Harry Gonso is a partner at Ice Miller LLP.  His primary areas of practice concentration are in general corporate and transaction law and life sciences.

Blog written by Harry Gonso and Jennifer Rhodes.

In the fifth in a series of life science distinguished speakers luncheons we were honored to have Jim Pearson who is the president and CEO of NICO Corporation, a medical device company providing patented technology for minimally invasive neuro, skull base and spinal surgeries.

Pearson, who is the former president and CEO of Suros Surgical Systems, discussed the successful internally-focused model he has used to grow two thriving life sciences companies.

One of his key discussion points was that to have a successful life sciences company you need a relevant innovation which can lead to intellectual property clearances which in turn can lead to sustainability and new markets.  He later mentioned that one of the pitfalls that companies or individuals may face is not truly understanding the reality of their ideas; a realistic evaluation to determine if the idea is a product, a company or is still in the idea stage.

Pearson's presentation also focused on the key ingredients that led to success at both Suros and NICO.  Companies, and in particular life science companies, need to have a several components in place in order to achieve and sustain growth – some key factors he mentioned were communicating and measuring progress, establishing cultural norms, and making sure every team member has "a win" (ownership, cash, and personal and professional growth).  NICO is run with a deep-rooted belief in the company's top 5 principals: execution, team work, unity, rewards system and balance.  The same philosophy was employed at Suros.

Potential business traps that entrepreneurial companies can fall prey to were also outlined.  Of particular focus was not assembling a strong management and board that can appropriately guide a company through its many phases.  Some of the other key pitfalls he discussed were related to staff.  One of which was not understanding the true power (or potential) of human capital and the other was not staying in touch with what is happening in the field on a weekly basis.

It was an interesting and informative luncheon.  We look forward to watching the progress of NICO and the impact it will have on Indiana's growing life sciences industry.

Dr. Eric Meslin, Director of the Indiana University Center for Bioethics, provided the keynote address during the Firm's life science distinguished speaker's series luncheon.  As an Associate Dean for Biothics at the IU School of Medicine, Dr. Meslin was able to offer a particularly worldly view to issues affecting ethics and health care.

Dr. Meslin's remarks were appropriately titled, "What in the World Does Ethics Have to do With Health Research?"  He made reference to the title several times during his remarks as he expounded on the theme and took an historical look at how ethics and health care have evolved.

Soon into his remarks, a photo from the Nuremberg trial appeared on the screen, an obvious response to the rhetorical question of, "why should we care?"  The photo featured 23 Nazi scientists who were accused, and later convicted, of some of the most heinous crimes known to man, in fact we call them crimes against humanity.  The trial resulted in the a document called the Nuremberg Code which many refer to as the first modern medical ethics, or research ethics document, which mandates that voluntary consent of the human subject is absolutely essential.

Dr. Meslin continued his remarks with more recent cases of unethical research, sometimes involving violations of human rights. Of particular interest was the Abigail Alliance case.  The issue involved a young woman who wanted to join a clinical trial but was denied the opportunity and died later in part as a result.  The case further complicated the issues involved in ethics and health care.

With more and more money being spent on research, the need for standardized documents and protocols increases.  According to one account, between 1998-2003, the global expenditures on health care research quadrupled to about $125 billion.  By 2000, 70 percent of all clinical trials were funded by the private sector. 

So, to quote Dr. Meslin, what in the world does ethics have to do with health research?  A lot.  As the good doctor states, all studies involving human subjects must, not may, must receive prior science and ethics review.  Collaborative research, especially research between economically and developed or developing countries, requires some common set of ethics guidelines or procedures.  Finally, we must learn from our past and make a pledge to never repeat any of the egregious crimes against humanity.

BioCrossroads recently announced the first recipient of the "Indiana Life Sciences Champion of the Year."  Appropriately, the accolade went to Mr. Leonard Betley, President and CEO of the Richard M. Fairbanks Foundation.

The award recognizes an individual who has made, "significant achievements in the development and promotion of Indiana's life sciences sector; personifies the emerging face of the Indiana life sciences industry; and promotes innovative development of the life sciences in Indiana."  Certainly Leonard fits the bill and his collaborative work in the life sciences sector is without question.

I had the privilege of working with Leonard when he was an attorney, and Managing Partner, at Ice Miller and in fact he recruited me to the Firm in 1980.  I consider Leonard a colleague and friend and couldn't be more pleased that his achievements are getting some well deserved recognition.  Leonard has had a remarkable career.  Throughout, his quiet effectiveness always lead those that he worked with, whether law partners, scientists or business people, to a successful event.  He had the uncanny knack of seeing the future and orchestrating people and events to take advantage of that vision.  Part of the folklore at Ice Miller is a retired partner's statement about him "I just wish Leonard would tell us how this is all going to work out."

In announcing the award, Gus Watanabe, of BioCrossroads wrote, "In you, we indeed found the perfect way to begin a long and distinguished tradition of honoring Indiana's true 'life science champions.'"  Well said.

Read the press release announcing the award.

We were fortunate enough to have Dr. Mervin Yoder join us for our second life science distinguished speaker's series luncheon.  Dr. Yoder is a professor of pediatrics and biochemistry and molecular biology at the Indiana University School of Medicine.  He has written extensively on human umbilical cord blood banking and stem cell research.  The timing of Dr. Yoder's remarks couldn't have been better as the Indiana statehouse recently signed legislation that established a public umbilical cord blood bank in Indiana (HB 1172).

Dr. Yoder focused his remarks on three areas: 

• cord blood and vessel origins;
• stem cell types and sources; and
• uses of umbilical cord blood.

There are two main categories of stem cells: embryonic stem cells (ES), which are derived from the cells of mammalian embryos, and adult, or somatic stem cells. 

Stem cells hold particular promise in the treatment of diseases affecting bone marrow, nerve cells, heart muscle cells and pancreatic cells specifically for their ability to self-renew, or to divide and give rise to other stem cells. 

Research into embryonic stem cells is relatively new.  The first cord blood transplant was successfully completed in 1989.  Since then, there have been 7,000 cord blood transplants and an increase in the number of cord blood banks.  Cord blood has been proven as an effective treatment for a number of blood diseases.  In fact, nearly 90 percent of children who have a fully matched sibling survive, but only 40-50 percent of patients receiving an unrelated donor transplant survive. 

Dr. Yoder concluded his remarks with a look to the future.  Specifically, he called on public cord blood banks to establish procedures and guidelines for collecting, maintaining and receiving donations.  He also issued an appeal to banks to continue to educate health care professionals about the guidelines and to work with the healthcare community to establish procedures concerning patient informed consent and privacy.  Finally, he issued a call to action to all in attendance to help promote public awareness of the benefits of cord blood banking and stem cell research.

Clearly the research at Indiana University and the passage of HB 1172 has put Indiana on the map with respect to cord blood banking.  Now's the time to expand our reach and continue to innovative and find new treatment options for life threatening diseases.

February 21, 2008, marked the inaugural of  Ice Miller's life science distinguished speaker's series.  We were fortunate enough that Homer L. Pearce, Ph.D., could join us as the featured speaker on the "Progress in the War on Cancer."  Homer spent the last 30+ years working in cancer research and development.   He also has a continuing distinguished career of scholarly publications, teaching and consulting and advisory services in the cancer field.

The unofficial war on cancer was declared in 1971 during President's Nixon State of Union address. Later that year, Nixon signed the National Cancer Act into law, declaring, "I hope in the years ahead we will look back on this action today as the most significant action taken during my Administration."  Since that time, over $200 billion has been allocated to cancer research.

Statistics surrounding the causalities in the war on cancer are staggering.  It is still a major disease.  Over 1.5 million Americans will be diagnosed with cancer this year – an average of one every 30 seconds.  About 600,000 deaths occur each year.  In 2010, cancer will likely be the leading cause of death in the U.S. 

But there is some progress in the war on cancer and Indiana's life science community is playing a significant role.  Indiana is home to some of the leading cancer research institutions, including Indiana University and the Purdue University Cancer Center.  Biotech companies are creating both innovative diagnostic tools and genome therapies.  Our major pharmaceutical companies are also bringing to market targeted pharma solutions.

Future prospects will likely include personalized drug protocols for each patient with treatment based on individual profiles.  New technologies in screening and detection will also play a major role as will prevention.

As Dr. Pearce observed, one thing is clear – a victory in the war on cancer can only be declared through a spirit of mutual trust and cooperation between all stakeholders.