The Patient Advocates

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PharmaVOICE Staff

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Nikki Levy
Caring Connections

Title: VP, Patient Engagement
Company: Alkermes Inc.
Education: BS, Communications, Illinois State University
Family: As a child of a single mom she learned to be fiercely independent, internally motivated and to value hard work
Hobbies: Running, reading, traveling
Awards/Honors: Marketing Excellence Award from Genentech
Social Media:
Tweet at:  @nikkilevy22

Patient-centricity is a term that many biopharmaceutical companies use to describe themselves; however, few deliver on the promise. Nikki Levy is standing out in this regard, truly walking the walk.

She draws on more than 20 years of experience building advocacy and patient engagement programs, creating strategic alliances, and fostering meaningful partnerships to support patients, their families, and society.

Ms. Levy loves working with patients and their families.

As VP of patient engagement at Alkermes, her role is to create connections between the company and the community it serves. She built the patient engagement function from the ground up and integrated it within an organization.

She is deeply committed to making the patient engagement function impactful for the mental health and addiction community. Ms. Levy understands that patients with mental health issues can feel extremely isolated, making it hard to engage these patients and their families.

Bolstered by the conviction that strengthening relationships with patient advocates would benefit both Alkermes and patient organizations, Ms. Levy brought together leaders from the company and advocacy groups in a day-long advisory board summit. Company leaders walked away with a better understanding of the challenges the community collectively faces along with innovative ideas for positive change.

She also developed and spearheaded the Alkermes Inspiration Grants program, which focuses funding innovative programs to support people affected by mental health conditions and substance use disorders and serve as a catalyst for change. Alkermes awarded $1 million to innovative organizations, making a real difference in their communities.

She represents Alkermes on FasterCures’ Patient Counts Leadership Council, comprised of organizations that share a commitment to building a science of patient input and expanding opportunities for patients’ perspectives to shape decision‐making at all levels of research and development. Additionally, she was recently appointed to serve on the advisory panel for FasterCures’ Health Data Basics project funded through a Patient-Centered Outcomes Research Institute (PCORI) Eugene Washington PCORI Engagement Award. The nature of health data is becoming increasingly complex, especially as new data sources such as patient registries and wearable monitoring devices contribute dynamic data to real world evidence. Through a three-phase, 18-month program, the project will gather data about the knowledge gaps and patient landscape to ultimately develop and pilot an educational tool to empower patients to use their health data for the good of their own health and others’.
Before joining Alkermes, Ms. Levy served in communications and patient advocacy roles at Vertex Pharmaceuticals and was the first chair of the company’s patient-centricity initiative. She was at the forefront of making sure that everything that Vertex Pharmaceuticals did had patient interest at its core.

Ms. Levy is uniquely equipped for the tough conversations and situations that come up when working directly with patients and advocacy groups and delving into the challenges they face each day.

For Ms. Levy, success is about relationship building, both in terms of the patients she serves and the team she leads. She is always thinking about how to make her team better and help them to grow.

Going forward, she would like to build leaders who can do great work for patients and families. (PV)

Michele Russell-Einhorn
Advancing Research Through Ethical Engagement

Title: VP, Human Research Protection Services and Institutional Official
Company: Schulman IRB
Education: BA, Hampshire College; JD, Magna Cum Laude, Boston College Law School
Family: Husband, Malcolm Russell-Einhorn
Hobbies: Cooking, traveling, playing guitar
Bucket List: To own her own farm
Awards/Honors: Partners in Excellence Team Award for the Personalized Cancer Medicine Protocol, 2011; DFCI Team Impact Award for the cancer center grant renewal, 2011; DFCI Significant Impact Award, 2009; Health Improvement Institute Award for Excellence in Human Subject Protections, 2009; NIH Group Merit Award, 2000; NIH Directors Award, 2000; NIH, Office for Protection from Research Risks, Special Awards, 1997, 1998, and 1999; NIH Award of Merit, 1997; Department of Health and Human Services, Office of the General Counsel, Performance Awards, 1992, 1993, 1994, 1995, 1996, and 1997; Department of Health and Human Services, Office of the General Counsel, Superior Achievement Award, 1992
Associations: Temple Sinai, Co-Chair of the housing committee to resettle Syrian Refugees; Public Responsibility in Medicine and Research; American Association for Cancer Research Translational Sciences Workshop for Basic Scientists; Tufts Center for Drug Development

In 1979, Michele Russell-Einhorn was ready to take on the world. She had just graduated from college and was working for Human Rights Internet, an organization dedicated to communicating the situation of dissidents throughout the world.

But a spinal fusion operation that was otherwise successful required her to have several blood transfusions. Life continued. She completed law school, got married, and had one child. But when pregnant with her second, she became very ill and it was discovered that she had a form of hepatitis. In 1986, it was referred to as non-A non-B hepatitis, an unfamiliar disease at the time with no treatment. It wasn’t until 1990 that it was finally given a name: hepatitis C. She knew that she had to keep moving forward and that research on this little-known condition would hopefully yield treatments.

In the meantime, Ms. Russell-Einhorn went on to serve as the assistant special counsel for ethics for NIH, the director of regulatory affairs for the Office for Protection from Research Risks and the Office for Human Research Protections, as well as the associate general counsel for the J. Craig Venter Institute.

During these years, she continued her education in hepatitis C, participating in survey and liver biopsy studies, and watching the results from the improved treatments involving pegylated interferon and ribavirin.

She joined the Dana-Farber Cancer Institute as senior director of the Office for Human Research Studies, overseeing the scientific review and institutional review board, and other regulatory matters, encompassing all cancer research involving human subjects conducted at the five Harvard clinical institutions as part of the Dana-Farber/Harvard Cancer Center.

While at Dana-Farber, Ms. Russell-Einhorn took a new three-drug combination approved by the FDA to treat hepatitis C, which  was touted as having a 90% success rate with few side effects. The first eight weeks were manageable for her, but then she came down with the serious and life-threatening rash that ended up as a black-box warning on one of the three drugs. Her viral load remained. Finally, two years later, she took Harvoni, a one-pill-a-day drug that cured her hepatitis C.

Enthusiastic, peppy, and able to manage multiple tasks with equal amounts of vision and energy, Ms. Russell-Einhorn has never allowed health issues to get in her way.

In her current role at Schulman IRB, Ms. Russell-Einhorn uses her experience as a patient to guide her vision as the VP for human research protection services and institutional official. The role is perfect for her as it allows her to bring together her enthusiasm for clinical research with her passion for protecting research participants.

She has a vision for streamlining and focusing regulatory knowledge to make Schulman IRB a stronger independent IRB, helping the organization grow its collaborative culture and cultivate expertise among her team members. She is keenly aware of the need for research to move forward quickly balanced with the critical importance of ethical oversight.

One of her most exciting professional experiences was working with the IRB at NASA.

“When astronauts go in to space they are research subjects,” she says. “It was fascinating to think through how regulatory requirements connect with 60-plus research experiments.”

Her selflessness and joy of learning is seen again and again through her dedication to mentoring the next generation of researchers. For Ms. Russell-Einhorn, success is measured through kindness, collaboration, and conscientiousness.

Ms. Russell-Einhorn also serves as co-chair of the subpart A subcommittee of the U.S. Department of Health and Human Services’ Secretary’s Advisory Committee on Human Research Protections. She is also a founding member and leader of the IRB Directors group for the National Comprehensive Cancer Network, and is a site visitor for the Association for the Accreditation of Human Research Protection Programs. She is also a member of the Vanderbilt University Steering Committee for an NIH Grant on Alternative IRB Models.

Each year, Ms. Russell-Einhorn participates as a faculty member at the American Association of Cancer Research’s workshop and Tufts CDD’s postgraduate course in pharmacology, drug development, and regulation. (PV)

Donna Wray
Straight Shooter Aims to Improve Patient Communication

Title: VP
Company: TGaS Advisors
Education: BA, Psychology, Bryn Mawr College; MSc, Computer Science, Villanova University
Hobbies: Saving trees, playing the ukulele, playing online word games
Awards/Honors: MM&M Awards Judge, PMSA, ePharma Summit
Associations: Tookany Creek Watershed Foundation, American Friends Service Committee, Dare Two Foundation for Prediabetes and Diabetes
Social Media:

Donna Wray, the first female VP at TGaS Advisors, single-handedly developed the digital and multichannel marketing practice (DMCM), which she now leads, project by project, client by client, chasing down every opportunity while simultaneously delivering beyond expectations. Under her leadership the DMCM solution went from supporting just six companies to about 30 digital and multichannel marketing groups across pharma. The team has supported 60-plus brands with tactical performance benchmarking, as well as strategic guidance around industry and ex-industry trends and strategies.

Ms. Wray values honesty and integrity first and foremost. In this industry, pharmaceutical marketing clients have vendors, partners, and consultants trying to sell them at every turn, and she provides an objective voice of reason. She is always straight with clients but in a helpful way about the value of their work for their end users even if it’s news they don’t want to hear. She often tells them, “You think X, but the benchmark data shows Y, so here’s what we need to do.”

Her current soapbox is helping clients improve brand marketing by improving patient communications to make life easier for patients and their families at a stressful time. This may not sound particularly revolutionary, but only 13% of companies attending last fall’s TGaS Client Summit have a program to improve clarity of communications to patients.

Ms. Wray reached out to the TGaS network to understand who in the organization is ultimately responsible for patient centricity, how they are measuring it, and the tangible examples of how they are making it easier for patients to understand their health, their medicines, and the importance of safety in medicine. She contacted the FDA, hospital systems, and patient advocacy groups to put a forum together to discuss health literacy and to build a brain trust of how every institution that interacts with a patient, either directly or indirectly, owes it to the patient to take a complex, sometimes scary diagnosis, and bring language down to a 5th grade reading level. Her theory is patient-centricity can only work if the patient understands what is going on.

Ms. Wray is on a quest to explore how companies can reinvent patient communications, making them more accessible while still adhering to the legalities. She has created a guide to point marketers to the many free resources and research available, and she is a member of the Health Literacy Initiative of PMRG (the independent, nonprofit trade association for marketing research in the healthcare industry).

Ms. Wray is exceptionally generous both personally and professionally, supporting her staff and colleagues at every turn. She invariably provides high-level insights based on a deep knowledge of her clients and the industry and where they need to focus to make a difference to the patients and healthcare professionals who depend on them.

“I’ve always liked to offer up my opinion,” Ms. Wray says. “I try to work hard to make sure I have something useful to say.”

Colleagues say her candid insights keep the team both grounded and inspired, and her wonderful sense of humor keeps everyone amused. Ms. Wray and her team have worked with 38 of the top 50 pharmaceutical companies, as well as many more smaller companies. Pharmaceutical clients report that she is a “straight shooter who is not afraid to tell it like it is,” and “one of the top minds in the space.”

Her personal insights, based on experiences on both the client and agency side, are invaluable to clients when evaluating their programs.

One client reported that Ms. Wray’s insights allowed the company to improve its programs to the point where certain measured initiatives were significantly better than the competitive set, netting the company nine Best of the Benchmark awards over the years. (PV)

Lisa Courtade
Making a Difference for Patients

Title: Executive Director, Global Customer & Brand Insights
Company: Merck & Co. Inc.
Education: BA, Marketing summa cum laude, Radford University; Master’s, Marketing Research, University of Georgia
Family: Father, for passing on his passion for education and a lifetime of learning, the value of hard work, and importance of discovering joy — she will miss him forever; husband and two sons, who keep her grounded and balanced.
Hobbies: Swimming, reading
Bucket List: 
To see her sons grow up to lead happy, healthy, successful lives, free from discrimination and fear of disease
Awards/Honors: TMRE EXPLOR Innovation Award Recipient, 2017; ARF David Ogilvy Big Data Award, 2016; ARF David Ogilvy Innovation Award, 2015; RBDR Client Innovation Award, 2014; ARF David Ogilvy Silver Award in Pharmaceuticals, 2013; Pharmaceutical Marketing Research Group R.R. Fordyce award for exemplary leadership, service and dedication to the healthcare industry and the healthcare market research community, 2013; Greenbook Research Industry Trends Top 50 most innovative client research teams, 2017
Associations: Healthcare Businesswomen’s Association; Marketing Research Institute International; Insights Association Board; University of Georgia Masters of Marketing Research Advisory Board; Rutgers MRIA Advisory Board; Pharmaceutical Marketing Research Association; American Association of University Women
Social Media:
Tweet at: @lisacourtade

Lisa Courtade, head of global customer and brand insights at Merck, is constantly pushing the boundaries to bring new thinking and new tools to shape the future of market research. A passionate advocate for delivering valuable solutions for patients, she was an early adopter of leveraging consumer packaged goods and retail methodologies in the pharma space. She employs the art of transforming insights into stories, applied behavioral economics, predictive modeling, and recently she has become intrigued by the possibilities of the use of artificial intelligence and automated real-time insights.

“I got into pharma because I was intrigued by the science,” Ms. Courtade says. “I have stayed because I believe that the work I do makes a difference in the lives of patients.”

She is not afraid to take risks on unproven methodologies, which is extraordinary considering the conservative nature of the industry.

Her leadership has led to the integration of biometrics, facial coding, neuroscience, and virtual reality into the Merck research toolbox. In doing so, she has uncovered not only paths to revenue growth but ways to reduce development costs and enhance process efficiencies.

Her continuing efforts to engage patients have led to meaningful improvements in the development and testing of health-literate communications and new venues for patients and caregivers to engage in the co-development of drugs. Her endeavors have earned her the Advertising Research Foundation’s David Ogilvy Award for creative insights in consumer advertising and the 2013 Pharmaceutical Marketing Research Group R.R. Fordyce award for exemplary leadership, service, and dedication to the healthcare industry and the healthcare market research community.

According to colleagues, she embraces collaboration over working in silos to gain the benefit of fresh perspectives and she strives for seamless integration between marketing and market research to arrive at richer insights and better outcomes. For example, Ms. Courtade has worked with external agencies to design collaborative partnerships that disrupt the traditional ad hoc project model for marketing research and harness a broad spectrum of talent to solve the pharma company’s most pressing business challenges, while creating competitive advantage for Merck. She is driven by a desire and higher purpose to serve the industry, and she continually raises the bar to deliver great value and deep insights that capture the hearts and minds of doctors, patients, and other key stakeholders. This ultimately helps Merck arrive at solutions that bring life-saving drugs to the people who need them the most.

In addition to her role at Merck, Ms. Courtade is a board member at Insights Association, the market research and analytics trade and professional association, and past president of the Market Research Institute International, a nonprofit offering global, market-leading continuing education programs for the practice of market research and insights  in conjunction with the University of Georgia.

One of her biggest career highlights occurred early on and cemented her passion for the industry. She was working with a team seeking to grow the market share of the inactivated polio vaccine. The organization had been focused on motivating healthcare providers, as was common industry practice. Ms. Courtade asked a naïve question about the perspectives of the parents during a discussion, which opened up the door of patient engagement.

“The research that we subsequently did among parents to understand their views on immunization and the risk of vaccine associated paralytic polio (VAPP) from the live attenuate oral product ultimately led to a profound change in the ACIP recommendations,” she says. “The company’s market share jumped from 2% to more than 80%. More importantly, while the live attenuated oral polio vaccine was an amazing product, we were able to shed light on how the risk equation had changed in the U.S. market. Since the recommended change in immunization practices, I know that because of the work that I led, hundreds of families have been spared the trauma of disability and death due to VAPP.” (PV)

Bill Hinshaw Jr.
Making Every Day Matter

Title: Executive VP, Novartis Oncology
Company: Novartis Oncology
Education: BS, Molecular Biology, University of Wisconsin – Madison
Family: Parents, Bill and Virginia Hinshaw, who are his biggest role models; maternal grandfather, Pops; brother, Louis; wife, Keri, who has been a supportive partner for almost 30 years; two sons, Kai and Ronan
Hobbies: Traveling, hiking, reading, fitness, skiing
Bucket List: Travel to the Amazon, Patagonia, and Alaska; coach young people on finding their purpose; have a place in the mountains and lakes to go with his family
Awards/Honors: Scrips “Deal of the Year” winner; multiple time President’s Club Winner (specialist and manager level); multiple time OBEA Award Winner; KOSMIC Award, Managed Markets Award; HR Contribution of the Year Award; Unit of the Year Winner; Best Practice of the Year Award Winner; multiple time Diversity and Inclusion CEO Award Nominee; multiple year recipient of Chairman’s Grant;  Presidents’ and Business Excellence Awards
Associations: BIO, board member; COTA observer board seat; NeuTec Pharmaceuticals, board member; Idenix, Cubist, Human Genome Sciences, Cerimon, Anadys, steering committees; American Liver Foundation; Crohn’s and Colitis Foundation of America; Melanoma and Hepatitis, support group founder; Detroit Chamber of Commerce; Association of Volleyball Professionals; Boy Scouts of America, Eagle Scout
Social Media:

Being able to make a meaningful difference in patient outcomes is Bill Hinshaw’s No. 1 objective. As executive VP, Novartis Oncology, Mr. Hinshaw oversees all commercial and medical operations, working hard to ensure the company is at the forefront of delivering breakthrough treatments, resources, and value for cancer patients.

Since his appointment to the role in 2014, the U.S. oncology team has successfully introduced three new chemical entities, four new indications, and received four breakthrough designations for strategic brands.

Colleagues say Mr. Hinshaw is a purpose-driven leader who is committed to transforming cancer care by empowering his team to deliver innovations that benefit patients. Mr. Hinshaw has championed strategic collaborations to help advance clinical trial design and access to Novartis’ medications, as well as to innovative pilot programs in areas of big data and next-generation marketing.

Mr. Hinshaw led the successful integration of GlaxoSmithKline’s oncology products into the Novartis portfolio and welcomed many new associates to the organization.

This transformational milestone enabled team members to further enhance their commitment to the oncology community by exploring the therapeutic potential of novel combinations that target multiple cancer pathways.

In addition to leading several innovation programs, Mr. Hinshaw works with the Novartis leadership team to outline areas that require change, and create an environment that supports transformation and encourages teams to be ambitious.

He believes innovation thrives on curiosity, and he encourages his teams to look outside of pharma for ideas at the same time he fosters an environment that encourages risk-taking and learning together.

Mr. Hinshaw says career highlights for him include playing a role in medical treatments that have helped transform the trajectory for patients with certain diseases — CML, hepatitis, GIST — and bringing forward new innovations, such as targeted and cellular therapies, to address unmet patient needs.

His goal is to play a meaningful role in transforming healthcare by leading talented, visionary, and committed teams.

Before his current position, he held several roles of increasing responsibility at Novartis in the United States, as well as roles enabling a strong global reach, including leading Novartis’ Group Emerging Markets, where he was responsible for more than 90 countries across the Novartis portfolio — animal health, vaccines, self-care, generics, and pharmaceuticals — and multiple business models.

He thrives on working with talented people who have a shared vision to make a difference. Mr. Hinshaw’s leadership style is characterized by his thoughtful approach and willingness to explore novel or unconventional methods to make scientific innovation a reality for patients. He promotes a culture of inclusiveness and workplace diversity based on respect, integrity, and cohesive teams.

People are motivated by purpose, Mr. Hinshaw believes, and so he keeps his team focused by reminding them about how important their role is to success and helping them to overcome obstacles.

As part of his desire to create a strong and engaging culture, Mr. Hinshaw expanded a recognition program within U.S. oncology, with awards distributed three times per year to acknowledge teams and individuals who have made a difference internally or externally.

He inspires through his focus on the purpose, patience, and in doing things the right way, even when difficult. (PV)

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