Dr. Susan Dana Jones (sjones
bptc
com) will be representing Angel Biotechnology at the 2011 World Stem Cell Summit in Pasadena, CA to be held from October 3-5. To meet with Dr. Jones at the conference to learn more about Angel’s cell therapy manufacturing capabilities, click here (sjonesbptccom) .
By: Susan Dana Jones (sjonesbptccom) , Julie Dishman (jdishmanbptccom) , and Howard Levine (hlevinebptccom)
Last week’s flagship biotechnology industry conference, the BIO International Conference held in Washington D.C., lived up to its promise of bringing together industry thought leaders, technology pioneers, entrepreneurs, and established service providers. Communication forums ranging from informal “meet-ups,” information-rich break-out sessions, partnering sessions and business forum presentations, to the vast exhibition hall with three on-floor theaters, enabled attendees to interact extensively, learn about new technologies, identify potential business opportunities, and understand the current and future drivers in the biopharmaceutical industry.
BPTC was present throughout the conference, including participating in the kick-off 5K run/walk in nearby Bluemont Park, VA, chairing a break-out session on the biomanufacturing capacity, leading a lively panel discussion on the challenges of manufacturing cell therapy products, and participating in several engaging one-on-one partnering meetings. We found the mood at this year’s conference to be optimistic and upbeat giving us the sense that after weathering the significant economic, regulatory, and technical challenges of the past few years, the industry has emerged leaner, stronger, and poised for success in the 21st century marketplace.
Both large and small companies highlighted their efforts to create platform technologies and discover new products that will enable the industry to develop and supply the world with life-saving, cost-effective medicines ranging from vaccines to reduce childhood mortality in developing countries to high tech autologous cell therapies to improve the outcomes for late stage cancer patients. The podium presentations in the biomanufacturing capacity conundrum session highlighted the impact of improvements in manufacturing technology as well as mergers and acquisitions and the globalization of the biopharmaceutical industry that have resulted in an industry-wide aggregate overcapacity. However, with most of this capacity controlled by a few select companies, supply and demand discrepancies could limit smaller companies’ access to production capacity in the future. Following the presentations, a lively discussion ensued as audience members speculated on whether the large-scale manufacturing facilities designed for low titer processes and recently mothballed or shut down by some companies could be re-purposed or recycled for use in manufacturing future biopharmaceuticals using today’s high productivity processes. Session participants also debated the various economies and diseconomies of scale of today’s facilities and processes and the technology barriers and breakthroughs that may change the manufacturing landscape in the future.
The emergence of biosimilar products was also a predominant theme at this year’s conference as it was last year. As we listened to the ever growing number of companies presenting their plans for developing and marketing these products, we begin to wonder what impact this will have on the industry over the next few years. We think that the large number of companies developing biosimilar products will lead to significant competition with many of the smaller companies in this space which will be forced to partner or license their products to compete as it is likely that only those companies with strong financial and marketing resources will be able to achieve any significant market share. Finally, as investors cautiously return to the biotechnology industry, we encourage them to take a long-term view, not hampering product and technology development with unrealistic short-term goals focused more on financial gain than truly adding value. It is important to remember that biopharmaceutical development is a highly risky and unpredictable endeavor that requires careful attention to the day-to-day details of product development without losing sight of the long term goal of bringing new and innovative products to the marketplace to help patients with devastating or life-threatening diseases live longer and healthier lives. By keeping this goal in mind, investors, inventors, and the industry as a whole can and will achieve the “Leadership, Partnerships, and Breakthroughs” which were the objectives of this year’s conference and reap the economic and social benefits of directing our knowledge and energy towards improving overall global health.
By Howard Levine (hlevinebptccom) , Susan Jones (sjonesbptccom) , and Julie Dishman (jdishmanbptccom)
Next week’s BIO International Conference promises to be an exciting global event covering important developments in healthcare, agriculture and the environment. As in years past, BPTC is pleased to be a part of this event that brings together so many of the entrepreneurs, innovators, and thought leaders in the biotechnology industry. BPTC is excited to have speakers in one of the main conference sessions and in a roundtable discussion hosted at the BioProcess International Theater in the exhibit hall.
As the cell therapy and regenerative medicine fields continue to progress, many of the products resulting from these new technologies are rapidly advancing into clinical development and in some cases into the commercial environment. At the same time, this growing important segment of the biopharmaceutical industry faces its own unique manufacturing, quality, and regulatory challenges to successfully bring more of these new products to the market. Recognizing the parallels between today’s cell therapy manufacturing hurdles and the early days of recombinant protein production, BPTC has begun to apply its skills and expertise in bioprocessing, Quality, and CMC regulatory to assist companies developing these cutting edge technologies. As part of this initiative, Dr. Susan Dana Jones, Vice President and Senior Consultant, will be leading a round table discussion on “Commercializing Cell Therapy – Challenges in GMP Manufacturing: Lessons Learned from MAbs.” This round table will be held on June 29th from 12:00-1:00 PM in the BioProcess Theater at Booth 1563 – Hall A in the BIO Process Zone.
Julia Dishman, Manager, Sales and Marketing, will also attend BIO, touching base with BPTC’s current client portfolio and meeting with companies to explain how BPTC’s broad expertise and vast experience can help companies develop and implement practical and efficient CMC strategies and fulfill their process development, manufacturing, outsourcing, and quality control requirements without adding costly headcount and infrastructure.
A few short years ago, the biopharmaceutical industry faced a serious risk of shortages in manufacturing capacity as many feared that there would be insufficient capacity to meet the growing demand for biopharmaceutical products. In response, there was a big push to expand or build new capacity coupled with concerted efforts to improve productivity and product yield at all stages of the manufacturing process. These initiatives, coupled with mergers and acquisitions, have resulted in today’s industry-wide oversupply of manufacturing capacity as well as a consolidation of capacity into the largest firms. This paradigm of supply and demand mismatches limits smaller companies’ access to capacity and will be explored in “The Biomanufacturing Capacity Conundrum: Matching Supply and Demand Over Space and Time” panel chaired by Dr. Howard L. Levine, President and Principal Consultant. The panel will be part of the Manufacturing of Biologics and Drug track, to be held on June 28th at 10:00-11:30 AM in Room 145A of the Walter E. Washington Convention Center. In addition to moderating the panel, Dr. Levine will also present “Global Trends in Biomanufacturing: Separating the Haves from the Have-nots.”
BPTC looks forward to meeting long-time friends and colleagues at BIO and hearing more about advances in technology, emerging products and companies, and current trends in the biopharmaceutical industry. And, recognizing that BIO is not all work and no play, Howard Levine and Susan Jones will be participating in the 2011 BIO 5K Run/Walk. Please contact us in advance to schedule a meeting or join us at the run/walk for a chance to meet informally and support diabetes research.
We look forward to seeing you in Washington!
Howard L. Levine (hlevinebptccom) , President and Principal Consultant will be moderating a session on “The Biomanufacturing Capacity Conundrum: Matching Supply and Demand Over Space and Time” in the Manufacturing of Biologics and Drugs Track to be held on June 28th from 10-11:30AM in room 145A. Susan Dana Jones (sjonesbptccom) , Vice President and Senior Consultant, will be presenting and participating in a roundtable discussion on “Commercializing Cell Therapy – Challenges in GMP Manufacturing: Lessons Learned from MAbs” to be held on June 29th from 12:00-1:00PM in the BioProcess Theater in the exhibit hall.
On May 20, 2011, Dr. Howard Levine will be speaking on the challenges in GMP manufacturing of pluripotent stem cells, applying lessons learned from monoclonal antibodies and other biologics manufacturing at the 17th Annual Meeting of the International Society for Cellular Therapy. The conference program includes sessions on stem cells, regenerative medicine and tissue engineering, cardiovascular cell therapy, and T Cell Immunotherapy. For more information regarding the conference, please click here. To schedule time to meet with Dr. Levine at the conference, please click here (hlevinebptccom) .
