March 15, 2017 (Vol. 37, No. 6)

Industry Watch: Panelists Discuss Narrowing Boardroom Diversity Divide

Of the 177 biopharma companies that went public from 2012–2015, women held just 11% of board seats. That percentage isn’t expected to reach 50% until 2056, according to life sciences recruitment firm Liftstream.

At the recent BIO CEO & Investor Conference in New York, panelists discussed narrowing the diversity gap. Faith L. Charles, a partner at the law firm Thompson Hine and leader of its life sciences group, spotlighted the Boardroom Ready program from Women in Bio, which prepares women executives for seats on public and private company boards.

Charles, who chairs Women in Bio’s New York Metro chapter, was one of 20 women selected from 70 applicants for the program’s inaugural class last year. The 20 women completed a five-day course that included board certification training and assistance for women seeking board opportunities.

“In the room of 20 women, very few knew how to network. That shocked me,” Charles said. “The women who I met were CEOs, COOs, heads of R&D. These people are unbelievably talented. They’re just brilliant women, and they just don’t know any people to help them get there.”

Getting “there” means securing a board seat, which all 20 aim to do by next year. Charles was named in September to the board of Agilvax, which develops cancer immunotherapies and targeted vaccines.

“Because we have four women investors, every time we make an investment, we take a board seat,” said Colleen Cuffaro, Ph.D., principal at venture capital firm Canaan Partners. “You have a woman automatically in the boardroom as the investor that’s able to bring that point of view into the conversation when we’re searching for an executive or an independent board member.”

Too often, she added, CEOs seeking board members stop at other CEOs: “That’s a biased population. You’re going to end up finding more men if that’s what you search for.”

Stephen M. Ritoch, chairman and CEO of life science recruitment firm Blaise Group International, said diverse boards reflect the priority placed by company leadership.

“We cannot represent and take care of the shareholder or the patient without having the best, most talented people,” Ritoch said. “That’s what having diversity does.” 

Discovery & Development: Mass Spec Pulls Its Weight in Drug Discovery

Global demand for mass spectrometry systems in on the rise, largely due to the burgeoning requirements of the life sciences, pharmaceutical, and clinical analytics industries. According to Research and Markets, the global market is expected to reach $7.3 billion in 2020, up from $4.9 billion in 2015, reflecting a compound annual growth rate of 8.1%.

Key to this growth is the rapid transformation from conventional mass spectrometry to high-resolution mass spectrometry for improved qualitative analysis. “One of the more recent examples of technological advancements in mass spectrometry is the adoption of matrix-associated laser desorption ionization imaging mass spectrometry, or MALDI-IMS,” notes another analyst, Transparency Market Research (TMS).

“This system allows for the examination and analysis of tissues from a diagnostic perspective and thus reduces the overall time required for complete analysis of the sample. Another recent development is the high-resolution accurate mass system (HRAM), which can detect as well as deliver simultaneously a higher resolution of the full product ion spectrum and mass accuracy.”

TMS, like Research and Markets, anticipates a growth rate of 8.1% for the global market, but TMS pushes its estimates out to 2024, when it expects the market size to reach $9.9 billion.

On the implementation front, deployments geared toward drug discovery emphasize not only high-resolution mass spectrometry, but high-throughput operations. For example, AMRI has entered an alliance with Bruker Daltonics and HighRes Biosolutions to help it perform high-throughput drug screening.

AMRI will deploy the new MALDI PharmaPulse system, which combines combine Bruker’s MALDI-TOF mass spectrometers with HighRes Biosolutions’ high-throughput robotics. The MALDI PharmaPulse system, AMRI said, will help it expeditiously identify “hits,” the drug development starting points, from large collections of compounds.

“The extreme sensitivity of Bruker’s MALDI-TOF technology enables us to execute thousands of assays an hour while providing a level of information that often exceeds traditional screening assays,” comments Grant Carr, Ph.D., senior director of lead discovery at AMRI. “When coupled with the HighRes’ automation and process integration capabilities embodied in the MALDI PharmaPulse platform, we anticipate that this technique will enable entirely new avenues of drug
discovery research.”

Genomics & Proteomics: Cell-Free DNA Isolation Gets End-to-End Solution

The collection and isolation of cell-free DNA for use in minimally or noninvasive liquid biopsy techniques is considered by many in the life science industry as a major advance in molecular diagnostics. Many companies been searching for paths into this burgeoning market, leveraging their technology and expertise in order to gain the necessary traction. MagBio Genomics recently announced the launch of a novel system for the collection, stabilization, transport, storage, and isolation of circulating cell-free DNA (ccfDNA).

The new Blood STASIS 21-ccfDNA tube for venous whole blood collection and room-temperature stabilization of ccfDNA, contains a proprietary reagent that prevents postcollection release of genomic DNA from white blood cells; resulting in efficient and accurate recovery of ccfDNA with minimal genomic DNA (gDNA) contamination leading to more informative and quality data.   

“Successful use of whole blood samples as liquid biopsies for cancer genomic research and Noninvasive Prenatal Testing (NIPT) is dependent on several factors, such as convenience, efficiency of blood sample handling, and quality of recovered ccfDNA,” stated Hyacinth Ntchobo, Ph.D., CEO of MagBio Genomics. “The choice of sample stabilization buffer also plays a key role, in that it must be compatible with a full range of liquid biopsy applications for genomic assays.”

The Blood STASIS 21-ccfDNA stabilization reagent is compatible with almost all genomic-related assays, and allows room temperature transport and storage of blood for 21 days, and epithelial cells for eight days. The unique features of MagBio’s Blood STASIS 21-ccfDNA tube significantly expand the range of liquid biopsy applications, such as NIPT and cancer genomic assays, and improve operational efficiency, reduce costs, and enhance outreach for receiving samples on local and international levels.

“These features break down the barrier of sample degradation caused by extended transit times and fluctuating temperatures and allow researchers to freely collaborate globally for ccfDNA analysis in NIPT and cancer research,” Dr. Ntchobo concluded. 

Small pieces of DNA are shed into the bloodstream when cells die. This cell-free DNA (cfDNA) is of clinical utility because it can indicate the seriousness of traumatic injury or the degree to which a donated organ is being rejected by a transplant recipient. For example, researchers at Stanford University showed that cfDNA can enable noninvasive diagnosis of heart transplant rejection. The researchers suggested that cardiac allograft rejection could be monitored by cfDNA analysis instead of endomyocardial biopsy, an expensive and invasive procedure. [Jonathan Bailey, National Human Genome Research Institute, National Institutes of Health]

Bioprocessing: Selecta Biosciences Chooses Lonza for Gene Therapy Production

Lonza Houston and Selecta Biosciences, a clinical-stage biopharmaceutical company focused on developing biologic therapies for rare and serious diseases, signed a strategic manufacturing agreement under which Lonza will produce an Anc80-AAV-based gene therapy product for Selecta’s proprietary program for the treatment of methylmalonic acidemia (MMA). The disease is caused by a rare inborn error of metabolism.

Lonza may also in the future produce other Anc80-based products for which Selecta holds exclusive options.

The relationship is intended to leverage Lonza’s expertise in the development of industrial-scale manufacturing platforms for viral-based products.  Data shows that Anc80-AAV, an in silico-designed synthetic gene therapy vector, has the potential to provide superior gene expression levels in retina, liver, muscle, cochlea’s outer hair cells, and other tissue targets in preclinical studies, as well as reduced cross-reactivity as compared to naturally occurring adeno-associated viral vectors (AAVs) that are currently in clinical development, according to Selecta officials.

“Lonza will utilize our extensive cGMP manufacturing knowledge and world-class quality systems to help Selecta Biosciences develop promising novel therapeutics for patients impacted by MMA and other devastating diseases,” said Andreas Weiler, Ph.D., head of the emerging technologies business unit for Lonza’s Pharma&Biotech segment.

“We at Selecta are focused on combining novel and proprietary viral vectors with our immune tolerance Synthetic Vaccine Particles (SVP™) to enable the first nonimmunogenic gene therapies, providing the potential for repeat dosing,” added Werner Cautreels, Ph.D., Selecta’s president, CEO, and chairman.

Bolstered by Deal with Eye Institute

 Last fall, Lonza Houston and the Massachusetts Eye and Ear® research center entered into an agreement designed to provide customers the ability to in-license Anc80 and other Anc-AAVs for the clinical development and commercialization of novel gene therapies.

Anc-AAVs are in silico-designed synthetic AAVs, developed first in the laboratory of Luk H. Vandenberghe, Ph.D., assistant professor at Harvard Medical School, and director of the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear. As part of the agreement, a platform development effort will be initiated with a focus on discovering additional next-generation Anc-AAVs.

By applying its AAV manufacturing technology innovation, Lonza said it will work toward the establishment of modern, best-in-class, large-scale manufacturing platforms for Anc80 and any future vectors generated out of Dr. Vandenberghe’s lab.

Under the agreement, Lonza will fund research at the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear to discover, characterize, and develop next-generation gene transfer reagents to improve upon important limitations of current AAVs, including preexisting immunity, manufacturing yields, immunogenicity, tissue tropism, and specificity.  

Molecular Diagnostics: Asterand Bio and MolecularMD Launch Therapeutic Biomarker Partnership

Asterand Bioscience and MolecularMD have launched a partnership focused on targeted therapeutic biomarker validation, optimization, development, and commercialization.

The partnership, whose value was not disclosed, is designed to combine MolecularMD’s expertise as a provider of molecular diagnostics products and services with Asterand Bio’s drug target and candidate validation capabilities. The companies said they aim to strengthen their offerings in assay development and validation, while creating a global footprint for delivering clinical trial sample analyses.

“This agreement brings together MolecularMD’s proven track record in clinical assay development and companion diagnostics with Asterand Bio’s human tissue procurement, characterization, and research services to provide a comprehensive approach to meet the needs of pharmaceutical, biotechnology, and diagnostic companies from validation of biomarkers and targets to assay development, through regulatory and clinical trials,” Asterand COO/CFO John Canepa said in a statement.

Asterand Bio has offices in Detroit and Royston, U.K., and was formed in 2006 through the merger of the human tissue biobank Asterand and human tissue-based drug discovery company Pharmagene. Asterand Bio is a global provider of high quality, well-characterized human tissue and human tissue-based research solutions to drug discovery scientists.

The company’s products are designed to accelerate the identification and validation of drug targets, as well as enhance the selection of drug candidates with increased likelihood of clinical success. Asterand Bio’s XpressBANK™ biobank contains several hundred thousand specimens from a broad range of therapeutic areas and including numerous ethnicities.

Based in Portland, OR, with additional operations in Cambridge, MA, MolecularMD develops custom clinical trial assays as well as companion diagnostic products, supporting clinical trial services and commercialization of targeted cancer therapies.

MolecularMD has developed and implemented what it says is the only standardized assay for quantification of BCR-ABL expression levels, which enabled Bristol-Myers Squibb and Novartis to gain approvals for their second-generation ABL kinase inhibitors Sprycel® (dasatinib) and Tasigna® (nilotinib), respectively. 

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