Emergent BioSolutions Inc. (NYSE:EBS) today announced that its Board of Directors has authorized management to pursue a tax-free spin-off of the company's Biosciences business into a separate, stand-alone publicly-traded company. The spin-off is expected to create two independent public companies with distinct strategic plans, growth strategies, and operational and development priorities.

The new Biosciences company, to be named at a later date, will focus on providing novel oncology and hematology therapeutics to meaningfully improve patients' lives. The core technology of the Biosciences company will be its ADAPTIR platform applied to immuno-oncology. Emergent BioSolutions will continue to operate as a global specialty biopharmaceutical company whose core business is focused on providing specialty products for civilian and military populations that address intentional and naturally emerging public health threats.

Gaithersburg-based biotech MedImmune entered an exclusive license agreement to work on vaccines targeting cancers caused by human papillomavirus, or HPV.

Under the agreement, announced Monday, MedImmune — the biologics research and development arm of U.K. pharmaceutical giant AstraZeneca (NYSE: AZN) – will collaborate with immunotherapy company Inovio Pharmeuticals. Inovio's "INO-3112" immunotherapy generates killer T-cell responses to destroy tumors associated with HPV. It is in Phase I and II clinical trials for cervical, head and neck cancers.

In response to a request from the Congress, NIH is developing a 5-year NIH-wide Strategic Plan to advance its mission to support research in pursuit of fundamental knowledge about the nature and behavior of living systems, and the application of that knowledge to extend healthy life and reduce illness and disability. Senior leadership and staff from all 27 Institutes, Centers, and Offices (ICOs) are contributing to the proposed direction and content of the Strategic Plan, with input from the Advisory Committee to the Director, NIH. The framework below identifies crosscutting areas of research exemplifying the breadth of ICOs' priorities and aims to outline a set of unifying principles to guide NIH in pursuit of its mission. The goal of this larger NIH-wide strategic plan is not to outline the myriad of important research opportunities for specific disease applications (as that is covered in the strategic plans from each of the ICOs, which will be referenced appropriately), but to highlight major trans-NIH themes. The Strategic Plan is due to the Congress in late December 2015.

MedImmune, a global biologics R&D arm of AstraZeneca, has entered into an exclusive clinical trial collaboration with Mirati Therapeutics, US-based oncology firm focusing on genetic and epigenetic drivers of cancer.

As part of the deal, a Phase I/II trial will be conducted to evaluate the safety and efficacy of MedImmune's durvalumab (MEDI4736) in combination with Mirati's mocetinostat in patients with non-small cell lung cancer (NSCLC), with the potential to explore additional indications in the future.

We told you Tuesday about the first-ever White House demo day on Tuesday, which featured 32 early- to growth-stage companies sharing their personal stories and demonstrating their technologies.

And now, some prizes: Six Greater Washington accelerators were awarded prizes from the Small Business Administration, the SBA announced. It was part of a $4.4 million national program encouraging entrepreneurship, according to the SBA.

Blood is one of those things Americans take for granted.

Here, when patients are rushed to the hospital after an accident and are losing a lot of blood, we assume the hospital will have units of donated blood ready to hook up when the ambulance arrives. We don’t think about how much each unit of blood costs — yes, it has a price — because we have health insurance that pays the bill.

Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, and BioChain, an early cancer diagnostic company with operations in both USA and China and Epigenomics' exclusive strategic commercialization partner in China, today announced that testing based on the proprietary Septin9 biomarker was included in the Chinese Guideline on Screening, Endoscopic Diagnosis and Treatment of Early Colorectal Cancer (CRC).

After 10 years as a successful veterinarian, Ignacio "Nacho" Pino decided to dedicate himself to work that could bring state-of-the-art biotechnology research to his home of Puerto Rico.

CDI Laboratories—a company he founded in 2008 along with Johns Hopkins University researchers Heng Zhu and Seth Blackshaw, JHU professor emeritus Jef Boeke, and two others (Dan Eichinger and Joe Bonaventura)—aims to produce research-grade protein and antibody products that support scientific research on cancer, autoimmunity, and infectious diseases. The company is one of more than 30 startups being showcased in Washington, D.C., today as part of the first-ever White House Demo Day, which will highlight the work of a diverse group of entrepreneurs from across the country.

AstraZeneca Plc and Isis Pharmaceuticals Inc. will work together, expanding an earlier collaboration, to seek gene therapy treatments for diseases affecting the heart, kidneys and the body’s metabolism.

AstraZeneca agreed to pay Isis an upfront fee of $65 million plus development and regulatory milestones for each program that the London-based drugmaker advances to clinical development, the companies said in a statement. Isis, based in Carlsbad, California, will earn tiered double-digit royalties on annual sales of each program.

Bye bye, ‘burbs. Vasoptic Medical is officially a city company now.

The medical device startup, which is making a device that allows primary-care doctors to give diabetes patients eye exams rather than making an extra trip to the eye doctor, completed its move from Columbia to Locust Point. The company’s new office is within Mindgrub’s climbing-wall-outfitted space near McHenry Row.

Secretary of Commerce Penny Pritzker announced the launch of the Economic Development Administration's (EDA) 2015 Regional Innovation Strategies (RIS) Program competition to spur innovation capacity-building activities in regions across the nation. Under the 2015 announcement, SBA will commit $10 million for two funding opportunities:

Positive results of Symbiomix Therapeutics' first pivotal trial for lead drug candidate SYM-1219, a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV), were presented today at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting in Portland, Oregon. The results from the multi-center, randomized Phase 2 trial showed that a single oral dose of SYM-1219 met the trial's primary endpoint of Clinical Outcome Responder and was well tolerated for the treatment of BV. Based on discussions with the U.S. Food and Drug Administration (FDA) at an End-of-Phase 2 meeting, the Company plans to submit the Phase 2 trial as one of two pivotal studies for a New Drug Application (NDA). A second pivotal trial of SYM-1219 is currently enrolling patients, with targeted completion by the end of 2015. If the second pivotal trial is successful, an NDA could be submitted in mid-2016.

Originally the national headquarters for WIB, the "Washington DC/Baltimore" chapter officially became its own chapter in October 2011. Located along the I-270 Corridor in Maryland and also covering DC, Northern Virginia and the greater Baltimore area, this setting is central to what Governor Martin O’Malley called, "one of the largest bioscience clusters in the nation, perhaps in the world."

The WIB-Washington DC/Baltimore Chapter community is dedicated to creating opportunities and careers for women in the life science industry and to encouraging women in our region to translate novel discoveries into products. Our chapter symbolizes the significance of promoting the dynamic women in the biotechnology and life sciences industry in this area and globally. Our membership consists of professionals at leading pharmaceutical, biotechnology, device and diagnostics companies, non-profits, academic institutions, and support service companies, including law firms, consultants, and financial service firms.

GSK and Save the Children have launched their third annual $1 million healthcare innovation award that rewards innovations in healthcare that have helped to reduce child deaths in developing countries.

Organisations from across developing countries can nominate examples of innovative health approaches they have implemented till September 7, 2015. These approaches must have resulted in tangible improvements to under five child survival rates, be sustainable and have the potential to be scaled-up and replicated.

Illumina, Inc. ILMN, today announced Illumina Accelerator—the world’s first business accelerator focused solely on creating an innovation ecosystem for the genomics industry—has selected three new startups for its second funding cycle. Selected from a competitive pool of highly qualified applicants, the new startups from across the globe are spurring genomics innovation in healthcare, agriculture, and the winemaking industry.

This paper is a final project from the NIH Foundation for Advanced Education in the Sciences course — TECH 566: Biotechnology Management

Starting up a company is a risky endeavor. From listening to the FAES 566’s course panel discussions this semester, it is clear that there are many challenges a Chief Executive Officer (CEO) will face and try to overcome while starting up and exiting his/her company. Fortunately, we also learned that there are numerous resources available to assist new entrepreneurs in developing strategies for management, funding, technology transactions, and approaches to exit, to name a few.

Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

Notices:

• Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval: Updated Notice
• (NOT-OD-15-128) National Institutes of Health
• Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards): Updated Notice
• (NOT-OD-15-129) National Institutes of Health|
• Findings of Research Misconduct
• (NOT-OD-15-131) National Institutes of Health
• Subscribe to Receive NIH eRA Service Information
• (NOT-OD-15-132) National Institutes of Health
• Notice to Modify RFA-RM-13-006 "NIH Pioneer Award Program (DP1)" regarding the Award Budget, Biographical Sketch, and Research Strategy
• (NOT-RM-15-015)NIH Roadmap Initiatives
• Notice to Modify RFA-RM-13-007 "NIH Director's New Innovator Award Program (DP2)" regarding Biographical Sketch and Research Strategy
• (NOT-RM-15-016) NIH Roadmap Initiatives

Program Announcements:

• Discovery of Genetic Basis of Monogenic Heart, Lung, Blood, and Sleep Disorders (X01)
• (PAR-15-314) National Heart, Lung, and Blood Institute
• Application Receipt/Submission Date(s): October 20, 2015; June 15, 2016; June 15, 2017; June 15, 2018 , by 5:00 PM local time of applicant organization.

Please note that most links to RFAs, PAs, and Guide Notices will take you to the NIH Web site. RFPs will take you to FedBizOpps. Links to RFPs will not work past their proposal receipt date. Archived versions of RFPs posted on FedBizOpps can be found on the FedBizOpps site using the FedBizOpps search function. Under “Document to Search,” select Archived Documents.

During a tour to Paris, Bruce Springsteen explained that his dream was for the US to adapt a Swedish style welfare state. The famous musician is far from alone in idealizing Nordic policies. The four Nordic nations (Denmark, Finland, Norway and Sweden) are often regarded as prime role-models the policies to be emulated by others. Internationally, advocates of left of centre policies view these countries as examples of how high tax social democratic systems are viable and successful. Paul Krugman, for example, has said: “Every time I read someone talking about the ‘collapsing welfare states of Europe’, I have this urge to take that person on a forced walking tour of Stockholm”.

Baltimore will be the first stop for billionaire investor and entrepreneur Steve Case, who in September kicks off a $1 million investment round.

Case, CEO of the Washington, D.C., venture firm Revolution, plans to invest $1 million in startups in cities that are off the beaten path for most venture capitalists. The Rise of the Rest bus tour kicks off Sept. 28 in Baltimore and will make stops in Philadelphia, Buffalo and Manchester and Portland, Maine.

Mobile health tools will be “a powerful equalizer” in terms of geographic health disparities, according to executives from the Aetna Foundation.

Aetna Foundation leaders Dr. Garth Graham, MaryLynn Ostrowski and Alyse Sabina said in a post on the Health Affairs blog:

Ever heard of a hospital setting up a digital health operation within a single center of excellence? We hadn’t, either, until this week, when the Temple Lung Center at Temple University Health System in Philadelphia announced the establishment of the Center for Digital Health.

Dr. Gerard Criner, founding chair of Temple’s Department of Thoracic Medicine and Surgery, which started up in February, leads the Center for Digital Health. He also founded and continues to serve as chairman of HGE Health Care Solutions, a Temple spinoff that has built a mobile app that helps clinicians manage patients with chronic obstructive pulmonary disorder.

Apparently, requiring scientists to state their objectives ahead of time makes a big difference.

Around 2000, the U.S. government ordered researchers conducting clinical trials with federal money to announce ahead of time which medical question they were hoping to answer.