Editing Wikipedia Entries on Indiana Women in STEM Fields

I had the opportunity to volunteer this past weekend for a project coordinated by the Indiana History Center and the Indiana State Library (Library Virtual Tour) that involved editing and adding details to Wikipedia entries on Indiana Women who were pioneers in science, technology, engineering, or mathematics (STEM) fields. The Event is part of an effort by Indiana Humanities' Quantum Leap Initiative to see how humanities intersect with STEM fields. 

The morning started with a one hour training session to provide instructions on the basic techniques used to improve Wikipedia entries or to write new ones, a task reserved for those who were very experienced in these procedures. For my first trial at editing, I chose the name of Beulah Wright Porter. Little did I know, she was a teacher turned physician and the first African American woman in Indianapolis to have her own medical practice. Dr. Porter was instrumental in fighting tuberculosis among African American youth and trained nurses to serve this segment of the population that was not allowed in hospitals. 

Indiana State Library, from southeast (source: Indiana State Library)

Ornate ceiling in Indiana State Library (source: Indiana State Library)

 My second contribution on The Grand Chapter of the Sisters of Charity (not to be confused with the Sisters of Charity of Saint  Elizabeth Ann Seton or the Daughters of Charity of Saint Vincent de Paul) had a relation with Dr. Beulah Wright Porter. The Grand Chapter of the Sisters of Charity was established by Dr. Porter and several other women helped the poor and need with food, clothing, and at-home medical care and healthcare, ultimately trying to establishing a small hospital in 1910 that closed soon thereafter due to financial issues.    

Reading room- Indiana State Library

As a scientist at heart, formerly working in neural stem cell research at Indiana University School of Medicine for 10 years, volunteering for a few hours on a Saturday morning to increase understanding about early pioneers in the STEM fields had special meaning. I thought about all the luxuries of today's medical facilities compared to starting from the ground up where there was no support for women or African Americans to be in this field in the early 20th Century. I am sure there were many trials and sacrifices.



The pioneers in each field pave the way for successive generations to build upon where they left off. We must learn about the history of our family, profession, City State, and Nation in order to become better and more engaged citizens and to avoid repeating mistakes of the past.  If you have not visited the Indiana State Library, it is a beautiful building with many historical paintings, ornate ceilings, and architectural details.

The 2017 Indiana Life Science Summit

Robbie Singh, MS, MBA

Indianapolis, Indiana USA

The 2017 Indiana Life Science Summit (ILSS), organized by BioCrossroads and its sister organizations BioSpeak and BioIntellex, took place in Indianapolis on October 9-10 at the JW Marriott. The 14th Annual Summit included an expanded Scientific Session featured TED-style presentations by industry and academic thought-leaders on global health, new ventures and capital formation, evidence-based medicine, accelerating innovation. A scientific poster session highlighted recent discoveries from industry and academia. The announcement and presentation of the “Watanabe Life Sciences Champion of the Year Award” to Dr. Virginia Caine of the Marion County (Indianapolis, Indiana) Public Health Department and Indiana University School of Medicine were acknowledgements of vision and innovation potential as well as a prolific career that has impacted many lives. Below are some highlights from the scientific and business track presentations that were extremely interesting and in groundbreaking areas of health and medical science.

Scientific Track TED-style Presentations

The Scientific Track presentations focused on the areas of immunology, oncology, and the combination of the fields in treating cancers. Dr. Christina Boduro, Senior Director of External Sourcing, Medicines Development Unit at Eli Lilly Research Laboratories acted as Mistress of Ceremonies.  Dr. Tom Bumol, Vice President of Biotechnology and Immunology Research at Eli Lilly, discussed innovations, successes, and areas of opportunity in developing novel treatments for immune-related conditions, which are on the increase. Areas of focus include Th17 cells, B cells and the BTK antigen, and the immune-inflammation response cycle playing a major role in autoimmune conditions such as psoriasis, rheumatoid arthritis, other inflammatory conditions (e.g. irritable bowel disease), and cancer. In terms of therapeutic targets, the major focus has been on modulating inflammatory cytokines tumor necrosis factor TNFa, Interleukins IL-6, IL-21, -IL-23, IL-33 to modulate the chronic inflammation  -->  repair --> memory cycle. The newly discovered potential of hetero-specific antibodies that can bind to two antigens, in this case cytokine receptors, are showing promise. The next generation therapies will involve checkpoint inhibitors such as Cyclin-dependent kinase (CDK) inhibitors.     

The second presentation was by Dr. Rainer Fischer, incoming CEO of the Indiana Biosciences Research Institute (IBRI). Dr. Fischer provided a brief history of immunotherapy since 1890. Most notably, there have been 18 Nobel Laureates; among them are Dr. Von Behring (1901 - discovering serum therapy and application to diphtheria), Dr. Porter and Dr. Edelman (1972 - elucidating the structure of antibodies, in 1984 a shared Nobel Prize by Dr. Jerne (development and control of the immune system) and Dr. Kohler and Dr. Milstein (producing the first monoclonal antibody).

Antibodies are compelling for treating disease because they generally have high specificity and low toxicity. Antibody-based sales account for 40% of pharmaceutical sales. Monoclonal antibodies (mAbs) are used in treating influenza, cancer, chronic inflammation, and cancer. In terms of manufacturing mAbs, the field of recombinant genetics to make 30+ constructs of recombinant immunotoxins has allowed for 90%+ survival during the manufacturing process, but there were huge immunogenicity and manufacturing problems. Moving from bacteria to human cells produced a better outcome.  The concept of having an Elite cell- a master / working cell bank can allow for the production of monoclonal cell lines. However, automating produces too many cell clones. There is a need for gene amplification to get in the gram/liter range that is optimal for manufacturing. Many regulations come into consideration for manufacturing including International Code of Harmonization ICH 8: Good Clinical Practice for Trials, ICH 9: Quality and Risk Management, ICH 10: Pharmaceutical Quality, and ICH 11: Development and Manufacturing of Biologicals. Controlling manufacturing costs is crucial. One of the novel techniques being used to lower costs and increase yields is to use plant-based manufacturing, namely tobacco. Other criteria to optimize antibody therapies include having DNA databases on disease survivors and those successfully treated.

The Afternoon Keynote presentation was by Dr. Michael Lynch of Roche Diagnostics on immuno-oncology and companion diagnostics. Companion diagnostics are tests that are paired with a drug and the diagnostic test must yield a specific result in order for patients to receive the medication. The drug and the diagnostic also have to launch at the same time.

PD-L1 (programmed death ligand 1) regulates T cell function and cell death. If PD-L1 binds to B7.1 receptor, it shuts down T cell operation in many if not all cancers. Immunotherapy is better and longer lasting in keeping cancer in check than chemotherapy alone, targeted personalized therapy based on genetics of the cancer combined with immunotherapy leads to the best outcome and longest survival time after treatment.

The diagnostic portion of companion diagnostic typically uses immunohistochemistry to detect the presence of the cancer cell antigen being tested. The complicating factor is that PD-L1 binds to many different cell types. If the biopsy taken yields a positive result, as interpreted by a pathologist, the patient receives therapy; otherwise the treatment requested by the oncologist cannot be provided. Thus, the role of a pathologist has changed dramatically in recent years from just taking a quick glance at a sample to confirm the cell type(s) present to being interpreter - of the staining or lack therein, cancer cell types present, immune cells invading the tumor - to being the gatekeeper to treatment.

Companion diagnostics present challenges for pathologists. There is new 2-day training for each diagnostic kit. Presently, four different diagnostic kits are on the market, two made by Roche subsidiary Ventana (SP142, SP263) and the other two made by DAKO (288-8, 22C3). Interpretation of samples requires practice and time. Each scoring assay is different and can take up to 5-minutes to read each slide. However the limiting step still is the time it takes the pathologists to interpret each sample; this is not a precise process due to the tumor spread, presence or absence of aggregates. The advent of 2-color multiplexing allows separation of tumor and immune cells.

Dr. Michael Kalos, Chief Scientific Officer of Cancer Immunology at Eli Lilly talked about future of immuno-therapies including cancer vaccines, cell engineering, and reducing toxicity. Multiple pathways toward the next generation of immune-oncology therapies include reprogramming, modulating, redirecting. For example, if a biopsy indicates the presence of T cells, then the target will be immunosuppression or if there are no T cells at the tumor’s edge, the therapy will focus on bring T cells into the tumor. Important next steps in immuno-oncology include understanding the molecular aspects of the disease, cancer cell sensitivity, learning from testing compounds in animal models and organoid cultures as well as focusing on translational medicine. Signaling pathways are complex. A new Lilly drug in clinical trials now is Abemciclin and targets Cyclin D and CDK4/6. Abemaciclin plus PD-L1 redirects, creating an inflammatory milieu. Another option is blocking one carbon metabolism by Methotrexate (Alimta) to initiate an immune response. Anti-VEGF plus PD-L1 increase the immune response.  

Business Session Day 1

Dan Peterson of Cook Medical served as Master of Ceremonies for the Business Track TED-style talks. Venture Capital funding, innovations in healthcare, drug development, combining the latest of data sciences and information technology (IT), and global health were themes of the Business Session.

A discussion of Indiana’s Life Sciences Funding started off the Business Track. David Johnson of David Johnson of BioCrossroads introduced Indiana’s Life Sciences industry and discussed recent news, including Cook Medical recently selling its Cook Pharmica division to Catalent that plans to expand in Bloomington, Indiana. Darren Carroll, Vice President of Business Development at Eli Lilly, discussed access to capital from the State’s start-up seed funds – Indiana Seed Fund I and II that have contributed venture capital to more than 24 companies.

Some of the successes include Assembly Biosciences $50 million licensing deal with Allergan to develop Assembly Biosciences’ microbiome gastrointestinal compounds for Crohn’s disease, ulcerative colitis, and irritable bowel syndrome. SonarMed is having great success with its neonatal airway monitoring device the recently gained FDA approval. FAST Biomedical, specializing in monitoring kidney function, recently received $5 million in Series A2 venture funding plus $3million from National Institute of Diabetes and Digestive and Kidney Diseases at the NIH. AgeneBio, specializing in mild Alzheimer’s disease has received $10 million from the National Institute on Aging to continue development of its compound in Phase III testing. DiagNotes, specializing in medical communications transcription (voice and text) and video chat for doctors has been very successful in its early startup phase. AB Biotechnologies, a GMP, GLP manufacturing company specializing in small molecules and liquid formulations, recently announced that it is building a new 23,000 square foot manufacturing facility in Bloomington, Indiana. One of the more famous success stories is Eli Lilly acquisition of CoLucid for $960 million to expand its migraine portfolio.  The recently developed Next Level Fund by Indiana Governor Eric Holcomb potentially has $250 million, some portion accessible to the life sciences and technology fields.

 From the Scientific Poster Session, one of my favorites involved creation of a memory stimulating smartphone / iPad app called The Snap Link, developed by Rahil Thanawala for use with mild to moderate Alzheimer’s disease patients. The principle behind the Snap Link is that it uses photographs to stimulate the memory; built initially for use with family photographs and name recall, it could be used with everyday objects too.

 

Lauren Dillard of Carlyle Investment Solutions spoke on the alternatives to venture capital, namely private equity. Ms. Dillard addressed a few highlights of why Indiana Seed Funds and Fund of Funds have been successful. As a venture investor, you give up liquidity of your investment. For the start-up company, there is less regulatory burden by accepting private equity. In the healthcare market, the sector has been focused on mergers and acquisitions. AlpInvest that manages the Indiana Future Funds has made $9 billion in investments and closed 15%; 50% have been healthcare companies, 32% pharmaceutical, 21% medical device. This means that Indiana is in very good shape in terms of funding for start-up companies.

Dr. Kuldeep Neote, from Johnson & Johnson Innovation, formerly of Eli Lilly, provided insights on a strategic Venture Capital model of investing in startups that Johnson & Johnson has pioneered. More than $3 billion has flowed into private biotechnology companies from established pharmaceutical and biotechnology companies. The new venture capital model involves having entrepreneurs in residence at a venture capital company who are ready to pounce on an opportunity and focus on short-term value creation within 5 years. This strategy is being called discovery-based capital. One example of this is Scotland’s Baillie Gifford manages a portfolio worth $181 billion. Baillie Gifford has invested hugge amounts into a handful of life science companies: $100 million to Curevac, $175 million to flatiron Health, $100 million to Ginko Bioworks, $130 million to Denali Therapeutics, $421 million to Intarcia, and 116 million in UNITY Biotechnology. The JNJ model involves development of 4 innovation centers that early stage companies are invited to join a JLABS, similar to biotech incubator. The start-up will pay rent and have access to capital from JNJ, business training programs, investor hubs, infrastructure, and access to innovation. There are no strings attached; if a start-up forms a partnership with a JNJ competitor; that is acceptable. Some successes include Arcturus, an RNA therapeutics company, and Vedanta Biosciences, a microbiome company that collaborated with Janssen Pharmaceuticals, a JNJ company after entering JLABS, the Innovation Center of JNJ.  JNJ invests nearly an equivalent amount in external research & development (R&D) as internal, amount to nearly $300 billion total. 

The last two presentations of Day 1 that I was unable to attend included discussions on accelerating innovation in the medical device arena by Gary Stevenson of MB Venture Partners. There was a presentation by Dr. Ken Payie of Mapp Pharmaceuticals on the role of antibody-based treatment for deadly disease epidemics such as Ebola.

The afternoon concluded with the announcement of the New Venture Competition Award Winners:

1^st Place: LoDos Theranostics co-founded by Purdue University Professor of Chemical Engineering, Dr. You-Yeon Won and Rachel Kim to develop radio luminescence therapy,  an ultraviolet radiation technique using nanoparticles to  enhance eradication of deep tissue cancers.

2^nd Place: The Bee Corp., an agriculture technology company founded by three IU alumni, was also a finalist. Its mission is to mitigate beehive loss through data analytics and software development.

3^rd Place: Indiana Lysis Technologies, LLC is a product-based drug-discovery company that utilizes nanotechnology to develop safer therapeutics to treat blood clots in the lungs, or pulmonary embolisms founded by Dr. Nathan Alves and Dr. Jeffrey Kline.

Business Session Continued Day 2

Congratulations to Dr. Virginia Caine of Indiana University School of Medicine for receiving Watanabe Life Sciences Champion of the Year Award. Dr. Virginia Caine joins great list of Indiana Life Sciences Champions. The Watanabe Life Science Champion of the Year Award is named and given in memory of brilliant scientist, Dr. Gus Watanabe of Eli Lilly.

There was an interesting presentation by June Wasser of Reagan-Udall Foundation for the FDA about their work on increasing patient access to medications in clinical trials, called expanded access clinical trials. The FDA, in 99% of cases approves access to the medications once the request is made into the company.  This includes connecting patients with research, providing access to big data, thus helping patients to feel informed in their treatment decisions. The Foundation has a directory of 36 companies that they have worked with in such endeavors, allowing patients to directly contact the companies about medications they feel may be suitable for their condition. One of the Foundation’s major programs is known as IMEDS (Innovative Medical Evidence Data System) – a big database for rare diseases, mother-child genetic linkages, and other real world evidence studies. The Foundation also works to provide compassionate use to medical devices.

Dr. Joe Singer of HealthCore, an Anthem subsidiary, spoke on increasing innovation in medical devices through Medical Evidence and Real World Evidence research. Innovation often occurs in post-marketing studies including ways to control cost, testing in various age groups, determining effectiveness, risks vs. benefits. Clinical trials tell us if product works and is safe, but not in whom. Discovery-based research takes 10 years to go from conception to clinical trials and FDA approval. There are several ways that studies on drugs continue even after FDA approval. Real world data (RWD) collection from the practice of Medicine, claims, and prescriptions dispensed versus the doctor’s orders in the electronic medical record (EMR). Real world evidence (RWE) studies involve collection of data using research methods.

Dr. Nitesh Chawla of University of Notre Dame’s Interdisciplinary Center for Network Science & Applications (iCeNSA) and Fellow at IBRI   gave a passionate talk about the applications of data that is known to families but not collected by doctors or other healthcare providers.  Further, many of our daily habits of living - eating, exercise, access to fresh fruits and vegetables, supportive family life, stresses, socio-economic status, cultural factors, lifestyle - are not discussed with our doctors. These factors are within the control of each individual and amount to 70-80% of the contributors to health and wellness being in our control, but are not collected into the EMR. Dr. Chawla has partnered with schools, hospitals community organizations, and, hospitals community organizations, and programs created by iCeNSAincluding MomLink, eSeniorCare, Childhood Obesity Project, and the Diabetes Management Program to develop an online database called CARE (Collaborative Assessment Recommendation Engine) to assess predictors of health and disease. The goal should be to determine individual risk for a disease and detect it at the earliest point possible to maximize the potential for treatment and even a cure, even with cancer. Next the focus of presentations changed to Global Health.

Dr. Bob Einterz, Director of the AMPATH Consortium and Indiana University Center for Global Health discussed the partnership that developed over the past 30 years between Indiana University School of Medicine and establishment of Moi University School of Medicine in Kenya to train physicians first to treat HIV/AIDS. The Program included exchanges where Kenyan medical students and faculty would come to Indiana University to go to Medical School and Indiana University faculty would go to Kenya to train students and faculty. The AMPATH Consortium brought together expertise from medical schools from across the United States. The needs of the Kenyan people also had to be addressed along with treating HIV/AIDS including addressing food security via the World Food Program, assisting with proper farming techniques through partnerships with Dow AgroSciences and the Purdue University Agricultural program.  Income security needs resulted in addressing ways to provide microloans and skills-based training to start a small business. As HIV/AIDS came under control, other healthcare needs including insurance and other emerging health issues such as preventing and treating heart disease,   hypertension, cancer, and diabetes. EMR systems have been introduced, partnering with Eli Lilly and other companies. Now, there are 500 clinics in Kenya that serve a population of 4.3 million people.

Dr. Emily Gurley of Johns Hopkins School of Public Health discussed another emerging disease trend in global health - Hepatitis E. It is not a new virus; rather it has existed of more than 100,000 years. It is the population density, ranging from 1,000 people per square kilometer to 200,000 people/sq. km. in slum areas of Bangladesh. Bangladesh is about the size of the state of Illinois and Hepatitis E arises largely due to fecal contaminated drinking water, arising because people often breach a main municipal water source to hook into it or get water from water pipes in the sewer system. These breaches in the water system dramatically increase the outbreak of Hepatitis E. Challenges treating the four genotypes pf Hepatitis E in Bangladesh included that there is a cultural resistance/taboo to drawing blood to check for the virus and it is difficult in a country like Bangladesh to maintain the cold chain necessary to get the sample back to the lab. The people will not go to a doctor because it is expensive and they will be unable to afford the treatment.

Hepatitis E in Bangladesh is a public health crisis. The hallmark of an infection is jaundice and often mysterious deaths of 10-20% of the pregnant women infected; others who are infected seem to suffer briefly and recover. Infection can be prevented by boiling the water, but most families share a stove and do not have time. In terms of prevention, there was a vaccine developed and trials were conducted in Nepal. Due to not having purchasing power, the vaccine was shelved after Phase III clinical trials. Other options on the horizon are development of a diagnostic that would analyze saliva; there is no need for a cold chain and less waste. Point-of-care diagnostics could be on the horizon, allowing patients to test their saliva. Now, a vaccine has been developed and approved; single dose packaging initially, now multi-dose formulation is in the works. The clinical trials were only on healthy adults, not pregnant women. Now, 20,000 pregnant women are being vaccinated to test the effects on them. Innovators need to understand challenges in the field, particularly when working abroad. Different models of financing care for local populations, ethnic and cultural differences need to be considered.   

Breaking news at the Indiana Life Science Summit was the announcement that the Indiana University Center for Translational Sciences Institute (Indiana CTSI) received perfect score on its NIH grant renewal. Special consideration was given for Indiana CTSI’s Global Health component.

The final presentation of the Life Science Summit was by Robert Coy, President and CEO of 16 Tech Innovation Community. New innovations planned to promote bus start-ups, attract developers, retain talent. 16 Tech is in close proximity to potential business partners: Indiana University School of Medicine, Eskenazi Health, Cook Regentec, and Eli Lilly and close to customers. 16 Tech is envisioned as a 60 acre life sciences, IT, manufacturing, live, work, and play environment. The current plans for development include a 5-story Innovation Office, new headquarters for the Indiana Biosciences Research Institute (IBRI), an Innovation Garage to serve as a start-up incubator or maker space for entrepreneurs, and a 300 unit apartment building. The 16 Tech site currently has IBRI located in the Biomedical Research Training Center (BRTC) and Cook Regentec.   

Please mark your calendars for the 2018 Indiana Life Science Summit: October 3-4, 2018

Sponsors of the Indiana Life Sciences Summit

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