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Content Writing certificate teaches leaders to engage and persuade

From internal planning documents to external media releases, a convincing piece of writing can be a key to success for business initiatives – and for the professionals who lead them.

Cornell’s Content Writing online certificate program, offered through eCornell, empowers students with techniques to present information succinctly and engage readers with actionable next steps. Lauren Chambliss, senior lecturer in the Department of Communication at Cornell’s College of Agriculture and Life Sciences, is the faculty author. Chambliss was a journalist for 20 years in Washington, D.C., before coming to Cornell. She previously served as director of communication for the Cornell Atkinson Center for Sustainability and now teaches full time.

In developing the certificate program, Chambliss noted a trend: Organizations expect professionals across career fields to take on – and excel in – writing-focused responsibilities. Recent studies on effective management, such as Google’s Project Oxygen, show that employers view strong communication skills as essential and closely associated with good leadership, no matter the sector.

“In today’s professional landscape, writing is not just a task for copywriters. It’s a valuable skill across various roles and industries,” Chambliss said. “Regardless of your job title, having a strong writing portfolio sets you apart, paves the way for career advancement and opens doors to leadership opportunities.”

Even standard presentations are being replaced with written content in some organizations. At Amazon, PowerPoint slides have been phased out in favor of six-page memos at executive meetings. The company’s leaders contend that the practice encourages employees to pack as much information as possible into their proposals, creating more convincing narratives.

Students earning Cornell’s Content Writing certificate complete two courses on conciseness and persuasiveness in copywriting and three courses on effective writing for digital contexts: websites, online media and social media. In addition to gaining an understanding of copywriting fundamentals, participants learn an increasingly important skill: content targeting. Students complete a variety of writing and self-editing exercises throughout the program, building toward a final project.

The program also offers a symposium: three days of live, interactive virtual sessions that enable students, Cornell faculty and industry experts to engage in real-time conversations about pressing topics in marketing and communications.

“Creating engaging, lively content across multiple platforms is critical in today’s professional world, whether you are a content creator, a business owner or a copywriter in a big company, government agency or non-profit,” Chambliss said. “Dynamic writing requires us to keep adapting and improving our skills.”

Cornell’s Content Writing certificate program prepares professionals to craft content that engages and persuades. Are you ready to discover current best practices for your business communications? Learn more and enroll now.

This story was drafted by eCornell marketing intern Justin Heitzman.

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Professionals navigate rising economies in Emerging Markets certificate program

Emerging economies, fueled by digital adoption, a growing middle class and urbanization, are full of unrealized growth potential. With potential risks and rewards fluctuating daily – and even hourly – investors and financial professionals must grasp the complexities to navigate volatile markets.

“It is truly a universal global challenge, as well as an opportunity,” said Andrew Karolyi, the Charles Field Knight Dean of the Cornell SC Johnson College of Business and author of the university’s Emerging Markets online certificate program. “Emerging markets have unrealized growth potential because they have inadequate capital to fuel growth.”

These markets, often referred to as the E20 – or with a more narrow scope, the BRICS countries – are barred from joining the “elite” group of developed countries in terms of GDP per capita, financial infrastructure and life expectancy rates because of a lack of foreign investments that would fund further development.

The phenomena forms well-paying investment opportunities in those markets counterbalanced by significant financial risks. Course content crafted by Karolyi and his co-authors, Lourdes Casanova, director of Cornell’s Emerging Markets Institute (EMI); Anne Miroux, EMI faculty fellow; and Wesley Sine, John and Dyan Smith Professor of Management and Family Business, covers six categories of those risks.

“Emerging markets are now mainstream; however, there is a lot of noise around them and limited knowledge,” Casanova said.

The four courses they created equip professionals with key concepts and tools to understand current economic events. From discussions of the effects of government intervention on the frequency and success of greenfield and M&A investments to examination of state-owned corporations in China and the impact of currency volatility, students will learn the correlation between the political landscape and market risks in the E20, including BRICS economies.

Tailored for financial services professionals and individuals interested in investment in emerging markets, the program is best suited for those with a foundational grasp of data statistics and business terminology.

Enrollment is now open for the Cornell’s Emerging Markets certificate program. Learn more about the program online.

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Cornell AI Strategy certificate prepares leaders to leverage new tech

In the era of artificial intelligence (AI), professionals across sectors are racing to strategize ethical and sustainable applications of the technology. Many organizations are actively pursuing AI knowledge not only to harness its potential but also to ensure responsible implementation.

Cornell’s new AI Strategy certificate program – authored by Soumitra Dutta, professor of operations, technology and information management in the Cornell SC Johnson College of Business – offers a nuanced curriculum for leaders who are ready to leverage the power of AI in various business contexts.

“Today virtually every single employee in an organization needs to understand something about AI. It doesn’t matter if it’s the senior executive in the boardroom, office worker or factory floor worker,” Dutta said.

The program, which is available through eCornell, includes six courses. Students begin with an introduction to AI then explore knowledge-based technologies, machine learning and data-based approaches to the technology. Later courses cover AI implementations across sectors, societal effects and the tech’s future prospects. Each module is designed to be applicable to the real-world concerns of any professional aiming to comprehend how AI integrates with business and society.

Upon completion of the program, students will understand how to:

  • Assess applications of AI in their organizations
  • Apply knowledge-based AI technologies to their organizations’ standard tasks
  • Address challenges by applying machine learning
  • Design strategies to implement AI systems across an organization
  • Examine the societal implications of AI in areas such as labor, privacy and ethics
  • Envision the development of strategies to preserve human dignity and agency while embracing the benefits of the technology

In light of the rapid evolution of AI, the program maintains a dynamic curriculum, emphasizing core principles and skills for comprehending the fast-changing discourse surrounding AI.

“It’s like an AI boot camp, ” said Dutta. “The program is sufficiently light on the technology side to give you enough background but sufficiently deep on the context and the strategy side. It gives you the technical background while hitting on all kinds of things happening in our world right now,” Dutta said.

AI is more than a tool; it’s a strategic necessity. Cornell’s AI Strategy certificate program prepares professionals to navigate the exciting yet complex future of the technology. Learn more and enroll today.

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Crunching Numbers: Understanding the Power of Statistics

Hand holding pen pointing at graph

Imagine being able to transform raw data into actionable insights, shaping the direction of your business and your daily life. This power lies in understanding and applying statistics – the foundation of informed decision-making, the catalyst for impactful change and the key to unraveling the complexities of our world.

Cindy van Es, professor of practice at Cornell’s Dyson School of Applied Economics and Management and author of the Business Statistics certificate program, is expanding our comprehension of the study of statistics and its practical application in diverse fields. From agriculture to digital analytics, her work equips us with tools to navigate the complexity of both the corporate realm and our everyday lives, with statistics as our guide. Van Es shared her insights in the Keynote webcast “Statistics: What Everyone Should Know.”

How has statistics changed over the years?

“There are so many things after teaching it all these years, but . . . it’s present in every field these days. Even when I was going through education, it was very much the scientists, but it’s moved into so many fields now. The explosion I’ve seen over my career, from the very quantitative fields, to now: Every field has a metric. So it’s good to have a little idea of what goes behind some of these things.”

What are some surprising ways statistical information is used?

“When I think about the kinds of jobs my former students have now, they work for Airbnb, or Expedia, or Hilton or in finance. Even in marketing, now: A lot of stores will track your eyes . . . to see how long you look at a product, and they can correlate that data with the scanner data to see whether you bought it or not, and did the red label make you buy it more than the blue label . . . . There are experiments going on all around you, even when you’re not aware of it. Maybe you work in a nonprofit and you’re doing an amazing job, and it’s a very meaningful project, but in order to get funding, you may have to quantify why it’s amazing: What are the outcomes, and what are the metrics? There’s so much now: It’s kind of ubiquitous.” 

Which type of statistics is the most challenging to learn?

“Statistics has two branches: Descriptive and inferential. Descriptive is when you take a sample, you describe what you have and you ask the questions: Do I want to make a graph of this? Or do I want to make a table? Or calculate what we call ‘summary statistics?’ Most people are pretty good at that. Inferential is where you want to make an inference about a broader group, about a population. If you see a poll in the news, you’ll see a little plus-or-minus margin of error. That’s because they’re doing inferential statistics. When you see ‘this percent of people in the country think this,’ it’s based on a sample – so what you’re doing is making an inference. That part of statistics is a little harder for students and people in general, I think, because first of all, the language of inference is probability . . . understanding risk, understanding probabilities, the human mind really doesn’t think that way. So inferential is usually more challenging.”

Is artificial intelligence being used in statistical processes and interpretation of data?

“Each new technology – computers, and then supercomputers, and then desktops – influenced how people teach statistics and use techniques . . . . Now the merger is more with computer science and info science, as opposed to just being applied to agriculture, or medicine, or biology. Now the whole discipline is merging. Statistics hasn’t caught up with how to use [artificial intelligence] yet . . . statisticians are just starting to look at it.”

Harness the power of data interpretation in Cornell’s Business Statistics online certificate program. You’ll develop a dynamic set of skills that can heighten your confidence, fortify your decision-making, and catalyze meaningful change.

Drafted by eCornell writing intern Milan Lengyeltoti, with first round edits from marketing intern Justin Heitzman.

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3 Ways to Sabotage Your Systems Architecture

Professor Oliver Gao studies air quality related to automobile emissions with researcher Shuai Pan.

As the adage goes, those who fail to plan, plan to fail. This is especially true in a rapidly evolving tech landscape. Systems architecture – the strategic art and science of designing complex foundations for software, hardware, networks, and even interactions between humans and machines – is a discipline that can help organizations plan ahead for growth, scale operations and reduce costs.

“We live in a time in which we will be confronted with complexities from various systems, ranging from healthcare to transportation. Our leaders and practitioners, executives and engineers, must be equipped with the right tools to address those complexities,” said Oliver Gao, director of systems engineering at Cornell, where he is also the Howard Simpson Professor in the School of Civil and Environmental Engineering.

Gao, faculty author of the Cornell Systems Architecture and Management program, identified three traps managers and developers should avoid to ensure their systems are successful.

1. Starting from scratch

“Systems architecture combines creativity and analytical rigor,” Gao said. “It is the most powerful way of thinking and making decisions to overcome challenges that are totally different from the challenges our ancestors faced.”

Yet, leaders do not have to reinvent the wheel. By leveraging current structures, organizations can extend the life of a system that has more function than flaws. This process can ensure that valuable data and performance is not degraded. While unproven methods for mapping form to function have higher risks for failure, building upon an established foundation can save time in development and deployment. Integrating with existing systems also preserves investments from the past.

According to Gao, a well-architected system makes an organization more agile and resilient against unknowns. To adapt and innovate faster, both engineers and team leaders should understand the frameworks already in place then make informed decisions on what can be enhanced or eliminated in response to business demands.

2. Disregarding data security

Information is the backbone of any system, but a single data breach can lead to demise: irrecoverable losses in finances, property and reputation. Interconnectivity in systems heightens the risk of leaving a door open to bad actors. Gao argues that security must be a core component of a systems architecture.

“This discipline is about thinking in systems rather than isolated components. A technical systems architecture must fit together strategically, just as every beam and wire must be positioned for stability and longevity in a structure such as a parking deck. Any vulnerability can result in significant harm to an organization, so systems need redundancies,” Gao said.

A secure system incorporates defenses against physical and digital threats, protections for proprietary data and recovery mechanisms. By taking a layered approach of encryption, auditing, training and more, Gao believes businesses can create sustainable systems.

3. Failing to future-proof

In an unpredictable digital ecosystem, solutions that work seamlessly today might not be equipped to handle tomorrow’s demands. An architecture that lacks scalability can cause costly disruptions as operational needs shift for a company. However, a well-planned architecture naturally evolves with an organization’s growth.

“It is important to listen to all stakeholders from the outset. It can’t be just the tech teams,” Gao said. “From the CEO to the finance team to the product managers to the front desk, everyone needs to be in the room to answer questions about their needs. Ignoring someone’s preferences can result in decreased productivity.”

Gao encourages systems architects to engage in a discovery process through interviews and research before starting a design to avoid wasteful allocation of budget, time and personnel resources on solutions that may not be effective or user friendly. Comprehensive understanding of organizational needs also ensures room for growth.

“Your company’s latest product offering could be quite different from earlier offerings. You might have to hire more staff. A system might not adjust to these changes immediately. If you’ve brainstormed how the future could look and tested for flexibility in the systems architecture, your solutions will be prepared to bend but not break,” Gao said.

Planning your systems architecture

As a leading expert in urban infrastructure, transportation, and environment systems analytics for smart communities, Gao has developed a Systems Architecture and Management program to help organizations understand the value of systems architecture related to performance, lifecycle cost, schedule and risk. He works directly with organizations to help their leaders examine their systems, characterize and prioritize stakeholders using network theory and more.

“Investing in systems architecture is investing in the foundation of an organization, enabling it to grow efficiently and successfully,” said Gao. “Systems architecture ensures that technology aligns with business objectives and paves the way for the future.”

The Systems Architecture and Management program is one of Cornell’s several custom live educational opportunities for corporations, nonprofits and other organizations. Learn more about the university’s enterprise programs online.

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The Age of the Mompreneur: Empowering Working Mothers

Modern societal shifts and emerging trends in the startup ecosystem present new challenges and opportunities for women, particularly for mompreneurs – those juggling the responsibilities of motherhood and entrepreneurship. The success of early-stage enterprises founded and led by women depends greatly on dismantling systemic barriers, including the uneven distribution of venture capital.

In the recent Keynote webcast “The Boss of Me: Entrepreneurship and Motherhood,” Andrea Ippolito – CEO of SimpliFed, director of Women Entrepreneurs Cornell, and lecturer in the university’s engineering management program – shared her experiences as a mother and businesswoman, delivering compelling insights into what it takes for women to thrive as working mothers in today’s competitive, fast-paced labor market. 

How has the landscape of entrepreneurship changed for mompreneurs, particularly during and after the COVID-19 pandemic?

“What happened is that by forcing us to be at home, we showed folks that we can be effective and efficient, despite what some CEOs are saying. We actually saw an increase of women starting companies. When you look at 2019 compared to 2021, in 2019, there were a whole lot less women starting companies, 28%. Whereas during the pandemic, 49% of new companies were started by women. It was a much more flexible work environment.

Before the pandemic, it was all about meeting in person or working through stakeholder meetings in person. My journey looked a lot different than someone that was in their 20s, pre-kids, that could hustle 24/7. And don’t get me wrong, I hustle 24/7. My effectiveness and efficiency of working has always been pretty “right on” with having kids. But the time horizon has taken me a little longer.”

What are some of the largest hurdles working mothers encounter when trying to found a startup, and how does societal infrastructure play a part in this?

“The infrastructure is not in place to help support [founders], especially parents, whether that’s paid parental leave, universal child care support. There are so many things that we need to do as a society to better support entrepreneurs getting their organizations off the ground.

Startups founded by women are more profitable, and they exit faster. If you are an investor, it’s in your best performance interest for your fund to invest in women. If we want to have a more profitable economy, and we know that startups are the engine for that, then we need more folks participating. And the biggest pool of people we’re not taking advantage of right now is women. We need to rethink the structures to help support them.”

What are your secrets to striking a healthy work-life balance that comes with being a businesswoman and a mother?

“One of the things we see often is, especially for women that are parents, is they feel like they have to hide different parts of their life. For me, I have a five-year-old. I have a two-year-old and a T-minus five-week-old. And I don’t try to hide it. There are times where, yes, I don’t want them around because I want to focus 100%. But I also don’t try to hide it.

There’s this big misconception that people are taking off in the middle of the workday, and they’re not focused. The reality is that by giving folks a more flexible schedule, you actually get more out of them. They value their work. They’re aligned with your mission. But you’re also respecting them as a human being as well.”

Can you share your insights on the bias in investment toward women-led startups? How does this coincide with major life events like motherhood?

“We know that women [are] seen as less investable. There are tremendous biases out there, no doubt. And the research has shown that. One of the things that I feel very strongly about is that by the time a woman gets enough experience, expertise, and confidence, it’s around the same time that she’s having kids. One of the challenges is how do you start a company when you have this crazy unpredictable life of being a parent.

Venture capitalists have to raise money from somewhere. They have to raise money from what are called limited partners, or LPs. And those limited partners are pension funds, college endowments, sovereign wealth. And so we need folks like limited partners, like college endowments, to actually invest more in women-led funds.”

How can businesses better support working mothers, particularly with regards to incorporating child care into their business models?

“I think more and more, we need to have universal child care as a federally-funded entity. The companies that find ways to support child care or maybe fund it as a benefit will do better. And so I think there’s a responsibility of larger organizations to have this as a benefit. And then for, say, small businesses where they don’t have, frankly, those types of funds or resources, I do think [we need] a government federal response. It’s good for our economy. It pays for itself. It creates an engine in our economy.”

In a rapidly evolving entrepreneurial world, businesswomen are breaking down barriers, mastering the juggling act of work-life integration, and shaping business models to include family needs. Learn how to navigate a tech career as a woman leader in Cornell’s Women in Product certificate program, designed by Andrea Ippolito or gain a better understanding of funding models in Cornell’s Startup Funding and Finance certificate.

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Shape the Future of Senior Living Management

Seniors flipping through memories in a photo album

Driven by longer lifespans and the aging Baby Boomer generation, the number of older adults in the United States is expected to exceed 80 million by 2040, accelerating the demand for senior living solutions. Professionals in the sector are adapting to provide affordable housing and quality care as demographics shift.

Heather Kolakowski, interim executive director for the Cornell Institute for Healthy Futures, and seasoned industry specialists discussed potential solutions for creating sustainable and inclusive senior living environments in a recent Keynote webcast, “Affordable Senior Living: Challenges and Opportunities Ahead.”

Subsidized or Affordable: What’s the Difference?

Rent-to-income ratios are a key indicator of housing affordability. Financial experts frequently advise families to spend below 30 percent of their income on rent, and those who spend more are deemed cost-burdened.

“We are currently in the midst of an affordable housing crisis, and you probably wouldn’t know that from looking at the housing prices these days,” said Severine Petras, CEO and co-founder of Priority Life Care. “Nearly one in three households devotes more than 30 percent of their income to their mortgages.”

Subsidized and affordable housing are two distinct yet related concepts. Subsidized housing, often supported by the Department of Housing and Urban Development through programs like Section 8, ensures individuals do not pay more than 30 percent of their income toward housing. Affordable housing refers to units that are offered below market rates without government support.

Rising Costs on All Fronts

With rent prices increasing faster than income growth, seniors will have difficulty finding affordable housing options in the future. Jay Woolford, senior vice president at CIRC, questions how providers will meet the growing needs: “As rents go up and the cost of housing continues to go up, how do we fill the gap for people? How do we begin to look at ways to manage housing costs and be able to provide them opportunities for nutrition, for transportation, for healthcare, for access to entertainment?”

Financing senior living facilities is another hindrance, with tax credit investors, opportunity zone funds, and volume cap bonds playing crucial roles. Woolford has explored alternative financing with his own Tukwila Village project, a mixed-used senior housing development project in Washington state.

“We were getting tax credit investors to put in the bulk of the equity for the project. We actually used opportunity zone funds as the final equity piece of that,” said Woolford. “But the struggle now is the availability of volume cap bonds. The demand is outstripping the capacity.”

Senior living management professionals also face rising labor costs and a reliance on government subsidies. With labor being the most significant expense for assisted living facilities, providers must find ways to balance the need for qualified staff with the rising costs of care.

“The bigger problem is operationally making sure that you’re able to meet the extreme demands on an expense side,” said Petras. “When you’re talking about the revenue, we’re talking about relying on a government subsidy.”

Creative Strategies for a Brighter Future

The community aspect of senior living alleviates the heftier burden of healthcare service costs seniors and their families would otherwise face with private care. Maintaining this important benefit for aging adults requires innovative solutions.

Tukwila Village demonstrates how cities can provide land to facilitate the development of affordable housing communities. “The property was actually owned by the city of Tukwila. They had aggregated a little under six acres. And we worked with the city to be able to put this together in order to do affordable senior housing on the property in conjunction with a number of other partners,” said Woolford.

Modular housing, which involves the assembly of prefabricated housing units, can offer a faster and more cost-effective approach to building senior living facilities.

“Manufactured housing has a dirty reputation, especially after a hurricane. But the reality is that new manufactured homes are actually built better today,” said Mitch Brown, principal consultant for Senior Housing Consulting. “The new regulations for building those communities are more rigorous in terms of tie downs and everything that has to happen.”

Cornell’s Senior Living Management certificate program introduces professionals to best practices for service excellence at senior living facilities. Learn more and enroll today.

Watch the full “Affordable Senior Living: Challenges and Opportunities Ahead” Keynote on the eCornell website.

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Cornell introduces new AI-focused Board Governance program

Cornell live immersion program participants engage in discussion

Blending resilience and risk is essential for companies that intend to survive today’s tech innovations, economic uncertainty and political pendulum swings. The greater the challenges, the greater the demand for leaders who can deliver an effective mix of foresight and strategic oversight.

Board Governance: Navigating Emerging Technologies and More in a Complex World, a new Cornell Tech immersion program slated for this fall, is set to prepare corporate board members for fast-paced evolutions in artificial intelligence (AI), geopolitics, cybersecurity, supply chains, sustainability and other areas driving the future of commerce.

Read the full story on the Cornell Chronicle.

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What is Your Style of Decision-Making? Strategize for Influence.

Imagine unlocking the secret to success in both business and day-to-day life. It’s all rooted in one critical talent: strategic decision-making – the essence of exceptional leadership, the engine driving meaningful change, and the spark igniting innovation.

Cheryl Strauss Einhorn, adjunct professor in Cornell’s SC Johnson College of Business, is a pioneer in shaping our understanding of this crucial skill. She is an accomplished author, educator, the creator of the AREA Method – a game-changing problem-solving approach – and the author of the Complex Decision-Making Cornell certificate program.

Her insights have reshaped how leaders steer their decision-making strategies and offer valuable lessons for navigating the complexity of the corporate world and your career.

Einhorn shared some key decision-making guidelines in a recent Keynotes webcast hosted by eCornell:

Understanding Strategic Choices

Einhorn believes that our problem-solving styles are behaviors with which we feel most adept and comfortable. She asserts, “we all have a comfort, a dominant problem solver profile. And we can all become more dynamic problem solvers.” This perspective champions the inherent adaptability within each of us to navigate different problem-solving styles.

The Adaptability of Problem-Solving Styles

Contrary to popular belief, problem-solving styles aren’t prescriptive. Instead, they offer space for adaptability and growth. Acknowledging our problem-solving styles provides a valuable opportunity for self-awareness and interpersonal development.

Einhorn defines five distinct styles of decision making that offer unique perspectives into the world of strategic problem solving:

The Adventurer: Einhorn describes the adventurer as “a very decisive decision maker. She knows what she wants. The future is endlessly more interesting than the present.”

The Detective: With a strong need for concrete evidence, the detective is “a slower decision maker because she wants to find data.”

The Listener: This style of decision maker is “relational, collaborative, trusting,” Eihorn said. “She emphasizes the importance of gathering input, and she likes to gather the wisdom and opinions of others.”

The Thinker: Someone who “values understanding the why and thinking about the different options.” This style represents a “thoughtful, careful decision maker.”

The Visionary: “A big, creative, out-of-the-box thinker.” Einhorn warns, however, that “this kind of decision maker could have a planning fallacy.” Visionaries can dream big and are often the source of innovative ideas, but they must stay grounded to avoid unrealistic expectations.

Decision-making styles are dynamic, changeable over time, and influenced by various factors such as age, experiences, and environments. For example, your style at work might differ from your style at home. Einhorn explains that you have the freedom to choose your problem-solving style based on the situation: “You could decide that you want to plan a meal as a visionary. You want to take a vacation as an adventurer. You want to buy insurance as a detective. And each of these opportunities are available to you once you understand the five different profiles.”

No “Perfect” Combination

Harnessing the power of strategic decision makers isn’t about achieving a “perfect” combination of problem-solving styles. The real value lies in understanding and leveraging diverse profiles to become more effective leaders.

Awareness of these profiles can offer insights into the kind of information each leader needs and highlight any cognitive biases that might obstruct effective problem solving. “You can learn what this means that you’re good at and the places where each of us might have mental mistakes that are most relevant to getting in our way. And then how we can make better choices together,” Einhorn said.

With this knowledge, we can fill gaps in perspective, ensure a more comprehensive understanding of situations, and contribute more effectively to collective problem-solving processes to foster strategic leadership and decision making.

In mastering the craft of strategic leadership, we pave our own route toward personal and professional achievement. Adopt an introspective approach and learn to leverage your unique problem-solving styles in Cornell’s Complex Decision-Making certificate program. You’ll gain a dynamic skill set to boost your confidence, empower your choices, and drive significant change in all aspects of your life.

Watch Einhorn’s Making Difficult Decisions Keynote webcast on the eCornell website.

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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.

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