Cell Therapy Manufacturing Q&A – The Big3Bio Interview with Barbara Nelsen

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Cell Therapy Manufacturing Q&A – The Big3Bio Interview with Barbara Nelsen

Nelsen Biomedical is a life sciences consulting firm specializing in strategic development for companies with innovative technologies, involved in emerging industries, and focused on expanding markets. Founded in 2011 by Barbara Nelsen, Ph.D., Nelsen Biomedical harnesses the energy, leadership and entrepreneurship of to Minneapolis, Boston and Chicago life sciences communities to drive strategic growth for life sciences companies worldwide. To learn more, visit www.nelsenbiomedical.com.

Barbara Nelsen 1134-2Big3Bio caught up with Barbara Nelsen, the CEO and founder of Nelsen Biomedical, to learn more about her firm and the launch of a new market research report called Manufacturing Matters in Cell Therapy.

Q: Why is Nelsen Biomedical releasing this new report, Manufacturing Matters in Cell Therapy?

Nelsen: We developed Manufacturing Matters in Cell Therapy to provide insights and recommendations to cell therapy companies, as well as investors interested in both therapeutics as well as the foundations for the industry. We want to help companies understand the smart ways to invest in new manufacturing solutions and facilities to reduce the risk of commercial failure. We provide an analysis of the wide range existing manufacturing systems currently in use for manufacturing cell and gene therapies, and highlight new solutions available or in beta-testing that provide closed, partially or fully automated manufacturing solutions.

Based on our firm’s work in helping life sciences companies develop strategic plans and partnerships as well as evaluate new market opportunities, this report also provides insights on how and where life sciences companies should consider manufacturing their products.

Q: Why the interest in cell therapy?

Nelsen: Cell and gene therapies have the potential to shift a significant paradigm within our industry — from managing diseases to curing them. The problem is how do we make a particular cell therapy solution commercially viable so that a manufacturer will want to bring it to market. Several milestone events that occurred last year indicate that now is the time to start a deeper dialogue throughout the industry about how to make this happen. Those milestones include:

  • Significant financial investment from venture capital and public markets;
  • Key strategic partnerships between young cell therapy companies and large pharmaceuticals; and
  • Success in the clinic with cellular immunotherapies.

Q: Do you think that many challenges and barriers still remain?

Nelsen: Successfully bringing cell therapies to more patients will require the development of manufacturing solutions that are efficient, cost-effective, and scalable. This is particularly true for the approximately 60% of cell therapies in development that utilize autologous cells.

One of the greatest challenges is the cost of goods. Take for example a biotechnology company that is targeting a solution for cancer. They may have been very successful in their clinical trials, but the cost of manufacturing the product could turn a promising new solution into a commercial failure.

Screen Shot 2016-04-05 at 4.49.06 PMQ: How did you develop your report?

Nelsen: This report is not your typical market research report with pages of just data. We did site visits with commercial and institutional manufacturing facilities to understand the current state of the art, and the challenges they were facing. We conducted extensive interviews with a number of biotechnology executives, analyzing their experiences and the results they achieved based on a range of manufacturing solutions currently in use – including nine options recently marketed or currently in beta-testing that provide closed, partially or fully automated manufacturing solutions.

Q. Does the report include thoughts about future trends relating to the manufacturing of cell therapy solutions?

Nelsen: Yes. Our report features competitive intelligence on large and small-scale automated cell culture equipment, new developments in cell and gene therapy technology, and a list of future trends that will affect cell and gene therapy manufacturing over the next five years. The report also includes opinions from key industry influencers and innovators at the forefront of developing and manufacturing cell and gene therapies including:

  • John Wilson, CEO of WilsonWolf
  • Jeff Liter, CEO of BMoGen and former COO of Progenitor Cell Therapies (PCT)
  • Mark Bamforth, CEO of Brammer Bio
  • Lee Buckler, CEO of Repligen

These influencers share critical insights on how today’s life sciences companies can overcome manufacturing barriers that are preventing them from successfully commercializing their cell and gene therapies.

Q: How can someone get Manufacturing Matters in Cell Therapy?

Nelsen: Visit our firm’s website at: www.nelsenbiomedical.com.

April 25th, 2016|

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