Top 5 News Stories 4/12 – 4/18

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1) Mass. life sciences firms look beyond VCs for funding - Worcester Business Journal, April 14, 2014

When Geert Cauwenbergh needed money for a life sciences startup in 2002, he knew where to turn: venture capitalists. Link

2) Both sides weigh in on South End biolab – Boston Herald, April 17, 2014

The battle between supporters and opponents of BU’s controversial South End biolab continued at a hearing yesterday during which city councilors considered a ban on some research, fearing it could lead to deadly disease outbreaks. Link

3) Merck Wins 2 FDA Approvals This Week – Reuters, April 14 & 17, 2014

Merck & Co said the U.S. Food and Drug Administration on Monday approved its grass pollen allergy drug Grastek, becoming the second such immunotherapy treatment to be given the go-ahead in recent weeks.  Link

The U.S. Food and Drug Administration has approved Merck & Co’s pollen allergy drug Ragwitek. Link

4) Genzyme marathon team bigger than ever, motivated by memories of 2013 - Boston Business Journal, April 17, 2014

A year ago, the 18 athletes on the Boston Marathon team running for Genzyme Corp. was the biggest the company had ever sponsored. Half of those runners never finished after the bombs exploded, but within a week they started planning for the 2014 race. Link

5) Pfizer, AstraZeneca back a new strategy for cancer drug R&D - Fierce Biotech, April 17, 2014

A pair of pharma giants have partnered with a prominent cancer research charity in the U.K. on an innovative new approach to testing targeted oncology therapies, building on the country’s national program for tumor testing in a way that may help make it a global center of cancer R&D. Link

 

Innovation & Opportunities in Pulmonary Drug Delivery

Guest Post by Craig Dunbar, VP, Product Development, Blend Therapeutics

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Big-pharma has long realized the unique value of inhaled therapies to treat chronic diseases by local delivery to the lungs. GlaxoSmithKline’s Advair™ Diskus is in a category on its own in the pharmaceutical industry, having lost US patent protection four years ago while increasing worldwide sales to over $8 billion in 2013. Teva and Sandoz have both admitted defeat in bringing a generic Advair™ on to the US market due to technical complexity and insurmountable regulatory barriers.

2006, the same year that Advair™ was approved, saw the first approval of a pulmonary insulin product, Exubera™, developed by Nektar and Pfizer. This marked a pinnacle of a decade long pursuit of new pulmonary drug development technologies to enable systemic delivery of proteins, with Pfizer having invested $2.8 billion in Exubera™, and competitors Lilly/Alkermes and NovoNordisk/Aradigm following suite with alternative technologies. However, Exubera was dogged by safety concerns, FDA recommending regular lung exams, a 6 month launch delay due to manufacturing difficulties, and poor acceptance by patients, physicians and payers. Just one year after launch the product was pulled from the market, marking the collapse of the pulmonary insulin market.

So where does this leave pulmonary drug delivery today? Mannkind recently (Apr 2, 2014) received an approval recommendation by FDAs advisory committee for Afrezza®, a pulmonary insulin product that improves glycemic control in type 1 and 2 diabetics, opening the way to approval in July of 2014. The boom and bust of the 90s decanted the more robust pulmonary technologies based on particle engineering and simple delivery devices, with Civitas continuing to develop Alkermes’ large porous particle technology for the treatment of Parkinson’s disease, and Pulmatrix developing novel particle engineering technologies for asthma. Further, new drugs, technologies, and clinical development strategies continue to emerge from both big pharma and small biotechs, recognizing the unique opportunities, and challenges, associated with inhaled therapeutics.

On April 29th, from 8-10am, MassBio is hosting a Forum on this important topic entitled Innovation & New Opportunities in Pulmonary Drug Delivery for Local & Systemic Treatment of Chronic Diseases.

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Register Today for 2014 MA CRO/CMO Symposium

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May 5th, 2014

Burlington Marriott, Burlington, MA

Register today!

Now in its third year, the Massachusetts CRO/CMO Symposium shines a spotlight on the strength and success of the CRO and CMO communities in the Commonwealth.

The Symposium draws more than 300 attendees to discuss and evaluate the best alternatives that have evolved in shortening time to market. A series of case studies, interactive panel discussions, and networking sessions provide ample time to explore the various techniques and approaches being used by both virtual and established companies.

FEATURING A FIRESIDE CHAT WITH INDUSTRY LEADERS

Simplifying the Drug Development Journey From Research to Treatment

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Emily Hickey, DVM, Ph.D., Corporate Vice President, In Vivo Discovery Research Services, Charles River Laboratories

 

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Mark Goldberg, President and Chief Operating Officer, PAREXEL International Corp

 

 

John J. Reddington, PhD, DVM

 

John Reddington, Ph.D., VP, Cambridge Biomedical (Facilitator)

 

 

AND A KEYNOTE STORY OF SUCCESS

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A Successful Massachusetts CRO –My Personal Journey
Barbara Osband, President & CEO, Cambridge Biomedical

 

This year, we’ll kick off the program with a discussion of how to build the Next Generation CRO/CMO Cluster, by sharing data collected in the first-ever MassBio CRO CMO Survey, and analysis of industry challenges and opportunities outlined in Impact 2020, the MassBio Strategic Report released this month.Impact 2020 logo

Other Discussions include:

  • The Virtual Model: Orchestrating Consultants and Distributed Research Organizations
  • No Industry Standards – What is the Best Metric? Trends with Organizations
  • The Hybrid Model – Integrating Internal and External Resources
  • Facilitated Roundtable Discussions

Don’t miss the Networking Luncheon, Closing Reception, and Breaks in the Exhibit Hall, where dozens of New England CROs and CMOs will showcase their services and expertise!

 

Register today!

 

Thank you to our sponsors!

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Welcome New Members!

Jasco LogoJasco Pharmaceuticals, LLC is a privately held, pre-clinical stage drug discovery company focused on the discovery and development of small molecule oncology therapeutics. Jasco was founded with a core expertise in high speed medicinal chemistry providing a launching point for a chemical genomics approach to the discovery of selective protein kinase inhibitors. The company’s vision is to rapidly and effectively develop pre-clinical oncology candidates through IND submission and then guide them through the clinical development process by means of strategic partnerships. Website.

Siro LogoSIRO Clinpharm, winner of Frost & Sullivan ‘Clinical Research Organization of the year’ India Healthcare Award 2012 & 2011, is a drug development solutions provider to the global healthcare industry. Our subject expertise gives us an edge in clinical trial management, clinical data management, medical writing, biostatistics and statistical programming, pharmacovigilance and clinical trial supplies management. We offer flexible business models across service verticals based on client needs. Website.

SynDevRx LogoSynDevRx is developing new and effective treatments for metabolic-related diseases including pre-diabetes, diabetes, obesity, dyslipidemia and fatty liver disease as well as treatments for cancer. Website.

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TCG Lifesciences Limited (formerly Chembiotek) is a leading contract research organization in early drug discovery and development. We are a part of ‘The Chatterjee Group’ (TCG), a global investment conglomerate headquartered in New York with strategic investments of over USD 1 Billion.

Spread over 250,000 sq. ft. of space our services span from specific solutions to integrated discovery projects across multiple therapeutic areas with focus on Central Nervous System (CNS), Inflammation & Pain, Metabolic Disorders and Infectious Diseases. Website.

uniQure LogouniQure is a leader in the field of gene therapy and had developed the first and currently the only gene therapy product to receive regulatory approval in the European Union. Website.

Vince & Associates Clinical Research LogoVince & Associates Clinical Research has been providing clinical research services to the global biopharmaceutical industry for over a decade.

We have assembled an experienced team of clinical research professionals focusing on quality research data while recognizing that speed, responsiveness and accountability are also core needs of our clients. Website.

Top 5 News Stories 4/5 – 4/11

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1) JobWatch: Massachusetts Reveals 2020 Vision - GEN, April 11, 2014

Massachusetts’ biopharma cluster is among the world’s biggest and best with more than 56,000 jobs, universities like Harvard and MIT, and a rich heritage stretching from Genzyme’s founding in 1981. Link

2) Lilly and T1D Exchange Announce Research Collaboration to Inform Development of New Initiatives to Advance Diabetes Care – Wall Street Journal, April 9, 2014

T1D Exchange and Eli Lilly and Company announced today they have entered into a research collaboration that will enable both organizations to gain deeper, real-world insight about the experience of people with type 1 diabetes, to identify new ways to improve care and advance outcomes.  Link

3) Genzyme to resubmit application for multiple sclerosis drug, Lemtrada, to FDA - Boston Business Journal, April 7, 2014

Genzyme announced today it plans to submit its once-a-year drug, which is approved outside the U.S. for multiple sclerosis, to U.S. regulators after it was rejected in December. Link

4) Biogen’s hemophilia hopeful scores a PhIII win as FDA awaits - Fierce Biotech, April 10, 2014

Biogen Idec’s ($BIIB) long-acting hemophilia A drug performed well in a late-stage study on children, the biotech said, giving it another Phase III victory as it races with rivals Bayer and Novo Nordisk ($NVO) to launch a more convenient treatment for the bleeding disorder. Link

5) UPDATED: Alkermes hits PhIII goal line with ‘blockbuster’ long-acting schizophrenia drug – Fierce Biotech, April 8, 2014

Alkermes has crossed the finish line in a Phase III schizophrenia study of a long-acting version of Abilify, picking up the statistically significant results needed to back a new drug application later in the year. The company’s shares ($ALKS) shot up 10% in early trading Tuesday. Link