Lisa recently sat down with Dana Tennis of RetirementDNA to discuss her background in biology, her memorable time at Georgetown, and her unique insight into the present and future state of biotech in San Diego and around the world.

Q1: You’ve worked the research bench, as they say. And now you’re one of SD’s legal stars. Tell us about your path, and how you arrived in San Diego.

I was a Biology major at Rollins College in Winter Park, Florida and then moved back to my home state of Maryland to attend Georgetown University School of Medicine for graduate school in Microbiology and Immunology.  After getting my Ph.D., from Georgetown, I applied for post-doctoral positions all over the U.S.  I narrowed it down to a post-doc at Roche in Nutley, NJ; UCLA; or La Jolla Cancer Research Foundation (now The Burnham Institute) in La Jolla, and interviewed in that order.  My last night in La Jolla, some post-docs from the Salk Institute took me out to Carino’s for pizza in La Jolla and while we were waiting for a table, we sat on the beach.  That was all it took for me to be convinced this was the city I wanted to move to after graduate school.

Q2: What are some of your fondest memories back at Georgetown? You must have some funny research stories!

I have some great memories of Georgetown.  I remember one winter evening walking over to the main campus from the medical school and running into Patrick Ewing.  I will never forget it because his ski jacket looked so small on him and the sleeves were at least 2-3 inches from his wrists.  He looked like this big kid in a little jacket! 

We worked hard in graduate school but also had a lot of fun, given our proximity to M Street in Georgetown.  We would set up experiments by about 4:30-5:00pm and wander down to Georgetown for happy hour.  As grad students, happy hour always meant cheap drinks and free food so that was dinner most nights!  We’d head back to the medical school building around 8pm and take off our gels or change culture media or do what we needed to do to finish experiments and head home by midnight.  Those were long days but we found ways to make them fun.

Q3: What are some of the biggest changes you expect to see in the biotech and life science industry over the next 5, 10, and 20 years?

I think we’ll see more “designer” or patient specific therapies.  It is becoming increasingly clear that most drugs are not one size fits all.  There are always going to be subpopulations that will not respond to particular drugs so I believe we’ll see more and more patient specific therapies, such as cancer vaccines.

I am also hopeful that the FDA will implement some guidelines with respect to generic biologics in the near future.  There have been many threats by the FDA over the past 7-10 years but I believe we will see some regulatory guidelines in this area over the next 5-10 years.

Q4: It seems like the VC side of the business is the one side of the business you have not tried. Would you consider it?

Never say never but I haven’t really considered it.  Right now, I have the best job in the world.  I work with leading edge technologies and top scientists, including several Nobel Prize winners, and innovative entrepreneurs in nearly every technical area of life sciences. I have many VC clients so I have had the opportunity to see that side of the business firsthand over the past several years.   I never get bored in my position and never have a day that isn’t filled with challenges.  That isn’t to say that the VC side of the business wouldn’t offer me the same personal and professional opportunities, but for now, being a legal, business and technology advisor to my clients is a job that I cannot imagine stepping away from.

Q5: What is the most important piece of advice you would give a firm looking for funding in the biotech space?

Every company is different and every situation is different, but generally speaking, I’d say “focus” is the key.  There are so many early stage companies that have several project areas and don’t have focus.  In order to attract top tier VCs and funding, you really need to show that you have project areas that are going to bring a return on the investors’ investment in a reasonable period of time, whether it means getting a drug to market or being acquired, for example.  Along with the focus, having realistic expectations as a CEO or biotech entrepreneur is always critical. 

Q6: Any thoughts on how biotech companies can better leverage and allocate the money they do raise?

I believe many of the biotech companies do a good job with the money that they raise.  If they have experienced VCs on their boards, it is hard to get too far off track with the money.  Again, I think focus is the key.  On the IP side, I would say that cheaper isn’t necessarily better.  I have come in and cleaned up many patent estates because the company tried to be cheap early on and didn’t get proper legal counsel in the process.

Q7: What do we need to do to improve speed-to-market for biotech companies?

The more resources a company has, the higher the likelihood that discovery and development will proceed at a faster pace.  Resources include financial and human capital!   In addition, as we all know, the FDA process could always use some improvement, but we’re getting there.  

Q8: What differences are you seeing - political, regulatory, religious or economic- in international biotech markets as compared to the U.S.? As a partner in a global law firm, you have a unique perspective.

Different countries have different standards on what is patentable so that factors into strategies for protecting products worldwide.  There are also differing political views on technologies such as stem cells, so for example, countries like Australia are much more liberal on the topic than the US.  India and China have been emerging recently as important markets for pharmaceuticals, for example, so product development and IP strategies have been expanded to include these countries in addition to the key markets previously considered, such as the US, Europe, Canada, Japan and sometimes Australia.

Q9: What are the global legal challenges related to patents for biotech companies?

There are different patent laws and different standards of patentability worldwide.  Unfortunately, we do not have harmonization worldwide at this time with respect to many patent laws and rules.   Many countries still do not allow patents covering methods of treatment of the human body, while others do.  Some countries like Japan, are more strict with respect to the scope of protection that they will allow.  The US is considering moving to an opposition practice similar to Europe, which will change the examination process and likely reduce the amount of litigation of patents in the US.  There are a lot of potential changes in the patent laws that we may see in the near future.

Q10: How do U.S. companies navigate global patent issues?

They hire experienced patent counsel who have worked with foreign counsel on patent issues worldwide!  No one can be an expert in the laws of each country so we have established long term relationships with foreign counsel and rely heavily on them for advice in our patent strategies depending on what the subject matter of the patent applications is and where our clients’ or their partners’ major markets are located.

Q11: What are your thoughts on the recent Supreme Court decision which changed the standard for determining obviousness of a new invention?

I have mixed feelings.  While the case relaxed the test for obviousness and allows for flexibility in determining whether an invention is obvious, with that flexibility comes unpredictability and possibly inconsistency.  It is a little unclear what standard will be applied at the USPTO and what standard will be applied by the Federal Circuit.  Time will tell.  In the more crowded areas of biotech, like antibodies, for example, I think the new rule (or lack thereof) will make obtaining patents more difficult.  However, in less crowded fields with some inherent unpredictability, as in stem cells, I think the new case will be less likely to affect patentability.

Q12: If you woke up as President for a day in 2008, what would be your top three initiatives?

Great question!  In no particular order:  1) Mandatory education and healthcare for all US citizens and those employed by US companies (e.g., including illegal immigrants in California that we choose to employ in our businesses); 2) Expand funding opportunities for stem cell research, cancer research and other areas of scientific research; 3) Determine a deadline for exit from Iraq.

Q13: We all improve by working on our weaknesses. What weaknesses does San Diego have as a biotech cluster city that you feel warrant improvement?

I have been in the San Diego biotech “cluster” for over 20 years now.  It is still a relatively young biotech community as compared with the Bay Area and Boston.  In order to be a more mature cluster, it takes infrastructure including top non-profit research institutes and universities, large pharma or large biotech companies, and adequate funding sources.  We can probably improve on the latter two aspects.  We have attracted J&J, Novartis, Pfizer and other companies to San Diego, and with that, we will continue to attract experienced executives who have been through discovery and development of products through to manufacturing and marketing.  San Diego does not have the depth of expertise in manufacturing and marketing so we need to continue to attract experienced folks in those areas.  We have a number of funding sources in San Diego, but it is light as compared with the Bay area or the Boston area.  Clearly, the more sources of funding we have locally, the more mature the San Diego biotech community will become at a faster rate.  Bay Area investors are pouring money into San Diego, but I think we could do better with a higher concentration of investors in our back yard.

Q14: You’re a great role model for women in science. Do you have a desire to leverage your status for young women?

I enjoy mentoring young women and encouraging them to be more involved in math and science.  I have spoken to many classes in elementary school grades through high school about cancer research and various careers in math and science.  I have spoken at several Association for Women in Science (AWIS) meetings about alternative careers in math and science and enjoy participating in those events.  I also serve as an “external mentor” for Deloitte as well as a mentor at my own firm.   

Q15: Lisa, you’re a parent, so perhaps this question is already on your mind. What do you feel we need to do in this country to catch up to other countries and instill a passion for math and science in our kids?

There have been a lot of studies and it is clear that we either lose or maintain our kids’ interest in math and science between 5th and 8th grade.  Those are the ages where it isn’t as “cool” to be smart and find science and math appealing, let alone do well in those courses.  We need to find ways to capture our kids’ interest at those ages and make math and science exciting and acceptable within their peer group.  There have been more and more summer programs focused on kids at those ages and with parents encouraging their kids to be more involved in these programs, I think we’ll be able to find the next generation of biotech and high tech entrepreneurs, scientists, engineers, etc.

Q16: San Diego has many great places to escape to your thoughts. Where do you go to get away and think?

I have a convertible that I like to use on weekends so driving up the coast with the top down anywhere from La Jolla up to Carlsbad where I can see the ocean and the dolphins playing in the waves is the best escape for me.

Q17: When you want to enjoy a quiet dinner in town, where is your favorite place?

Just about any place with good seafood or a good view, and preferably both!  If I want to get my “Maryland crab fix”, I’ll go to Oceanaire for crab cakes.  For the view and good seafood, I like Pacifica in The Plaza in Del Mar.

Q18: Lisa, it’s time for our classic question. What is the signature Haile dish to prepare? What wine would accompany your dish and what music selection would be playing in the background?

As much as I love to cook, I don’t make the time often enough.  When I do have the opportunity, I usually make baked or grilled sea bass with lemon and capers and a bit of Grey Poupon mustard on top, with a side of brown rice and asparagus.  I don’t follow the “rules” with wine so I typically pour a nice red blend or a smooth cab regardless of what I am eating!  Frank Family, BV, or Galleron are my current favorites.  For the music, I’d say something older like Jackson Browne or Van Morrison.

Thanks, Lisa.