Monthly Archives

January 2020

So, You Want to Join a Life Science Startup?

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Why You Should Consider Workplace Culture Before Taking the Leap

The startup mythology has its origins in the tales of geniuses like Walt Disney, Bill Gates and Jeff Bezos’ going from small California garages to world domination. And the startup mystique became part of popular culture with Silicon Valley companies like Google and others creating workplace cultures where employees skateboarded down hallways, enjoyed yoga and meditation sessions onsite, and blew off steam with breaks at the company-provided vintage arcade and craft coffee bar.

These startup stereotypes bely a stark reality, however: Most startups are risky and operate on tighter budgets until they survive long enough to mature and raise ample funding.

If you get in at the right inflection point, the spoils of joining a startup can be life-changing. Regardless, leaving an established life science company for a bioscience startup is a tough decision defined by the high-risk, high-reward nature of these fledgling companies fighting to win funding and bring its product to the market.

For those in the early stages of their life science career, joining a bioscience startup could be a no brainer—there’s likely a lot less risk and so much more to gain. For the less experienced, stock options are not the only potential windfall; startup culture will likely furnish development opportunities to less-experienced workers not readily available to them in larger, established biotech or big pharma organizations.

Click here to read more via BioBuzz.

AMPEL BioSolutions Announces Gene-Based Lupus Diagnostic At Biotech Showcase In San Francisco

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SAN FRANCISCOJan. 17, 2020 /PRNewswire/ — AMPEL BioSolutions’ Co-Founder and COO/CSO Dr. Amrie Grammer today at the Biotech Showcase at JP Morgan Healthcare announces the kickoff of a Series A $12.5M raise to commercialize LuGENETM, a gene-based diagnostic.  AMPEL’s initial focus is Lupus, but the test can be used for many autoimmune or inflammatory diseases.  AMPEL’S goal is to have its test available for routine use by physicians within the next few years.

LuGENETM is a breakthrough in precision and personalized medicine that could revolutionize the way doctors treat chronic diseases, like Lupus.  The lab test, only a concept for the last few years, is now ready for commercialization for practical decision support for precise drug treatment based on a patient’s genes.  LuGENETM will transform the way doctors treat chronic diseases by using the information gathered by the lab test and analyzed by machine learning to predict a flare and treat it before it even begins, saving patients from pain and inconvenience of a disease that otherwise drastically affects their lives.

“Predicting lupus disease flares, allowing initiation or modification of disease-modifying therapies, should have an important impact on patient health,” stated Mary K. Crow, MD the Physician-in-Chief, Hospital for Special Surgery, Weill Cornell Medical Center and Former President American College of Rheumatology. “LuGENE seems to be an important step in that direction.  Application of knowledge of molecular mechanisms to aid in patient management is the future of lupus care and will benefit patients and improve outcomes.”

Click here to read the entire press release.

Novavax Granted Fast Track Designation for NanoFlu in Older Adults

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GAITHERSBURG, Md., Jan. 15, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M™, in adults 65 years of age and older.

“The FDA’s decision to grant Fast Track Designation for NanoFlu reflects the urgent unmet medical need for a more effective vaccine against influenza, particularly in the older adult population which often experiences serious and sometimes life-threatening complications, of the disease” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness. We look forward to working closely with the FDA through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations.”

The ongoing Phase 3 clinical trial is intended to evaluate the immunogenicity and safety of NanoFlu compared to the quadrivalent formulation of Fluzone. The trial’s primary objectives are to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains compared to Fluzone, and to describe its safety profile. Top-line clinical data from the trial is expected by the end of the first quarter of 2020 and could support a U.S. biologics license application (BLA) and future licensure of NanoFlu using the FDA’s accelerated approval pathway.

Click here to read the entire press release.

New Decade, Old Challenge: BioManufacturing Workforce Development Remains Key to Industry Growth

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The BioHealth Capital Region (BHCR) experienced significant change in 2019 that has set the table for an intriguing 2020.

How 2020 plays out across the region is unknown.

However, if you’ve followed BioBuzz throughout the past year, it is abundantly clear that workforce development strategy, investment, and support will be a critical issue for the next decade in the BHCR. In addition to change and growth across more traditional life science sectors, the ascension of personalized medicine within the region, which includes a host of new and growing regenerative medicine, cell therapy, and gene therapy companies, has transformed the region’s workforce needs.

How the region develops its workforce to support traditional life science growth and adjusts—or, for that matter, does not—to the accelerating growth in the cell and gene therapy sector is a big unknown and an even bigger, ongoing challenge. Developing talent for the emerging cell and gene therapy industry is just one piece of the region’s workforce development puzzle, albeit a crucial one.

A cohesive, well-funded workforce development strategy that brings together industry, government, academia and various life science support organizations is essential to retain and attract the talent needed to keep the BHCR healthy and growing. The region has made real progress in talent development; the BHCR has one of the deepest, most skilled and highly educated workforces in the world. However, as science and technology advances, biohealth clusters like the BHCR need to be agile enough to stay ahead of the innovation curve.

Workforce challenges remain to be overcome, including balancing collaboration with competition for talent, expanding the talent pipeline and securing the funding required to support essential workforce development programs across the BHCR.

Click here to read more via BioBuzz.

6 People in the BioHealth Capital Region You Should Know In 2020

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2019 was a year of change for many BioHealth Capital Region organizations. The past year has seen a host of notable leadership transitions that are sure to have an impact in the region.

The Maryland Department of Commerce said goodbye to Secretary Mike Gill and welcomed Secretary Kelly Schultz; the Office of Bio and Life Sciences saw turnover as well. TEDCO’s President John Wasilisin resigned early in the year and CEO George Davis left in June. David Peter departed from MCEDC.  Jarrod Borkat, who had spearheaded the BioHealth Capital Region strategy for more than five years departed in 2018, and even MedImmune itself, the proverbial anchor biotech for the region, disappeared this year after finally being absorbed by AstraZeneca.

Change is inevitable and is often a creative force that generates an opportunity for new leaders to emerge and drive new levels of influence and innovation.

So, who are these emerging leaders in BHCR?

We’ve identified five new faces that we believe will play prominent roles that will influence and shape the future of the BHCR.

Click here to read more via BioBuzz.

Emergent BioSolutions Receives EMA Agreement for Proposed Development Path of Investigational Chikungunya VLP Vaccine Candidate

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GAITHERSBURG, Md., Jan. 13, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced that it has received agreement from the European Medicines Agency (EMA) to pursue its proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate. The company has proposed conducting a safety and immunogenicity Phase 3 trial using Serum Neutralizing Antibodies (SNA) as an immune correlate of protection to predict clinical benefit of the vaccine candidate.

“Emergent is encouraged by the concurrence we have received from EMA in paving the path for chikungunya vaccine development based on SNA as the surrogate endpoint,” said Abbey Jenkins, senior vice president and vaccines business unit head at Emergent BioSolutions. “As a leading provider of travel health vaccines, Emergent seeks to address the threat posed by this highly debilitating virus by defining a realistic and optimal path to bring to market a much-needed chikungunya vaccine that could potentially serve patients worldwide. We look forward to continuing to work with regulators, including the U.S. Food and Drug Administration (FDA) with whom we had our End-of-Phase 2 meeting last December, as we plan to initiate a pivotal Phase 3 trial this year and define the approach for a post-approval confirmatory efficacy trial.”

Click here to read the entire press release.

QIAGEN celebrates surpassing 2,500 cumulative placements of QIAsymphony

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Hilden, Germany, and Germantown, Maryland, January 9, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the 2,500th placement of QIAsymphony, the leading Sample to Insight workflow automation solution for molecular laboratories worldwide, in Tübingen, Germany.

Cenata GmbH is a medically led genetic diagnostic laboratory offering prenatal testing, and repeat customer of the QIAsymphony, purchasing this milestone QIAsymphony SP as the third unit in their lab, expanding capabilities for circulating DNA purification and other applications.

“The QIAsymphony in our lab is in near-constant use,” explains Dr. Karina Häbig, Scientific Coordinator of Cenata GmbH in Germany. “For our non-invasive prenatal testing applications, especially the Harmony® Test, it gives us consistent results with automation while lowering our hands-on time and ensuring quality.”

“2,500 cumulative QIAsymphony placements represent a great milestone for QIAGEN and are proof-point for a new era in laboratory automation that began in 2008. Today, QIAsymphony is considered a trusted workhorse in molecular testing labs worldwide whose continuous enhancements and ongoing menu expansion enabled numerous breakthroughs in science and helped diagnostic decision making to improve outcomes for over a million patients,” said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area “And the remarkable success story is not over yet. Building on the established market leading position for QIAsymphony, we are further expanding the system’s capabilities. The new QIAsymphony PowerFecal Kits add to the growing number of applications that cover different sample types and testing technologies – from liquid biopsies to tissue samples, from PCR to NGS.”

Click here to read the entire release.

Adaptive Phage Therapeutics Awarded Initial Contract with Department of Defense

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GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced the Department of Defense (DoD) has awarded APT a contract of $10.2 million for the development of PhageBankTM a personalized bacteriophage therapeutic for the treatment of bacterial infections. The award is designated to conduct a clinical trial, with the goal of making PhageBank phage therapy available to treat multidrug-resistant (MDR) and complicated infections.

“This is a promising step toward making phage therapy available to military and potentially non-military patients alike as a rapid and cost-effective option for multi-drug resistant bacterial infections. Building on the US military’s impressive history in antimicrobial research, including the advanced development of penicillin prior to the Second World War, APT’s PhageBank is now the first phage-based therapy to be selected by the Department of Defense for advanced development,” said Greg Merril, Chief Executive Officer and co-founder of APT. “APT’s proprietary technologies enable the rapid administration of phage therapy as a precise treatment tailored to a patient’s individual infection. Our dynamic, adaptive approach translates to a therapeutic option that potentially will target a broadening spectrum of bacteria over time.”

Click here to read the entire press release.

NexImmune Expands Executive Team With Appointments of Chief Medical Officer and Chief Financial Officer

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GAITHERSBURG, MD — January 08, 2020 – NexImmune, a clinical-stage biopharmaceutical company developing novel immune-therapeutics based on a proprietary Artificial Immune Modulation (AIM) nanotechnology platform, announced that industry veterans Han Myint, MD, and John Trainer, MBA, have been appointed as the Company’s Chief Medical Officer and Chief Financial Officer, respectively.

Dr. Myint commented, “I am very excited to join NexImmune at such a time where I can leverage my professional experience to oversee the Company’s first two clinical trials for NEXI-001 and NEXI-002 in patients with relapsed forms of Acute Myeloid Leukemia (AML) and Multiple Myeloma, respectively. The Company has developed a novel technology that direcects endogenous T cells against multiple tumor antigen targets. For patients suffering from a variety of cancers, I believe this approach has the potential to deliver potent anti-tumor activity while minimizing potential off-target toxicities, and I am looking forward to working with team to make this a reality for these patients.”

Trainer commented, “The tremendous potential of the NexImmune AIM platform in multiple types of cancer and other disease areas is a significant growth opportunity. Scaling up and financing this growth through additional capital raises, partnerships and a potential IPO will be a top priority. I’m excited to be a part of the NexImmune team as we push forward on our mission to help patients.”

Dr. Myint most recently served as the Vice President of Global Medical Affairs – Myeloid Diseases at Celgene. While in that role, he led the Global Franchise Team – Myeloid, and worked very closely with cross-functional teams representing commercial, market access, regulatory, translational and clinical functions to create a cohesive global disease strategy for all development stage compounds in the Myeloid disease pipeline including AML, Myelodysplastic Syndrome (MDS), Myelofibrosis and Thalassemia. Prior to his six year tenure at Celgene, Dr. Myint practiced academic hematology at multiple prestigious institutions, including Rush University in Chicago, and became a Fellow at the Royal College of Physicians and Royal College of Pathologists in London, England. He has expertise and clinical experience in hematological malignancies and stem cell transplantation. Additionally, Dr. Myint built a FACT-accredited and Center of Excellence-Designated Transplant Program at the University of Colorado, Denver, while becoming a fellow of the American College of Physicians.

Trainer most recently served as Vice President and Head of Partnering & Strategy for MedImmune, the biologics-focused R&D unit of AstraZeneca. There, he led all in-licensing, out-licensing and collaboration work for MedImmune including such transactions as the spin-out of Viela Bio (which raised a $250m Series A). Trainer was also responsible for working with partners such as Johns Hopkins University and the NIH to help develop promising new companies and technologies. Previous to that role, Trainer was Vice President, Corporate Development for AstraZeneca and the commercial leader for AstraZeneca’s Infection, Neuroscience and Gastrointestinal group globally, as well as holding a variety of financial, transactional and commercial roles at MedImmune. He received his MBA from Harvard Business School and his undergraduate degree from Harvard College.

Scott Carmer, President and CEO of NexImmune, commented on the additions to the Company’s Executive Leadership Team, “I am thrilled to have both Han and John join our team. Individually, each is a highly respected and accomplished industry leader. Together, their combined experience, expertise and leadership will be a strong complement to those of our existing executive team. As we initiate our first clinical trials in 1Q2020, NexImmune is now poised to exploit the full potential of our unique technology platform for the benefit of patients in need.”

Click here to read the entire press release.

TEDCO’s Maryland Innovation Initiative Infuses $2.63M in New Round of Projects

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COLUMBIA, Md.Jan. 8, 2020 /PRNewswire/ — TEDCOMaryland’s economic engine for technology companies, announced its recent round of funding for select projects through the Maryland Innovation Initiative (MII). This round of funding includes project grants for technology assessment and investments in the spin-out companies, from its five partner universities for a total of $2.63M.

Established in 2012, the MII program was created as a partnership between the State of Maryland and five Maryland academic research institutions: University of Maryland, College ParkUniversity of Maryland, Baltimore CountyUniversity of Maryland, BaltimoreJohns Hopkins University; and Morgan State University. The program’s mission is to accelerate promising technologies with significant commercial potential to market while leveraging each partner University’s strengths.

“MII is an ideal representation of the support TEDCO gives to companies from idea and development phases to successful commercialization,” said Arti Santhanam, executive director of MII. “We are especially proud that the MII portfolio is a reflection of the diversity of technology space and applicants that these partner universities bring to the table. Our companies have leveraged these strengths to jumpstart their innovative products and bolster the innovation ecosystem in Maryland.”

Click here to read the entire press release.

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