Change Agents

Contributed by:

PharmaVOICE Staff

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

These forward-thinking individuals are disrupting the status quo and setting the strategic direction for their companies to capitalize on the opportunities that will shape the future of the healthcare ecosystem.

Put people first, the rest will follow

Sparking innovation by…
collaborating with new and existing partners to strengthen the resilience of the pharmaceutical supply chain

Heather Zenk, Pharm.D.
Title: President of Distribution Services
Company: AmerisourceBergen
Education: B.A., College of St. Benedict,
St. Joseph, MN; PharmD, University of Minnesota
Associations: Licensed Pharmacist in Minnesota & Illinois; GS1 Global; Healthcare Distribution Alliance
Twitter handle: @Healthcare_ABC

When the COVID-19 pandemic spread across the world, Heather Zenk was reminded of the Winston Churchill quote: “Never let a good crisis go to waste.”

“While there was a lot of uncertainty and fear during the early days of the pandemic, this quote inspired me to have a change agent mindset — especially as I led the COVID-19 taskforce at AmerisourceBergen,” Heather says. “While the pharmaceutical supply chain performed very well, we came to work every day thinking about how we could adapt our processes or even create incremental solutions to help our manufacturer partners, provider customers, and the public at large. This time has taught me that scary moments in life and career can foster tremendous growth, if approached with the right intention and mindset.”

As president of distribution services at AmerisourceBergen, Heather’s role has been critical in protecting and securing the supply chain amid the pandemic and bridging the gap between manufacturers and providers to get COVID patients the treatments they need. She and the taskforce team adapted the company’s approach to business continuity plans during the pandemic to add increased focus on human capital. During any crisis, the company prioritizes supporting families and their local communities, in addition to finding solutions for how to access a building, communicate with the national guard, and assessing damage to property.

Heather strives to lead with purpose, authenticity, passion, honesty, and integrity each day — no matter the obstacles she faces.

“My purpose-driven attitude and resilience are exactly why I was able to quickly adjust my strategy during the pandemic,” she says. “I knew my purpose, and I kept it top of mind even through the most challenging times.”

Reliable information during the pandemic was key for everyone, so Heather and her team committed to operating openly and transparently, even to the point of over-communicating, even when it was hard.

People are the priority for Heather. “I want my people to believe that they matter — their ideas, their safety, their work product are paramount. I want my team members to feel like they can truly bring their whole selves to work. I believe that authenticity brings the best ideas to the table, so as a leader, I’m very focused on creating a culture that is open, honest, and accepting. When we put people first and foster them in a culture that’s built on acceptance and respect, we can do powerful things.”

During the pandemic this meant ensuring her team members understood the greater role they were playing, the vision and opportunity to help the country, and staying true to AmerisourceBergen’s purpose to create healthier futures.

She looks for team members who are passionate and understand the important role the pharmaceutical supply chain plays in serving the public and manufacturing partners.

Having had several mentors who helped her succeed, Heather finds it incredibly important to be a mentor and help others reach their full potential. The best part is forming that relationship and watching individuals take flight, she says.

Helping to support the next generation of leaders is also a priority for Heather, who recognizes that for any company to be successful in the long term, it requires team members to feel respected and empowered daily to do their best work.

“As such, I always encourage two-way communication with my team, giving individuals opportunities to voice their opinions, concerns, and share what they need to be successful and reach their full potential,” she says.

Since joining AmerisourceBergen 15 years ago, Heather has climbed rapidly through the ranks, a path that has been very different to what she imagined when she went to pharmacy school.

“I thought I’d spend my career in a retail setting, supporting patients and keeping them adherent to their therapies,” she says. “I’m not sure pharmacy-student Heather would ever imagine eventually leading a pharmaceutical wholesaler’s taskforce to address a global pandemic. I wish I could tell my younger self not to worry so much about change, to stay calm, jump in, and swim with it like a current carrying me to my next opportunity.” (PV)

Live. Learn. Laugh.

Sparking innovation by…
focusing on the virtues of the virtual world

Kumar Badampudi, MBBS
Title: VP, Medical Affairs & Strategy
Company: MedTrix Healthcare Communications Pvt. Ltd.
Education: MBBS, Medicine, Andhra Medical College; Master’s in Public Health, Western Kentucky University
Company Awards: Employee of the Year several times in the past
Giving Back: Orphaned children
Hobbies: Reading, writing, hiking

In his eight years with MedTrix Healthcare Communications, Kumar Badampudi, MBBS, has played a critical role in the company’s transformation from a fledgling conventional agency to one with award-winning projects employing cutting-edge virtual reality (VR) and artificial intelligence (AI) technologies.

Kumar cites his most recent projects as his career highlight so far. “About three years ago, I was a key driver of a strategy that aimed to combine our knowledge of pharma, medical science, and technology to identify congruencies between medical communications and newer digital technologies,” he says. “This strategy resulted in the development of four distinctly unique projects that not only employed the latest technology in medical communications but used it in ways that uniquely enhanced the effect and outcome for pharma, HCPs, and patients.”

Kumar notes that these projects won several accolades, contributed 40% to 60% of the agency’s annual revenue, and supported a 40% compound annual growth rate (CAGR) in the last three years. But they weren’t without difficulties.

“Driving the strategy was challenging because it involved cross-functional collaboration where technology teams had to understand medical science, and medical writers had to know practical aspects of technology for the strategy to work,” he says.

The first test faced by Kumar and his team was making anatomy lessons with dissection of cadavers available outside the dissection theater, which was done through the HoloLens Anatomy facial anatomy application. For it to work, medical specialists had to perform their tasks in a way that met the requirements of the technology, and software professionals had to understand facial anatomy and the methodology of instruction.

“My goal was to facilitate all aspects of this project and launch the application at a large conference,” he recalls. “The first sign of success was our ability to perform three complex tasks at the same time — perform a dissection session that was carefully scripted, set up technology infrastructure to capture 3D images, and optimize the output for use in a mobile platform.

“I worked with the teams and was also involved in conceptualization, execution, and development,” he continues. “We launched the application in an event with more than 600 participants and received extremely positive feedback from both experienced surgeons and new graduates.”

Being a physician himself, Kumar realizes that physicians train for years to make independent decisions that impact patient lives directly, and effective communication with HCPs should factor this in. The positive reviews garnered by the HoloLens app shows communicating with HCPs and facilitating learning in the way they are accustomed to — by active experience, reflection, and deduction — is a successful strategy.

Kumar also was a key architect of the Patient Case Player, which reimagines patient case studies and incorporates machine learning to make a case study personally relevant for every user. In its development, he encouraged the user experience design team to see themselves not as graphic designers but as experience designers whose objective is to evoke emotional responses with design. One team member says this advice elevated the team’s aspirations and made them look at their work in an entirely different light, leading to a Patient Case Player design that was praised all around by oncologists.

Kumar says he seeks to inspire others by setting an example with his actions, listening to colleagues’ challenges, and supporting colleagues in their aspirations.

“I aspire to achieve big things and believe that is it important to remain compassionate and humble while driving myself and inspiring others towards those dreams,” he says.

Kumar‘s leadership style is calm and unassuming. “I acknowledge achievement and effort readily and openly,” he says. “To be a leader and to be successful, you have to inspire trust, team up with individuals whose skills complement yours, and be able to kindle drive and dedication.”

He embraces his role as mentor. “The best part of mentoring someone is the knowledge that I am part of their journey toward success, and that I may be able to help prevent some of their failures by sharing lessons I learned through my successes and failures,” he says. (PV)

Act or accept

Sparking innovation by…
identifying — and then rejecting — beliefs about how something should work

Roshawn Blunt
Title: Managing Director
Company: 1798 LLC, a Fingerpaint company
Education: MBA, Kellogg Graduate School of Management at Northwestern University
Personal Awards: MM+M 2021 Hall of Femme
Associations: Healthcare Businesswomen’s Association, Central San Diego Black Chamber of Commerce
Giving Back: Medical debt, access to healthcare, education, animal rights

Eleven years ago, Roshawn Blunt started 1798 at her kitchen table. Two years ago, 1798 achieved a size, a revenue, and a corporate reputation that attracted Fingerpaint’s attention. Eighteen months ago, the company was acquired and began its integration with Fingerpaint.

“The highlight of my career was watching my team pull together during this time of change,” she says. “One major challenge would have been stressful enough on my team, but together we weathered two challenges: the COVID-19 pandemic, and an acquisition. I couldn’t be prouder of my team for its perseverance.”

At Fingerprint, Roshawn is leading the development of Photo 51, which is focused on helping to accelerate go-to-market strategies for gene and cell therapies.

Colleagues say her experience gives her the foresight to solve even the most challenging of market access problems and, ultimately, to get extremely important therapies into the hands of patients.

“After focusing on market access for more than 20 years, I am more than simply proficient in my field, I am prepared to have thoughtful discussions on topics that will drive clients’ goals,” she says.

Being an entrepreneur comes with many roles and challenges, Roshawn says.

“You are building a team, making decisions, wading through the loneliness of knowing how much rests on your shoulders alone, making do with limited support, never having enough time in the day to accomplish all your tasks, and obtaining and maintaining the revenue needed to ensure that the employees who put their faith in you will always be compensated,” she says. “You face these challenges daily for years. If you’re lucky, your company grows large enough that these challenges dim. When that happens, though, you face a new challenge: scaling your organization while maintaining its culture.”

Before founding 1798, Roshawn held a variety of strategic reimbursement, health economics, and commercialization positions at different companies, including Amgen and Biosense Webster, a Johnson & Johnson company, where her team was responsible for developing the global value propositions and for managing all health technology assessments for 20 countries, including the United States. Through alliance development initiatives and a comprehensive publication strategy in the United States, the company achieved national coverage in advance of FDA approval of a therapy.

“Since I was a teenager, I wanted to work on policy issues in public administration, and this remains on my to-do list,” she says. “Until I make it happen, however, I know that my purpose is to continue to work on market access projects to help patients — particularly those who have government-sponsored healthcare — obtain the therapies they need. Although I don’t work for the government, I remain current on federal and state legislation and regulations, ensuring I have the knowledge to help my clients navigate the complex healthcare landscape.”

Roshawn does what it takes to understand an issue and outline an appropriate solution and to thoroughly prepare for everything, and she encourages her team to do the same.

“I show my team that even though I’m the boss, I’m not above doing QC on a document, or taking notes on a call for a client,” she says. “I want my behaviors and actions not only to reflect the culture of excellence I strive to provide for our employees, but also to communicate that opportunities exist for those who are willing to invest in themselves and spend time helping their colleagues learn.”

Advice from a mentor led Roshawn to follow Miles’ Law maxims, including, “The responsibility of every manager exceeds his authority, and if he tries to increase his authority to equal his responsibility, he is likely to diminish both.”

This guidance, she says, was a useful reminder when navigating the corporate landscape as a mid-career professional.

As a mentor, Roshawn says she has learned more about the next generation’s motivators and values. She seeks to guide up-and-coming leaders by asking them what they really want to do and how she can help them.

“When individuals speak passionately about their goals, it’s imperative that I listen and act with those goals in mind,” Roshawn says.

Beyond the workplace, Roshawn has been involved with many organizations throughout the years that are vital to championing more support, diversity, and opportunities for women in the industry, including the Healthcare Businesswomen’s Association, the Diversity Alliance for Science, the Pacific Southwest Minority Supplier Development Council, and the Women’s Business Enterprise National Council. (PV)

Become the change you want to see

Blazing new trails to…

Kamala Maddali, Ph.D.
Title: Global VP
Company: Deep Lens
Education: DVM, Ph.D., Pharmacology, University of Missouri
Personal Awards: NJBIZ Healthcare Hero, 2016-2017
Company Awards: Presidential Award, Cancer Genetics Inc.
Community Awards: Women Empowerment Award, 2018
Associations: Paltown, Cancer NJ, Love Heals Cancer, Aarogya, Indo-US Rare; Advisory Board Member for AAPM COVID Global Taskforce; Adira Foundation; Vice Chair for the Women in Bio (WIB) Philadelphia chapter; Forbes Business Council, 2020

Kamala Maddali, Ph.D.’s mantra for leadership is to “spread some sunshine” by being passionate and positive about her commitment to patients’ health through her collaborative mindset in moving precision/personalized medicine forward.

Dr. Maddali has held positions as a precision medicine executive at Fortune 100 and 500 companies.

While working at Merck & Co., Dr. Maddali played a pivotal role as a biomarker scientist who understood the various pharmacological and toxic effects of investigational drugs across multiple therapeutic areas in oncology, neurology, and obesity disorders. She gained extensive experience as a chief scientific commercial liaison for precision medicine at top-tier central laboratories and reference laboratories, including Quintiles, now IQVIA, and Quest Diagnostics.

She also spent time as VP, biopharma collaborations and companion diagnostics, at Cancer Genetics Inc., where she played a pivotal role in developing the biomarker and companion diagnostics strategy in the context of pharma novel drug development programs. Cancer Genetics is a global company whose state-of-the-art diagnostic technologies help determine what will work best for each individual cancer patient and light a path for biophamaceutical companies working with immunotherapies. She promoted the proper use of biomarkers, personalized medicine, and diagnostics in drug development and patient management to bridge the gap between drug and diagnostic industries. It was at Cancer Genetics that she began questioning why there wasn’t a better way to determine the best options for cancer treatment and matching patients with cancer-related trials. She realized that technology could be used to help oncologists with their decision-making.

And now here she is as the global VP at Deep Lens, addressing the very challenges in healthcare that she once spoke about. Deep Lens is a software company focused on a groundbreaking approach to faster recruitment of the best-suited cancer patients to clinical trials.

Dr. Maddali also founded and is president of Health Collaborations LLC, a healthcare consulting firm focused on building partnerships between the U.S.-based and ROW companies in the precision medicine space.

She is committed to saving lives, to empowering those affected by cancer, and to inspiring younger generations to follow a path to healthcare and be the future of global community health.

Colleagues say Dr. Maddali’s cross-collaborative mindset comes from her unique healthcare background and her personal experience living with a neurodegenerative rare disease with symptoms similar to multiple sclerosis and Parkinson’s. As a result, she has become a patient advocate, working to bring hope and solutions to all patients.

Whenever possible, Dr. Maddali wants to ensure the patient’s voice is heard, and she strives to provide every patient with powerful tools from science and innovation to improve global community health. Her personal experience has given her a unique, empathic voice in precision medicine.

“Throughout my career, I have committed to building long-term strategic partnerships across the healthcare industry as well as bringing empathy and humanity into profit-oriented environments,” she says. “As a rare disease patient, I want to guide innovators toward investments that are both empathetic and profitable.”

With more than 20 years of experience implementing corporate strategic initiatives, she has been instrumental in the continual advancement of precision medicine. Her many levels of expertise include biomarkers and companion diagnostics, devices, therapeutics, recruitment of patients, patient engagement, patient experience, and empowerment.

Several healthcare technology companies have tapped Dr. Maddali to serve as an executive advisor to cultivate artificial intelligence, digital health, and solutions centered on modern precision medicine. With the increased interest in patient-centricity in clinical trials and clinical research, her involvement with patient advocacy and support groups in converging precision medicine, clinical trials, and clinical research could make a significant difference.

Dr. Maddali says her life journey has taught her that as humans we have to be doing humane business that impacts and helps others. Science coupled with compassion is a business model built for success, she explains, especially in the worldwide healthcare community.

A strong advocate of women empowerment, Dr. Maddali launched the Women in Bio Philadelphia chapter to foster leadership among women in life sciences and she was recognized for her efforts during a NYSE closing bell ceremony in 2017.

Dr. Maddali has strong medical, scientific, as well as rare disease roots, which gives her an edge as a visionary leader who fosters collaboration between medical, patient, and healthcare innovation sectors. Her greatest career highlight includes facilitating the partnerships with pharmaceutical companies, patient advocacy groups, and physicians.

Her most challenging assignment is learning more about how the biomedical industry views patient engagement. “We as an industry must work together to better understand the patient journey for real-world applications of innovation,” she says. (PV)

Committed, collaborative, and compassionate

Blazing new trails to…
empower the next generation of leaders

Melissa Barnhart
Title: Executive VP, Group Client Director
Company: CMI Media Group
Industry Awards: “Woman of Influence” by HM Exchange; Judge for the FiercePharma Awards; Moderator at EyeforPharma Patient Summit
Company Awards: Employee of the Year Compas; Employee of the Year CMI Media Group
Twitter: @CMIMediaGroup

A trailblazer in the industry, Melissa Barnhart is sought out by colleagues and clients alike for her ability to think through problems and create innovative, first-to-market ideas that help clients grow their business and exceed goals.

She goes above and beyond to deliver high-quality, innovative, and highly targeted media campaigns to her clients. She collaborates with publishers, clients, and other agencies to make sure everything is working in concert.

From management of branded promotional items all the way to brand strategy, Melissa puts the customer first and activates what they need to achieve success. She makes it her mission to understand the heart of what will drive results for clients.

Clients say Melissa is always responsive to feedback and takes a thoughtful and intelligent approach to accountability. She employs her impressive diplomacy skills to put aside personal issues and focus on solutions — without ever getting defensive or being sidetracked by ego or emotion. She has an intuitive foresight of what a client would want/expect, or what would help facilitate conversations, and meetings are that much more productive because of it.

The results speak for themselves. Before her current role, Melissa led CMI Media Group’s gain-share media programs, resulting in $40 million incremental revenue for a top 10 pharma client.

“I was responsible for the integration of U.S. and ex-US omni-channel HCP media for a top five pharma client’s oncology portfolio, identifying areas of efficiencies across multiple regions, and oversaw the integration of a strategic planning methodology across 30-plus clients, using CMI Media Group’s ADAPT — (audience driven agile planning and targeting) methodology for all media activity,” she says.

Ultimately, what matters to Melissa is knowing that the programs her teams have recommended and launched have positively impacted patients’ lives — be it new product therapeutic launches or new ways to engage with patients, caregivers, and healthcare providers.

Melissa’s management style, sincerity, openness, and dedication have earned her the respect, support, and admiration of her entire team. Her positive, can-do attitude has resulted in a thriving company culture and very low staff turnover.

She motivates her team by working with them to showcase how each team member is contributing to the larger project purpose.

“I have found that once people understand the why, they are more willing to get behind their leader,” she says.

Melissa has found that an honesty policy is key to building trust, as is bringing others along, providing context so when they’re in the position to make decisions they feel empowered and confident in their abilities.

“I lead with open communication, strive to be supportive, inclusive, collaborative, empowering team members to make decisions and challenge the status quo,” she says.

To help her colleagues deal with the upheaval of COVID, Melissa has reiterated the importance of work-life harmony, checking in on the team to see where they’ve needed additional support.
She encourages people to take a break from Zoom and helps colleagues new to working from home to set boundaries.

Mentoring is important to Melissa, and the best part for her is seeing people gain confidence and realizing their potential is limitless. She seeks to help others build their leadership style and offers candid information about the steps and missteps in her own career, and what she has learned with the benefit of hindsight.

One important lesson from her career is that when things don’t go as planned, it often works out for the best. Another is to always tell the truth then you’ll never get caught in a lie.

She says she would like to be remembered as someone who looked at any challenge as an opportunity, being creative in identifying new ways to achieve something great together, as well as someone who showed respect to all, applied trust and open communication, and empowered others to succeed.

Outside of work, Melissa dedicates her time to supporting non-profit organizations focused on literacy and education. (PV)

Innovation through AI for a better world

Igniting change by…
using AI to accelerate clinical trials, quell the pandemic, and re-establish global health and normalcy

Malaikannan Sankarasubbu
Title: VP, Artificial Intelligence Research
Company: Saama Technologies
Education: Bachelor’s degree, Information Technology, SSN College of Engineering, Chennai, India
Personal recognition: 2021 PM360 ELITE, Data Miners category; Distinguished Alumni Award, 2020, SSN College of Engineering, Chennai, India
Associations: IDLI — Founder; — Co-founder
Hobbies: Biking, running, volleyball
Twitter handle: @malai_san

Malaikannan (Malai) Sankarasubbu is leveraging AI to reshape the life-sciences industry and digitally transform drug development. His visionary aspiration is to accelerate the drug development timeline by 50% over the next five years. He is well known throughout the industry for his ability to turn hordes of numbers and research into actionable insights. His innovation and collaboration have resulted in significant advances to the industry, and his mentoring of the next generation ensures that his impact will be long-lasting.

Previously, he had pioneered Saama’s Smart Data Query (SDQ), a domain-centric, deep learning/AI system that learns patterns to decide whether queries need to be raised during clinical research. SDQ classifies predictions across 10-plus categories and more than 80 subcategories, generates clinical query text automatically, and reviews only those data points with clinical discrepancies. Sponsors can view clinical data in SDQ with deep integration with EDC systems, track and measure machine feedback, and approve, reject, and put discrepancies on hold.

Like many others, the year 2020 was a pivotal one for Malai as he tackled the challenge that was facing all of humanity by assuming the mantle of several crucial biopharma industry initiatives and turning enormous amounts of data into actionable insights. When the entire world came calling on drug developers to mitigate the novel coronavirus with treatments, Malai used his AI expertise and experience to accelerate drug developers’ science.

In 2020, SDQ was leveraged by a major pharmaceutical company in its COVID-19 vaccine mega-trial to shave an entire month off of the clinical development process and bring a much-needed vaccine to market to help fight the global pandemic. As a result of infusing process and technology optimizations into SDQ, under Malai’s oversight the platform helped reduce data review cycle times to a consistent sub two-day cycle and enabled delivering the data base for analyses faster than any trial in the company’s history. Malai helped ensure SDQ produced exceptional data quality throughout the trial, which on any given day was more than 100 million clinical data points for the vaccine trial.

Malai also helped pioneer additional innovative, new COVID-19 research last year by developing the Interpretable Machine Learning Classifier to discriminate COVID-19 positive coughs from both COVID-19 negative and healthy coughs recorded on a smartphone. This type of screening is non-contact and easily applied and helps reduce workload in testing centers as well as limit transmission by recommending early self-isolation to those who have a cough suggestive of COVID-19. The two datasets used included subjects from six continents.

Malai was also integral to another COVID-19-related milestone in 2020. In response to the pandemic, the White House, the Allen Institute for AI (AI2), and leading research groups created the COVID-19 Open Research Dataset (CORD-19), a publicly available database containing more than 140,000 scholarly articles about COVID-19, SARS-CoV-2, and related coronaviruses. Recognizing the imperative need to expedite COVID-19 research, within days Malai spearheaded the development of a semantic search capability to help the global research community use this database even more effectively.

Malai adheres to a collaborative approach to problem-solving. “You only have 24 hours in a day to solve problems,” he says. “If you want to solve complex problems, inspire others to solve them with you. My team wanted to contribute to ending the COVID-19 pandemic, so there was a common sense of purpose that kept the team motivated during the COVID period.”

These incredible achievements have occurred within the 18 months, but Malai’s influence and impact on life-science analytics extend throughout his career. A community builder, Malai founded the Indian Deep Learning Initiative (IDLI), a Facebook group with more than 10,000 members, to spread knowledge of AI and analytics to the world. He also co-founded, an open data platform computing tool for regional Indian languages, such as Tamil, Malayalam, Telugu, and Bengali.

Malai says he is passionate about inspiring the next generation to take up analytics challenges on their own and collaborate, and he applies this passion within Saama as well as to the more abundant life-sciences and technology industries. (PV)

Helping people view things in a different light

Sparking innovation by…
illuminating the path of what is possible rather than what might be obvious or expected

Christine Roth
Title: Senior VP, Global Oncology Therapy Area Head
Company: GlaxoSmithKline
Personal Awards: TJ Martell Women of Influence Keynote
Company Awards: Pinnacle Award for marketing innovation, Excellence in Leadership Award
Associations: American Society of Clinical Oncology, American Society of Hematology, Healthcare Businesswomen’s Association
Giving Back: Warrior Canine Connection, Delaware Valley Food Bank

Christine Roth’s career has been driven by her enduring passion to find cures for cancer patients. After starting her career as a scientist, Christine joined Bristol Myers Squibb, where she was one of the early pioneers in immuno-oncology through her work on Yervoy (ipilimumab) for melanoma.

While Christine looks back fondly on that experience, she says those were incredibly challenging years. “After decades of failures and doubt that engaging the immune system to fight tumors was likely to work, my team, working on an early immuno-oncology medicine, set out to attack the opportunity on multiple fronts,” she recalls. “While waiting for the data to mature, we had to begin the process of overcoming that negativity, engaging those who would become champions for the science, and creating a comprehensive communication plan to build belief in the promise of immuno-oncology.”

The initial data showed little benefit in terms of disease progression, however Christine says investigators reported clinical improvements in patients.

“This discrepancy set off a concerted effort to better understand the kinetics of response, which helped define the right expectations for endpoints in future clinical trials,” she says. “It was an exciting ride with lots of twists and turns along the way. Today, we are addressing the new challenge in immuno-oncology, which is to extend the benefits of immunotherapy to a broader range of patients through novel combinations with the next wave of immuno-oncology innovation.”

Today, Christine calls her return to GlaxoSmithKline in 2017, after a couple of years at Novartis, her biggest career highlight. As senior VP, global oncology therapy area head, she is leading the rebuild of GSK’s global oncology business and contributing to the transformation of GSK into a new biopharma-focused company.

“I am so energized by our new ambition to deliver a step-change in performance and have a positive impact on the lives of more than 2.5 billion people over the next decade,” she says.
“This role fully leverages all of my diverse experiences across companies, functions, therapeutic areas, and geographies. At GSK, it has been tremendously fulfilling for me to help deliver the first wave of oncology pipeline innovation to patients and accelerate the delivery of our mid- and early-stage pipeline.”

In the first three years of GSK’s oncology reboot, Christine’s teams have built a comprehensive package of specialty pharma capabilities in addition to new oncology medicines. They have also delivered new therapeutic options to oncology patients with unmet needs.

Christine says she’s laser-focused on building GSK’s oncology business to critical mass. To that end, she’s also been exploring ways to build a pipeline of diverse talent.

The first thing Christine looks for when building a team is someone who conveys his or her ability to put the team ahead of themselves, which she believes is an essential part of a high-performing culture. “Next, I look for a general sense of intellectual curiosity,” she says. “To me, that signals the desire to push beyond the obvious to get to that next level of customer insight or more innovative thinking. For my leadership team, I look for people who have the ability to both drive results today and define the path to future growth.”

For Christine, part of the enjoyment she derives from the mentor-mentee relationship is freedom from the accountability of managing the person. “Instead, I have the freedom to support their journey of self-discovery,” she says. “The biggest reward for me is playing a role in eliminating self-doubt and helping people to successfully stretch outside their comfort zone.”

Her peers and mentees describe Christine as a champion for inclusivity for all. She is a senior sponsor in GSK’s Accelerating Difference program, a development opportunity for women and ethnically diverse employees who receive one-on-one and group coaching, dialogue sessions, and senior-leader sponsorship.

“My job as a leader involves creating a culture and an environment that drives deep engagement, where our people can have the courage to take smart risks and still feel safe to bring their best self to work, and where they can reach their full potential,” she says. “If you get all this right, business results follow. And all of this is easier when your team knows who you are, what you stand for, and that they can trust you. I’ve always aspired to maintain my authenticity, and I am grateful that I have a team that welcomes and appreciates that in me.” (PV)

Leading with authenticity

Igniting change by…
continuing to develop the next generation of leaders

Ellen Street
Title: Executive VP, Product and Quality Management
Company: eResearch Technologies (ERT)
Education: MBA, University of Texas at Austin; Bachelor of Mechanical Engineering with a Business Minor, Villanova University
Industry Awards: Four-time Sigma Board Achievement (Top 5% of sales team); Omega Society; President’s Award Winner, Six Sigma Greenbelt Certification; Selected to attend multiple highly competitive GE Corporate Executive leadership Development programs
Community Awards: Montgomery County Community leader
Associations: American College of Healthcare Executives, Healthcare Businesswomen’s Association, Society of Women Engineers, Tau Beta Pi
Giving Back: Food banks and Groups providing healthcare to underserved populations; Education & Extra-Curricular Participation including Scholarships to support student engagement in Band/Music programs; Advancement of professional women to lead the transformation of healthcare
Twitter: @STramblings

With laser-like precision implementing transformative initiatives, Ellen Street is focused on generating innovative ideas and solutions to impact the future and improve worldwide patient health.

As co-leader of ERT’s product organization, Ellen drives the business forward at an accelerated pace by bringing ERT product lines together to become more scalable and efficient, and to provide the best, science-driven, most seamless customer experience and workflows. In addition to this over-arching role, Ellen leads ERT’s cardiac, eCOA, wearables, and digital biomarkers product lines, as well as ERT’s quality and regulatory organization.

Among her accomplishments at ERT is growing the cardiac safety business through a transformative time, with significant improvements in clinical trial technology and methodologies for early phase characterization of cardiac safety with more efficient study designs, reduced study timelines, and more confidence in the safety as compounds progress.

She brings with her significant achievements from her time at GE, including leading a $550 million U.S. P&L with more than 250 commercial team members spanning five sales channels.

Over a three-year period, Ellen and her team consistently grew orders in the range of 104% to 110% per year leading to both market share gain and a 34% increase in operating margin.

Her toughest assignment was in 2007 when she was tasked with designing, building, and leading the go-to-market strategy for a “start-up” emergency care-focused segment in healthcare. “While my company offered a variety of medical device and imaging technologies that are often used in an emergency care setting, no one had ever really focused on the needs of this important care area in the U.S. healthcare system,” she says. “Despite the financial meltdown in late 2008, and the need to completely revise and pivot the strategy to focus on leveraging existing sales team members from other channels, I grew emergency care orders by more than 200% in the first full year and over 150% the following year.”

Ellen combines her focus on the business side of her role while prioritizing the protection of employees. She makes time to work with employees who are struggling, while also being involved with hiring and recruiting.

During COVID-19, Ellen helped her team by checking in with them regularly, participating in employee-driven events that included virtual roundtables, trivia game competitions between ERT locations, and posting of “ERT Life” pictures as people share their day-to-day happiness and local activities.

Described by her colleagues as a stellar example of someone who works hard, empowers her team, and treats everyone, at all levels, with the utmost respect, Ellen leads by example and jumps in as a player-coach whenever necessary. An authentic leader, Ellen strives daily to communicate transparently, model accountability, build trust, and treat everyone with respect. She values a diversity of ideas and sees her role as an “integrator” across the organization to ensure alignment as well as ensuring a clear understanding of interdependencies.

She currently formally mentors three individuals and is on the “personal board of directors” for several others with whom she has built connections with over the last 25 years.

“The best part for me is the mutual learning and watching people take new paths that have given them new opportunities and energy to overcome obstacles and succeed,” she says. “I am passionate about challenging cross-functional teams to leverage processes, technology, and offerings with value propositions that accelerate growth and leverage the best ideas from anywhere,” she says. “I love to instill a sense of purpose and a desire to go above and beyond. I am also more of a systemic thinker, so I challenge team members to take a broad view and make sure they understand the interdependencies of their decisions or recommendations.”

Taking risks and considering new challenges have been integral to Ellen’s professional growth. “I learned the most by taking on new opportunities that I had not originally envisioned pursuing,” she says. (PV)

Dr. Digital

Blazing new trails to…
push the needle forward — always

Christian Rodgers
Title: Head of Digital
Company: Pascale

Christian Rodgers, aka Dr. Digital, is lauded by both colleagues and clients for his strategic expertise, industry knowledge, digital mastery, and team leadership that pushes the boundaries of pharmaceutical digital marketing.
Undoubtedly following Christian’s digital lead, the group of associates who nominated him not only sent in their accolades in writing, but they also made an effective digital video of their testimonies.

He inspires them to continuously elevate the work that they produce for clients.
Christian’s industry knowledge and understanding of healthcare marketing keeps the agency on the cutting edge of the space and producing the best work possible. He encourages the entire team to further their own professional development, and he provides team members with the resources to do so.

Clients say Christian Rodgers is their go-to guy for all things digital marketing. He brings his A-game and his A-team, and he’s always ready to go. He continually impresses those around him by his skilled leadership in putting the best teams together, the insights he brings to the table, and how he challenges his clients to make a bigger impact.

Christian says there is a saying within healthcare companies: “No one wants to be the first to do something new, yet everyone wants to be the next to do it.” However, Christian is always thinking ahead and looks to position clients for the future, which often means trying things that haven’t been tried before.

He has created a great deal of trust through his commitment and devotion to his clients, which opens them up to taking risks in a slow-to-change industry like healthcare.

Christian fully understands pharma, medical, and digital media and is able to take very complex ideas and put them into actionable concepts that work on social media to help educate physicians or patients in whatever social media forum necessary.

Christian and his team have brought the idea of influencer marketing to healthcare digital strategies and have created a program to identify and accelerate the profile of targeted individuals who are key to a client’s brand. For example, Christian and the team have identified doctors who are awesome on TikTok or Instagram, who might not yet be key opinion leaders in the wider sense.

But by cultivating and developing these voices, peer-to-peer conversations can be facilitated. This type of networking has become more important than ever during the pandemic when face-to-face connections were not happening.

Christian joined the Pascale team over six years ago, and his innovations in pharmaceutical digital marketing have been groundbreaking. He launched the social media practice in 2015, when pharmaceutical brands and medical devices were just beginning to take social media marketing seriously.

A determined vision guided Christian’s work as the agency built out its digital capabilities and team. As head of digital for Pascale, he has worked on the launch/re-launch of several pharmaceutical brands, including the launches of a few black-box drugs.

Since coming on board at Pascale, Christian has created a 10-person digital team and has built Pascale’s digital work into a seven-figure business. Even during the global pandemic, he grew Pascale’s digital revenue by 44% from 2020 to 2021. His dedication and attention to detail has allowed Pascale to build an industry-leading community management and response protocol that’s been recognized by the FDA.

Thanks to Christian’s mastery of all things digital, his team can map out and activate a plan in record time, no matter the size or type of client. A notable element of his leadership style is that internally, Christian structures his team into groups that have their own identity and ways of working. This allows individuals to shine as they are empowered to bring their personality and special skills to each project. The groups are connected to each other by bridges so that, although the “template” of success remains the same, people are free to achieve the end result in ways that match their own style of working. Once projects are up and running, he “consist-ifies” what works well, and incorporates those successes into the game plan across all clients.

Christian’s digital leadership instills immense confidence, which in turn strengthens relationships, ultimately leading to long-term collaborations and repeat business.

“I see my role as teaching what I know, and steering team members toward achieving their goals,” he says. “Getting individuals on a team rowing in sync and in the same direction is critical, along with securing the resources so that decision-making happens as close to the front line as possible.”

Christian’s ability to always deliver and inspire are much-appreciated by his teams and clients. Christian calls this being #responsiveAF. (PV)

The biggest regret in life is the risk you didn’t take

Blazing new trails to…
encourage creativity, as that takes courage

MaryAnne Rizk, Ph.D.
Title: Managing Partner
Company: Rizk Management Consulting
Education: Bachelor’s of Engineering, Stevens Institute of Technology; Masters of Science, Management, Stevens Institute of Technology; Ph.D., Technology Management, Stevens Institute of Technology
Personal Awards: Merck Award of Excellence, Oracle Award of Excellence
Company Awards: Most Innovative/Admirable Organization
Community Awards: Presidents Awards, Stevens Institute of Technology
Associations: Digital Advisory Board, Prix Galien Digital Health; Board of Directors, HBA; member, Women in BIO; member, NYCHBL; Board Committee, SCRS Innovation Council; advisor, DIA, Pink Socks
Hobbies: Skiing, biking, swimming, golfing, traveling, cooking, wine tasting,
raising dragons
Twitter handle: @RizkManagement

Colleagues have called MaryAnne Rizk, Ph.D., “the partner to all partners.” It’s an identity she wears proudly. “The moments I’ve cherished across my career journey — taking big leaps — required a main active ingredient: strategic partnerships,” Dr. Rizk says.

In one of many examples, as a pre-IPO executive at Medidata, Dr. Rizk was responsible for accelerating startup growth for the company and executing a corporate strategy partner initiative that led a private startup company to be publicly traded on Nasdaq.

“As the founder of the Medidata Partner Program, I had led strategic partnerships and alliances across 60-plus CROs, which included more than 1,000 certifications globally on Medidata Rave EDC,” she recalls. This allowed partner CROs to build offerings around the technology they were just accredited in. As a result, global market share expanded rapidly, with a 35% increase in revenue growth, which led to Medidata’s accelerated IPO.

Now, as managing partner of Rizk Management Consulting, Dr. Rizk provides advisory consulting services around strategic partnerships and outsourcing to organizations in the life sciences. Her background in pharma, technology, and CRO organizations gives her a unique pedigree of experience.

“My career has always been full of assignments to develop a road less traveled, forging new paths of business and growth,” she says. “As a trailblazer, I seek to set the world on fire with ideas to transform with innovation powered with strategic partnerships.”

This forward-looking stance left Dr. Rizk well-prepared for the seismic shifts resulting from the pandemic.

“Even before COVID hit, my most challenging assignment was advancing the expansion of decentralized clinical trials,” she says. “I learned how important it was to embrace the idea that the operational level is equally important as the strategy level. Most tech organizations know how important it is to build the most innovative solution around where the puck is going and not where it is. Once COVID hit, the rest of the world caught up with a vision I’ve been advocating, and a forced culture emerged.

“Culture eats strategy for breakfast,” she adds. “The culture of an organization always determines success regardless of how effective a strategy may be. While strategy defines direction and focus, culture is the habitat in which strategy lives or dies. Strategy focuses on resourcefulness and skillfulness, while culture defines engagement, passion, and execution.”

Dr. Rizk says one of the best pieces of advice she ever received was to teach others how to fish, so to speak. “Going back to the days of creating a powerhouse SaaS partnership model, it’s all about empowering clients to do it themselves,” she says. “It’s the same basic principle for inspiring teams. Create a level of autonomy demonstrated with earned experience and watch magic start to happen at a rapid rate across the ecosystem of your partners. This is where innovation happens.”

Dr. Rizk brings this philosophy to what she refers to as a “visionary pacesetter” leadership style, involving a ton of high energy and a dynamic work environment. “While the bar may be high, the exciting journey includes support, coaching, and empowerment of the team to find their entrepreneurial path on how they can get there,” she says. “The goal is to empower all to aspire to win. My style helps companies grow, unites teams, and fast-tracks breakthrough milestones.”

Dr. Rizk focuses her team to find their “Ikigai,” which is the Japanese concept meaning “reason for being” that is the intersection where passion plus mission plus profession plus vocation meet.

As a leader, Dr. Rizk looks to ignite fire. “I seek to understand what drives people, finding out their why, and developing a hand-to-glove fit in their assignments to hit their personal goals as they strike the corporate objective,” she says. “The inspiration comes from within as they understand the purpose and how their work creates that domino effect impact. The result: home runs.”

Dr. Rizk embraces her role as mentor, “sharing pearls of wisdom to those who want to have a strand of experience to leverage.”

One piece of advice she offers up is to rely on your trusted tribe and treat them like the family they are.

“Your career growth depends on a network of professionals who will grow with you,” she says. “If you want to go fast, go alone. If you want to go far, call your tribe. The power of partnership is exponential.” (PV)

Bringing science, people and business together

Igniting change by…
Being curious

Angie Namenuk
Title: Executive Director, Development Sciences Business Management and Communications
Company: Genentech
Education: B.S., Chemistry, Willamette University; MBA, Business Administration, Graziadio Business School of Pepperdine University; Certificate in Project Management, University of California Berkeley; Certified Professional Coach, IPEC
Personal Awards: Pepperdine University George Award Recipient, 2012
Community Awards: San Carlos Honorary Service Award
Associations: Co-Founder Kahawa Foundation; Healthcare Businesswomen’s Association (HBA); Board of Directors, Donor Sibling Registry
Giving Back: Kahawa Foundation, which she co-founded
Hobbies: Biking, hiking, gardening

In her role at Genentech, Angie Namenuk bridges two disparate worlds: science and business. Angie leads the day-to-day business operations and processes for Genentech’s Development Sciences organization, a team of about 700 global employees that enables the translation of promising molecule discoveries from research into therapeutic development. She also is responsible for creating the infrastructure that optimizes and enables scientific innovation such as strategic planning and communications, resource allocation, contracts, and much more.

Angie is passionate about science, people, and business. “I want to leverage my deep experience in science and business to create organizations that optimize how they work together in the overall interest of making innovative medicines for patients who need them,” she says.

Bridging disparate worlds seems to be in Angie’s DNA. She spear-headed the initiative to optimize the interface and alignment between pharma and diagnostics for Roche, Genentech’s parent company. “While both groups were quite innovative and already had existing processes in place for working together, they were also misaligned on some key factors like decision-making and joint goals,” she says. “I drove conversations that teased out why the misalignments existed and how we might solve for them. We invested significant time in relationship building, deepening our understanding of each aspect of our business, and establishing new business processes that optimize how we work together. I’m very proud of this work because the partnership between Roche Diagnostics and Roche Pharma is critical for the patients served and the overall success as a company.”

Her toughest assignment came when Roche acquired Genentech in 2009. At the time she was head of the Development Sciences operations, overseeing multiple aspects of business operations for the scientific organizations. “With the acquisition came restructuring, and, ultimately, an organizational design that was complicated, yet created enormous opportunities,” she says. Connecting and aligning different parts of the organization at first felt overwhelming, but she learned to love understanding challenges in the context of the local organization and culture, then lifting up and thinking about operations in a broader more systematic way.

Throughout her career, curiosity has guided Angie, who says complex organizations need leaders who continuously ask questions and seek answers from all areas of the company.
Of equal importance to curiosity is being authentic and inspiring trust, which sets the stage for employees to be more comfortable with themselves.

As a leader, she strives to ensure everyone sees how their contributions are valued, and she empowers her team members to solve problems themselves while ensuring she is there to support them if they need it.

“When you can inspire others to think together and leverage each other, it can result in a very engaging and creative environment where solutions are well-positioned to meet the needs of multiple stakeholders,” she says.

Mentoring is important to Angie, who looks after rising talent in the organization and engages with STEM students from underrepresented groups, as well as serving as a mentor for Women Unlimited.

Angie says sharing her personal story has been important too. Her mother, who was widowed young, raised Angie and her two sisters by herself, and that struggle motivated Angie to attend college to ensure she had more choices in life.

“As a result, I am a first-generation college student raised by a single mother,” she says. “I am also a member of the LGBTQ+ community and mother of two children. It’s been important to me to share my story with openness and authenticity. People in an organization need to know that many people, including or even especially leaders, have gone through struggles or have things about them that make them different — and it’s ok.”

Angie is passionate about paying it forward. She co-founded the Kahawa Foundation, after attending a leadership training program in Tanzania that focused on addressing cervical cancer issues in Subsaharan Africa. During their journey, Angie and her co-founders visited and worked with local healthcare leaders to identify needs and solutions to reduce the burden of cervical cancer in the area, which is the No. 1 cancer killer of women in Tanzania, even though these deaths would be preventable with the proper screening and treatment available in other developed countries. (PV)

Delivering sales

Blazing new trails to…
adapt a selling model in a post-COVID world

Dave Mauro
Title: Executive VP, Business Development
Company: Antidote Technologies
Education: B.S., B.A., University of Delaware
Giving Back: Molly Ann Tango Memorial Foundation
Hobbies: Reading — mostly non-fiction and current events

When Dave Mauro joined Antidote Technologies in the summer of 2020, the company was already feeling the impact of the COVID-19 pandemic that had begun a few months earlier. With many clinical trials paused, patient recruitment was on hold as well, so Antidote had to pivot and adjust to handle the stall in its business model.

As executive VP, business development, Dave hit the ground running with confidence and professionalism. He set the stage for steady growth in the third and fourth quarters of 2020, and by the end of the year Antidote had posted a revenue increase of 66% over 2019 and saw its number of projects more than double from the previous year.

And 2021 has started with a bang as well, with Antidote having closed three COVID-19 treatment studies totaling more than $5 million in bookings during the first few weeks of the new year. This puts Antidote on track to have its best year yet.

“I’m fortunate enough to be doing exactly what I want to be doing — helping an emerging company with a very important mission achieve our growth targets,” Dave says.

While Dave is proud of Antidote’s progress toward those targets, he’s also striving to be a mentor and role model for what he describes as “a highly dedicated and fun group of people who joined Antidote in order to help connect individuals to lifesaving or life-altering clinical trials.”

He’s proud of the fact that many of his previous direct reports refer to him as a mentor. “The best part of being a mentor is found in the famous quote about teachers: ‘They affect eternity. One can never tell where a teacher’s influence stops,’” Dave says. “I see many of my former direct reports currently leading sales teams, and it makes me very proud in knowing that they might be using some piece of advice that I gave them years ago.”

Colleagues and mentees praise Dave’s approachability, genuine empathy, openness, and passion for the work he does. They say these qualities, along with his easygoing nature and sense of humor, help to facilitate the professional development of everyone around him.
“I’ve learned that one of the best ways to inspire people is to provide frequent reminders of their specific important contributions to the team goals,” he says. “People are inspired when they feel part of something bigger than themselves.

“Another lesson is to demonstrate your trust by seeking out their opinions and empowering them to make big consequential decisions,” he adds. “Nothing is more inspiring to an employee than knowing their decisions and opinions are valued.”

Early in Dave’s career, as he learned how to become a pharma sales manager, a mentor told him something surprising and profound: always remember that recognition is a far more powerful motivator than money. That insight became the guiding principle in his leadership philosophy.

“It’s a commonly held belief that sales executives are ‘coin-operated,’” Dave says. “Although it’s true that monetary compensation is how many sales execs keep score, what’s most important to the vast majority is the sincere and timely recognition of their achievements — especially in front of their peers. Never miss an opportunity to shine a spotlight on a job well done.”

Dave says he hires people that he trusts, and demonstrates that trust by giving them plenty of room to do their job, while always being available to provide guidance and support. He never ends a one-on-one call with one of his sales executives without asking if there’s anything he can help them with.

“I once overheard one of my long-tenured sales executives describe my leadership style to a new hire,” Dave recalls. “She said, ‘As a manager, Dave is not a control-freak, but he is an information freak.’ Knowing this person well, I am convinced she meant it as a compliment, and we both laugh about it years later.

“As a leader, I feel it’s my obligation to understand the details around the challenges my direct reports are facing, so that I can be in a better position to offer assistance,” he adds.

Like many leaders, Dave says keeping his team focused, motivated, and happy during the past 18 months of the pandemic has been an incredible challenge. “Amplifying this challenge for me has been the fact that I joined Antidote in the midst of COVID-19, and therefore have not met any of my new colleagues outside of Zoom,” he says.

During this period of virtual connection, Dave has helped motivate his team by providing them with the flexibility to do their work at a time and place that is best for their family. “I’ve been giving my colleagues the authority to make decisions on how they can achieve the results we desire in a manner that may be different in structure than we had originally planned,” he says. “The added stress that COVID puts on working families with young children is devastating to morale unless leaders convey a sense of trust and flexibility.”

One thing Dave knows now that he wishes he’d knew earlier in his career is that he often learns more from his losses than from his wins.

“When I was a younger sales executive and sales manager, I would want to bury a disappointing loss as quickly as possible and move on,” he says. “Only later in my career did I realize the value of placing a strategic lens over an unsuccessful sales engagement in order to identify areas that can be improved. As soon as I learned to accept that mistakes are a part of every sales engagement, I became much more effective at anticipating challenges and obstacles in subsequent opportunities.” (PV)

Keep moving forward

Sparking innovation by…
collective creativity

Kristen Hege, M.D.
Title: Senior VP, Hematology/Oncology & Cell Therapy
Company: Bristol Myers Squibb
Education: B.A., Dartmouth; M.D., Univ California, San Francisco
Personal Awards: PhRMA “We Work for Health Champions” Award, 2013; Fierce Biotech “Top 12 Women in Biopharma 2015” Award & Article, 2015; Best Clinical/Translational Paper of the Year Award from Journal of Immunotherapy for Cancer, 2017; Healthcare Businesswomen’s Association (HBA) Luminary Award 2019; Nature Medicine 1 of 50 featured researchers celebrating 50th anniversary, 2019; Society for Immunotherapy of Cancer 35th Anniversary Collaborator Award, 2020
Community Awards: San Francisco Business Times Most Influential Women in Bay Area Business, 2020
Associations: American Society of Clinical Oncology (ASCO); American Society of Hematology (ASH); Society for Immunotherapy of Cancer (SITC); American Association for Cancer Research (AACR); New York Academy of Science (NYAS)
Giving Back: Equal Justice Initiative; Algorithmic Justice League; Pursuit of Excellence; Breakthrough San Francisco
Hobbies: Alpine, skate, and backcountry skiing around the world; backpacking; running; mountain biking; listening to audible books
Twitter handle: @KristenHege

A pioneer in the industry, Kristen Hege, M.D., has been part of some of the most exciting and groundbreaking science the life-sciences community has seen.

She started her career as a research fellow in the lab at a small San Francisco Bay Area biotech company working on CAR T cells for treatment of cancer and HIV infection in the early 1990s, before this field was “hot.” In 2010, she joined Bristol Myers Squibb, where she oversees early clinical development for a number of different treatment modalities including CAR T, T-cell engagers, monoclonal antibodies, and small molecules.

Her big career moment came in March with the approval of Abecma, the first-in-class CAR T cell therapy for multiple myeloma.

“It has been very gratifying to come full circle back to CAR T cells and have the opportunity to partner with bluebird bio to bring this BCMA-directed CAR T cell product from target selection to FDA approval,” she says.

Developing a novel breakthrough therapy at breakneck speed poses innumerable challenges, she says.

“Add to that the complexity of patient specific, genetically modified, living cells as the drug product,” she says. “We did all of this only about four years from the first patient-dosed study to completion of the pivotal registration trial and submission for FDA approval, and you can imagine the nimble, laser-focused, problem-solving, parallel processing mindset required.”

Through most of her career, Kristen has focused on early-phase development of next-generation cancer therapies. “While many of these programs still fail, this is where scientific disruption achieves its first proof of concept,” she says. “This stage of development requires an innovative mindset, curiosity, and a passionate and focused determination to interrogate the lessons learned from early failures and apply them to enhance the probability of future success. If you are lucky enough to experience one of these disruptive successes after decades of earlier failures, it’s is an incredible experience.”

Kristen says she seeks to hire great talent, often without a lot of real-world experience, and then invests her personal time and energy in their training and education. She looks for people with raw talent, curiosity, humility, a sense of purpose beyond personal advancement, and a “can-do” attitude who thrive on challenges and redirection.

She says her focus now is to help guide and develop the next generation of physician and clinical scientists to accelerate the development of more cutting-edge and disruptive technologies that will really move the needle for treatment of cancer and other serious diseases.

She mentors a number of predominantly female rising stars and has built a strong mentor/mentee relationship with a woman she mentored as a college intern 10 years ago, through her first biotech job and now in a Ph.D. graduate school program.

“I took her on her first ever wilderness backpacking trip in the California High Sierras, and since then she has backpacked all over the world and we take at least one trip together each summer where there is plenty of trail time to discuss science, careers, society, and everything in between,” she says. “This summer she will co-lead a backpacking trip with me for the inaugural class of summer interns who we are hosting at BMS as part of our Bay Area diversity STEM initiatives.”

Kristen also hosts summer interns and has co-chaired a series of conferences through the Society for Immunotherapy of Cancer, which focus on women early in their careers.

To manage the challenges of COVID-19, Kristen leaned into her mentoring techniques to keep the team inspired and focused. She implemented a biweekly team newsletter, virtual gatherings, and social activities. With her San Francisco team, she spearheaded a series of drive-by meet-and-greet dinner pick-ups for families from a local cafe, owned by one of her UCSF thoracic surgeon colleagues. “These were followed by virtual dinner hour Fireside Chats with inspiring local figures, including Joe DeRisi, the ‘virus hunter’ spotlighted in Michael Lewis’ The Premonition,” she says. (PV)

Beating cancer is in (MY) our blood

Blazing new trails to…
work together for better therapeutics and cures for blood cancer patients

Amy Burd, Ph.D.
Title: VP, Research Strategy
Company: The Leukemia & Lymphoma Society (LLS)
Education: Ph.D., Pharmacology, University of Minnesota; B.S., Biochemistry, Ohio Northern University
Personal Awards: Appointed to lead the Beat AML Project, which is part of the Cancer Moonshot that was announced in 2016 by the then Vice President Joe Biden (now President)
Associations: American Society of Hematology
Giving Back: The Leukemia & Lymphoma Society, both working for the society and supporting its activities and events so that it can continue to do great work

Amy Burd, Ph.D., has one very simple, yet highly complex, professional goal: To develop better, more effective, and tolerable cancer drugs for patients living with blood cancers.

From an early age, Dr. Burd was committed to improving cancer treatments. After getting her degree in biochemistry and doctorate in pharmacology she worked at a variety of research jobs, including in immunology at Boehringer Ingelheim and as an oncology portfolio manager at Bayer Pharmaceuticals.

She then joined The Leukemia & Lymphoma Society (LLS) to become the senior director of its Therapy Acceleration Program (TAP), a strategic initiative through which LLS partners directly with biotechnology companies to help accelerate the development of promising therapies in blood cancer.

In her current role as VP of research strategy at LLS, Dr. Burd provides strategic planning and oversight for mission special initiatives. Her career highlight has been to lead the Beat (acute myeloid leukemia) AML Master Clinical Trial, the first collaborative precision medicine clinical trial in blood cancer, which was also part of the Moonshot program that Vice President (now President) Joe Biden announced in 2016.

“The highlight of this opportunity was on Thanksgiving Day in 2016 when the Beat AML team — rather than eating turkey — was focused on making the first treatment decision using genomic data for this trial within seven days, this was a real breakthrough because of the technology,” she says.

AML is one of the most lethal blood cancers that takes more than 10,000 lives in the U.S. per year. The trial used advanced genomic technology to identify each patient’s cancer-driving genetic mutations so that it could match each patient with the most promising targeted treatment. It involved more than a dozen sub-studies, 16 sites, nine pharmaceutical partners, and 1,065 patients.

“To coordinate all of this effectively is a major feat; the trial has been successful so far due to the numerous technologies that were implemented to streamline this large umbrella trial operationally,” Dr. Burd says. “In fact, because of the remote digitization of the trial technologies, when the pandemic hit, we did not need to scramble as much, as we had already built remote data monitoring into our master protocol.”

It was not without challenges, however, in particular getting all of the partners to embrace the new technologies the team needed to use, such as a centralized oversight platform, remote data monitoring and digitized protocols, and different management strategies than what is typically used in traditional trials.

“We hope that this trial will set a new precedent for other precision oncology trials that include multiple cohorts,” she says.

Early in her career, Dr. Burd thought the only path to developing novel therapeutics was by working at a pharmaceutical company, but she has learned the importance of non-profit organizations in the drug development process, and how they are the voice of the patient.

Dr. Burd describers herself as persistent and creative, two traits that are absolutely necessary in her pursuit to improve the lives of cancer patients. She is persistent in her commitment to do a good job, she takes pride in her work, and she sets a good example for others to follow.

Persistence also requires patience, which is especially important when engaging in drug discovery and development because of the number of the number of years it takes to develop new therapeutics. As for the creative piece, she says when you are creative, you get your work done by finding pragmatic approaches to solve problems. “This was the foundation of the Beat AML Master Trial both in trial design and execution,” she adds.

In leading her teams, Dr. Burd creates a vision and then empowers those around her to achieve that vision. “I find that having a goal of how to improve the lives of cancer patients inspires others to work together in ways they didn’t even think was possible,” she says.

A mentor and sponsor of next-generation leaders, Dr. Burd teaches courses in drug discovery and development and biomarkers at a local university, and through these activities she passes along the knowledge she has accumulated over the years and the passion and possibilities of science that she embraces. “I believe that by teaching, I can fuel a love for science and have a tremendous impact on young people who will be our next generation of scientists,” she says.

A strong believer in work-life balance, Dr. Burd knows that to maintain the creativity and energy to be innovative it’s crucial to switch gears and disconnect at the end of the workday. (PV)

Good things come in little packages

Sparking innovation by…
challenging conventional thinking to come up with new ideas and approaches, and supporting the team in bringing innovations to the drug programs

Robert R. Goodwin
Title: VP, Head of Operations Center of Excellence in Global Product Development
Company: Pfizer
Education: MBA, Pharmaceutical and Chemical Studies, Fairleigh Dickinson University; M.S., Research Measurement and Quantitative Analysis, Southern Connecticut State; B.S., Psychology from Eastern Connecticut State University
Company Awards: 2002 Pfizer Global Research and Development Award for implementation of Electronic Data Capture; 2005 Pfizer Global Research and Development Award for Harmonizing the clinical processes across Clinical and Operations post Wyeth merger
Associations: BioStats and Data Management Working Group; Past board member of CDISC; Current member of TransCelerate operations board; Current member of SCDM advisory board; Co-chair of Vulcan HL7/TransCelerate research accelerator
Giving Back: Connecticut Cancer Foundation

Let’s cut to the chase: Rob Goodwin, backed by an incredible team around the globe, condensed a normally eight-year clinical trial process for a COVID-19 vaccine down to less than a year using operational efficiencies. As VP and head of the Operations Center of Excellence Global Product Development at Pfizer, Rob and his team were integral to fast-tracking the vaccine for COVID-19.

Rob directed the team to use innovative tactics such as implementing remote site access and monitoring technology for clinical trials that not only increased efficiency but allowed as many people as possible to social distance and remain safe, as well as instituting parallel processing and waiving the 30-day IND application waiting period.

Additionally, from July to October of 2020, Rob helped Pfizer enroll more than 45,000 people in the COVID-19 vaccine’s landmark clinical trial. Under normal circumstances, recruiting that many participants would take two to three years. When the results came in that the Pfizer vaccine was more than 94% effective at preventing symptomatic COVID-19, Rob and his team cheered, cried, and celebrated together. “Being a member of the Pfizer COVID-19 vaccine team and helping to bring one of the most vital components necessary to put an end to the worst pandemic in a century has without a doubt been the highlight of my career,” Rob says. “I am humbled and proud of the clinical trial volunteers, clinical sites, healthcare workers, and our own team who worked to bring this breakthrough vaccine to the world.”

Rob has been an innovator in pharmaceuticals, clinical trials, and research for almost 30 years. In fact, he has been implementing cloud services at Pfizer trial sites since 2016, bringing clinical trials and potentially life-saving care to those who normally would not have access.

While the vaccine success alone warrants his being named to the PharmaVOICE 100, there’s more to Rob as a leader than just his business success. Though he’s always looked for way to bring better and faster treatments to patients, Rob is defined by his dedication and compassion.

His leadership style is a blend of authentic, participative, strategic, and coaching. He cares about people and wants everyone’s voices to be heard. He also expects them to bear down and follow through.

“I strongly believe there’s always opportunities for learning and growth no matter what stage you are in your career,” Rob says. “When I took the role, while I had certain leadership capabilities, I had a lot to learn about regulations and the different cultural norms across the 55-plus countries where we had resources. Every day was new and at times I felt unsure of myself, but my team helped me through it. In this experience, I grew a foot in my career.”

The pandemic was difficult for his teams, and as a face-to-face communicator, it was also quite difficult for Rob. “At the beginning, I made sure to stay connected with my leadership team as much as possible with twice-a-week group meetings that weren’t always focused just on work,” he says. “With the larger organization, we tried to keep things light and joyful by sending out notes, making some fun videos, and sharing as much information as possible about the vaccine development during townhall meetings. We all grew closer as we supported each other with the daily ups and downs.”

Rob actively mentors both employees and students. “Mentorship is really a two-way street, and it’s rewarding to both share my experiences with others but to also learn from them,” he says. “I’m currently sponsoring a new rotational program for recent graduates that we are very excited about to help develop new and upcoming talent.” (PV)

Together we can accomplish more than alone

Sparking innovation by…
building diverse teams

Melanie Gloria
Title: Senior VP, Development Operations
Company: Horizon Therapeutics
Personal Awards: Luminary, 2020, Healthcare Businesswomen’s Association; Crain’s Notable Women in Health Care
Associations: Board of Directors for Lake County Haven
Giving Back: Lake County Haven, Make-A-Wish Foundation, Leukemia & Lymphoma Society, rare disease

Melanie Gloria’s past experiences and perspectives as both a patient and a healthcare practitioner have served her well in her position as senior VP, development operations, for Horizon Therapeutics.

Not only is Melanie a cancer survivor, but her son was diagnosed with a rare disease when he was 5 years old. Before entering the life-sciences industry, Melanie’s career included a stint as an oncology nurse, where she cared for patients in one of the most difficult moments of their lives.

These combined experiences feed into Melanie’s mission to help more people by developing treatments for rare, autoimmune, and severe inflammatory diseases. She cites the development of Tepezza to treat thyroid eye disease as one of the highlights of her career.

Melanie’s colleagues say she brings a keen sense of emotional intelligence to everything she does. She plays a pivotal role in ensuring Horizon’s programs are moving with urgency while setting a high bar in terms of scientific rigor and testing standards. She and her team orchestrate programs and regulatory functions, including pharmacovigilance, to ensure that Horizon’s trials result in robust data and its treatments meet stringent safety requirements.

Melanie knows firsthand what it feels like to be on the patient side of this process, and she is driven to ensure that the patient voice is always part of Horizon’s practices. This is what inspires her and her team to excel in their work, and this sense of purpose echoes throughout their company.

Melanie is also dedicated to supporting development and career growth for her team members. “Some of the other moments in my career that stand out are when I have supported my staff’s development and I see them advance to achieve their career aspirations,” she says. “I want to be remembered as someone who was driven to bring therapies to patients but also as an empathetic leader who addressed patients’ needs and the needs of my colleagues.

“I flex my approach based on the situation and am very supportive of my team,” she continues. “I look for what motivates the individual and link what we need to accomplish based on their personal motivators or ‘whys.’”

As a leader, Melanie considers herself “very adaptable and driven, as well as someone who maintains a growth mindset.

To help her team navigate during the pandemic, Melanie leaned into her super-power of empathy. “It was important to understand that everyone was struggling and had different challenges,” she says. “People needed support and I wanted to give them the flexibility they needed to manage their lives.

“I am super-fortunate to have a team of passionate individuals motivated by our work, but it was isolating and hard,” she adds. “So, we stayed connected via coffee chats and virtual happy hours.”

Melanie is passionate about mentoring young professionals and emerging leaders both inside and outside the workplace. She often meets with her mentees to share her knowledge and experiences and help them identify their own career paths.

“Mentorship takes time and commitment to really get to know the individual and help them network and grow over time,” she says. “The best part for me is seeing the mentee grow and develop and knowing I played a small part in helping them on their journey.”

Melanie is a strong advocate for non-linear growth due to her own experience early in her career. Even though she was eager and motivated, Melanie was left out of opportunities due to more limited experience in specific areas or roles. Thus, she actively seeks and helps individuals who carry the same passion, desire, and willingness to learn that she had when she was first starting her career.

Still, Melanie keeps in mind one of the best pieces of professional advice she’s ever received. “I always remember that you can’t force people to follow — you have to bring them along,” she says.

“I also have learned that getting a foundation of experience is really important, and that you need to focus on the now rather than what’s next,” she adds. “Additionally, building a network is not just important, it is critical.”

Melanie’s dedication to giving back goes beyond being a mentor at Horizon; she generously pays it forward within the extended community. She volunteers with the Make-A-Wish Foundation and the Leukemia & Lymphoma Society, organizations she developed relationships with during her time as an oncology nurse. She is also an advocate for people like her son who live with rare genetic disorders, providing a voice for what is often an underserved community.

In addition, Melanie serves on the board of directors for Lake County Haven, an organization that empowers homeless women and their children to achieve permanent, independent living. Horizon also sponsors the organization, among other local partnerships in Illinois. (PV)

Innovation is change management in disguise

Sparking innovation by…
creating a space that rewards risk-taking

Joe Dustin
Title: Head of Clinical Innovation and Change Management
Company: Bristol Myers Squibb
Education: B.S., Computer Information Systems & Political Science, Roger Williams University
Company Awards: Nine-time President’s Club Winner, Medidata
Associations: Regional Advisory Council, Drug Information Association (DIA); Leadership Council, North America CNS Summit; member, Digital Medicine Society (DiME); co-lead of eSource Workstream, TransCelerate BioPharma; coach, Readington/Tewksbury Junior Baseball League
Hobbies: Musician — guitar, bass, drums, violin; tech enthusiast, world traveler; whiskey connoisseur; biohacker; model rockets; cryptocurrency
Twitter handle: @eClinical

There is a reason Joe Dustin’s Twitter handle is @eClinical. He’s known throughout the industry as a leader who is dedicated to transforming clinical trials and the role patients play in them, enabling research participants to become true collaborators in developing new medical treatments and breakthroughs.

According to his peers, Joe has long understood that as digital health puts power in the hands of patients, the nature of their role is shifting toward that of a healthcare consumer. In fact, throughout his career, Joe has been a visionary, translating what that shift means for those enrolled in clinical trials and how industry stakeholders must evolve what they are doing to not only accommodate but also engage patients.

Joe says he’s seen a lot during his nearly two decades in the clinical trial industry, but he counts being part of the founding team that built out the patient cloud business at Medidata as his biggest highlight. “We took patient cloud from an idea and an experimental app to a solution that changed the way we thought about mobile health in clinical trials and surpassed our growth targets nearly every year,” he says. “We started in 2013 as an innovation project, and it is now a full-on decentralized clinical trial solution. The team was amazing, and we had a lot of fun along the way.”

One of his most exciting assignments has been transitioning from a tech company to a pharma company and building out a new function all during COVID while being fully virtual. “There are many of us across the business that were recently hired into roles that will benefit from an alternate approach,” he says. “To make change a reality, taking calculated risks on ideas and people is crucial to success. I am excited to see what the future will bring.”

Joe pushes colleagues across the industry to challenge the status quo, learn from their failures, and be open to doing things in new and different ways for the benefit of the patients they serve.

“I try to lead by doing,” Joe says. “I always want to try to set a good example and give a good direction to a task or goal. I also try to bring an alternate perspective to ideas and initiatives.”

Joe says he sees value in assembling a team that has different life experiences, backgrounds, industry exposures, and skill sets. “It’s easier to hire people who don’t need much training,” he says. “But hiring someone outside of the comfort zone can yield better results in the end and make for a stronger team.”

Joe says his leadership style is always evolving, and that he thrives on collaboration. “I want to empower people to do their best work and be better at recognizing the individual strengths within a team,” he says. “This evolves as teams — and their leaders — evolve.”

Joe brings a longstanding commitment to sharing his tremendous depth and breadth of clinical trial technology knowledge with others to enrich and grow the community.

“I always loved working with internship programs and new entrants to our industry, and I would even go back to my university and speak at the business school about what clinical trials were and their importance,” he says. “My best practice has always been to say, ‘never be afraid to not know the answer.’ We are always learning, and it’s better that we learn from each other, no matter our seniority.”

Joe’s colleagues and partners all say how passionate he is about what he does. “I tend to make bold statements to get my point across in memorable ways,” he says. “I always loved going from the boardroom in the morning presenting a strategy then to the engineering floor in the afternoon to geek out with the teams building the next innovation. You have to have both and then it never feels like work.”

Joe’s attitude has always been to work hard and play hard. “As long as work has an element of joy and fun to it, then it will never feel like work — even during the rough patches,” he says.

Speaking of rough patches, this philosophy has served Joe well during the COVID pandemic.
He says his secret to keeping his teammates motivated and inspired has been laughter. “You can’t take yourself too seriously,” he says. “And in a time where social interaction was at an all-time low, you need to laugh, especially in a situation where you have never met your new co-workers in person. Your teams need to know you have a personality.” (PV)

Bringing ideas to life

Sparking innovation by…
fusing diverse talent

Sofia Mubarak Baig
Title: Executive VP, Integrated Delivery Enablement Office (IDEO)
Company: Parexel International
Education: BSc. (Hons) Chemistry, University of Birmingham, UK
Personal Awards: Graduate of first company High Potential Program/mentored by Founder & CEO for 9 months — only 12 leaders were selected out of the entire company to participate in this program; Honorable mention: Anne B. Sayigh Excellence in Leadership Award

Over the past two years, Sofia Mubarak Baig has led the transformation of the way Parexel delivers its business. This multi-year and multi-phased initiative has been a huge undertaking and Sofia’s toughest assignment to date, since it impacts more than 15,000 people across the commercial, delivery, and finance functions.

“Transformational initiatives, are by their very nature, incredibly difficult undertakings,” she says. “The challenges grow exponentially when they impact such large numbers of employees and span multiple years with a broad and deep set of changing stakeholders to manage. Add to this mix the fact that we are a service company, where operational changes of this nature are visible to our clients, so it is critically important that everything goes seamlessly. To heighten the challenge, COVID hit during one of the most critical phases of this program. I can safely say, this change initiative has kept me busy and on my toes.”

Throughout her tenure at Parexel, Sofia has helped to reduce development cycle times, support sponsors with developing and implementing innovative clinical development strategies and, ultimately, helping to get new medicines to patients in need more quickly.

She describes one of her biggest career highlights as being able to double the productivity of the clinical research associates (CRAs) at Parexel, while maintaining the expected quality standards. “This was the single largest and most distributed function in the company ­— it required engaging greater than 3,500 employees spread over 50 countries, in 70 offices, across six continents. It really tested my ability to work effectively across borders, time zones and cultures,” she says.

A leader in driving diversity, Sofia helped to get Parexel’s women in leadership program going and played a leading role in hiring the head of diversity. She served on the gender partnership steering committee and has helped on the multicultural committee within the company.

Colleagues describe Sofia as an unflappable, balanced expert, a reassuring presence, and a safe pair of hands in the face of daunting challenges. She has always worked relentlessly to deliver organizational goals and business results that may seem impossible to some — be they deploying new innovations, improving operational efficiencies, or driving business growth. “I tend to lead from the front and take accountability and ownership of the outcomes — both positive and negative,” she says. “This has often required me to proactively engage the team, remain laser-focused — despite all the organizational distractions — and be bold and ambitious about the end goal.”

A thoughtful and articulate dissenter, Sofia has never been afraid of questioning the accepted norms or countering the prevalent narratives. She has reinvented herself several times, taken on some of the most difficult assignments and led challenging change efforts that others either failed to deliver or didn’t want to touch with a bargepole.

Sofia is also adept at acknowledging people’s perspectives, uncovering the nuance of their beliefs and encouraging them to bring their best work to a project. She has created some of the most diverse, inclusive, and high-performing teams by focusing on performance and not conformance.

As a leader, Sofia is transparent and authentic and has no pretentions of leadership grandeur. She flexes whatever leadership muscle is needed to get the outcomes. Her pragmatism acts as a force to push others gently but firmly away from whatever didactic or confrontational tendencies might otherwise rule their actions, and toward a shared positive trajectory.

Relationships are key to career success, Sofia says, noting that the shift from meritocracy to relationship/stakeholder management is a subtle one which, if you do not notice, can become a career derailer.

She has mentored many leaders over the years and is an active sponsor, particularly to those who may be somewhat disadvantaged in a corporate setting. “I make sure their successes are highlighted at the right time, in the right places,” she says. “I recommend them for assignments and initiatives that showcase their talent to others. If necessary, I will counter any false narratives that may be circulating the corridors.” (PV)

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