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June 14, 2023 | Interviews

Patient Voice to Data: How Novartis Is
Listening Up, Harnessing RWE in APMAby Anju Ghangurde

Physician-turned-pharma executive Iris Zemzoum leads Novartis in the Asia
Pacific, Middle East and Africa (APMA) region. She tells Scrip how the Swissgroup is empowering patients to help shape the future of healthcare and also
partnering across the diverse region to leverage real-world evidence.

Not all pharma executives can perhaps relate to the patient journey as closely as Iris Zemzoum,
Novartis’s president for the Asia Pacific, Middle East and Africa (APMA) region. The
gynecological oncology physician-turned-pharma executive has likely seen patients in their mostvulnerable state and “understands their challenges first-hand.”It’s those kinds of sharp yet delicate insights that Zemzoum hopes to build on as companies likeNovartis seek to improve health literacy, empowering patients to “speak up for themselves” andalso amplify patient voices giving them a “seat at the table” in health policy-shaping.
"From the beginning my driver and North Star has been the patient,” declared Zemzoum in aninterview with Scrip outlining the strides made by Novartis’s fledgling initiative, Alliance andPartnerships for Patient Innovation and Solutions (APPIS), which she spearheads.
The APPIS platform essentially brings together different voices across the healthcarecommunity, helping to drive patient action and impact in the diverse APMA region and beyond(many countries outside of APMA are already participating in the platform). Since its inception

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2in 2021, it has convened more than 2,000
people across the spectrum of healthcare
in over 60 countries.
Discussions are also underway with otherregions around how the platform can be
replicated in other markets, the executive
indicated.

Leap of Faith
Zemzoum, who made a career switch tothe biopharma sector in 2003 from being a
consulting physician at the department ofobstetrics and gynecology, University
Hospital TUM Munich, clearly knows athing or two about the complex patient
journey.

How Novartis Is Tailoring Its Strategy In
Asia Pacific, Middle East and Africa
By Anju GhangurdeDec. 22, 2021 Iris Zemzoum, Novartis
Pharma's president for Asia Pacific, Middle
East and Africa, outlines how the company isshaping its strategy in the region, whichcomes with “extremes” in market profiles, viaa distinct archetype that factors incommonalities between national healthcaresystems. The company is also progressing
interesting initiatives in digital therapeutics.

Read the full article here

She described her own crossing toindustry as “more of an evolution,”though.
The executive perhaps had a bird’s-eye view of things very early on at the university hospital as ayoung co-investigator in breast and ovarian cancer therapy trials. Meeting one of her “rolemodels in research and patient engagement,” Dr Nadia Harbeck at ASCO 2023 recently,
Zemzoum acknowledged, in an online post, that she was lucky to have been picked by Harbeck towork with her in the breast cancer research unit at TUM Munich University.
Harbeck, who serves on the ESMO executive board, is director of the Breast Center and holds thechair for Conservative Oncology at the department of obstetrics and gynecology, LMU University
Hospital, Munich, Germany, among a string of other key positions; she is one of the mostfrequently cited clinical researchers worldwide.
The trials experience clearly exposed the young Zemzoum to research and the industry,attending congresses along the way and also seeing some of the research work that thedepartment did in collaboration with pharma get published.
“I think that’s what intrigued me or raised my interest in the industry,” Zemzoum said but
admits that when she left the university hospital, she wasn't “100% sure” it was the rightdecision.

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3“But if you don't try, if you don't explore, you will never know. So, I took the leap of faith. It was
one of the best decisions of my life because I had it all - the science, global perspective and I still
had what was always my North Star (the patient) and the possibility to shape the healthcare
environment to focus on what is needed to better health for patients”.

APPIS-Related Traction
Shaping the healthcare environment with the patient at the fulcrum is among the areas where
the Novartis executive appears to be putting pedal to the metal and there are signs of early
momentum in the some of the 30-odd markets that fall under APMA.
Zemzoum outlined how an APPIS-related effort in Taiwan led to the co-creation of a journal
article on the importance of incorporating the voice of patients in health technology assessment(HTA). Authored by Prof. Fei-Yuan Hsiao from Taiwan’s Pharmaceutical Benefit andReimbursement Scheme (PBRS) committee (the local HTA body) together with cancer patientorganizations, it was published this year in the Journal of the Formosan Medical Association.
In another instance, the Swiss multinational backed the breast cancer advocacy group ICanServe
Foundation’s “The Circle of Life” project in the Philippines. The project builds the data anddigital infrastructure of the Ating Dibdibin, the community-based early breast cancer detection
program. (Also see "Novartis’ Bouchard on Delivering Personalized Cancer Medicine in Asia Pacific,Middle East, Africa" - Scrip, March 23, 2022.)
Digitalizing the program will facilitate efficient monitoring of patients for early detection andtimely consult at the primary care level, implying fewer late diagnosis that require specialist careand more advanced diagnostics and treatments. The innovative system is expected to serve as abackbone of implementation of Philippines’ National Integrated Cancer Control Act andlocalization in local government units.
Several big pharma peers are similarly investing and working independently or alongside partnerorganizations to improve and amplify programs to educate and empower patients. For instance,
Pfizer Inc.’s “Find Your MBC Voice” was created by the US multinational with the help of patientadvocates to help people with metastatic breast cancer understand their diagnosis and consider
treatment options.

Listening to Patients
Zemzoum underscored that it's really important to listen to patients, because “they give you theright clues of what their needs are, and how they can navigate every single step of their journeyin the healthcare system, which is really complex, to ultimately have a great outcome.”
But industry also needs to recognize that these complex healthcare system issues can’t be solved
on its own and requires collaboration with all stakeholders, whether it's the healthcare
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4professional, payer or government, she added.
“We need to sit together and understand how it is feasible to best treat [patients] and get the best
outcome for that specific patient in a specific disease area and then work together to shapepolicies or healthcare solutions for that patient.”
Referring to some “frightening” statistics, Zemzoum pointed out that while the APMA region ishome to over half of the world’s population, this segment of the population also has some of thelowest levels of healthcare – “the inequity, even amongst our region, is shocking.”
She highlighted breast cancer as an example where according to the World Health Organization,
survival rate in India is 66% versus around 40% in South Africa, compared with 90% of survival inhigh income countries.
“Just looking at the statistics we know what we have to do ….we can’t stay still and just watchthat inequity. But to break down these barriers, we need to act. We need to act really fast, and weneed to act together,” Zemzoum stressed.

Growing Importance of Real World Evidence
While pharma has long touted patient centricity as being at the core, the increasing influence ofthe patient voice in the evolving healthcare landscape also makes the association symbiotic.
Improved patient experiences, health outcomes and also business results are among the key
benefits that can accrue.
Real-world evidence (RWE) that factors
the real-world experiences of patients inunderstanding the effectiveness oftreatments can be pivotal across theproduct life cycle – various stakeholders
and agencies are also increasingly callingfor more patient-centric drug
development and evidence-generation
recognizing the significance of thesepatient inputs.
The EU, for instance, has made significant
strides in the area. The Data Analysis andReal World Interrogation Network(DARWIN EU), an EU-wide platform that’s
been operational for a year, delivers realworld evidence from across Europe on
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EMA Makes Progress on Real-World
Evidence ‘Use Cases’ with HTA Bodies &Payers
By Vibha Sharma
April 24, 2023
The European Medicines Agency is looking athow it can generate real-world evidence onmultiple myeloma and non-small cell lungcancer using its new DARWIN EU platform sothat the outcomes can also be of use for healthtechnology assessment bodies and payers.
Read the full article here

5diseases, populations and the uses and performance of medicines. The European Medicines
Agency was recently reported to be evaluating new use cases for cancer via the platform. (seeside bar) (Also see "Canada Publishes Real World Evidence Guidance For HTA And Regulatory
Decision Making" - Pink Sheet, May 23, 2023.)
Industry experts have in the past noted that similar to real-world evidence, patient experience
data is important in almost all stages of the product lifecycle—not just in the post-marketing
aspect. “For example, understanding the treatment pathways and patient experiences on firstline therapies can help shape what comparators and outcomes should be captured in future
randomized controlled trials to differentiate the drug in the market,” a senior executive fromAetion, a healthcare technology company that provides decision-grade real-world evidence
solutions to biopharma companies, payers, and regulatory agencies was earlier reported assaying.
Novartis’ Zemzoum underpinned the value of real world evidence, now seen as “very critical” tosupport healthcare policy changes and decisions taken by major stakeholders in the healthcaresystem.
“We've been investing quite a lot in
partnerships with different stakeholders
to explore and provide enough support on
the data analysis of real-world evidence,”
she explained.

Global Medical Sciences Group Looks
at Benefits, Challenges and Risks ofUsing RWD
By Vibha Sharma

She outlined how Novartis was trialing a
new model of treating cardiovasculardisease (CVD) patients in Australia - theASCERTAIN implementation sciencestudy that is expected to review around
600 patients across 20 sites in thecountry.

June 12, 2023
The nonprofit Council for International
Organizations of Medical Sciences (CIOMS)
has issued draft recommendations on using
real-world evidence for the approval, use andreimbursement of medicinal products.

Read the full article here
The study has been designed by and will
be overseen by experts from the Monash
University’s Victorian Heart Institute and enabled by technology provided by e-health company
Telstra Health.
“That is a great collaboration which will inform us in terms of real-world evidence, how we canbetter manage the patient,” Zemzoum said.
The new hyper-care model of care pilot is expected to help improve patient management via
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participating clinics with the support of digital tools (such as educational text messages,questionnaires) and nurse practitioners. Empowering GP clinics with all the tools could improve
the outlook for heart patients in Australia.
“Australia has a CVD emergency - every 12 minutes there is a patient dying from a cardiovascular
event. So, it's really something that Australia needs to focus on,” the Novartis executive added.
If successful, the new model can be scaled nationally, helping to address the treatment gap
experienced by Australians with CVD, in particular those in rural and remote settings.

Management of ASCVD in the UAE
Along similar lines, Novartis had earlier
entered into a memorandum ofunderstanding with the Department of
Health Abu Dhabi to support its digital
health strategy and establish a population
health management model to address
atherosclerotic cardiovascular disease(ASCVD). The effort is expected tosignificantly reduce the burden of heartdisease in the United Arab Emirates byadvancing prevention, early intervention,and care management.
“Through analysis of local RWE data, weare actually able not only to highlight thecurrent burden of disease and the unmet
needs in the system, but also to forecast
the future burden using different disease
impact simulators,” Zemzoum explained.

BioAsia 2023: Leaders from Novartis,
Apple Talk Innovation, Tech, Data
Privacy
By Anju Ghangurde
Feb. 28, 2023
BioAsia 2023 was a melting pot of ideas with
Novartis's CEO and a senior executive fromApple, among others, discussing a range oftopics including the potential of novel
therapies and platforms such as siRNA andradioligand and also where things wereheaded as the union of technology andbiotech drives new insights into biology andpromises to help reimagine healthcare.

Read the full article here

Moreover, such efforts can also
demonstrate the savings for the healthcare system from tackling such a high burden disease upfront.
“So, these insights will ultimately help healthcare systems, in this case, the Department ofHealth Abu Dhabi to inform their healthcare policies and evaluate and implement solutions andeven establish new standards in the management of ASCVD,” Zemzoum added.

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7The executive, though, did not want to get drawn into specific product-related uptake in thesemarkets, given certain confidentiality aspects and other nuances.

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