1) FDA Approves ARISTADA™ for Treatment of Schizophrenia – FierceBiotech, 10/5/2015
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA™ (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an injection. Alkermes is preparing to launch ARISTADA immediately.
2) Genzyme is not calling its newest MS drug a ‘cure’, but it looks like one in most patients – BBJ, 10/8/2015
Genzyme did not use the word “cure” in describing the results of the longest-duration study yet of its multiple sclerosis treatment, called Lemtrada, in a statement early this morning. But the results suggest that after two rounds of treatment, one year apart, most patients in two late-stage studies still experienced significant improvements in their symptoms five years later.
3) Meet the Boston Business Journal’s Power 50 – BBJ, 10/6/2015
The power players in Boston are the ones getting things done and leading change in the Boston economy. With that in mind, we welcome you to our fifth annual Boston Business Journal Power 50. This was a tough list to compile, most notably because Boston’s economy just keeps getting better — and the number of powerful Bostonians is increasing.
4) Cambridge firm expects rapid hiring as genomics work expands globally – BBJ, 10/8/2015
WuXi NextCODE, a Cambridge-based genomic-sequencing company, already has catalogued and analyzed the genetic information of Iceland’s population, and is on its way to cataloguing parts of the U.K. and Chinese populations as well.
5) Bay State biotech leaders blast Turing CEO – BBJ, 10/5/2015
If biotech industry leaders agree on anything, it’s that Turing Pharmaceuticals chief executive Martin Shkreli has made life difficult for all of them. “I don’t even say his name,” Massachusetts Biotechnology Council president Bob Coughlin declared, referring to the New York drug company chief executivewho recently acquired a generic medicine to fight parasitic infections and hiked its price from $13.59 to $750.
KinderPharm is a specialty pediatric CRO with expert resources focused exclusively on pediatric drug development. We work collaboratively with our partners to advance innovative pediatric products through all stages of the development process. Our “Single-Point-of-Accountability” model for formulation development, pediatric PK/PD analysis, pediatric dose prediction, clinical trials and regulatory submission provides an efficient and effective one-stop shop for our clients. Website
Raze Therapeutics is discovering the next generation of oncology therapeutics that target metabolic pathways essential to cancer growth and survival – one-carbon (1C) metabolism. The function of 1C metabolism is to drive rapid biomass accumulation. Using our proprietary platform, we are developing a pipeline of selective 1C metabolism therapeutics for specific solid and hematologic cancers. Raze was founded by scientific leaders in metabolism and cancer biology and is led by an experienced biotech management team. Website
Toxic Reports focus is to offer analytical services for rapid testing of the world’s most hazardous chemicals such as Dioxins, PCBs, PBDEs , PAHs and chlorinated pesticides in food, water, breast milk and human blood samples. Website
CONTINUUS Pharmaceuticals was founded in 2012 and has been a proud member of MassBio since 2014.
CONTINUUS Pharmaceuticals is a spin-out company of a $65 M collaboration between MIT and Novartis on continuous manufacturing. We design and build, and run manufacturing processes that can be located directly at the client site. Our novel technology platform that encompasses the entire range of drug production, from chemical synthesis to final formulation, provides our pharmaceutical and generic clients with an exceptional “one-shop solution” for all of their drug development and manufacturing needs. Our success is based on the establishment of long-term partnerships with our clients.
Co-Founder and Chief Business Officer Bayan Takizawa says there are 5 key elements that set CONTINUUS apart from other companies:
1) Systems Approach: Manufacturing is traditionally a fragmented process. CONTINUUS takes a systems approach to provide an integrated manufacturing solution that is literally continuous – it runs 24/7! All unnecessary steps are removed to ensure the most efficient process possible.
2) Novel Technologies: CONTINUUS does not use conventional technologies that are used in batch manufacturing. For example, many manufacturers use conventional ovens to dry their drugs; CONTINUUS utilizes a novel continuous dryer that requires only one minute to turn a dilute drug suspension into dry, flowable particulate.
3) Flexibility: CONTINNUS’ manufacturing lines are 1/10 the size of traditional lines, which allows a great deal of flexibility for the customer. The manufacturing can be done at CONTINUUS’ facility or on-site at the customer’s facilities.
4) Fully Automated Process: A fully automated process reduces costs and the chance of human error. Furthermore, our processes are maintained in steady-state, which is a much better means of ensuring high-quality drugs than what is employed in batch manufacturing.
5) Reduced Lead Times & Costs: In 2011, a pilot plant at the Novartis-MIT Center for Continuous Manufacturing demonstrated that their technology platform, Integrated Continuous Manufacturing, or ICM, has many advantages over batch manufacturing. CONTINUUS took a process that normally takes 200 days in batch, and reduced it 48 hours – that’s over a 90% reduction! The footprint was also reduced by about 90%, and they project that they will be able to lower costs by approximately 50%. This will be a significant benefit for pharmaceutical companies that employ CONTINUUS’ technology. More importantly, the better quality of their drugs will benefit patients.
Watch CONTINUUS Pharmaceutical’s introductory video or visit their website at http://www.continuuspharma.com/ to learn more.
1) Industry officials talk drug costs, disclosure at Mass. biotech caucus – State House News, 10/1/2015
Biotechnology experts on Thursday agreed that high cost of developing medications must be addressed, but said legislation to require disclosure of development costs is not the solution.
2) FierceBiotech’s 2015 Fierce 15 – FierceBiotech, 9/30/2015
Whatever lies ahead for biotech in 2016, we can now look back on a 3-year-long stretch of good times for the industry. Venture groups have used the wave of biotech IPO exits and M&A deals to go back and raise more money from institutional investors. And as billions of dollars in fresh capital has converged with brilliant new scientific thinking, the result is a whole new wave of standout innovators as represented here by the Fierce 15.
3) FDA Approves Bristol-Myers’s Yervoy, Opdivo for Treatment of Melanoma – WSJ, 10/1/2015
The U.S. Food and Drug Administration approved the first therapy combining two cutting-edge cancer drugs that unleash the body’s immune system against tumors—a combination that will cost more than $250,000 per patient for the first full year, according to its manufacturer.
4) Cambridge drug firm Infinity earns $130 million milestone from AbbVie – BBJ, 9/30/2015
Infinity Pharmaceuticals announced today that the company has enrolled the 120th, and final, patient into a mid-stage study involving patients with a form of blood cancer, resulting in a payout that doubles its cash on hand.
5) Third Rock launches cancer-fighting startup – Boston Globe, 10/1/2015
Third Rock Ventures, a prominent Boston life sciences investor, has launched a cancer-fighting startup with funding from two other investors.
What if you could pick out early warning signs of heart conditions out of somebody’s Fitbit data?
It turns out that you can.
This technology was developed by Mike Klein, a neuroscience Ph.D out of McGill University, as part of the Insight Health Data Science Fellowship. Insight offers a Fellowship three times a year where academics learn the applied data science skills they need to work in industry. Klein had already used machine learning in his research — it comes in handy when interpreting fMRI data — but at Insight he picked up industry standard tools and data science workflow to work with messy dataset. As a long-time wearable user, Klein was fascinated by the Health eHeart study at UCSF where over 30,000 participants have contributed their Fitbit step data and clinical information (anonymized) to help study heart disease. After many hours of wrangling and feature engineering, Mike was able to predict early warning signs of heart conditions based on walking patterns extracted from Fitbit records.
“I was excited to be able to leverage my existing knowledge of machine learning techniques to attack a problem in a new domain area with very different sorts of data. Both the industry focused tools and the pace (a sprint!) were very different at Insight and, in the process, I learned a great deal about working with sparse/unbalanced datasets. – Mike Klein
Klein wasn’t the only one in his cohort to come up with a data-driven solution. Greg Koytiger, former postdoc in systems biology at Harvard Medical School, was interested in precision medicine on cancer therapeutics. “The motivation is to save time and cost on finding the right patients for the right treatment”, Koytiger said. He built a series of models trained with gene expression profiles of human cancer cell lines to predict the link between genome-wide expression and drug sensitivity. By applying his models to breast cancer patients treated with Docetaxel, Koytiger showed that the model correctly identified 91% responders and 85% non-responders.
Predicting drug response will help oncologists identify the right drug for their patients and for pharmaceutical companies design targeted proof of concept trials for experimental therapeutics. Using sparse linear models allowed me to understand the genes responsible for drug resistance and sensitivity thereby shedding light on potentially interesting new biology. ” – Greg Koytiger (recently signed an offer with Immuneering after completing the Health Data Science program).