BPI West Brochure is Now Available for Download | Save $500 Now, Rates Increase Friday

Break down the barriers between departments and stages of development at BPI West - the industry's first and only phase-based format event! 

Download the Brochure Now.

BPI West is one-of-a-kind phase-based format is designed to capitalize on the latest approaches and technologies to help move the pipeline of next generation drug candidates closer to approval. Collectively share ideas, strategies and solutions to improve speed, cost and quality from basic research to commercial manufacturing.

Top 3 Reason Why You Can’t Miss BPI West:

1. Learn how to streamline and accelerate the development to approval process by collaborating at the interfaces of discovery, R&D, process development, and manufacturing
2. Discover the latest tools, technologies, and strategic approaches to increase efficiency, productivity, and cost savings at every stage of development
3. Foster the cross-fertilization of new ideas and perspectives to reach new levels of clinical and commercial success

This new format will bring together experts from every discipline and stage of development to achieve the common goals of optimizing speed, reducing cost, and improving quality from basic research to commercialization. Benchmark best practices, hear exclusive case studies and new data presentations at BPI West in Oakland, CA.

Don't forget! This Friday, December 18th is your last chance to save up to $500! Use the code BPIWEST16BL to save - Register here.

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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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BDP Week 2015: Extractables and Leachables

By: Maribel Rios, Managing Editor of BioProcess International

On Tuesday afternoon, 31 March 2015, the single-use track of the BioPharmaceutical Development and Production (BDP) Week meeting in Huntington Beach, California, focused on the challenges associated with particles and extractables and leachables (E&L). Bobbijo V. Redler, PhD (Merck & Co., Inc)  began by defining the terms and the different types of E&L studies, including controlled extraction studies (screening), simulation studies, leachables testing (using methods validated for registration), and routine monitoring (also using validated methods). She reviewed simulated study designs, the use of various analytical techniques for E&L studies, and efforts of the E&L team of the BioPhorum Operations Group (BPOG).

James Vogel (The BioProcess Institute) presented on the work of the Bio-Process Systems Alliance (BPSA) on its 2014 particulates technical guide, “Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Processing Equipment.” The 12-chapter compendium is targeted for both end users and supplies of single-use components and systems. The session ended with a roundtable moderated by Redler. Panelists included Weibing Ding (Biogen Idec), James Vogel, and Michael Rupperto, PhD (Material Needs Consulting). The session consisted of a Q&A with attendees. Various issues were discussed, including the following:

·         Whether the BPOG extractables protocol published last year (Ding W, et al. Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing. Pharm. Eng. Nov-Dec. 2014) actually is a “best practices” document and if it truly can be used for “comparability.” Panelists said that the protocol does provide some flexibility, the document is a “step forward,” and that ASTM (Association for Standards Testing and Materials) and USP (US Pharmacopeia) Chapter <661.3> work is ongoing.

·         Whether it is better to discontinue use of a component is easier than to conduct continuous monitoring for extractables. The panel answered that the decision is often a matter of time and cost and that the material may have unique properties that are needed.

·         How to determine a threshold for extractables information and the definition of BPA-free. The panel emphasized the importance of smart material selection, paying close attention to materials, including secondary packaging, and continually assessing risk.

·         Whether the BPOG protocol (above) should actually be more rigorous. The panel mentioned that not many company are conducting in-process leachables testing for process equipment, reminding attendees that suppliers are responsible for extractables tests and end users are responsible for leachables testing. The general intention is to get single-use implemented quickly. 

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BDP Week 2015: BPSA Roundtable

By: Maribel Rios, Managing Editor of BioProcess International

The Bio-Process Systems Alliance (BPSA) presented a single-use applications roundtable on Monday, 30 March 2015, at the BioPharmaceutical Development and Production (BDP) Week meeting in Huntington Beach, California. Mark Petrich, PhD (Merck & Co., Inc.) moderated the panel consisting of Jerry Martin (Pall Corporation), Jeffrey Carter, PhD (GE Healthcare), James Vogel (The BioProcess Institute), and Todd A. Kapp (Parker-Hannifin Corporation). Martin started with a historical review of the BPSA, a trade organization formed in 2005 and now consisting of 46 member companies (suppliers and end users) whose goal is to “advance single-use worldwide and facilitate implementation of single-use technologies.” 

Carter and Vogel then reviewed BPSA’s active and recent projects, consisting of the following:

·         Single-Use Manufacturing Component Quality Test Matrices (currently under final review and should be available for the BPSA Annual Summit, 13-15 July 2015, in Washington DC)

·         Change Notification Practices (currently in the initial stages of documenting)

·         Extractables (currently continuing collaboration with other organizations such as ASTM, ASME-BPE, and USP)

·         Quality Agreement Template for Single-Use Biopharmaceutial Manufacturing Products (published July 2014, currently soliciting feedback from users of the template, with possible future revisions)

·         Particulates Guide, a 12-chapter compendium addressing why particulates are an issue, how to identify them, and so on (currently soliciting further input)

The roundtable concluded with Knapp presenting the future focus of BPSA, including the annual summit and its new scholarship fund.

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