Immunotherapy, Bioinformatics, Devices: EPPICon 2017 Preview

 

One of the latest most talked about buzzwords in cancer treatment is “immunotherapy” where body’s immune system is used to wage a war against the cancer cells. Cancer cells divide rapidly than ordinary cells and manage to evade the immune system. The focus of a range of immunotherapies is to put body’s immune system on high alert so it can easily locate and destroy cancer cells.

This year, EPPICon (annual flagship conference at eppicglobal at www.eppicon.org) will focus on Immunotherapy, Bioinformatics, and Devices. Another recent buzzword, “bioinformatics” focuses on harnessing technological advances for management and analysis of data, for cancer immunology and immunotherapy.  The hope is that more reliable and comprehensive picture can emerge of tumor genomics landscape and that can point a way towards more effective personalized medicine.

Immunotherapy often involves delivery of a cocktail of immune drugs to awaken the body’s immune system and put it in a “ready” mode to get rid of the cancer cells. Implantable devices can be used to provide regular dosages of medication for several days or everyday for a few weeks and can be used to make localized delivery.  This convergence of technologies makes it an interesting time for treatment of cancer and other diseases.  

EPPICon, EPPIC’s all day conference will be held on Saturday, March, 25th at Crowne Plaza, Burlingame, CA and has a fabulous lineup of keynotes, speakers, and panels.

Morning keynote, Ira Mellman is VP of Cancer Immunology at Genentech and has an illustrious career in solving most profound health problems with strong research, grounded in science.  He spent 20 years at Yale University School of Medicine, prior to joining Genentech in 2007.  After the keynote, the conference program will continue with excellent speakers and panels with a special speed pitch session thrown in, where startups looking for funding will have an opportunity to pitch to a panel of investors and receive critical feedback, in real time. At the end of the day, 2017 “EPPIC Eleven” awards will be given out to chosen startups, from around the globe.

To register for the conference, please go to www.eppicon.org .

Critical Attributes in Leaders at Various Stages of Leadership Journey

EPPIC, an entirely volunteer driven, non-profit organization, found with a mission to create a forum to leverage entrepreneurship, mentoring, and networking opportunities in life sciences, celebrated its 15^th anniversary, at TiE office, in Santa Clara.  The event, sponsored by Genentech, was attended by 110 life science professionals, and served as an early introduction to 2014 Eppic Annual Conference, scheduled for February 1, 2014, at Westin, South San Francisco.  The agenda for this anniversary event included 3 excellent panels and concluded with a keynote by Ann Lee, Senior Vice President of Global Pharma Technology Development at Genentech/Roche.

Here is the brief synopsis of the keynote.  Lee shared her own personal leadership journey and discussed the critical skills necessary at various stages of leadership for anyone following a similar career path.  During entry into the professional world, as a research fellow, it is critical to have technical expertise and grit to take the initiative and making contributions of value.  On the next step in the leadership journey, at the level of Director, one assumes greater share of managerial responsibilities and providing effective leadership to the teams.  At this time, hiring the best, becomes a critical responsibility.  As one progresses to Senior Director level, ability to communicate effectively with the seniors, becomes crucial.  This is a transition from technical mindset to be able to hone in on key points and communicate them effectively.  It also becomes important to focus on providing guidance and developing others as it is increasing not about you along, but increasingly it is about others in the team.  Lee emphasized that authenticity becomes critical as people will watch for congruence between what you say and what you do.  Greater self-awareness will enable greater authenticity, said Lee.  At VP and Senior VP level, one requires courage because one may be called on to make many tough decisions including work force reductions, killing a multi-million dollar project that may be eating up resources and so on.  Principle centered approach can effectively guide a person in making those critical decisions.  And just as one influences an organization with their decisions, organizational values also play a key role and guide the decisions, of its leaders.  For instance, Genentech takes great pride in being patient-centered company and decisions are often made after considering the impact on patients.  At this stage, leaders also have to focus on strategy and change and have to lead with a long-term vision, as opposed to fighting fires.   People look to the leaders for inspiration.  Mindfulness or daily meditation can help a leader be more effective, said Lee.

Lee then discussed Genentech/Roche’s commitment to diversity.  (In addition to recruitment for biotech and medical device companies, I also offer corporate trainings on diversity and global inclusion and in 2010, I did training for almost 400 Medtronic employees in India http://bit.ly/W33tZ2, and this part of Lee’s talk was very interesting to me.  Here is a link to my interviews http://bit.ly/ZpNwhN ).  Lee said that her company employs 2200 people, at 4 different sites, with a lot of functional diversity. Working across cultures is frequently challenging, because there is often distrust, preconceived notions, and logistics challenges, including ill timed phone calls, that exacerbate problems.  Instead of delving immediately into work, it is often more productive to set aside time for getting to know people and develop personal relationships, with team members at remote locations.  When working through preconceived notions and unmet expectations, it is important to maintain a balanced perspective and give credit for positive intent, and to seek to understand before being understood, said Lee.  Genentech/Roche has a commitment to increasing the number of women in the workforce and make opportunities for advancement, available to women.  However, it is not about quotas, said Lee.  A diverse workforce enhances and enriches the entire team and increases the diversity of thought, which in the end always leads to better problem solving, greater creativity and higher productivity, she said.

Lee also touched upon importance of work-life balance and flexibility in an individual and within an organization.  In the end, it is always about relationships.  Relationships with colleagues, allies, coaches, and sponsors are all different and need to be maintained differently.  For instance, coaches may talk to you but mentors talk with you and sponsors may talk about you, sometimes even when you are not present.  Summarizing and sharing the learnings from her own leadership journey, she said “be authentic, have greater self-awareness, and play to your strengths”.  Additionally, “you need to pursue your passion, do what you love, be resilient and face challenges head on”.  And finally, “remember that relationships matter and define your own path to fulfillment”, said Lee.

A sign at Genentech headquarters in South San Francisco, California. (Photo credit: Wikipedia)

EPPIC will host its Annual Conference on February 1, 2014 at the Westin in South San Francisco.  Mark your calendars for a great conference with excellent keynotes and panels on a variety of topics and watch out for preview blogs on the event.  Register early at www.eppicglobal.org, before the event gets sold out.

EPPIC 2013 Annual Life Science Conference Highlights

EPPIC 2013 Annual Life Science Conference Highlights

The annual EPPIC Life Science Conference (www.eppicglobal.org) takes place on the day before the start of the J. P. Morgan Healthcare Conference, each year, and offers a forum for information, networking, and mentoring. This year, the conference took place at the Westin SF Airport Hotel on January 6, 2013 and was jointly chaired by Ramani Aiyer, EPPIC President & Principal at Shasta Bio Ventures and Geetha Rao, CEO of Springborne Life Sciences and VP of Corporate Development at Triple Ring Technologies. The Gold sponsors of the event were Global Industry Analysts http://www.strategyr.com, Camargo http://www.camargoblog.com, Merchant & Gould http://www.merchantgould.com, Morrison Foerster http://www.mofo.com, Vivo http://www.vivoventures.com, and WSGR http://www.wsgr.com. Below are the highlights from the conference.

Plenary Talk – Carlos Olguin

The conference opened with plenary remarks by Carlos Olguin, Head of Bio/Nanotechnology/Programmable Matter Group at Autodesk and was moderated by John Cumbers, Head of Synthetic Biology & Resource Utilization in Space at NASA Ames. If you are wondering what has Autodesk to do with life sciences, the talk was an eye opener about interesting things happening on the boundary between bio-nano technology with 3D visualization, simulation, and design. Autodesk professionals bring design and engineering knowledge and look at ways to program matter, through scan, modify, and print pattern, said Olguin. Scan in the case of molecular biology is akin to sequencing DNA, modify refers to modeling, simulation, and optimization and print alludes to synthesizing the DNA. Looking beyond molecular biology, design and engineering in manufacturing as a whole may shift from being top down to self assembled, from being inert to being alive, from being generic to personalized, and from being product oriented to being service oriented, said Olguin. The talk was a clear indication that interesting, cutting edge stuff is happening on the boundaries between disciplines and that is where we will see some breakthrough advances take place in the years to come.

Personalized Medicine Panel

Personalized Medicine Panel was moderated by Sara Kenkare-Mitra, SVP of Development Sciences at Genentech. Brian Naughton, Founding Scientist, 23 and Me, Eric Sasso, VP of Medical and Scientific Affairs at Crescendo Bioscience, and Deborah Kilpatrick, Chief Commercial Officer at CardioDx discussed the implications of efforts in personalized medicine for chronic diseases.

Crescendo Bioscience is a molecular diagnostics laboratory focused on rheumatology. Currently,  assessment of rheumatoid arthritis disease activity depends on subjective clinical indicators and is a time consuming process. Crescendo is developing quantitative, objective, biology-based tests intended to provide rheumatologists with deeper clinical insights, said Naughton. The blood test, commercially available since  2010, integrates the concentrations of 12 serum proteins associated with rheumatoid arthritis disease activity into a single objective score to help physicians make more informed treatment decisions.

CardioDx offers Corus CAD blood test that can quickly and safely identify symptomatic patients unlikely to have obstructive coronary artery disease (CAD). However, getting physicians to think differently about using these tests versus imaging based tools, is a challenge, and “we are asking them to trust biology and not just an image”, said Kilpatrick. Currently, 75% of its commercial use is by primary care physicians and about 25% by cardiologists. Cardio Dx works the referral channel from an advocacy standpoint. An additional benefit observed by CardioDx is that after the test, the compliance to statins among patients is dramatically improved. Thus the test leads to a behavior change that would not otherwise occur.

23 and Me has an exciting story and it will again be covered in greater detail in my JPM post. The exciting development is in dramatic reduction of cost. Naughton shared that now it is within the reach of everyone and for $99, any consumer can get all sorts of information about their genetics, including increased risks for diseases like AMD, Alzheimer’s and others The panelists discussed their strategies for broadening the use of their tests with partnership opportunities and for other indications. Hearing about advances in personalized medicine, beyond oncology, was exciting.

Panel on Repurposing of Drugs

Mahendra Shah, partner with Vivo Ventures, moderated the panel that focused on repurposing of drugs. While new drugs cost upwards of $1.1B to develop and bring to market, and take over 10 years, once approved, there is no guarantee that they would be commercially successful, said Shah. The knowledge accumulated, can be analyzed to see the effectiveness of old drug for new usage. NIH is also planning to make an extensive database of old drugs available, to enable scientists to look for new indications.

Ken Phelps, CEO of Camargo Pharmaceutical Services, talked about the regulatory pathway in repurposing of drugs. Camargo specializes in FDA’s 505(b)(2) drug approval process. In 2011, more 505(b)(2) NDAs were approved than 505(b)(1) compounds, said Phelps. Sharing the history of 505(b)(2), Phelps emphasized that currently over 3000 drugs are still on the market that were introduced prior to 1962, when they were not required to be shown to be efficacious, and they are for taking. There are also compounds with new chemical entities and new indications that are available. He observed that it is important to identify compelling commercial differentiation and then take the knowledge available in the public domain, think outside the box, and use it effectively.

Warren Cooper, President at Coalescence was CEO of Prism Pharmaceuticals, a venture backed company that he led from inception to sale of the company to Baxter in 2011. According to Cooper, in repurposing a drug, same criteria should be used as NCE; identification of well defined clinical need, market value, and willingness to adopt and obtain reimbursement, technical feasibility, ability to protect from generics for meaningful period of time, and positive financial justification. What is different from NCE is that compound has a history and sometimes that is helpful and sometimes a hindrance. The deeper the history, the higher the challenge it may cause in the regulatory pathway of repurposing. Cooper discussed the example of injectable amiodarone that was originally developed for use in cardiac arrhythmias and was transferred at Prism Phrama, into NEXTERONE, from IV to ready to use pre-mixed product. The regulatory challenges required rewriting of the label and negotiations with FDA on labeling.

Jaisim Shah, Board Director at Igdrasol, discussed the key drivers for drug repurposing that include, reduction in cycle time, lower cost, better success rate, and quicker ROI for investors. Drug repurposing sales are up, to $20 B this year, said Shah. In 2012, as Chief Business Officer of Elevation Pharma, Shah led the sale of the company to Sunovian for upto $430 million, contingency based deal. The company took glycoyrrolate, a generic drug, approved decades ago by the FDA, and reformulated the compound for use with a nebulizer for chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis. It is found to be a well tolerated, tasteless, and stable formulation.

Panel on Technology Innovations that Shorten Therapeutic Product Development Life-Cycles

Moderated by Mohan Srinivasan, Director at Bristol-Myers Squibb, the panel discussed diverse and new technology adaptations aimed at compressing lifecycle and boosting success rates for drug development. Currently, for each new therapeutic, the product life-cycle ranges between 9 to 15 years and costs over a billion dollars. Can this be significantly shortened by adapting technology advancements in other sectors?

Chunlin Wang is Senior Scientist & Director of Informatics at Stanford Genome Technology Center. In last several years, Wang has been analyzing sequencing data generated by 454 FLX, I1-lumina GAIIx, HiSeq, MiSq, Ion Torrent and Pacific Bioscience platforms for various projects including drug-resistant mutation detection, whole genome sequencing, immune repertoire sequencing, high resolution high-throughput HLA genotyping and new virus discoveries. Using novel sequencing approaches to speed up drug development is one of the best ways to reduce costs, said Wang.

Scott Turner is EVP of R&D at Kinemed Inc. focused on the field of stable isotope research. Turner is leading the research into novel in vivo applications of stable isotopes in diseases. With its patented isotopic tracer technology, Kinemed enables its clients to track key chemical pathways within living systems and look at bio-chemical processes that are targets of drugs. Focusing on study in intact organism provides integrated systems biology information underlying the root causes of disease, said Turner.

Nikesh Kotecha is CEO of Cytobank Inc., a company focused on providing scientific, informatics and software solutions for cytometry. Cytobank focuses on analyzing single cell technologies and has created Cytobank, a cloud-computing platform for flow cytometry data. The Cytobank project grew out of Kotecha’s focus in Dr. Garry Nolan’s lab at Stanford University in developing a diagnostic for juvenile myelomonocytic leukemia and on analysis methods for single cell assays. Thus they take an interdisciplinary approach to address biological and clinical problems to help companies bring together their laboratory bench work and informatics needs. Cytobank is taking this beyond flow cytometry to mass cytometry, for identifying biomarkers, useful in personalized medicine, said Kotecha.

Pradeep Fernandes, co-founder and President of Cellworks Group, was most recently VP and GM of Synthesis Solutions at Cadence Design Systems, following its very successful $120M acquisition of Get2Chip in 2003.  Currently, a great deal of data is being generated.  Software is a tool that can be leveraged to manage and visualize large data, extract trends, generate insightful data and eventually predict information from large data sets, said Fernandes.  CellWorks takes in vivo and in vitro data and clinical trends and tries to build dynamic models that simulate disease phenotypes in computers and can be used to perform mechanistic studies.  This information is used to predict effects of new therapy and gain new biological insights regarding toxicity and biological efficacy of drugs.  CellWorks has an internal pipeline of therapies and is in collaboration with Astra Zeneca, Genentech and other companies interested in driving selection of therapies.

Speed Pitch, Accent on Youth, Speed Networking

In Speed Pitch, early stage life sciences companies were given the stage for a quick 5-minute pitch about their idea, technology, or company. The companies presented to the entire audience and obtained quick feedback from the distinguished VC panel and gained exposure to showcase to various potential collaborators, partners, and investors. Selected presentations are highlighted on the EPPIC website and other promotional material.

The Youth Panel was An Eppic Annual Conference First. This panel gave an opportunity to budding high school and college age scientists to showcase their outstanding research and later ask questions of each other’s research and future goals etc. The purpose of this panel was to inspire excellence among young people but these exceptionally bright, charming youngsters inspired the audience and left everyone spell bound.

Finally the Speed Networking event gave an opportunity to meet conference attendees in quick three-minute introduction and card exchange rounds.

This was a great conference that provided wonderful networking opportunity and was followed by more relaxed networking and wine reception.

Women in Biotech

Women in Biotech

EPPIC is an organization that promotes networking, entrepreneurship and mentoring for life science professionals, and is dedicated to creating US-India life science synergy and partnering opportunities.  EPPIC annual meeting will be on January 6, 2013 and to register, please go to www.eppicglobal.org .

Recently EPPIC held an interesting event “women in biotech” to hear the perspectives of the prominent women leaders from the industry. As a Diversity and Inclusion Trainer, I found this event very enlightening.  Anula Jayasuriya, Managing Director with Evolvence India Life Science Fund and Invascent Advisory moderated the event.  Jayasuriya shared some interesting stats.  For instance, do you know that 7.1% of successful companies have women executives versus 3.1% of unsuccessful companies?  Jayasuriya asked some pointed questions of the panelists and the responses were equally insightful.

All the panelists talked about the importance of some really good mentors, in their career progression.  Their mentors helped them see their true potential early on in their careers, and guided them during key phases in their careers.  When asked, if they felt excluded from existing networks, the panelists seemed to agree that they frequently experienced being excluded, during early stages in their careers.  Debra Riesenthel, Consultant and Former CEO of Novasys Medical, shared that while men frequently had activities like golf that they shared, during company events, their wives went on shopping trips, and she was often mistaken for an admin.  While “men get promoted on potential, women often get promoted on performance”, said Reisenthel.  Karen Drexler, Founder & Chair of the Board at Cellscape, agreed and said, women often feel they have to be better than men to be recognized”.  According to Sara Kenkara-Mitra, Vice President of Development Sciences at Genentech, there is a subtle bonding and camaraderie that exists among men because of their ongoing banter and playful competitiveness, whereas women do not do well, in that area.  She advised, women find their voice and get comfortable in speaking up.  Janet (Jian) Xiao, Partner with Life Science Group at Morrison & Forester, Palo Alto (host for the evening event), said, often when men say something it looks real but when women say something it has to be real.  According to Daria Mochly-Rosen, Senior Associate Dean and George D. Smith Professor of Translational Medicine at Stanford University School of Medicine, women often cannot afford the time to hang around and engage in small talk.  However, this also gives an advantage to women, she said.  Women have to disengage and switch off to focus on other priorities like picking up children, thinking about meal preparation and that often gives them an ability to approach the task with renewed perspective and sharper focus.  Kenkara-Mitra observed that while exclusion can be a barrier, things are changing rapidly and women should not consider it a major barrier.

The panelists discussed issues like differences between male versus female bosses in terms of how they relate to their bosses and the bosses’ perceptions of them.  They also shared the role of their life partners or spouses, in their career.  It seemed, almost all of the panelists had a strong and steadfast spouse who strongly supported them in their careers in various ways, including handling meals, childcare, and at times, even taking a back seat in their own careers.  The panel ended with panelists sharing their observations on how diversity of perspectives and styles enriches the workplace and makes the workplace better for everyone.  The panelists shared advise and tips on how women can progress in their careers.  These included, seeking guidance from a mentor to becoming a good listener to finding a voice and speaking up to being a keen observer.

For more information and to register for EPPIC annual conference, go to www.eppicglobal.org .  For information in “Diversity & Inclusion Training for Effective Global Business Practice”. please contact me at wd_darshana@ hotmail dot com and please click the link below for other similar article on diversity and inclusion in medical device company, Medtronic — http://alturl.com/qkxy7 .