Jeff Peng outlines the roles and relationship of industry, academia, and non-profit organizations in drug development, and reflects on how it could be a lesson for the advancement of cultured animal products in this informative essay.
Jeff Peng has been working in the Bay Area biotech and pharmaceutical industry since 2001. He currently works on drug development on rare genetic diseases at BioMarin Pharmaceuticals Inc. in San Rafael, CA, from early stage research through market application. He is passionate about the topic of animal welfare in research, and the implementation of new technologies to improve human and animal well-being.
Jeff composed the following essay to create a framework for cultured meat research modeled after the analogous non-profit, research and industry sectors of drug development.
Three Key Players in Drug Development
Modern drug development is only possible with the collaborative efforts of three key players, whose overlapping interests provide mutual benefit for the overall shared goal of improving human health. The role of government funding to support this process has relatively decreased; a study found that industry supported 62% of biomedical research in the United States in 2000, almost double the proportion in 1980 (Bekelman et al., 2003). As it becomes increasingly difficult and expensive to bring innovations to market, the alliance between these three players has become vital to the successful development of new technologies.
The main goal of industry is simply profit. Industry operates on funding primarily from investors and sales. The methods employed to achieve objectives are: intellectual property, market exclusivity, exclusive/preferred relationships, and maximizing operating efficiency.
The main goal of academia is knowledge and recognized expertise. Academia operates on funding from multiple sources: government or non-profit grants, industry-sponsored studies, and sale/licensing of discoveries. The methods used to achieve objectives are: targeting high-impact discoveries, publishing a broad body of studies, visibility at talks and conferences, recognition as “key opinion leaders,” and leveraging their vast network of basic laboratories and hospitals to conduct studies that are not constrained by commercial concerns.
The main goal of non-profits is advocacy. The majority of funding from non-profits come from private donations. The methods used to achieve objectives are primarily: raising public awareness, education, connecting communities and interested parties, awarding grants when public government funding does not match the public need, and providing additional infrastructure to academic research such as financial oversight, marketing, or regulatory support.
While these three work collaboratively to bring beneficial technologies to market, it is important to note when their values can, and often will be, misaligned.
Knowledge (Academia vs. Industry)
Industry focuses on practical application of scientific discovery only and will not spend resources on discovery that doesn’t ultimately impact the bottom line positively. The regulations surrounding drug safety do not require proof of clear understanding of mechanism of action, further incentivizing a utilitarian approach to food/drug development. Academia, on the other hand, is not constrained by commercial concerns and can be pursue any interesting scientific question, even those that will be unlikely to result in any practical purpose.
Ownership (Industry vs. Academia and Non-profits)
Industry relies heavily on trade secrets and intellectual property for profit, and thus are often at odds with the “open-source” philosophy of academia. This disagreement often arises during publication of information. While much importance is tied to publication in the “publish or perish” world of academia, publications often have the ability to significantly influence the commercial success of a drug and thus industry would prefer to hold control of publication. In an assessment of life-science academics, 27% of those with industry funding went through delays of more than six months for publishing their study results (Blumenthal et al., 1997). Furthermore, negative results are almost never published due to lack of any financial incentive for industry to do so.
Non-profits are aligned with academics in this case, placing greater value on transparency for public knowledge, and expediting potential collaborations based on this new knowledge rather than protecting trade secrets.
Responsibility (Industry vs. Non-profits)
While industry and non-profits share the goal of improving the health of patients, industry is ultimately beholden to their shareholders, while non-profits are beholden to the segment of public they represent. Examples where conflicts arise in drug development include advocating lower prices for patients, pushing for increased Compassionate Drug Use in clinical trial enrollment.
Perceptions and attitudes may also thus create conflict. A non-profit advocacy group for a genetic disorder recently lambasted a pharmaceutical company for developing a “cure” for their disorder which they consider a way of life, not a disease.
Communication (Non-profit vs. Industry vs. Academia)
The focus and value of communication is unique to each party. While the primary communication method of industry is through press releases and announcements to Wall Street, academics communicate through technical scientific talks and presentations, and non-profits connect science directly to the public. Thus, the tactics of non-profit communication often involve use of influential figures/celebrities to communicate to the public and distilling technical and scientific information to be accessible to the public. This underlies a key function of non-profits – bringing the public into the process of development.
The Drug Development Process – Who Does What, When?
While the development path differs from product to product in the health industry, there is a typical pattern in how the three key players work together in bringing a new product to market. First, early discovery research in academia is conducted, supported by public funding and/or supplemented by non-profit grants. The resulting knowledge is owned by the university and the public. If the technology has promising commercial application, it is then licensed or purchased by interested industry parties. Industry will become increasingly committed to additional expense and activities of development as it reaches the market, while academia and non-profits typically lend a supporting role. Upon market release, technology and resulting profit are generally fully owned by industry shareholders and investors. The role of the non-profit remains important throughout the entire process, and does not stop upon successful market release of the drug.
Non-Profit Opportunities during Drug Development
There are many opportunities for non-profits to contribute positively during the drug development process, from discovery to market.
Fundraising: Disease advocacy groups often utilize private donations in the form of awarding grants to research labs where government funding falls short.
Awareness: Public awareness serves to increase funding for public research, which in turn promotes greater understanding of indication/problem, and may provide more targeted/intelligent development strategies for industry. For instance, an academic study to understand the prevalence of depression increased public awareness of how widespread the issue is, and allowed Merck to make more informed decisions on their global regulatory/marketing strategy for anti-depressants.
Infrastructure Support: Non-profits often supply supporting infrastructure that is often present in industry, but missing in academia such as financial, legal, PR support. This may be provided by industry donations in varying degrees. For instance, California Institute for Biomedical Research (Calibr), Calibr is an independent, not-for-profit organization that is receiving $92 million from Merck over 7 years. Calibr provides academic collaborators a range of industry infrastructure support and any investigator can approach Calibr. If a project demonstrates proof of principle, Merck may choose to become a formal collaborator or decline and return the rights to the technology to the academic institution and Calibr.
Connecting Communities: Non-profits maintain a large database of interested parties or patients, and can bring awareness of new technologies or clinical trials to these communities. Often, they will help academia or industry to connect eligible patients for study enrollment.
Advocacy: Once a technology is released to market, non-profits may assist in pushing for greater accessibility and proliferation of the technology. The advocacy may take form in the shape of influencing public opinion to then influence legislation. For instance, one investigational new drug was approved for clinical trial by one international regulatory agency, and not another. The non-profit group for this disease worked with patients in countries where clinical trials were unavailable, to influence local representatives to question or change the regulations to allow approval.
Implications and Key Takeaways for New Harvest
The relationships of non-profits, academia, and industry is not unique to the pharmaceutical industry and is widely applicable to any disruptive technology that has potential for greatly benefiting society. The model is highly applicable to the technology of cultured meat, with implications on the role New Harvest may play.
Like all fields of research, government funding for cultured meat has not been significant or sufficient to fund its development, with only the Dutch government providing $4 million for research and moderate interest from NASA for implications on space exploration. Generally reduced government funding for research and increased financial difficulties in discovery research make the alliance between industry, academia, and non-profits more important to the successful development of any new technology, including cultured meat.
Cultured meat is in an early discovery phase, with proof of concept only very recently released. Thus, we are at the most fast-paced and exciting time for a non-profit advocacy group. Awareness and public support for cultured meat still need significant improvement, with cultured meat often associated negatively with the unjustly maligned technology of GMOs. Informal public polls usually reflect support at ~50% or less, while negative commentary in traditional and social media appear regularly. Case studies on acceptance of controversial new medical technologies may benefit New Harvest in determining an appropriate strategy for successfully shaping positive public opinion and awareness.
New Harvest also is at a crossroads in determining the level of involvement with industry in supporting development of this technology. Should New Harvest seek increasingly dependent relationships with industry for funding, in the model of Calibr? Given the financial unsustainability of remaining independently funded by individual donors, it may be a viable option. Such an option would likely greatly reduce the scope of New Harvest’s mission to fit the business purposes of its industry donor. It’s important to note that unlike the pharmaceutical industry which has established profitable industry players in the market, such an option may not even be possible for New Harvest.
Unlike the pharmaceutical industry, established regulations for cultured meat are not in place. The Bayh-Dole Act (P.L. 96-517, Patent and Trademark Act Amendments of 1980) requires academic institutions that receive federal funding for research to collaborate with industry if they make a discovery that could benefit the health of the American public. It’s unclear whether this law would apply to cultured meat, or if any laws exist at all to facilitate the research of this technology. The legislative and regulatory void is a significant opportunity for New Harvest. In the same way that non-profit disease advocacy groups can move their supporters to influence legislation to improve accessibility to new drugs, New Harvest has the opportunity to directly or indirectly shape the regulatory space through advocacy, to ease the advent of cultured meat to market. There have already been multiple rag-tag efforts from cultured meat supporters to influence governmental bodies, such as a “We The People” petition on the White House site urging for increased federal funding for cultured meat research.
Finally, like in the development of treatments for disease, the communities are fragmented by different values, lack of awareness, or even just geographically. The role of a liaison between communities that has traditionally been fulfilled by non-profits, bringing together interested parties and establishing beneficial partnerships, will continue to be one of the most vital roles that New Harvest will undertake.