Mark Wade, Global Practice Leader | TransPerfect

Mark P. Wade holds the position of Global Practice Leader at TransPerfect Life Sciences the largest Language translation company globally, where he is the resident SME for all clinical trial processes and translation. Mr. Wade’s 20 years in Life Sciences includes International Regional Director for EMEA at Ethicon and Ethicon Endo Surgery, Johnson & Johnson companies (NYSE: JNJ). For almost ten years Mr. Wade was Global Practice Leader at another global language translation company. He is a published expert in Electronic Clinical Outcomes Assessments (eCOA) including two eBooks, Clinical Posters and numerous articles in trade journals. He has significant experience and has published in Clinical Services, Patient Recruitment and Site Selection. Mr. Wade has Chaired, presented and published Posters at DIA Annual Symposia and numerous other internationally recognized conferences. He is an active committee member of ISOQOL Translation & Cultural adaptation (TCA) Special Interest Group (SIG), ISPOR TCA SIG and DIA Endpoint Study Group.

Michael Dorrell, Alliance Director – Digital Patient Solutions/Translation Services | AstraZeneca

Life Science Professional across Pharma/Biotech – eCOA/Translations/Patient Centricity Champion. Astrazeneca’s ambition is to transform the lives of patients with improved outcomes and a better quality of life, through more effective treatment and prevention, ultimately working toward a cure for some of the world’s most complex diseases.

Paul O’Donohoe, Senior Director, eCOA Product and Science | Medidata Solutions

Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for providing strategic oversight of the development of Medidata’s electronic clinical outcome assessment technologies, and supporting internal teams and partners around the implementation of industry, regulatory and scientific best practices in clinical trials using mobile health technologies. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and was previously the Industry Vice-Director of the C-Path ePRO Consortium.

Katja Rudell, Senior Director, COA, CDDS | Parexel

Katja Rudell is the Team Lead of the COA Science department in Parexel’s Clinical Data and Digital Services department. She is a COA instrument developer and has been working in Industry for 12 years and consulting for three years.

Helen Kitchen, Vice President, Clinical Outcome Assessment | Clarivate

Helen is the Vice President of the Clinical Outcomes Assessment team at Clarivate. Helen has 13 years’ experience of developing PROs and other COAs for clinical trials in line with regulatory (FDA, EMA) requirements. Helen has developed and validated multiple COAs for clinical trials and supported sponsors in achieving FDA label claims. Helen specializes in COA reviews according to regulatory (FDA/EMA) requirements and qualitative research methods using creative, patient-centered techniques. Helen has conducted qualitative interviews with patients and clinicians in multiple therapy areas with extensive experience in women’s health and autoimmune conditions. Helen is an active member of the ISPOR and ISOSOL and a specialist trainer in qualitative interviewing skills, mixed methods research and PROs for HTA/reimbursement. Helen has an MSc in Health Psychology from Sheffield Hallam University and a BA (Hons) in Psychology from the University of Manchester.

Ash Rishi, Founder | COUCH Health

In his own words, Ash is a ‘failed neuroscientist’. Not one to let a failure hold him back, Ash has crafted a career where he gets to show is passion and support for inclusive healthcare practices every day. Ash shares over 15 years of experience in creative communications, patient and community engagement, and inclusive recruitment strategies for clinical trials. As the proud CEO and Founder of COUCH Health, he’s driven to make a difference, and is inspired to defy the odds, always standing up for what’s right. As well as running COUCH Health, Ash has recently launched the COUCH Health Academy an online learning platform dedicated to improving health equity and dedicates his time to raising awareness about via Demand Diversity.

Sevtap Rowland, Head of Functional Service Provisions | MAC FSP Solutions

Sevtap Rowlands is Head of Functional Service Provision at MAC Clinical Research. o With 12 years of industry experience in a variety of clinical research roles including safety & governance, CRA and even leading international multi-disciplinary teams, Sevtap has a solid understanding of the clinical research market and has expertise in leading high-performing teams and successful studies. MAC Clinical Research is a global contract research organization (CRO) providing end-to-end clinical trial services. Established in 1988 as one of the UK’s first memory clinics, MAC has evolved within the clinical research industry with 8 fully-owned research facilities and expertise covering a wide range of therapeutic areas. MAC offers many solutions to pharmaceutical and biotech companies including Clinical Research Services, Pharmaceutical Services, Scientific Solutions, Site and Patient Services, and FSP solutions.

Nadia Deller, Senior Study Start Up Associate | Innovative Trials

Nadia is responsible for providing seamless start up activities for all projects across Innovative Trials. Alongside this Nadia is Co-Chair of the E&D committee which aims to drive internal and external DE&I training, raise awareness and provide tangible solutions to increase diverse enrollment across clinical programs with the patient centricity at the heart of what we do. Innovative Trials is a leading global clinical trial patient recruitment company. With over 10 years of experience, Innovative Trials deploys “boots-on-the-ground” patient recruitment experts in over 70 countries, addressing individual sites’ unique patient recruitment and retention challenges in local language. Innovative Trials has experience in 25 therapeutic areas and 90+ conditions.

Pierre-Frédéric Omnes, Executive Director | TransPerfect

Pierre-Frédéric Omnes is a subject matter expert on global Clinical Trials Regulatory Operations, Study Start up, and EU Clinical Trial Regulation (corporate readiness, implementation, EU Portal, transparency). Pierre has over 20 years of experience in global Clinical Research Organizations and Pharma Companies as Regulatory Affairs consultant. Pierre supported in the last 15 years the coordination, support and oversight of numerous multinational clinical trial applications globally for small molecules, biologics and advanced therapies across several therapeutic areas as well as EU Clinical Trial Regulation (EU CTR) readiness activities. Pierre is chairing the ACRO’s (Association of CROs) EU Scientific and Regulatory Committee and is involved in several representative activities related to the EU Clinical Trial Regulation. Since 2019 Pierre is one of the industry representatives and Sponsors’ Lead Sponsor Product Owners in the EMA New Delivery Model Initiative for the development of the EU Portal (Clinical Trial Information System, CTIS). This EUCTR engagement continues post EU CTR Go Live for continued improvement of CTIS functionalities.

Jost Leemhuis, Safety Science Partner and Global Business Lead | Roche

Board certified physician, Pharmacologist and Toxicologist former Assistant Professor at the medical University of Freiburg, Germany. Since 25 years in Pharma Development, 10 years in the Pharmaceutical Industry (Roche, Drug Safety) Current main topics: Safety input into HTA, Pharma Development and Patient Centricity.

Soren Skovlund, Senior Director, Head of Patient Engagement | Evidera

Soren Skovlund, PhD, is the global Senior Director and Head of Patient Engagement at Evidera. He has two decades of experience advocating for and leading patient-centric initiatives across the value chain and health sectors. Soren Skovlund has a doctorate degree in patient engagement from the Medical Faculty of Aalborg University in Denmark and co-authored more than 45 scientific publications. He was involved with EUPATI and co-developer of the quality criteria for patient engagement of the PFMD. Evidera is an industry leader in patient-centered experience research and development and validation of outcome measures for patient-focused drug development.

Mark Wade, Global Practice Leader | TransPerfect

Mark P. Wade holds the position of Global Practice Leader at TransPerfect Life Sciences the largest Language translation company globally, where he is the resident SME for all clinical trial processes and translation. Mr. Wade’s 20 years in Life Sciences includes International Regional Director for EMEA at Ethicon and Ethicon Endo Surgery, Johnson & Johnson companies (NYSE: JNJ). For almost ten years Mr. Wade was Global Practice Leader at another global language translation company. He is a published expert in Electronic Clinical Outcomes Assessments (eCOA) including two eBooks, Clinical Posters and numerous articles in trade journals. He has significant experience and has published in Clinical Services, Patient Recruitment and Site Selection. Mr. Wade has Chaired, presented and published Posters at DIA Annual Symposia and numerous other internationally recognized conferences. He is an active committee member of ISOQOL Translation & Cultural adaptation (TCA) Special Interest Group (SIG), ISPOR TCA SIG and DIA Endpoint Study Group.

Mona Khalid, Vice President, Value Demonstration, Health Economics & Patient Access | Endpoint Health

Endpoint Health’s mission is to ensure that patients get the best treatment possible for their unique biology and disease, by developing precision therapies. Mona was previously at Galapagos, where she was Vice President, Head of Evidence Generation. Prior to this, Mona spent a decade leading teams within the pharmaceutical industry to ensure optimal evidence for, and access to medical interventions. In her role at Takeda Pharmaceuticals, she was Global Head of Evidence and Value Generation, leading the creation of evidence packages used for regulatory and reimbursement purposes. During Mona’s career, she has worked on launching several therapeutics in the biologics, small molecule and stem cell therapy spaces, including Entyvio®, Alofisel®, and Jyseleca®. Mona has particularly strong therapeutic area expertise in respiratory and immune-mediated inflammation.

Jost Leemhuis, Safety Science Partner and Global Business Lead | Roche

Board certified physician, Pharmacologist and Toxicologist former Assistant Professor at the medical University of Freiburg, Germany. Since 25 years in Pharma Development, 10 years in the Pharmaceutical Industry (Roche, Drug Safety) Current main topics: Safety input into HTA, Pharma Development and Patient Centricity.

Ashley Duenas, Senior Research Associate | Evidera

Ashley Duenas, MSc, is a Senior Research Associate with the Patient-Centered Research (PCR) group at Evidera. She is involved leading a variety of research efforts related to the development of Patient Reported Outcomes (PROs) for use in clinical trials. She is passionate about involving patients not only in the PRO development process but throughout the drug development process and in the real world setting. She has been involved with several patient engagement initiatives, including the development of the PFMD multi-stakeholder guidance on how to involve patients in COA strategy, developed with patients and other contributors from pharma. Prior to working at Evidera, Ms. Duenas led public health initiatives for underserved communities in London and New York City. She has a Master of Science degree in public health from the London School of Hygiene and Tropical Medicine with a focus in health services research and a Bachelor of Arts degree in psychology from Columbia University.