The big deal about the just-completed J.P. Morgan (JPM) 38th Healthcare Conference had little to do with big M&A deals, because there weren’t any. This time last year, the $74-billion Bristol-Myers Squibb acquisition of Celgene was announced, as was Eli Lilly’s takeover of Loxo Oncology for $8 billion.

There were no such blockbusters this year, though there was an interesting potentially up-to-$2 billion-plus collaboration: MorphoSys outlicensed ex-U.S. commercialization rights to its anti-CD19 Fc-engineered antibody tafasitamab to Incyte, with the companies agreeing to co-commercialize the B cell malignancy candidate Stateside.

Image: A dearth of deals, Illumina’s double launches, and the usual crowds marked the 38th J.P. Morgan 38th Conference. - https://www.genengnews.com

When was the last time you analyzed how much you should pay your board members? How do you know if you are paying too much or not enough? In this article we examine the results of our most recent research that highlights how much board members should receive in compensation.

Business size, industry, structure, complexity, the number of yearly meetings are just a number of variables you have to consider when setting your board remuneration programs. Private companies tend to struggle with board compensation because it is difficult to find accurate benchmarks for director pay.

SAN FRANCISCO, Jan. 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.

Why me?

I have spent the last 20 years as a serial CEO of multiple healthcare startups, as well as spending the last 3 years as a corporate/strategic venture capitalist. I have made many mistakes and gotten lucky on more than a few occasions. What I hope to accomplish in this blog is simple: educate and, on a good day, entertain. There are many that are much, much more successful than me (nearly everyone in Silicon Valley!). There are some that are worse (also in Silicon Valley...e.g. Elizabeth Holmes re: Theranos). I am not from Silicon Valley. If you have questions, comments, or suggestions (future topics), please feel free to reach out to me.

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BioSciCon, Inc., a woman-owned small business based in Rockville, Maryland focused on providing a low-cost and accessible diagnostic system for the detection of cervical cancer announced today that it is seeking a partner to make its proprietary MarkPap® platform available to women in low- and middle-income countries.

According to BioSciCon Director and President of the Global Academy for Women’s Health Dr. Olivera Markovic, “In low- and middle-income countries (LMICs), thousands of women still are dying needlessly every year from cervical cancer due to the astonishingly low screening in LMICs for this highly preventable disease. Our kit and screening model, if applied as designed, could prevent the deaths of about 300,000 women annually, through improved and expanded screening and early detection of cervical cancer.”

The idea for BioSciCon was conceived by Drs. Olivera and Nenad Markovic upon discovery of a new bioactive protein residing only in specimens obtained from abnormal cervical tissues. Continued success of their team of scientists led to the development of a proprietary technology for visualization of this protein by simple laboratory pathology means known as the CAP-PAP Test. The MarkPap® System has been tested in more than 2000 women and proven to result in faster, less expensive and more accurate diagnosis of cervical cancer than the conventional Pap and liquid-based Pap test.  These improved outcomes have been documented in more than 60 publications in peer-reviewed  journals and in the reference guide “What Every Woman Should Know about Cervical Cancer”).  To further the company’s mission to save women’s lives through early intervention in LMICs, BioSciCon is seeking a partner to distribute MarkPap kits to underprivileged women in low resource settings.

Click here for more information.

AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for FARXIGA® (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.

Hi, I am Harsha Rajasimha, Founder and Chairman of IndoUSrare, an independent non-profit organization focused on helping patients with rare diseases of Indian origin in the USA, India and globally with a vision to build collaborative bridges between the east and the west to accelerate research and development of diagnostics and therapies through education, advocacy, research & grants.

WASHINGTON – The National Capital Consortium for Pediatric Device Innovation (NCC-PDI), in collaboration with MedTech Innovator, is now accepting applications for its showcase pitch event on March 23, 2020, in College Park, Maryland. The competition is focused on pediatric devices in three areas of critical need: cardiovascular, orthopedic and spine, and neonatal intensive care unit (NICU).

Up to ten companies selected from this event will move on to the “Make Your Medical Device Pitch for Kids!” on Oct. 4, 2020 in Toronto, Canada, to compete for up to $250,000 in grant awards. These companies also receive a spot in the MedTech Innovator 2020 Accelerator – Pediatric Track, which provides a customized curriculum and in-depth mentorship.

BioMarker Strategies, LLC, today announced that the National Cancer Institute (NCI) has awarded the Company a Phase II Small Business Innovation Research (SBIR) contract to continue development of its PathMAP® Immunotherapy test to predict clinical response to PD-1/PD-L1 targeted immune checkpoint inhibitors, both alone and in combination with chemotherapies, for individual patients with non-small cell lung cancer (NSCLC). The contract totals $1.5 million over two years.

Image: https://finance.yahoo.com

A company developing treatments for drug-resistant bacterial infections is getting a boost from the Department of Defense.

Gaithersburg, Maryland-based Adaptive Phage Therapeutics, also known as APT, said Tuesday that it the DoD had awarded it $10.2 million to fund a clinical trial to develop its personalized bacteriophage therapeutic, PhageBank.

CHICAGO/TEL AVIV-YAFO (January 7, 2020) – LionBird has a new partner: Robert Lord. Lord is the co-founder of Protenus, a healthcare compliance analytics company from LionBird’s second fund. Lord joins LionBird to provide strategic insight as the company prepares to hone its digital health focus for its upcoming fund, LionBird III. In addition to his role at LionBird, Lord is the Chairman of the Board of Protenus, providing support to the Protenus team while also completing his medical degree at Johns Hopkins University School of Medicine.

BioSpace is proud to present its NextGen Bio “Class of 2020,” a list of up-and-coming life sciences companies in North America that launched* no earlier than mid-2018.

To come up with this list, BioSpace sorted companies into that age grouping, and they were then weighted by a number of different categories and finally ranked in a cumulative fashion, based on the points awarded for each category. These categories were: Finance, Collaborations, Pipeline and Innovation (view methodology below).

Image: https://www.biospace.com

Here we are… 2020. As we approach this new decade with a fresh lens of excitement and rejuvenated ambition for impact, there are a few fundamentals that we should review. Elements we all know are important in our commercial strategy, yet can be abandoned in the hustle of launching a new product, service, or company to market. We should take a moment to reflect on the past decade’s success and challenges specific to the life science industry. Many questions still remain as we progress into the new year—will painful blood draws finally be a thing of the past thanks to Velano Vascular’s needless vascular access device? Or, could cutting edge digital health companies, such as Livongo or Virta Health, eliminate chronic conditions like Type 2 diabetes? Further, many often wonder, will traditional pharmaceutical drugs be replaced by Prescription Digital Therapies (PDT) altogether? 

Oncology, neurology, and fatty liver disease are among the areas where one can expect to see significant activity this year, according to forecasts from investment bank analysts.

Anticipated highlights for 2020 include potentially the first regulatory approval of a drug to treat the liver disease nonalcoholic steatohepatitis, or NASH; the launches of two new drugs for sickle cell disease; and late-stage data for a drug to treat amyotrophic lateral sclerosis, among others. Several company executives also shared their insights in a story published over the weekend.

Competition for startups aims to increase the pace of development and commercialization of critically needed pediatric medical devices. In the world of innovation, devices used for pediatric medical care, particularly the very young, are lagging behind those created for adult purposes. A contest is now open, inviting innovators to do something about it. Top contenders will be awarded with support from an innovation accelerator to further develop their device and an opportunity to win up to $250,000 in grant money.

A new initiative spearheaded by Johns Hopkins is setting out to organize and grow the digital health community in the region, with an aim of fueling successful startups.

The Chesapeake Digital Health Exchange (Chesapeake DHX) wants to create more connectivity between the stakeholders in digital health, such as companies, investors and healthcare providers. The regional effort aims to include Maryland, D.C. and Northern Virginia.

COLUMBIA, Md., Jan. 8, 2020 /PRNewswire/ -- TEDCO, Maryland'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 Park; University of Maryland, Baltimore County; University of Maryland, Baltimore; Johns 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.

The Center for Innovative Technology (CIT) today announced that CIT GAP Funds has invested in Herndon, Va.-based Jeeva Informatics Solutions Inc. (Jeeva), a precision medicine data science company focused on significantly accelerating clinical trial operations by taking trials to patients’ homes. Using AI and digital health technologies, Jeeva fast tracks patient recruitment, improves adherence to trial protocols, and reduces patient burden and dropout rates, solving some of the pressing challenges in bringing innovative medicines to market effectively. Jeeva plans to use the GAP Funds investment to advance customer pilot projects and use cases for further validation.

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 has been appointed as the Company’s Chief Medical Officer. Additionally, John Trainer, MBA has been appointed as the Chief Financial Officer.

Image: https://biobuzz.io

NexImmune, a clinical-stage biopharmaceutical company developing novel immune-therapeutics based on a proprietary Artificial Immune Modulation (AIM) nanotechnology platform, announced that industry veteran John Trainer, MBA has been appointed as the Company’s Financial Officer. Additionally, Han Myint, MD has been appointed as the Chief Medical Officer.

SANTA CLARA, Calif., Jan. 7, 2020 /PRNewswire/ -- Based on its recent analysis of the global single-cell analysis market, Frost & Sullivan recognizes LumaCyte, LLC (LumaCyte) with the 2019 Global New Product Innovation Award for its groundbreaking Laser Force Cytology™ (LFC™) technology. The solution accelerates therapies and analytical insights by enabling new cell discovery, characterization and phenotyping across broad applications. LumaCyte's recently launched flagship platform, Radiance®, is an automated, high-content, label-free single-cell analysis and sorting platform. LFC™ helps labs and biopharmaceutical organizations cost-effectively optimize viral quantification for example, which are critical assays for vaccine and cell and gene therapy development and production, leading to easier sample preparation, shortened detection time, and high-quality, objective data.

GAITHERSBURG, Md., Jan. 09, 2020 (GLOBE NEWSWIRE) -- 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 directs 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.”

Alexandria Real Estate Equities, Inc. (NYSE:ARE), an S&P 500® REIT, is the first and longest-tenured owner, operator, and developer uniquely focused on collaborative life science, technology , and agtech campuses in AAA innovation cluster locations, including Greater Boston, San Francisco, New York City, San Diego, Seattle, Maryland, and Research Triangle. Alexandria has a longstanding and proven track record of developing Class A properties clustered in life science, technology, and agtech campuses that provide our innovative tenants with highly dynamic and collaborative environments that enhance their ability to successfully recruit and retain world-class talent and inspire productivity, efficiency, creativity, and success.

The University of Maryland School of Pharmacy welcomed nearly 200 researchers from across the University of Maryland, Baltimore (UMB) and Johns Hopkins University (JHU) to the second UMB-JHU Joint Symposium on Drug Discovery on Dec. 3. Organized by Paul Shapiro, PhD, professor and chair of the Department of Pharmaceutical Sciences (PSC) at the School of Pharmacy, and Barbara Slusher, MAS, PhD, professor of neurology at the Johns Hopkins University School of Medicine and director of Johns Hopkins Drug Discovery, the symposium provided an open forum for scientific exchange and interactive communication among students, postdoctoral fellows, and faculty from two of Baltimore’s preeminent academic institutions.

Image: Nearly 200 researchers from across UMB and JHU gather for the second Joint Symposium on Drug Discovery. - https://www.umaryland.edu

ROCKVILLE, Md. & FOSTER CITY, Calif. & HANGZHOU, China--(BUSINESS WIRE)--Jan. 6, 2020-- GlycoMimetics, Inc. (NASDAQ: GLYC), a leader in the field of applied glycotechnology for cancer, and Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies, announced today an exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.

The largest biotechnology incubator of its kind in New York City has opened at 180 Varick Street in Hudson Square.

BioLabs @ NYULangone is designed to attract the nation’s most innovative companies working in early stage life sciences.

The co-working facility currently has 22 companies and is expected to house more than 40 early-stage biotechnology and life sciences companies, 160 scientists, business personnel and support staff, in 50,000 s/f of newly renovated and fully equipped laboratory and office space.

Image: Lieutenant Governor Kathy Hochul joins representatives of NYCEDC, NYU Langone Health and BioLabs at the official opening. - https://rew-online.com

President Moon Jae-in announced in May that the government would designate the biohealth industry as one of the three new sectors for future growth, help the industry account for at least 6 percent of the global pharmaceutical and medical device market share by 2030, achieve $50 billion biohealth exports, and nurture the sector as one of the five major export industries.

The announcement came during his visit to Osong, North Chungcheong Province, which has a cluster of biotech research firms.

Image: http://www.koreabiomed.com

Scientists from the Institute of Human Virology (IHV) at the University of Maryland School of Medicine (UMSOM) this week proposed a new theory, based on the findings of three previously published studies, to improve the efficacy and safety of immunotherapy drugs. The theory calls for a new design for these drugs that would prevent side effects like life-threatening immune system reactions and enable a higher dose of the drug to be administered.

Image: https://www.umaryland.edu

The Maryland Technology Development Corp. and the National Institute of Standards and Technology awarded four companies a total of $448,000 to develop NIST-licensed technologies for the market, TEDCO announced Tuesday.

The NIST Science and Technology Entrepreneurship Program (N-STEP) focuses on commercializing NIST research. It lets NIST researchers who have left the agency or will soon be leaving the agency to commercialize technology they researched.

Image: Money, money. In this Sept. 24, 2013, file photo, freshly cut stacks of $100 bills make their way down the line at the Bureau of Engraving and Printing Western Currency Facility in Fort Worth, Texas. (AP Photo/LM Otero, File)

Eight months after Maryland Technology Development Corp. halted investments through some of its funds, the state-backed organization announced Friday it is ready to accept new applications from startups seeking investment.

TEDCO has launched a new online application process for several of its funding programs: the Rural Business Innovation Initiative, Builder Fund, Seed Fund and Maryland Venture Fund (MVF). New investments through these programs have been on hold since June, while TEDCO has enacted legislature-directed reforms prompted by a damaging audit report aimed particularly at the MVF.

The University of Maryland School of Medicine is being recognized by a national news publication for groundbreaking biomedical research that “is making the world a better place.” The publication, WIRED magazine, is featuring the innovative work of UMSOM’s Samuel Tisherman, MD, professor of surgery, and the University of Maryland R Adams Cowley Shock Trauma Center on a list of 19 items or advances recognized in 2019. 

GERMANTOWN, Md., Jan. 2, 2020 /PRNewswire/ -- Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, announced today that it will refocus the company on healthcare, change its name to Precigen, Inc. and, effective immediately, has appointed Helen Sabzevari, PhD, as President and CEO. The new Precigen will encompass Intrexon's wholly-owned healthcare subsidiaries Precigen, ActoBio Therapeutics, Exemplar Genetics, and its majority ownership interest in Triple-Gene, as well as equity and royalty interests in therapeutics and therapeutic platforms from companies not controlled by Intrexon. Randal J. Kirk has been appointed Executive Chairman.  Additionally, Intrexon has executed binding agreements to sell its smaller non-healthcare businesses for $65.2M plus certain contingent payment rights and entered into an agreement to sell $35M of its common stock.  The proceeds from these transactions, combined with the company's cash and short-term investments on hand at December 31, 2019, approximates $175 million thus attaining Intrexon's year-end objective.

The Healthcare Technology Report is pleased to announce and recognize a unique set of accomplished women playing vital roles in some of the most important global companies shaping the future of biotechnology. The awardees of 2019 were each selected based on a detailed review of the depth of their professional experience and the caliber of their career achievements. These women are leaders not only in title or position but based on what they’ve been able to accomplish inspiring the teams and organizations around them. They have also demonstrated a commitment to the advancement of biotech. We congratulate each of this year’s awardees of The Top 25 Woman Leaders In Biotech of 2019.

Image: https://thehealthcaretechnologyreport.com

COLUMBIA, Md. (January 3, 2020)—TEDCO, Maryland’s economic engine for technology companies, announced today that its programs: Rural Business Innovation Initiative (RBII Fund), Builder Fund (Builder Fund), Seed Funds (Seed Fund) and Maryland Venture Fund (MVF) are now accepting applications for investments. 

In accordance with new statutory requirements enacted by the Maryland General Assembly during the 2019 legislative session, TEDCO has developed and adopted regulations governing its investment programs.  The new law also tasked TEDCO with developing an application process for its investment programs. With the new regulations in place and a compliant on-line application portal up and running, TEDCO is now able to begin accepting applications.  

2019 was an eventful year in the BioHealth Capital Region (BHCR), to say the least, and BioBuzz has been there to document it every step of the way.

Whether it was the retirement of the MedImmune brand, Viela Bio’s $150M IPO, the $1.2B acquisition of Paragon Bioservices, Kite Pharma’s new manufacturing site in Frederick County, Maryland, an HIV cure emerging in Maryland or our continued coverage of the region’s expanding cell and gene therapy cluster-it’s been a truly remarkable year within the BHCR.

Image: https://biobuzz.io