Category Archives: Guest Bloggers
Guest post by Konstantin Linnik, Ph.D., a partner in the Boston office of Nutter McClennen & Fish LLP and a co-chair or the Legal & Regulatory Working Group at MassBio and Isaac Hubner, Ph.D. a senior associate with the firm.
Whether you are dealing with a “simple” confidentiality agreement, a consulting agreement, or a multi-billion-dollar license, legal provisions are often a source of misunderstanding, confusion and frustration.
Thinking about consulting for a local biotech, starting a new job or even a new venture? Brace yourself for a barrage of legal implications you may not have thought existed.
On January 28, 2016, MassBio will host an expert panel provocatively entitled “Decoding Legal Mumbo-Jumbo.” The MassBio panel is composed of lawyers as well as non-lawyers including a business development executive. The goal of the panel is to help the audience learn to spot legal pitfalls and opportunities that are so often overlooked in real-life business settings.
The story of Dr. Joseph Grocela, a urologist at MGH who moonlighted as a medical device entrepreneur, serves as a good example of how misunderstanding a basic legal provision in your employment contract may lead to dashed dreams and a lengthy legal dispute to boot. Read the rest of this entry
By: Michael Cohen, Founding Partner, Cohen Partners
Imagine preheating the fresh air drawn in on a steamy July afternoon because your smart building thinks it’s below zero outside.
That’s what happened recently at a Genzyme facility in Massachusetts, but the people working in the offices, labs and biomanufacturing suites didn’t realize there was a problem because the air-cooling system went into overdrive and chilled the preheated air before distributing it throughout the building.
“Simultaneous heating and cooling is a big issue,” said Steven P. Driver Ph.D., Energy Program Manager at Genzyme. “Our biggest offenders are green buildings. When things go out of calibration, we go through a lot more energy.”
Driver was a panelist at the MassBio Forum, Selling Sustainability – How You Can Incorporate Efficient Practices Now on October 28, 2015 that focused on sustainability programs and energy efficiency best-practices for life sciences research laboratories and biotech manufacturing companies. Read the rest of this entry
For Life Sciences companies, compliance with both the U.S. and global transparency requirements is a complex and ever-changing task. Multiple layers of legislation – from state and federal to international – have been enacted to create transparency in the interactions between pharma and medical device companies and healthcare providers that make up their massive customer base. These requirements include the Sunshine Act, various U.S. state laws and European laws and directives specifying how transfers of value (TOV) from pharma companies to physicians must be tracked and reported. For example, the European Federation of Pharmaceutical Industries and Associations (EFPIA) directive covers 33 countries in Europe. In addition, local European laws exist and vary, such as in France, Portugal and the Netherlands. Other countries like Japan and Australia and emerging markets like Columbia and Turkey have also enacted local or regional laws or directives governing TOV transparency and reporting.
Taking up the challenge
While the laws provide the benefit of increased transparency, their complexity and swiftness of implementation left many companies unprepared to meet them efficiently or effectively. The reasons are many, including:
- Infrastructure – Many affected companies simply did not have the means and processes in place to properly capture, gather, manage and report the data needed to adhere to the compliance mandates.
- Point-of-transaction technology – There were no efficient or automated ways to capture the TOV data at the point of a transaction. Often used manual reporting tends to be fraught with human error and misreporting.
- Data management – The sheer volume of internal and external data to keep track of make it difficult for Life Sciences companies to manage it reliably.
- Multiple, disparate sources systems – Numerous systems and data sources across various geographies add to the complexity of global compliance.
- Currency conversion – Transactions may be captured in one currency but must be reported in another currency.
- Managing cross-border interaction – Without a comprehensive or single system for tracing TOV data, Life Sciences companies lack visibility to accurate, complete data.
- Data privacy – In the EU, Hospital Casemix Protocol (HCP) data is mandated for privacy laws.
- Consent Management – Related to EFPIA, HCPs must consent to be reported individually; otherwise, they appear in aggregate. Compliance management systems should be able to capture and manage this requirement.
Gerry Cox is COO and Co-Founder of Velesco Pharmaceutical Services. Velesco Pharma collaborates with small to mid-size pharma and biotech companies providing CMC drug product services during the critical early phase of new drug development. He oversees company operations and business development activities. In his 25 years in the industry, Gerry has worked extensively in both the drug developer and CRO/CMO segments
The CRO/CMO community in Massachusetts consists of a range of vibrant organizations partnering with pharmaceutical and biotech companies developing important new medicines. This segment of our life sciences community delivers many of the key activities needed for new drugs to move through the complex phases of development.
MassBio has kicked off a new series of educational Forums highlighting the role of the CRO/CMO segment. The first segment, Current Trends and Best Practices in Outsourcing Part 1: Early Stage Drug Development, was held on September 15th and emphasized the interplay between developers and CROs during the early phase of drug development.
Session highlights included:
- The differing outsourcing needs of larger vs smaller biotech companies.
- The strong desire of drug developers to work with CROs with a high level of flexibility and responsiveness.
- Working directly with the scientific team at a CRO.
Part two will be held on October 20th and is entitled Current Trends and Best Practices in Outsourcing Part II: Early Stage Clinical Manufacturing. Leaders in the biotech and pharmaceutical industries will gather to share their experiences in early stage clinical manufacturing.
Topics to be covered include:
- cGMP manufacturing
- What to look for in a CMO
- Regulatory considerations
This upcoming forum, along with the CRO/CMO Symposium to be held on November 13th, provides a unique opportunity for those in the pharma R&D community to gather and explore best practices in developing successful collaborations. There is also an opportunity for the respective CROs & CMOs participating in these events to meet and learn more about one another. The many synergies between our organizations provide an opportunity to share ideas and enhance the high quality services currently in demand in our industry.
Guest postings on the MassBioHQ blog in no way represent the opinions or endorsement of MassBio or its officers, directors, employees, agents, and consultants. MassBio does not represent or guarantee the truthfulness, accuracy, or reliability of statements or facts posted under the Guest postings on the MassBioHQ blog. MassBio accepts no liability for errors, omissions or representations. The copyright of guest content belongs to the author and any liability with regard to infringement or intellectual property remains with the author.
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).