Pharm Exec’s 11th annual list spotlights a select group of biopharma managers who are poised to help chart the industry’s path forward. We present the diverse stories of 10 rising executives-and detail how each are changing the ways leaders direct critical industry functions such as R&D, data and analytics, patient advocacy, business, commercialization, and human resources

	This year’s class of Emerging Pharma Leaders embody the many changes that pharma has made to navigate the many complexities in the industry. Newly-created titles that oversee functions that have only come into higher priority in the past five years; executives that have traversed non-pharmaceutical paths to bring different perspectives to their current position; and those that realize the most successful executives are the ones that recognize talent and bring their successes forward. 

received over 100 nominations, and the final 10 selections were judged in a blinded process by three members of 

’s Editorial Advisory Board, and a former Emerging Pharma 

Leader representative. Judging criteria was based on the nominee’s current role; progression of their career; education and extracurricular activities to enhance leadership; and specific case examples. The final 10 are those individuals that have exhibited the qualities, knowledge, and skills that show they have what it takes to make the tough decisions that will continue to face manufacturers in the coming years. 

	In many of the profiles you will read in the pages ahead, and many that you have read in the past, you can’t help but notice some similarities. These individuals share a passion for their profession and they are vested in directly touching patients’ lives. In no other industry do we see this level of commitment, personal reward, and true belief in the difference science and medicine make to the world. 

	Congratulations to this year’s Emerging Pharma Leader alumni and thank you for sharing your inspiring stories.

Christopher Boone, VP, Head of Real-World Data & Analytics, Pfizer

	When Christopher Boone’s children ask him for career (or life) advice, he simply tells them to “always follow your passion,” and though he says they leave the conversation perplexed, due to its lack of clear direction, he feels strongly that it’s advice that has served him well.

	 	By following his passion, Boone now serves as VP and head of the Global Real-World Evidence Center of Excellence at Pfizer. It’s a position that fittingly pulls together all of his previous experiences, and maybe most interestingly, it is a job that didn’t exist five years ago-a testament to the changing landscape of the pharmaceutical industry. 

	“Candidly, there is no structured academic or professional training to prepare for this job,” says Boone, who 

holds a PhD in public affairs from The University of Texas at Dallas; a masters in healthcare administration from The University of Texas at Arlington, a bachelor’s degree in business administration; management information systems from The University of Tulsa; and several executive certificates from Harvard University’s John F. Kennedy School of Government. “One cannot create a standard candidate profile [for this position]. Unfortunately, it’s not like I could identify an existing leader who has mastered this job and suggest, ‘Hey, teach me what you’ve learned in today’s environment so that I may be successful in this role.’” 

	One characteristic that has made Boone successful is his insatiable desire to learn and attempt new endeavors. It’s how he landed as the CEO of the Health Data Consortium, a public-private partnership working with the White House and the US Department of Health and Human Services focused on advancing open health data in the US under the Obama administration. 

	It’s also how Boone would join Avalere Health as a VP spearheading real-world informatics and digital strategies. And, before that, in various health informatics and patient advocate roles at the American Heart Association, Cook Children’s Health Care System, and other Texas-based integrated health systems. 

	While he was always interested in data and technology, Boone didn’t have a true passion for the general application to purposes that did not improve human life. One of his personal drivers for pursuing transformation within healthcare using data and technology was a life-threatening, health-related incident that happened with his mother. Boone says it could have gone much smoother for everyone involved, from the doctors and hospital administrators to his mom and family, if the appropriate health data-sharing technologies were in place. 

	“At the time, I was relatively early in my career and convinced that my destiny was to be a CEO of a hospital system,” he says. “And I was putting all the pieces in place to achieve that vision, such as working on my masters in healthcare administration and being active in many civic organizations. However, it was that moment that I realized that I could do something greater by enabling the healthcare world with informatics and data. I felt like it was my calling and knew we really needed to do something to transform the industry.”

	In each position Boone has held, it has opened his eyes to another perspective or tool that he should pursue to make him more effective. “Honestly, I would love to tell you that I had this master plan for how all of my passions and interests would converge, but I’d be lying-I only wish I had that foresight,” he says. “The only objective I had was to continuously press forward with pursuing my passion, my calling if you will.”  

	Boone knows that to be successful, you do not always need to be the smartest, but you do need to build a team of very smart and talented people and provide them with the tools to succeed in their respective fields. 

	“The key to any great leader is to know thyself, which means recognizing and embracing your own strengths and weaknesses,” he says. “I know that if I have a great team with the appropriate mixture of talents and skill sets, then we can do great things.” 

	Boone credits this perspective to his time playing football growing up, where you are taught to go out on the field with 10 teammates, each with a specific role, responsibility, and skill and to perform collectively to the best of their abilities. Boone also credits his humble beginnings. 

	“I grew up in a relatively poor community in southwest Dallas called Oak Cliff,” he says. “When you have that type of life experience, it tends to manifest itself into a certain level of humility when you are leading people, but it also allows you to better connect with people from all walks of life because you see something in everyone. Clearly, I don’t come from a privileged background, so I don’t see myself as any better than the next person; but I do have the utmost gratitude for the extraordinary opportunities I’ve been blessed to experience, and seek to enable others to accomplish the same.” 

	Boone’s passion for health data doesn’t stop at the office. He is a featured speaker on the topic at a number of different venues and conferences; has an active Twitter account-

-where he shares his knowledge; serves on a number of nonprofit boards supporting the cause; and acts as an adjunct professor of health informatics at the University of Cincinnati. Teaching the next generation of leaders might be one of Boone’s most challenges jobs, given the fast-changing industry. But the fact that he is in a position that was created less than a decade ago, it also makes him the most qualified. 

	“There is definitely a tendency for students to want to jump right into the highly technical aspects of the course,” says Boone. “But the reality is, the digital world is evolving rapidly and getting more and more automated, which means by the time they are out of school, their core technical skills may be obsolete. I try to concentrate on enhancing their critical-thinking and building the necessary soft and technical skills that could be transferrable, such as leading project teams, communicating with non-technical audiences, and actually solving real-world problems using data.” 

Hong Cheng, Head of Research Strategy & Effectiveness, Sanofi

	Imagine being in your early 20s, enrolling at a university in another country where you didn’t know the language and moving there alone. Pretty scary, right? 

	That’s exactly what Hong Cheng did, which eventually led to her current position as the head of research strategy and effectiveness at Sanofi Research and Development in Massachusetts. Surrounded by a family of artists while growing up in China, Cheng’s dad didn’t want her to go into the art industry. Instead, as she tells it, “he wanted me to do something different.” Lucky for both of them, Cheng’s mother worked at a pharmaceutical company and after spending one day shadowing her there as a little kid, Cheng fell in love with science-and the white lab coat, a traditional symbol of a bench scientist.

	Cheng holds a PhD in biochemistry/organic chemistry from the University of Maryland, and conducted her postdoctoral research at Harvard University Medical School. While she says being in a research lab was important to help craft her skills and education, her passion was more about helping people. Cheng wanted a career where she could make, and see, a direct impact. 

	That’s when she entered industry, starting at a small biotech as a scientist. As Cheng moved to larger companies, she also took on more responsibility, including project leadership, and teams-building and management. Meanwhile, she quickly realized that in addition to the science behind the drugs, she wanted to learn the business side of industry. 

	To achieve this, Cheng attended the MIT Sloan School of Management, earning her executive MBA in 2015. Cheng credits this experience as being one of the best educational lessons of her life, and something she encourages others to pursue. “They said, ‘a scientist’s view is very narrow. We see the science, but we don’t see the broader view of the industry,’” recalls Cheng of the time before she started the program. “During orientation, they said, ‘this program is going to transform you.’ I didn’t believe it.” 

	But Cheng admits the instructors did deliver on their promise, noting that because it wasn’t a healthcare-specific MBA program, there were people across all industries in the classes, allowing for more diversified learning. “During the program, I began to realize that one really had to think not just about the science, but how to integrate scientific discovery with the demand of the industry growth.”

	This is why when Cheng mentors younger scientists, she encourages them to understand the business perspective. “It makes you become a better leader, communicator, and drug developer,” says Cheng. “Most people who come talk to me about their career, my advice is that first you need to work diligently to really understand the science and how drug discovery works. Then go and learn the business thinking to help you be able to articulate strategy, drive for efficiency, and be more effective. The majority of the time I see a scientist do a lot of great science, but they don’t know how to communicate effectively to make upper management understand the business impact of what they are doing.”

	Cheng’s passion for building the next generation of scientists and drug discovery strategists stretches across the world. In fact, she played an important role in building Sanofi’s global research organization, establishing the Global Research Leadership Team, and formulating the company’s research strategy. She worked closely with the oncology leadership group in rebuilding Sanofi’s preclinical pipeline in cancer. Cheng also played a key role in strategic planning for Sanofi’s research presence in China.

	When she’s not speaking at a global conference or discovering new drugs, Cheng lends her skills to helping biotech startups with guidance on raising funds, marketing, and articulating their strategy. Cheng is particularly focused on supporting companies run by female CEOs, and serves on a panel of mentors for Springboard, a non-profit organization whose mission is to help women CEOs be successful. 

	It can get a little clichéd, but people often say “follow your passion,” and that’s exactly what Cheng has done when it comes to shaping her career path. “I never imagined I would go to business school,” she says. “I was a hardcore scientist. I never had a goal of becoming a CEO or CFO.” But Cheng’s passion to go outside the box and make a bigger impact led her down a path she never dreamed of. “I have to be passionate and believe in it, if I am going to do something.”   

Kathryn Corzo, VP, R&D Global Project Head, Isatuximab, Sanofi

	It would be easy to attribute Kathryn Corzo’s career path in the biopharma industry to two distinct influencing forces-and leave it at that.

	One was her father, an engineer, who taught Corzo from a young age that there was always a way to solve and fix a problem no matter how complex, which instilled in her a love of science and technology. The other was when a close relative was diagnosed with cancer at  a young age. Corzo was already studying pharmacology at Massachusetts College of Pharmacy and Health Sciences, where she would earn a pharmacy  degree, and had started working at the Dana-Farber Cancer Institute in the experimental therapies 

unit, but the experience of watching a loved one undergo “extremely difficult” treatment ingrained in her a personal mission and focus that continues today: steer efforts in drug development to bring novel and urgently needed therapies to patients with cancer. 

	Both of those examples serve as logical stage-setters for a career in pharma and medicine, but as Corzo’s journey shows, when peeled back to reveal the diverse trajectories and connections along the way, there is usually much more to the story. Those early, defining influences and events all circle back and contribute to what Corzo says is a deeply-rooted purpose to grow and accelerate innovation from the ground up.

	“I love startup opportunities, even in large companies,” says Corzo, who today works for Sanofi as VP and R&D global project head for isatuximab, the company’s late-stage investigational drug for multiple myeloma-a new indication to Sanofi-and lead cancer candidate in its oncology-hematology pipeline.

	Corzo originally joined Sanofi in 2010 as associate VP of global development operations and strategic planning, attracted by the opportunity to get in the door as the Paris-based drugmaker was reinventing its global oncology business, establishing headquarters for a new cancer unit in Cambridge, Mass. Earlier in her career, Corzo was integral to two other starting-point endeavors in big pharma. The first was at Roche in Basel, Switzerland, where she was a market manager for a number of countries and then assumed a business development role during the beginnings of Roche Molecular Systems. Corzo was part of the startup team and contributed to the development and launch of Roche’s genome sequencing tool, the precursor to today’s standard next-generation sequencing technologies. She also managed a portfolio of drugs that included the cancer therapy Neupogen.

	Later, Corzo returned to the US to become a key part of Lilly’s inaugural entry into oncology. Working in what she called a “startup environment,” Corzo played a significant role in the development and commercialization of blockbuster cancer drugs Gemzar and Alimta across several indications, helping to build Lilly’s oncology business in various assignments-from clinical research to medical affairs to sales leadership-over nearly 12 years at the company.

	In between Lilly and Sanofi, Corzo even got a taste of the more traditional startup world, serving a stint as senior director, clinical liaison and medical communication, for epigenetics-focused startup Syndax Pharmaceuticals.

	“I’m not a person who has stuck with a single line of growing my career in a particular function or a particular expertise,” says Corzo, a native of Massachusetts, who grew up in the town of Andover. “What I’m able to bring my team is an agnostic view in the sense that all expertise and perspectives mean something to me. …When you just work in R&D, you’re a bit isolated from what happens commercially-particularly from a market-access perspective.”

	This appreciation of the value chain has guided Corzo at each of her big pharma stops, where she has built multifunctional expert teams in several areas. For example, in her global program head role at Sanofi, she has merged strategies across preclinical, biomarkers, clinical development, biostatistics, regulatory affairs, biologics CMC (chemistry, manufacturing, and controls), commercial, market access, medical affairs, and other functions such as digital. 

	Over the course of her career, Corzo’s ability to manage complex programs in varied and dispersed markets was vital in the development and launch of four major cancer therapy brands. She hopes isatuximab will be the fifth. Corzo has shepherded the advancement of isatuximab, a monoclonal antibody, from pre-proof of concept to a clinical program that now includes four pivotal Phase III trials, the first of which was completed recently evaluating the drug in combination with other cancer agents. Isatuximab has been given orphan-drug designation in the US and European Union for patients with relapsed/refractory multiple myeloma. A regulatory filing is possible in the next six months, according to Corzo.

	“In a way, it’s like a mini-CEO role,” she says of the project head responsibility at Sanofi, where, in the case of isatuximab, Corzo directs program execution across more than 50 countries. “I feel very accountable for the significant investment that we’ve made in this asset, and also making sure as we develop the asset, that patients around the globe will have access to it.”

	In positioning isatuximab as such, should it win approval, Corzo credits her team’s commitment-having overcome “major challenges” to get to this point-and what she calls Sanofi’s unique “project-centric culture.” She’s glad as well, she says, for the supportive vision of Sanofi’s new R&D head John Reed, who joined the company in July after five years at Roche. “Our team was one of the first [at Sanofi] to have a patient advocate participate on the project team to provide insights,” says Corzo. “And we brought our commercial and market-access colleagues in early on in the project, right after proof of concept, so that we could work those into the development strategy. I believe that good drug developers are not just those that have clinical insight.”      

	Corzo also stresses the importance of industry-academia collaboration. In the leaner stages of isatuximab testing, she helped establish an agreement with the University of California, San Francisco (UCSF), which performed preclinical, translational, and clinical work-generating insights that ultimately led to one of isatuximab’s Phase III studies. Corzo and her team have formed other research partnerships to assess combination therapies or biomarkers, including with the International Myeloma Foundation.

	“The future is around collaboration,” says Corzo, also pointing to the need for greater relationships with regulators and health insurers. “Because patients are waiting. Patients are waiting for new therapies and new innovation.”

	Internal initiatives within pharma can impact this effort as well. Corzo was recently selected as one of 40 executives across various disciplines and cultures in Sanofi to participate in the company’s new innovation group, called Ignite. The leaders are connected with the global innovation accelerator ecosystem  inside and outside the organization. Corzo, who fondly remarks of “the number of mentors that have helped guide my career and were willing to take a bet on me,” now mentors female entrepreneurs through programs at MIT and the Springboard platform. And with her sights on opportunities to assume greater business responsibility in new drug  development and boost her analytical skills, Corzo is currently enrolled in the Executive MBA program at MIT Sloan School of Management, with graduation next June.   

	It seems the married mother of one, a daughter starting college, is following her own advice to new professionals entering pharma, perhaps inspired to pursue a similar leadership track that she did.

	“Be bold, take career risks, and don’t be afraid of diversification,” says Corzo, an avid marathon runner, who has participated in races on all seven continents. “It’s important for a leader to recognize progress, whether it’s success or failure. Because, either way, we are advancing scientific progress and we are one step closer to helping patients who need our commitment to developing new therapies.”

Greg Griesemer, SVP, HR and Communications, G&W Laboratories

	"Are you good with people, have no marketable skills, and want to make a lot of money?”

	Those were the exact words in a newspaper ad that Greg Griesemer answered after graduating college-Franklin & Marshall with a pre-law degree. Already accepted to law school, Griesemer made the choice to forgo that route and instead pursue the opening with a staffing recruitment agency, much to the delight of his parents. 

	“They were really psyched at that time, recalls Griesemer, 43, with a laugh. “After a private college education, deciding to go into a commission-based sales role-they didn’t see the return on investment.”

	But little could anyone predict then, Griesemer’s early experience as a headhunter (he got the job) would be

 a springboard to an expansive and difference-making career in talent and HR leadership in the pharmaceutical and healthcare industries, with the Pennsylvania native looking back on those years as critical in shaping his professional identity.  

	“I answered that crazy ad, and when I sat down for the interview, the gentleman across from me said, ‘I’m not going to teach you how to recruit. I’m going to teach you long-term consultative selling, where the relationship is at the center of everything that you do,” says Griesemer. “That is a foundational item for me that still carries through to today.”

	Griesemer is currently senior VP of HR and communications at G&W Laboratories, a company specializing in the development, manufacturing, and sales of generic pharmaceutical products, including topical creams, ointments, lotions, suppositories, oral liquids, and oral solids across a number of therapeutic areas. His pivot to pharma began in 2002, when Johnson & Johnson, then looking to beef up its staffing group supporting the New Jersey operations, hired him into their central talent identification team, liking Griesemer’s recent background at the time recruiting for engineering and operations positions in pharma and medical device. After almost seven years at J&J, including promotions into a variety of recruiting leadership roles and ultimately to director of the company’s global recruiting operations, Griesemer went on to Endo Pharmaceuticals as senior director of talent acquisition and HR operations. 

	He then segued to the broader healthcare world, joining insurance giant Cigna as talent director, and followed that with a stint in the diagnostics space with Ortho Clinical Diagnostics, before landing back in pharma. At each strategic stop, Griesemer says he’s held firm to the principle of “paying it forward”-not just for the next person that would step into his position, but in building strong and lasting networks and connections along the way.

	“One lesson I learned from my father, is always leave things better than you found them, especially before you give it to someone,” says Griesemer, whose father was a factory worker for 35 years. “I remember when I was 10 or so, I saw him out back washing and detailing the car he just sold. That really stuck with me all these years. I’ve had the benefit of being able to experience different organizations, and I’d like to think that I’ve applied that value as I’ve moved from one to the other.”

	Several company-scale examples offer proof. At J&J, Griesemer was part of the core team that led the evolution of its consolidated staffing arm from a 35-person team in 2002 focused on hiring for the NJ-based operating companies, to a centralized, global function of over 200 employees hiring across 18 countries by the time he left in 2009. At Endo, he was a key HR contributor during a fundamental shift in the company’s business strategy, which was moving from pure-play pain management to a holistic pelvic healthcare focus. Griesemer joined Ortho Clinical Diagnostics shortly after The Carlyle Group acquired it from J&J in 2014, directing the staffing of critical functions needed for the business to operate as a stand-alone entity. He developed hiring, talent management, and diversity and inclusion strategies-helping shape the company for a future sale or IPO. 

	Griesemer joined G&W Labs in August 2016 and quickly rebuilt the company’s HR function-from people and policy to process and systems-over the course of nine months. The HR infrastructure at the time was admittedly broken, having never been harmonized as G&W diversified its portfolio with acquisitions from Teva and Actavis in the prior years. 

	“We got lean very quickly in HR,” says Griesemer, who works out of G&W’s headquarters in South Plainfield, NJ. The company of roughly 750 people also has locations in Pennsylvania and North Carolina. “[But] I’ve always led small but powerful teams to get a lot done in a short period of time. I’d rather have a Navy SEAL Team Six than a battalion.”

	A nimbler structure and approach may be more effective in today’s larger business climate for generics, an industry “under assault,” according to Griesemer. Generic drugmakers in the US have had to navigate headwinds such as pricing pressure, consolidation of competitors and customers, and a more competitive market due to FDA approving a record number of new generics. "As part of the HR leadership team, regardless of the role you play, you have to be a businessperson first, HR person second,” says Griesemer, who, in 2013, completed the HR Strategy Program at Cornell University. “You need to have a broader view of the ‘HR system’ that you think will work well with the environment that you’re in.”

	With a framework in place, it then becomes a matter of enabling employees to more comfortably embrace shifts in the industry and business, says Griesemer. “It’s our job as the HR function to engage them in a way that they’re enrolled in the change that they’re experiencing, not just passive receivers.” 

	Griesemer, a single father to two daughters, age 7 and 9, believes good HR leaders and teams, in any industry, during periods of what he terms “deconstruction” on the macro level and internally, are those that recognize what motivates their employees inside and outside the company, and understand the “whole-person” picture in the context of ownership and accountability in employee development.      

	“That allows people to bring their full selves to work and emotionally feel good, even if they’re in a time in the industry or a company that’s not overly positive,” says Griesemer. “I do think there is a fine line with HR-driven initiatives from the center. I’d rather figure out how to continually equip managers to drive the engagement at their team level-and focus on how people are feeling.”

	Griesemer also points to the importance of employees self-managing the experiences needed to develop as roles and responsibilities evolve. That could include things like forming a “personal board of directors,” if you will, where Griesemer encourages employees to seek out diverse viewpoints and insight from advocates, mentors, colleagues, etc.-especially those with different opinions and life experiences. 

	In Griesemer’s line of work, it ultimately comes down to the human element. And that goes for those who manage the process as well. For Griesemer, he cites the always well-timed guidance from his mother and others in giving him perspective as he embarked on his latest challenge. “She would say, ‘you need to pull the bow back to shoot the arrow forward.’” A tinge of schmaltz, yes, but Griesemer believes those simple moments of wisdom have reflected in the career decisions he’s made to this point, including G&W, which next year celebrates its 100th anniversary as a values-based, privately-held, family-owned and operated company.

	“I really feel like I’m where I need to be and in the chair I need to be in,” he says. “I’d like to continue to help organizations through the pains associated with growth and change.”

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Pharm Exec’s 11th annual list of rising leaders highlights 10 pharma managers who are poised to help chart the industry’s path forward. 


Pharm Exec's Emerging Pharma Leaders 2018

A growing range of MBAs with concentrations in pharmaceuticals and healthcare management are on offer in university curriculum from coast to coast. Pharm Execlooks at how three of the top programs in the US prepare their students for industry success

Pharm Exec, pharma business consultant and MBA tutor John Ansell noted that the previous decade had seen “a marked increase in the variety of specialist pharma MBA courses on offer.” Among these was a proliferation of online and mini-MBAs, but also an increasing number of full-time, “traditional” programs that offered varying degrees of focus on pharma and healthcare issues. Four years on, as these programs continue to grow in number across the US (and the world), potential students who are lucky enough not to be too restricted by cost, location, and/or ability may find choosing the right one a tricky prospect. 

	Websites such as find-mba.com and MBA Crystal Ball help to make the selection easier. Find-mba this year highlighted six US institutions in its global “Top Business Schools for Healthcare/Pharma/Biotech 2018”-including Rutgers Business School (New Jersey), Vanderbilt University’s Owen Graduate School of Management (Nashville, TN); and Case Western Reserve University’s Weatherhead School of Management (Cleveland, OH)-while MBA Crystal Ball listed 21 schools in its “Best MBA Programs for Healthcare 2017,” which span the country from UCLA’s Anderson School of Management to Cornell University’s Johnson School of Business. As helpful as they are, such rankings require some further investigation, as each school’s pharma/healthcare offering can vary from fully specialized MBA programs to a series of elective courses. For example, where Boston University’s Questrom School of Business offers a specialized Health Sector MBA, UCLA Anderson students choose to specialize in healthcare through elective courses in their second year. 

spoke to program leaders from three of the top universities offering MBAs with pharma/healthcare concentrations to outline the structure of their courses and to consider the question that may challenge pharma-oriented students as they pursue the MBA path-that is, to specialize or not to specialize?

Saint Joseph’s University (Philadelphia, PA)

	Saint Joseph’s University (SJU) developed a Pharmaceutical Marketing MBA track as far back as 1991. Its current AACSB-accredited Pharmaceutical & Healthcare Marketing MBA requires the completion of 24 two-credit courses for a total of 48 credits. Core business courses-“designed to ensure that all students in the program have that common body of knowledge necessary for advanced study in business”-include Product Management, Pricing, Supply Chain Management, Pharmacoeconomics, and Global Corporate Strategy (with students traveling to Ireland in July 2019). The electives include Pharmaceutical Strategy, Creating Effective R&D, and Health Policy.

	Key to the SJU model is flexibility; it offers online and in-person (weekend) program delivery to meet the needs of working, adult students. As such, students tend to have a wide range of experience. 

	“On average, our students have 11 years of pharma and healthcare industry experience, which takes them typically into a manager or director role,” says Terese Waldron, director, Executive MBA and Industry-Focused MBA programs at SJU. “But we are also seeing students that are in their late forties and fifties coming back to school, looking for a second or third act. Students can take up to five years to complete their program if they need to. They can opt out of the program for a year if they’re on maternity leave, for example. There are nuances related to our flexibility that I think are missing from other models and other competitors.”

	The SJU program also differs from most of its MBA competitors in its heavier focus on pharma and healthcare-around 50% of the class work. As the SJU literature maintains, “it’s not just an MBA with a concentration-it’s a program designed for professionals with established careers in sectors such as pharmaceuticals, biotech, medical device, diagnostics, and healthcare.” Waldron adds that “our accounting faculty, our finance faculty, and our management faculty all teach their courses through the lens of the pharmaceutical and healthcare industry. So, there’s a great deal of focus and less distraction in the classroom. The content is truly relatable and actionable for many students seeking some early ROI. The value that the students can get in the classroom can be applied as soon as they go back to work on Monday morning.”

	Rutgers Business School (Newark, New Brunswick, NJ)

	Rutgers’ Pharmaceutical Management MBA program was launched in 2000, instigated by a Novartis seminar in the late 1990s that highlighted the concern that the MBAs the industry was recruiting still needed further training in pharma and healthcare. Given New Jersey’s position as “the Mecca of the US pharmaceutical industry,” it was suggested that NJ-based Rutgers develop a suitable program. “We didn’t know at first how long the program would last,” says Mahmud Hassan, PhD, the program’s director, “but quickly we were amazed with the quality of the applicants.” 

	With industry assistance, Rutgers developed a curriculum with six pharma-specific courses: US Healthcare System and Managed Markets, Legal & Ethical Issues of the Pharmaceutical Industry, Pharmaceutical Industry Structure & Dynamics, Pharmaceutical Marketing Research, Pharmaceutical Product Management, and Managing the Pharmaceutical Sales Force. (A course in market access was later added to the curriculum.)

	The Rutgers program can be pursued on either a full- or part-time basis, requiring 60 hours of course work to complete the MBA degree, including 18 hours focused on pharmaceutical management. While the course does not admit anyone with less than three years full-time work experience, “that experience can be in any industry: IT, consulting, finance, marketing, pharmacy,” says Hassan. “But it’s important to have real-world experience.” 

	The average age of Rutgers’ pharma MBA students is around 29. Students in the full-time program are given paid summer internship placements at the end of the first year. “There is a big demand for the intern positions,” says Hassan. “Most of the students come back to start the second year of the program with a full-time job offer.”

	As well as offering courses taught by “high-ranking and highly qualified pharma personnel who are either retired or still active in the industry,” Rutgers sponsoring companies, such as Bristol-Myers Squibb, Johnson & Johnson, Bayer, and Novartis, invite the students to their sites once a month to keep them informed about the current environment. “The students that come out of our program do not need further training or orientation in pharma - they are ready to go,” says Hassan.

	Columbia’s renowned MBA program offers electives in Healthcare and Pharmaceutical Management (HPM), which include Innovation in Global Healthcare, Healthcare IT Principles and Opportunities, and Pharmaceutical Drug Commercialization. The school does not offer a specialized healthcare MBA track, but is a general MBA program “that gives students options to take as many or as few courses as they want concerning healthcare,” says Professor Linda Green, HPM faculty director. “There’s a whole slew of things that students can take advantage of to tailor their experience at the school to their specific interests. We’re extraordinarily flexible in that regard.” 

	The HPM track offers extra-curricular activities such as lunch and learns and an annual healthcare conference. Columbia’s guest speakers comprise a “Who’s Who of industry leaders,” says Green, including CEOs of major companies, major hospitals, and government representatives. “We also have a very active alumni group, so there’s a tremendous amount of interaction and networking with industry.”

	Students on the Columbia HPM track are encouraged to take advantage of the healthcare courses taught at other Columbia schools that may enhance their knowledge of the field. MBA students may count a combined maximum of 6-credits of graduate-level courses from other Columbia Schools toward the MBA degree. 

	There is no shortage of applicants for Columbia-Green notes that it is “really hard to get into the school.” Generally, Columbia students have been out of their undergraduate degrees for four to five years and all have some career background. Almost all the students do an internship, and, as for subsequently finding a job, Columbia “has one of the best employment records of any school.”

	While MBA programs such as the ones outlined are noted for the quality of their pharma and healthcare concentrations, potential students and employers may question how much concentration is necessary. Scores of past and present executives have led pharma and biotech firms with a “traditional” MBA under their belt. 

	Columbia’s Green says, “Our feeling at the school is that an MBA is supposed to be a generalist degree to prepare you for the world of business. A specialized MBA that takes away some of the flexibility compromises this idea. Anything you teach that’s very specific to an industry right now is likely to be outdated very rapidly.” It’s much more important, says Green, to prepare students “with general perspectives and tools and frameworks for understanding the world of business.” Also, she notes, students can “start off on one path and generally wind up somewhere else; I think very few people really know with any certainty where they are going to be or will want to be in five years”. The Columbia MBA, she adds, “prepares students for the long run, both while they’re within our full-time program and also as alums.”

	While he notes that, on the Rutgers program, students “from a science background tend to do better,” Hassan also says that employers in the industry “do not really emphasize the need for pharma experience.” More important, he says “are original, clear thinking and good leadership qualities. You need to be able to combine skills in finance, supply chain, economics, accounting, and business all in one.”

, however, John Ansell noted that “[a]lthough some issues the pharma industry faces are no different to those applying to any other, many are. With time at a premium, a specialist pharma course can cut more quickly to the chase, addressing topics of most relevance to pharma participants”. Waldron says that for people who choose to stay in the pharma industry, “there’s no substitution for the model that SJU offers.” SJU data points to up to 80% of its students being promoted before they even graduate. “That is unheard of in most industry standards,’” she says. “We believe that it’s the program concentration that gives them that differential.” The SJU model also continues to evolve to reflect the ongoing transition of the pharma and healthcare sectors. “We have an integrated approach, which creates a greater value and understanding of the entire healthcare space,” Waldron says. 

	This broad approach means that, for students wishing to make a career change down the line, the SJU MBA “can take them anywhere.” Waldron adds: “Pharma is still one of the most respected industries in the world and it has given business some of its best practices. It’s no shortcoming to make that selection and then make a career change later on. It’s about equipping a student to be more holistic in their approach to a particular industry, and that’s a transferable skill.”

	Whether a student opts for a specialist or a more traditional MBA, Green reminds us that “the value of the MBA very much depends on the school and its reputation in general.” That so many of the US’s top schools are featuring pharma and healthcare tracks in their long-established MBA programs is certainly a positive development for the industry. It also underlines M. Filtz’s comment that the business of healthcare “meshes with [the] millennial worldview, which tends to be entrepreneurial and strongly idealistic”.[i] While many of the graduates of these programs are still a little too young to have reached the very top positions in the industry, we can surely expect to see them making a difference-both entrepreneurially and idealistically-in the years to come.

[i] M. Filtz, “How MBA programs can help students tap into a wide range of roles in both big and small pharma firms”, find-mba-com (August 20, 2013). Accessed September 20, 2018.

s European and Online Editor. He can be reached at julian.upton@ubm.com 

A growing range of MBAs with concentrations in pharmaceuticals and healthcare management are on offer. Pharm Exec look at how three of the top programs in the US prepare their students for industry success.

Choosing the Right Track: Pharma & Healthcare MBAs

	As usual, in the world of apps and such, I’m a day late and a dollar short. I do not like the navigation system in my car, so I use Google Maps on my phone to get where I need to go. It doesn’t send me on crazy routes and I can choose to take alternates in case of traffic. But in just one week, I heard about the Waze app quite a few times. At first, I thought we were talking about Shazam, which is how you find out the name of the song by holding your app to the source of the music. But no. Waze is GPS navigation that is crowdsourced to

 include “live” navigation. Avoid a pothole? Check. Cop ahead? Check. Re-routing around a parade? Check. It’s GPS on steroids, which Google bought in 2013. Check. 

	It used to be in the job market, you could pretty much rely on the tried-and-true methods to navigate your way to a good job or profession. Go to college, get a degree, start into an entry-level job and then move your way up. Eventually, another degree would put you in the running for a better position in the same company or for a closely-related company that would scoop you up. 

	But the current roadmap for a career is not so direct. There are generational gaps on what people can expect will happen to them. Currently, the average number of jobs held by baby boomers is 12. For millennials, that number is already at three to four jobs, and they haven’t even tapped out yet. 

	In the pharmaceutical industry, we can see more clearly than ever in this year’s annual Emerging Pharma Leaders issue that there is no hard and fast direct route for getting ahead either. This year features more titles that didn’t exist five years ago, more diverse paths these professionals took to get to their current position, and a bit more awareness and positive reflection on the skills and attitudes that got them where they are today. 

	Let’s plug that into our Waze for Jobs in Pharma app. This is what it would pop up:

		Curious About Commercial (or another part of the business)

	A key for Waze to function optimally is to thumbs up or thumbs down the information that appears on your screen. While, personally, I find that distracting when you are driving, if you don’t agree or disagree that you did see the pothole, police officer, or parade, then the information you pass along to the next person is going to be that much less accurate. 

 knows they didn’t have a Waze to get where they are. But, philosophically, they abide by the idea that sharing information and imparting advice will make those behind them that much more aware. Many EPLs teach, mentor, and give back to others. The following are just a few words of advice from our EPLs for those on the pharma journey:

“I try to concentrate on enhancing their critical-thinking and building the necessary soft and technical skills that could be transferrable, such as leading project teams, communicating with non-technical audiences…”

“Be bold, take career risks, and don’t be afraid of diversification…”

“...seek out diverse viewpoints and insight from advocates, mentors, colleagues, etc.-especially those with different opinions and life experiences.”

“...all of us are better than any one of us.”

From the Editor

As this year's installment of our Emerging Pharma Leaders shows, the current roadmap for a career in biopharma requires its own "Waze"-like navigation.

Getting Where You Need to Go

	Vienna’s tradition as a powerful European hub lives on: just like 150 years ago, when the city hosted a breakthrough meeting on the emerging technologies of 1868, it is aiming to do the same in 2018. Back then, it was the crucial International Telegraph Conference that established common regulations for international service. Right now, in the face of rapidly developing healthcare innovation, it was the location for a string of meetings intended to bring a new sense of order to the regulation of medicines. 

	Early in September, Austria, the current president in office of the European Union’s health council, brought to its elegant capital dozens of ministers, senior officials, and diplomats from across the continent for an ambitious and broad-ranging two-day review of norms, ranging from paying for innovative medicines to making a success of digital health. And as the month moved toward its end, Vienna again welcomed further batteries of officials in a bid to get some real action out of all the talking it generated.

	The health council meeting took as its starting point the growing challenges of assuring access to innovative medicines-the focus of ministerial concern since the Italian presidency in 2014, supported in recent years also by the UN High Level Panel on Access to Medicines, the World Health Organization (WHO) Fair Pricing Forum, an Organization for Economic Co-operation and Development (OECD) Health Ministerial last year, and the European Commission’s own expert panel on investing in health. And the tone of the Austrian presidency’s attentions was evident from its formal invitation, with frequent references to “a significant increase in spending for high-priced medicines,” to “growing pressure to sustainably maintain the high quality of care in Europe,” to “differences between member states” in availability of innovative medicines, and “evidence … that many newly authorized drugs do not provide any (additional) patient-relevant benefit.”

	To tackle these challenges, it is “necessary to adopt a more specific approach in the general debate,” according to the presidency. Its declared goal is “to identify and implement relevant and concrete measures.”

	One such area where these “concrete measures” may be introduced, according to the presidency, is in doing something about the “often unstructured” exchange of information between approval authorities and payers, 

leaving the organizations that have to pay for medicines suffering an information deficit and uncertainties over upcoming costs. 

	Another difficulty identified by Austria is “the fact that there is no mechanism to disclose pricing models or the level of research and development expenditures”-subjects where information is “often hampered by confidentiality clauses.” Access to information on public money spent on the development of a medicine would make it possible to use the public contribution as an argument in pricing negotiations, it says. 

	Elsewhere, the presidency highlights criticisms about inadequate levels of evidence to demonstrate patient benefit, studies suggesting limited value in newly authorized drugs, and weak criteria for pricing and reimbursement decisions. Expanding the evidence criteria for approving new medicines could ensure that additional patient-relevant outcomes are measured in the approval process, it suggests.

	The presidency focused particular attention on questions of wide availability of new medicines. “Despite the fact that the vast majority of innovative medicines are centrally approved, there are strong timing differences in the availability of new medicines between the EU member states,” it says. “Significantly deferred” market launches in some member states average up to two years after the granting of authorization, it complains. In other words, the current EU rules do not provide adequate supply requirements for the whole EU market. One recommendation the presidency makes is for a stricter interpretation of the existing rules so that manufacturers would risk losing their authorization if a new medicine was not widely marketed. This, it says, “could provide an additional incentive to speed up the market launch of authorized medicines in Europe.”

	What are seen as malfunctions of the EU’s incentive schemes for drug research also come under the Austrian spotlight. It homes in on the lack of control on some manufacturers’ use of the orphan drug scheme to gain unjustified advantage from it. One of the targets is “the fact that it is possible to extend therapeutic applications for active substances with orphan designation at any time without a new authorization procedure.” The active substance may be used for a much larger patient population than originally indicated in the application for orphan status, and the revenues generated cast doubts on the eligibility of such products for favorable financial treatment, in the presidency’s view.

	On digital health, the Austrian concern is that Europe is still far away from exchanging data across all areas of their health systems, and insufficient use of the potential benefits is being made. Barriers to interoperability in standards, formats, compatibility, reliability, or accessibility have not been overcome. As a result, the objectives for optimizing care and research will remain unattainable, it warns.

	In addition, Austria is continuing to work toward agreement on the proposed-and highly contentious-new rules for coordinated health technology assessment, and to promote the adoption of a recommendation on strengthened cooperation against vaccine-preventable diseases.

	To push forward this ambitious agenda, Austria recalled senior EU officials to Vienna for several working sessions in late September. A meeting of national directors responsible in each of the member states for drug policy started by exploring how to improve the availability of medicinal products-and included discussions on incentives in the pharmaceutical system, and “a strategic discussion on the importance of the pharmaceutical policy for current political debates.” The problem of access in specific European markets featured prominently, with particular attention to the supply obligations, following up on the informal council meeting.

	This was followed by a session with the broad title of “Matching Health Needs and Pharmaceutical Research-How to Set the Research Agenda for Public Health.” The costs of R&D of pharmaceuticals are often co-financed by public funds, but because public health authorities have insufficient knowledge of the global structure of companies’ R&D funding, they cannot actively steer research toward unmet medical needs, said the presidency. So it wants to create a platform to improve exchange between national health and research administrations, universities, funds, and international organizations. 

	There were also meetings in Vienna of a cooperation mechanism among European medicines agencies on legal and legislative issues, the coordination group of national medicines agencies for mutual recognition and decentralized drug authorization procedures, the Network of Competent Authorities on Pricing and Reimbursement, and “learning meetings” of the EMA’s Pharmacovigilance Risk Assessment Committee, its Pediatric Committee, and its Committee for Medicinal Products for Human Use. 

	How much will all this achieve-above all in the three months that now remain until Austria hands its presidency over to Slovakia? Closer cooperation among national authorities on information relating to pricing and reimbursement is already underway in pockets of Europe, but has yet to translate into any impact on decision-making, because negotiations on each product remain a national matter between government and manufacturer, cloaked under deep secrecy over the terms-and neither side at present seems ready or able to break that tradition. Methods for evaluating new drugs are in constant evolution, but any change in the rules would require legislation-and that would, in turn, depend on a consensus on approach that does not at present exist. Similarly, tightening marketing obligations so companies have to launch their drugs everywhere in Europe looks at present a non-starter: the most recent official EU pronouncements have been very negative about the concept. 

	The review of incentives is a live issue that is already in progress, but is unlikely to result in much more than tweaks to the current system. And on digital health, any movement there depends more on national engagement than on any edict from the EU level. 

Reflector is Pharmaceutical Executive’s correspondent in Brussels

Columns

What will come out of Austria’s shakeup of European pharma rules?

Vienna’s Vision on Health Regulation in Europe

	 If you think about the stereotypical big-city internship, the image of a college-aged student fetching coffee may come to mind. 

	But that was definitely not the case for Armand Avetisian, who spent the summer of 2018 as a business development intern at EpiVax Oncology in New York City, where he worked side-by-side with the company’s CEO and Co-Founder, Gad Berdugo.

	“It was a very unique experience working directly with the CEO on strategic direction,” says Avetisian, who is pursuing his master’s degree in biomedical engineering at Columbia University, where he’s slated to graduate in December. “I learned a lot about the business side of things, which is what I needed to work on. ... I would hear 

stories from my friends that have supervisors a year or two older than them and here I am sitting next to the CEO. It really helped take me to the next level.”

	Avetisian’s internship was made possible by the New York City Economic Development Corporation’s (NYCEDC) LifeSci NYC Internship program. The program is a core component of NYCEDC’s $500 million, 10-year LifeSci NYC initiative to accelerate growth of the life sciences industry and to create 16,000 new, good-paying jobs. The goal is to attract and prepare a diverse range of NYC students for careers in the life sciences sector and to ensure that it has a wealth of talent to fill the industry demand for high-quality jobs.

	It was the first official year for the program after running a successful pilot internship in 2017. Host companies ranged from early-stage startups to large pharmaceutical and biotech organizations, as well as other companies such as advertising agencies and public relations firms that serve the life sciences community. 

	Doug Thiede, senior vice president of life sciences and healthcare at NYCEDC, explains that as the internship program evolves, it will create a community within the NYC life sciences ecosystem that will build on the previous year’s progress and experience. 

	To help drive this evolution,  NYCEDC held various business-type events prior, during, and after the internship program for participants to come together for networking and learning.  

	“We hope that when they come out of school, they go back to work at an organization in the New York City life sciences,” says Thiede. “It is really a building block for the future.”

	The program is a win-win for the companies and interns involved, organizers believe. For Avetisian, who previously focused on the research side of the industry, it wasn’t just about helping make his skill set more well-rounded in today’s environment, but it also diversified his career options. 

	“It opened my eyes up to a ton of different career paths,” says the born-and-bred New Yorker. “I can stick with more research or go into everything from business development to venture capital and investing. This opportunity gave me a great skill set that I can use to launch my career.”

	For the companies, particularly those such as EpiVax, which recently opened offices in NYC, the program allows them to explore the local resources.

	“I was sent at least a dozen strong resumes,” says Berdugo, whose company is developing precision cancer immunotherapies based on mutanome-directed neo-epitopes. “The talent pool was really impressive.”

	Interns can sometimes get a bad rap with upper management, but Berdugo encourages C-suite executives to work with younger, aspiring leaders, describing Avetisian as a quick learner, good communicator, intelligent, and having a positive attitude, all of which is essential when working in a start-up environment. 

	“He knows he has a job offer when he graduates Columbia,” says Berdugo. “The door is always open.”

’s Senior Editor. She can be reached at 

New life sciences internship program has high-level mission. 

Crash Course in Strategy

Issue PDF

Click the title above to open the Pharmaceutical October 2018 issue in an interactive PDF format.

Pharmaceutical Executive, October 2018 Issue (PDF)

	The critical need for new medicines to combat infectious diseases that fail to respond to current medical treatment is prompting FDA to join with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in this area. A main problem is that current payment and coverage policies for new drugs encourage widespread use of the

 product to generate a sufficient return on investment to companies sponsoring research on new treatments. But to remain effective against lethal pathogens, new antimicrobials need to be used very sparingly, cutting revenues in the process.

	These financial obstacles have curbed industry investment in developing new antimicrobials. The Pew Charitable Trusts reports that as of June only 

42 new antibiotics were in clinical development to treat serious bacterial infections

. Just one in five, moreover, are likely to succeed, and only a handful have potential to address serious resistance problems, such as  gram-negative bacteria, which cause particularly hard-to-treat infections.

	To address this crisis, FDA commissioner Scott Gottlieb recently unveiled a 2019 Strategic Approach for Combatting AMR (antimicrobial resistance) at a meeting last month organized by Pew. The plan includes policies and programs to encourage development of new drugs, diagnostic tests and vaccines; to promote responsible stewardship of antimicrobials in animals and humans; to improve surveillance of antimicrobial use and resistance; and to advance research for developing new tools, standards and policies in this area.

	Key to spurring innovation in this field is to devise new reimbursement strategies to support the development of products that would be prescribed and used on a highly limited basis. In a 

, and again at the Pew conference, Gottlieb 

 for devising innovative milestone payments and subscription fees for developers of products targeted at multi-drug resistant organisms.

	To maintain a robust pipeline for antibiotics, Gottlieb recognized the need to “change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains.” One proposal is a subscription-based model that charges hospitals a flat rate or licensing fee for access to a certain number of doses each year of a new antimicrobial. By creating a predictable revenue stream, this kind of “pull incentive,” Gottlieb explained, would “create natural markets for drugs targeted to rare but dangerous, multi-drug resistant pathogens that can threaten human health.”  

	FDA is working on pilot programs or demonstrations of such reimbursement strategies with the Centers for Medicare and Medicaid Services (CMS) and other health and research agencies, such as the Gates Foundation, the Center for Medicare and Medicaid Innovation, and the Biomedical Advanced Research and Development Authority (BARDA), along with insurers and payers. These might include add-on payments for new technology, including antibacterials drugs that meet public health needs.

	FDA’s initiative for combatting AMR also includes a new 

 to support antimicrobial stewardship in veterinary settings. A main aim is to curb the use of antibiotics to promote animal growth. Another part of FDA’s plan involves improving surveillance of antibiotic use in humans and animals to track infections more quickly and help determine when antibiotics should be used and then discontinued. This involves refining standards for transmitting data on antimicrobial sales and on-farm product use. Equally important is support for developing 

 diagnostics able to detect disease rapidly, identify appropriate treatment, and track resistance. FDA also seeks to clarify standards for transmitting lab test results related to antimicrobial use and resistance.

	To advance regulatory science in this area, the Office of Antimicrobial Products in the Center for Drug Evaluation and Research (CDER) has requested input from stakeholders on developing an annual list of science initiatives likely to spur development of new antimicrobial products. In June, FDA issued draft guidance to help manufacturers utilize the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) in developing new therapies. The program was authorized by the 21st Century Cures Act, but has been challenging for both sponsors and FDA to implement. The guidance describes how sponsors may seek approval of qualifying treatments for small numbers of seriously ill patients based on data from smaller, shorter or fewer clinical trials.

	In addition, the Center for Biologics Evaluation and Research (CBER) is promoting development of non-traditional alternatives to small molecule drugs, including bacteriophages, live biotherapeutics and fecal microbiota for transplant. CBER also is exploring vaccines to prevent infections caused by microbes resistant to current treatment, which ideally would reduce the risk of infections that require treatment with new antimicrobials.

’s Washington Correspondent. She can be reached at 

The regulator teams with other health agencies on strategies to combat antibiotic resistance, reshape R&D incentive schemes.

FDA Launches Major Push for New Antimicrobials

The need to look beyond the function’s traditional performance measures to the one that really matters-patient outcomes 

	"Between stimulus and response there is a space. In that space is our power to choose our response. In our response lies our growth and our freedom.”

	This quote from Victor Frankl perfectly reflects the mindset of great medical affairs teams in pharmaceutical companies at the moment. The time is now, and it is for the medical affairs function to determine if it wants to have a bright future and be a true partner and a leading value driver.

	For pharma organizations in the past, the commercial function was the only lead in setting and driving the strategy. Medical affairs, in addition to the license-to-operate function, provided mostly on-demand medical information services, as well as support on an 

basis in key external experts’ engagement and internal and external medical education. The key performance indicators (KPIs) and the resulting perceived value were related to these support activities, and were expressed in inconsequential metrics, including but not limited to the number of visits to external experts and the number of evidence-generation activities and publications.

	Innovative specialty and ultra-specialty pharma companies have recently invested heavily in expanding the medical affairs function, due to the complexity of therapeutic areas and medicines, with more and more medical affairs colleagues working in the field, while at the same time improving the quality and impact of those medical teams. They, in essence, are internal experts employed by the company. This dynamic changed the scope and value of medical affairs dramatically. From our perspective, however, the purpose of being (raison d’etre) for medical affairs is to ensure the best patient outcomes via shaping the practice of medicine through evidence generation and scientific exchange activities, and enhancing patient access to the best available treatment by demonstrating its value to payers, physicians, and patients.

	The only way to achieve best patient outcomes for the medical affairs function is a true peer-to-peer partnership with external experts, scientific societies, academic institutions, and research groups, as well as the entire medical community involved in patient care. In order to become a partner, you need to be considered as a peer in a specific therapeutic area.

	But what can make a good pharma medical affairs professional a peer to an external expert, in addition to having in-depth scientific, clinical, and medical knowledge in the relevant therapeutic area and medicine(s)? The answer is an ability to understand patients’ needs, think across therapeutic areas, assess clinical value, analyze risk versus benefit, and exploit technological advances.

	In addition, a sustainable, trustful, and successful partnership is only possible in cases where external experts engage with medical affairs professionals as peers; have confidence in our unbiased data; look to us for our medical expertise and scientific reference; and want to involve us and collaborate in evidence generation, policy shaping, regulatory, and patient access activities, as well as listen to us at scientific forums, because we own the science they value. Medical affairs has a huge ethical responsibility in creating this trusted and sustained partnership. 

	Medical affairs is the only function to systematically provide the physician’s perspective to the drugmaker.

The medical science liaisons (MSLs) bring these insights back into the company, based on a peer-to-peer discussion. By listening carefully to the medical community, the medical strategy will be adapted with the patient outcome as the sole goal. Indeed, the best medical professionals, physicians, and medical professionals of pharma companies alike, always have the patients’ needs at the forefront of their minds and actions. They always see the disease through the patients’ eyes and help the company to transform patients’ needs into their deliverables. This is non-negotiable and medical affairs should proudly represent this point of view.

	In turn, higher investment in headcounts and quality, with a specific focus on external scientific exchange and education activities (by MSLs), the quality of the output, and the greater responsibility regarding evidence generation activities to fill evidence gaps has led to an increased demand from the business to measure the value of medical affairs.

	Many companies developed KPIs, measuring the number of external engagements with targeted experts per quarter, the number of publications in peer-reviewed journals based on evidence-generation activities, and the number of medical education events or advisory boards. These numbers are extremely important for internal

 tracking and benchmarking but do not fully reflect the real value of the leadership role of medical affairs. They, instead, result in a “KPI trap,” where medical affairs produces ever-bigger dashboards that do not reflect the true value, leading to a misunderstanding and a perception of medical affairs as a cost center. 

	That returns us to the pragmatic challenge of the medical affairs function, having to show the value and impact to the business first, and, next, to the patients, physicians, and payers. Relevant value measurements should be related to mainly two deliverables and supplement traditional numerical KPIs.

		Access to our medicines for the right patient at the right time.

		Shaping medical practice based on evidence generated in collaboration with external experts and payers to optimize patient treatment and outcomes.

The need to look beyond the function’s traditional performance measures to the one that really matters-patient outcomes. 

Pharmaceutical Executive-10-01-2018