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Big, bigger, but will they be the biggest? The past, present and future of MAbs in the market place

Monday Jun 15, 2015

By Dawn M. Ecker  (deckeratbptcdotcom)  

The modern biotechnology era began in 1982 with the approval of Humulin in 1982[a], the first recombinant product. Throughout its 32 years of existence, the biopharma industry has grown tremendously, launching over 200 biopharmaceuticals. As indicated in Figure 1, the 182 currently marketed products have generated an unprecedented $152B in global sales[b] in 2014. When the current number of pipeline products in development are coupled with discoveries and technological advances in the biopharmaceutical sciences, product revenues for the biopharmaceutical industry can only continue to grow.

For a third consecutive year, Humira is the world’s best-selling biologic and for the last two years, sales of Humira have exceeded $10B. The first biologic to break the $10B barrier in 2013, Humira sold $12.5B in 2014, recording the highest sales for a recombinant product since the beginning of the modern biotechnology era. Table 1 displays the remaining top ten biopharmaceuticals of 2014, which include a cytokine, two insulins and seven antibody-based products. The antibody product Lucentis, which has made its initial debut in the top ten in 2014, has the distinction of being the first commercialized antibody fragment product produced using a microbial system.

Looking back a decade to 2004, when biopharma was in its twenties – total sales for the then 88 approved products didn’t quite reach $50B. The top ten selling biopharmaceuticals back then were slightly more diverse, with four hormones, three antibody products, two cytokines and an insulin. Interestingly, in both 2004 and 2014, the top ten selling products comprised nearly half of all biopharmaceutical sales and four of the top ten products in 2004 have remained on the top ten list for 2014: Enbrel, Remicade, Rituxan/Mabthera, and Neulasta/Neupogen. Gone from the 2004 top ten list are the four epoetin-based hormones, the human insulin and the cytokine, replaced with insulin analogs, and more antibody products.

Ten years ago, monoclonal antibodies were beginning to make their presence known, and now, MAbs are a formidable portion of today’s biopharma landscape. Surveying the overall recombinant biopharmaceutical pipeline, it is clear from our bioTRAK® database, that antibody products dominate the development pipeline. Of the nearly 400 products in late stage development (Phase 2 through BLA/MAA/NDA application), over 80% are antibody related products. Looking closer at the antibody products and fragments in development, nearly 10% of these antibody products are produced in microbial systems. With several companies developing single chain, domain fragments and some full-length antibodies in non-mammalian systems, potential exists in the next decade for the additional commercialization of these microbial-based antibody products.

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Slide2As the development and commercialization of antibody products continue to forge ahead with no slowdown in sight, we can be assured antibodies will remain the cornerstone of the biopharmaceutical market for the foreseeable future. When looking forward to 2025, does the past decade suggest that Enbrel, Remicade, Rituxan/Mabthera, and Neulasta/Neupogen will continue to be amongst the top 10? Will microbial manufactured antibodies and fragments be “the next big thing”? Only time will tell, but we can’t wait to see.


[a]http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm081964.htm#ftn10back

[b] http://www.bptc.com/pipeline-databases.php

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Contracting – how to make it a win-win

Friday Jun 12, 2015

By Al Doig  (adoigatbptcdotcom)   and Patti Seymour  (pseymouratbptcdotcom)  

Global prescription spending exceeded $1 trillion in 2014 and revenues from biopharmaceuticals accounted for nearly 15% of this spending. Almost a third of all drug products in development are biopharmaceuticals that will contribute to the total pharmaceutical spend going forward. This anticipated biopharmaceutical sector growth will have a significant impact on future pharmaceutical company revenue. An increase in biopharmaceutical development will also drive growth for contract manufacturing services. On June 17 at BIO 2015 in Philadelphia, Patti Seymour, Senior Consultant at BioProcess Technology Consultants, will lead a panel discussion in the BioProcess Theater on “Managing the Contract Relationship”. Joining Ms. Seymour in this discussion will be Stephen Taylor, SVP, Commercial at FujiFilm Biotechnologies; Justin Skoble, Senior Director, Technical Operations at Aduro Biotech, Inc.; Tom Douville, Director, Biopharmaceutical Development at Kolltan Pharmaceuticals, Inc.; and Lily Vakili, Senior Counsel at Faber Daeufer & Itrato PC.

This panel will explore the selection and contracting process for developing and manufacturing biopharmaceuticals beginning with a detailed request for proposal (RFP). Preparing an RFP helps the client think through its needs and allows the CMO to provide an appropriate proposal, which can then form a basis for CMO evaluation and negotiation. A step-by-step negotiation process might begin with a letter of intent leading to a master services agreement that represents the appropriate interests of both parties. Contracts for biopharmaceutical develop and manufacturing services require both sides to consider a number of critical issues including risk management, intellectual property ownership, dispute resolution, cost control, access to data and information and timely performance.

The panel, representing the client and contractor perspectives, will use results from BPTC’s most recent bioPULSE® survey, Key Considerations for Selecting an Outsourcing Partner, and contract negotiation case studies to illustrate approaches and outcomes to achieve mutual agreement regarding risk, failed batches, timelines, costs and data/information access, etc. This shift toward collaborative working relationships is good business for the CMOs. Clients benefit by in getting their biopharmaceutical into the clinic. Next week’s panel is sure to provide insight into the issues facing clients and CMOs. Visit us at booth #3230 after the panel to continue the conversation.

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Can we have it all? The quest for quality, cost and speed in Biopharma

Wednesday Jun 10, 2015

By Al Doig  (adoigatbptcdotcom)   and Tom Ransohoff  (transohoffatbptcdotcom)  

At BIO next week in Philadelphia a panel of experienced biotech executives will tackle this question. There are important drivers in our industry for improving cost, quality, and speed. Until now, conventional wisdom said you could choose two of the three. Today, we are asked to deliver on all three areas simultaneously with no likely trump card in the deck. The need for speed is the upshot of breakthrough therapies, the boom in biosimilar interest and new discovery opportunities. The focus on Quality by Design (QbD) requires a deeper understanding of our processes then ever before. Finally, competition from biosimilars and healthcare cost controls are forcing us to focus on reducing our cost of goods sold (COGS) and development costs.

The panel at BIO will explore the options and opportunities likely to assist in meeting the challenges. Operational excellence initiatives and related efforts, such as advancements in platform processes, can help improve performance, but truly novel approaches and the introduction of new technologies will be critical to meaningful progress. The implementation of new technologies, such as continuous processing, process analytical technologies, and novel facilities concepts will be a focus for the discussion. Novel approaches to critical operational areas such as supply-chain management will also be party of the discussion.

The panel chaired by Tom Ransohoff, BPTC and four other biopharma veterans: Joanne Beck, Shire; Parish Galliher, GE Healthcare; Lynne Frick, Pall and Mark Brower, Merck, will convene in the BPI Theater at BIO (Booth #3207 in the BioProcess Zone) at 12:00PM on Tuesday, June 16, 2015 (not Thursday, June 18 as previously indicated and published in the May issue of BPI). This discussion, of course, takes place within an industrial context in which innovation or even incremental change is a high-risk game. Sign up for our RSS feed to follow this discussion in a follow-on blog from BPTC summarizing the panel’s thoughts and suggestions and if you’ll be in Philly don’t forget to visit BPTC at booth #3230 to share your experiences. We look forward to lots of comments and discussion.

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The BIO International Convention

Sunday Jun 7, 2015

Join BPTC at the annual BIO International Convention in historic Philadelphia, PA from June 15-18, 2015 to exchange ideas and insights on biotech’s most relevant and timely topics with the industry’s thought-leaders. Two of our consultants will be leading roundtable discussions in the BioProcess Theater. Patti Seymour, Senior Consultant and supply chain expert, will be moderating a discussion on “Managing the Contract Relationship” on Wednesday, June 17 from 12-1:30PM and Tom Ransohoff, Vice President and Principal Consultant, will be moderating a discussion on Thursday, June 18 titled, “Stretching for the Trifecta: Innovative Strategies for Speeding Development, Lowering Costs and Enhancing Quality.” We encourage you participate in these discussions and stop by booth #3230 afterwards to meet with our subject matter experts and explore how we can support the technical, strategic, and regulatory aspects of your biopharmaceutical development programs.  Can’t wait until June? Email us  (jadamatbptcdotcom)   to discuss your immediate needs now!

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Biopartitioning and Purification 2015

Friday May 29, 2015

Frank Riske, Ph.D., Senior Consultant and process development expert with broad expertise in biopharmaceutical development, management, and process implementation, will be attending the Biopartitioning and Purification 2015 conference in Vienna, Austria from June 7-10, 2015. This premier meeting in the field of separations has a special focus on two-phase separations. Dr. Riske looks forward to taking advantage of this opportunity to exchange knowledge and perspectives from industrial and academic participants. To schedule a meeting with Dr. Riske to discuss your process development and purification challenges, click here  (friskeatbptcdotcom)  .

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