	Though the landscape of network late night talk shows has shifted, it’s good to know there is a “top 10” list with staying power. In its 

, more than 100 doctors and researchers at the Cleveland Clinic recently selected the top 10 transformative efforts they feel hold the greatest promise in impacting the practice of medicine in 2017. We’ve highlighted a few of the picks here, ones that span the technology spectrum from seemingly sci-fi science to low-tech, basic methods requiring little more than a box and a stamp.

USING THE MICROBIOME TO PREVENT, DIAGNOSE AND TREAT DISEASE

 With a better understanding of the plethora of microbes that call our bodies their homes, researchers hope to be able to impact a range of diseases now considered, at least in part, impacted by the microbiome, from GI issues to seemingly unrelated conditions like

Researchers are just beginning to grasp the scale of the microbiome, gaining a picture of the populations of healthy bugs throughout our different organs, the chemical miasma that they manufacture and what an imbalance might look like. A $121 million investment in the National Microbiome Initiative signals greater recognition of the field. Biopharma investment could be an even greater marker as developers are progressing treatments with technologies that go substantially deeper than probiotic products on your grocer’s yogurt shelf.

AUTOMATED CAR SAFETY FEATURES AND DRIVERLESS CAPABILITIES

 Emergency medical professionals know better, but those of us with a biopharma mindset don’t always include car accidents in our models of the healthcare system. A staggering 94% of accidents involve human error. And the costs are substantial: 38,300 fatal car crashes occurred in 2015, along with a $1 trillion hit to the US economy in healthcare costs and loss of productivity. One wonders how 

considerations for a revolution in transportation will be addressed in another Trumpian $1 trillion figure, the promise for a massive infrastructure spend by the coming administration.

 The early alterations are already on the road: collision warning, automatic braking and lane drift assist are just the tip of the iceberg. Smarter systems for cars are the now, but the future, most believe, will be fully automated cars. Auto and tech companies are leading the way with investment. Given the car’s place in our society, the impact on the medical and insurance practices, as well as the overall economy and culture, will be profound.

3-D VISUALIZATION AND AUGMENTED REALITY FOR SURGERY 

 Intricate surgeries, notably those in ophthalmology and neurology, require microscope oculars or other camera systems. These surgeries have limitations-the physical strains on the surgeons and limited peripheral vision, to name a few.

 Surgeons are experimenting with immersive, high-resolution 3D environments, allowing them to work with their heads up, while the stereoscopic system can provide visual templates that may make for better and more efficient, effective and safe surgeries.

 HPV sits silently in women around the world, infecting nearly 80% of those who are sexually active. Cervical cancer resulting from the viral infection kills close to a quarter of a million a year, with 85% of the fatalities 

occurring in the third world, rural and remote regions, where screenings are relatively rare.

 Self-administered test kits-a swab, test tube and mail-in box-will be deployed in large scale in 2017. Global organizations like Gavi recognize defeating HPV as a key developmental goal for empowering women. Though not strikingly high tech, the hope is the simple effort can help get a grip on a devastating affliction.

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Cleveland Clinic looks at the big medical innovations in store for 2017.

Medical Game-Changers Beckon

	There are two ways that Africa presents itself to the world. There is the untapped growth model, where the region is positioned as a future global economic powerhouse; and the troubled, post-colonial legacy profile, of a “dark continent” mired in poverty, corruption and the toxic mix of ethnic and religious rivalries that perpetuate civil conflicts-a civilization at war with itself. In healthcare, statistics on public health show Africa posting major gains against infant mortality and life expectancy. But this is balanced by a huge demographic challenge-Africa is literally running out of space for its people-along with poor infrastructure and a woefully disconnected network of trading relationships.

	Another imbalance is that between the desire of major equity investors to find investment targets of a suitable size, quality and depth and the impact of depreciating local currencies 

and slower economic growth. The latter tends to deflate such opportunities and push investors to smaller projects with lower returns and much longer time-frames to cash out.

	Which of these dueling perspectives will prevail is a critical strategic question for big Pharma investors seeking potential returns from Africa’s storehouse of raw, unlocked assets-assets that create new opportunities and a better life for patients. To help answer that question, 

 talks with our Editorial Advisory Board member Les Funtleyder, portfolio manager for New York-based E Squared Capital and consulting partner to Blue Cloud Investments, a private equity investor focused on midmarket opportunities in the sub-Saharan region of Africa.

How do you see the current status of the continent as a place for healthcare investments? Is the global biopharma community discounting the potential opportunities in Africa from a favorable demographic of young, highly productive workers interested in improving their health status? 

 There is no simple answer, because Africa is not a monolith. Prospects vary significantly by country. In some countries, healthcare-and access to it-is improving. In others, the trend is in the opposite direction. There are 54 sovereign states in Africa, more than any other continent. Efforts to align these countries around a single universal platform for health provision, investment and financing have not moved forward. In addition, the economic model throughout Africa is focused largely on extractive resource industries like mining and oil-“get rich quick” projects that add little of substance to the local economy, especially given the collapse of global commodity prices in the last three years.

	Finally, healthcare infrastructure is uneven by country and is not connected across the region. That leads to major delays and uneven care for patients. My firm is supporting a local investment in a central diagnostics lab, which is a big precedent for the region since in most African countries there is no such venue.

What you are saying is that Africa lives and dies by shifts in the global prices of key minerals and other commodity assets. Why is this approach to investment different than in healthcare? 

Healthcare is not a good, but a service highly dependent on human capital. This is a problem for the region, because even if the health system has the necessary physical infrastructure, such as out-patient clinics, hospitals and pharmacies, you still require highly skilled people to make it function properly. What the region needs is a strong network of medical schools to turn out physicians, nurses and also the technicians to manage the technology that keeps it all running.

	On the positive side, Africans are quite good at building out capabilities in mobile technologies developed for other sectors and applying these to healthcare. I travel to Africa frequently; I often run in to Facebook executives looking to find commercial applications around social media and the growing Internet community. The region also has a truly advanced mobile phone culture. Some countries, like Ghana and Rwanda, have proven adept at leveraging this high level of mobile penetration to address health access problems. Telemedicine is a good example.

According to the International Finance Corporation (IFC), an affiliate of the World Bank, the total healthcare market in sub-Saharan Africa today is approximately $35 billion. That’s a relatively modest sum-equivalent to just half of J&J’s annual revenues as a single company. How big will the market be by 2025? 

This number is not as small as it seems, especially given the double-digit annual growth rate for the sector. That means, in 10 years, the healthcare market will have doubled-at least. We know this from data showing that sales of healthcare products and services tend to rise faster than GDP.

How would you assess the current state of health infrastructure in Africa. Which countries are leading the way? 

Africa does not carry the burden of the costly, aging physical plant associated with large healthcare systems in the US and Europe. The industrialized world is grappling today with a lot of redundant facilities that should be mothballed. Defects in the health supply chain require multiple interventions, which are wasteful. Hence, Africa has the luxury of digesting these learnings and starting anew. And that requires a lot of investor money, loans and creative financial assistance, which is good for firms like mine. In Africa, healthcare is all about compiling the capital to grow and then deploying it wisely.

	A big element is philanthropic and donor aid, particularly from multilateral agencies like the World Bank and NGO powerhouses like the Gates Foundation. An interesting trend is how big private equity investors tied to the extraction industries are moving to diversify by investing in healthcare projects. Their interest is in supporting projects valued in excess of $50 million. Smaller firms are following their lead, taking part in projects worth less than $20 million. My firm, Blue Cloud Investors, is one of these; we focus on projects that are already up and running, but need to expand their range. We call this brown field investing. Our expertise is with the middle market of healthcare in Africa. Generally, we see ourselves moving up the value chain rather than down it.

An example of a brownfield project is when a pharmacy chain in Ghana with five pharmacy outlets wants to expand this network to 10. Blue Cloud is helping to make this happen. We also focus heavily on the due diligence process, looking for management that follows standard Western business practices, such as GAAP.

What are the pitfalls, lapses and problems that you encounter when seeking attractive investment candidates in Africa? Are there strategies to help mitigate exposure to these challenges? What are the key elements of a “best practices” list to ensure successful investing in the African market? 

The essential issue is the quality of governance. Management practices, the business plan and accounting standards must be reviewed and certified air tight. Information that is taken for granted in the US, like articles of incorporation, are not always evident in the African context, which often relies on little more than a handshake between parties. That is not enough.

	The second issue of note is you can never assume that an investment relationship will culminate in an exit path. There is no guarantee that someone will acquire your stake or that the initial deal will culminate in an IPO and eventual status as a public company. Capital markets in the region, outside South Africa, are too small and immature to accommodate the desire to put business development on a stable path to growth. Be ready, instead, to invest in a debt instrument of some kind, such as a revenue participation note, to ensure there is a financial return without having to wait for an IPO or acquisition that may never happen.

	The third challenge is handling currency fluctuations, which can gyrate wildly in Africa and affect the bottom line. Hedging strategies are important.

	One widely cited problem I would discount is political uncertainty. We have been investing in the region for many years and it has not surfaced as an impediment to our plans.

	Putting all these factors together, I believe the safest, most reliable “best practice” markets in the region are the English-speaking countries of West Africa, led by Ghana, and, of course, South Africa and Botswana. Angola is a country with significant assets, and, hence, opportunity in healthcare, but it does have its share of governance problems, not to mention the language barrier. We have yet to consummate any deals in East Africa, but we are actively exploring the investment landscape. There is a lot of untapped potential there, in Ethiopia (where demographic projections show a population of 178 million by 2050), Kenya, Tanzania and Rwanda. Conversely, most of central Africa is a conflict zone.

What do you see as the current strategy of the big Pharma players in Africa? Is the commitment to the region real or overstated? 

Most of big Pharma looks at Africa as a sidebar in their overall strategy for emerging country markets. I am not saying it’s invisible; just an area that they keep monitoring to identify opportunities over the long-term. Some companies have organized internal VC units that invest selectively in projects in the region. This gives them exposure to a market with minimal investment risk. It’s an excellent way to survey the lay of the land. Companies with a more advanced view are promoting joint ventures with local partners, which gives them a front-row seat in evaluating strategies on key topics like supply chain management, pharmacy distribution and who the competition is among local pharma players.

	Overall, the perception is Africa will eventually be a serious market with add-on growth potential. It’s a big, diverse continent of mainly young people with middle-class aspirations, all of whom are ready to consume medicines that lead to better health. Partnering is the way to obtain a full understanding of the potential opportunities while building a reputation for local engagement and trust. The strategy is to put a few small stakes on the ground and then see what happens.

What are the “no-go” issues and areas? 

US companies have to be eternally vigilant about the reach of the Foreign Corrupt Practices Act (FCPA). Business and even personal staff activities in Africa must be constantly monitored from HQ. The UK has a tough extraterritorial anti-corruption statute, too.

	There are cultural pitfalls as well, which are not limited to US investors. Chinese-backed investments in Africa have created friction with the locals, suggesting that political winds in the region can shift from one extreme to another. Once greeted as a generous rich uncle, China is now viewed more dubiously, although its presence in Africa does give governments leverage against traditional US and European donors.

First off, every country in Africa is different; there is no single script to address the culture difference. Generally, that first hard-charging, get-to-the-facts meeting agenda is not going to win points among African partners. Trust is paramount in relationships and that takes time to establish. Being 100% transparent is actually not appreciated in most African countries. You have to allow for some nuance. What must be remembered is that Africans like to cultivate relations while US executives are comfortable with a return-driven, transactional mindset. But if you meet the Africans halfway, the payoff can be substantial. You need to find and then rely on a cadre of reputable local contacts to build reputation as a good corporate citizen. One bad apple can create a crisis and lead to a costly disinvestment.

	It’s also true that foreign drug multinationals present in Africa are all partly motivated by a desire to demonstrate to African partners there is a social impact from their investments. This is a non-economic factor that we often underestimate as a source of good will in growing the bilateral relationship.

How ingrained is social investing-that mix of profits and philanthropy-in the business strategy for investors in Africa? 

My view is that profitability always comes first. If the business is not an ogoing concern, then it is a charity. A sustainable, profitable business has room for doing good precisely because it makes money. There is some interest in Africa in social investing, particularly among big European companies. US drugmakers are a bit behind on this indicator, but more companies are actively considering it. Unfortunately, however, there is no metric that might define what social investing is. There are some useful proxy measures. One example is if a company succeeds in the marketplace by increasing patient access to medicine or adding capacity to health infrastructure, then that action carries a social benefit that people want.

Can you identify industry players that are “doing it right” in the Africa region? 

Hospital operators are well-positioned to benefit from the demographic surge in Africa. That’s because most care is delivered in acute rather ambulatory settings. Devices and diagnostics based on “frugal innovation” are another. Biopharma has a specific set of challenges, including a complex pricing dynamic and distribution channels that tend to get complicated at that crucial “last mile” to the patient. Even medical device companies are beginning to dip their toes into the African market. But I caution we are in the early innings of the investment game in the region. The analogy is with China in the 

1980s. There is so much development yet to come.

	I believe in the notion that change provides a tremendous opportunity for profit. And there is certainly a lot of change taking place in Africa. What is cool about this region is it serves as a template for new approaches to technology. There is a demand for reliable, durable and very cheap technologies with mobile applications that transcend geographies. For example, unmanned drones to replace gaps in transportation infrastructure may be poised to flourish in Africa, earlier perhaps than in the industrialized countries. “Smart” technology with the ability to overcome supply chain or service barriers could put Africa in the lead on logistics innovations, proving them equally relevant to the market’s needs in North America and Europe.

Can you identify a potential disruptor coming from Africa that might impact healthcare markets here in the West? 

We are already observing interesting ideas at work on the distribution of drugs to remote or rural settings-I mentioned the drone example. Africa’s experience is also useful in advancing reliance on do-it-yourself diagnostics, using telemedicine’s data retrieval technologies. Cold storage vaccine facilities powered by solar energy cells is another. Each of these can be done at less cost than the conventional approach. It’s frugal science at work; the more this happens, the more it disrupts the big Pharma business model. 

What do you reserve as your biggest criticism of the way big Pharma companies invest and operate in Africa? 

Africa is admittedly a long-term play. But for big Pharma, everything is about short-term performance. That’s the heart of the problem. The majors see Africa as presenting good long-term rewards countered by significant short-term risk. In our view, the best way to balance the two is to start small and gradually work your way up the investment pole, relying on partnerships to hedge any liabilities. Starting small also enables investors to learn about the local climate for business, which is always an asset for reputation over the long-term. The final element is a CEO or someone in senior HQ management who cares enough to declare a vision for the company that expressly includes Africa-a vote of confidence in the market.

is a Healthcare Portfolio Manager at E Squared Capital. He can be reached at 

Features

In a continent marked by stark differences in governance, growth and market potential, the best bets must be pursued off script.

Investing in Africa: How to Do It Right

	In the eight years since the global financial/banking crisis and subsequent recession across most of the world’s leading economies, many of the emerging markets have proven to be much more resilient economically as well as becoming the longer-term engines for economic expansion, compared to the more stagnant health economies in Europe, Japan and the US.

	Emerging markets outside these traditional, established terrains are, therefore, strategically critical to large multinational pharmaceutical companies. However, as the business and political environment in a number of these markets has become increasingly tough and unpredictable (e.g., Brazil and Russia) and others have accelerated their economic development, management needs to revise corporate strategies and “go-to-market” approaches. Support and expertise is needed from the very top, i.e., board level. This article gives some perspective on how boards can support the business to win in emerging markets, against increasingly challenging market conditions and competition.

	In our recent publication, “Insights into the future of top pharma boards,” we analyzed the background, profiles and experiences of board directors in the 15 largest (by revenue) pharmaceutical companies in the world, all of which are still headquartered in the US and Europe. We also interviewed a significant number of these directors, both executive and non-executive, to understand better how board compositions are changing and to identify the key skills and competencies that will be required in the future.

	The ability of boards to tackle effectively the complex and unique challenges of succeeding in emerging markets has developed as a key theme from our study. 

	Over the last few decades, large pharma companies have been trying to expand their presence in emerging markets outside of the US and Western Europe. Indeed, a higher mission to make new medicines accessible to under-served populations, especially in these regions, seemed to be compatible with the significant business objective of achieving top-line growth.

	It should be noted that the pharma business environment in emerging markets has always been different and often difficult for the top multinational companies. Many factors account for this difficulty, including government protectionism of local  drugmakers (mostly, in generics) and often a lack of

 IP protection, since many emerging economies do not recognize international patent law in their particular legislation. Additionally, the recent implementation of more aggressive pricing and reimbursement policies as well as compliance and ethical considerations have restricted daily operations and raised concerns about the short- and long-term growth opportunity for multinationals in these countries (see chart). 

	For example, since the top 15 pharma companies all trade in the US, the DoJ’s rules and code of conduct applies wherever they do business in the world, even though “different” and seemingly less ethical practices may be commonplace and indigenous to a number of emerging markets which they serve, potentially giving local competitors an unfair advantage.

	Emerging markets account for 20% of revenues, on average, for the top 15 pharma companies-mostly generated from China, India, Russia, Brazil, Mexico and Turkey. The significant growth opportunity associated with generally increasing economic prosperity and healthcare spend further highlights the importance of capturing these markets to achieve future global success. However, the apparent unpredictability of several emerging markets has forced the leadership teams of the top pharma organizations to analyze and review more critically their previous strategies for extending into non-traditional pharma markets.

	One of the key findings from our survey was that revising and improving business strategies requires input and advice from senior leaders with genuine understanding and successful track records in those markets, as they each have individual cultural, political and commercial differences that require non-traditional approaches and strategies for success.

	Boards of top pharmas are increasingly challenging company strategy across all markets, including in non-traditional pharma markets. Given the long-term potential for exceptional growth in many of these emerging markets, it is crucial that boards provide relevant and informed input to the development of a long-term vision for their company’s presence in these regions. It is also important that boards provide strategic responses to the arising and enduring challenges that inevitably come with entering or expanding in those markets.

	A closer look at the current board composition of the top 15 pharma companies shows that 40% have three or more board directors with hands-on operating experience in emerging markets (see chart). On average, 22% of the total board seats of the top 15 pharma multinationals are held by these directors with operational experience in emerging markets.

	Board directors can play a key role in guiding executive management to understand the social and political circumstances and risks associated with 

individual countries and regions. For pharma companies, this suggests a need to appoint board members with relevant experience in those emerging markets as well as a profound understanding of individual market dynamics (political, cultural, social, legislative and commercial).

	For example, it may be important to understand and consider which are the dominant ethnic and religious groups in a particular less homogeneous market and then to tailor the market access strategy accordingly. Likewise, in some of the emerging economies, which are less open to foreign competition, the best way forward for a pharma multinational may be to form a joint venture with an existing local company, thereby creating a “win-win” strategy, which generates revenue growth and increased employment for both parties rather than trying to compete with them on unequal terms.

	As a result, an effective board should include not only directors with commercial talent and experience but also directors with a strong political and social understanding and credibility with a country’s leadership, as well as financial acumen, regulatory affairs and government affairs experience to navigate these environments successfully and maximize the growth opportunity.

	Our point of recommendation here would be to extend a “board diversity” definition to a broader meaning that reflects a potentially large patient base in emerging markets and the business acumen to work effectively in those markets-whether this implies a variety of nationalities, a diversity of hands-on operating experience in emerging markets or global mindsets.

	In addition, the board can advise the company on optimizing talent strategies and extending talent pools-from the board level to country heads-to make the most of opportunities in emerging markets. Boards can also advise the executive management in establishing an appropriate skillset by defining key competencies required for success in an emerging market, having determined any significant competency gaps and ensured that the talent strategy is tailored and adjusted accordingly, i.e., in both developing internal talent and hiring additional external professionals.

	Although the current economic challenges facing several of the emerging markets-e.g., Russia and Brazil-may be restricting their short-term growth potential, in the longer term, emerging markets with growing populations and increasing wealth are likely to be strategically critical to success in the pharmaceutical sector. To be most effective in capturing share in these markets, board composition at top pharma companies needs to better reflect emerging market perspectives and experience. This diversity will reflect increased specialist knowledge of the key dynamics and different cultures of emerging markets and, therefore, increasingly help to address significant proportion of growth and market opportunities.

 is a consultant in Russell Reynolds Associates’ Global Healthcare Sector, Digital Transformation Practice and Board Practice. He can be reached at 

 is Global Knowledge Leader for Healthcare at Russell Reynolds Associates. She can be reached at 

How a strong corporate board can help ignite success in these regions.

The Winning Edge in Emerging Markets

A veteran journalist and driving force behind NOVA, the longest, most successful science series on television, has some straightforward advice to a complex industry with an image problem: make your business a business of inspiration, where the return is measured in passion-and the sheer, simple pleasure of finding things out

	Communicating the value of medical research is a challenge that continues to dog both big Pharma and the small biotechs that depend-literally-on the kindness of strangers. Even though a recent Pew Research Center poll found that medical innovation, including new drugs, is by far the largest driver of positive public attitudes toward science, the industry still faces a skeptical audience. The perception is that interactions with external stakeholders are fragmentary and one-sided, leaving unresolved basic questions of public interest like where ideas that lead to new medicines originate, the real cost of private-sector R&D, and the transparent disclosure of test results.

	Appealing, inclusive answers to these questions are frankly hard to come by. Many experts contend the industry must take the leap in confronting its own vulnerabilities, addressing facts that are inconvenient rather than underplaying or avoiding them altogether. But how? What is the best way to communicate, inform and engage in a manner that is credible and compliant with regulation and the law, while incorporating the interests of diverse stakeholders, from investors to payers to the individual patient?

 for the industry demands more than just doing great research; it’s important that people understand its inherent virtue, too. The Galien USA Foundation, which plays a singular role in recognizing the best in new drug innovations, brought new attention to effective communication in science by giving its 2016 

public service award to one of the leading lights in science journalism: Paula Apsell, senior executive producer of NOVA, the US Public Broadcasting Service’s (PBS) long-running TV science program.

	Combining state-of-the-art visuals with creative story-telling-inviting viewers inside to see how real scientists “do it”-NOVA has transformed how we educate on the big, mystery-laden questions that have always been the special realm of science. Debuting in 1974, it’s been on the air in the US for 43 years, a time span that exceeds the duration of legendary series 

-combined. The stats on NOVA speak for themselves: an average four million viewers per episode, with more than one million digital impressions per day logged through its various associated platforms, all connected through an integrated 

	On the margins of the Prix Galien USA Foundation dinner awards program on Oct. 27, 

 sat down with Apsell to obtain insights from her four decades covering science, public health and the R&D industry. The conversation includes her unique perspective on improving the way the biopharma industry communicates value to the public and other stakeholders whose actions are likely to set the future prospects for innovation. Her bottom-line advice? Tell a good story; uncover a mystery to be solved, which are replete in basic drug research; and make it matter-because it pinches the human soul.

 Can you highlight the key influences on your life and career? As a young woman, what brought you into journalism and television broadcasting? How did science turn out to be central to the endeavor?

 I struggle to find a direct relationship between what I was when I started in this business and where I am today, decades later. I grew up in Marblehead, Massachusetts, a town on Boston’s north shore, with deep roots dating back to the pre-revolutionary era. My parents were both born in the US, the children of Jewish immigrants from Eastern Europe. They believed strongly in education. Neither would call themselves intellectuals but it was expected we would study hard and do well in school. What helped my growth as a person is the support-and confidence-I got from my parents. They thought anything I did was just wonderful.

	I took an early interest in science in high school, particularly chemistry. I then went to Brandeis University, a liberal arts college very strong in the sciences, which encouraged, and still does, students to stretch themselves and sample courses in a wide variety of disciplines. In contrast to young people today, who seem so fixated on their future, I wasn’t all that concerned about what I might do with my education. I had no money, but I was too busy consuming a daily smorgasbord of tantalizing ideas to worry about what I was going to do with my life. I was on scholarship, so I was assigned a work-study job in the high energy physics lab, where I scanned bubble chamber images for the research team. Conveniently, I met a PhD student at the lab named Sheldon Apsell, who eventually became my husband and father of my two daughters. Sheldon is an inventor and entrepreneur who is now CEO of a non-profit called the Academy of Applied Science, which runs several programs to encourage kids to develop an interest in the sciences and invention. We have two daughters, one a physician, the other a television news producer.

 Graduation from Brandeis was followed by a hard landing. I had to find a job, and like many young women at the time, I sought a position in social work. I actually fantasized I might be a probation officer and save the world. Not surprisingly, I couldn’t find a job. One day, I was on my way back from an interview, when I got lost. I ended up in front of a building in Allston that turned out to be the home of WGBH. I walked in and asked the receptionist about job postings. She looked at me and said “I think Janie and Nike are looking for someone.” She dialed them up and both came down to the lobby to meet me. The two women, only a few years older than I was, worked in the station’s scheduling department. They were looking for someone to assume a job they were fervently hoping to shed-typing up the daily broadcast logs to document every piece of content that ends up on the air. An incredibly tedious task, made worse by the fact I was a horrible inept typist; mercifully, this job has been automated for years. But since the logs had to be circulated everywhere in the station, the job gave me face time with senior executives as well as the opportunity to learn the logistics of television producing. I was quite lucky that a position no one wanted turned out to be a great launching pad for me.

	After a year in that role, I developed an idea for a radio program, The Spider’s Web, dramatizing children’s literature. I convinced the head of WGBH’s FM radio unit to let me do it as a volunteer, while still typing the TV logs. He said yes, for reasons I still don’t understand, and I think it surprised both of us that it turned out to be a pretty good show, won many awards, and stayed on the air for years after I decided to move on as part of WGBH Radio’s news team. I became an on-air news reader and was assigned to cover the Massachusetts State House.

	I had great mentors at the station, including my friend Judy Stoia, and I learned a huge amount about how to identify the lead in any story and how to write fast-skills that I still use constantly. But after a couple of very exciting years covering state politics, a wonderful opportunity opened up for me and a chance to move out of radio and into film and television.

Yes. At the time, NOVA was a fledgling initiative entering its second season on Boston’s WGBH Channel 2. The unit was looking for a production assistant (PA). Back in my days as the station log typist, I had gotten to know Michael Ambrosino, the WGBH programming executive who came up with the idea for a documentary series focused on science. A true visionary, Michael prevailed despite enormous skepticism in the broadcast industry against anything so “heady.” The idea of NOVA took me right back to the passion for science I had developed in high school and college. I knew right away I had to apply for the PA position, even though, as a full producer in radio, I was making good money. And, frankly, I didn’t know one end of a film camera from the other.

	I was also intrigued by the new people Michael brought in to help launch the series. Most were British, from the BBC, due to its commitment-fairly unique at the time-to make science relatable through great storytelling and top-quality photography. When NOVA broadcast its first hour-long program in 1974, our sister series, BBC Horizon, had already been on air for at least a decade.

How did you fare in those first few days as a NOVA production assistant?

I started the job with not much in the way of training; it was pretty much sink or swim. On my first day, I was told we were doing a program, called The Plutonium Connection, where we had a graduate student devise a recipe to build an atomic bomb and then asked nuclear scientists to assess his 

work and the likelihood of nuclear weapons technology falling in the wrong hands. I was told to set up a three-week shoot all over the country, and somehow, with the help of colleagues and my radio journalism training in asking questions, I figured it out. I won’t say it wasn’t intimidating, but I came to 

love this improvisational, learn-by-doing approach, and I had some very talented people to learn from. I have never looked back-and it’s been a very long time.

What was novel and distinctive about NOVA? To what factors do you attribute its success?

 Our success comes down to one thing, which has not changed over the years. NOVA was designed to tell good, accessible stories about science. To show viewers something with a visual impact they could not get in ordinary life; and to depict scientists as characters-real people with a great passion for what they were doing. Michael Ambrosino always said science is story, and if we tell it right, with great pictures and strong characters, people will watch.

	And they did, from the start. Our premise was that curiosity is an innate human trait and there’s a thirst to know more about science and engineering and the mysteries of the world around us. Nevertheless, PBS, then in its infancy, and my station, WGBH, took a huge risk in supporting the series, especially in the early years, when there was so much on the line. Commercial broadcasting had a terrible track record in this area, 

 notwithstanding. Walter Cronkite was passionate about science, but even he could not persuade CBS to keep his series 

on the air. To counter that, NOVA had to add something special. We needed to be in the entertainment business and in the education business; but most of all, we needed to be in the inspiration business.

What do you mean by that-the business of inspiration

 Our objective was to depict science as a quest for knowledge, driven by the hunger of researchers and scientists to understand the universe and our place as human beings in it. Every NOVA program seeks to engage our viewers’ curiosity by searching for answers to some critical questions. That approach mirrors the paradigm of science as the process of finding something out, rather than just a collection of facts to be learned. We want to show what goes on in scientists’ minds. What leads them to adopt a particular perspective, conduct an investigation, and come up with an answer-one that may have to be reevaluated in the light of new evidence? Ultimately, following this interconnected process is the story NOVA aims to tell.

	One of the most inspiring early assignments I had at NOVA was a program on the eradication of smallpox. At that point, I was an associate producer, setting up a shoot in Bangladesh of what were then thought to be the last two cases of smallpox in the world. My producer, an incredibly talented man named John Angier, was very excited about this and crushed, as we all were, when a 

 in Bangladesh prevented us from going. It turned out to be a lucky break for me, because I was deputized to create the program from archival footage and interviews that could be done in the US. And what an opportunity-to spend hours filming public health doctors like Don Henderson, who just recently passed away, the incomparable Bill Foege, and many others responsible for one of the greatest achievements in medicine. It was my first film, and was I ever hooked!

	When I had my first daughter, I left NOVA and eventually went to work at the ABC affiliate in Boston, WCVB, as senior producer of medical programming for Dr. Timothy Johnson, another amazing mentor. After my second daughter was born, I was extremely fortunate to be accepted into the first year of what is now called the Knight Science Journalism Program@MIT. This led to an invitation to return to NOVA as the series executive producer.

Can you name other programs that brought NOVA to the attention of the medicines profession and healthcare community?

Certainly one of the best was the life stories of seven students at Harvard Medical School, whom we followed in a series of programs broadcast over 22 years, the last of which we ran just a few years ago. We followed a similar concept to UK director Michael Apted’s “Seven Up” films, tracing the life trajectory of the students and how each of them took different paths; some with great results, others not so great. The scars imposed by a life in medicine showed through in that series, which allowed us along the way to raise questions about healthcare in this country. We showed quite graphically through the twists and turns in the lives of our seven subjects what a career in medical practice is really like, in terms of both the toll it takes and the rewards and joys. I loved working on those shows, and I think they showcase the unique nature of NOVA. After all, how many broadcast series get the opportunity to tell a story that extends out 22 years?

	NOVA has also been a leader in documenting progress in medical research. Together with my colleague Graham Chedd, I made the first TV documentary on genetic engineering and recombinant DNA in the late 1970s. After that, we made a multipart series on genetics called “Secret of Life.” This was followed years later by a special on the race to sequence the human genome and, more recently, an episode on personalized or genetic medicine.

	We are planning to build on that tradition with a program explaining and exploring the impact of CRISPR technology. Working with the Howard Hughes Medical Institute, we broadcast a powerful program on the vaccination controversy. And this past season, we showed “Can Alzheimer’s Be Stopped?,” reflecting the progress being made to understand the disease and developing drugs to treat it. All of these programs have extensive educational resources for teachers and students and a broad array of digital features on pbs.org/NOVA.

What have you learned about the scientific method over the course of your career in television programming?

As NOVA’s executive producer, I see my mandate is to explain how everything in science, including the life sciences, begins with basic research. We saw how the so-called “War on Cancer” declared by President Nixon did not result in the cures that were hoped for. Cancer, like so many diseases, is complex, and the process of curing and treating disease has to start at a much more rudimentary level, with an awareness of how life evolves, how cancer cells take root and multiply in the human body and what therapeutic tools and platforms are most relevant to destroying these invaders. All strands of the problem have to be disentangled, requiring enormous investments of time, resources and money before you get a payoff. But of course, the struggle is worth it in that new medicines and diagnostics will keep us healthy and cure illness. I believe NOVA’s body of work

 in medical science makes this important lesson very clear.

	Like other professions, patience in science is a virtue and this spills over to our field as well. Making films for television is still a handcrafted industry. Each program is bespoke; it’s built by hand. And now, of course, with the digital revolution, we have a much bigger canvas to fill. TV is just part of our mandate, and we’re working on applying the same focus on creativity and craft to a medium with different demands-the online space.

Do you strive to be provocative in how you create these stories for the viewer? Isn’t creative tension fundamental to the scientific inquiry

 I love to make programs on topics that the public thinks you can’t render well visually. Mathematics is one that comes first to mind. We did a program called 

, funded with a grant we obtained from the Simons Foundation. It posed the question-is mathematics a human invention or a discovery rooted in nature? This idea arose when I attended a lecture by the scientist Mario Livio, who was speaking to a group of high school kids about his book 

 The teens’ reaction was so enthusiastic, we started to think seriously about making this show. What ultimately persuaded us was how fascinating the question was. Still, we needed to figure out how to visualize a very abstract topic. This program was nominated for an Emmy, and was incredibly popular both on TV and online, a heartening affirmation that we can successfully offer our fans programs on demanding topics if the story and the visuals are right.

 Ideas for programs come from everywhere. Scientists approach us frequently. We review all the scientific journals and the general press. Independent producers pitch us ideas, and we work with international production companies on co-productions, where we have editorial input and control over the US version. We want to focus on important science topics, but topics don’t necessarily make good stories. So we’re looking for a natural storyline-a mystery to be solved, a mission to be accomplished, an obstacle to be overcome. That’s the basis of any good story, and a science story is no different.

In a broader sense, how hard is it to be in broadcast journalism today? Are the many disruptive challenges, including social media, eroding the public’s faith in your business model? Is all the background noise of populist rhetoric degrading the commitment to quality in science programming?

 No, none of the above. NOVA is doing very well, and while cable channels will from time to time produce science docs, any direct competition is minimal. Anyway, competition makes you stronger and we have a lot of stylistic range to experiment with to make the series even more distinctive-without dumbing it down, which is something we will never do.

	 The big challenge for us is financial. Quality is expensive. PBS supports NOVA generously, but that doesn’t allow us to do everything we want to do. Like miniseries and specials. Like the other signature series at WGBH, which produces a large proportion of PBS programming, we expend a huge amount of energy raising money from foundations, individuals, and corporations who want to be associated with what’s often called the “gold standard of science programming.” We have a good track record, including in the pharmaceutical industry. Johnson & Johnson was NOVA’s sponsor for more than a decade and companies like Merck and Pfizer have also stepped up to the plate. Right now, we’re underwritten in part by Cancer Treatment Centers of America. But across the PBS landscape, it’s become more difficult in recent years to find corporate support, and that’s been disappointing. To be completely transparent, I hope perhaps the award I received from the Galien Foundation or this article might inspire some interest from the pharmaceutical and biotech industries. Sponsoring NOVA conveys a very important message-that science is crucial to understanding our world and ourselves and to living more healthy and productive lives-and that surely is something we can all agree on.

Isn’t the main competition to NOVA coming from the digital space?

In some sense, yes, that’s true. Some years ago, the National Science Foundation (NSF) reported that the Internet has overcome television as the place where most Americans get their science news. But, as you know, the Internet is still a wild frontier, with voices coming from every direction and no check on quality. In the digital landscape, NOVA stands out, as a source that people trust. This has created great opportunity for us to reach out to a large, diverse and generally much younger audience than we serve on broadcast. We are able to provide our long-form episodes, as well as short-form videos like our popular 

series on YouTube, which has almost nine million views; 

 We have NOVA Labs, a digital platform for teens that enables them to get involved in research, and a series of thought-leader columns on science policy, NOVA Next. This has driven social media, and NOVA was the first PBS primetime series to surpass a million followers.

	The challenge is connecting all these new platforms in a seamless and integrated way-one big NOVA that incorporates many forms of video, audio, the key social media platforms like Facebook and Twitter, our website and of course the weekly broadcast series on PBS. An example of this multi-media approach is the program we did in 2015 when the New Horizons probe reached Pluto, taking the first clear pictures of that dwarf planet, so far from Earth. This proved enormously successful in the number of people being able to access it in many different ways, all connected with the NOVA brand.

	The point is I see the digital revolution not as increasing competition but as extending our reach and the potential for enhancing public understanding of science. It’s certainly expensive to maintain and grow this presence; our digital commitment requires a mounting level of investment in order to stay current with technology and to realize the potential of this medium to engage new audiences that may not even own a television. And by doing so, I am confident we are ensuring NOVA’s future.

You cited NOVA Next as a short-form program focused on science policy issues. Where are you taking this concept around the big policy issues confronting the science enterprise? What additional efforts are you making to extend and embellish the NOVA brand?

 One thing we are doing is to provide more analysis and context around breaking science news. NOVA Next provided a very early report on the CRISPR gene editing platform with a detailed and easy to follow explanation of the technology and its revolutionary and controversial implications. New long-form articles come out weekly, with daily updates and shorter features. We focus on science stories like artificial intelligence and climate change, which have important policy implications. NOVA also has a broadcast spin-off called 

, which focuses on current research with a slightly more segmented approach, telling in each program a number of stories that can be knitted together around a single, salient question; for example, can we build an artificial brain? One of the areas of research we will cover in 

 is the research and treatment potential of the microbiome.

Is science successful in making its case to the public, other stakeholders and the political establishment? Why is it important that science is seen by the public as an institution of integrity with the capacity to improve the future?

 When I began producing NOVA, most scientists I encountered thought that being on television was a waste of time. Communicating science to the public was not seen as carrying much value for the profession. Today, the situation has changed, and that’s great for us, because NOVA could not have continued this long without the support of the scientific community. Scientists now recognize that public support is absolutely necessary to advance their work. We see many scientists who have turned out to be articulate, skilled communicators in their respective fields, and some like Neil deGrasse Tyson, who appeared on NOVA and hosted 

 for many years, have become stars in their own right.

	Yet, I am dismayed by the lack of public understanding of science that I see. Numerous studies reveal that significant numbers of people are skeptical of climate change and reject evolution, and that a small but vocal minority questions the value of vaccination, probably the most important public health tool we have to protect children and fight disease. We are filming a program now on the impact of the water crisis in Flint, Michigan. The breakdown in public confidence caused by the failure of government to protect the safety of the water supply has induced a health crisis where the public is not heeding basic hygiene warnings because it comes from authorities they no longer trust. All this testifies to the fact that the connection between science and the public is not strong enough, and that there is plenty of work yet to do.

Are there pressing issues that NOVA has covered that require more understanding and dialogue between scientists and the public?

 One of the most difficult issues to explain to the public is climate change. Climate itself is a hugely complex system and predictions about our climate future involve significant doses of uncertainty. It’s a largely invisible, long-term problem that-let’s face it-given our inaction is inherently depressing. Not exactly the stuff that big audience grabbers are made of! Yet it’s critically important that we take it on, find new ways to make the story compelling, and engage the public around what might be the most important science issue of our time. NOVA has been making programs on climate change since the 1980s, and while I won’t pretend to have it knocked, there’s no question-we will keep on doing them.

What has changed in your perception of the willingness of scientists to cooperate in confronting the major policy challenges in medical research? Do you agree that improving health through research requires joint actions to ensure resources are effectively deployed?

 Absolutely. I see far more focus on work that is interdisciplinary and linked to partnerships that can advance progress. There is less of a division between pure science and applied science than in the past. In fact, it’s been years since I have seen these two terms in common use. Back then, a scientist might be insulted if you suggested that there might be a commercial objective for his or her work. This no longer seems true. Many scientists are very happy to know that what they do plays a role in actually helping people. Providing that this goal doesn’t detract from basic research, that’s got to be good for society.

 How well is the R&D-based biopharmaceutical industry faring in promoting the virtues of medicines innovation to patients and society? From your perspective as an impartial science communicator, what are the industry’s strong points?

NOVA programs have always emphasized how difficult it is to make progress in human health. In terms of complex systems, the human body, including the brain, is in a class of its own. Additionally, as I have come to see through our medical programming, there are many ethical, logistical and financial issues associated with the clinical trials that are needed to assess the safety and 

effectiveness of any new potential treatment.

	One show I produced decades ago when I worked with “Dr. Tim” Johnson was about Alzheimer’s disease. Called 

, it was particularly fascinating to me because it revealed a new understanding in gerontology that dementia is a pathology, not an inevitable condition of old age. And that meant it might be treatable or could even be cured, if science could lead to a better understanding of what’s going wrong in the brain of the victims of this terrible disease.

	 We followed this perspective in more detail in the recent NOVA program, 

, in which we documented the complex course of several clinical trials testing different drugs to treat and even prevent this emerging public health emergency. The program attracted a large viewing audience and, I believe, provided a real public service in showing people how important both basic research and clinical trials are to finding treatments for the diseases we worry about.

	We could not have done this program without the cooperation of drug companies, like Genentech, Lilly and Biogen that took a real risk in letting us cover trials without any idea whether they were going to be successful or not. It’s crucial for the industry to take these risks with credible science journalists, and let the real stories come out, whether it’s a success or failure. The public needs to understand the role that failure plays in science, especially medical science, where more drugs fail in trials than succeed. But those failures ultimately lead to cures.

	We did many events around the country to promote NOVA’s Alzheimer’s program, and from the response we got, it helped people understand the need to enroll in clinical trials and what a slow, difficult and costly process it is to create the medicines we need to treat and cure disease.

	Another NOVA program told a similar story about the difficult nature of creating new drugs. 

 told the story of the growth of personalized medicine, based on an individual’s genetic code. Among other diseases, we looked at cystic fibrosis and how the pharmaceutical company, Vertex, succeeded after more than a decade of study in creating a medicine able to help just 4% of children with this often fatal condition. That is not a lot of children, but it changed their lives immeasurably for the better and, hopefully, will lead to additional medications that will treat even more children who suffer from this debilitating disease.

Are there organizations that you can cite as effective communicators in making science resonate with the public?

 The NSF has a consistent record in making large investments in making science accessible to the public. So, too, does the American Association for the Advancement of Science (AAAS). There are several foundations that come to mind as well. The Carnegie Corporation of New York is one; another is the Moore Foundation, and the Sloan Foundation is an amazing supporter of efforts to enhance public understanding of science in media, books and even on the Broadway stage and feature films.

	These foundations also place a strong emphasis on community outreach, education and digital innovation, which is so important in positioning science for the long-term. There are also a number of private foundations and individuals who support the work we do.

	I think backing solid science journalism is a good investment and studies show it brings with it significant public appreciation and good will. We are certainly appreciative of the funding we receive from external donors, which this season includes Farmers Insurance, Cancer Treatment Centers of America, the David H. Koch Fund for Science and, of course, PBS and CPB, which provide the bulk of our funding.

	As I mentioned earlier, the pharmaceutical industry has given us support for NOVA and specific projects, in particular Johnson & Johnson, Merck and Pfizer. We welcome new partners, who share our commitment to science, public understanding and science education to benefit society and improve the lives of untold numbers of people.

’s Editor-in-Chief. He can be reached at 

Pharm Exec sits down with veteran journalist Paula Apsell, the driving force behind the long-running PBS science series NOVA. Apsell offers straightforward advice to the biopharma industry: make your business a business of inspiration, where the return is measured in passion-and the sheer, simple pleasure of finding things out.

Paula Apsell: A Storied Life in Science

How life sciences companies can institute a manufacturing Excellence program in their global product strategies-with the goal of delivering competitive advantage, at lower cost.

				Instituting manufacturing excellence should be an immediate and core priority for biopharmaceutical companies that want to achieve a sustainable competitive advantage.

	Manufacturing excellence is characterized by a company’s ability to understand network capacity, focus on manufacturing performance, manage risk through its quality systems, employ people with the right skillsets and apply technology and analytical tools to improve product quality and company profitability. 

	Biopharma companies can realize considerable benefits from instituting or strengthening manufacturing excellence-transformative efforts at several large companies already have delivered hundreds of millions of dollars in cost reductions. For example, one global player in the industry recently delivered more than $400 million in potential annual savings through its manufacturing excellence initiatives. Another transformation at a biopharma company generated savings of $100 million and enabled the manufacturing organization to increase its flexibility and to increase its output by 23%.

	While a complete transformation may not be appropriate for all companies, the potential financial and operational benefits of pursuing manufacturing excellence may be significant. Conversely, failing to deliver manufacturing excellence may result in shrinking profits from topline deterioration and rising production costs.

	Historically, the biopharma industry was not known for being on the leading edge of manufacturing excellence, relative to other industries. Biopharma manufacturers largely focused on delivering quality products, while avoiding risk, often with little emphasis on optimizing manufacturing. However, emerging market and technology trends and a shift toward risk management are making manufacturing excellence critical to the future strength of biopharma companies’ top and bottom lines.

	One key sector trend is the transition from producing traditional blockbuster drugs to targeted, niche therapies (e.g., orphan drugs) with smaller patient groups. These drugs increase manufacturing complexity due to their smaller batch sizes, which require more frequent equipment changeovers. These changeovers present more opportunities for quality failures and put greater pressure on manufacturing organizations to be efficient.

	The small-batch nature of targeted therapies means that the volume of a product on the market will be lower than for conventional drugs. This presents topline pressures that compel companies to focus, more than ever, on increasing speed to market to maximize the total lifetime sales of therapies. Although regulatory reviews and clinical development are often perceived as the main drug approval bottlenecks, the FDA Center for Drug Evaluation and Research noted in December 2015 that manufacturing is often a rate-limiting factor in achieving expedited approval because of the inability to quickly scale production.  Each day a launch goes past its scheduled date, drug developers lose as much as $600,000 in foregone sales for niche products and as much as $8 million for larger volume therapies. 

	Today’s global regulatory environment also factors into a company’s pursuit of manufacturing excellence. Global deployment of orphan drugs is crucial to maintaining topline performance due to lower volumes, so the manufacturing requirements of multiple regulatory bodies must be considered concurrently or in rapid succession.  One reaction that companies may have is to build overly complex, costly, and risk-averse quality systems that are not sustainable. Avoiding risk does not necessarily ensure high product quality, and it can drive up costs and limit the manufacturing organization’s ability to institute improvements to gain production efficiencies.

	The increasing prevalence of targeted therapies, such as CAR-T and gene therapy, is prompting companies to employ novel manufacturing processes, which further emphasizes the need for manufacturing excellence. For example, CAR-T therapy requires processing a patient’s own T-cells to fight diseases like cancer, moving manufacturing closer to the patient and limiting economies of scale. Also, in the instance of CAR-T, typical manufacturing processes, testing, and controls cannot readily be leveraged to create a cost-effective process.  Companies will need to rethink how manufacturing, quality control and quality assurance interact with the patient to effectively and efficiently create and deliver such novel therapies.

	Finally, the trend toward global manufacturing calls for an increased focus on finding, hiring and retaining talented people-particularly in leadership roles-who can deliver manufacturing excellence. The leadership skills needed going forward are not necessarily the same as those needed in the traditional landscape of blockbuster drugs and lesser cost pressures. Competition for the best talent can be fierce, requiring companies to be strategic in their approach to identify, attract, retain and develop people with the right skillsets for tomorrow’s manufacturing environment.

	Achieving manufacturing excellence is not easy-it requires company leaders to align and focus the entire organization, like never before, on developing and implementing transformative initiatives that promote efficiency and flexibility. The process starts with a well-defined business strategy followed by a capabilities evaluation to define the type of transformation that is required-from simplifying a quality management system to overhauling global operations. Ultimately, companies that proactively take steps to drive manufacturing excellence could gain a competitive edge.

	What does manufacturing excellence look like?

	Many manufacturing excellence principles are common across industries; however, there are some focus areas that are specific to biopharmaceuticals. The chart below shows the critical elements of biopharmaceutical manufacturing excellence.

	Companies need to understand their network capacity to flex production to market demands, avoid unnecessary capital expenditures and prevent product shortages, particularly for life-saving drugs. While this need sounds obvious, gaining a thorough understanding of network capacity is not easy. When a company has a global network of facilities that may start and finish a manufacturing process in several geographic regions, it can be difficult to tell where the true bottlenecks exist. Too often, as demand rises and puts pressure on existing production resources, management’s first reaction is to decide that more capacity and facilities are needed. Fear of a market shortage compounds this issue and can lead to potentially unnecessary decisions to expand capacity.

	In reality, what appears to be a capacity constraint issue is often an underutilization issue in disguise. As leaders better understand the capabilities of each facility and the interactions among them, a clear picture of perceived versus actual constraints may emerge and show what the organization is truly capable of producing. For example, one major biopharma company recently assessed its network of multiple manufacturing plants, along with its plans for two additional sites and a CMO to support production. The assessment found that significant unrealized capacity existed in the current network and could be realized through simple efficiency projects. Some of the resulting capacity gains were driven by cycle time reductions and additional operating days from maintenance optimization. The additional identified capacity alleviated perceived constraints on manufacturing capabilities. In today’s ever-changing landscape, a thorough understanding of network capacity can allow companies to make better strategic decisions, to cross-utilize their assets to manufacture several products and to plan for complexities associated with manufacturing a larger portfolio of niche therapies.

	Historically, quality and delivery have been the biopharma industry’s primary manufacturing drivers. This may be acceptable for companies producing high-volume, high-margin drugs; however, as patent cliffs and the rise of generics phase out the blockbuster era, companies also need to focus on manufacturing performance and more aggressively balance quality and delivery with costs to create an efficient operation. Still, executing on this may be difficult in biopharma organizations where cost pressures have not been as prevalent historically.

	Focus areas for cost reduction depend on specific business needs. For a manufacturing system that requires minimal flexibility, common lean principles to reduce waste can be effective. In most cases, however, systems need to flex to market demands, new products and changing regulatory requirements. Therefore, it is important to identify which assets and process steps can provide flexibility and which can be removed. Manufacturing performance is not just about direct manufacturing costs; it’s also about balancing flexibility with both direct and indirect costs.

	To enable topline growth, leaders need to develop flexible manufacturing capabilities that can produce many products quickly and scale to meet demand, while also managing costs. Targeted therapies are driving smaller production batch sizes and increasing the frequency of changeovers. This reduces economies of scale and makes production more difficult to manage. These two levers need to be balanced; leaders should look for win-win opportunities to drive both cost and flexibility improvements, such as reducing changeover time to concurrently enable more frequent product changes and reduce overhead costs incurred during production downtime.

	Strong, integrated quality systems are essential to achieving manufacturing excellence. Quality affects all aspects of a company-from its reputation, sales and costs to its working environment, employee morale and retention capabilities. To enable manufacturing excellence, companies must be compliant and deliver high-quality products, while not getting paralyzed by fear of regulatory citations and observations. Company leaders should create and nurture a culture where

 employees are able to raise their hands about potential issues, without fear of retribution.

	Sometimes when production issues arise, companies alter manufacturing process parameters and retest products without conducting proper root-cause analyses to uncover the reasons for the failures. Instead, quality should be addressed directly and proactively by embracing quality by design, improving quality controls, adopting forward-looking compliance metrics and emphasizing a culture that respects and builds quality into everyday business operations.

	If a company’s quality management system and culture do not empower employees and incentivize problem-solving and a “right-the-first-time” mentality, then its leaders must identify ways to transform the quality mindset. Only then will the company move from firefighting and applying temporary solutions toward manufacturing excellence.

Employ capable people with the right skillsets

	Employing and developing capable leaders with the right managerial and technical skills is critical to delivering manufacturing excellence. Biopharma manufacturing has traditionally focused on skillsets built around the technical aspects required to manufacture quality products. While quality is still paramount, leaders today must balance quality, cost and market demands while also managing production complexity. In addition, as the scope of leaders’ responsibilities expands to include global coordination and a focus on cost, they will need to develop a workforce that can execute against more and more demanding objectives. This presents challenges for the talent lifecycle.

	Biopharma companies have several options to attract, retain, and cultivate top talent:

 This requires organizations to become much more sophisticated at leadership development. Companies also will need to identify future leaders who may currently be in technical roles. Dimensions for evaluating leadership potential should be created and used to assess high-performers.

As leadership challenges increase, the demand for current industry executives will also increase. To compete for top talent, companies should develop attractive incentive packages that balance the appropriate salaries and bonuses with the required skillsets and desired autonomy levels.

Compete for top talent in other industries.

 There are many adjacent sectors, such as medical devices, advanced technologies and, to some extent, consumer products, which have similar leadership challenges but do not necessarily require the same baseline technical skillsets. Biopharma companies should consider bringing in proven leaders from other industries. For this approach to be successful, companies will need to refine their definition of a “qualified leader” skillset and find ways to test and evaluate external candidates against these parameters.

How a Manufacturing Excellence program can deliver competitive advantage to a fast-changing global product mix-at lower cost,
and with an unexpected workforce dividend to boot.

Pharmaceutical Executive-12-01-2016

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The Winning Edge in Emerging Markets

Paula Apsell: A Storied Life in Science

Going to the Edge

Trump Administration Offers Relief, and Challenges, for Pharma

Executive Pay and Innovation

Science: The Communal Language

Will NICE ‘Go Commercial’?

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Pharmaceutical Executive, December 2016 Issue (PDF)