Setting Goals, Meeting Needs: For Sandra Horning, rooted as a practicing oncologist, researcher, and professor, harnessing the patient experience has been the driving force in a career-spanning and service-focused mission to fight disease and accelerate the delivery of new medicines

	It only takes a second to know that Dr. Sandra Horning is a Midwesterner at heart. Her innocent accent recalls the fact that she grew up in Creston, Iowa. But Horning’s childhood was far from quiet.

	Horning unwittingly learned about medicine at an early age. After experiencing several serious family illnesses, she underwent a couple of unrelated surgeries herself at the age of six. While the situation was scary, Horning hung tough and was able to find a silver lining. Her admiration for her pediatrician, combined with the 

mysterious nature of medical science fostered a lifelong interest in the field.

	“Medicine seemed to me to be a really exquisite blend of science and helping people,” says Horning, named this year’s Woman of the Year by the Healthcare Businesswomen’s Association (HBA). “That was very attractive to me.”

	She also noticed all the doctors were men and all the nurses were women at the time. It was then that she announced she wanted to be a doctor. Instead of feeling threatened, Horning embraced the challenge.

	Just as she was planning to enter medical school at the University of Iowa, Horning was dealt another health blow: This time she received news that her father had terminal cancer. The experience again pushed her forward and fortified her resolve to become a doctor.

	Horning next spent three years in New York completing her internship and residency in internal medicine. From there, she headed to Stanford University for her oncology fellowship, where she remained as a researcher, professor, and practitioner for nearly 30 years.

	“In the school of medicine, you basically do three things,” says Horning. “One is you educate. For me, it was about educating trainees who were already physicians specializing in oncology and in my area of expertise, lymphoma. You do research, and the research I did was clinical research, which means involving patients. And I practiced oncology in a very active clinic, taking care of patients in the hospital as well.”

	Though she spent most of her life in medicine, as a physician, academic, and educator, Horning’s path to pharma wasn’t a traditional one. In fact, she only moved into the industry in the last 10 years.

	“It was a rather late transition compared to many,” she says. “But for me, it was really about the timing being right.”

	Horning’s career experience had prepared her for the move, though, and she was ready to take on a leadership role. She had held several significant leadership positions at Stanford, nationally and internationally, and served as president of the American Society of Clinical Oncology (ASCO) from 2005-2006.

	The combination of her drive to lead and the opportunity-filled field of oncology made Horning feel that the timing was right.

	“I lived through the valley of death in terms of the lack of progress in oncology treatments to emerge in what I would call the golden age of oncology, where the science had developed and ripened to a place where we could really help patients through the development of highly active drugs,” she says. “That was very exciting for me.”

	As a senior investigator in two Phase III trials for the drug Rituxan, which was developed by Genentech and Roche, Horning appreciated the major, positive impact the drug had on her patients and her practice. She was eager to continue and grow that type of work.

	“It was really that experience that compelled me to want to do it again, make more drugs like Rituxan available to patients,” she says.

	While Horning’s personal past wasn’t easy, her professional journey was likewise challenging. She and her female colleagues were often met with resistance as they rose through the ranks. She describes women in medicine at that time as “pioneers.”

	“I feel that I was constantly underestimated in terms of whether I would achieve my dream of being a physician-whether I would or could excel in medical school, residency, or fellowship,” she says. “It was a continuous theme when I got into the academic ranks: whether I would succeed in getting tenure; whether I could secure grants; whether I could be an academic leader; and later, whether I could successfully transition to industry, or be a strong people leader as well as a technical expert.

	“On the other hand, I would say I was also supported, because a few significant champions opened doors for me and made my eventual success possible. And I’m very grateful for that.”

	Horning’s challenges extended beyond just being a woman. She faced questions of credibility, having moved directly from academia into a leadership position in pharma, becoming the global head of oncology 

for Genentech and Roche in late 2009, following a recommendation from a former colleague.

	“I obviously had a steep learning curve and had to navigate that at the same time that I was establishing my leadership,” she says.

	It didn’t help that Horning joined Genentech shortly after the acquisition by Roche. Integrating two cultures with very proud histories was also something to overcome, she says.

	After being head of oncology for four years, Horning was faced with another formidable learning curve when she moved into the chief medical officer role. Leading the 5,000-person global product development organization required her to reach beyond her expertise in oncology and hematology to oversee all therapeutic areas and all aspects of development.

	“What kept me going was my passion for the field of medicine, for patients, for wanting to make a contribution to society, and the purpose I derived from long-ago personal health issues-knowing how these affected my family and me, and wanting to make it better for others,” she says.

	Horning’s strong science background, excellent work ethic, and thirst for knowledge also helped her overcome these obstacles.

	“Science is the core of Genentech and Roche’s business, so Sandra’s impressive clinical science background was a natural fit,” says former colleague Gisela A. Paulsen, MPharm, senior vice president, global head, product development clinical operations at Genentech and Roche. “What made her an exceptional leader was how she paired her intellectual capacity with her innate ability to educate. Because of her experience in academia, Sandra came to Genentech and Roche with the technical knowledge and the ability to teach those around her.”

	During her tenure, Horning’s teams secured approval for 15 new medicines and many more new indications for approved medicines. Two additional therapies are expected to receive FDA approval this year. When it comes to being successful in drug development, Horning says the most important ingredient is having a novel drug that addresses an unmet medical need. “Once you have a great product, it’s really being able to tell the story of the medical value so that it’s widely recognized and clear,” she says.

	Other strategies Horning suggests include:

		Considering access and affordability very early in development and building that story concurrent with the drug’s development.

		Identifying appropriate physician champions, educating them, and partnering with them.

		Having a strong commercial team at the time of the launch.

	“Sandra is one of the brightest persons I know,” says Paulo Fontoura, another former colleague, today senior vice president and global head of development for neuroscience medicines at Genentech and Roche. “The depth of her knowledge about anything is just amazing. She has a true curiosity about things and doesn’t really rest

 until she has the answer-and she doesn’t settle for good enough.”

	Fontoura describes Horning as being “comprehensive” when it came to researching an unfamiliar topic. She wouldn’t just educate herself by reading articles, for example. She also saw the value in interacting with and learning from others.

	“Sandra always made sure to listen to a lot of people,” says Fontoura. “She’d listen to all the experts and ask really deep questions to try and find out as much as possible. She was somebody who was open to feedback and other views, but she would certainly make up her own mind in the end.”

	In 1996, Horning had to face the realities of cancer from a new angle when she was diagnosed with breast cancer.

	“[Given my] experience with my family and all my experience with my patients, as well as my knowledge of oncology, I kind of expected to have cancer at some point in time,” says Horning. “What surprised me is that it occurred so early in life, when I still had children at home.”

	While her knowledge of the field was certainly useful, Horning says it was her patients that really made a 

difference. “Going through cancer treatment while I continued to practice created a very special bond with them,” she says.

	As an oncologist, Horning had witnessed many of her patients undergo a personal epiphany during their treatment, often expressing ways they planned to do things differently in their lives. Horning didn’t feel like she had to change her path, however. For her, it was all about “doubling down.”

	“It did help me to better understand the fear of death, the desire to live,” she says. “One of the first projects that I worked on in my academic career involved the curative treatment of young patients, where I focused on their fertility after treatment and their ability to maintain healthy lives as survivors. Survivorship has been something that has interested me throughout my career. When I was president of ASCO, we set up some of the survivorship programs, and it resonated that I was a survivor myself.”

	The journey helped Horning realize how much life there is to live after survival. “That’s really increased my passion for not only wanting to develop curative treatments for patients, but also to focus on quality of life and survivorship,” she says.

	Horning’s personal background and experience in clinical practice helped her keep patients at the forefront of every decision and prompted her to consider what the right thing for patients was during the drug development process.

	“We had this motto, ‘Patients are waiting,’” she says. “Especially when patients have a really serious or terminal disease, every hour, every day, every week that goes by is important. So we focused a lot on acceleration, how fast we could get medicines developed and launched and in the hands of physicians. We had examples where patients were literally waiting, and we were able to deliver our new medicines within hours of approval.”

	Horning’s responsibility to patients was even evident during moments of failure.

	“Once, when we had a trial that did not work, her first reaction was to say, ‘I’m so sorry, because patients were really counting on this,’” says Fontoura. “What mattered to her was not the scientific success or progression and milestones, it was patients who were waiting for something, and we didn’t manage to give it to them. That really drove home what her value chain was: First of all, the patients.”

	In an effort to streamline the development process, Paulsen recalls one of Horning’s boldest moves: a complete overhaul of the teams that manage molecules through Genentech and Roche’s development lifecycle.

	“She pushed the organization to work in new ways, adopt iterative work processes, and embrace learning over perfection,” says Paulsen. “Her example catalyzed a 5,000-person organization to initiate a series of initiatives aimed at accelerating every aspect of the development process, from protocol writing to clinical trial execution to regulatory filings. The cumulative impact of these efforts has shortened the previous time for development by several months to date, and we are not done yet.”

	As part of Horning’s initiative to bring drugs to market more quickly, she and her team supported the creation of new regulatory pathways, including FDA’s breakthrough designation. Genentech and Roche led the industry with 32 new breakthrough designations across a variety of therapeutic areas in just seven years. They also pioneered a new regulatory endpoint, pathologic complete response, which allows for early approvals in early stage breast cancer.

	“Sandra was among the pioneers cooperating with the FDA on faster ways to develop medicines, with an ethical focus on getting these to patients as quickly as possible,” says Fontoura. “She worked closely with other key drivers for this to happen.”

	Once again, it seems timing played a role in Horning’s success. At the time she approached FDA, there was a growing buzz around oncology. Research on promising new mechanisms was prolific. Regulators also knew patients facing lethal cancers were waiting for more options and didn’t have time to waste. This, perhaps, created an openness to think about new pathways, says Fontoura.

	“I think regulators, pharma, and the community generally saw this as an opportunity,” he says. “This has since opened up [opportunities in] other therapeutic areas, and that is really exciting. It’s one of those things when we look back, that people will say, ‘This was a turning point’ in the regulatory process, when people recognized that the one-size-fits-all ends up not fitting anyone and that you really have to take a different approach.”

	Former colleague Quita Beeler Highsmith, vice president and chief diversity officer at Genentech, sees Horning as a “visionary, mentor, and trailblazer.”

	“I have witnessed firsthand how Sandra can be a game changer for this industry,” says Highsmith. “She has influenced patient outcomes by leading a record number of industry breakthrough therapy designations, has served as the American Society of Clinical Oncology president, and her leadership allowed for Genentech to be a driving force to bring more diverse patients into clinical research.”

	Horning’s sense of service transcends her ability to connect with patients; it has also allowed her to establish herself as a respected leader in the industry.

	“Being an effective leader in today’s environment means having a service mindset,” says Horning. “An effective leader needs to have a vision; be an architect of the strategy and create the environment where molecules and people thrive; build a team of A players; and serve as a coach to focus on the success of others, the organization, and the molecules.”

	In addition to Horning’s scientific excellence and care for patients, Fontoura believes her ability to change has been integral to her success-not just having the courage to change herself but the power to catalyze change in others.

	“She was willing to let go and push others to the forefront,” he says. “When you have such high standards and work ethic, your first instinct is to do it yourself. But she really was able to transform herself and inspire others to do the same. I think she found that secret of great leadership, which is that sometimes when you step back, you create space for others to multiply your impact.”

Horning helped coach and develop many leaders at Genentech and Roche. “In many ways, that’s probably part of her legacy that’s going to outlive her, perhaps even more than the scientific one,” says Fontoura.

	Among those colleagues were a number of women who identified with some of the same professional challenges Horning faced throughout her professional journey and welcomed her example. Horning was now in a position to pay it back and inspire other women in the industry.

	“In the field of science, it is very important to recognize women thought leaders that are making extraordinary breakthroughs to drive science and medicine for the next generation of physicians and patients,” says Beeler Highsmith. “What I admire most about Sandra is her authenticity, her drive to make a meaningful difference for patients, and her role-modeling of what it means to be a bold leader. Plus, she is a style icon.”

	Toward the end of 2019, Horning felt satisfied with what she had accomplished at Genentech and Roche and decided it was time to begin a new chapter of her life. In January, she joined forces with industry visionaries as a co-founder of EQRx, a company committed to making innovative medicines available to the public at lower prices, where she continues to be an advisor. In February, she joined Gilead Sciences and Moderna as a board member.

	“I felt the time was right for me to move into a third act, another area of life where I felt like I could continue to contribute and give back,” she says. “What I want to do is be of service to the management and executive teams of new and established biotechnology companies. I’d like to bring my expertise and leadership experience to assist companies in making great medicines for patients.”

	Though Horning has traveled a long way to get to this point in her career, it’s her sincere and unwavering passion for medicine, which blossomed early in life, that still keeps her going today.

	“One of the most devastating things for me in life was losing my father at a young age,” she says. “Witnessing that loss with its permanent impact on me and my family, and then going on my own journey of illness, followed by the exhilaration of restored health and the ability to live a full life after a serious illness-those are poignant and precious experiences that continue to motivate me today.”

’s Senior Editor. She can be reached at 

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For Sandra Horning, this year's Healthcare Businesswomen’s Association Woman of the Year, harnessing the patient experience has been the driving force in a career-spanning-and service-focused-mission to fight disease and accelerate the delivery of new medicines.

HBA's Woman of the Year 2020: A Motivated Mission

Exploring just how far new industry initiatives and strategies are pushing the needle on diversity and inclusion in pharma 

	 	In the last decade or so, the issue of diversity and inclusion (D&I) has advanced steadily within the life sciences discourse, its growing prominence reflected in the job titles that have emerged at senior levels among the front rank of pharma companies. The industry now boasts heads of diversity & inclusion, chief diversity officers, and corporate leads in D&I, culture, and engagement. To convey the message that D&I is no longer simply regarded as a “nice to have,” or approached as an add-on to existing anti-discriminatory compliance, the industry has boosted its efforts from hiring policies to media campaigns. But the argument persists that pharma is well behind the curve when it comes to realizing its D&I goals, particularly at the senior and board levels, where women remain under-represented (and where people from ethnic and racial minorities remain very under-represented). As this journey toward achieving real balance and representation goes on, 

 spoke to leading D&I exponents from two big pharmas (Novartis and AstraZeneca) and consultants with long experience of recruiting emerging leadership talent to see how far the latest industry initiatives are moving the needle on D&I.	 	“Our inclusion and diversity strategy has been essential in ensuring we keep our collective efforts focused,” Rebekah Martin, SVP, Reward and Inclusion at AstraZeneca, told 

. She reports “significant strides” in the company’s D&I activities, with D&I now established as one of the three pillars of its People strategy, which “has helped us to embed inclusive behavior and leadership throughout the company.” She goes on to outline the recent recognition AZ has received for its D&I efforts. “We were one of 325 companies selected for this year’s Bloomberg Gender-Equality Index, which distinguishes companies committed to transparency in gender reporting and advancing women’s equality,” says Martin. “We earned a 100 on the Human Rights Campaign’s index to designate AstraZeneca one of the 2020 Best Places to Work for LGBTQ Equality. [And] last year’s Hampton-Alexander Review named AZ plc as one of the top 10 best performers in the FTSE 100 for representation of women on the combined executive committee and their direct reports.”

	Over at Novartis, Vice President and US Country Head, Diversity and Inclusion, Marion Brooks says he has seen a lot of progress during his 20-plus years with the company. “The level of focus has definitely grown 

. It is now “a fundamental part of Novartis’ cultural aspirations, as well as its strategic priorities.” The company has established three global strategic imperatives: “diverse people, inclusive environment, and shaping our society,” says Brooks, under which there are six initiatives: gender balance in management; pay equity and transparency; attracting and retaining diverse talent; creating inclusive learning offerings for everyone; LGBTI equity; and strengthening employee resources groups (ERGs).

	The latter, particularly, play a major role in the pursuit of improved D&I. Novartis has over 60 ERGs globally which, according to Brooks, “really help us to support the values and behaviors, as well as the business codes, of our organization.” Before taking his current position, Brooks spent 20 years on the commercial side of Novartis, but during that time he was heavily involved with ERGs, leading one for a number of years. “ERGs help to foster a level of belonging between the organization and its associates and drive our inspired, curious, and unbossed culture,” he explains.

	AstraZeneca has upwards of 15 ERGs worldwide, led by volunteers. They play an important role, says Martin, “in continuing the dialogue throughout the year, keeping our efforts aligned to our business strategy, and providing capabilities to drive forward our inclusion and diversity strategy.” One example is AZ’s SAFE

 SPACE ERG, which has been “hugely successful” in supporting colleagues and improving the dialogue around mental health. Another ERG, which originated from AZ employees, is AZPride. Last year, AZPride ran the “This is Me” campaign, which saw employees sharing their stories of coming out and their experiences as a member or ally of the LGBT+ community. “These powerful stories,” says Martin, “were spread internally and externally through our social media platforms throughout Pride month and provided education and an opportunity to connect across the organization.”

	While these D&I initiatives can be very effective in addressing issues that affect an increasingly diverse workforce, there is something of a first-world sensibility to many of them. Multinational companies like Novartis and AZ are well used to operating sensitively within disparate cultures-this in itself requires diverse and inclusive thinking- but can a western-hatched approach to D&I be meaningfully implemented in every corner of the world?

	Brooks believes so, and says it’s important for Novartis to make a global impact in this way. Over the last decade, he explains, D&I has become more of a global function and a globally aligned strategy at Novartis. “It’s a part of everything that we do, and it should show in our day-to-day actions,” he says. “We have over 108,000 associates and we operate in over 100 countries, so we have a huge opportunity to help to effect change across the globe.” One example is taking a stance on global topics such as equal pay. “Those are opportunities for us 

not only to influence and impact our associates but also to help shape the reality of the individuals in the countries where we operate,” says Brooks.

	Martin asserts that a global approach to D&I is achievable with the “right framework in place.” Last year, AZ launched its Global Inclusion and Diversity Council. Chaired by AZ’s CEO, Pascal Soriot, it “has enabled us to set the tone from the top,” says Martin. The Council includes representatives from each of the senior executive team areas and key geographies, and its “outputs have been really effective as we now have a global approach that is locally relevant.” The company also has a Global Standard for Inclusion and Diversity, “which sets out how we foster an inclusive and diverse workforce where everyone feels valued and respected because of their individual ability and perspective,” adds Brooks.

	Certainly, AZ appears active in promoting its global D&I efforts. In 2018, it held a crowdsourcing event to help shape the next phase of its strategy, with employees across the world contributing to the activity and generating more than 56,000 ideas, according to the company. Last year, for the first time, AZ held eight “Empowerment Summits” across the US, Asia-Pacific, Brazil, Sweden, Poland, and the UK. “While the approach is global, all of the content is curated by local teams to ensure it is relevant and effective,” explains Martin. “They were so successful that we have plans for expansion to other countries this year.”

	Pharma companies’ D&I web pages are filled with inspiring copy, but it can be more sobering to compare the sector’s position on the diversity curve with that of smaller biotechs (and other advanced industries). While the recent BIO report, 

Measuring Diversity in the Biotech Industry

, highlighted areas where the biotechnology sector requires major improvement-for example, 88% of the companies responding to the survey had a white, male CEO and only 16% reported having goals to promote or develop women-it also pointed to an emerging trend whereby startup businesses “are generally better than their larger counterparts at recognizing the value of diversity,” says Chris Coe, executive vice president of Talentmark.

	“In the report, pre-revenue, smaller, and private companies all showed positive outcomes for representation,” he told 

, pointing to findings that show pre-revenue organizations are more likely than profitable organizations to have executive levels that are at least 25% people of color; small businesses are more than twice as likely to have a female CEO, compared with larger companies; and privately held organizations are more than three times as likely to have a person of color as CEO.

	“These results may seem unfairly skewed for big pharma,” adds Coe, but “it can be far easier for fledgling businesses to establish a culture of inclusiveness and attract a more diverse workforce.”

	Katy Wallace, principal consultant in the life sciences practice at Berwick Partners, observes that “the entry points in the smaller businesses are better for more diverse candidates, because they tend to be more able and willing to challenge the status quo-this is a key factor in improving and championing diversity.” She explains:

 “Big pharma is definitely moving in the right direction, but progress is slower than we see in some sectors. Some feel that this redefinition of what leadership looks like hasn’t resonated enough in the larger organizations, but it is more of a challenge in pharma to change quickly as so much of the hiring at grass roots is dependent on education. However, when this barrier of entry is removed, unconscious bias is also removed, people are then weighed and measured more fairly on their skills, which allows for a more diverse candidate pool.”

	As big pharma is cash rich, change is typically driven by a need to change, which can be down to loss of revenue or legal implications, says Wallace. So that pressure for diversity hasn’t been as strong or as visible as it is now in big pharma. “It is being addressed for sure, and there are some wonderful initiatives in place,” she says. “However, the problem I see with candidates coming up through the ranks is that they don’t feel the speed of change is sufficient and, therefore, will look to work with businesses they feel are more adaptive and action-orientated when it comes to addressing diversity.”

	An area where life sciences as a whole is now starting to struggle and, therefore, is going to have a “real problem” in the future is initial grass-roots attraction, notes Wallace. “We will struggle to get these people through the door.” The industry, she says, should be trying to do more to work with schools, particularly disadvantaged schools, which don’t have the resources or the teaching power, to help push students through the STEM subjects.

	At the university level, the industry should be helping to make sure candidates don’t drop out of their field of study. Wallace welcomes all initiatives going on within life sciences businesses to encourage a more diverse and inclusive culture, not least the creation of a chief inclusion officer, “which denotes a real desire of the boards to make meaningful change in this area.”

	But, she adds, “the industry also needs to be looking at what it can be doing outside of businesses, in the community at entry level.”

	While, in Wallace’s opinion, pharma seems to have been misguided in considering diversity as a gender issue alone, she notes that pharma initially made outstanding progress in areas such as increasing female representation on boards. But in recent years this progress has slowed down somewhat. “There may have been a bit of complacency, with some of the bigger businesses saying, ‘Okay, we’ve got one woman on the board now, that’s great.’ The problem is, what happens when that woman leaves, and the board goes back to zero female representation, which unfortunately has happened? No one was looking at that.”

	Wallace notes that if an organization has more female leadership, it’s proven that the sense of inclusiveness filters down through the company, and that’s not just an increase in female leaders, but leaders from racial and ethnic minorities too. It’s also been proven, she says, that more diversity heeds better operational results and share performance that is being recognized by some of the industry’s leading businesses. But it doesn’t necessarily rely on a “top-down” approach. “How do you get women and diverse candidates into those positions in the first place? Eighty percent of directors are male,” notes Wallace. “Progress needs to come from 

the bottom-up, because your pull of leadership comes from underneath; it comes from succession and how can a business promote diversity at board level; if it lacks the numbers lower down, it becomes an impossible fight for the boards.”

	Wallace does say, however, that “the gender-balance conversation is starting again.” She is hopeful that the sector will change over the coming months and years. “We do have more female/diverse leaders, so we’ve got more female/diverse influencers across the industry, which keeps the conversation alive.”

	AZ’s Martin reports that the organization improved female representation at management levels from 39% in 2012 to 45.4% in 2019. And at Novartis, “right now, 44% of our managers are female, and overall, 50% of our workforce is female,” says Brooks. “As the statistics improve,” says Wallace, “we’ll be able to see the positive effects a truly diverse and inclusive culture has on bottom-line profit, which hopefully, in turn, will continue to drive more diversity.”

	Martin agrees that her organization’s D&I work “is far from done.” She stresses, though, that AZ is always striving to achieve more. The company’s recent external activities, for example, include joining the United Nations Free and Equal Standards for Business-aimed at tackling discrimination against LGBTI people-and committing to the United Nations Women’s Empowerment Principles dedicated to corporate actions to endorse equality.

	As for Novartis, of its six D&I initiatives, pay equity and transparency is to be executed and rolled out in the US in June, and gender balance in management is “a goal for us by 2023,” says Brooks. He adds that the company has implemented new hiring guidelines that address female as well as ethnic and racial diversity in the US, and has hired a D&I scouting and recruiting team for the first time “to help us to engage with diverse communities and to build a pipeline of diverse talent.”

	Like other organizations, AZ and Novartis have also reached an understanding of D&I’s “strategic and economic” importance to their businesses. Key to D&I’s wider acceptance and implementation is its growing impact on the bottom line. “D&I has become a competitive advantage,” says Brooks. “The data show that diverse organizations and teams deliver three things that more homogenous teams do not: higher revenue, more innovation, and they are more responsive to customer needs. Whether you’re a little league team or a major corporation, you want to deliver on those three benefits.”

	At AZ, Martin believes there’s no doubt that “having an inclusive and diverse workforce was pivotal to our success in returning to growth and essential for our success today.” Bringing together different ways of thinking, she adds, is “the foundation of the company’s ability to innovate, which is a differentiator for us and has propelled our growth at an individual and company level.”

	Martin is keen to emphasize, however, that business growth is not the main goal of D&I. “It’s just as important that we are doing the right thing and nurturing a values-based culture where we can all enjoy coming to work every day.”

’s European and Online Editor. He can be reached at 

Recognizing that diversity and inclusion is no longer simply a “nice to have,” pharma has boosted efforts in this areas. But just how far are new industry initiatives moving the needle on D&I?

Doubling Down on D&I

	There is no shortage of ideas on which to write for this month’s column. I’m talking about COVID-19 and what it meant to industry in the month of March, which is coming to an end as I write this. I’m sure most of us had a similar experience ending February and into early March. What we first thought was in our control, was not.

 And for CEOs and executives answering to the needs of their local, state, or country governments, as well as the well-being of their employees, it has been nothing but crisis management since mid-March.

	Let’s take a look at some highlights. As of this writing, biotech and pharma analysts were reporting that the impacts of COVID-19 were still materializing, but maybe more noticeable in some areas vs. others. For example, manufacturing was reportedly stable as most staff were deemed essential personnel. On a smaller R&D scale, one biotech executive told me his lab staff were working in shifts of four around the clock, observing all distance and safety precaution recommendations.

	The FDA had not lost steam in reviewing applications as of press time. In fact, the agency announced the approval of Bristol-Myers Squibb’s Zeposia (ozanimod), for relapsing forms of MS on March 26, however, it was also reported that the company was going to delay the drug’s launch due to the pandemic. It will determine new launch timing in conjunction with discussions with the neurology community.

	For sales representatives, those in the US and globally are working from home and using virtual interaction. This is par for the course for medical professional outreach, however, it’s usually only part of the outreach, not the sole means of communication. In early March, Veeva Systems offered its CRM users a 

 to its add-on module Engage Meeting, designed to enhance HCP-to-sales rep communication. At the time, it was highlighting the issue solely in China where sales reps were advised not to call on customers to avoid exposure but also to allow doctors to remain focused on treating patients with the virus. But non-COVID drug information still needed to be delivered. To date, Veeva Systems has provided free licenses to more than 150,000 users globally.

	If the necessity to share medical information to doctors on the daily has been greatly impacted, so has the release of scientific and trial results presentation at annual therapeutic meetings. For example, ASCO, previously scheduled from May 29-June 2 in Chicago, has been 

, with no official word on a replacement event at press time.

	Meanwhile, another event, the 5th Annual School of Gastrointestinal Oncology (SOGO) multidisciplinary education conference was converted from a live, in-person event into a virtual 

*. Companies continue to explore other ways to inform the medical community of scientific data.

	As for clinical trials, that area is affected in different levels across the board. Pfizer, Merck, and BMS have temporarily suspended screening and enrollment in some studies. Others, including Vertex, are exploring virtual visits for trial participants. And, in what looks to becoming a rallying cry for implementing decentralized and remote clinical trials and bringing studies into the 21st century, 

many companies are offering services and software

 to address clinical trial needs during COVID-19.

	Besides the necessity to quickly develop a vaccine, as well as tests, biopharma has stepped up. Merck donated 500,000 personal protective masks to New York City Emergency Management; Horizon Therapeutics, in partnership with Illinois Gov. JB Pritzker, provided $500,000 to the Illinois COVID-19 Response Fund and $500,000 to the Illinois Biotechnology Innovation Organization (iBIO) Institute’s COVID-19 Response Fund. And Eli Lilly increased its COVID-19 testing capability in its home state, using the company’s research labs to analyze samples taken in Indiana healthcare facilities, such as nursing homes and emergency rooms.

	So, what does the future hold for pharma post-COVID?

	Speculation that the industry could turn its negative image around and stress the scientific advances it brings to the quality of human life in the background of COVID is not a reach. Will clinical trials truly turn the tide in trial monitoring so that it is more efficient and patient-directed? Will digital tools and platforms begin to be used more freely in organizations by both internal teams and external HCP communications?

	Only time will tell. As much as we all want to get back to life as it was, there may be some things that will never be the same, and some things that could get even better.

Editor’s Note: This live-to-virtual meeting was produced by our parent company, MJH Life Sciences.

From the Editor

Speculating the downstream impact on industry practices is just that right now-speculation. What is sure is some things will never be the same, and some things could even get better. 

COVID-19 Ripple Effects for Pharma

	In today’s hypercompetitive biopharmaceutical marketplace, prescribing behaviors are shifting rapidly, in line with fast-paced, market-moving events. A high-volume prescriber of a drug can quickly become a low-volume prescriber and vice versa. Unfortunately, too many biopharma segmentation and targeting plans are built for the more static industry of the past, basing plans on historical prescription volume. This leads to three big problems for brand marketers:

		Inability to counter competitors’ launches.

	The key to success is to create targeting plans that get ahead of tomorrow’s prescriptions. But a backward-looking volumetric approach to targeting can inadvertently lead a brand team to overcommit resources to reaching historically high-volume prescribers, often at the expense of middle-tier or low-tier ones who may be on the cusp of becoming top prescribers in the near future. These 

 can represent a significant opportunity for a brand. The traditional approach similarly can’t help a team recognize when a prescriber is on the verge of switching a significant number of prescriptions for the company’s brand to a competing brand (

). And it certainly can’t help a brand team identify those who don’t yet write the company’s drug but are ripe to be converted (

	If a brand team were able to identify these emerging growers, switchers, and adopters, it could use a custom mix of sales and marketing tactics to reach them with messages that resonate and convert these emerging brand opportunities. But this proactive effort is impossible when a brand team relies on historical prescription data trends to dictate its future targeting strategy. By overhauling the old framework and deploying sophisticated big data management, advanced analytics, and machine learning (ML) techniques, teams can uncover the hidden trends within large volumes of prescriber- and anonymized patient-level data, identify strategically important prescribers, and proactively increase the breadth and depth of prescriptions.

	ML can help a brand team discover underlying patterns within big data sets that aren’t easy to discern using traditional analytical approaches or simple rules-based algorithms. Armed with these insights, the team can identify the distinguishing characteristics of emerging growers, switchers, and adopters. From there, it can score and rank target HCPs or accounts within each category based on the likelihood of growth, switching, and adoption in the near-term, and create a dynamic target list that drives the call plan. After that, the  team can craft and deploy tailored sales and marketing tactics and messages to engage with these targets and convert them.

	One of the biggest impediments to successfully executing ML projects is poorly organized data. The brand team must create an organized repository of prescriber- and anonymized patient-level data and incorporate data on its current sales and marketing outreach. It should fold in prescriber attributes, prescription data for competing drugs, as well as relevant information about patients’ treatment journeys, where applicable.

	Another step in implementing dynamic targeting is to measure its effectiveness. A small portion of the sales force can continue to use the traditional, volumetric-based targeting plan, while the majority of the sales team uses the new ML-based plan. The brand team can then compare sales results to measure and validate the effectiveness of its new approach.

	Industry trends give biopharma companies little choice but to embrace ML-informed dynamic targeting. Some companies have already fully integrated ML-based insights into their call plans. Others operate in an intermediate stage on this path toward dynamic targeting. For example, a firm may still use a traditional, volume-based call plan, but also leverage simple rules-based algorithms to analyze recent prescribing trends and send time-sensitive alerts to reps regarding targets in their territories. But these algorithms and alerts can miss the underlying prescribing patterns and emerging trends that ML techniques would help the company identify. It can also be onerous for reps to change their call plans on short notice in response to these ad hoc alerts.

	Companies in this intermediate stage should seek to push beyond it. A wholehearted embrace of ML-driven dynamic targeting as the basis of call plans will help them navigate a rapidly changing prescriber landscape with necessary agility.

 is a Partner, both at Beghou Consulting

Columns

The key to success in a hypercompetitive marketplace is to create targeting plans that get ahead of tomorrow’s prescriptions.

Prescribing Patterns: How to Get Ahead of the Trends

	It may seem inappropriate-not to say tactless-to be discussing a subject as mercantile as the price of medicines in the midst of a crisis of such dimensions as the novel coronavirus pandemic, with its growing human cost right across the world. But conspicuous among the many things that the current health crisis is demonstrating- from the heroism of healthcare professionals to the base cupidity of thefts of protective equipment-is the continuing need for the development of novel and effective medicines. And that, in crude terms, depends on putting investment as well as investigation into the process-investment that springs from the public purse, or from the revenues earned on earlier innovations, or from the expectation of a return on investment made now and in the future.

	Who should put the money into research, who should benefit from the results, and who should pay for them are the questions that have underpinned these discussions for decades, and will doubtless continue to do so once the current crisis is resolved. But as the coronavirus began to wreak havoc on the ordered existence that two generations have come to take for granted in the developed world, the questions were thrown into high relief by a challenging initiative from one of the biggest organizations that pays the price for medicines: the Association Internationale de Mutuelles (AIM). AIM is a grouping of mutual benefit societies that spans 30 countries and meets the healthcare bills of a quarter of a billion people and pays out some $300 billion a year.

	Much of AIM’s business is in Europe, and it has proposed “a European drug pricing model for fair and transparent prices for accessible pharmaceutical innovations.” The calls for “fair prices” and “access” are well-trodden ground in Europe (although the resulting footprints have tended to leave a confused jumble rather than any clear pattern), but the originality of the AIM approach is to set out an actual plan for how to achieve the objective.

	In summary, AIM suggests allowing an initial lump sum of €250 million for the R&D for each new drug, and to determine in advance the amount of R&D for the treatment of a single patient, based on theoretical prevalence of the condition. Adjustments upward could be made for “real” R&D expenses-to a cap of €2.5 billion-and for a smaller target population. For a high-prevalence disease, the model foresees R&D for the treatment of a single patient ranging from €20 to €1,200, according to the amount spent on R&D. For an ultra-rare disease, the allowable R&D for the treatment of one patient could rise to €1 million over the duration of the treatment, and for a life-long treatment, the model would consider a 10-year duration, meaning a cost for R&D around €100,000 per year. Allowances would be made for production and information costs and for a profit of 8%, and an “innovation bonus” of 5% to 40% could be granted in respect of added therapeutic value against available alternatives.

	In a recognition of the diversity of national economies in Europe, AIM says the calculation method would deliver only an average fair price that would then be adapted to each country in line with its GDP. For an average price of €10,000 per treatment, actual prices would therefore range from €2,300 in Bulgaria to €20,500 in Ireland and €29,500 in Luxembourg. And that average price could be further adjusted in light of the price for the product in countries beyond Europe with a comparable standard of living and health system, unless the company could demonstrate that the resulting price does not cover the costs.

	The formula would result, AIM says, in a hepatitis C medicine that today costs €40,000 being available at a European average price of €845 (and at €195 in Bulgaria and €2,500 in Luxembourg). Similarly, oncology products that today cost more than €50,000 would have been in the range of €5,000 to €10,000.

	AIM has been promoting its concept around Europe’s political institutions, arguing that the current pricing system permits “excessive profitability as the final price bears no comparison with the development costs that are usually used to justify pharmaceutical costs.” It claims that its model would provide “fair prices of medicines to reward what (really) matters.” And it underlines, as a leading payer, that “the fairness toward industry would go together with fairness toward health systems.”

	This is sensitive and controversial territory in European policymaking, and the AIM proposal touches on many issues where opinions are sharply divided. No drugmakers have yet come out with explicit comments on the proposed model, but there are inevitably many questions and definitions that would need further refinement for it to gain political momentum.

	Meanwhile, amid the confusions and uncertainties of the rapidly-growing healthcare emergency, the European private-sector pharmaceutical industry is pointing to what it has done and what it is trying to do to respond to 

the need for care. The main industry body, the European Federation of Pharmaceutical Industries and Association (EFPIA), is repeatedly emphasizing its commitment to seeking solutions, and is flagging up its members’ engagement in collaborative research programs to fast-track therapeutics and diagnostics, their donations of investigational compounds with potential as emergency treatment and for clinical trials, and their work in researching vaccine candidates.

	But the messages carry a far-from-subliminal reminder that there is a bottom line to this activity. “The type of research effort needed to address a global health threat cannot be created in a vacuum or turned on and off when Europe needs it. It takes decades to build the right research ecosystem that can respond quickly to such a public health emergency,” said EFPIA Director General Nathalie Moll, as isolationist shutdowns were biting into normal life across the continent.

	The industry’s public pronouncements tend to shy away from direct mention of needing adequate prices, preferring more nuanced allusions to ensuring patient access to innovation, maintaining a dynamic environment, or other similar circumlocutions.

	One of the crucial conditions, Moll said, was “an intellectual property framework that inspires long-term investment into our R&D infrastructure.” Her trade expert Koen Berden reinforced the message: “Research in general, and research into innovative medicines and treatments in particular, can be characterized by being long-term, high-risk, and expensive.”

	Moll reiterated that standard argument that one successful medicine has to earn back not only the R&D costs of the development of the drug itself, but also the costs made for all other failed R&D attempts and compensate capital providers for the risk they have taken with their investments.

	The message is even clearer in a paper circulating within EFPIA  that calls for a shift toward outcome-based pricing for medicines. This shares with AIM the conviction that “current pricing approaches are simply not fit for purpose for some of the innovations now coming to market”-but it diverges widely in its conclusions.

	It candidly states that “a sustainable system should balance budgetary needs (i.e., budget limits and predictability) while maintaining the necessary incentives for continued innovation. The failure to reach such a sustainable approach to medicines pricing is already leading to a situation where many patients do not receive the treatments they need and deserve.”

	With the current prominent display of society’s dependence on medical innovation to provide solutions to new diseases, the tide of public opinion may be flowing at present in favor of funding innovators to come up with vaccines and treatments that have real value, with less attention to price. But in the post-corona relaxation-whenever it comes-the discussion will again be reignited about where value and price converge. And the old dictum will again be cited: “A cynic is someone who knows the price of everything, and the value of nothing.”

Reflector is Pharmaceutical Executive’s correspondent in Brussels

With coronavirus a stark backdrop, European initiative pushes for “fair” drug prices to spur investment in pharma innovation. 

There’s No Easing the Price-vs.-Value Debate

	The reimbursement of emerging durable and potentially curative cell and gene therapies challenge US payers due to their high upfront costs. In addition, the lack of long-term clinical durability data amplifies uncertainties that complicate payer coverage and reimbursement determinations. These cell and gene therapy characteristics could negatively impact patient access and, ultimately, future developer innovation.

	The Financing and Reimbursement of Cures in the US (FoCUS) project was launched in 2016 by MIT’s NEWDIGS Initiative with the objective of elucidating the challenges and financial impact created by durable/potentially curative therapies and providing implementable models to manage the financial impact on the US healthcare system. To that end, FoCUS has conducted two surveys to reveal present payer perspectives regarding current and future management of high-cost durable therapies with one-time administration.

	The first FoCUS payer survey (FOCUS I) was conducted in August to September 2017 as the initial chimeric antigen receptor (CAR) T-cell therapies, Kymriah (tisagenlecleucel/Novartis) and Yescarta (axicabtagene ciloleucel/Kite Pharma) were being approved. It consisted of structured telephone interviews with 15 payers across multiple payer segments.

 At that time, payers had variable awareness and readiness to manage the new cost of these and other emerging gene therapies such as Luxturna (voretigene neparvovec-rzyl/Spark Therapeutics), which was approved in December 2017. One-third of these payers were newly aware and learning about these therapies, with 40% watchfully waiting and 27% engaged in active management. Payers were open to financing mechanisms, with 47% expressing a willingness to engage in innovative financing models, performance-based annuities, and risk-pooling.

	Additional payer surveys were published by the Alliance for Regenerative Medicine (ARM) and the National Association of Managed Care Physicians (NAMCP) of 36 respondents in March to June 2017

 and the National Pharmaceutical Council (NPC) of 21 respondents in February to March 2018.

 While specific questions and methodologies differed, in combination, the three surveys reported a general progression in awareness and concern regarding management of durable therapies, with 10% (ARM/NAMCP) to 27% (FOCUS I) and, ultimately, 100% of payers (NPC) reporting having started to consider coverage or operational issues associated with these treatments.

	The most recent FoCUS payer survey (FOCUS II), consisting of 15 online questions, was conducted with clinical and financial health plan leaders from 77 US payers between September 2018 and April 2019 (note: Novartis gene therapy Zolgensma was approved in the US in May 2019 and launched two months later). The survey again focused on assessing payer perspectives regarding current and future management of high-cost durable, potentially curative therapies with one-time administration.

	Participants in the FOCUS II survey represented 153 payer segments, including commercial fully-insured plans, self-insured employers, Medicare, and Medicaid. Payers ranged in size from less than 5,000 insured lives to upwards of 50 million and in total covered over 280 million lives (see Table 1).

	The survey did not control for more than one person from the same plan completing the survey. Results from intermediaries such as pharmacy benefit managers were excluded to the extent they could be identified.

	Respondents self-identified among roles in pharmacy (53%); medical (31%); human resources and benefits (9%); and finance and actuary (7%).

1) While payers are concerned about financial risk and impact of high-cost durable therapies, nearly all are covering them

	All payers have some level of concern related to the financial risk and impact of these treatments. Eighty percent of payers rate their concern as high or extremely high, with 39% of 153 payer segments rating their concern as extremely high, 41% as high, 18% as moderate concern, 2% as slight concern, and 0% as no concern.

	When analyzed by payer segment, commercial fully-insured plans expressed the highest levels of concern, with 93% reporting a high or extremely high concern and 7% reporting a moderate concern (see Figure 1). In comparison, only 50% of self-insured employers reported a high or extremely high concern, with other payer segments in-between, with 76% reporting high or extremely high concern.

	Payers selected a number of reasons for their high or extremely high concern:

		The total cost is material for the plan (98%).

		Drug performance risk (effectiveness and durability) (91%).

		Actuarial risk (likelihood of encountering an orphan case) (91%).

		Payment timing relative to benefit realization (offsets may not cover the high cost of treatment) (84%).

	Other identified reasons for high concern include:

		Burden of multiple high-cost therapies.

		Concern about what this will represent in three to five years with respect to total cost.

		Operational management of a larger pipeline.

	Nearly all payers surveyed (99%) currently covered one-time, high-cost durable therapies; 46% cover all treatments then approved, while 53% cover some. For those covering high-cost durable therapies, payers are evenly divided regarding utilization management practices. Forty-eight percent cover high-cost durable therapies as specified in the FDA-approved label. Forty-nine percent apply utilization management coverage with more restrictions than the FDA-approved label. Three percent cover with less restrictions than the label.

	Commercial fully-insured payers are the most restrictive, with 62% managing coverage with more restrictions than the FDA-approved label. Fifty-four percent of Medicaid plans reported utilization management that was more restrictive than the label, with 44% covering as specified in the label. Medicare Advantage is the least restrictive, with 67% managing consistent with the label and 31% more restrictive.

	Case management is used by 82% of payers and centers of excellence (COE) are required for 64% of payers surveyed. Thirty percent restrict use of all high-cost durable treatments to COE, while 34% restrict some of these treatments to COE.

2) Payers are motivated to manage the financial risk associated with durable one-time treatments differently, making this a high priority over the next two years  

	In contrast to high-cost chronic treatments such as Spinraza (nusinersen/Biogen) or Onpattro (patisiran/Alnylam Pharmaceuticals), the majority of payers reported they were moderately, very, or extremely likely to change how they manage the financial risk associated with one-time, high-cost durable treatments (see Figure 2).

	Payers were somewhat mixed regarding the importance of high upfront cost per patient and cumulative per member per month (PMPM) to their organization’s serious consideration of alternative approaches to manage financial risk of one-time, high-cost treatments. Thirty-nine percent rated both factors as equal. Thirty-one percent reported that high upfront therapy cost per patient is much or somewhat more important, while 26% reported that high total PMPM impact is much or somewhat more important. Neither factor would trigger serious consideration of an alternative payment model for 5% of those surveyed.

	Implementing new management strategies for these therapies is a near-term objective. Fifty-seven percent of 77 payers surveyed expect to implement a new management strategy in the next one to two years, while 13% already have. Figuring out the best way to finance new high-cost durable therapies is a high or very high priority for 76% of payers surveyed, a medium priority for 21%, and a low priority for 4%.

	New strategies that payers reported have already been implemented included value-based or outcome-based agreements and changes in provider contracting, including carving out payment for these treatments to a third party such as reinsurance or risk pools and global case rate payments.

	Payers expressed interest in multiple financing approaches for the future. Overall, payers were most interested in short-term milestone-based contracts, defined as contracts of less than two years duration where the therapy is paid for upfront and the plan receives refunds tied to performance (see Table 2).

	Self-insured employers were most interested in population risk-pooling, stop-loss/reinsurance over the broader population. Installment payments, annuities without a performance component, were the least appealing, with only one-third of commercial plans to a low of one-seventh (14%) of Medicaid respondents expressing interest.

3) Addressing contract terms and barriers will matter

	Payers see multiple benefits of alternative financing approaches:

A follow-up survey of clinical and financial health plan leaders uncovers evolving approaches and views on the management of high-cost, curative-intended treatments with one-time administration.

Pharmaceutical Executive-04-01-2020

HBA's Woman of the Year 2020: A Motivated Mission

Doubling Down on D&I

COVID-19 Ripple Effects for Pharma

Prescribing Patterns: How to Get Ahead of the Trends

There’s No Easing the Price-vs.-Value Debate

Payer Perspectives on Gene Therapy Reimbursement

Covid-19 Pandemic Thrusts Biopharma R&D to Forefront

Transforming the CIO Role to Embrace Digital Health

Pharmaceutical Executive, April 2020 Issue (PDF)

Country Report: The Czech Republic