Interview with NeoStem CEO Robin Smith Part 1

I recently met the CEO of NeoStem, Dr. Robin Smith, at the 2012 World Stem Cell Summit in Florida. We had a great talk and I invited Dr. Smith to do an interview for my blog. She agreed and has provided very frank answers to my questions, some of which I think were very difficult questions. I want to thank Dr. Smith for participating in this interview and providing such detailed, frank answers.

Today’s post is Part 1 of two of this interview. In a few days, I will post Part 2, which is focused in depth on VSEL, ES cells, and iPS cells.

PK: On your company’s website you list three assets: Amorcyte, Athelos, and VSEL. Can you briefly fill us in on where each product stands in terms of its development and importance to the company?

Smith: NeoStem’s most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC (“Amorcyte”), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001’s efficacy in preserving heart function after a heart attack. Athelos Corporation (“Athelos”), which is 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSEL™ Technology platform which we hope to bring into human testing for boney defects in 2013.

PK: What about NeoStem Family Stem Cell Banking? Is that an important part of NeoStem? Finally, how does PCT fit in?

Smith: If we can imagine a future wherein stem cell therapies are increasingly prevalent, we can also imagine that stem cell banking, of both cord blood at birth and adult stem cells from healthy donors, will be increasingly important to provide viable cells for potential autologous therapies. NeoStem has its early roots in this banking business and continues to offer the service of collection and storage both for private individuals and for client companies developing cell therapy products. We anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. NeoStem’s contract development and manufacturing service business, Progenitor Cell Therapy (PCT), supports the development of proprietary cell therapy products, both for NeoStem’s internal development and for a variety of cell therapy industry clients. In addition, PCT has provided services to over 100 clients in its 13-year history, and is the only contract manufacturing organization to have worked with a client’s product (Dendreon, Inc.’s Provenge) through all of the phases of clinical trials and ultimately to FDA approval. PCT offers its clients and NeoStem cell processing and development capabilities on both the East and West Coasts of the U.S. and the ability to cost effectively develop cell therapy products.

PK: There has been some confusion amongst the members of the stem cell field over the relationship between NeoStem and The Vatican, particularly as it relates to funding from The Vatican to NeoStem. Can you clarify this by commenting on the relationship and the objectives related to the funding?

Smith: In May 2010, NeoStem and the Pontifical Council for Culture announced the Vatican’s first-ever contractual collaboration with an outside commercial venture to advance adult stem cell research. Through the Pontifical Council for Culture’s charitable foundation, STOQ International, the Council made an economic commitment of one million dollars to start the collaboration. Some writers have mistakenly said that the Vatican invested in NeoStem, but that is not the case. The Vatican and its entities are not investors in NeoStem. The Council has set aside funds from philanthropic supporters to support the joint initiatives, which have been used for activities such as the 2011 Vatican Adult Stem Cell Conference and a journal of articles produced after that conference. NeoStem and the Stem for Life Foundation have also supported the joint collaboration initiatives and believe the collaboration and joint initiatives benefit the field of regenerative medicine and fulfill the mission of the foundation, as well as benefit Neostem shareholders.

PK: What about the support of Stem for Life Foundation by NeoStem? Isn’t it unusual for a for-profit publicly traded company to have a relationship of this kind with a private, at least in part ideological foundation? How did this come about and why? Any particular reaction from investors?

Smith: The Stem for Life Foundation was established in 2007 with the mission of educating the public, convening the best minds in adult stem cell medicine and research, supporting clinical research, and subsidizing adult stem cell collection and storage for those who need it most such as first responders.  It is founded on science and the hope for medical advances, which are agnostic pursuits.  While founded by NeoStem, over the past 5 years the foundation has received significant donations and maintains the status of a public charity.  In addition, the Stem for Life Foundation maintains independent Scientific and Interdisciplinary Advisory Boards, consisting of leading names in cell therapy, medical and business communities, including Drs. Anthony Atala, Stephen Nimer and Martin Bednar.

PK: I’m interested in your new book with co-author Monsignor Tomasz Trafny. What was the impetus for this and what are its key messages? Why should people interested in stem cells read it?

Smith: Today we face a great challenge of education.  Misperception about adult stem cell research interferes with funding needed to bring these therapies through the clinical development cycle.  People need to be educated about the advancements in stem cell research and understand the advances, efficacy and safety profiles of adult stem cells and the hope for those people around the world who suffer from chronic and debilitating disease. It’s through a lack of understanding of this fact that we now have a political and financial environment which is driven more by emotion than data.  The goal of this book is to help educate people that all cells are not alike and that different cells will have different therapeutic potential, and do so in a positive way that will advance the field as a whole and give people hope around the world that huge medical advances are in the making.

Stay tuned for part 2 of the interview coming soon!