About

We are facing a ‘new normal’ based on the current experience in clinical trial conduct during a pandemic.

Difficulties in reaching sites have led to a new concept of facing clinical development in a multi-factorial way; such as a more pragmatic approach for sites monitoring, a creative risk analysis and contingency while still maintaining data quality and compliance.

PPCD 2021 focuses on how this influences the patient’s journey and involvement as partners of clinical research and what strategies we have put in place for the next steps to the ‘new normal’!

Discussions will include:

  • Industry and patients: Multifactorial journeys to engagement
  • Regulatory agencies: Involving patients in the process
  • Hybrid clinical trials: The new norm
  • Changing clinical development: Lessons from Covid 19
  • Compassionate use and patient access: A look at the options
  • The patient experience: Testimonials and information exchange

Scientific Board
Nancy Meyerson-Hess - Consultant Clinical Research, Chief Compliance & Regulatory Officer at eMQT, Expert Partner at admedicum
Raphaela Schnurbus, PhD - Business Development Director at Premier Research, Clinical Research Solutions Management – Milan, Italy
Mimi Choon-Quinones - Founder and Chairman, Board of Trustees, Partners For Patients NGO

Who should attend?
The conference is addressed to those with a strong interest in integrating patient expertise into their strategies and operations in healthcare development.
Attendees from Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic Centres, Hospital Centres, Patient Associations and Clinical Technology companies involved in clinical development from early phase up to late-stage development and market authorization will have the opportunity to discuss with experts and patients.

Programme

All the below mentioned times are CEST

28 September 2021
09:30 am
09:45 am
Welcome
09:45 am
10:15 am
Public guidance, patients’ voices
Victoria Thomas - Head of Public Involvement at National Institute for Health and Care Excellence (NICE)

This presentation will use NICE’s experience of working with patients and carers to demonstrate the value of the patient voice in developing guidance at a national level. Alongside this the presentation will discuss mechanisms by which these population-level guidance recommendations can support patients and clinicians in making indvidualised decisions about treatment and care.

10:15 am
10:45 am
Artificial Intelligence (AI) contribution in Decentralised Clinical Trials (DCTs)
Bhupathy Alagiriswamy - Clinical Scientist at Boehringer Ingelheim

AI has the potential to transform key steps of clinical trial design from study preparation to execution towards improving trial success rates, thus lowering the pharma R&D burden.

Decentralized Clinical Trials (DCTs), which put the patient at the center of the trial experience and incorporate digital technologies, and artificial intelligence (AI) are combining to transform clinical research. Organizations are marrying DCT methodologies with AI in innovative ways to reshape workflows across the clinical lifecycle, from trial design and patient recruitment to evidence generation—and are seeing striking decreases in both the time and cost of clinical studies.

Today, there are at least 25,000 clinical trials offering a form of open source data. With the right analytical tools and AI, the industry can take advantage of this rich data to optimize patient recruitment, increase patient retention, reduce timelines, and maximize study results in future trials. AI can also expedite target validation, trial design, and patient identification.

DCTs can also reduce time and cost of clinical studies by expanding patient access and retention as a result of allowing patients to participate safely and conveniently in their homes. The net effect is an improvement in data quality as site-based transcription is eliminated plus an increase in efficiency for patients, sites, and study teams. Together, AI and DCTs can be a powerful force.

DCTs fuel AI engines since they inherently capture massive real-world, real-time data from diverse patient populations more inclusive of the diverse world in which we live. By combining both innovations, companies will improve three crucial areas of clinical trials: trial design, patient recruitment, and evidence generation.

10:45 am
11:00 am
Break
11:00 am
11:15 am
Decentralised Clinical Trials - setting the scene
Andrea Ochoa - Vice President, Global Study Start Up at Premier Research

Clinical Trials as we knew them before Covid-19 pandemic, may have become the old version of clinical trials and decentralized clinical trials a new paradigm that insists on coming to stay.

While decentralized clinical trials is not something new, it has been just recently when it is in everybody’s mouth.

With the extraordinary need for a different approach to face to face interactions and specially in order to stay away from the pandemic most demanded locations, hospitals, what was mostly the “future” for clinical trials, suddenly become the priority.

Does it mean the term “decentralized clinical trials” is just one easy way to describe the new version of clinical trials? Can we implement all what we envision? How ready are the different stakeholders to embrace such decentralization?

Answers to those questions and more will be discussed during our meeting, looking forward to see you all!

11:15 am
12:00 pm
PANEL DISCUSSION | Decentralised Clinical Trials
Bhupathy Alagiriswamy - Clinical Scientist at Boehringer Ingelheim
Jennifer Cain Birkmose - Vice President, Global Head of Patient Access and Community Engagement, Swedish Orphan Biovitrum
Natacha Bolaños - Global Alliances Manager, Regional Manager, Europe at Lymphoma Coalition
Sara Cazzaniga - Clinical R&D Manager at Italfarmaco SpA
Andrea Ochoa - Vice President, Global Study Start Up at Premier Research

The session will be moderated by Andrea OchoaVice President, Global Study Start Up at Premier Research

More details available soon

12:00 pm
12:30 pm
Decentralised clinical trials and diversity: Sharing insights from patients and physicians
Sarah Pilkington - Associate Director, Patient Innovation Center at Parexel International

Over the course of the last year, the traditional clinical trial model was flipped upside down. Sites, patients and sponsors were forced to think about study conduct in an entirely different way. As a result, DCT studies have become a “new” normal. Enabling research participation from home using a decentralized model seems to be the perfect solution to improving patient accessibility and diversity. But is it really that simple?

In this session, we will share feedback and guidance from patients and physicians on successfully deploying DCTs to improve ethnic, racial, cultural, and linguistic diversity in research and ensure the best result from a site, patient, and sponsor perspective.

12:30 pm
1:15 pm
Lunch break
1:15 pm
1:45 pm
Start and end with the Patient
Theodora Varkonyi-Weisz - Senior Director Patient Advocacy & Public Affairs EMEA CEE, New Markets at Ionis Pharmaceuticals

Patient Advocacy is a strategic function within the company that serves as a bridge to establish relationship between the patient community and the industry, serving to inform research, development and regulatory strategies, support market access processes.

By putting patients, caregivers in the center of everything we do not only serve patients and making a difference in their lives but also enables biopharmaceutical companies to better understand their conditions, symptoms to develop appropriate diagnostic tools and innovative medicines.

Patient Advocacy impacts every part of the business like research programs, patient focused drug development, clinical study design, supports HEOR and data collection, regulatory and market access processes therefore the importance of early patient involvement is key.

To be able to achieve all of this we need to develop trustful relationships with the patient groups and collaborate in partnership, not only hear but listen to the patients.

By focusing on the issues that are critical to patients and involving them in the decision making process enables them to be part of the mechanism by having a positive impact shaping clinical study designs, health care policies.

We shall empower patient advocates and communities to increase their ability to serve members through growth and independence and strengthen their belief that their voice matters.

1:45 pm
2:05 pm
Empowering children and Young people for the active involvement in the design of clinical trials and medical devices
Begonya Nafría Escalera - Patient Engagement in Research Coordinator at Sant Joan de Déu Children’s Hospital

Background
Children and young people’s participation in health, research and innovation is a fragmented practice across Europe. Minors have the same rights than adults. When they are enough mature they deserve, beyond the right to express their views, the opportunity to be heard and included in any activity that can matters them. This applies to health, research and innovation.
In the last decades, many industries have developed the right methodologies and processes to involve their customers in the design and delivery of its services or products.
Health sector time by time is moving to this new paradigm of cross-collaboration between the different stakeholders involved. When these activities refer to children and young people, to guarantee their active engagement for co-designing patient centric initiatives it’s essential to educate them in this role.

Aims
Develop the YEAH (Youngsters Engagement Active in Health) training programme to educate young people in the field of patient engagement in the design of clinical trials and in the development of medical devices addressed to the paediatric population.
Co-design the seven training modules, including specifically activities related to the engagement of young people and how to assess the patient experience of the young people participating in clinical trials.

Methods
Active involvement of members of three Young Person’s Advisory Groups members from the teams of Liverpool, Riga and Barcelona in the co-creation of the educational resources to be integrated in a digital toolkit.

Results
Digital toolkit addressed to train members of YPAGs, High School students and young citizens. Accessible in English and in Spanish. Addressed to YPAGS, patients organizations and secondary schools.
Discussion
Involve children and young people in the co-design of clinical trials and medical devices guarantees suitable products to this target population. Prior to involve them and to guarantee a meaningful participation it is essential to educate them in this innovative citizens’ involvement field.

2:05 pm
2:20 pm
Break
2:20 pm
2:50 pm
Tailoring Patient Engagement in Clinical Research across the development process
Marta Garcia Manrique - R&D, Chief Patient Officer at Servier International

The presentation will cover the following points:

  • Progress on medical science is a priority for health industry and patients
  • Integration of patients` needs and experiences, in additional to clinical and academic knowledge, seems an effective way to develop innovative and effectives drugs
  • The incorporation of patients as active partners in the R&D process needs to be extended across the whole process of R&D in a coordinated and effective manner
  • These exchanges should be based on transparency, collaboration and mutual interest
  • Practical examples of PE in R&D will be used to illustrate the different ways to engage with patients and the impact on projects
2:50 pm
3:35 pm
PANEL DISCUSSION | How can patient experts be integrated into decision making and communication of molecular testing?
Doris Christiane Schmitt - Consultant for patient communication
Trishna Bharadia - Health Advocate & Patient Engagement Advisor, Independent
Paola Kruger - Patient Expert - EUPATI
Mary Lynne Van Poelgeest-Pomfret - President WFIPP, Co-Chair European Health Coalition, Vice-chair European Forum for Good Clinical Practice - EFGCP
Maya Zlatanova - CEO and Co-founder of FindMeCure Ltd

The session will be moderated by Doris Christiane SchmittConsultant for patient communication

Biomarkers are getting more and more important in order to identify subgroups for personalized Oncology. Breast Cancer or Lung cancer are good examples for individual treatment options and longer survival rates.

  • How can we reach out for more voice in local health care system?
  • What can we do to raise awareness of better information in testing cancer tissue in public?
  • Are there already best practic examples in patient organizations?
3:35 pm
3:45 pm
Conclusion
Speakers
Mimi Choon-Quinones
Info Scientific Board

Mimi Choon-Quinones

Founder and Chairman, Board of Trustees, Partners For Patients NGO
For the past 30 years, Mimi is helping Patients and Caregivers Access Medicines through Policy-Shaping & Research By Partnering w/ patients, WHO, WEF, HTAs, Pharma, Civil Society, Families and Survivors. Mimi is the Chairman, Board of Trustees at Partners for Patients NGO (Serving 193 United Nation Countries For Non-Profit). She founded the organisation in 1990. Her first partnership over 30 years ago was with The International Lions Club and New York City Schools serving Glaucoma  Patients. Over the years, she also worked very closely with The African Enterprise to help educate HIV orphans including supporting a food, medical and orphanage program. Recently, her research included partnering with Sub-Sahara Africa medicinal military leaders to spur policy-shaping to support healthcare infrastructure improvements in Uganda, specifically to find the cure for Burkitts Lymphoma and Blood Cancer. In addition to her volunteer work at the Betty Ford Childress Segment and Butler Research Center she is also employed at the International Myeloma Foundation. Her role at the IMF is Sr. Vice President, Global Policy, Access, Research and Advocacy in 140 countries and through relationships and partnerships.  Mimi has successfully created multilateral and bilateral agreements and collaborations. Mimi has worked in Pharma for +25 years working at Merck, Novartis and Roche. She is passionate about advocating for people, patients and caregivers by shaping healthcare policies, advancing medical knowledge, driving innovative digital solutions in the quest to increase medical access to treatments for patients, especially in the most marginalised regions of the world.
Nancy Meyerson-Hess
Info Scientific Board

Nancy Meyerson-Hess

Consultant Clinical Research, Chief Compliance & Regulatory Officer at eMQT, Expert Partner at admedicum
Nancy Meyerson-Hess has over 30 years of experience in clinical research. She has led global teams of clinical research professionals within pharmaceutical and contract research organizations. She has been responsible for strategic planning and implementation within clinical operations and development for new chemical entities and treatment approaches. She has previously held Senior Management positions in clinical research and development, for pharmaceutical companies such as Roche, Pfizer and Gruenenthal. She has focused on providing best practices for success in clinical research, in areas such as Good Clinical Practice and Inspection Readiness. She has extensive experience in patient-centered activities and solutions. Nancy provides support to biotech and pharmaceutical companies within clinical research, quality and patient oriented activities, such as admedicum Business for Patients, a company dedicated to patient engagement activities in the pharmaceutical and medtech fields. She is a frequent speaker at international Conferences on clinical research and compliance. Nancy is a native New Yorker who has studied psychology and ethology and neurophysiology in the US and the UK. She lives in Munich with her family.
Raphaela Schnurbus
Info Scientific Board

Raphaela Schnurbus

Business Development Director at Premier Research - Clinical Research Solutions Management – Milan, Italy
Degree in Pharmaceutical Sciences from University of Heidelberg - PhD in Molecular Biology/Biochemistry from LMU in Munich - 20 years of experience in the Drug Development Industry. Raphaela brings with her significant scientific expertise that allows her to be a reliable partner for business expansion of service providers in the drug development industry. In the last decade her job has included oversight of Marketing, Business Development and Client Services including Vendor Management for full and functional clinical research services for phases I to IV in main therapeutic areas and rare diseases; she has created partnerships with clinical CROs in Europe and globally and integrated complement services (e.g. drug supply, central lab, preclinical support). She has many years of experience as a consultant to the German/Italian pharmaceutical industry. She regularly attends international conferences and training programs and keeps a close check on market trends and innovation in clinical development. Oriented towards the latest trends in digitalization and real world data collection (real world evidence), she applies her knowledge about technology and regulatory aspects to create awareness among stakeholders in favour of patient-centric trials and provides industry partners with premium support in preclinical and clinical phase drug development. Raphaela is part of the German and Italian associations of Pharmaceutical Medicine (DGPharMed, SIMeF) and since 2018 part of the scientific board of the annual event Patient Partnering in Clinical Development (PPCD). She successfully completed the educational activity from Drug Information Association (DIA) related to Patient Engagement in Drug Development.
Bhupathy Alagiriswamy
Info Speaker

Bhupathy Alagiriswamy

Clinical Scientist at Boehringer Ingelheim
Bhupathy is a qualified Pharmacist, with over 15 years of experience in the Clinical Research Industry. He worked with leading Pharmaceutical companies and CROs in diversified Clinical trials. He is a Tech enthusiast, he developed a great passion for disruptive technology solutions in digital healthcare. He is an entrepreneur, and his strong skill sets are Artificial intelligence in Clinical research and Virtual trials. His vision to enhance patient care by cost-effective drug development using disruptive technology.
Trishna Bharadia
Info Speaker

Trishna Bharadia

Health Advocate & Patient Engagement Advisor, Independent
Trishna Bharadia is a multi-award winning health advocate and patient engagement champion. She is based in the UK but works nationally and internationally with multiple stakeholders to ensure the patient voice is embedded throughout the medicines development lifecycle and healthcare journey. This includes consultancy, speaking, writing, media outreach and co-creation of content, services, products and information. Particular areas of interest include good patient engagement practices, diversity and inclusion in healthcare, and patient involvement in publications. Of her many awards, she has been recognised by the UK Prime Minister's Office with a Points of Light Award for services to patient communities, and has been awarded Honorary Membership of the Faculty of Pharmaceutical Medicines of the Royal College of Physicians of the UK for her patient engagement work.
Jennifer Cain Birkmose
Info Speaker

Jennifer Cain Birkmose

Vice President, Global Head of Patient Access and Community Engagement, Swedish Orphan Biovitrum
Ms Jennifer Cain Birkmose, Is the Vice President, Global Head of Patient Access and Community Engagement, Swedish Orphan Biovitrum. She is also currently a Member of the executive board of the Medicines for Malaria Venture. With a deep commitment to patients and health care systems, Jennifer has served in a variety of public and private leadership roles such as the Region Head, Market Access Roche, Project officer, European Observatory on Health Care Systems, WHO Regional Office for Europe and World Bank Consultant. She is a Tedx Speaker and a lecturer at INSEAD business school.
Natacha Bolaños
Info

Natacha Bolaños

Global Alliances Manager, Regional Manager, Europe at Lymphoma Coalition
With a broad background as cancer rehabilitation specialist through exercise referral, Natacha is an EUPATI fellow with significant experience in patient advocacy and patient education in the field of cancer. Before joining Lymphoma Coalition in 2017, she had successfully held Patient and Public affairs roles in cancer charities in Spain since 2011. Natacha was appointed Board Member of ECPC from 2016 to 2017 and is currently member of the EHA´s European Affairs Committee, the ESMO Patient Advocacy Working Group and the EBMT Patient Advocacy Committee. She is also member of the GoCART Coalition and contributes to other projects at European level, as Harmony Alliance. Natacha is a true believer in the power of cooperation. She has worked at a national and European level with multi-stakeholders’ partnerships, educational groups, and she is deeply interested remove barriers to access to care for patients with lymphoma and to improving the quality of life for patients. Natacha has contributed to Health Technology Appraisal processes and is frequently invited to provide the patient perspective in different scenarios. In addition to the role at EU level, she is currently member of the Institutional Working Group on the Plan to Access Advanced Therapies in the National Health System in Spain.
Sara Cazzaniga
Info Speaker

Sara Cazzaniga

Clinical R&D Manager at Italfarmaco SpA
Sara Cazzaniga is a senior nurse and biologist by training. After 10 years of experiences as a senior intensive care nurse, she had moved to the clinical research field starting as a CRA in an Italian CRO. She has over 15 years of experience in clinical research, where she covered different roles in this field, CRA, Project manager, Clinical Trial lead, Clinical leader. Sara is currently a Clinical R&D Manager at Italfarmaco. In this role, Sara is responsible to develop, the strategic plan for the relevant investigational medicinal products and to implement clinical research projects. Particularly, she has to integrate scientific knowledge and operational expertise to define and suggest to clinical development plan. She also coordinates the Patient Science Liaison team, with the aim to engage the patient communities and help clinical trials meet families' needs along the way. She has been working in pediatric and rare diseases since 2013.
Marta Garcia Manrique
Info Speaker

Marta Garcia Manrique

R&D, Chief Patient Officer at Servier International
Originally graduated as a Pharmacist in Madrid, and later completed my academic education with an MBA and a Master in Public Health from Liverpool University. Over 25 years of international experience  within the pharmaceutical industry in Regulatory Affairs, Medical Affairs, Marketing, Scientific Communications and  Clinical Operations in global and local positions in areas from cardiovascular to oncological diseases. In the last 2 years my main professional interest has shifted towards Patient centricity within clinical development, recently taking on new responsibilities as R& D Chief Patient Officer. My current responsibility is the incorporation of patients´ voice across the research and development process of new medicines. This covers the development and coordination of project and study patient centric plans, identification of best-practises and development of KPIs in a cross-traversal manner with patients partners and internal stakeholders.
Paola Kruger
Info Speaker

Paola Kruger

Patient Expert - EUPATI
Paola has a background in EU Public Affairs and after being diagnosed with a neurological chronic disease she has turned her attention to Patient Advocacy and she has participated in the European IMI-funded project EUPATI (European Patients’ Academy on Therapeutic Innovation). Since then she has been included in EMA’s Patient Experts List and she is speaker at numerous national and international events on the subject of patient involvement in clinical research and she trains patients and patient organizations on the R&D of medicines. Member of the ISPOR Patient Roundtable, she represents patients in several boards and Scientific Committees. Her main area of interest is how to engage patients in clinical research, as she believes that good research needs to involve patients from the beginning and incorporate their voice.
Roger Legtenberg
Info Speaker

Roger Legtenberg

Senior Partner admedicum Business for Patients and former CEO of a CRO
Roger J. Legtenberg, Ph.D. is a Senior Partner & Head of Benelux Region at admedicum Business for Patients, experts in patient engagements and patient access to innovative services and products. Roger is the former CEO of PSR Orphan Experts, a rare disease specialized CRO, as well as a former senior executive in biotech & medtech companies. With over 20 years of experience in clinical trials and a strong passion to reduce time for patients to new effective treatments he is currently accelerating patient-focussed drug development within admedicum. Roger obtained a Ph.D. in Cardiovascular Physiology from the University of Nijmegen, the Netherlands.  
Begonya Nafría Escalera
Info Speaker

Begonya Nafría Escalera

Patient Engagement in Research Coordinator at Sant Joan de Déu Children’s Hospital
She has long experience in the field of the involvement of patients and families in research initiatives. She has also a personal story as a caregiver and patient advocate because is the sister of a young adult with cerebral palsy. Her areas of expertise are focused in paediatric patients involvement in research and specifically in the field of clinical trials. Other relevant background of her profile is: Fellow of EUPATI (first cohort), Coordinator of eYPAGnet (European Young Patients Advisory Group Network), Coordinator of Kids Barcelona (YPAG of Sant Joan de Déu Children’s Hospital), member of Children’s Medicines Working Party of EFPGCP, volunteer member of the Editorial Board of Center for Information & Study on Clinical Research Participation (CISCRP), reviewer of Research Involvement and Engagement Journal, Chair of the Educational Committee of ICAN (International Children’s Advocacy Network) and member of the Patients and Families working group of EnprEMA (European Network of Paediatric Research of EMA). Coordinator of the cross-cutting theme of patients involvement in Conect4Children project (pan-European paediatric clinical trials network) and participant of PARADIGM project, both funded by IMI. Coordinator of the Share4Rare project, funded by the European Commission (H2020) that has the aim to develop a digital platform addressed to improve the research in the field of rare diseases through the collective intelligence of patients and families. The main aim of all the activities leaded or participated by Begonya is to achieve a better quality of life for the paediatric patients thanks to research and new therapies.
Andrea Ochoa
Info Speaker

Andrea Ochoa

Vice President, Global Study Start Up at Premier Research
Andrea Ochoa is Vice President, Global Study Start-Up, at Premier Research. Ms. Ochoa has more than 20 years of clinical operations experience in a variety of roles, specializing in study start-up for the past 10 years. In her current role, she oversees Premier Research’s global start-up function while providing expert advice and strategies to operationalize and navigate the complex global regulatory and start-up environment. Prior to joining Premier Research, Ms. Ochoa held several positions of increasing responsibility at MDS Pharma Services and INC Research. She has a master’s degree in Cognitive-Behavioral Therapy from the Luria Institute in Madrid, Spain, and bachelor’s degrees in psychology (National Distance Education University, Madrid) and law (Complutense University of Madrid). Ms. Ochoa is certified as Lean Sigma Green Belt since 2009.
Sarah Pilkington
Info Speaker

Sarah Pilkington

Associate Director, Patient Innovation Center at Parexel International
Sarah Pilkington is an Associate Director within Parexel’s Patient Innovation Center, dedicated to improving access to clinical research and patient and caregiver experience. Ms Pilkington has worked within clinical research organizations for 9 years with much of this time dedicated to patient access, recruitment and retention. Ms Pilkington is passionate about making healthcare and clinical research more accessible to all, while ensuring patients and caregivers receive the support they truly need throughout clinical trial participation and beyond.
Doris Christiane Schmitt
Info Speaker

Doris Christiane Schmitt

Consultant for patient communication
Doris C. Schmitt has studied pedagogy and psychology. She is a freelance consultant and speaker for pharmaceutical companies and communications trainer for cancer patients and health care professionals. When diagnosed with breast cancer, she became aware of the importance of adequate information about the disease and the challenges cancer patients are facing when talking to their doctors. Several of her articles about the importance of effective doctor-patient communication have been published in German and English media. Therefore she was offered a membership with VMWJ as medical journalist. Since June 2008 she is member of the board of the worldwide only patient driven breast cancer bio bank PATH and member of the Executive Team EUPATI Germany.
Victoria Thomas
Info Speaker

Victoria Thomas

Head of Public Involvement at National Institute for Health and Care Excellence (NICE)
Victoria Thomas has run the Public Involvement Programme at NICE since 2009, and has been with the Programme since 2001. Following a degree in Art History, Victoria has worked exclusively in the public and voluntary sector, specialising in healthcare quality improvement activities and in patient and public involvement. Victoria’s MSc, in Science and Society, concentrated on issues of science communication, science and the public, and lay people’s engagement with evidence-based healthcare initiatives. Victoria has an interest in shared decision-making, in particular the role of national guidance as the basis of informed decision-making by both patient and clinician.
Mary Lynne Van Poelgeest-Pomfret
Info Speaker

Mary Lynne Van Poelgeest-Pomfret

President WFIPP, Co-Chair European Health Coalition, Vice-chair European Forum for Good Clinical Practice - EFGCP
Mary Lynne Van Poelgeest-Pomfret is a long-standing international patient advocate promoting the rights of patients at both national and international levels. A member of several patient advocacy movements and organizations like IAPO (International Alliance of Patient Organizations) and EPF (European Patients Forum). She has organized several workshops and given numerous presentations at major international scientific and patient advocacy organizations. She is also a member of the EFPIA PatientThinkTank. She became Vice-Chair of EFGCP as of March 2017 and is keen to actively contribute to the work of EFGCP, primarily from the patient perspective. She participated in the first EUPATI workshop of patient advocate experts in Frankfurt in September 2012 and actively participates in EUPATI. Lynne became the President of WFIPP - World Federation of Incontinence and Pelvic Problems in January 2011: an international umbrella organization dedicated to enhancing the rights of patients suffering from incontinence and pelvic floor dysfunction in general. In this capacity the latest initiatives include a collaborative agreement with the European Association of Urology relating to patient advocacy issues and the upcoming project Support In Continence, to be launched October 2020. Also until April 2016, chairperson of the ICP – Netherlands Interstitial Cystitis Patients’ Organization. More recently she became a member of the ‘Core Board’ for one of the EIP – AHA Focus groups led by the University of Valencia, Spain. Member of the PACT Steering Committee and also a member of PARADIGM as patient engagement representative of EFGCP. Also as EFGCP a member of the Consortium for the IMI project ‘Conception’ These latter initiatives are very much concerned with access to healthcare and patient engagement throughout healthcare in Europe. Member of several scientific advisory committees and panels, including the EMA and the European Association of Urology. Recently selected to become a member of the panel of patient experts with active participation in, for example, healthcare decision-making within the EU. Also recently was invited to become a member of the EAU Patient Advocacy Group (EPAG) and a member of the Patient Information Advisory Council. She is also now Co-Chair of the European Health Coalition. Lynne worked for Shell in the Netherlands for 23 years and has a BA degree from the UK and Drs. Degree from Leiden University in the Netherlands.
Theodora Varkonyi-Weisz
Info Speaker

Theodora Varkonyi-Weisz

Senior Director Patient Advocacy & Public Affairs EMEA CEE, New Markets at Ionis Pharmaceuticals
Theodora Weisz is Senior Director Patient Advocacy & Public Affairs EMEA CEE, New Markets at Ionis Pharmaceuticals in the field of rare diseases, concerned with advocacy, policy, disease and diagnostic awareness building, support and education of patients, care givers and patient group leaders. She is passionate about giving a voice to patients on the public healthcare and political sphere, through regulators, health-care providers and the medical communities. On a voluntary basis, she co-founded the Swiss FH Patient organisation, has been an active supporter of the creation and establishment of new patient organisations in Europe, a member of the European Atherosclerosis Society (EAS) and EURORDIS, former board member of the FH Europe Network and industrial advisor partner of the Alliance. She has gained extensive experience in several pharmaceutical companies over the last 20 years in different countries and functions. In recent years she has been an international speaker at cardiovascular and metabolic disorders congresses, several patient organisation-driven global events on the topics of patient advocacy, policy and engagement as well as managed access pathways. Theodora holds a Master’s degree, her educational background is both scientific/medical and commercial/business. She speaks seven languages fluently and in 2014 was selected as one of the ‘young talents’ within the pharmaceutical industry. She was granted Akcea’s recognition award for outstanding contribution of the EMA approval process support in 2019.
Philipp von Gallwitz
Info Speaker

Philipp von Gallwitz

Co-Founder admedicum Business for Patients and Patient Activist CDKL5
Philipp is Managing Partner and one of 2 co-founders of admedicum Business for Patients, European experts in patient engagements and patient access. In this function and as a father to a 20-year old daughter living with the rare genetic disease CDKL5 he has been passionately advocating for involving the patient view in research & development since many years. He is a member of the patient expert pool of the European Innovative Medicines Initiative (IMI). While working with patients and patient organizations every day Philipp has gone through a 20 year long international management career with Grünenthal GmbH in Europe, USA and Latin America, being closely involved in many clinical development programs. He is a lawyer by training, registered at the bar of Cologne, Germany.
Maya Zlatanova
Info Speaker

Maya Zlatanova

CEO and Co-founder of FindMeCure Ltd
Maya Zlatanova is the CEO and Co-founder of FindMeCure Ltd. - a company dedicated to developing tools that bring research closer to patients. Her passion is bringing better patient understanding in the operational conversation about clinical trials thus solving the patient recruitment and retention challenges.
Training

Pre-Conference Training
27 September 2021
2.00 pm to 6.00 pm CEST – Online

Remote and Decentralized Trials: a Patient Focused Approach

How to avoid hype and create value for patients and sponsors

Introduction
Remote or decentralized trials are currently a hot topic; among others, driven by the restrictions and concerns of patients and trial sites during the Covid-19 pandemic. Industry is trying to find the right way to design trials with remote and decentralized virtual parts to enhance enrolment and keep retention high.
However….

  • How can we make sure that all the good ideas stand firm when those who must live through the clinical trial really make up their mind whether to participate or not?
  • Do clinical trial participants really like to have a blood draw at home?
  • Do they trust the nurse coming to visit their child without a doctor?
  • Do they appreciate the advantages of e-ICF, regardless the disease?

Programme
This course will address methodologies of patient partnering and patient engagement before and during the design of your clinical trial.
The focus will be on remote / decentralized trials. Still, the conclusions will be transferable to most other aspects of patient input into clinical trial design.
The course will navigate you through materials, methodologies, procedures, and tools that can be used in real practice to follow recent FDA guidance for PFDD (patient focused drug development) and recommendations of the EMA.

Topics:

Overview of Patient Involvement at FDA and EMA
– Patient Focused Drug Development Guidance and practice by FDA.
– Recommendation guidance and practice by EMA.

Case Study and Break Out session 1:
– Patient involvement in the design of a decentralized clinical trial (patient relevance impact & opportunities – e.g., diversity, ethical/privacy elements, endpoints etc.).

Proven methodologies and tools for patient involvement I

Case Study and Break Out session 2:
– Patient involvement in the design of a decentralized clinical trial (practical & logistical impact – e.g., patient enrollment & retention, telemedicine etc.)

Proven methodologies and tools for patient involvement II

Break Out session 3:
– Moderated group work on conclusions and results (key take-home learnings & ideas) from the training session.

At the end of the course there will be an opportunity for virtual networking among participants.

Who should attend?
Small Biotech / Start-up Leadership (IND/clinical stage), Clinical Operations, Clinical Development, R&D Strategy, Patient Affairs/Relations, Patient Experts, and those who want to become one, Medical Affairs, R&D Project Management.

Teaching methods
Case studies, procedures, and methodologies tools for use in practice.
Highly interactive moderated exchange of practical experience regarding challenges and solutions.
Break out working sessions, including preparation of presentation of practical learnings and conclusions for full conference audience next day.

Lecturers
Philipp von Gallwitz,
Co-Founder admedicum Business for Patients and Patient Activist CDKL5
Roger Legtenberg, Senior Partner admedicum Business for Patients and former CEO of a CRO

At the end of the training, you will be able to…

  • Differentiate between hype and actual value of remote/decentralized parts of a clinical trial.
  • Identify where and when involvement of patients in your trial design discussion can really be valuable.
  • Ask the right questions regarding patient relevance of remote/decentralized clinical trials.
  • Define different methodologies for efficient patient involvement in clinical trial design.
  • Explain to others why patient engagement in clinical trial design is valuable for your organisation.
Contacts

Ilaria Butta
Events & Training Executive
ilaria.butta@lsacademy.com
+39.379.1492960


Registration Fee

Conference:
€ 490,00* Early Bird fee until 06 September 2021
€ 630,00* Ordinary fee
€ 290,00* Freelance, Academy, Public Administration

The fee includes: access to the virtual conference, organizational support, certificate of attendance, slide presentations in pdf format provided post-conference.

Pre-Conference Training:
€ 440,00* Early Bird fee until 06 September 2021
€ 590,00* Ordinary fee
€ 265,00* Freelance, Academy, Public Administration

Fee includes: access to the virtual training, organizational support, certificate of attendance, slide presentations in pdf format provided post-course.

Pre-Conference Training + Conference:
€ 795,00* Super Early Bird fee until 31 July 2021
€ 835,00* Early Bird fee until 06 September 2021
€ 1.150,00* Ordinary fee
€ 495,00* Freelance, Academy, Public Administration

Fee includes: access to the virtual training and conference, organizational support, certificate of attendance, slide presentations in pdf format provided post course and conference.

* for Italian companies: +22% VAT

Past Conferences
2020
How to Best Integrate Patients into your Strategies and Operations in Clinical Development - STEP III
2019
How to Best Integrate Patients into your Strategies and Operations in Clinical Development - STEP II
2018
How to Best Integrate Patients into your Strategies and Operations in Clinical Development
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Sponsors
Partners
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<p style="text-align: center;">Virtual conference with presentations, slots for Q&amp;A and discussion among delegates.<br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>

Virtual conference with presentations, slots for Q&A and discussion among delegates.
LS Academy will provide the link to join the conference some days before.

<p style="text-align: center;">Virtual conference with presentations, slots for Q&amp;A and discussion among delegates.<br />
<em>LS Academy will provide the link to join the conference some days before.</em></p>

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