At Biotech Week Boston, we sat down with Tyler Merkeley, Health Scientist, Head of Special Projects & Portfolio Management at BARDA for an exclusive interview. He was also a panelist on the discussion on “How to Overcome the Funding Gap for Biotech Start-ups and Emerging Companies“.
The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services office responsible for procurement and development of countermeasures principally against bioterrorism, but also including chemical, nuclear and radiological threats. Naturally, they are responsible for a national preparedness for pandemic and emerging threats.
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A whitepaper from New England Controls
By necessity, pharmaceutical manufacturing must be highly controlled. When excursions, or any event that falls outside of normal operation, take place during the manufacturing process, a chain of evaluation must occur to ensure the proper response and control takes place. As such, an excursion can have a severe impact on the process, including delays in lot release, loss of batches, or receipts of non-compliance.
New England Controls has developed an automated excursion management solution that uses Emerson’s Logbooks software in conjunction with a manufacturing execution system (MES) and a distributed control system (DCS). By working together, Logbooks, the MES, and the DCS make the process of identifying, classifying, and correcting excursions much easier. The automated excursion management system monitors events that have been classified as excursions, and when these events occur, they are automatically passed to the automated excursion management system. Automated entry of these items prevents users from needing to interpret what is important at the time of the excursion and removes the possibility of transcription errors.
The automated excursion management system drives a resolution workflow involving several individuals or groups within the organization. The number of groups involved is based on the classified severity of the excursion which is introduced to prevent Quality from reviewing low impact items that don’t require Quality input. These groups include:
- Manufacturing Operator – An operator who witnessed the excursion occur is responsible for performing an initial review, where he or she provides additional information to the automatically collected Information.
- Manufacturing Supervisor – A manufacturing supervisor ensures that the proper information was recorded and/or can resolve excursions classified as being owned by manufacturing. This prevents a Quality representative from having to review low impact excursions.
- Manufacturing Sciences – A manufacturing sciences representative can optionally be involved in the review process for specifically evaluating the science behind the change in the process caused by the excursion.
- Quality Representative – The quality representative will review the most severe excursions and take necessary action, which might include attaching justification documents or acknowledging that the issue requires further investigation, which he or she does by creating a CAPA. Quality only is involved in excursions classified as requiring quality or for unassigned excursions that are too generic to classify.
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There is an investment gap between research funding programs and venture capital investors where early-stage biotechnology companies struggle to obtain funding. As such, companies have to be creative on where they raise funds and how they allocate it. They must also use different strategies to shorten the regulatory process, enabling them to maximize their patent portfolio life. The article examines how companies are using new business models, reducing costs, accelerating development as well as obtaining alternative capital.
Some of the business models we will be looking into are the virtual company model (a model where the company hires a minimal amount of permanent staff), as well as discussing new partnering arrangements with CROs (such as the one with CatoBioventures). Also examined are some of the ways companies can use to reduce costs such as Microdosing (also called Human Phase 0 studies) and Outsourcing Abroad (mostly for CMO and CRO services).
Then follows a brief overview of the different FDA programs available to increase the speed of an early biotech regulatory process: the four main programs examined in this article are Fast Track Designation, Breakthrough Therapy, Priority Review, and Accelerated Approval Designation. Finally, we complete our overview with a short presentation on two innovative funding opportunities, Philanthropy foundations Venture Capital (which are VC arms of traditional philanthropies) and Equity Crowdfunding (raising funds through a large number of individuals in exchange for equity).
The object of this article is to generate thoughts and ideas for early biotechnology companies, and should be a useful thought starter for many starting their journey in fundraising.
Author: Jean-François Denault is a consultant specialized in Market Research for Life Sciences companies. With 15 years of experience, he has worked with many clients, from start-ups to global pharmaceuticals. He can be reached at email@example.com