Magazine Article | October 31, 2013

NeoStem's CEO Spearheads Stem Cell Research Collaboration With The Roman Catholic Church

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By Rob Wright

There are three taboo topics at work — sex, politics, and religion. You would think discussing science should therefore be acceptable. However, strike up a conversation on stem cell research, and you’re likely going to be covering all three of those taboo topics.

Now imagine you are the CEO of a stem cell therapy research and development company, and you decide to discuss the benefits of stem cell research with the executive leadership of one of the largest and wealthiest organizations in the world, which, by the way, has also taken a firm and very public position against the use of embryonic stem cell research — the Roman Catholic Church. That is exactly what Robin Smith, M.D., chairman and CEO of NeoStem (NASDAQ: NBS), decided to do. Not only did Smith strike up a conversation, she and the team at NeoStem successfully orchestrated what has been characterized as the Vatican’s first-ever contract of collaboration with an outside commercial venture to advance adult stem cell research.

This unprecedented initiative pairs NeoStem and the Stem for Life Foundation (SFLF), a public charity it helped form and for which Smith serves as president and chairman, together with the Pontifical Council for Culture and its charitable organization — Science, Theology and the Ontological Quest (STOQ), an alliance of experts from the disciplines of science, theology, and philosophy. The purpose of this collaboration is to promote and conduct an interdisciplinary dialogue to build a bridge between science and theology. This union also is intended to expand research and raise awareness about adult stem cell therapies and explore their clinical applications in the field of regenerative medicine as well as the cultural impact of such research. Smith shares her insights on the purpose and process of brokering a deal with a religious organization, something many scientists might view with skepticism.

It’s Not About Religion
When Francis Collins, M.D., Ph.D., was nominated for the position of NIH director in 2009, some members of the scientific community publicly questioned how Collins, an avowed Christian, could lead the NIH when his faith positioned him as an advocate of profoundly antiscientific beliefs. NeoStem’s Smith has faced similar controversy. In 2011, UC Davis School of Medicine associate professor Paul Knoepfler, Ph.D., described the collaboration between the Vatican and NeoStem as a $1 million gamble, questioning the mixing of science and religion. “To shy away from a certain group that has an incredible influence on over a billion people because its religious beliefs are different than yours, just doesn’t make sense,” Smith states. “It is not about religion, nor my religious beliefs. This is about education.”

According to Smith, there is a tremendous amount of confusion between the types of stem cell research being conducted. “If you look at the progress that’s been made over the last 10 years, people really don’t get it,” she states. “They don’t understand how much progress has been made using adult stem cells as the source of cells. Today there are 4,600 adult stem cell trials and only 26 embryonic.” Further, Smith notes, many followers of the Catholic Church don’t realize the Vatican is not opposed to adult stem cell research and even stem cell research involving fetuses that have been spontaneously aborted. Smith believed a collaboration with the Vatican could help clear up some of the confusion and misinformation around stem cell research, which would be in the best interest of those looking for cures for chronic diseases and NeoStem shareholders. Fostering that kind of understanding would also help to meet the stated objectives of the Stem for Life Foundation (SFLF) — raising public awareness of adult stem cell therapies and supporting adult stem cell R&D. But before the Vatican and NeoStem could embark on the task of educating the 1 billion+ followers of the Roman Catholic Church on stem cell research, they first needed to become educated about each other. “After the first meeting, I sent representatives of the church home with 80 articles on stem cells,” she explains. Smith, who is Jewish, also went out and bought Catholicism for Dummies by Rev. John Trigilio Jr. and Rev. Kenneth Brighenti. “There are things they don’t believe in, such as IVF [in vitro fertilization], and so it’s important to understand their sensitivities,” she states. The process of due diligence on the part of all collaborators, from the initial meeting to the signing of an agreement, took about five months — a fairly quick process when you consider the conservative nature of the parties involved. Dr. Smith noted the process of creating the collaboration moved much more quickly when compared to discussions NeoStem has had with large pharma companies and other industry partners. “With strategic partnerships,” says Smith, “it takes time to find the right fit, at the right time, with the right budget cycle.” She says in the case of a strategic partnership, one party is usually asking for something, while the other gets something, which can take time to negotiate. With the Vatican collaboration, there was no real negotiation. “We set forth with what we wanted to accomplish, how we could do it together, and put it on paper,” Smith states. At the top of Smith’s list of keys to moving the process along she placed trust. “They had to get comfortable we would not do something that would be in opposition to their faith,” she states. “They really trusted us to respect their beliefs.” Second on the list was communication, closely followed by goals. With the primary goal being education, the collaborators began to set out how to go about educating.

The Mission Of Education
The education process not only involved teaching the followers of the Catholic Church about adult stem cell research, but helping thought leaders of science and theology gain an understanding of one another. One of the best mechanisms by which to do this is through a conference with “open dialogue.” It took about a year and a half to put together the first conference, held at the Vatican, Nov. 9-11, 2011, and titled, “Adult Stem Cells: Science and the Future of Man and Culture.” It included adult stem cell research experts, recognized leaders in life sciences, medicine, religion, ethics, public policy, as well as CBS award-winning medical broadcast journalist, Max Gomez, Ph.D. “We felt that if we could get a statement from the pope during the event saying he supports adult stem cell therapies, people would truly believe the Catholic Church was supportive of this science, which would be monumental,” says Smith in regard to gaining buy-in from the masses. “We told the pope we intended to write a book as another component of the educational process.” Entitled, The Healing Cell: How the Greatest Revolution in Medicine Is Changing Your Life, the book is co-authored by Smith, with Monsignor Tomasz Trafny and Max Gomez. It also includes a foreword by Gianfranco Cardinal Ravasi, president of the Pontifical Council for Culture, and an address by Pope Benedict XVI, which states, “In general, no such ethical problems arise when stem cells are taken from the tissues of an adult organism, from the blood of the umbilical cord at the moment of birth, or from fetuses who have died of natural causes.” This type of statement from the pope is exactly what the collaboration team hoped would move their educational initiative forward.

The book, published April 2, 2013, was followed by the second international educational conference at the Vatican. Building upon the success of the previous conference, this year’s tripled in the number of attendees and included correspondents from the Wall Street Journal, CBS, NBC, and Fox, actual stem cell patients, top-level researchers from the likes of the Dana-Farber Cancer Institute and the University of Texas MD Anderson Cancer Center, as well as numerous industry executives from such well-known companies as Pfizer and Celgene. “We also brought students in from around the world via a student ambassador program, to create a bigger education platform,” states Smith. “Not only do we have to educate church leaders and individuals, but you have the whole secondary process to help the next generation of thought leaders understand the science, misconceptions, and the various issues surrounding stem cell research.”

According to Smith, the collaboration has set its sights on milestones around electronic media, e-learning, DVDs, and social media. The collaboration also would like to raise money to help fund stem cell research. “Until investors see there is a pathway to commercialization and a clear regulatory pathway to approval, funding will not be plentiful,” she affirms. “In the meantime, we need to look for support through foundations, grants, and philanthropic money and create a forum for funding these programs.” Smith believes the collaboration a success, pointing to the fact that even with the changing of the pope from Benedict XVI to Pope Francis, the partnership was extended through 2020.

NeoStem’s CEO has had a busy year, co-authoring and publishing a book, moving the company from trading on the NYSE to the NASDAQ, brokering an agreement with the Vatican, hiring a new CFO, CMO, and executive vice president, and receiving a Key Founder’s Award from the Vatican. Investors have been taking notice of Smith’s efforts. With the stock trading around its 52-week high of just under $10 (at the time of this writing), some analysts are anticipating an even greater upside, especially if the company gets good news on AMR-001, a treatment targeting patients at risk from congestive heart failure, significant arrhythmias, premature death, and acute coronary syndrome — a $1.2 billion market.


Is Mixing Religion And Science A Good Idea?

According to the University of Maryland Medical Center, a growing number of studies reveal that spirituality may play a bigger role in the healing process than previously thought. Qualities like faith, hope, forgiveness, and the use of social support and prayer seem to have a noticeable effect on health and healing. For example, a 35-year clinical study of Harvard graduates revealed that graduates who expressed hope and optimism lived longer and had fewer illnesses in their lifetime. Results from several studies indicate that people with strong religious and spiritual beliefs heal faster from surgery, are less anxious and depressed, have lower blood pressure, and cope better with chronic illnesses. “When people have a health illness, they either go to religion or reject it,” says Robin Smith, M.D., the chairman and CEO of NeoStem. Some may argue that spirituality or prayer in treatment is merely a placebo effect. They may be right.

In the January-February 2013 issue of Harvard Magazine, Ted Kaptchuk, a professor of medicine at Harvard Medical School and the director of the Harvard-wide Program in Placebo Studies and the Therapeutic Encounter (PiPS), reported a very interesting finding just two weeks into a randomized clinical drug trial. Nearly a third of the 270 subjects complained of awful side effects. All of the subjects had enrolled in the study hoping to alleviate severe arm pain. In one part of the study, half of the subjects received pain-reducing pills; the others were offered acupuncture to alleviate the pain. In both cases, people began calling in complaining of side effects, which just so happened to be the same as the side effects they had been warned the treatment would produce. More astoundingly, other patients reported real relief, and those who received acupuncture felt better than those on the anti-pain pill. No study had ever proven acupuncture to be superior to painkillers — neither did Kaptchuk’s. Here’s why. The pills were placebos consisting of cornstarch. The acupuncture needles were retractable shams that never pierced the skin. The study was designed to compare two fakes. Researchers have found that placebo treatments can stimulate real physiological responses, and thus why one of the key components to gaining drug approval is proven superiority of an active medication over placebo. According to Kaptchuk, the challenge now is to uncover the mechanisms behind these physiological responses – what is happening in our bodies, brains, in the method of delivery (e.g. needle versus pill), in the room where placebo treatments are administered (e.g. calming physical surroundings, caring versus curt doctor) — because the effect is actually many effects woven together. While at it, perhaps researchers should investigate spirituality’s impact on the placebo effect. Rather than trying to separate science and religion, let’s take a closer look as to how they may, or may not be, inextricably intertwined.

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