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Agios Fellowship Program

Agios, in collaboration with MCPHS University, offers a unique fellowship program to promote the role of the Doctor of Pharmacy (PharmD) within the biopharmaceutical industry. A fellow gains extensive experiences through various practical activities in both industry and academic settings, which could enhance the potential for accelerated career development. Currently, Agios has the following fellowship programs:

  • Medical Safety & Risk Management
  • Clinical Supply Chain (New Program)
  • Regulatory Affairs – Clinical Strategy (not recruiting for a 2021-2023 fellow)
  • Regulatory Affairs – Chemistry, Manufacturing, and Controls (not recruiting for a 2021-2023 fellow)

Fellowship Overview

This fellowship program is designed to offer Doctor of Pharmacy graduates in-depth experience within a biopharmaceutical industry setting. In addition, PharmD graduates will have the opportunity to enhance their clinical and academic background in conjunction with MCPHS University. Overall, this fellowship program will provide the training and experiences necessary to prepare the fellow for a career in the competitive pharmaceutical industry.

Please see our brochure for additional details and feel free to review the content below.

About Agios

Agios is a biopharmaceutical company passionately committed to applying scientific leadership in the field of cellular metabolism to transform the lives of patients with cancer and rare genetic disorders. Metabolism is a complex biological process involving the uptake and assimilation of nutrients in cells to produce energy and facilitate many of the processes required for cellular division and growth. Agios believes that dysregulation of normal cellular metabolism plays a crucial role in many genetic diseases. We believe Agios is a first mover in using cellular metabolism, an unexploited area of biological research with disruptive potential, as a platform for developing potentially transformative medicines. Agios intends to apply a deep understanding of metabolism, coupled with the ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way cancer and rare genetic disorders are treated.

Agios has a dynamic culture, which supports our employees’ unwavering commitment to science and patients. World-class founding and leadership teams with the experience and track record to provide the insights required to develop groundbreaking medicines lead a group of exceptional employees.

We pride ourselves on fostering an interconnected environment that encourages creative scientific collaboration across disciplines. Our unique culture, combined with the commitment and passion of our team, reflect our belief in an “other side of possible” approach to our challenges and our work.

About MSRM

Medical Safety & Risk Management (MSRM) is responsible for managing the safety profile of products throughout their lifecycle through the continuous monitoring, assessment and communication of safety information. As such, MSRM plays a key role in the management of emerging safety signals in drug development and for maintaining this activity for products in the post-marketing setting. MSRM also ensures on -time reporting of high quality individual case reports and as well as the creation and timely submission of aggregate safety reports to fulfil global regulatory requirements. In addition, MSRM is an active participant in the creation of clear, consistent, and accurate product labelling and other product-related information.

Fellowship Goals and Objectives

The goal of the Agios MSRM Fellowship Program is to give the fellow hands-on knowledge of US and global pharmacovigilance activities including a broad understanding of global pharmacovigilance regulations, pharmacovigilance operations, aggregate safety reporting signal detection, and risk management across all stages of drug development, from early stage to post marketing.

Objectives include

  • Developing a strong safety risk management knowledge base and applying those skills practically in the arenas of signal detection and signal management
  • Obtaining well-rounded knowledge of country-specific pharmacovigilance regulations
  • Cultivating strong communications and project management skills
  • Collaborating cross-functionally with various departments within the company as a partner in the product development process

Program Design

As an integrated member of the MSRM team at Agios, the fellow will be provided with a vast array of invaluable opportunities across both the rare genetic disorders and oncology portfolios. These opportunities will enable the fellow to gain real-life pharmacovigilance experience and will deeply enhance their professional knowledge. Over the two years, the fellow will take on projects of increasing scope and responsibility while obtaining a deep comprehension of safety’s roles, responsibilities, and day-to-day tasks, as well as familiarize themselves with the complexities and cross-functional nature of the drug development process.

With the mentorship of the fellowship team at Agios, the fellow will have access to the following career-enhancing activities and responsibilities:

Year 1

  • Work with safety operations colleagues to gain a solid understanding of roles and responsibilities in individual case management and medical review of cases
  • Understand global pharmacovigilance regulations and begin applying knowledge to ensure compliance
  • Observe how safety interacts with other functions and actively participate in these interactions
  • Gain a solid understanding of signal detection, signal evaluation, and risk management activities
  • Become integrated in the cross-functional teams
  • Review safety sections of the protocol, informed consent form, and other study-specific documents ensuring accuracy and consistency
  • Participate in the creation of aggregate safety reports for submission to regulatory agencies worldwide

Year 2

  • Take responsibility for safety for one or more protocols as a Risk Management Lead and represent MSRM at cross-functional meetings
  • Author/review safety sections of the protocol, informed consent form, and other study-specific documents
  • Participate in generating responses to safety-related health authority queries
  • Contribute to Safety Risk Management Plans, the safety sections of the Investigator’s Brochure, and aggregate reports including Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, and Periodic Adverse Drug Experience Reports
  • Assist with the coordination of the Safety Management Team for the assigned product

For more information or questions, please contact:
Peter Hawkins
Peter.Hawkins@agios.com

About Clinical Supply Chain

The Clinical Supply Chain group at Agios develops the strategy for and manages all aspects of drug supply for investigational studies and expanded access programs. Responsible for end-to-end supply chain management, Agios Clinical Supply team members collaborate across a multitude of departments in drug development and oversee activities between the drug product manufacturing and dispensation to patients at the clinic. These activities include determination of drug demand forecasts, development of packaging and labeling supply plans, facilitation of manufacturing with external vendors, setting up global distribution strategies, and development of risk mitigation plans. As an integral part of clinical program and study teams, Clinical Supply members also contribute to clinical study protocols, provide guidance on patient centric packaging design, participate in the build of randomization and trial supply management (RTSM) systems, and develop the masking strategy for blinded studies. Supporting multiple quickly growing programs, the group utilizes industry expertise and explores cutting-edge technology to continuously improve the way Agios delivers medications to patients.

Fellowship Goals and Objectives

The fellow will gain hands-on knowledge of Clinical Supply Chain activities within the Technical Operations organization and gain an extensive understanding of the drug development process.

Objectives include:

  • Develop end-to-end clinical supply chain knowledge and be able to apply their skills practically to drug supply management at the clinical study and program level
  • Cultivate strong communication, leadership, and project management skills
  • Collaborate cross-functionally with various departments within the company as a partner in the drug development process
  • Understand the requirements for supplying drug phase 1-3 studies, US only and global studies, blinded studies, Investigator Sponsored Trials (IST), and Expanded Access Programs (EAP)
  • Effectively coordinate activities and communication with vendors within an external manufacturing and logistics network

Program Design

As an integrated member of the Clinical Supply Chain team at Agios, the fellow will be provided with a variety of opportunities for growth and development within the oncology and rare genetic disease portfolios. Through an intensive and cultivating environment, the fellow will gain hands-on clinical supply chain experiences to further enhance their professional knowledge. Assuming increasing responsibility over the two years, the fellow will obtain a deep comprehension of clinical supply chain’s role, responsibilities, and day-to-day tasks as part of a cross functional team to support global drug development.

Through the afforded mentorship, leadership, and empowerment of the fellowship team at Agios, the fellow will have access to the following responsibilities:

Year 1

  • Integrate into the Clinical Supply Chain/Technical Operations teams
  • Learn how to interpret clinical study protocols to determine drug demand and supply strategies
  • Support the Clinical Supply team in completing day-to-day drug supply management tasks
  • Observe how Clinical Supply team interacts with other functions within Agios and external vendors and actively participate in these interactions
  • Gain an understanding of hands-on training in applicable clinical supply technology platforms
  • Transition to full responsibility of clinical supply activities for early phase and Investigator Sponsored Trials
  • Gain exposure to the entire Supply Chain Organization, including Commercial Supply, Clinical/Commercial Supply Planning, and Logistics

Year 2

  • Take responsibility for drug supply activities as a Clinical Supply lead for one or more global clinical trials
  • Be responsible for drug demand forecasting, trial monitoring & resupply planning, study technology set-up, risk mitigation plans, and global distribution strategy and activities
  • Schedule and facilitate packaging and labeling manufacturing with external vendors
  • Collaborate regularly with Clinical Operations, Quality Assurance, and Regulatory Affairs to efficiently deliver clinical supplies while ensuring compliance to all applicable laws and regulations
  • Contribute to program level supply planning to determine drug product manufacturing timing and allocate inventory amongst clinical studies
  • Become proficient in using drug forecasting technology to create a drug demand model for applicable clinical studies
  • Represent Clinical Supply Chain as an active member of clinical trial working groups and project teams

For more information or questions, please contact:
Carrie Cammarano
Carolyn.Cammarano@agios.com