Personalized medicine is getting implemented through new treatment modalities. Such individualized approaches create new challenges for drug development, especially in the analytical space. With growing precision medicine successes, a balanced approach between individualization of treatments and standardization of methods and materials will become a driver for the broad success of urgently needed new treatments.

• Scarcity of material for analysis

• Representative analysis for therapeutic cells

• Can cell-based therapies be scalable?

Anka Ehrhardt
Director, Cell-Based Sciences

Merck

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Personalized healthcare is the next evolution of how we deliver outcomes to patients. We are moving away from treating diseases and towards treating people and bringing outcomes that matter to them. Key to unlocking the promise of personalized healthcare is community involvement… community leadership. This discussion talks about ways in which community-led innovation can bring about the transformation of healthcare towards a more human-centered, personalized approach.

– The value of first-mile health and important role that a community plays
– The value of community-led innovation to a pharmaceutical company’s innovation cycle
– How we can leverage the community to help us innovate our business?

Michael Duong
Head of Innovation

Hoffmann-La Roche Ltd.

New drug approvals for asthma, COPD and other chronic common diseases remain low. Taking a Precision Medicine approach to find the Right Patient will be part of the solution but current examples remain firmly aligned to oncology. By leveraging the worlds genomic data to find new targets and precision medicine strategies, exploiting large phenotyped patient cohorts to understand disease drive and heterogeneity, and accessing target tissue non-invasively to enable longitudinal monitoring of disease activity and drug response, we can change the target paradigm and link the right target to the right patient from the start and finally bring Precsion Medicine to the Respiratory and Immunology therapeutic area.

– New drug approvals for asthma, COPD and other common diseases remain low
– Taking a Precision Medicine approach to find the Right Patient is part of the solution
– By leveraging the worlds genomic data, exploiting large phenotyped cohorts and accessing target tissue non-invasively, we can change the target paradigm, linking the right target to right patient from the start

Adam Platt
Vice President and Head of Translational Science and Experimental Medicine, Research and Early Development, Respiratory and Immunology (R&I), BioPharmaceuticals R&D

AstraZeneca

The relationship of digital innovation in healthcare and the rise of empowered patients is closely tied.

In order to really make an impact in healthcare patient partnership is key and collaborating and understanding patients early is a key to interesting worthwhile innovation. Leading with technology and with human experience is wrong.

In the talk we will go to the origins and meaning of patient participation and see how it develops in different part of healthcare to support growth and innovation

Uri Goren
Head of Marketing and Customer Experience

Novamed

As one of the world’s fastest growing investment sectors, digital health has witnessed a more than 84% growth in venture funding from $31 billion to $57 billion 2021. United States and European countries are two major markets which occupy over 90% market share.

Within the industry, the number of the new entrants also has a significant increase, the funding and market impact have remarkable enlarge during last year. Several factors are converging to spur investments in those high potential unicorns, this speech will go through four major digital health segments: Telehealth& telemedicine, Mobile Health, Wearables and Healthcare Analytics & Health Information technology to see what makes a digital health unicorn.

Dominick Kennerson
Global Head G4A – Digital Health Partnerships
Bayer

This session will focus on:

• Basic understanding of what is a medical device
• Difference between SiMD and SaMD
• QMS requirements for developing SaMD
• Regulatory activities for Changes to SaMD
• Validation requirements for SaMD development

Vivek Thakkar
Regulatory Program Director – Personalized Healthcare – Digital Health
Genentech

Multiple myeloma (MM) is a clonal hematopoietic disorder
characterized by proliferation of clonal malignant plasma cells in the
Bone Marrow microenvironment, monoclonal protein in the blood or
urine and associated with organ dysfunction.
Despite advances in therapy, MM remains an incurable malignancy,
and most patients eventually become refractory to currently available
treatments. Only 10% – 15% of patients achieve or exceed expected
survival compared with the matched general population. There is no
single standard of care for R/R MM, and treatment is affected by
several factors, including age, performance status, comorbidities,
and the type, efficacy, and tolerance of the previous treatments,
underlying a strong unmet need for novel treatments for patients with
R/R disease.
In my presentation I will first review the overall portfolio at
Roche/Genentech in the Multiple Myeloma space. Then, since T-cell engaging
therapies represent a novel and promising new mechanism
of action to achieve anti-myeloma activity in patients who are R/R to
existing standard of care therapies, I will discuss in more details the
clinical activity and biomarkers finding for our T cell-dependent
bispecific antibody Cevostamab in R/R MM.

Cedric dos Santos
Director, Head of Multiple Myeloma and
Myeloid malignancies including AML
and MDS,  Genentech

Targeting myeloid cells within the tumor microenvironment has
emerged as an area of interest because of data demonstrating that
myeloid cells can inhibit the efficacy of immune checkpoints in
cancer. Differences between mouse and human biology of myeloid
cells are one challenge that makes it difficult to predict efficacy in
humans. We will review ongoing trials that target myeloid cells in
patients and discuss opportunities to understand and target
myeloid cells in patients.

• Overview of myeloid cells in the tumor microenvironment
• Differences between human and mice which make mice poor
  predictors of response in patients
• Examples of targeting the tumor microenvironment and impact in human
• clinical trials spectrum of indications

Michelle Kinder
Scientific Director
Incyte

CAR T-cell immunotherapy has achieved remarkable success in
selected haematologial malignancies. However, solid tumours remain
impervious to this therapeutic approach. In this talk, I will present
data from the dose escalation phase of a phase 1 clinical trial in
which panErbB specific CAR T-cells are delivered using the intratumoural
route in patients with relapsed refractory head and neck
cancer. I will also introduce a novel technology designated parallel
CAR which harnesses dual co-stimulation by CD28 and 4-1BB,
enabling superior anti-tumour activity in several pre-clinical tumour
models.

• An update will be provided on a Phase I clinical trial of panErbB
  CAR T cells in refractory head and neck cancer
• A new generation CAR technology known as parallel (p)CAR will
  be presented
• Examples of efficacious pCARs will be presented across a
  spectrum of indications

John Maher
Chief Scientific Officer
Leucid Bio

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Vamsi Krishna
Medical Director and Global Safety Officer,  Amgen

• Overview of the first guidance on using cloud computing with
  medical devices and QMS
• The challenge of integrating modern computing technologies
  (smartphones, cloud, AI/ML, 3rd party software and data, EHRs
  systems, etc..) with medical devices
• Compliance while evolving responsibly from a continuously
  validated state to an intermittently validated state
• Future standards work supporting this shift

Pat Baird 
Regulatory Head of Global Software Standards, Philips

Randy Horton

Vice President of Solutions and Partnerships, Orthogonal

• Why is a patient-centric approach important?
• What are the benefits?
• Current trends and experience
• What are PSPs?
• How is the Medical Information department handling PV aspects?
• How to focus on a patient-centric approach?
• How/Why to use plain language for patients when contacting them?

Yvonne Nanciu
Country Head Pharmacovigilance Germany, Bayer

Covid-19, the first alarming pandemic of the third millennium, has caused global public health and economic crises, necessitating rapid development and deployment of vaccines. The worldwide response has been unprecedented with government, academic, and private partnerships working together, rapidly exchanging information and ultimately changing the traditional, lengthy approaches in vaccinology with new emerging technologies offering a promising solution for faster and more flexible development of vaccine candidates that will positively change the global pandemic preparedness strategy.

The monitoring of adverse reactions associated with vaccination is one of the most important factors in vaccine safety. Although vaccines are among the safest medicines on the market, vaccines are not completely risk-free, and adverse events may occur following vaccination. Careful assessment of any adverse events following immunization is essential to distinguish those that are causally linked to the vaccination from those just coincident in time, in order to prevent vaccine distrust or misperception and to ensure an efficient vaccination campaign especially in the context of a global pandemic.

The objective of this presentation is to critically review the most up-to-date available safety data on different Covid-19 vaccines and vaccine candidates in clinical development, understanding their specifications from the mode of action to effectiveness in the context of a challenging global vaccination campaign.

Alex Bica
Director, Global Clinical Safety and Pharmacovigilance, Global R&D, CSL Behring

Intro: This topic shall cover the digital technologies that have redefined the way how patients access /seek healthcare services and the way how physicians deliver patient care.

Key topics:
1. The power of data and data-driven insights: PHR/EHR
2. Tele medicine: the new way of seeing a doctor
3. Self-monitoring of disease outcomes and safety by patients & real-time reporting
4. Prognosis and disease outcomes monitoring
5. Retention of patients and patient delight/satisfaction thru technology-driven patient care

Karthik Anantharaman
Chief Operating Officer,  Roche

While breast cancer care has improved significantly over the past decades, its occurrence still stays very high. In the USA alone 1 in 8 women will be diagnosed with invasive breast cancer this year. Today, care is not always effective, largely a one-size-fits-all approach, and struggling to keep up with demand. How can we leverage digital technological advances in our global fight against breast cancer?

Anirudha Dambal
Vice President, Women’s Health,  Siemens Healthineers

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Why is it so difficult to get a patient for a trial? And once recruited, why is it so difficult to keep the patient in the trial and on the study drug? And has the pandemic stirred this up? Let’s look at what discourages patients to get into, and remain in a trial. And with that in mind, what does the ideal patient-centered protocol looks like? Are patient-centricity and regulatory requirements compatible?

*Why is it so difficult to get a patient interested in a trial?
*Why is it so difficult to keep the patient in the trial and on the study drug?
*What discourages patients upfront, and while in the study?
*What does the ideal patient-centered protocol looks like?
*Pandemic mitigation measures

Maarten Boomsma
Clinical Research Director
Sanofi

A robust patient retention strategy of enrolled subjects is essential in clinical trials.
If retention is not adequate, the data set to be evaluated may be insufficient, cause an excessive decrease of statistical power, and/or introduce bias that invalidates the work done.
A different perspective is needed to find new ways to support sites and patients to be motivated to continue participating in the large duration of clinical trials with complex protocols procedures.
Advanced technology offers new interactive content that gives patients a new opportunity to better disease control during the treatment phase. Investigational sites can also easily use the advanced technology by means of a single sign on an integrated platform to save time during their data entries tasks and data review.
The results will be illustrated by means of two different study cases using the same strategy and same technology to explain how important is to take a different outlook to the traditional studies.

What is the problem?
What Sponsor can do to increase patient retention expectations?
Which clinical technologies can support patient-centric and retention approaches?
Quality By Design mobile patient-centric application development.
Which are the challenges to overcome?
Can we measure success?

Diego Herrera
Head of Clinical Data & Information Management
Almirall

Healthcare providers worldwide are facing burgeoning patient demand and associated costs that challenge the very financial stability of services to patients.
The World Health Organisation (WHO) predicts the cost of managing chronic diseases will be 80% of total healthcare expenditure by 2020, with substantial and continuing growth in the numbers of patients with chronic disease. The current model of care for most nations’ healthcare delivery has changed little over the last half-century, whilst advances in diagnosis, medical knowledge, and health informatics, and associated technologies have grown substantially. The fortress structure of Acute (Hospitals), Primary Healthcare, Mental Health, and Social Care is being transformed into a patient-centric integrated care model.
The application of a closed-loop Telemedicine ecosystem using remote vital signs monitoring and predictive algorithms to manage patients with chronic disease will significantly improve patient outcomes and quality of life whilst substantially reducing costs.

Tackling the Burden of Chronic Disease with Digital Health
Telehealth
Remote patient monitoring
Advanced wearables
Predictive analytics & patient segmentation on the basis of risk

Michael John Miller
Digital Health Technical Advisory Group (DHTAG) Roster of Experts
WHO

Technology has had a transformation role in many business sectors in recent decades—and healthcare is also advancing as we become increasingly connected, leading to exciting new areas in healthcare, such as telemedicine, personalized medicine, and predictive medicine. Digital solutions have also gained prevalence, entering the healthcare space and becoming a part of many digital health programs. At the same time, we are seeing an increase in the use of health data, and artificial intelligence and machine learning are helping us to use this data to positively impact health outcomes.

This talk will discuss experiences entering into the connected care space, the potential of digital health and data science, and the changing role of chatbots and artificial intelligence, social media, and web means for our ability to support patients.

Design and development of connected health experiences
Innovating patient support and patient engagement
Integrating technology and data in a programmatic way

Sander Ruitenberg
Global Digital Health Solutions Head
Novartis

Digital Health has the power to revolutionize healthcare if appropriate regulatory frameworks are in place that support the unique and iterative nature of stand-alone software solutions. This presentation explores some of the key challenges that must be addressed when developing fit-for-purpose regulatory frameworks for software products: determining when software is and is not a medical device, risk-based approaches to classification of software as a medical device (SaMD), and creative regulatory approaches to software change management. A review is also provided of some of the unique approaches to software regulation that global regulatory authorities are exploring or have implemented.

Software use cases in the medical device and pharmaceutical communities
Approaches to determining when software is a medical device
Software as a Medical Device (SaMD) classification and clinical evidence requirements
Approaches to the regulation of AI-based SaMD
Regulator efforts to evolve regulatory frameworks for software products

Nathan Carrington
Head of Digital Health and Innovation
Roche Diagnostics