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Craig Wylie

Managing Partner

Head of Arthur D. Little USA

United States

With 30 years of working in the life sciences industry, Craig focuses on the effective delivery of quality and regulatory compliance in the highly regulated life sciences environment.

Areas of Focus

Education

Stirling University
BSc Computing Science and Management Science

Past Experience

PA Consulting Inc.
Partner
KPMG
Director

Craig is a Partner at Arthur D. Little, based in Boston, and a member of our global Healthcare & Life Sciences Practice.
Craig’s work includes Quality and Regulatory Operations, Clinical Trial Operational Effectiveness and Manufacturing Compliance, in particular supporting the integration of quality systems post merger, the resolution of audit and inspection findings and process improvement and simplification.

 

Craig has a background in Quality Operations, IT and Clinical Development, and focuses on pharmaceutical and medical device companies helping to ensure the effective implementation of quality and regulatory compliance within this highly regulated environment.

 

Craig has worked with many of the world’s largest Life Sciences firms on aspects of their quality and regulatory environments; this has included work on remediation of warning letters and consent decrees.

 

Craig strongly believes that effective quality management should be an enabler of value within the organization, not a burden. Effective quality and compliance systems guide thinking without stifling innovation.

 

Prior to Arthur D. Little, Craig was a Partner at PA Consulting in the UK and the US, where he led the global quality and regulatory team.

Healthcare & Life Sciences
Managing competition, price and access
Craig Wylie, Vikas Kharbanda, Dhiraj Joshi
High medicine prices impose a burden on national healthcare systems, where pharmaceuticals account for a significant share of spending, especially for countries in the early stages of maturity in the pharma sector. Competition authorities have expressed concerns that access to affordable, innovative drugs may be at risk due to high prices, market withdrawals or other business strategies, along with national governments’ limited bargaining power against pharma companies.
Find out more
Healthcare & Life Sciences
Managing clinical trials during COVID-19 and beyond
Ben van der Schaaf, Ben Enejo, Craig Wylie, Tom Teixeira, Rick Eagar
One of the many consequences of the COVID-19 crisis has been difficulty in continuing to enroll and run clinical trials, which typically involve large numbers of people interacting in multiple geographies. Arthur D. Little (ADL) has pioneered and deployed a new, risk-based predictive analytical approach, powered by machine-learning technology. It enables pharma companies to make much better predictions and forecasts to support decision-making around key issues, such as adapting patient targets to favor less affected and recovering geographies, program extensions, and new trials.
Find out more
Transforming healthcare – How curative therapies will disrupt the market
Craig Wylie, Rebecka Axelsson Wadman, Vikas Kharbanda, Dr. Ulrica Sehlstedt
The shift to curative treatments promises to transform the entire healthcare ecosystem. Patients whose conditions were previously managed through ongoing, long-term medication can now be cured through specific courses of treatment. This transforms their lives – but, as this article explains, it also has a disruptive effect on the wider market, shifting payers’ expenditure, increasing the importance of first-mover advantage for pharmaceutical companies, and changing care models for healthcare providers.
Find out more
Healthcare & Life Sciences
Future health
Craig Wylie, Rebecka Axelsson Wadman
Find out more
Healthcare & Life Sciences
The advent of consumer owned genetic profiles
Craig Wylie
Access to genetic information is becoming critical to the effectiveness of a new wave of medical treatments that are becoming available now. Personalized genetic services companies will act as a disruptive forces that are consumerizing genomic testing and driving rapid transformation of an industry that we expect to become a major force in personalized medicine. In this report, we consider how large this industry is likely to get in the next 10 years and start to evaluate how pharmaceutical companies, payers, providers and medtech companies will be impacted by the shift.
Find out more

Craig is a Partner at Arthur D. Little, based in Boston, and a member of our global Healthcare & Life Sciences Practice.
Craig’s work includes Quality and Regulatory Operations, Clinical Trial Operational Effectiveness and Manufacturing Compliance, in particular supporting the integration of quality systems post merger, the resolution of audit and inspection findings and process improvement and simplification.

 

Craig has a background in Quality Operations, IT and Clinical Development, and focuses on pharmaceutical and medical device companies helping to ensure the effective implementation of quality and regulatory compliance within this highly regulated environment.

 

Craig has worked with many of the world’s largest Life Sciences firms on aspects of their quality and regulatory environments; this has included work on remediation of warning letters and consent decrees.

 

Craig strongly believes that effective quality management should be an enabler of value within the organization, not a burden. Effective quality and compliance systems guide thinking without stifling innovation.

 

Prior to Arthur D. Little, Craig was a Partner at PA Consulting in the UK and the US, where he led the global quality and regulatory team.

Healthcare & Life Sciences
Managing competition, price and access
Craig Wylie, Vikas Kharbanda, Dhiraj Joshi
High medicine prices impose a burden on national healthcare systems, where pharmaceuticals account for a significant share of spending, especially for countries in the early stages of maturity in the pharma sector. Competition authorities have expressed concerns that access to affordable, innovative drugs may be at risk due to high prices, market withdrawals or other business strategies, along with national governments’ limited bargaining power against pharma companies.
Find out more
Healthcare & Life Sciences
Managing clinical trials during COVID-19 and beyond
Ben van der Schaaf, Ben Enejo, Craig Wylie, Tom Teixeira, Rick Eagar
One of the many consequences of the COVID-19 crisis has been difficulty in continuing to enroll and run clinical trials, which typically involve large numbers of people interacting in multiple geographies. Arthur D. Little (ADL) has pioneered and deployed a new, risk-based predictive analytical approach, powered by machine-learning technology. It enables pharma companies to make much better predictions and forecasts to support decision-making around key issues, such as adapting patient targets to favor less affected and recovering geographies, program extensions, and new trials.
Find out more
Transforming healthcare – How curative therapies will disrupt the market
Craig Wylie, Rebecka Axelsson Wadman, Vikas Kharbanda, Dr. Ulrica Sehlstedt
The shift to curative treatments promises to transform the entire healthcare ecosystem. Patients whose conditions were previously managed through ongoing, long-term medication can now be cured through specific courses of treatment. This transforms their lives – but, as this article explains, it also has a disruptive effect on the wider market, shifting payers’ expenditure, increasing the importance of first-mover advantage for pharmaceutical companies, and changing care models for healthcare providers.
Find out more
Healthcare & Life Sciences
Future health
Craig Wylie, Rebecka Axelsson Wadman
Find out more
Healthcare & Life Sciences
The advent of consumer owned genetic profiles
Craig Wylie
Access to genetic information is becoming critical to the effectiveness of a new wave of medical treatments that are becoming available now. Personalized genetic services companies will act as a disruptive forces that are consumerizing genomic testing and driving rapid transformation of an industry that we expect to become a major force in personalized medicine. In this report, we consider how large this industry is likely to get in the next 10 years and start to evaluate how pharmaceutical companies, payers, providers and medtech companies will be impacted by the shift.
Find out more

More About Craig
  • Stirling University
    BSc Computing Science and Management Science
  • PA Consulting Inc.
    Partner
  • KPMG
    Director