Welcome New Members

2The Mass Technology Leadership Council (MassTLC) is the region’s leading technology association and the premier network for tech executives, entrepreneurs, investors and policy leaders. MassTLC’s purpose is to accelerate innovation by connecting people from across the technology landscape, providing access to industry-leading content and ideas and offering a platform for visibility for member companies and their interests. Link

NTSAD_logoNational Tay-Sachs & Allied Diseases Association (NTSAD) is one of the oldest patient advocacy groups in the country. We focus on funding research, supporting over 500 families and individuals worldwide, and raising awareness to prevent disease. Link

 

VBI_Logo-Md1VBI Vaccines, Inc. (Nasdaq: VBIV) is a biopharmaceutical company developing novel technologies that seek to expand vaccine protection in large underserved markets. VBI’s eVLP vaccine platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus. The company’s lead eVLP asset is a prophylactic Cytomegalovirus (CMV) vaccine; VBI has initiated work for GMP manufacturing of its CMV candidate for use in formal preclinical and Phase I trials. The company’s second platform is a thermostable technology that enables the development of vaccines and biologics that can withstand storage or shipment at constantly fluctuating temperatures. VBI has completed proof of concept thermostability studies on a number of vaccine and biologic targets. VBI is headquartered in Cambridge, MA with research facilities in Ottawa, Canada. Link

Top 5 News 10/10/14 – 10/17/14

Top 5 logo1) AbbVie board recommends against $55b merger with Shire, Boston Globe, October 16, 2014
The biopharmaceutical company AbbVie Inc. reversed course on its planned acquisition of specialty drug maker Shire PLC this week, but Shire, which has major operations in Massachusetts, will remain a strong company without the deal, analysts said. Shire was the target of the $55 billion merger, which would have been one of the largest in Massachusetts history, similar in size to Procter & Gamble Co.’s takeover of Gillette Co. in 2005. As an independent company, analysts said, Shire still has several successful drugs on the market and promising treatments under development. Link

2) Novartis psoriasis drug benefits outweighs risk-FDA staff, Reuters, October 16, 2014
The benefits of Novartis AG’s anti-inflammation drug outweighed the risks in using it to treat a type of psoriasis, staff reviewers at the U.S. Food and Drug Administration said. The injectable biologic, secukinumab, is part of an eagerly anticipated class of drugs called IL-17 inhibitors that have shown unprecedented success in plaque-psoriasis, the most common form of the painful skin condition. Link

3) J&J adds an $817M cancer drug pact with ambitious Aduro, FierceBiotech, October 16, 2014
A banner year for Berkeley, CA-based Aduro just got better. The biotech has inked its second licensing pact of the year with Johnson & Johnson, which kicked in a $30 million upfront and boosted its total milestone package to the $1 billion-plus category. Link

4) FDA moves cancer drug closer to approval for Pfizer, The Day, October 16, 2014
The U.S. Food and Drug Administration has accepted an investigational Pfizer Inc. cancer medication for priority review, meaning it could be approved for marketing within the next six months. Pfizer said Monday that the FDA has accepted its new-drug application for palbociclib, already given breakthrough status by the agency as a first-line treatment for one form of breast cancer. Link

5) FDA Approves Gilead Sciences, Inc. (GILD)’s New Hepatitis C Drug Harvoni, BioSpace, October 10, 2014
The U.S. Food and Drug Administration (FDA) has approved the first once-a-day pill for the treatment of hepatitis C, the company that makes the drug, Harvoni, said this week. Gilead Sciences announced Friday, October 10, that the pill, which is a cocktail of ledipasvir and sofosbuvir (known under the brand name Sovaldi), has been cleared for use in the main subtype of hepatitis, called genotype 1, which accounts for more than two-thirds of the nation’s cases. Link

Redefining Value in the Era of Value Demonstration – Guest Post by Leora Schiff

One of MassBio’s Impact 2020 report’s key recommendations is for MassBio to begin driving the conversation on defining value and reward for innovation. To start the conversation, MassBio is hosting a three-part Forum series this fall focused on value. The series kicked off earlier this month, and the next session is on November 20th. In the meantime, we’re pleased Leora Schiff was willing to share her perspective with us!

By Leora Schiff, Principal, Altius Strategy Consulting

leoraThe biotechnology and pharmaceutical industries are undergoing rapid, disruptive changes that will require rethinking of fundamental assumptions regarding the value of therapeutics and the nature of healthcare delivery. Increasingly, market power is being shifted away from physicians and payers towards patients and caregivers, professional organizations and newer stakeholders including accountable care organizations (ACOs), and pathway companies. In addition, all stakeholders are becoming more sophisticated and demanding in terms of their expectations related to the benefit-risk and benefit-cost calculations for drugs.

The price-protective nature of the US market is coming increasingly under fire. In addition to health insurers, ACOs, pathway companies and professional organizations are weighing in on the need for cost-effective treatments to improve patient outcomes and control ballooning health-care costs. Patients are also becoming more aware of the comparative price of care as they are increasingly asked to share the cost of healthcare through increased insurance premiums, large deductibles and more substantial co-payments.

As the concepts of patient-centered healthcare make their way into clinical practice, physicians are being encouraged to consider not just the patient’s clinical situation, but also the patient’s lifestyle, beliefs, financial situation and appetite for risk versus potential clinical and/or quality of life reward in selecting the best treatment choice to meet patient needs.

What does this mean for biotechnology and pharmaceutical companies?

Given these changes, it is no longer possible for biopharmaceutical companies to assess product opportunities and project future product pricing and revenues based simply on broad categories of comparable therapeutics and order of market entry. In the new era of value demonstration, drugs are being evaluated in the context of the current standard of care and the additional benefit that they provide – or not – in terms of efficacy, safety, patient quality of life and cost.

Read the rest of this entry

Welcome New Members

logo-mainNew England Controls is the leading solutions supplier of process control equipment and related services in the New England region. We participate in the Life Sciences, Power Generation, Pulp & Paper, Gas Distribution & Transmission, Water & Waste Water, and various other industries. As the local business partner for Emerson Process Management, New England Controls delivers a broad scope of products along with the engineering, training, maintenance and asset optimization services required to solve your most challenging process control needs. Link

pblogo_0Parabase Genomics is a molecular diagnostics company developing next generation sequencing based tests for use in neonatal and pediatric diagnostics. We are a team of innovators with expertise in genomics, pediatrics, and computational biology committed to improving the lives of children with genetic diseases. Our goal is to improve the standard of care in neonatal intensive care units (NICU) and pediatric wards by replacing hundreds of currently used single-gene-disorder tests, which require months to run and cost tens of thousands of dollars with the LifeTime NewbornDx test. Our proprietary test is a targeted sequencing panel designed by experts to simultaneously evaluate hundreds of known genetic disorders from a blood spot in 48 hours. This vast improvement in time to diagnosis leads to better therapeutic options, better patient outcomes, and lower costs due to less testing and shorter hospital stays. Link

Top 5 News Stories 10/4/14 – 10/10/14

Top 5 logo1) Charlie Baker and Martha Coakley discussed the life sciences in Massachusetts at the 2014 MassBio Gubernatorial Candidate Forum at the Royal Sonesta Hotel in Cambridge on Monday. Read coverage here:

 

2) Amgen declares a head-to-head PhIII win for Humira biosimilarFierceBiotech, October 8, 2014
Amgen has taken a big stride toward gaining regulatory approval for its biosimilar of Humira, AbbVie’s megablockbuster anti-inflammatory. The Big Biotech reports today that its knockoff of Humira–dubbed ABP 501–hit its marks on equivalency for efficacy and safety for treating plaque psoriasis. Link

3) Endo International plc (ENDP) Pays $2.6 Billion For Auxilium Pharmaceuticals (AUXL), Auxilium Drops QLT Inc. (QLTI) Deal – BioSpace, October 9, 2014
Endo International plc (ENDP), headquartered in Dublin, Ireland, and Auxilium Pharmaceuticals, Inc. (AUXL), located in Chesterbrook, Penn., announced today they have signed an agreement to merge. Link

4) FDA Grants Priority Review to Blinatumomab in Adult ALL – OncLive, October 9, 2014
The FDA has assigned a priority review designation to blinatumomab as a treatment for adult patients with Philadelphia chromosome-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), according to Amgen, the company developing the immunotherapy. Link

5) Novartis works with Bristol-Myers Squibb to test lung cancer drugsReuters, October 6, 2014
Swiss pharma group Novartis AG said on Monday it would work with Bristol-Myers Squibb Co to test the U.S. drugmaker’s immuno-oncology drug Opdivo in combination with three of its own experimental lung cancer drugs. Link