Publication Strategies for Biotech Commercialization, By Karen Ring, PhD

How Publications Drive Commercialization: Drs. Jon Block & Natalie DeWitt

By, Karen Ring PhD

The famous quote “Publish or Perish” doesn’t solely refer to the pressure for academics to publish continuously in order to maintain a successful career. To succeed in the current life sciences industry, biotech, pharma and medical device companies also need to publish their results in peer-reviewed journals to promote and commercialize their technologies. 

“How publications drive commercialization” was the topic of discussion at Bay Area LifeTech’s (BALT) latest Meetup on Monday November 10th. The event was held at DLA Piper and featured speakers Jon Block, PhD, and Natalie DeWitt, PhD. Jon is the Founder and President of the Jon Block Group, which is a clinical affairs consulting firm that helps clients execute effective publication strategies to expedite regulatory clearance and reimbursement approval on cutting edge technologies. Natalie is a former Senior Editor for Nature, and currently is the Director of Research Development at Baxter Laboratories at Stanford.

“This event was meant to provide a platform for discussion on what publication strategies biotech companies can use to move their programs forward,” explained BALT founder Luke Lightning, PhD. “The two speakers have phenomenal backgrounds and experience in helping their companies and/or agencies succeed in gaining FDA and/or NIH approval.”

Jon Block opened the discussion with a talk on “Driving Commercialization by Executing a Robust Publication Strategy.” He highlighted the following points:

The main driver of publications in industry now is reimbursement: if you publish, you will profit.

Publications promote credibility, drive commercialization, and result in better company valuations.

Publish early and often to build momentum and control your publication process to create a message that you can disseminate and repeat through future publications.

Consider quality vs. quantity. Home run publications are always fabulous, but they are rare and short-lived victories. Base hits (more frequent, smaller journal publications) are essential to maintain excitement and interest your technology.

Have a wide publication scope. Publish in different journals to attract broader audiences and consider different types of publications such as open-access journals, editorials, or commentaries that can provide alternative and insightful scientific perspectives.

Natalie DeWitt continued the conversation by sharing her tips for scientific publishing from an editor’s perspective. Natalie detailed the “ins and outs” of the publication process from submission to acceptance to dealing with rejection letters. She also discussed tips on how to get your paper in top-tier journals such as Cell or Nature, which currently accepts less than ten percent of total submissions. She explained that publications that make it to the big leagues are conceptually novel (i.e. editors have not heard of the discovery before), are technically convincing, and have findings that important to the field as well as a broad readership. 

Natalie kept her talk light by mentioning that high-impact journals like Nature make mistakes (e.g. rejecting the “Kreb’s cycle” paper whose author later received the Nobel Prize), and that you shouldn’t take rejection to heart. She ended by saying that while publications are important, “You shouldn’t judge people’s careers based on publications metrics and journal impact factors. You should look at what they’ve done throughout their careers.”

Overall, the speakers engaged the crowd of over 50 BALT attendees in a dynamic and informative conversation on how publications are essential for product commercialization and reimbursement and how to pursue the most effective publication strategy in biotech.

 Jon Block, PhD.

  

Natalie DeWitt, PhD and BALT founder Luke Lightning, PhD.

Bay Area LifeTech Explores Berkeley Biolabs by Karen Ring, PhD

Bay Area LifeTech Explores Berkeley Biolabs (October 3, 2014)

By: Karen Ring, PhD

Where are the major innovation hotspots for Life Sciences in the Bay Area? While Stanford and SF/Mission Bay easily come to mind, you might not know that another thriving center is located nearby in Berkeley, called Berkeley Biolabs. The mission of Berkeley Biolabs is to foster innovative research by providing space and support to scientists and biotech entrepreneurs. Bay Area LifeTech (BALT) had the pleasure of touring Berkeley Biolabs last week and met with the founders and entrepreneurs who are bringing exciting scientific ideas and products to life.

The tour included an introduction to Berkeley Biolabs by Co-Founder Ryan Bethencourt and Community Manager Mary Ward and short presentations by companies including Valen Scientific (Converting waste to biofuels) and Algas Biotechnologies (rechargeable algae-based batteries). For a list of the companies currently in Berkeley Biolabs, check out their portfolio. The tour was followed by a networking happy hour held at ACME Bar. 

BALT will host another exciting networking event in October titled “Spotlight on Bay Area Entrepreneurs”, which will be held on Wednesday October 29^th.

Event Photos:

Mary Ward, Community Manager, introduces the concept of Berkeley Biolabs to the BALT crowd.

Jayaranjan Anthonypillai and Michael Strawn of Valen Scientific talk about converting organic waste into biofuels.

Ryan Bethencourt, Berkeley BioLabs Co-Founder, shows off a rechargeable, algae-based battery developed by Algas Biotechnologies.

Frank Kusiak (Technical Project Manager at Lawrence Hall of Science) Luke Lightning, PhD (BALT founder, Business Development at LAUNCH.co), and Karen Ring, PhD (Postdoc at the Buck Institute, Events Correspondent at Big3Bio) at the BALT happy hour held at ACME Bar.

Steve Burrill Highlights Major Transitions in U.S. Healthcare at UCSF’s 14th Annual State of the Life Sciences Industry, By, Karen Ring Ph.D.

Steve Burrill Highlights Major Transitions in U.S. Healthcare at UCSF’s

14^th Annual State of the Life Sciences Industry

By, Karen Ring Ph.D.

In the 14^th annual address on the State of the Life Sciences Industry, Steve Burrill, founder and CEO of Burrill & Company, gave an overview of the current standing of the life sciences industry and detailed major transitions in U.S. healthcare in the next decade. The event was hosted by the Entrepreneurship Center at UCSF and was the introductory class to a popular team-based entrepreneurship course called “Idea to IPO”. 

Overview on 2013 in Life Sciences

2013 was an exciting year for the life sciences sector with 52 companies going public and raising a total of $7.5 billion from investors. This was an impressive increase in the number of IPOs compared to 2012, when 16 companies went public and raised $1.1 billion. Burrill attributed this past year’s booming prosperity to a strengthening U.S. economy, the approval of 39 new drugs in 2012 by the FDA, the success of established biotech and pharmaceutical companies, and the high demand for novel therapeutics, diagnostics, health-related technology. 

He also touched on trends that are reshaping the life sciences industry including major acquisitions by big pharma (e.g. Onyx by Amgen) instead of building in-house programs, broadening investor interest and capital inflows into healthcare, development of biosimilar drugs and specialized therapeutics for orphan diseases, and an increase in clinical trial transparency.

Major Transitions in US Healthcare

With the advent of Obamacare, major changes to the U.S. healthcare system and market are already happening. Burrill listed a number of significant differences that will occur. The U.S. will experience a transition from a “one size fits all” model towards precision medicine and personalized healthcare. Promoting and incentivising patient wellness will be the main focus of the new system, which is already burdened with treating costly chronic diseases and caring for an aging baby boomer population. 

While drug discovery and novel therapeutics will remain important, diagnostics and personalized therapies will be in high demand as precision medicine, which combines molecular profiling of patient genomic information with clinical and pathological data, will identify which patients respond positively to specific drugs or vaccines thereby offering the most effective treatment with minimized consequences. Furthermore, where money was previously funneled into doctor-administered procedures, the balance will be tipped towards paying for treatment outcomes, which will shift the focus towards overall quality of care rather than quantity. 

Accompanying all these changes, Burrill predicts a massive consolidation and integration of the healthcare system in the next five years. 

Personalized Healthcare and Digital Health at the Forefront

Burrill explained that digital health companies are revolutionizing our healthcare system by providing tools, technology, and applications, involving telemedicine, electronic health records, patient monitoring services, population health management, “big data” analysis, and hospital administration. Personalized healthcare aided by digital health technology will allow patients easier access to medical and clinical information, and will provide health plans and treatments tailored to individual patients. 

Additionally, digital health partnered with precision medicine will foster predictive and preventative means to anticipate disease, identify drug-drug interactions, and vastly improve the efficiency and effectiveness of patient care. Digital health has already had a large impact on U.S. healthcare and will continue to do so as venture capital funding and the number of digital health IPOs rise over the next year. 

What 2014 Holds for Life Sciences

Burrill’s prediction for the state of life sciences industry in 2014 was positive yet practical. He discussed how there would be continued success but a slowing in momentum with regards to number of IPOs and amount of capital raised compared to 2013. He pointed out that under Obamacare, there will be more pressure by payers on drug companies to lower costs of new therapeutics, and to prove that these new drugs are cost-effective compared to similar drugs already on the market. 

Patients will switch from passive to active roles in wellness management aided by the abundance of clinical data at their finger tips, diagnostics will be in higher demand, and innovation will focus heavily on treatment and prevention of chronic diseases, such as diabetes and dementia, that have become global epidemics. 

Burrill closed his address by reiterating his main point about how U.S. healthcare is moving away from its original focus on medical procedures and costs towards a system that embraces values and overall health outcomes.

Karen Ring is a Postdoctoral Scholar at the Buck Institute for Research on Aging. To contact Karen, email at Ring.Karen@gmail.com. 

Bay Area LifeTech Hosts Young Innovators in Oncology

By: Karen Ring, PhD

Bay Area LifeTech (BALT) hosted an event titled “Young Innovators in Oncology” at the Netherlands Consulate General in San Francisco on December 5, 2013. The talk featured three speakers, two academics, Francesca Gazzaniga and Marvin Tannenbaum from UCSF, and an entrepreneur, Shawn Carbonell from OncoSynergy. The event brought in new faces from all over the bay area including a high school student who was interested in Cancer research. Luke Lightning, PhD, founder of BALT, along with support from Robert Thijssen and Natasha Chatlein of the Netherlands Office of Science and Technology (NOST) succeeded in throwing another captivating and informative event. Below are summaries of the talks by the three speakers.  

Francesca Gazzaniga is a graduate student in Dr. Elizabeth Blackburn’s lab at UCSF. Dr. Blackburn received the Nobel Prize in Physiology or Medicine in 2009 for her discovery of the telomerase enzyme and how it maintains telomere length. Telomeres are sequences of DNA at the ends of chromosomes that act as caps that prevent chromosome shortening and loss of important genetic information during cell division. Francesca’s graduate research focuses on the role of telomerase in breast cancer. Breast cancer is the number one cause of cancer-related death in women and accounts for almost 30% of all diagnosed cancers in women. Breast cancer is a heterogeneous disease, which is why having a library of tissue samples or cancer cell lines is extremely valuable for studying this disease. Francesca has access to 50 human breast cancer cell lines and made it her goal to study telomerase activity and telomere length in each of these lines. Interestingly, she and Dr. Imke Listerman, a postdoc in the Blackburn lab, found that both telomerase activity and telomere length varied in all 50 lines and that telomerase activity was elevated in basal breast tumors, which is the most metatstatic form of breast cancer. She also identified specific genes and cell signaling pathways that correlated with telomerase activity and telomere length in these cancer cell lines. The telomerase gene, hTERT, correlated with telomerase activity, which was to be expected. Interestingly, the apoptotic pathway, a form of cell death, also correlated with telomerase activity. Francesca suggested that new therapies targeting breast cancer in women should use a two-pronged approach that targets both telomerase activity as well as cell death.

Marvin Tannenbaum, PhD, is a postdoctoral scholar in Dr. Ron Vale’s lab at UCSF. Dr. Vale received the Lasker Award in 2012 and is an expert in studying molecular motors, which are proteins that carry cargo to different parts of the cell along tracks called microtubules. Marvin’s postdoctoral work focuses on the role of molecular motors in cell division and cancer. Cell division (or mitosis) is a mechanical process, which involves the duplication and separation of chromosomes coordinated with the division of the cell. A bipolar mitotic spindle composed of microtubules and molecular motors mediates chromosome segregation. A specific molecular motor, Eg5, promotes bipolar spindle assembly and is essential for proper chromosome segregation. Inhibition of Eg5 function results in the formation of a monopolar spindle structure and prevents chromosome segregation and cell division. Cancer cells are notorious for uncontrolled cell division and consequently, inhibition of Eg5 has been pursued as a target to halt cancer cell growth. Eg5 inhibitors are already in clinical trials and results so far show low toxicity but also low efficacy with tumors acquiring resistance early on in treatment. Furthermore, cancer cells can grow and divide without Eg5 function. Marvin hypothesized that other molecular motors must compensate for Eg5 function. Using an RNAi knockdown screen, he was able to identify Kinesin12 (K12) as the molecular motor that can act with Eg5 to promote bipolar spindle assembly. When he inhibited Eg5 function and overexpressed K12, he saw that cells could still form bipolar spindles and divide, proving that K12 can take over Eg5 function. Furthermore, when he took Eg5 resistant cancer cells and treated them with RNAi against K12, he saw 100% formation of monopolar spindles and no cell division. Thus Marvin proposed that he has found an alternative target for treating cancer cells that are resistant to Eg5 inhibitors.

Shawn Carbonell, MD, PhD, is the founder and CEO of OncoSynergy, a biotechnology startup located in Mission Bay, San Francisco. A former brain surgeon trainee turned entrepreneur, Shawn’s goal is to bring “Targeted Synergy” to cancer therapeutics. His company has initially focused on pursing novel therapies for glioblastoma (GB), the most malignant type of brain cancer that has a median survival rate of 12 months. Avastin, a monoclonal antibody developed by Roche, is an inhibitor of angiogenesis (blood vessel formation) and is approved for recurrent GB. Unfortunately, approximately 40% of GB patients are non-responders to Avastin and patients that do respond typically see a more aggressive recurrence of their cancer after several months. Faced with these daunting facts, Shawn proposed an idea that an effective cancer treatment could come in the form of a single drug that attacks a spectrum of cancer promoting mechanisms, i.e., Targeted Synergy. He focused on integrins, which are transmembrane receptor proteins that mediate cellular adhesion and are a critical path for interactions within the tumor microenvironment that drive tumor growth and progression. By using a monoclonal antibody called OS2966, which selectively modulates β1 integrins, Shawn and colleagues were able to inhibit GB cell migration, adhesion, and angiogenesis in vitro. Additionally, they observed complete growth inhibition, a reduction in growth factor receptor expression, and a pro-apoptotic effect in human xenograft models of Avastin-resistant GB. OS2966 is a drug platform that also prevents spontaneous lung metastasis in a triple negative breast cancer model. Shawn believes that OS2966 has blockbuster potential because of its multiple mechanisms of action and dramatic activity in several aggressive cancer models. OncoSynergy plans to initiate Phase I clinical trials in GB in 2016. Additionally, they are developing two other drug platforms called OS47720 and OS342. The latter is being advanced to treat dermal neurofibromas in Neurofibromatosis Type 1. 

As the official blogger for BALT, I’d like to wish everyone the happiest of holidays and thank those of you who have supported and attended BALT events in 2013. I’d also like to give a special shout out to BALT sponsors Cell Signaling Technology, Medline, and NOST. BALT is planning to welcome 2014 with a brand new website and will also be looking for member feedback on fresh ideas for BALT events. Lastly, the next Meetup scheduled is the State of the Life Sciences Industry with Steve Burrill on Thursday, January 16^th 2014 at UCSF, Mission Bay. 

Karen Ring is a Postdoctoral Scholar at the Buck Institute for Research on Aging. To contact Karen, email her at Ring.Karen@gmail.com.