Bringing New Science to Market

Medical supplies and drugs, including a syringe, surgical mask, and pills

Medical innovation is reaching new heights every year. What scientific breakthroughs can we expect on the market in the coming decade? What challenges will we face in adopting them?

Professor Sean Nicholson, director of the Cornell Sloan Program in Health Administration, welcomed Wyatt Gotbetter, SVP and worldwide head of Parexel Access Consulting, and Dr. Gregory B. Franz, MD, MPH, MHA, hematologist and medical oncologist at the Kirkland Cancer Center, to explore answers to these questions in the recent Keynote webcast “Bringing New Science to Market: Innovation, Adoption, and Health Policy Challenges.”

Biotech and pharmaceutical firms spend about $80 billion each year on research and development in order to try to bring new therapies to the market. What is in the pipeline that might have a big positive effect on the health of the population in the future?

Gotbetter: “If we think just about the past five years, and of course that includes the pandemic, I think the rate of innovation and the number of launches has been remarkable. We can’t have this discussion without acknowledging the validation and the importance to all of us of the RNAi vaccines from BioNTech and Moderna. Moderna, on the heels of that success and being flush with sales of their COVID vaccine, is really advancing a number of therapeutic products as well as vaccines – really advancing their RNAi technology into the therapeutic space and oncology specifically.

In the same time, we’ve seen the approval of a couple of CAR-Ts truly advancing life-saving therapy in hematology and oncology. I think we’ll see gene therapies becoming safer and easier to manufacture, hopefully at lower costs. There’s just a pipeline of literally hundreds of programs where we’ll see gene therapy go from rare disease and disease that has very, very high morbidity perhaps into things managed more chronically with small molecule drugs – like heart failure.”

We have a couple of CAR-T therapies on the market that are Food and Drug Administration (FDA) approved. Are there similar kinds of classes of compounds that have yet to be approved that you think might potentially have a similar health impact?

Franz: “Leveraging the immune system to identify and kill cancer cells – that’s really what’s going on here. This is T cells doing what T cells do against cancer cells. I know that’s a very simple explanation. It’s very difficult to develop these compounds and to do this safely, but I think that’s where the money and the future is.”

It takes a long time, and it’s very expensive for biotech and pharmaceutical firms to run clinical trials and, even preceding that, to identify compounds that are promising enough to start a clinical trial. The current estimate is about $2.6 billion in investment across a portfolio of compounds in order to statistically assure a company that they’re going to have one approved compound. Where do companies come up with that money, and in the current climate, is it difficult for companies to raise the funds they need in order to invest in those drugs?

Gotbetter: “That $2.6 billion figure also includes the cost of failure. Even if we think about a successful drug compound, if you boil down the numbers, hundreds and hundreds of drug candidates will be considered before you start your phase one and then roughly one in ten of those will make it through to approval. It’s fraught with risk. But even if you could streamline that process, you’re probably looking at hundreds of millions to a billion dollars.

The amount of money that’s poured into the biotech sector over the past few years has been remarkable. We’ve seen, though, a massive sea change in the past year. Biotech has been the engine of discovery and innovation for large pharmaceutical companies. The largest companies in the world that certainly have formidable R&D engines employing thousands of people still turn to biotech to find innovation, to find a compound that has been tested, that shows a proof of concept, and can move forward.

The headwinds of the past year or two – interest rates and some of the perceived threats of the Inflation Reduction Act, which could reduce pricing power of the industry – has really slowed down [venture capital] funding.

I think what that means is that probably the rate of innovation will slow down a little bit in the sense that there may be fewer programs being pursued simultaneously, so a company may really focus on the crown jewels instead of many at once. Then biotech may again have to be more reliant on Big Pharma once they’re in the middle of their development versus a period where they probably could see funding to go all the way through.”

What are the factors that make a drug widely adopted?

Franz: “In the medical oncology world, it’s really all about safety and efficacy. Is the drug difficult to give? Does the patient have a lot of adverse side effects? How do you manage those side effects? But most importantly, you’re looking at endpoints: PFS, or progression-free survival, and OS, or overall survival. Duration of response and response rate are biggies and, of course, the toxicity profile. All those together are important. The better the PFS and OS, the more successful the drug is going to be.”

Are biotech and pharmaceutical firms doing anything to try to run their trials differently – to be less expensive, to be shorter, to have higher probability of approval?

Gotbetter: “The FDA provides a rubric that says for very life-threatening diseases, it will work with the industry sponsor to find a way to streamline the therapy. We have names for that in the U.S like breakthrough therapies and accelerated pathways, where you get more support and guidance from the regulatory agency, but you’re also partnering with them along the way to find a way to expedite the study.

There’s a lot of companies that are using all sorts of AI, computational methods and synthetic biology to [speed up the trial process].”

Historically, clinical trials have been dominated by white men. Are biotech and pharmaceutical firms trying to diversify those trials? What are the implications potentially of a more representative group of patients in the testing phase?

Gotbetter: “There are mandates coming from the FDA and other governments, and I think very sincere efforts from the pharma industry and from clinical research organizations who enroll and operationalize the studies to really bring diversity into studies. There’s an awareness in society for many reasons, for many historical wrongs, we need to bring more diversity into everything we do. It’s to really ensure that when we study a drug, we’ll be able to show efficacy in different populations because we’re not all the same. Historically, if you were to develop a drug for people of European descent, across the globe in Asian markets, they would want to know that there was a study being done in populations for which the results were meaningful for them. As we take that to other populations, to different age groups, different genders, it’s the right thing to do.”

 

This post has been edited for length and clarity.

Want to learn more about the future of biopharma? Register for Cornell’s Biotech and Pharmaceutical Management Immersion Program and watch the full Keynote “Bringing New Science to Market” webcast online.

4 Ways to Leverage AI in Your Corporate Strategy

Rendering of pathways in the human brain with a lighted background

With the swift expansion of artificial intelligence, automation tools are now readily available to corporations and consumers alike. Companies are integrating new technologies to avoid falling behind their competition and appearing out of touch with trends that matter to their employees and customers.

But the steps to incorporate and embrace emerging tech can be challenging. Expert faculty from the Graduate School of Management at Cornell’s SC Johnson College of Business identified four best practices senior executives can employ to capitalize on advancements in AI and dodge common pitfalls.

1. Innovate early – with startup partners.

In its 2022 Global AI Adoption Index, IBM reported that 35 percent of companies were using AI and 42 percent were exploring AI for future implementation. Findings from Grand View Research indicate this tech adoption will drive the market size to $1.8 billion in revenue within seven years. To remain competitive in this environment, leaders can collaborate across companies to use AI in ways that set them apart from major rivals.

Swift changes in tech-driven markets demand innovation and adaptation, but many businesses are optimized to resist change rather than embrace it, leading to fewer risks – and rewards. The hesitation to adopt can be a danger to the bottom line.

“Executives can avoid this stumbling block by implementing agile methods and building mutually beneficial partnerships with startups driving innovation in their areas of need,” said Stephen Sauer, senior lecturer of management and organizations and Entrepreneur in Residence for the college. “Established companies can benefit from the tech experimentation that is more common in newer businesses while giving these partners the wisdom of experience.”

Karan Girotra, Charles H. Dyson Family professor of technology and management, adds that when tech advances rapidly in times of political and socioeconomic uncertainty, leaders can underestimate the rate of change and overestimate the ability of past expertise in helping them tackle the environment.

“Executives need to adopt a learn-it-all, not a know-it-all, mindset. Leaders need to embrace smart, cheap and fast experimentation to try out many new initiatives and learn fast,” Girotra said.

2. Choose accuracy over convenience.

Information may be more accessible than ever, but discerning fact from fiction grows more difficult each day. The convenience and speed of generative AI make it easier for audiences to accept and share information without examination. However, the perils of using incorrect data, which range from operational shortfalls and security threats to public relations crises and financial losses, can ruin organizations.

“The increasing amounts of misinformation with which we are all confronted today – including from AI errors – can undermine our problem-solving efforts,” said Risa Mish, professor of practice of management. “Now, more than ever, leaders must be able to guide their teams in understanding what we know versus what we are assuming we know.”

According to Mish, AI exists to help us tackle complex issues in a way that balances efficiency, thoroughness and accuracy, but leaders should be willing to learn how to apply the technology responsibly.

“Corporate decision-makers should first work to comprehend core AI concepts. Then start with small-scale projects to test the tech in their operations,” Mish said. “This requires leaders to build cross-functional teams that understand the organization’s strategy and can align AI with goals.”

3. Recognize your biases.

Incorporating machine intelligence into business operations may require leaders to reassess their approach to corporate ethics. AI systems operate on data provided by humans and can perpetuate prejudices as a result. If not carefully monitored, this can lead to unfair outcomes for workers, customers and other stakeholders.

“Leaders need to be aware that we are all susceptible to biases which can negatively impact our decision-making and behavior. We naturally look for, remember, favor and interpret information in a way that confirms our previously held beliefs or values. We also discount or reject information that runs counter to these beliefs and values,” said Michelle Duguid, associate professor and associate dean of diversity, inclusion and belonging.

While AI can expedite decision-making for hiring, business forecasting, surveillance and more, Duguid encourages senior executives and their teams to take precautions against complacency. Instead, firms can develop quality assurance processes to ensure automated outputs meet their corporate standards.

“Senior executives need to be able to think strategically about potential risks and challenges, and make informed decisions that align with the company’s overall goals and values,” said Sauer. “Strategic thinking is a team effort, and the more leaders are able to build teams with diverse opinions and experiences – what we call ‘heterogeneous task cognition’ – the more successful they will be in combating any biases that might creep in with the use of AI and other digital technologies.”

4. Use AI as a supplement, not a replacement.

More than 40% of business owners are concerned about an overdependence on AI, according to a recent Forbes Advisor survey. Automation has the potential to replace human workers in certain roles, leading to job displacement, changes in employment patterns and economic disruption.

“Advances in AI and other digital technologies present businesses with a once-in-a-generation opportunity to reinvent their products and processes,” said Girotra. “At the same time, there are several pitfalls – technologies that do not live up to their promise, new business models that have no feasible path to profitability, the large negative externalities that these innovations place on society. Businesses that blindly embrace these opportunities, or those that are paralyzed by the pitfalls, are unlikely to survive.”

Looking at AI as a tool with capabilities and limits, and creating a builder culture, Girotra says, is key in taking advantage of the opportunities.

Elizabeth Mannix, Ann Whitney Olin professor of management agrees. When leaders have self-awareness of their own strengths and weaknesses – and they are cognizant of their impact on others – they can lead with intention and create an environment in which their team members can thrive alongside AI.”

 

Faculty from Cornell University have designed online certificate programs on a variety of in-demand leadership, technology, business and finance topics, including change management and digital transformation. An AI strategy certificate from the SC Johnson College of Business is also available online through eCornell.

Cornell Tech launches new product, technology leadership program

Students at Cornell Tech

As the demand for product managers and tech executives continues to grow, Cornell Tech has purposefully designed a flagship Product and Tech Executive Leadership Program in collaboration with eCornell, offering professionals a unique opportunity to enhance their leadership skills and take their tech innovation strategies to the next level. The program aims to equip participants with the necessary expertise to navigate the rapidly evolving digital landscape.

Designed for mid and senior-level product managers, engineering leaders and technology professionals with experience leading teams, the three-day immersive program will take place Sept. 19 to 21, 2023, at Cornell Tech in New York, NY.

Read the full story on the Cornell Chronicle.

Cornell debuts biotech, pharma management program

Networking at Cornell Tech

As biotechnology and pharmaceutical professionals continue efforts to make advances in medicinal drug formulation, safety and efficacy, experts in the field are implementing innovations to address regulatory hurdles, research costs and global health challenges.

The new Biotech and Pharmaceutical Management Program offered through the Cornell Jeb E. Brooks School of Public Policy is designed to give leaders the opportunity to explore industry trends and cutting edge research with a cohort of peers, executives and renowned faculty from the university.

Read the full story on the Cornell Chronicle.

Pre-college big data certificate offered free to Cornell community

Close-up of hands typing on a laptop

A new pre-college certificate program designed to help high school students develop data analysis skills complementary to a wide range of academic and professional fields will be offered at no cost to the children of Cornell faculty and staff and underserved students nominated by local high schools and other partners.

“Big Data for Big Policy Problems,” offered by eCornell in collaboration with Cornell’s Jeb E. Brooks School of Public Policy and the School of Continuing Education, is a rigorous, non-credit version of the course offered to Cornell students.

Read the full story on the Cornell Chronicle.

Crypto Regulation: Can Securities Laws Keep Pace with Innovation?

Nearly everyone agrees that the crypto asset market needs more robust regulation, but there is much disagreement about what the laws should look like as well as who should be legislating and enforcing them.

One key concern is whether crypto assets are commodities or securities, which raises crucial issues about which governing organization should be responsible for oversight and enforcement. Additionally, laws are struggling to keep pace with technological innovation, thereby increasing the potential for scams, fraud and poor practice.

Charles Whitehead, Myron C. Taylor Alumni Professor of Business Law at Cornell Law School and author of Cornell’s Securities Law certificate, discussed the shifting regulatory environment around crypto and what’s next for the revolutionary technology in a recent webcast, “Crypto Regulation: Can Securities Laws Keep Pace with Innovation?”

In the U.S., there are several regulatory bodies overseeing crypto assets. Does this make sense, and if not, why?

It’s referred to as the regulatory alphabet here in the United States: SEC (U.S. Securities and Exchange Commission), CFTC (Commodity Futures Trading Commission), OCC (Office of the Comptroller of the Currency), CFPB (Consumer Financial Protection Bureau). It’s a reflection of the way in which we think historically about how to regulate the industry. The problem is that over time the historical distinctions have fallen away. What may or may not be a banking practice can now pop up in the securities industry. The way we think about regulation and the industry has changed over time, largely reflecting the innovation in the industry itself. Crypto is highlighting a fundamental flaw with the U.S approach to financial regulation, which is that we don’t have a central regulator.

There needs to be a focus on anti-fraud. There needs to be a focus on protecting consumers. The real debate is who is going to do this. I would suggest it’s the SEC.

Why is the SEC uniquely positioned to oversee this?

The SEC is a consumer financial regulator. Their fundamental goal is to protect consumers. They were set up with a view toward protecting retail investors. The regulations that the SEC has for broker dealers, exchanges and people that take custody of these assets were intended to protect investors against the things that you see with FTX: people losing money and the scams that are out there right now. The SEC already has a toolkit, and it makes sense for the SEC to pick this up.

Is crypto more like a currency than a security? It seems like that is how it’s being used or advertised. Why not categorize it that way?

If I were taking crypto and buying a sandwich with it, that would look much more like a currency. That is something that really doesn’t need the protections of the securities laws. To the extent that it’s being used as a way to promote investment, it begins to look a lot more like a security.

Crypto assets are used primarily as speculative investments, which is not in line with the stated vision of most projects out there. How should regulators navigate this?

The whole rationale behind crypto assets was decentralization — a way to create a non-centralized, non-government-controlled medium of exchange across multiple parties. The vision was that it would provide banking attributes without necessarily having a bank, that you’d be able to use crypto assets as a means to support parts of the community that otherwise were not being properly supported by the financial industry. That’s largely not been the case. You can argue that in some cases people pursuing crypto deals are taking advantage of the folks that crypto initially was intended to support.

There will come a time when crypto will begin to look more like a commodity or more like a currency. In that case, the need for regulation drops away. We’re just not there yet. There should be a regulator focused on consumer protection precisely because of the scams.

One of the throughlines here is technological innovation. Law is unable to keep pace, and that creates an environment with increasing potential for fraud like what we saw with Sam Bankman-Fried, the founder and CEO of the cryptocurrency exchange FTX.

FTX is a huge blow to the integrity of the industry just because FTX was viewed as the safe place in which you could do trading activity. The other part is it was done offshore in the Bahamas, so it was being done away from the direct regulatory oversight that you might otherwise see. A large part of what was happening there would have been either prohibited or regulated were we to treat these underlying instruments as securities.

You can’t trust the markets to police themselves. This is a common view that the market will police itself, and that if there had been a problem with FTX, it would have been uncovered much earlier because the market or participants in the market would have seen this. In an enthusiastic market like crypto, you don’t see that type of oversight.

As of August 2022, whitehouse.gov. tells us that the estimates of the total global electricity usage for crypto assets are between 120 and 240 billion kilowatt hours per year. Is there any push to regulate this side of things?

There already are rules in place and government groups like the Department of Energy and the Environmental Protection Agency that have the ability to step in, look at the issues and potentially regulate the usage of electricity, consistent with their mandate for environmental protection and energy conservation.

I would ask not whether we should look at this but whether we’re being broad enough. If electricity is an issue and energy is an issue for crypto, let’s look at the New York Stock Exchange and stocks and bonds that are trading. I believe there are huge amounts of energy being expended there as well.

Want more? Explore Charles Whitehead’s Securities Law certificate program delivered by eCornell.

This post has been edited for length and clarity.

Hear more from Whitehead in the webcast “Crypto Regulation: Can Securities Laws Keep Pace with Innovation?”

Sustainable preservation certificate launches to address climate concerns

Whether living in urban centers or rural farming towns, people are becoming increasingly concerned about the impact of climate change on their lives. That concern is accelerating the growth of “green” building and energy efficiency initiatives. But Katelin Olson, Ph.D., visiting lecturer in Cornell University’s College of Architecture, Art, and Planning, says communities may be overlooking an equally important climate solution: sustainable historic preservation. By reusing the existing built environment, sustainable preservation is an essential tool for meeting climate goals.

“The greenest building continues to be the one already built,” says Olson, who is a certified planner. “As we seek greater energy efficiency, it is tempting to think we can build our way out of our environmental crisis. But that’s not a financially possible or reasonable solution.”

Read the full story on the Cornell Chronicle website.

New Cornell certificate helps create the ethical data science workplace of the future

We increasingly place our trust in algorithms, whether applying for a mortgage, a new job; or making personal health decisions. But what about the security system that uses facial recognition and locks out a 55-year-old office custodian from her night shift? Or the groups of people automatically cropped out of photos on social media? These are the unintended, and often unfair, consequences of data science tools amplified across millions of users. They’re also highly preventable.

This is the lesson that lawyer and epidemiologist M. Elizabeth Karns embeds in every data science and statistics course she teaches in the Department of Statistics and Data Science. Her students will be deciding how to use data in the future, and while bad decision-making in business isn’t new, Karns says it’s the accelerated and aggregated effect of today’s data science applications that’s so dangerous: individual, team or even a whole company’s worth of decisions, can instantly affect the lives of millions of people. Moreover, the torrent of new technologies is moving faster than our regulatory systems, leaving a gap in accountability. Even data scientists themselves often don’t know exactly what’s happening inside their algorithms.

Read the full story on the Cornell Chronicle website.

Data policy program boosts high school students

This spring, more than 100 underserved high schoolers in New York, Florida and Michigan participated in an expanded online data policy and analysis program, in which they explored pressing policy issues such as income inequality, racial justice and climate change through economic and sociological lenses.

The program – developed by eCornell, the School of Continuing Education (SCE) and the nonprofit National Education Equity Lab (NEEL) – was led by Maria Fitzpatrick and Matthew Hall, both professors in the Department of Policy Analysis and Management, in the College of Human Ecology. In examining important issues – including education equity and COVID-19 – students sought to determine how big data is being used to address policy problems in the United States and across the globe.

Students had the opportunity to learn directly from Cornell faculty via virtual office hours, lab sessions and one-on-one facetime.

“Maria Fitzpatrick and Matthew Hall have been forces of nature in providing transformational opportunities to students who need it most,” said Leslie Cornfeld, NEEL’s founder and CEO.

During a closing ceremony May 26, Provost Michael I. Kotlikoff praised the high school scholars for their achievements, saying he was proud of Cornell’s leadership in this effort with the Equity Lab as it reflects Cornell’s commitment to equity, access and opportunity.

Fitzpatrick called the program “one of the best teaching experiences of my career.”

Last summer, eCornell and NEEL piloted a high school program with Donna Haeger, professor of practice in the Charles H. Dyson School of Applied Economics and Management, based on Haeger’s popular on-campus spreadsheet modeling courses. To expand the collaboration, this spring eCornell and SCE worked with NEEL to offer a three-credit online undergraduate course, Big Data for Big Policy Problems (PAM 270).

Many of the 16 schools participating in the high school program signed on to provide supervising teachers, who coached and helped all students with time management. NEEL provided a Chromebook to any student without access to a laptop.

“Cornell University’s leadership is a national model for what selective universities can accomplish in the education justice space,” Cornfeld said.

“With this expansion, Cornell has powerfully demonstrated their commitment to racial and economic justice. They’re not just talking the talk. That commitment should make current and future students, as well as alumni, proud of their alma mater.”

One such future student is Melanie Lantigua, a high school student from the Bronx who successfully completed the course and will be attending Cornell this fall as a first-generation student.

“I hope Cornell continues to offer opportunities like this to scholars in underserved high schools across the nation,” Lantigua said during the ceremony. “We need opportunities like this to show colleges – and ourselves – what we can do.”

Jamie Bonan ’18 is a content marketing specialist at eCornell.

Ansys ushers in a new era of online learning with Cornell Engineering

/ Key Highlights

Ansys is transforming engineering curricula through a partnership with Cornell University to develop simulation courses, supplementing online learning
Cornell’s SimCafe tutorials will now be accessible on the Ansys Innovation Courses platform
Ansys and Cornell University’s Sibley School of Mechanical and Aerospace Engineering are transforming online engineering curriculum with new simulation-based online courses. The collaboration satisfies the increased demand for remote learning and brings simulation software to the forefront of teaching.

As graduating engineers and young professionals face demanding positions and high expectations in the workplace, Cornell and Ansys are arming them with access to world-class simulation education. Through this collaboration with Cornell, Ansys lowers the barrier for simulation education and equips a new era of engineers to succeed within advanced engineering teams, who increasingly leverage simulation to solve complex engineering problems.

Faculty from Cornell’s College of Engineering will design and develop courses with eCornell, the university’s external education unit, while Ansys provides support for the inclusion of real-world application examples and detailed technical write-ups of problem formulations, engineering assumptions, simulation approaches and results interpretation. The courses’ flexible format enables participants to complete the curricula on their own timelines. Courses will be offered for both students and professionals seeking to bolster their skillsets. Additionally, Cornell has chosen the Ansys Innovation Courses platform to host their existing SimCafe tutorials. Cornell will work closely with Ansys to migrate all of their tutorials to the Innovation Courses learning structure, resulting in more than 50 new Cornell courses, adding to the more than 75 existing Ansys Innovation courses.

“Simulation is a disruptive technology that can be used to transform engineering curriculum at the university level,” said Rajesh Bhaskaran, Swanson director of engineering simulation at Cornell University’s Sibley School of Mechanical and Aerospace Engineering. “As simulation becomes a standard feature of curriculum for teaching physics and applications, nearly every engineering graduate should be able to use simulation software effectively. Together with Ansys, we look forward to preparing engineers with the simulation skillset they need.”

“Through our continued collaboration with Cornell University, we are helping students and professionals engineer what’s ahead throughout every stage of their career,” said Prith Banerjee, chief technology officer at Ansys. “As simulation continues to revolutionize how engineering is done, the eCornell courses, supplemented by our Ansys Innovation Courses, will ensure that participants gain the experience needed to excel in the ever-changing industry.”

The Cornell courses are now open for registration. To learn more or to sign up, please visit https://ecornell.cornell.edu/certificates/engineering/fluid-dynamics-simulations-using-ansys/. Ansys Innovation Courses are available at https://courses.ansys.com/.

/ About Ansys

If you’ve ever seen a rocket launch, flown on an airplane, driven a car, used a computer, touched a mobile device, crossed a bridge or put on wearable technology, chances are you’ve used a product where Ansys software played a critical role in its creation. Ansys is the global leader in engineering simulation. Through our strategy of Pervasive Engineering Simulation, we help the world’s most innovative companies deliver radically better products to their customers. By offering the best and broadest portfolio of engineering simulation software, we help them solve the most complex design challenges and create products limited only by imagination. Founded in 1970, Ansys is headquartered south of Pittsburgh, Pennsylvania, U.S.A. Visit www.ansys.com for more information.

Ansys and any and all ANSYS, Inc. brand, product, service and feature names, logos and slogans are registered trademarks or trademarks of ANSYS, Inc. or its subsidiaries in the United States or other countries. All other brand, product, service and feature names or trademarks are the property of their respective owners.

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