Post-election policy and drug development: Now what?

At the Biotech Showcase, Alice Valder Curran, head of the firm’s Global Regulatory and IPMT practice, moderated a panel comprised of Julie Gerberding, Executive VP and Chief Patient Officer of Merck & Co. Inc.; Peter Kolchinsky, Founder and Managing Partner at RA Capital Management; and Greg Simon, Consultant at Simonovation LLC. Valder Curran and the panelists conducted a post-election discussion of key issues likely to affect biopharma companies under the new administration, including as influenced by pandemic-related efforts.

Valder Curran teed up a discussion of how pricing and reimbursement challenges are exacerbated by decades-old statutory regimes, which have not kept pace with science, or the evolution of the health care marketplace. Speaking from experience in her personal practice, Valder Curran echoed Kolchinsky’s explanation of how life sciences companies tend to not be concerned about reimbursement for their treatments until later in the development process, because there’s an assumption that an effective treatment will be paid for, and will be paid for reasonably. Kolchinsky described the market expectation as: “Surely, America is not going to bludgeon our [health care innovation] into the ground with terrible policy.”

In her remarks, Valder Curran agreed with Gerberding that the COVID-19 public health emergency has elucidated the market problem of how to encourage investment in pandemic-related health care products: treatments that society hopes it will never have to use. Valder Curran pointed out that 2020 has demonstrated the importance of the life sciences industry to the economy as a whole, while noting that how we discuss drug pricing issues also depends on whether health insurance coverage is guaranteed to all patients. The panel also analyzed how diagnostics are also playing an increasingly important role as companion products to new therapies during the pandemic.

Valder Curran has also recently led a discussion on the impact of the U.S. election on the life sciences and health care industry, which we have summarized online here.

The digital health care revolution

At the Digital Medicine Showcase, Jodi K. Scott, partner in the Hogan Lovells Medical Devices & Technology practice and co-leader of the firm’s Global Digital Health Team, led a discussion with Bill Evans, CEO of Rock Health; Douglas Lee, VP of Business Development for Bayer Pharmaceuticals; and Beth Rogozinski, CEO of Oncoustics. They analyzed how the COVID-19 pandemic has led to an influx of market adaption and funding for digital health technologies this past year. The panelists explored partnering and investment trends, the regulatory landscape, and the cutting-edge digital health technologies transforming health care, speculating on what this ultimately means for patients, payers, digital health companies, and investors.

Focusing on commercialization issues for digital health technologies, Scott teed up a conversation about how market differentiation is key for companies competing in this space. Scott’s clients run the gamut from traditional medical device companies, to biopharma companies, to traditional software companies entering the health care space, and speaking from her decades of experience, Scott said that more regulatory changes are necessary to facilitate innovation in the digital health care.

During the COVID-19 pandemic, Scott explained, temporary guidances were implemented to accelerate digital health innovation, but the continuation of these policies after the public health emergency ends remains in question. Scott remarked that she has been impressed and incredibly proud of how industry has stepped up to fill the need created by the COVID-19 pandemic – to innovate, accelerate development and timelines, work collaboratively with FDA, and find the resources that are needed – all while tending to patients.

Responding to a question on ownership of data – the “lifeblood” of digital health – Lee explained that patients own their data; however, digital health companies do not need to own data in order to be successful – they merely need access to data. Building on that conclusion, Scott pointed out that while the patient owns their digital data under current laws, moving forward, regulators will need to make decisions on new types of privacy rights that no one had previously anticipated. Evans, meanwhile, warned against the replication of failed data driven models. Scott has recently discussed these and other AI issues in a webinar that we summarized online here.

The panelists concluded that from telemedicine and virtual clinical trials, to remote patient monitoring and digital therapeutics, digital health technologies are here to stay, and will play a critical role in the way we treat and cure diseases for the foreseeable future.

Seed Financing: Value Creation - Laying the foundation to raise money

Back at Biotech Showcase, Jon Layman, partner in the Hogan Lovells Private Equity & Funds practice, discussed seed financing with Ben Johnson, Managing Director of Life Sciences for Silicon Valley Bank; Stephen F. Flaim, Senior Special Advisor and Investor-in-Residence at the NIH; Beth Hoffman, the Founder, President and CEO of Origami Therapeutics, Inc.; Tomas Landh, Innovation Sourcing VP and Senior Principal Scientist for Novo Nordisk; and Una S. Ryan, Managing Director at Golden Seeds. They analyzed how laying the foundation to raise money involves intellectual property protection, demonstrating credibility by attracting grant monies, and understanding and articulating growth plans.

Citing his 25 years of legal work with venture capital financing in the life sciences and technology sectors, Layman explained how seed rounds have expanded dramatically in recently years, to now include anything from early stage convertible notes and SAFE’s (simple agreements for future equity) to priced equity financings. Layman emphasized the importance of companies finding what he called “smart capital” – investors contributing something more than just financial assistance. This means that founders need to think hard about what their company needs in terms of connections, expertise, and networking, and try to source investors that can bring that to the table.

Layman also advised that start-ups should refrain from giving up board seats too early if possible, which could result in losing control of the company. Instead, the panelists agreed that investors should be long-term partners in the business that share the founder’s vision. The panelists concluded by agreeing that successful innovators must understand the importance of learning from others, and surrounding their company with advisors who can guide them.

Authored by Aaron Armstrong