Retrospective Sample Collection

Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • March 25, 2015

Sample Access and Profiling for Biomarker Discovery to Help Rescue or Reposition your Drug

With personalized medicine becoming more commonly accepted, an increasing number of drugs in development have a biomarker strategy. In situations where a drug has not performed as well as hoped, a biomarker strategy could potentially rescue the drug or increase market uptake through the use of a companion diagnostic.

Almac have developed a service to enable biomarker studies to be carried out retrospectively in trials where there was not one in place from the start.

This service includes obtaining ethical approval and corresponding consent, identification of clinical information for patients in partnership with investigators, contractual arrangements, sample sourcing and providing full logistical and regulatory oversight of sample preparation, shipping, receipt and biobanking.

Almac have a team of highly experienced experts that work exclusively in the delivery of this service, that have:

  • Established workflows for projects of this type
  • Expertise and experience of ethical submission and regulatory requirements in a range of countries and institutions
  • A prepared bank of template documentation for this type of study
  • Experience of working with large number of recruiting sites worldwide
  • Relationships with many different investigators and background staff in recruiting centres
  • Extensive experience in contractual arrangements for sample access and shipping worldwide
  • Global capabilities to expedite the process of clinical site participation and sample access
  • Experts in sample preparation, packaging and shipping
  • Experience in study design and delivery of large research studies which involve a wide range of downstream genomic and proteomic assays that impact upstream sample selection and preparation
  • Specialist knowledge and vast experience of working in a range of oncology indications

In this webinar, Almacs head of project management Dr Peter Kerr, along with Michael Sloan, VP of Business Development, and Kinga Wojciechowska, lead project manager for Ethics and Tissue Collection, will give an overview of the service. The talk will highlight the reasons for the development of the service and give some details on the potential benefits to biopharma. The details of the service will then be explained and a case study used to elucidate the process, there will then be an “ask the experts” Q&A session where the team will address your questions.

Speakers

Dr. Peter Kerr, Head of Project Management & Product Development, Almac Diagnostics

Peter Kerr leads the project management and product development activities at Almac Diagnostics. The team work with the Pharmaceutical industry on the discovery, development and delivery of biomarker services often as part of a companion diagnostic pipeline. This team are also responsible for AlmacDiagnostics’ product development pipeline of prognostic and predictive biomarkers.

Peter studied in Cambridge University before postgraduate work at Edinburgh and Glasgow universities leading to a PhD. He worked on the functions of BRCA1 and BRCA2 in the Breakthrough Breast Cancer Research Centre at the Institute of Cancer Research in London before establishing and managing a microarray facility there. He then worked as a Programme Manager with the NCRI Informatics Initiative in London before joining Almac Diagnostics in 2006.

Michael Sloan, Vice President, Business Development, Almac Diagnostics

Michael Sloan has been VP of Business Development for Almac Diagnostics since 2005. He has full responsibility for the overall management of the company’s business development activities and driving the growth of the company.

Michael has a BSC in Commerce and MSC in Corporate Leadership and was educated at the University of Birmingham, Napier University, Scotland and at Ivey Business School, Canada.

He has over 20 years in senior business development and management roles in the biotech 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.

Kinga Wojciechowska, Project Manager - Ethics/Tissue Collection, Almac Diagnostics

Kinga Wojciechowska is an Ethics/Tissue Collection Project Manager for Almac’s Diagnostics Business Unit. She is responsible for managing retrospective sample collection projects, ethics approval and sample sourcing processes on behalf of multiple clients globally. Kinga graduated from the Polish Naval Academy of Gdynia Institute of Social Science with a Master’s Degree in Maritime Administration and Economics. She has considerable knowledge regarding international regulations, inter-governmental and non-governmental organizations and multinational corporations.

Who Should Attend?

This session will benefit senior scientists and clinical trials executives involved in biomarker strategies for pharma and biotechnology companies worldwide

Xtalks Partners

Almac

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the Pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

Almac Diagnostics operates as a subsidiary of the Almac Group and focuses on the discovery, development and delivery of novel prognostic and predictive tests. Partnering with the bioPharmaceutical industry the global company supports the discovery, development and delivery of companion diagnostics. AlmacDiagnostics has a pipeline of oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.

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