Thursday, January 29, 2015

BDP Week Football Spectacular: Save 49% when you register to join us at BDP Week!

This Weekend Only: Register for Biopharmaceutical Development & Production Week by Sunday, February 1 with priority code BDP15SB49 and you will save 49% (up to a $1800+ savings) off the standard rates.

Co-Located with:
Single-Use Applications & Flexible Facilities
March 30 - April 2, 2015
Hyatt Regency Resort & Spa 
Huntington Beach, CA
Mention priority code BDP15SB49

BDP Week provides you an immersive 4-day learning and networking experience—that will help you to:
  • • Get focused learning on Single-Use Applications and Flexible Facilities from these two established, co-located events.
  • • Discover technological and scientific advances improving cost, speed and productivity in process development
  • • Gain strategies to avoid pitfalls, maximize efficiencies and alleviate bottlenecks with elaborate coverage of manufacturing technologies for emerging biologics.
  • • Apply new found knowledge gained from 180+ speakers and demo new technologies from 70+ exhibitors for immediate advancements of your process and products.
  • • Connect with 800+ biopharmaceutical development and manufacturing peers to, swap ideas, and generate business outcomes with fun, casual networking functions.

Questions? Email Jennifer Pereira.

*This promotion is only valid January 29- February 1, 2015 only. 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 IBC approval. 


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Friday, January 23, 2015

Genetic Engineering: It's Not Frankenstein

Today's guest post comes from Genome Editing Applications sponsor Horizon Discovery.

Genetic Engineering: It's Not Frankenstein
Author: Hannah Murfet (PCQI, BSc). Quality and Regulatory Manager

Genetic engineering often faces unjustified bad press with regard to genetically modified crops, however genetic engineering continues to provide great promise for drug discovery, assessment and production. We must apply care and regulation to allow continued advances to focus of human treatment and not enhancement, science should not allow us to create a monster.

Genetic engineering put simply is the adjustment of the instructions of our cells, the smallest functional unit of life. The genome is the sequence of information required to code for an organism. this consists of a long code represented by 4 letters (G, A, T and C). The sequence of these letters codes for the proteins and how often they are produced. Changes in the coding of these 4 letters take a range of forms from single letter changes, insertions and duplications.

Genetic engineering is routinely applied in medical treatment, particularly with the mass production of human insulin in bacteria since 1982 (1). In this example the gene for insulin was inserted into bacteria, the bacteria then produce insulin protein which can then be purified for medicinal use. The future of this technology has continued with antibody therapy, where immune proteins are engineered and produced for targeted treatment of cancer and autoimmune disease.

Scientists are able to make use of changes in coding to further our understanding of disease models such as cancer, where changes in the 4 letters can lead to changes in the way our cells behave (2). Cell and animal models can be used in early stage drug trials to determine effectiveness and resistance.

The future of genetic engineering takes this a stage further to target the cells in our bodies. This technology makes use of a virus to insert a gene to treat disease where the coding defective, Glybera is the first drug of this kind to be recommended for approval (3). The cost of these therapies is currently high, but the field of genetic engineering is continuing to evolve and new technologies such as CRISPR are being adopted (4).

Right now all the work in this field is creating some positive enhancements for medicine. With careful control and regulation the prospects for drug development and treatment have massive potential, however we must take care of the ethical implications of genetic alteration, particularly anything that may lead to human enhancement - we certainly don't want to create any monsters!

(1) http://www.brighthub.com/science/genetics/articles/21983.aspx

(2) http://www.oapublishinglondon.com/article/607

(3) http://www.nature.com/mt/journal/v20/n10/full/mt2012194a.html

(4) http://www.bio-itworld.com/2014/5/22/advances-genetic-engineering-american-society-microbiology-meeting.html



Genome Editing Applications will take place will take place March 18-19, 2015 in Boston.  Find out more about the program.  As a reader of this blog, you can save 20% off the standard rate when you register to join us and mention code D15223BLG.  

This is co-posted on LinkedIn


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Thursday, January 22, 2015

Right Drug, Right Time

Today's guest post comes from Genome Editing Applications sponsor Horizon Discovery.

Right Drug, Right Time
Author: Hannah Murfet, Vice-Chair CQI Next Generation Network

“Right first time” is a concept familiar to the quality profession, but it is taking on a whole new meaning since the emergence of personalised medicine. Personalised medicine aims to eradicate an often random and reactive approach to patient care by employing techniques such as genetic testing to ensure treatment is more likely to be effective and safe in a specific patient population.

Traditional approaches to drug treatment generally take a population-wide trial and error approach. That is to say that the drugs used for treatment are known to be generally effective, but their specific effect on an individual patient is often unknown. Drugs are typically tested on large patient populations in order to test for safety and efficacy. As the patient population is seldom uniform, the efficacy is reduced as the drug works well for some and not others. Personalised medicine has the opportunity to change this by allowing us to use the right drug at the right time – a prime example of root cause analysis.

The successes of personalised medicine are staking up, and include genetic testing for breast cancer, chronic myeloid leukaemia and colorectal cancer. One very well-known example is screening for BRCA1 and BRCA2 gene mutations to predict whether a patient needs preventative breast cancer treatment. Other examples include targeted therapy based on chromosome alterations in patients with chronic myeloid leukaemia and KRAS gene mutations used as biomarkers to predict the success of specific drug treatments for colorectal cancer. Seemingly, the possibilities for personalised medicine are endless.

While the upfront costs of personalised medicine are initially higher, they will be reduced in the long term as the cost of quality is reduced by removing the expense of ineffective and repeated treatments. It’s a tremendously exciting time for the pharmaceutical and medical device fields, but I also feel those in the quality profession can take something from this. The application of the right drug, at the right time, has parallels with the work of the quality profession. We aim to use the right tool, the right approach and the right improvement at the right time. So let’s take a ‘personalised medicine’ approach to business improvement. I’m sure the results will be just as powerful for improving quality.

Genome Editing Applications will take place will take place March 18-19, 2015 in Boston.  Find out more about the program.  As a reader of this blog, you can save 20% off the standard rate when you register to join us and mention code D15223BLG.  

This post is co-posted with the CQI Blog.


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Wednesday, January 21, 2015

ADC emerge as leading cancer treatment option

Antibody Drug Conjugates (ADCs) are an ideal way to target cancer cells while missing the cancer cells.  Two ADCs have jumped to the top of the treamtent list -brentuximab vedotin which treats lymphomia and ado-trastuzumab emtansine which treats breast cancer.

As their success grows, and more therapies using this technology are being developed, finding safe manufacturing methods for ADCs has posed to be the next big challenge. According to BioProcess International, there are four key factors of an ADC that must be in tact to produce a working ADC: the antigen, the targeting antibody, the linker, and the payload. In order to create more drugs at a larger scale, researchers are focusing development methods that reduce heterogeneity and ways to create site-specific conjugations.  Not only that, but finding these two things are some of the next key challenges for scientists:
  • -How to increase clinical impact for tumors that display heterogeneous expression of a target antigen
  • -How to improve outcomes for those ADCs that show promising early efficacy before tumors develop resistance.

What do you see as the next big breakthrough in antibody drug conjugate therapy?

This year at BDP Week, we'll have an afternoon dedicated to New Modalities and Next Generation ADCs – Challenges in Development and Production with presentations from companies including MedImmune, Sutro Biopharma Inc. and CytomX Therapeutics, Inc.  For more information on this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15155BLOGJP to save 20% off the standard rate.


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Thursday, January 15, 2015

Continuous Processing The Good, The Bad and the Unexpected

Continuous processing is easier said, than done. It promises to make biomanufacturing more viable,
but will it delver?

At BDP Week, industry experts will share the good, the bad and the unexpected to help you reduce manufacturing costs, improve product quality and increase flexibility while reducing risks.

Continuous Processing Programming Highlights Include:
  • • Media Development Strategies for Platform and Late Phase Cell Culture Process
    • -Wenge Wang, Ph.D., Senior Principal Scientist, Bioprocess R&D, Pfizer
  • • Upstream Disposable Technology Supports the Implementation of Continuous Processing
    • -Shaun P. Eckerle, Principal Scientist, Cell Culture Development, Patheon Biologics
  • • Downstream Processing and New Technology for Continuous Chromatography
    • -Maria Ekblom, Senior Project Manager, Chromatography Systems, GE Healthcare
  • • Ultra Scale-Down Characterization Of Bioprocessing Materials for the Early Prediction of the Impacts of Industrial Scale Continuous Centrifugation on the Recovery and Purification of New Therapeutic Candidates
    • -Alex Chatel, Ph.D., Bioprocess Enterprise Fellow, Biochemical Engineering, University College London, United Kingdom
  • • Continuous Chromatography: The Good, the Bad, and the Unexpected
    • -Oliver Kaltenbrunner, Ph.D., Scientific Director, Chemical Process R&D, Amgen
  • • How to Optimize the Perfusion Rate in High Cell Density Perfusion of Chinese Hamster Ovary Cells Culture in Stirred Tank
    • -Veronique Chotteau, Ph.D., Prinicpal Investigator, Researcher, Cell Technology Group, School of Biotechnology, KTH, Royal Institute of Technology, Sweden
  • • Integrated and Fully Continuous Processing of Recombinant Therapeutic Proteins – From Cell Culture Media to Purified Drug Substance
    • -Veena Warikoo, Ph.D., Director, Purification Development, Genzyme
  • • Exploring Options for Achieving Diafiltration in a Continuous Process
    • -Alex Brinkmann, Engineer III, Biogen Idec
  • • ASAP (Automated Seamless Antibodies Purification): Toward a Fully-Disposable Process
    • -Benoit Mothes, Pharm D, Senior DSP Scientist, Sanofi, France
  • • Continuous Downstream Processing: Where Does It Fit?
    • -Moderator: Marc Bisschops, Ph.D., Scientific Director, Tarpon Biosystems
  • • Single-Use Chromatography Platform For Monoclonal Antibody Purification
    • -Renaud Jacquemart, Ph.D., Senior Scientist, Process Sciences, Natrix Separations
  • • Exploring Options for Achieving Diafiltration in a Continuous Process
    • -Alex Brinkmann, Engineer III, Biogen Idec
  • • Processes of the Future : Single Use, Closed and Continuous for Faster, Cheaper and Safer Manufacturing
    • -Sébastien Ribault, Ph.D., Director Biotechnology/Life Science, Head of BioDevelopment Center, EMD Millipore

Plus, do you have new research to share with your industry colleagues? We’re searching for the newest, innovative findings to be presented by our attendees in poster displays at BDP Week. Submit your abstract today.

Now is the time to make plans not attend BDP Week for end-to-end bioprocessing solutions that will help you guarantee reproducible results and manufacturing success.  Register to join us March 30-April 2, 2015 in Huntington Beach, California.  As a reader of this blog, when you register to join us and mention code XB15155BLOGJP, you save 20% off standard rates.


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Tuesday, January 13, 2015

Single-Use Applications 2015

Join us for Single-Use Applications 2015 to learn how to optimize time-to-market, overcome complex drug product and manufacturing challenges, and ensure successful implementation and integrity of single-use adoption and deployment.

The event features 10 Case Studies and 2 Interactive Q&A Sessions on Today's Most Pressing Single-Use Challenges including:
  • • Ensuring Successful Single-Use Implementation and Integrity: Case Studies from: Amgen and Merck & Co.
  • • Single-Use Implementation and Transfer: Case Studies from: Genentech, Merck & Co. and Public Health England
  • • BPSA Roundtable: Interactive Q&A: The Road Ahead: Issues Impacting the Accelerated Adoption of Single-Use Technologies
  • • Single-Use Considerations for Cell Culture Applications: Case Studies from: NIH and Shire
  • • Single-Use Applications in Upstream Processing: Case Studies from: Shire HGT and KPI Biopharma
  • • Production and Regulatory Considerations for Single-Use: Case Study from: Protein Sciences Corp.
  • • Overcoming Challenges Associate with Particles and Extractables & Leachables: Interactive Q&A: Extractables & Leachables
>> View the Single-Use Agenda
>> View the Full BDP Week Agenda
>> View the Agenda-a-Glance (PDF)

Single-Use Applications 2015 will take place from March 30-31, 2015 in Huntington Beach, CA.  It Flexible Facilities & Biopharmacuetical Development & Production Week is co-located with taking place on March 30 - April 2, 2015.


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Thursday, January 8, 2015

The Top 10 Ways to Improve Speed, Quality, Efficiency and Compliance | Register this week and present your poster for free!

IBC's Biopharmaceutical Development & Production Week (BDP Week) will take place March 30 - April 2, 2015 at the Hyatt Regency Resort & Spa in Huntington Beach, CA. This year, we’re pleased to announce that it is co-located with Single-Use Applications & Flexible Facilities.

The event offers the most in-depth coverage of bioprocessing topics on the market with 10 Focused Conference Tracks to help you improve speed, quality, efficiency and compliance.  What are our top 10 topics?



1. ADC Development & Production: Explore revolutionary approaches to development, scale up, formulate, and produce next generation ADCs that are more potent, stable, and have dramatically increased therapeutic windows.



2. Analytical Methods & Technologies: Maximize process and product quality, from comparability and characterization strategies to QbD concepts to HCP quantitation and control to aggregation and subvisible particle analysis.



3. Upstream Processing: Increase cell culture productivity, product quality, and efficiency through innovative technologies, platforms, and approaches to streamline development and reduce time to large scale production.



4. Single-Use Applications: Optimize time-to-market, overcome complex drug product and manufacturing challenges, and ensure successful implementation and integrity of single-use adoption and deployment.



5. Downstream Processing: Optimize efficiencies during harvest and purification of high cell density processes, continuous platforms and emerging modalities through the integration of disruptive technologies and methodologies.



6. Flexible Facilities: Novel and adaptable production strategies and solutions for the multi-product-centric biomanufacturing landscape.



7. Manufacturing Efficiencies: Achieve and maintain operational excellence with solutions to the emerging challenges of increasingly diversified portfolios in a global marketplace.



8. Quality and Control: Develop and benchmark protocols with a focused look at the latest challenges, best practices, and future trends for process validation and viral safety.



9. Bispecific Antibody Development & Production: Utilize new molecule design approaches, development strategies, and platform production processes to overcome the unique challenges of this transformative class of therapeutics.



10. Manufacturing Quality & Control: Develop and benchmark quality assurance and quality control protocols to meet compliance expectations for environmental, contamination, and manufacturing controls.


Plus, at BDP Week you have access to meet with the leaders in the industry with more than 165 speakers, 80+ Case Studies, 85+ New Data Presentations, 70+ exhibitors, 80 scientific posters and 800 attendees. This is the only event that can provide you this much in-depth biopharmaceutical development and manufacturing coverage in just 4-days!

Free Poster Offer 
Present your poster for free! Register for BDP Week with code BDP15LIA16 and present your poster for free! This code also includes the 20% discount off the standard rate you receive as a reader of this blog. This offer expires Friday, January 9.

Have any questions? Email Jennifer Pereira.

You can also enter to win a free pass to this year's event.  Head to Twitter and retweet this tweet to enter!


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Wednesday, January 7, 2015

Antibody drug conjugates and their complexity

ADCs are changing the way we fight cancer. While a few are on the market at the moment, over 200 are in preclinical development and over 30 are currently in clinical trials. Author Ronald A. Rader believes that the market will grow to just under $10 billion within the next 10 years.

With the complexity of antibody drug conjugates and their production, the industry is at an interesting intersection when it comes to their production and disposal.   Among the things that make these drugs extremely complex include hormones, biological toxins. Other challenges presented by author Rader of ADCs include:
  • - Combining and balancing optimal MAb specificity
  • - Handling MAb-linker-drug binding chemistries
  • - Controlling intracellular toxin release
  • - Preventing premature toxin release
  • - Manufacturing with concerns for worker safety and environmental release
How are companies overcoming these challenges?  Read the full article at BioProcess International.

The challenge of ADC development will be extensively covered at Biopharmaceutical Development and Production Week this March. Robert Lutz, Ph.D., Vice President of Translational Research & Development at ImmunoGen will present Clinical Development of ADCs - How are We Doing?, coverign many of the challenges of the production of ADCs. As a reader of this blog, if you'd like to learn more from Lutz and about ADCs, you can save 20% off the standard rate when you register to join us with priority code XB15155BLOGJP.


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Tuesday, January 6, 2015

Next Generation Protein Therapeutics Summit: Preliminary Agenda

IBC’s 10th Annual Next Generation Protein Therapeutics Summit delivers the very latest results from an ever expanding number of multifunctional molecules in development and offers you the best opportunity to learn from world-renowned academics and industry visionaries who are expanding the frontiers of biologic drugs.  It will take place May 18-20, 2015 in San Francisco, CA.

This Summit is the industry’s most comprehensive conference for sharing new ideas to accelerate the discovery, engineering and development of alternative scaffolds and novel protein therapeutics to create differentiated drugs. By attending, you will gain valuable knowledge from more than 40 presentations showcasing new, unpublished data and exclusive case studies, including lessons learned from the most-recently approved ADCs and Bispecific therapeutics.

Agenda Sessions:
  • • Recent Advances in Discovery Technologies
  • • Development of Immunotherapies
  • • Creative Protein Engineering and Design Approaches
  • • Next Generation Bioconjugates
  • • Unlocking New Biology with Novel Scaffolds and Antibody Fragments as Therapeutics
  • • Addressing Difficult Targets with Protein Therapeutics
  • • Delivery of Proteins
  • • Emerging Methods and Technologies for Screening, Selection and Sequencing
  • • Novel Therapeutic Peptide Development
  • • Bispecific and Multispecifics - New Advances and Approaches
  • • Bispecific and Multispecifics - Engineering Developability into Multi-Functional Protein Therapeutics
  • • Bispecific and Multispecifics - Clinical Case Studies
  • • Molecular Imaging
  • • Aggregation and Immunogenicity

Confirmed Speakers Include:
  • • Peter Senter, Ph.D., Vice President, Chemistry, Seattle Genetics
  • • Jennifer Cochran, Ph.D., Associate Professor of Bioengineering and Chemical Engineering, Stanford University
  • • K. Dane Wittrup, Professor, Chemical Engineering & Biological Engineering, MIT
  • • Gary Starling, Ph.D., Associate Vice President, Biologics Discovery Operations, Merck
  • • Robert Lutz, Ph.D., Vice President, Translational Research and Development, ImmunoGen, Inc.
  • • Robyn Barfield, Ph.D. Group Leader, Bioconjugation, Catalent Pharma Solutions
  • • Dimiter Dimitrov, Ph.D., Senior Investigator, Protein Interactions, National Cancer Institute, NIH
  • • Arne Skerra, Ph.D., Chief Scientific Officer, XL Protein
  • • Dasa Lipovsek, Ph.D., Senior Principal Scientist, Bristol-Myers Squibb
  • • David Urech, Ph.D., Co-CEO and Chief Scientific Officer, Numab, Switzerland
  • • Joachim Feldwisch, Ph.D., Director Preclinical Development, Affibody Ab, Sweden
  • • Catherine Hutchings, Ph.D., Antibody Alliance Management & Strategic Partnering, Heptares Therapeutics Ltd., United Kingdom
  • • Andrew Bradbury, Ph.D., Ph.D., Research Scientist and Team Leader, Los Alamos
  • • Patrick Baeuerle, Vice President, Research; General Manager, Amgen Research GmbH, Germany
  • • Aaron Sato, Ph.D., Vice President of Research, Sutro Biopharma
  • • Volker Schellenberger, Ph.D., President and CEO, Amunix
  • • Zhenping Zhu, MD, Ph.D., Executive Vice President, Global Biopharmaceuticals, Kadmon Corporation
  • • Kaspar Binz, Ph.D., Vice President and Co-Founder, Molecular Partners AG, Switzerland
  • • Olivier Laurent, Ph.D., Vice President, CMC, Ambrx
  • • Steven Jacobs, Ph.D., Associate Scientific Director, Biologics Research, Janssen R&D
  • • Antonin de Fougerolles, Ph.D., Chief Scientific Officer, Ablynx, Belgium
  • • Dragan Grabulovski, Ph.D., Chief Scientific Officer, Covagen AG, Switzerland
  • • Fredrik Frejd, Ph.D., Chief Scientific Officer, Affibody AB, Sweden
  • • Bradley Pentelute, Ph.D., Assistant Professor, MIT
  • • Jean E. Lachowicz, Ph.D., Chief Scientific Officer, Angiochem
  • • Mark Dennis, Ph.D., Principal Scientist, Antibody Engineering, Genentech, Inc.
  • • Gregory C. Ippolito, Ph.D., Research Assistant Professor, Department of Molecular Biosciences, The University of Texas at Austin
This event is taking place on May 18-20, 2015 in San Francisco, CA is co-located with IBC's Bioconjugates: From Targets to Therapeutics and Cell Line Development & Engineering conferences. With these 3 established events, under one roof – you can cross-fertilize with multiple disciplines to gain new ideas to help you propel promising candidates toward commercial success. Find out more about attending all three events with our Best Value All Access Pass.


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Friday, January 2, 2015

Flexible Facilities 2015

Get a comprehensive look at the flexible, multiproduct centric, biomanufacturing landscape from senior level executives and scientists from biopharmaceutical firms, CMOs, technology providers, engineering firms and regulatory groups. Explore the evolving biomanufacturing landscape and beyond through shared case studies on flexible facility implementations, lessons learned and practical experience.
  • • Non-Classified, Closed and Other Considerations and for Single-Use Implementation
  • • Process and Facility Design Strategies and Considerations
  • • Process Development and Manufacturing Strategies
  • • Design, Management and Implementation Considerations for Flexible Facilities
  • • BPOG Session
  • • Biomanufacturing of the Future
Plus, our speaker list features experts from: Shire, Sanofi Pasteur, EMD Millipore, Texas A&M Center for Innovation in Advanced Development and Manufacturing, Genentech, Development & Production, Public Health England, NNE Pharmaplan, University of Massachusetts Medical School, Biogen Idec, BPOG, GSK Biologicals and more!

>> View the Flexible Facilities Agenda
>> View the Full BDP Week Agenda
>> View the Agenda-a-Glance (PDF)

This event is co-located with Single-Use Applications & Biopharmacuetical Development & Production Week taking place on March 30 - April 2, 2015.  As a reader of blog, when you register to join us and mention code XB15155BLOGJP and save 20% off the current rates!


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Friday, December 26, 2014

Join us for a Web Seminar: Exploring Purification Boundaries with Cadence™ Inline Concentrator


Date: Wednesday, Jan 28, 2015
Time: 10:00 AM - 11:00 AM EST
Speaker: Chris Forespring, Sr. Manager, BioProcess Engineering , MedImmune
Register to join us.  Mention priority code Webinar_FOB

About the web seminar:
Thorough evaluation of emerging technologies is a key determinant for identifying process improvement opportunities in
existing and future bioprocess facilities. Successful implementation through process coupling and/or elimination of non-value added processing steps could result in both novel facility-fit solutions with alternative processing options and provide major cost savings at clinical and commercial scales.

In this context, a collaborative study has been undertaken to demonstrate the use of Cadence™ Inline Concentrator (ILC) linked to several potential processing steps such as perfusion, pre-capture chromatography, in-process volume reduction, and UF/DF. ILC is a disposable, self-contained, and easy to use, single-pass tangential flow filtration (TFF) device. The feasibility and performance of ILC modules were successfully evaluated and demonstrated over a wide range of feed streams at varying concentrations and process temperatures.

Participants will learn:
  • -How the ILC technology is an important addition to the process development toolbox for platform process development.
  • - How the ILC can remove constraints in existing facilities and increase the flexibility of manufacturing.
  • - Specific ILC applications with industrial biomolecules and the impact on the existing processes through detailed end-user case studies.


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Tuesday, December 23, 2014

It doesn’t show signs of stopping… Let is sale! Let it sale! Let it sale!

‘Tis the season! As our holiday gift to you, here’s 30% off the standard rates when you register for Pharma and Healthcare events from now through Wednesday, December 31! Use the code “Holiday30” at checkout.

These events were specially selected for your interests:

19th Annual Drug Delivery Partnerships
January 29-30, 2015 in Boca Raton, FL
> The largest strategic drug delivery and device partnering community to strike your next big deal, catch up on the future of innovative technologies, and stay FDA compliant.
- Find out more about the event.
- Register to join us.

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.
- Find out more about the event.
- Register to join us.

IBC’s Biopharmaceutical Development & Production Week (BDP)
March 30 – April 2, 2015 in Huntington Beach, CA
>Join us to gain strategies to avoid pitfalls, maximize efficiencies and alleviate bottlenecks with elaborate coverage of manufacturing technologies for emerging biologics. Visit the website for full details.
- Find out more about the event.
- Register to join us.

Partnerships in Clinical Trials
April 22-24, 2015, 2015 in Boston, MA
>Accelerate your speed to market by leveraging new partners, new technologies, and new business models at the must-attend clinical event of the year!
- Find out more about the event.
- Register to join us.

IBC’s 17th Annual TIDES
May 3-6, 2015 in San Diego, CA
>The #1 forum for CMC, Clinical and Discovery Scientists to Accelerate Oligonucleotide and Peptide Product Development. Visit the website for full details.
- Find out more about the event.
- Register to join us.

Have any questions? Email Jennifer Pereira.

Happy Holidays!


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Thursday, December 18, 2014

Striving to find new development methods for chemically defined media

In a recent article at European Business Review, Francesc Gòdia took an in-depth look at how to scale up the production of cell culture media in a safe way.  Reliability of supply, variability in performance and risk of viral infection has caused manufacturers to find new ways to develop these cell cultures.  The race is on and three alternatives to traditional methods are insulin, trasferrin, and albumin.  To examine the opportunities, Gòdia designed an experiment that screened for optimal compounds and another that optimized their concentration.  Read the results on page 36 of the European Biopharmaceutical Review.

This March, Gaurav Chauhan, M.S., Associate Scientist II, Cell Culture and Fermentation Sciences, MedImmune, will be on hand to share the presentation A Mathematical Model: Predict How HTST Impacts Media Treatment and Resolve Scale-Up Issues at Biopharmaceutical Development and Production Week.  For more information on this session and the rest of the program, download the agenda.  If you'd like to join us March 30-April 2, 2015 in Huntington Beach, California, as a reader of this blog when you register to join us and mention code BDP15JPLA2, you can receive the current lowest rate available to the event!


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Thursday, December 11, 2014

Announcing Your 2015 TIDES Keynote Lineup

IBC's 17th Annual TIDES meeting is coming to San Diego, CA on May 3-6, 2015.This is the leading forum for CMC, clinical and discovery scientists in the oligonucleotide and peptide industry to share best practices and new technologies to help you:
  • • Accelerate your promising therapeutic to market
  • • Ensure accurate CMC submissions
  • • Comply with emerging regulatory expectations
  • • Apply best practices from leading preclinical/clinical projects
  • • Improve process development timelines

This year, we move coasts and provide you visionary keynotes sharing key success factors for drug development and manufacturing highlighting these areas:
  • >Antisense Technology: Stanley T. Crooke, Ph.D., Chief Executive Officer, Isis Pharmaceuticals, Inc.
  • >RNAi Therapeutics: John Maraganore, Ph.D., Chief Executive Officer, Alnylam Pharmaceuticals
  • >Peptide Therapeutics: Torsten Hoffmann, Ph.D., Executive VP and CSO, Zealand Pharma A/S
  • >Oral Peptide: Kunwar Shailubhai, Ph.D., Co-Founder & CSO, Synergy Pharmaceuticals, Inc.
And don't forget - as a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off the standard rate!


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Thursday, December 4, 2014

What is next for immunotherapy?

We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We continue our interview series off with Omid Hamid, MD, Chief of Research, Immuno-Oncology at The Angeles Clinic and Research Institute.

As we wrap up our interview series with our Antibody Engineering speakers, Dr. Hamid answers this final question:
What is next for immunotherapy?
Dr. Hamid: The future for immunotherapy in solid tumors is bright. There are many avenues to take. We are looking at bispecific antibodies that are antibodies that bring two things together, like a T cell close to the tumor and then initiating an immune response. We are looking at adoptive T cell therapy where you take the T cells out of the tumor and grow them and then re-infuse them into patients. That is also referred to as “TIL Therapy” as is done at NCI and other major academic centers. We are looking at trying to bring that to community cancer centers and all patients. Again, combinatorial therapies with other immune therapies, including IL-2, anti CTL 4 therapy coming forward. And this will move quickly now that the field of oncology has understood these benefits. 
Now, as we talk about combination, we talk about where the field is going. Let’s not forget that immuno-oncology can be paired with many different modalities. We are looking at the ability to initiate or improve immune response through radiation – so called “Abscopal Effect”. We are looking at the role of chemotherapy within oncology or target therapies, which is something that I haven’t spoken about. But, the first checkpoint inhibitor to be approved was Ipilimumab and it was approved at the same time that BRAF targeted therapy was approved in metastatic melanoma. Today we have multiple trials looking at combinations of BRAF targeted therapy and immunotherapy with PD-1, PDL-1 and anti CTLA 4.

So, what’s next is happening now. I would support patients looking into options with any one of these modalities. What we have seen is that even heavily pre-treated patients and patients with rare tumors may have the possibility of benefiting from these modalities.

Dr. Hamid will be presenting The Promise of PD1 Checkpoint Inhibition for Multiple Solid Tumors on  next Wednesday, December 10 at the Antibody Engineering and Therapeutics event. For more information on his session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code XD14172BLOGJP, you can save 20% off the standard rate.


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Thursday, November 27, 2014

Who is the right patient for this immune therapies?

We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We continue our interview series off with Omid Hamid, MD, Chief of Research, Immuno-Oncology at theThe Angeles Clinic and Research Institute.

Today's question for Dr. Hamid is:
Who is the right patient for this therapy? Are there any predictive and prognostic markers?
Dr. Hamid: Great question. That’s like the “Holy Grail” now. Can we find out who can benefit prior to treating them? Immune therapies take time to show response. Immune therapies are not 100% for everyone. We are seeing better response rates than historically with immunological therapies with PD-1 inhibition and PDL-1 inhibition, but can we improve that?

What I say is that we are not there yet, but we’ve taken the right steps. Initially, PDL-1 staining of tumor was thought to be a great biomarker; a great predictive marker. We thought if you were negative you didn’t respond and if you were positive you had
great chance of responding. Now early data has shown that PDL-1 negative and PDL-1 positive response, possibly the negative has a lower response rate, but still a significant response rate where this would not be a gatekeeper for whether patients get therapy or not.

What we’ve also found is that PDL-1 expression changes during therapy. So, there are groups looking at whether we can predict response by looking at changes at tumor PDL-1 expression. John Powerly presented at ASCO 2013 looking at circulating biomarkers of T cell activation and response. So, still a very early undertaking, but we are moving forward.

The Pembrolizumab Study Keynote 001 had an interesting poster at ASCO that looked at initial tumor burdens. That is, how much tumor does a patient have and whether that predicts full response. Interestingly – in a small sub-set – it was the strongestpredictive marker for response (Joseph et al).

So, we’re moving forward and the good news is that almost every clinical trial that is being put together for PD-1 and PDL-1 inhibition and for combination is doing biomarker correlates, whether it’s blood, tumor or archival tissue, etc. So, we are getting closer to that answer.

Dr. Hamid will be presenting The Promise of PD1 Checkpoint Inhibition for Multiple Solid Tumors on Wednesday, December 10 at the Antibody Engineering and Therapeutics event. For more information on his session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code XD14172BLOGJP, you can save 20% off the standard rate.


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Wednesday, November 26, 2014

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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Friday, November 21, 2014

Novartis invests in gene editing technology

Announced earlier this week, Novartis will be joining in forces with Atlas Venture, a partnership created to back start up Intellia Therapeutics which will focus on gene editing technology in the oncology field. One of the key players in the start- up team is the former chief scientific officer of AbbVie, John Leonard and they will be based in Camebridge, Massachusetts.  The key technology CRISPR Cas9, which according to Fierce Biotech, works by developing  host bacterial cells incorporate short bursts of DNA sequences from invaders that can trigger disease which has the potential to create huge shifts in oncology treatment.  They are in-licensing this technology from Caribu Biosciences.

Plans for the initial work include:
Initially Intellia plans to focus on ex vivo work, where cells are collected from patients and then modified for therapeutic purposes before being injected back into patients--with applications relevant to CAR-T and checkpoint inhibitors. An in vivo approach can later be used to correct genes found inside cells, with applications in ophthalmic, central nervous system, muscle, liver, anti-infective and other disease.

This March at the Genome Editing Applications event, Caribou Biosciences will be joining us at the event to share more about this technology in the presentation Crisper Designs for Cas9-mediated Genome Engineering.  For more information on this session and the rest of the program, download the agenda.  If you'd like to join Caribou Biosciences in Boston March 18-19, as a reader of this blog, when you register to join us and mention code D15223BLG to save 20% off the standard rate. Have any questions or want to get involved? Reach out to Jennifer Pereira.


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Thursday, November 20, 2014

Where do you see the immune checkpoints and immune therapies field going?

We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We continue our interview series off with Omid Hamid, MD, Chief of Research, Immuno-Oncology at theThe Angeles Clinic and Research Institute.

Today's question for Dr. Hamid is:
Where do you see the immune checkpoints and immune therapies field going?

Dr. Hamid: Well, the future of this field is bright. To begin with, this field will expandto multiple solid tumors and multiple indications as I’ve just alluded to. As we moveforward, immune checkpoints and immune therapies will start to proceed in the normal fashion that traditional chemotherapy did. That is, if we could get good response and good benefit as a single agent, can we have combinatorial therapy showing even better benefits for our patients while being able to mitigate toxicity? 
At ASCO 2014, Mario Sznol updated the recent data of Ipilimumab and Nivolumab in combination for malignant metastatic melanoma. This was data initially presented by Dr. Jedd Wolchuck in The New England Journal of Medicine in 2013. The updates are just as promising. Although there was a bump in toxicity, response rates may have been greater. There is an indication that possibly there can be improvement in duration of response. Now, this has to be born out in randomized studies. But, as we speak today, a major Phase III randomized trial – double blinded – looking at the combination vs. each single agent alone, and blinded, has accrued and we’re awaiting that data. 
But it’s not just for melanoma anymore. It’s for multiple solid tumors. Combinatorial trials of immune check inhibitions are now accruing for lung cancer, head and neck cancer and other solid tumors. In addition, it’s not just checkpoint inhibition alone. Clinical trials are looking at PD-1 inhibition with other forms of immune manipulation. Most importantly, IDO inhibitors and oncolytic therapies. By themselves, these therapies are promising and, hopefully, in combination the promise can be improved and we can move forward in that way.

Dr. Hamid will be presenting The Promise of PD1 Checkpoint Inhibition for Multiple Solid Tumors on Wednesday, December 10 at the Antibody Engineering and Therapeutics event. For more information on his session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code XD14172BLOGJP, you can save 20% off the standard rate.


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Wednesday, November 19, 2014

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.

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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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