scenario for running in silico and test in Ames
• Determine how much and when to perform potential genotoxic impurities (PGI) fate mapping
• Discussion on approaches to cumulative control of multiple impurities

Featured Sessions

• FDA's Guidance for Industry Genotoxic and Carcinogenic Impurities in Drug Substances and Products
  

Chris Riley, President, RILEY AND RABEL CONSULTING SERVICES

• PhRMA ATG GTI Working Group Update & Industry Survey Results!
  

Nancy Benz Project Leader, Process Analytical Chemistry, GPRD ABBOTT
PhRMA ATG GTI Working Group

We look forward to seeing you in Princeton, NJ.

P.S. Register and Save $200 off the standard registration by using VIP Code: 0TB3WA

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CROs 2009 Workshop Video

For those who missed the workshop last month in Orlando, we are providing unlimited access to this timely workshop to all Partnerships attendees and their colleagues. And since we understand your training and travel budgets are limited at this time, this video workshop is completely free of charge.

Simply click the link below to watch the video at your leisure, and feel free to pass along to your CRO colleagues.

http://www.iirusa.com/cropartners/BDWorkshop.xml

If you are in business/corporate development, sales, marketing, client relations, account management, operations or project management at a CRO or other outsourcing provider, this video workshop will help you achieve your professional development goals including:

• Demonstrate value to Sponsors who are increasingly pushed to make decisions based solely on cost
• Understand how downsizing in pharma will make micro-managing a thing of the past as CROs take over as the ‘doer’
• Access the right people (decision makers) in an organization to approach for new business opportunities -- and getting them to return your call
• And much more....

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