The words you are searching are inside this book. To get more targeted content, please make full-text search by clicking here.
Discover the best professional documents and content resources in AnyFlip Document Base.
Search
Published by gstrawa, 2017-01-25 12:56:42

new_test

Key focus areas:


Featured Projects and Platforms








Our five strategic focus areas guide our pursuit of excellence
in achieving the mission of Medical Affairs. The project and
platforms featured in this chapter enhance our ability to
achieve a customer centric development strategy that is
agile and future-focused. The PDMA teams responsible
for their development are available to support you in
creating a roadmap for delivering superior medical
CUSTOMER
outcomes, increasing access to our medicines and CENTRICITY
better managing stakeholders. People Launch Access
Digital PHC 2.0
AGILITY










Launch

With the multiple new molecular entities (NMEs) More specifically, the aim is to:
and major line extensions in the Roche product
portfolio to be launched within the next few years, • Optimize the processes and tools for the launch
excellence in PDMA pre-launch and launch rea- preparation, pertinent to the Medical function
diness is critical. • Develop a high level medical resources guidance
(global/regional/local)
To ensure launch readiness, the objectives of the • Develop a framework that aims to build further
PDMA Medical Launch Readiness project are to medical launch competencies
enhance and ensure excellece in medical launch
readiness capabilities at Roche, building on the
existing Launch Excellence framework.








Access

Access is an organizational priority at Roche and PDMA contributes by helping to bring the unique
a broad and multidimensional challenge. Our aim voice of patients and physicians to the discussion
at Roche is for every person who needs our pro- in the following projects:
ducts to be able to access and benefit from them.
For Roche, Access refers to when all relevant fac- • PD4Access: Generating and communicating
tors are in place for a patient to have the oppor- appropriate data to provide and maintain.
tunity to receive the diagnostics and medicines to Access to Roche medicines by molecule or
achieve optimal outcomes. disease area
• Medical4Patients: A toolkit and framework that
Medical affairs (i.e. PDMA and Local Medical Affairs provides best practice guidance to ensure
(LMA)) has an absolutely critical role to play in that all medical personnel involved in Access
obtaining and maintaining Access, and we should planning are delivering value to our internal
have bold aspirations to make sure we meet and and external partners
exceed that expectation.

PHC 2.0
(For images see presentation PHC Core Deck)


Big data, from details about the human genome • transform research and development so it is
to digital health records, are shifting the bounda- more effective and efficient,
ries of what is and will be possible in medical • and allow for better decisions in patient care.
research and patient care. Opportunities in both
science and technology allow for a next transfor- Roche’s vision is to unlock the full potential of
mational step. personalized healthcare for patients through the
development of breakthrough medicines and
At Roche, we call this the next stage in Personali- leading diagnostics. In pursuit of this vision,
zed Healthcare – working together in healthcare we are developing our capabilities and building
to combine insights from multiple data sources strategic partnerships so new information and
with sophisticated analytics to: insights lead to the right treatment for the right
patient at the right time.









Digital

Institutions are integrating Digital Health in the Within PDMA, the primary focus is on the
way they deliver care and information to their pa- benefits digital can bring to:
tients and in the new way they collect long term
clinical grade information. The need for a strategy • Patients, through a higher standard of care
in PDMA, centered on patients and HCP needs (clinical-grade digital information, medication

that accelerate access to care and tailored infor- adherence, virtual patient support and
mation is clear. digiceuticals) and easy access to tailored
education
By leveraging existing technical capabilities and • HCPs, through patient care tools including
focusing on the development of new technology, diagnostics, convenient access and manage-
the Digital Health (DH) stratgic framework enables ment of information and communication tools
PDMA to deliver better care and more in-depth
information to patients and providers through The TECHealth project enables PDMA to develop
methods that are more convenient to access, more DH capabilities, drive transparency and foster
personalized and more cost effective. communication around PDMA DH projects and
nurture strategic partnerships across Roche
(PDSO, Corporate Digital and GPS etc).
Please visit the Digital Hub for more information
on projects and to keep up to date with upcoming
TECHealth events.








People

At the center of all activity, PDMA people drive
the strategic priorities and translate innovations
in science into better lives for patients. To support
our people, eagle 2.0 is a program that provides
competency-based learning tools and facilities
to the people and experts in PDMA to further ex-
pand and grow their capability to deliver medical
excellence through Roche medicine.

MEDICAL4LAUNCH:


Optimizing Patient Impact








The launch preparation model
for Medical must evolve to
reflect the key elements of the
“new normal” as follows:


Launch-readiness has become one of 1 Deliver Medical value as the key
our key strategic focus areas, based on differentiator in a competitive
our observations of the “new normal” environment
emerging from multiple launches (inclu-
ding new TAs for Roche) in an increa- 2 Engagement with a broader base of
singly competitive environment. To deliver stakeholders (e.g. patients, nurses,
excellence in launch preparation, and to etc.) and broaden cross-functional
collaboration
fulfill our mission to develop and drive an
industry-leading medical strategy optimi-
zing patient impact, Medical Affairs needs 3 Increased opportunities to
to continuously evolve by adjusting and leverage digital technologies and
multi-channel medical education
anticipating its operating model in a in product strategies
quickly changing landscape.
4 New medical competencies,
including expertise and mindset















Rethinking Medical in the Launch Process




In 2016, a cross-functional project team co-spon- • Evolving the Medical Strategy in the launch
sored by the MAC and PDM-LT was put in place preparation
to advance the Medical launch preparedness • Maximizing Medical contributions toward
framework post BAP 3, building on the existing Cross-functional Launch Planning
cross-functional Launch Excellence (LEx) frame- • Providing Resource Guidance to resource
work and on outputs from other initiatives (e.g. smartly and efficiently throughout the
M4P, MSL MOVE, etc.). With new TA entries and pre-launch phase
major line extensions and global/region/affiliates • Sharpening leadership and a Competitive
in scope, the project team objectives were to Mindset, and building the right Competencies
address Medical Excellence in Strategy and across the Medical Affairs network
Execution in Launch Preparation by:

Team structure and responsibilities Key activities




The MEDICAL4LAUNCH wave 1 project team involved 13 core Medical Strategy
members and 8 advisory team members, more than 30 project • Mindset shift to a broadened strategic
team members in total, and global coverage via 3 work streams: and agile approach
• Greater emphasis on customer-centricity
• WS 1 – global activities, processes and tools • Enhanced approach to strategic planning
• WS 2 – affiliate/regional activities, processes and • Strengthened cross-functional alignment
tools (Region Europe stream)
• WS 3 – resources and competencies
Cross-functional Launch Planning
30+ as key contributor and strategy driver for
• Medical role: Clear positioning of Medical
defined cross-functional pre-launch activities
Project team

members +8 Medical Resourcing



• Activity-based consistent guidance for
3 Advisory team data-driven and informed conversations
with management
• Ensure the right balance of Medical
members
involvement at the right time
Work


Streams Cross-regional Competitive Mindset and Competencies
• Foster competitive mindset
& Cross-functional • Enhanced knowledge of DAs and product
• Understanding of product landscape in
the market







Coming in 2017
M4L project outcomes will be introduced at
the Annual Medical Director (AMD) meeting
in March 2017, kicking off the rollout of the
M4L framework throughout 2017.
Intranet site
MLR.roche.com



2016 2017

May June July Aug Sept Oct Nov Dec Jan Feb Mar




Phase 1 Phase 2 Phase 3
Scoping Diagnostic Solutions Development Validation Roll-out







August mid December AMD
until mid December until Feburary

Integrating patient and nurse engagement


into Medical Affairs practice








The primary reason we all come to work every day is to improve patient care.
However, to truly realize patient-centricity, we need to shift our mindset and
put patients at the center of our decision making. To support this process,
the Medical Affairs vision and strategic pillars for patient and nurse relations
have been developed, based on internal and external barriers, challenges,
opportunities and focus areas. The integration of patients and nurses into the
Medical Affairs practice bridges science and patients to significantly increase
the impact of our programs, help us better address unmet patient needs
and ultimately improve patient care.













Three key imperatives drive our strategy






The PDMA Patient and Nurse Engagement team trials and other evidence generation activities.
helps generate integrated insights from Finally, we provide medical education,
patient and nurse organizations to inform the communications and interactions with nurses
Medical Affairs strategy and activities using and patients both within and outside of clinical
multiple channels, collaborating with internal trials. This includes medical services for patients,
expert functions and producing actionable relationship management with patient and nurse
results. We contribute to evidence generation organizations and collaboration with patient
by systematically implementing patient and experts on topics of mutual interest.
nurse perspectives in Medical Affairs clinical





1 2 3






Becoming a trusted Shaping imperatives by leading Creating standards
partner change and innovation into existing and processes
Medical Affairs practice


Insights Evidence generation Education/ Medical Services
(non registration) Communication and Medical Access

A brief retrospective of our key Initiatives

and collaborations in 2016





Strategy and scope of Medical Affairs to engage with
patients & nurses to complement cross-functional
collaboration alongside the lifecycle of the molecule


Value recognition External partnerships Innovation into existing practice
& resource based on internal and external
insights and collaboration


‘Can do culture’ within Defined Roles Skills, capabilities,
compliance/legal framework & Responsibilities confidence in Medical Affairs


International collabroration: Key Initiatives:
Affiliates/Regions, Global Crossfunctional 1. NMPC Clinical Trial Platform for patients
PGR Working council and other global 2. Collaboration with patients/nurses in
functions PDMA clinical trials







Feb. Patients perspective in PDMA clinical trials




The Lebrikizumab team received valuable in- arms (incl Placebo) is needed, that support and
sights from an asthma patient organization training of investigators with relevant information
representative into the UPSIDE study, which was will help to build trust as well as adherence to
a planned trial for supporting reimbursement protocol, and that it is important to better
discussions. Patient perspectives confirmed our highlight the benefit that the study will bring to
assessment of the clinical trial, namely that patients as well as payers.
information and education of benefits of all study









May Medical Information for Patients:

Patient Standard Responses

Approximately 15% of the medical information an initiative to provide high-quality standard
(MI) queries Roche receives worldwide are from patient responses that inform on the appropriate
patients. This represents a tremendous oppor- use of our products for when Roche affiliates
tunity for medical departments to better serve receive unsolicited questions from patients about
the patient community worldwide by ensuring the our products or disease areas and make them
consistency and quality of information we provide. available to the entire MedInfo@Roche network.

In Medical Affairs, we have the product knowledge
most relevant to our patients hence having a tre-
mendous opportunity to positively impact patient
care. This is why PDMA and USMA partnered on

June MS nurse in PDMA Member of Patient

clinical trial steering committee Focused Medicines Development (PFMD)

In collaboration with the Medical team Roche officially became a member of a cross-
and the Patient and Nurse relations team, industry and patient organization initiative called
Roche invited a nurse to participate in the Patient Focused Medicines Development (PFMD).
clinical trial steering committee of a PDMA The aim of PFMD is to systematically involve
clinical trial. Valuable input was received patient's perspective in the process of drug
already in the first meeting, which made the development. PDMA Medical Liaison is leading
team adding the input into the protocol. this collaboration from a Roche perspective.

Click here to learn more
about PFMD





July MS Beyond the pill deep dive and

co-creation workshops

The “Beyond the Pill” (BTP) project is a cross-
functional initiative to understand how Roche
can improve patient lives beyond our treatments.
The team organized two "deep dive and a co-
creation workshops" in July and November
using interactive, creative working sessions with
patients, patient advocacy group representatives,
nurses and physicians from France, Switzerland,
UK and Italy to gather insights and understand
the unmet needs of MS patients and where we
can add value beyond our treatments including
digital health solutions.





"It feels like having the
chance to accompany
Roche´s journey into MS.
I like that very much"









Initiated clinical trial platform for patients
and bringing insights
The clinical trial platform for patients is now The project team conducted an iAdvise with five
NMPC approved! The clinical trial platform patient organization representatives from Europe
for patients also called Pioneering Healthcare and North America to understand the information
(PioHC) platform has the goal to provide an and support needs of patients diagnosed with
online tool for all Roche sponsored clinical breast cancer when it comes to treatment and
trials in lay language and to direct patients to clinical trials. The project team also conducted a
the investigational site. The pilot is focusing market research in Breast Cancer, IPF and lung
on Breast Cancer. This cross-functional Roche cancer to systematically understand the needs for
Pharma project is led by PDMA patient and such an ecosystem in the US, Germany, Italy and
nurse relations and is co-sponsored by PDMA France. The launch of the Breast Cancer pilot is
Medical Liaison and PDG. It has been developed expected in Q1/Q2 2017.
and built according to global compliance
guidance.
For more information about the platform
visit our website at:
www.pioneeringhealthcare.com

July Medical Patient and Nurse Leadership Team




Creation of the Medical Patient and Nurse Roche seems to be a leader in
Leadership Team (MPNLT), with Medical Affairs
Membership from EU5, US and the regions, strategic thinking and the group
created and developed a strategic framework to gathered around the round table
integrate patients and nurses into the Medical
Affairs pillars – offering us valuable external and was illustrative of that.
internal perspectives. I was absolutely delighted to play
a small part in your event.



Victoria Harmer, Nurse



Sept. Patient Hemophilia Advisory Board Roche Patient Group Council




First global Hemophilia Patient Advisory Board led Establishment of the Patient Group Council with
by the Hemophilia Medical Team to gain insights membership of all patient/patient group focused
on the unmet need of patients with hemophilia A functions at Roche Pharma under the sponsors-
as well as to understand their perspective on the hip of Global Health Policy and the chair rotating
profile of Emicizumab and other treatments. between PGR, PDMA and pRED. The purpose
of this council is to champion the holistic in-
tegration of the patient voice across the entire
molecule lifecycle. Focus areas were identified
for 2016/2017, providing guidance, processes
and affiliate support; managing relationships and
sharing knowledge.




Oct. Discussion of the protocol and
digital clinical trial strategy in IPF

The PDMA protocol with the goal of understan- confirmative of the study design, providing us
ding the “early” course of idiopathic pulmonary with important information about the education of
fibrosis/interstitial lung disease (IPF/ILD) was clinical trial participants as well as investigators
discussed with an IPF patient and representative and has been driving the development of the digi-
of the German Lungenfibrose e.V./European IPF tal strategy within the study (e.g. selection of daily
patient organization. The input received was very spirometer, patient engagement app etc).











Nov. Patient Biotherapeutics Advisory Board


Nine patient advisors from NA, Europe and APAC tives on unmet needs along the patient journey
joined a breast cancer and hemato-oncology pa- with a focus on information and educational gaps
tient advisory board held in Zurich and led by the related to treatment decisions and patient-doctor
Biotherapeutics Team, providing their perspec- communication.

Nov. Long standing consultative breast

cancer committee


The first Breast Cancer Standing Patient Committee
organized by the Patient and Nurses Relations
Group and the Breast Cancer GMT took place in
Zurich with representatives from patient organi-
zations in Europe (Germany, Sweden, Austria,
Spain and Israel) and one patient from Switzerland
as a standing group. The aim of this pilot initiative
was to get advice on the patients’ perspective into
our clinical trials and all related aspects (e.g.,
study design, assessments, protocols, informed
consents, lay information or recruitment strategies).






Quotes


This meeting is really important
to us – I want patients to be seen as

real people and not just as subjects
or numbers.

This was a fantastic meeting;
very informative, open and honest,
which I really appreciate.







Since 10 years I’m advocating


to get patients to provide input


into clinical trials and now it


is finally happening.








Dec. Patient Insights Council of TransCelerate



The Patient Insights Council of TransCelerate
was formed and the PDMA Patient and
Nurse Relations Team is representing Roche
at this important group informing about all
initiatives at TransCelerate.

Overcoming the barriers to Access:


The Medical4Patients (M4P) Access Project








Access continues to be of critical importance to patients and to Roche. It represents
a strategic priority and Medical Affairs, in partnership with Market Access, has a
unique and valuable perspective to play. To be successful we need to appropriately
understand care pathways and correctly determine evidence needs as well as
effectively being able to generate and communicate the resulting evidence to payers,
HCPs and broader stakeholders. To drive this commitment forward and to optimize
and co-ordinate how we enable access to our medicines, the Medical4Patients (M4P)
Access Project Toolkit has been developed to enable confident and consistent
navigation around Access topics; to act as a single point of reference for relevant
resources; and to define what, when & where Medical Affairs should take the lead
or bring a voice to the discussion.









Medical Affairs plays a critical role in enhancing

value and increasing Access to Roche medicines



In 2014, we set the Corporate goal of increasing Through PD4Access we have already started to
the proportion of patients in emerging markets make significant changes in how we approach
who have access to our medicine (e.g. to increase evidence planning and generation. However,
Herceptin and Mabthera access from 29% to 40% as we move towards a more holistic and integ-
by 2017). As we develop and bring to market our rated evidence approach, it is vital that we draw
next wave of innovative medicines, it is imperati- upon all of the strengths and capabilities our
ve that we work collaboratively to ensure access organization has to offer, to both contribute the
for as many patients as possible. In particular, necessary insights as well as communicate the
we need to leverage Medical Affairs' ability to evidence we are generating. The M4P toolkit
bridge clinical development with clinical practice and framework makes this possible.
to identify and address the key Access barriers.












Identifying the Generating and Understanding
practical actions Putting the communicating how to reach/
necessary to spotlight on appropriate engage the
harness the power best practices evidence, insights relevant
of Access for and knowledge stakeholders
patients

A short preview of the M4P Toolkit and Framework



The M4P Toolkit has been created local, regional or global level. This is a
primarily for Medical Affairs person- one-stop-shop designed to spark new
nel involved in defining and executing ideas and to put the spotlight on best
medical strategy. It is also a valuable practices through the Product Journey
resource for other Roche stakeholders or Patient Journey. It is designed to be
involved in Access, as well as for those used in collaboration with the other
working in other Roche functions with Access partners to support in develo-
an interest in how Medical Affairs con- ping Access strategy and integrating
tributes to improving Access throug- this into the Medical plans. It provides
hout the patient journey and product direct access to a broad range of best
lifecycle. The M4P Toolkit has been practice recommendations and case
developed to support Medical Affairs studies to help develop a more robust
showing where they should take res- Access strategy (in both developed
ponsibility with regards to Access on a and emerging economies) which:


1 Provide strategic and tactical guidance on how
to better ensure access to Roche products
• Product Journey/Evidence Access themes:
relevant key processes and plans driven by the
product lifecycle, i.e., ideally planned and exe-
cuted through defined stages of the lifecycle.
• Patient Journey/Capability Access themes:
largely independent of the product lifecycle, i.e.,
executed on an ongoing basis depending on
>150
Delivered a toolkit with pages of the specific hurdles identified by each country
related to product requirements.
strategic guidance for product journey / evidence 2 Highlight the role of Medical Affairs
9
and patient journey / capability spanning key as a relevant contributor (and cross-functionally
100
access themes with over pages of relevant) by sharing value stories from within
Roche backed by compelling evidence that can
supporting resources be tailored to a local context
20 3 Provide Medical Affairs with a better
Global and regional workshops &
understanding of the Access environment and
events conducted stakeholder needs including important resources
regarding healthcare system driven planning
38 20 4 Enhance the knowledge and skills
Medical & people, Public Affairs,

RWDs, Regulatory, Commercial and IT colleagues related to Access topics with links to relevant
Access-related resources and courses as well as
directly contributed to the M4P project role-specific expectations and competency as-
sessments via the eagle Competency Framework

Watch the Videos:
Senior Leaders Video:
http://we.intranet.roche.com/sites/
pd-medicalaffairs/projects/medical-
affairsaccess/pages/default.aspx
As far as possible, the guidance and activities
Infographic Video: http://we.intranet. provided by the M4P Toolkit have been tailored to
roche.com/sites/PD-MedicalAffairs/ regional and local needs. Any examples or best
projects/medicalaffairsaccess/Pages/ practices have been included that comply with
Project-Updates.aspx
the applicable local regulations in the country
Toolkit of execution however adopting these within in a
http://m4p-toolkit.roche.com different geography or setting will always requires
verification against local regulations.
Intranet site
medical4patients.roche.com
It is intended that the M4P toolkit will be reviewed
Contact in 2017 and updated to help embed the knowledge
[email protected] and competency within the organisation

Foundation Medicine Inc. (FMI):


A Major Step Towards Individualizing Cancer Care





FMI

Cancer care is becoming personalized; moving towards in Numbers
individualized treatment plans. Advances in molecular
profiling means response to therapy can now often 1 1
be predicted and making it easier to match patients st AMP delivered in RIME,
180
4
to effective and safe treatment. Many new therapies just months 3 internal
target tumors based on their unique molecular medical physicians

profile, rather than their site of origin. 18 education events
TAEs
11
from countries Over
In 2015, Roche entered a strategic collaboration involved by Roche 100,000
(ex-US) actively
with FMI. The combination of FMI’s pioneering
approach to genomics/molecular information and in 2016 patients profiled globally
Roche’s expertise in oncology will advance 4,000
personalized cancer treatment. Over physicans involved globally
300
Over clinical trials with more
25
than industry
partners use FMI as the testing
Increasing Patient Eligibility and platform of choice

Closing Data Gaps



FMI’s comprehensive genomic profiling services Within just 4 months and out of the usual review
are moving to the forefront of individualized cancer cycle, the Roche FMI team have delivered the
care. In NSCLC, evidence on FoundationOne ® first annual medical plan, allowing the provision
supports patient eligibility for treatment: Key manu- of FMI services in 18 ex-US territories to begin.
scripts published in The Oncologist and Clin Cancer
Research revealed that, in NSCLC, FoundationOne Actions have been taken to improve the under-
®
could identify CRGAs in ALK and EGFR that were standing of comprehensive genomic profiling and
missed by other methods. the value of FMI’s services, including internal trai-
ning and educational activities at key congresses.
• FISH testing missed 35% of ALK rearrange- For example, we reached 180 physicians with our
ments identified by FoundationOne ® satellite Symposium at MAP and more than 60%
• Hotspot testing missed 17% of exon 19 EGFR reported that they acquired new knowledge to
deletions identified by FoundationOne ® apply in clinical practice.

The missed EGFR CRGAs respond to TKIs in The FMI partnership delivers high-
75% of cases. 78% of the patients for which quality comprehensive diagnostics
FoundationOne found ALK, CRGAs responded
®
to ALK inhibitors. Disseminating clinically rele- to patients, serving one of the pillars
vant evidence and internal launch readiness are of the PHC 2.0 framework in the
critical to bring FMI’s benefits to patients.
advancement of cancer care.


CRGA: clinically relevant genetic alteration



More details about Summary report of our
the impact of FMI 1st Global Meeting


Watch the video here www.foundationmedicine.com

Data Generation Process Within FMI




a FFPE tumor sample b Sequencing library c Analysis pipeline d Clinical report
preparation











DNA Extraction Sequencing Analysis & Interpretation



Additional data generation is planned with the been provided to affiliates to prepare for launch
local aim of closing data gaps on the clinical and to offer continuing support post-launch. This
utility of FMI services and the global aim of includes advice on how to respond to customer
linking FMI profiling to decision-making/patient requests, generate evidence and implement
outcomes in priority indications. Guidance has education/communication activities.



Publications Snapshot


72

Foundation Medicine in Medical Information peer-reviewed
The commercialization and promotion of FMI products are recent manuscripts
developments. Therefore, customers primarily requesting general infor- 75
mation is within expectation. MI processes, systems and knowledge 5
articles were not in place prior to April 2016. The inquiry volume is abstracts across
still low but growing. Standard knowledge has been transferred from congresses
FMI to Roche and is shared globally with the affiliates. The analysis of 17
non-standard requests is ongoing. Interim processes for inquiry hand- oral presentations
ling, including escalation to FMI, are in place and the global usage 58
of MI atlas as the IT system to handle these inquiries will facilitate posters or
further knowledge sharing and oversight. We have had 133 inquiries poster discussions
since April 2016 tracked in the MI atlas – 94 of them from physicians
with the next biggest customer group, patients with 18 inquiries.



“One of the best
meetings I've attended.
Many Thanks!!
Train-the-Trainer Prof. Peled & Moch
Courses very very good &
were the stars –
80 relevant sessions!!’’ Relevance of discussion 4.4
to meeting objectives
participants from
18
Affiliates' medical
and commercial teams with sessions on basic Insights provided by 4.4
the presenter
molecular biology, FMI reporting and curation, Value of the case-based
the value of NGS in clinical practice tumor board session 5.0
and an interactive, case-based lung
and tumor board session. 0 1 2 3 4 5

Digital Health@PDMA:


Transforming the future of healthcare








Technology is transforming the way care and information is delivered and PDMA recognizes
that remaining a leader in healthcare means keeping pace with digital health transformation.
Clinical institutions are already piloting new technologies that improve the way they manage
patients and introducing novel ways of collecting clinical grade data through consumer
devices. The opportunity to do much more than provide medicines is growing, and through
our deep understanding of medicine and commitment to innovation, we’re uniquely placed
to lead the transformation. In 2016, PDMA developed the Digital Health Strategic Framework
exploring unmet needs of patients, the competitive landscape, and PDMA’s strategic objecti-
ves. We forged new relationships with
key internal partners and identified
external collaborations that can make
digital health a reality for Roche.







The Digital Health Framework






The Digital Health Strategic Framework sets the
foundation for innovation by:

• Accelerating integration of Digital Health • Driving external collaborations with institutions,
solutions into Medical Strategy patient associations and HCPs on prioritized
• Connecting PDMA to key innovation portfolios pilots
within the Roche organization through the • Establishing Roche as a trusted partner for
newly formed Digital Health Advisory Council innovation beyond our molecules


Digital Health opens up new opportunities There is a lot to do and we
around key stakeholder needs:
must fundamentally shift
Patients want more active involvement in their disease
1 management and healthcare solutions. They’re eager for our mindsets, our culture
options that are convenient, mobile and portable
and our capabilities to

HCPs need more precise, clinically relevant, timely, transform ourselves into the
2 personalized information about their patients. They want
to offer better care with safety management and home agile, experimentally-minded
monitoring and are excited about increased patients’
adherence and compliance
solutions-provider we need
Payers want to collect new economic and clinical to be at Roche to maintain
3 information in more cost-effective and efficient ways.
They’re interested in Population Health Tools, Claims industry leadership in the
Administration & Adjudication, QOL measurement,
Cost Effectiveness & Utilization, Information and digital age.
Communication tools
Nico Andre, Head Global Medical Affairs at Roche

Finding your way around Digital Health



The PDMA Digital Hub offers the latest news and The TECHealth Community focuses on science, education
project information. It includes a lexicon of all the and technology. Members can gain and share learnings on
language needed for the digital era, and a detailed digital health activities and news at Roche and beyond. It also
strategic framework showcases our focus for 2017. provides information on the latest digital health events inside
and outside of Roche and reports on the latest trends through
selected links and blogs from internal and external experts.
75%
More than of all patients Visit the PDMA Digital Hub and join our community today.

expect to use digital services in the future.
The Digital Health team is a newly established team working
2014
In , digital health closely with the global medical teams to support advancing
digital health solutions across TAs. The Digital Health team
$ 6.5
investments topped billion. works strategically with key innovation partners within Roche
including PDSI, GPS (Digital Excellence), Health Technology
Office, PDMA IT, USMA and leading affiliates.




Intranet sites Contact
pdma-digitalhealth.roche.com [email protected]
http://pdma-digitalhealth.roche.com/
Ongoing Pilot Projects techealth.html




Multiple Sclerosis IPF
Beyond the Pill services IPF patients and clinicians need more information about the risk
Vitality, mental health, cognitive issues and fatigue are of disease progression to decide when best to initiate treatment.
poorly addressed with current MS services on the market. Patients have difficulty in finding HCPs knowledgeable about IPF
Fatigue prevails in most MS patients, and 70% of patients are frequently misdiagnosed and undergo invasive, expensive tests
face psychiatric comorbidities, such as depressive symp- as part of their diagnosis. To address these needs, PDMA is setting
toms, making them priority areas for better patient support. up a trial in ‘early’ disease patients with suspicion of IPF/ILD in a
The MS “Beyond the Pill” initiative is aimed at addressing real-world setting: a study following patients’ lung function and
these unmet needs, helping patients fully engage in life. activity using remote monitoring devices.




Hemophilia

This project contributes to the Hemophilia community by addres-
sing unmet needs through digital health solutions and generates
The pill Around the pill Beyond the pill Integrated care
longitudinal comparative real-world evidence for Roche. PDMA
Neuroscience Digital Biomarker is collaborating with Patient Associations and Roche affiliates
In addition, we are also advancing our development of to either bring non-commercial digital health solutions to coun-
next-generation patient monitoring technologies. Digital tries currently without any or to extend existing solutions to meet
biomarkers derived from data generated from consumer additional unmet needs expressed by the community (e.g. passive
devices such as smartphones and wearables have the activity tracking).
potential to increase precision in clinical decision-making
and even predict disease course. Our researchers have
developed a suite of smartphone assessments that allow the
continuous monitoring of symptom fluctuations across a Oncology
number of neurological conditions, including Parkinson’s
disease and multiple sclerosis. These assessments will Our focus is to identify opportunities where digital health
complement the conventional physician-led assessments, solutions can be used to generate quality of life and activity
which are limited by the availability of expert centers, are data in clinical trials, preferentially through wearables or other
resource intensive and represent only a snapshot in time. passive means, to support trial objectives and evaluate the utility
Early data collected in our Parkinson’s clinical program of passively collected metrics (e.g. alternative QoL measures
provides new information on patients’ symptom fluctua- through passively collected metrics vs. manual surveys). PDMA
tions, disease progression and impact on their daily living is currently working with the Breast Cancer team on a potential
and in MS, through partnerships with leading treatment exploratory arm in the IMpassion 132 trial and, in parallel, are
centers, we are applying these technologies to transform working with the MOLT to identify additional opportunities
the way the disease is managed in clinical practice. based upon PDMAO's prioritized study proposals.

Developing medical competencies


and leadership within Medical Affairs






Engaged and empowered people are what will make us successful in Medical Affairs
and enable us to achieve our vision of transforming clinical practice. PDMA has
developed a series of learning programs and eagle competency framework to
enable different Medical Affairs functions at global, regional and local
levels to develop key medical competencies and accelerate leadership
in Medical Affairs at Roche.



eagle leverages
the power of one
shared platform for
competency-based
learning across the
Medical network.
eagle 2.0



Advancing competencies across the medical With eagle 2.0 we are further advancing common
network to deliver tangible medical value standards and transparency about the expecta-
tions for different roles, as well as improving easy
eagle supports our strategy of developing talents access to key learning resources. Based on the
by offering a structured framework, tools and excellent feedback from the implementation of
resources. By building and advancing critical eagle in affiliate medical roles, we have collabora-
functional competencies, we can better address ted with other PD functions to expand the frame-
the evolving needs of external stakeholders, work for affiliate roles in safety, quality, clinical
including healthcare professionals, patients and operations and regulatory. This has allowed us to
other decision-makers. The eagle framework reduce complexity, with eagle 2.0 serving as a
provides clarity on the key capabilities needed single platform for all Affiliate Medical roles regard-
and the directions on where to focus in a contin- less of their PD ‘home’ function, thereby supporting
uously evolving medical affairs environment. the PD "smarter together" vision.


“eagle is really adding value for our partners
and colleagues in the countries. It shows that
88%
we are professionalizing our approach to of colleagues replied that the eagle
building our organization as the important A recent survey
competency assessment tool helps identify
key driver of our joint strategy, allowing demonstrates
us to connect to the PD organization,’ ----- a major positive
personal learning needs
Niko Andre, Head of PDMA and Chair of impact of eagle. 82%
agreed that eagle facilitates
the Medical Affairs Council
valuable development discussions with line
82%
managers agreed that eagle helps to find
Explore the eagle portal – Identify your strengths and key areas relevant courses, resources and development activities
home of learning for PD and
Medical Affairs for personal development using the
online competency assessment tool
Understand the Medical Search the Learning Curriculum
Competencies you and your to discover a range of courses and
teams need to be successful in learning resources tailored to your excellence
eagle achievement growth
your current or future role needs
learning engagement

Participants find the
program a fantastic
opportunity to accelerate
development
of medical leadership
MedicalLeaders@Roche (ML@R) at Roche.



Accelerating medical leadership across
the medical network

Being a leader in Medical Affairs requires the The annual program focuses on key competencies,
continuous learning and development of new including building the medical strategy and
skills and competencies. Under the sponsorship creating messages for both internal and external
of the Medical Affairs Council (MAC), the PDMA stakeholders. Patients also advance their finance
Competency Development team runs an annual knowledge and go through practical exercises
modular program called Medical Leaders@Roche and discussions on how to use this knowledge
(ML@R). It is aimed to accelerate the develop- for decision-making. An interactive panel on
ment of medical leadership across the medical Launch Readiness with senior leaders encourages
network, providing opportunities for experience dialogue and covers different perspectives on
and exposure, and enabling participants to work pre-launch challenges, including prioritization
on strategically important projects under the and competitive fitness. The program allows
guidance of senior leaders. the participants to build their networks across
the organization. Importantly, they also work in
2013 groups on MAC strategic focus areas and

Since , present the outcomes to MAC/PDMLT.
71
colleagues have participated in ML@R

programs across the Medical network.
50%
reported career changes with increased

responsibilities since their program participation



Participants
rate the value of the
program highly, since

CMD Induction the CMD induction
program’s launch
in 2010.

Preparing newly joined CMDs for taking
the medical lead in their affiliates

The PDMA Competency Development Team offers Faculty interactions and network
an annual onboarding program for newly joined
Country Medical Directors (CMDs) aimed at network building opportunities receive
building and understanding what support they can
expect from global functions. It delivers information
around the PDMA strategic directions and key inter- constantly high scores, and greatly
nal stakeholders. Thanks to the invaluable contribu-
tion of its global/regional faculty and the opportuni- facilitate the onboarding of newly
ties to interact with colleagues from PDMA, regions
and beyond, the program significantly facilitates the joined CMDs
onboarding of new CMDs and network building
opportunities, enabling them to take the medical
lead in their respective affiliates more quickly.

PDMA Leadership Summit Medical Excellence

Foundations Course



Building a culture of leadership and change Onboarding course for new CMMs builds
key capabilities for success
The PDMA Leadership Summit was an excellent
first step towards generating an empowered The Medical Excellence Foundations course is
leadership community. Thirty-five PDMA leaders run in close collaboration between PDMA and Re-
spent 1 ½ days learning, discussing and reflecting gional Medical Affairs teams. The course enables
on four key themes and how they help us move new Country Medical Managers (CMMs) with less
our organization forward as leaders and ambas- than one year’s experience to build key capabilities
sadors for meaningful change and evolution. for success in their role. The course focuses on
• Leading in complexity to apply the knowledge efficiently in the new role.
building fundamental knowledge...as well as how
The content includes fundamental principles of
• Culture perceptions medical strategy and planning, evidence generation,
scientific communication and expert collaboration
• Behavior patterns and is updated on a regular basis to meet the
needs and expectations in an evolving medical
• Change Leadership affairs environment. The strategic content and
guidance is developed by PDMA Competency
Development. The program faculty consists of
global, regional and affiliate Roche experts
The event offered participants a better under- who share their experience, best practices and
standing of the impact of their role in building a resources for further learning.
positive culture in Medical Affairs in a transfor-
ming world of leadership. It also prepared them “After working as a Medical Manager for five
to actively practice leadership in their everyday months, this training gave me a clear overview of
work with team members, senior leaders, and my responsibilities and tasks and provided answers
colleagues across a complex organization. to the questions I had thus far.”
35 “Very practical in explaining strategies, situational

PDMA leaders jointed
analysis and medical objectives. Methodically
linked to offer a complete picture.”

the day summit 4 2016

courses offered in
in Region Europe and EEMEA
82 25
participants from over countries
90%
Positive feedback: overall satisfaction


PDMA

Leadership
Summit






CMD
induction

MedicalLeaders
@Roche










‘In Action’ Programs Global MSL Manager/

Lead Program



Transforming SMTs and IMTs into Building a strong and focused MSL team
high performing teams
As a follow-up to the 2015 MSL MOVE initiative,
Our two 'In Action' Training Courses (SMTiA and the PDMA Medical Liaison and Competency
IMTiA) strengthen the strategic role of Medical Development conducted a capability diagnostic
Affairs within the organization by evolving Study across the MSL organization to gain deeper
Management teams (SMTs) and International insights into MSL and MSL lead/manager deve-
Medical teams (IMTs) into high performing teams. lopment needs in Roche. The two-day, face-to-
Both courses use an interactive, three-day study face program provided participants opportunities
simulation format. The SMTiA course focuses on to advance their competencies in scientific
the planning and conducting of a PDMA study, communications and medical strategy, as well as
whereas the IMTiA challenges participants to leadership specifically focused on the following
develop a medical strategy and plan suppor- four key topics:
ting concrete business needs. In both courses,
leadership coaches provide feedback on working • Disease-based territory
skills, strengths and areas for improvement with
regards to teamwork, leadership and commu-
nication. Teams have an opportunity to present medical plans
the outcomes of their work to senior leaders and
experts, who provide feedback and approval or • Insight planning and communication
denial of their plans. In IMTiA, board members
are from Medical and Business, representing a • Coaching on scientific exchange
truly collaborative effort between PDMA and GPS.
• Field oversight and

SMTiA
“One of the most interesting events I have ever coaching
attended in my EIGHT years in Roche. The oppor-
tunity to learn from this valuable experience was
amazing, and I am already more prepared to deal
with whatever comes my way through my studies.” 2016
Piloted in November
22
IMTiA
“Really appreciate the ‘real work’ simulation with attendees
exercise with challenging presentations.” 4

“A good overview with a global perspective of the from regions
medical plan and interaction with the strategy.”


Click to View FlipBook Version