How to Overcome the Funding Gap for Biotech Start-Ups

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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Infrastructure for Cell Culture Process Acceleration

How to streamline development and production of cell culture acceleration and optimization

A surfacing trend in the industry is the interest in continuous bioprocessing. The continuous system makes an attractive option to increase the throughput of the plant allowing manufacture of large amounts of product in a facility with a flexible platform of smaller scale bioreactors. The challenges of the biotech industry offer opportunities to spur innovations in process development. Many biologics manufacturers successfully transition from batch processing to continuous processing to maximize flexibility and minimize the cost of goods (COGs), benefiting from standardization, simplified scale-up, and more consistent product quality. An integrated continuous biomanufacturing (ICB) platform has an advantage over conventional approaches, because of its reduced volumes and footprint, and no scale-up is required between development and manufacturing. Both mAb and non-mAb manufacturing-process architectures could converge in the future and be consolidated within the same facility, offering even greater flexibility and savings. At the same time, these platforms usually deploy a combination of single-use bioreactors that are assembled in a modular fashion and can feed simultaneously and timely into the same train. In fact, platform continuity, clarification built-in operational design, 10-15 fold higher cell densities, and easy logistics due to integration add up for an overall bioprocessing intensification. These kinds of setting converge with emerging tools to deliver a streamlined, high throughput, highly automated, pipeline that is easy to operate.

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Shifting Business Models

How early-stage biotech companies can bridge the investment gap

Early biotechnology companies sought to replicate the big pharma model, building an integrated company that went from research all the way to direct sales. But these models proved quite costly to build up and maintain. They increased pressure on fundraising while allocating financial resources to non-critical services.

That’s why many biotechnology companies today adopt a more flexible model, building virtual organization which hires a minimal amount of permanent staff, often working over a dispersed geography while coordinating multiple external resources such as CROs, CMOs and consultants (regulatory experts, patent lawyers, accountants) that are utilized on an as-needed basis. This reduces the companies’ burn rate to a minimum while emphasizing research and development.

Before using this model, the start-up has to answer a number of questions such as:

  • What are the core competencies the company wishes to keep in-house?
  • What is the selection process which will be used to choose partner companies?
  • Should the company use a single provider or select multiple ones?
  • Which contractual model will be used with collaborators?
  • Will it involve some form of risk sharing (i.e. using equity as payment)?
  • Is the company willing to use independent contractors for specific functions?

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[Whitepaper] How Early-Stage Biotechnology Companies Can Bridge the Investment Gap

An exclusive whitepaper

Whitepaper Overview: 

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.

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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 jf.denault@impacts.ca

The Value of Small Scale Studies

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BioProduction recently caught up with Brij Patel, Deputy Manager and Assessor, MHRA to find out more about his upcoming talk at this year’s event and what attendees can take away from his session

BioProduction (BP): Could you give us a brief overview of your key research interestes?

Brij Patel (Brij): Originally, my research experience stems from work with vaccines and drug delivery technology. I still remain interested in vaccines and biotech products, but now from a regulatory perspective (where I have had considerable experience as a regulatory evaluator for biological products on both MHRA and EMA applications).

BP: What can industry gain from this?

Brij: The ultimate aim is to attain regulatory approval – as fast and as efficiently as possible. My previous regulatory experience would provide an insight into how regulators assess risks and solutions.

BP: And what work will you be presenting at BioProduction this year?

Brij: EU regulators have now come across a number of QbD applications for biological products. There is obviously a “disconnect” between industry and regulators. I would like to present a reflection on regulatory experience with biological QbD

BP: What will our delegates gain by attending your presentation and session? What is the message you would like them to leave with?

Brij: Some of the key issues include agreement on risk assessments, the value of small scale studies, and regulatory flexibility. Communication (appropriate detail, at the right times, FTF meetings) is critical in order to persuade the regulator when deviating from the usual

BP: How will the industry look in 2-3 years? What challenges will still remain/would have been overcome?

Brij: QbD principles will be built into most programmes. The issue will be how to get ROI

BP: What did you want to be when you were young?

Brij: Useful

For more information about Brij’s talk and all of our other presentations, please visit our website or download the brochure