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Almac West Coast USA Roadshow 2027

Complimentary Diagnostic and Regulatory Pathways Session At Your Premises

Register your interest

Almac West Coast USA Roadshow 2027

“From Biomarker Promise to Patient Selection: A practical roadmap to assay development and companion diagnostic (CDx) success, including utilisation of IVDR & Health Institution pathways in EU Trials”.

For convenience, our Almac Diagnostic Services Experts will visit your premises for a complimentary 1-2 Hour biomarker programme and regulatory discussion.

Topics include:

Content can also be tailored to your needs.

Our Experts

Professor Richard Kennedy

Global VP of Biomarker Development & Medical Director

Almac Diagnostic Services

Professor Richard Kennedy

Professor Richard Kennedy is Global VP of Biomarker Development, Medical Director and CLIA compliant Laboratory Director at Almac Diagnostic Services. He is responsible for the application of the company’s technology into medical practice. He graduated in medicine from Queen’s University Belfast in 1995. As a post-graduate he trained as a medical oncologist and received a PhD in Molecular Biology in 2004. From 2004-2007 he worked as an instructor in oncology at Harvard Medical School, USA, where he identified novel biomarkers and drug targets for cancer treatment. In August 2007 he joined Almac Diagnostic Services as the director of a CLIA compliant diagnostics laboratory and has been involved in the biomarker design for several international clinical trials. In 2012 he established a research group in Queen’s University Belfast focussed on various aspects of stratified medicine. Richard Kennedy currently sits on the CR-UK new agents committee, MRC Biomarkers steering group, the National Cancer Clinical Trials Steering Group, the Enterprise Ireland Technology assessment panel and the all-Ireland Breast Cancer Predict Consortium. Previously he was a member of the CR-UK biomarker steering group and the Breast Cancer Campaign scientific advisory board.

Dr Katarina Wikstrom

Global VP of Product Development Almac Diagnostic Services

Dr Katarina Wikstrom

Dr. Katarina Wikstrom (PhD) has worked for over 20 years in the field of translational molecular oncology and holds the position of VP Global Product Development at Almac Diagnostic Services. Katarina obtained a PhD in experimental pathology from Lund University, and subsequently completed a postdoctoral fellowship on the molecular mechanisms of prostanoid signaling in vascular haemostasis and oncology at University College Dublin. Since joining Almac in 2009 Katarina has built up a breadth of experience in the biomarker field with particular focus on assay development and validation. Katarina has overall responsibility for all product development activities at Almac Diagnostics Services, from design of novel biomarker assays across a range of technologies, to validation and manufacture of clinical trial assays and companion diagnostics. Based in Durham, North Carolina, Katarina also has responsibility for Almac Diagnostic Services’ US laboratory.

Dr Stewart McWilliams

Global VP of Quality and Regulatory Affairs

Almac Diagnostic Services

Dr Stewart McWilliams

Stewart McWilliams leads the Quality Management and In vitro Diagnostic Regulatory affairs activities at Almac Diagnostic Services. The team work with the pharmaceutical industry on the Quality and Regulatory aspects of CDx Development and Commercialisation. This team are also responsible for Almac Diagnostic Services’ Laboratory Quality Management systems ensuring compliance with ISO13485, CLIA (Federal and New York State CLEP), ISO15189 and the College of American Pathologists accreditation requirements. Stewart studied in Queens University Belfast where he attained his degree and PhD in Molecular Oncology before postgraduate work at The Welcome Trust Centre in Dundee. Stewart has managed the implementation of various Quality Management Systems including ISO13485, GCP, CAP accreditation, New York State CLEP and CLIA. He is also Almac Diagnostic Services Designated Individual for the purposes of the UKs Human Tissue Act.

Michael Sloan Global

VP of Commercial Operations

Almac Diagnostic Services

Michael Sloan Global

Michael Sloan is Global VP of Commercial Operations at Almac Diagnostic Services. He has full responsibility for the overall management of the company’s business development, marketing, project management and product management functions.

Michael has a BSC in Commerce and an MSC in Corporate Leadership and was educated in the University of Birmingham, Napier University, Scotland and the Ivey Business School, Canada. He has over 30 years in senior management and business development roles in the life science and medical device sector. He has worked in both start up and multinational companies. His previous experience including Managing Director for BSN Medical UK a Smith and Nephew and Beiersdorf JV and Executive Director for Amtec Medical Ltd.

Register Your Interest

Register your interest for the specific date and time you would like Almac Diagnostic Services to come onsite to deliver a roadshow session to your team.

There will be options each day for morning, lunch, or afternoon workshop slots. Please select your preferred slot(s), and we will endeavour to accommodate your choice or revert with an alternative option. If your preferred time is unavailable, we will contact you with an alternative option.

You may wish to choose 1 hour, 1.5 hours or 2 hours as a session duration. The 2 hour session time would be an extended workshop which could also cover off topics of specific interest to your team(s) in attendance.

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To learn more about our services, please visit Almac Diagnostic Services