PRISME Forum ORGANIZATION
The mission of PRISME will be to provide a forum for the exchange of non-commercially sensitive information among its Members in order to enhance the efficiency, effectiveness and impact of global Research and Development Information Management and Information Technology (“R&D IT”) organizations within the biotechnology and pharmaceutical (“biotech and pharma”) industries.
PRISME will be devoted to improvement of general business conditions in the biotech and pharma industries and will not provide any services that would normally be carried out for profit. PRISME will observe all relevant anti-trust requirements and will not facilitate or allow discussions regarding commercially sensitive or confidential information. PRISME will not engage in any political or legislative activities.
The major goals of PRISME will be to:
1. Establish and maintain a network among the Members that fosters open communication of non-commercially sensitive information.
2. Educate Members regarding best practices in R&D IT in the biotech, pharma and other industries.
3. Promote the development and use of open standards for applications utilized in biotech and pharma R&D.
4. Create opportunities for open and informal dialogue between the Membership and suppliers of IT products used in biotech, pharma R&D and related life sciences organizations.
5. Alert Members to new and emerging information technologies and products of special relevance to biotech and pharma R&D.
6. Operate at all times within the statement of compliance as set out below.
The major activities of PRISME will include:
1. Semi-annual meetings of the Members (usually once in Europe/once in North America);
2. Commissioning of working groups to conduct research and investigation into topics of interest to the Members;
3. Inviting experts to present technology and product development overviews to the Members;
4. Conducting benchmarking exercises regarding general directions and trends in R&D IT management or technology among the Member companies (without disclosing directly or indirectly any proprietary or commercially sensitive information);
5. Special Interest Groups will be utilized to focus on specific topics of note to the Membership.
PRISME Forum MEMBERSHIP
PRISME Forum Membership Qualification
Membership in PRISME is to a senior R&D Information Management, Information Technology, Informatics, or equivalent leader (the “Member”) of any company that conducts discovery, development and/or regulatory submissions for proprietary pharmaceutical products. A company, in circumstances dictated by its organization structure and activities may have more than one person as a member. Any person satisfying these requirements may become a Member by agreeing in writing to abide by the terms of this Organizational Charter and remitting payment of dues in accordance with Section XI.
Statement of Compliance
All meetings, working groups and communications will be open to all Members and any records thereof will be non-confidential and available for inspection by any Member. The Members acknowledge that discussing any commercially sensitive topics, including costs, volumes, inventories, sales level methods, channels of distribution, access to future products, markets, current or future prices, profitability, contract pricing or trading terms is prohibited. The Members of PRISME will strictly comply with all laws relevant to their activities, including US state and federal anti-trust laws and European competition laws.
PRISME Forum Obligations of Members
Each Member of PRISME agrees to:
- Attend and participate in at least one meeting per year;
- Abide by the rules and intent of the Organizational Charter;
- Vote on issues submitted to the Membership by the Chair;
- Conduct himself or herself in a manner that respects diversity among the Members;
- Not disclose any commercially sensitive information or information that may be deemed confidential by the Member’s company or any supplier to, or customer of, the Member’s company;
- Pay all dues owing from their Membership;
- Pay for all costs of transportation, lodging and other individually incurred costs as a result of participation in PRISME activities and meetings;
- Delegate attendance at any meetings of the Membership may occur only with prior approval by the Chair. Member participation is encouraged;
- Meet agreed commitments and deadlines;
- Respond promptly to communications from other members.
Membership rights of Members may be terminated by the Chair for repeated failure to meet the above obligations. Members may terminate their own participation in PRISME immediately upon notice to the Chair. In neither instance will any portion of the Member’s dues be refunded, however, dues are transferable to another qualified person within the same company as the terminated Member.
PRISME Forum Member Rights
Each Member in good standing of PRISME will be entitled to:
- Attend and participate in semi-annual meetings and all other activities sponsored by PRISME;
- Vote on all issues submitted to the Membership by the Chair for decision;
- Receive all documentation and materials made generally available at meetings and in working groups;
- Delegate attendance and participation in any PRISME working groups;
- Receive the results of any informal benchmarking activities in which they choose to participate.
PRISME Forum Dues and Contributions
PRISME will collect revenues only to the extent necessary to defray the costs of its meetings and activities. Annual dues will be proposed by the Chair and voted upon by the Membership. Contributions may be solicited in appropriate circumstances from vendors participating in meetings or other activities to defray operating expenses directly related to such vendor’s participation. PRISME is not organized to generate a profit and no part of its earnings, if any, will benefit any member or member company.
Any official decision or action of PRISME will be presented to the Membership by the Chair for voting on the basis of one vote per dues paying member or members emeritus. Voting may occur at semi-annual meetings and/or via electronic mail. Decisions will be made by majority vote provided a quorum of two-thirds of the Members participates in the vote. In the case of voting via electronic mail, Members will have five business days in which to cast their vote by return electronic mail. A quorum will have been established when two thirds of the Members have cast their vote by the end of the fifth business day. If at the end of the fifth business day no such quorum has been obtained, the vote will not be effective.
PRISME will continue to operate indefinitely unless terminated by vote of two-thirds of the Members or by declaration of insolvency by the Chair. Upon termination, the Secretary/Treasurer will liquidate any assets, pay all legal debts, and donate the balance of funds to a charitable organization selected by the Chair that is qualified under section 501(c)(3) of the Internal Revenue Service code. No payment or refund of dues will be made to any Member or Officer as a result of termination except for reimbursement of expenses incurred on behalf of PRISME in the normal course of its business.
PRISME Forum OFFICERS and COMMITTEES
PRISME is intended to operate as an informal association of qualified and interested parties (as defined in section II). The business of PRISME will be conducted in accordance with fair and democratic parliamentary procedure.
Officers will be appointed by the Membership to coordinate activities and ensure the continuity of PRISME as follows:
A Chairperson (the “Chair”) will be appointed from the Membership by a majority vote of the Members for a two-year term. The obligations of the Chair will be to:
- Establish and communicate meeting agendas;
- Conduct business and facilitate discussion at meetings;
- Assist in recruiting new Members;
- Appoint Committees as necessary to further the goals of PRISME and recruit volunteers from among the Members to serve on such Committees;
- Ensure the appointment of Officers;
- Oversee the work of the Officers and Committees;
- Approve the annual budget, membership dues, and major expenditures;
- Review the financial status of PRISME at least once per year;
- Transfer responsibilities to the Chair’s successor.
A Secretary/Treasurer will be appointed upon nomination by the Chair and vote of the Membership for a two-year term coextensive with the term of the Chair. The Secretary/Treasurer may be appointed from the Membership or externally. Where the Secretary/Treasurer is not a Member, he or she will not have voting rights. The obligations of the Secretary/Treasurer will be to:
- Establish and maintain a corporate record book containing the Charter, meeting minutes, and legal documents establishing and defining the status of the organization;
- Assure the accurate preparation and timely distribution to the Members of meeting minutes;
- Propose an annual budget and membership dues prior to each fiscal year;
- Collect dues;
- Review and approve hotel, restaurant and other contracts for meeting related expenses provided the contract prices are within budgeted amounts;
- Review meeting expenses and submit them to the Chair for approval;
- Remit payment for obligations incurred by the organization and approved by the Chair;
- Submit all forms due to governmental agencies including but not limited to tax filings;
- Report to the Members annually on the financial and legal status of the organization;
Upon occasion, the Membership has the option to elect a former member “Member Emeritus”. This would be granted in the case where an individual who no longer qualifies under “Member Qualifications” above as a member. This would generally be applied to an individual retiring from a member company and would be bestowed as an honor. The individual would be excused from the Membership Fee and would maintain all the obligations and rights of members including voting on issues brought before the membership.
Board of Directors
PRISME will maintain a standing Board of Directors as follows:
- The Board of Directors will be chaired by the PRISME Chair. Members for the Board of Directors will be selected by the Chair in consultation with the membership.
- It will either directly conduct or commission sub-committees of the Members in order to complete the following activities or others as determined during the normal course of business:
Plan PRISME meetings as follows
- Schedule and lead Program Committee teleconference meetings and distribute minutes of same;
- Prepare an agenda for the next regular meeting of Members in conformance with the guidance provided by the Members at the previous meeting;
- Recruit speakers and consult with the speakers on the development of appropriate content for the meeting;
- Work with the meeting coordinator to select the venue, meals, and provide lodging support;
- Review and approve meeting materials prepared by the meeting coordinator;
- Communicate the agenda and meeting logistics to the Members; and
- Review the materials to be distributed to the Members following the meeting including but not limited to handouts and CDs.
- Recruit new member companies to participate in PRISME
- Recruit replacements for Members who are no longer eligible for membership due to changes in job or role and enhance the diversity of the group;
- Resolve issues regarding qualification for membership;
- Review the Membership Directory published by the meeting coordinator at each meeting for completeness and accuracy.
- Act as a smaller leadership group for the organization as deemed appropriate by the Chair and the membership. All activities of the Board of Directors will be communicated to the Membership, and if approval is needed, voting as describe below will be conducted.
PRISME Forum Chair
Dan Chapman, PhD, leads the IT New Medicines Information (NMIM) Management group at UCB.
Dr. Chapman’s team is driven to create an enabling environment of data that will help the scientific community derive better insights and promote data driven decisions. A core belief of the NMIM team is that the use of innovative technologies will lead to improved processes and support more efficient research. The responsibilities of the NMIM team include data capture platforms (ELN, Registration systems, LIMS, Logistics, Assay Data, MDM), Data Architecture (Responsible for integrating both out internal and external data to ensure that the right data is available to UCB scientists) and a team of data scientists providing bespoke tools and visualizations aimed at providing insights to UCB scientists.
Dr. Chapman has led the IT aspects of a number of acquisitions including emerging technologies new to UCB. He has over 20 years’ experience working within the Pharmaceutical industry in a variety of Informatics and IT roles. He received his PhD in Chemistry from Warwick University; he transitioned to informatics during post-doctoral research at Cambridge University as part of the CLIC consortium.
Dr. Chapman was elected PRISME Forum Chair at the November 2018 PRISME Forum Business Meeting.
Matteo di Tommaso
OUR MEMBERS INCLUDE:
BOARD OF DIRECTORS
VP, R&D Informatics, Celgene
John Apathy joined Celgene in 2013, leading its Global R&D Informatics efforts for the IT organization. He brings over 25 years of experience in Pharmaceutical new product and R&D capability development across the Pharmaceutical/Biotech, Life Sciences and Management Consulting industries.
Mr. Apathy has extensive knowledge and experience based upon leadership positions within both industry and consulting at Celgene, GlaxoSmithKline, Pfizer, Wyeth, Accenture, Eli Lilly & Company, PA Consulting Group, and Solutia Pharmaceutical Advisors.
He is also an experienced leader in strategy, processes, and systems for development and commercialization of new pharmaceutical products—skills and experience include delivery of strategy, large-scale program management, product development processes, life-cycle extension, product launch (particular emphasis on the Early Development phase of Pharmaceutical R&D, combining technical knowledge with change leadership, consulting problem-solving, strategy development, and change management processes).
Vice President, R&D IT, BMS
Alastair Binnie is Head of Information Technology for Research & Development at Bristol-Myers Squibb. In this role he is accountable for planning and delivering all aspects of IT’s value proposition to BMS R&D, which includes digital platforms supporting discovery, preclinical, translational medicine, clinical development, regulatory sciences, pharmacovigilance, and medical affairs. His mission is to enable R&D by providing the right tools and the right data, to the right scientists, at the right time.
He joined BMS in 1999 as the leader of the Discovery Automation team in Wallingford, Connecticut, and progressed through a range of leadership roles in research technology and IT, assuming his current role in 2015.
From 1994-99 he led the Discovery Technologies group at Glaxo Wellcome R&D in the UK.
Prior to joining the pharmaceutical industry, Alastair worked as a design engineer in the space industry, developing instrumentation for microgravity research for the European Space Agency.
He is a current or recent Board member of global life-science technology industry groups, including PRISME, the Society of Laboratory Automation and Screening, and the Pistoia Innovation Alliance. He represents BMS on the New Jersey Technology Council.
Alastair grew up in Scotland. He has degrees in mechanical engineering, design engineering and industrial design from Brunel University, Imperial College of Science and Technology, and the Royal College of Art.
Head of IT New Medicines Information Management, UCB
Dan Chapman, PhD, is part of the leadership team within Informatics at UCB with responsibility for Software Development and Architecture and Therapeutic Informatics (UK).
Dr. Chapman has 15 years’ experience working within the Pharmaceutical industry in a variety of roles.
After completing a PhD in Chemistry at Warwick University, he transitioned to informatics during post-doctoral research at Cambridge University as part of the CLIC consortium. Dr. Chapman joined AstraZeneca in 1997 and worked on a variety of global projects before joining UCB in his present role in 2005.
Since then, he has driven several projects to revolutionize the informatics platform within UCB and is currently actively involved in promoting Data Science across UCB.
Vice President, Enterprise Applications Business Technology, CSL Behring
Previously, David was Vice President, Research and Development Informatics at Amgen. Prior to that, he led Amgen’s Global Commercial Operations and Corporate Functions IS group. David has also led Amgen’s International IS function based out of Zug, Switzerland, and before that, the IS group supporting Global Development functions.
Earlier in his career, David worked at Eli Lilly in various roles in Australia, New Zealand, and the US. David holds a Bachelor of Business from the University of Technology, Sydney.
Head of pRED Informatics, F. Hoffmann La Roche Ltd.
Martin Erkens, PhD, leads the Pharma Research and Early Development Informatics organization (pREDi) of Roche. Data science supporting drug projects as well as Research and Early Development workflow solutions are among the key contributions of Dr. Erken’s organization. He was responsible for supporting multiple mergers and acquisitions, implementing a wide range of diverse solution including a digital media environment for early development, a research imaging data warehouse, a efficient data review tool for early clinical studies and a LIMS for the omics labs.
Prior to becoming head of pREDi, Dr. Erkens ran various IT teams in the clinical space and was responsible to implement global systems for drug project and portfolio planning, global sales reporting, electronic data capture of clinical trials (the first large cloud system at Roche), clinical imaging and a system environment for the internal clinical Phase I unit. During this time he also led a program establishing a complete new blue print of the system landscape supporting clinical development resulting in an investment program over 5 years and 100+ mUSD investment.
Dr. Erkens received his PhD in Mathematics (stability theory) from Albert Ludwigs Universität, Freiburg. He also holds two degrees in Mathematics and Physics (“Diplom” and “Staatsexamen”) from the same university.
Head, R&D-IT, Pharma-Research, Bayer
Andreas Friese started his professional career as a software developer in 1987 at Schering AG, Berlin, Germany. From the beginning, he was focused on IT solutions that addressed specific needs of the Research organization. Over the years, he held various positions as system analyst and project manager – all with focus on Research specific systems or projects.
In 1999, Mr. Friese moved to Richmond, CA, USA as an IT Business Partner for the Medicinal Chemistry department of Berlex Biosciences. During the merger of Schering AG with Bayer AG, he returned to Germany.
Based in Wuppertal, he is Director of Research-IT for Bayer.
VP, Global Head,Medical IT, Sanofi
Dr. Gien is the Global Head, Medical IT at Sanofi.
He is a Chemical Engineer by training and holds a PhD in Organic Chemistry. His PhD work focused on leveraging Artificial Intelligence technologies and retrosynthetic analysis to build a system helping chemists in the design of synthetic routes.
Dr. Gien started his career in the Exploratory Unit of Sanofi’s Hungarian affiliate in Budapest then took charge of Information Systems for Industrial Chemical development at Sanofi’s Sisteron site. He led then Global Discovery Research Information Systems at Sanofi-Synthelabo, then Sanofi-Aventis in Montpellier, before taking on his role of Global Head, Clinical IT in Paris area in 2010.
Director R&D Information Research, AbbVie Library Sciences & Academic Partnerships, AbbVie
Lars Greiffenberg, PhD, MS, holds a MS in Biology and a PhD in Microbiology and has more than 15 years of experience in the field of integrated R&D IT solutions and translational informatics. He held different R&D IT management positions at Aventis Pharma and Sanofi-Aventis in Frankfurt before relocating to the Sanofi site in Toulouse, France where he was Global Head of Solution Center Translational Medicine with responsibility to manage and lead a global program to enable translational science at Sanofi.
In 2014 he joined AbbVie in Ludwigshafen (Germany) as director of R&D IT and Translational Informatics. In this role he is heading business IT support covering data and solutions from early discovery up to Medical Affairs. In 2017 he extended his responsibilities including now global Library Sciences at Abbvie. He is driven by the ambition to transform the way we access, consume and leverage literature in the future. He recently established a team at AbbVie, dedicated to use modern methods and algorithms to extract and visualize mechanistic disease information from literature content.
In 2018 he further enlarged his area of responsibility to incorporate the Academic Partnerships Organization which is leveraging an AbbVie-Campus at the University of Illinois Urbana-Champaign. Lars is active in several pre-competitive organizations including IMI, PRISME Forum, Pistoia Alliance and EIT-health.
Vice President, R&D IT, Global Quality IT, HR IT, Enterprise Data Management & Analytics, Alexion
Martin Leach, PhD, has over 20 years’ experience in Informatics and IT leadership in Biotech, Academia, and Pharmaceutical companies.
As Vice President IT at Alexion, Dr. Leach is currently responsible for the IT strategy and teams that provide technology and data solutions for R&D and Global Operations. Global Operations at Alexion is very broad covering all Facilities, CMOs & Manufacturing Plants and Global Quality Functions.
Dr. Leach previously worked as the Vice President R&D IT and Head of the Global Data Office at Biogen. He has also led the development and management of IT innovation projects and relationships with GoogleX and MIT Media Lab. Prior to Biogen, he was the Chief Information Officer at The Broad Institute of MIT and Harvard, based in Cambridge, MA and a member of the MIT CIO council. Prior to The Broad Institute, he led IT in support of the research environment for Discovery & Preclinical Sciences at Merck. Finally, Dr. Leach is a Member of the Board of Directors at Smpl Bio and an advisory board member of Sierra Ventures and Canaan Partners venture companies.
Head of Research Management Systems, Research IT, Takeda
Tomoyuki Matsunaga is Head of Research Management Systems in Global Information Technology at Takeda Pharmaceutical Company. His role is to lead any strategic IT operations for common management processes and workflows of research activities in conjunction with other functional research IT groups, such as Discovery, Preclinical and Translational Sciences. He is also the site IT manager at Shonan Research Center in Japan.
Mr. Matsunaga started his career in Central Research of Pfizer Japan in 1991 as a research scientist. After 5 years in Natural Product Screening department, he moved to Research IT group in the company and worked on various projects of global discovery research information systems. He joined Takeda in 2008 as an Associate Director in Research IT, and took the current position in 2014.
He obtained his MBA from Kenichi Ohmae Graduate School of Business and MSc, Medical Sciences from University of Tsukuba.
SVP R&D IT, GSK
Mike Montello joined GSK in August 2018 as SVP, R&D Tech and is responsible for transforming the R&D Tech capability and platform. Mike partners with the R&D leadership team to focus technology resources to enable a step change in R&D science and performance, HCP and patient centric solutions, and simplification of processes and tools. He is accelerating the integration of the next wave of innovative technologies and agility while maintaining compliance and quality across R&D systems.
Previously, Mike was VP, Divisional CIO (Quintiles), and Global Head of R&D Information Technology for IQVIA, responsible for strategy and innovation initiatives that help R&D Solutions stakeholders accelerate clinical development, leverage evidence for protocol design and planning, improve operational execution, quality, patient safety, and investigator performance.
Prior to joining IQVIA in 2015, Mike led R&D Information Technology at Shire Pharmaceuticals, a global rare diseases biotech. As a member of Shire’s Information Technology leadership team, Mike led IT integration of multiple biotech acquisitions and led HCP and patient centric technology initiatives and strategic roadmap across R&D.
Prior to Shire, Mike worked at Accenture for 12 years as a management consultant and outsourcing leader in Health and Life Sciences practices. In addition to his industry role at IQVIA, he delivered innovative data and technology driven solutions for 6 of the top global Pharmaceutical and Healthcare companies including Pfizer, Merck, BMS, Biogen, Daiichi-Sankyo, and United Health Group. Mike holds a bachelor’s degree in Mechanical Engineering from the Pennsylvania State University..
PRISME Forum Board Secretary/Treasurer
Dr. Sandler provided leadership and technical expertise for Research & Development computing in the pharmaceutical industry. Most recently, he led teams to provide information technology support at several Pfizer Global research and development sites in the United States and the United Kingdom.
Dr. Sandler received his PhD in Physics and Astronomy in July of 1977 from the University of Missouri-Columbia.
Senior Director, Oncology & Vaccines R&D Business Technology, Pfizer
Susie Stephens is a strategic leader in the pharmaceutical industry with over two decades of experience in informatics, science and technology. She is currently Senior Director for R&D IT for Oncology and Vaccine at Pfizer.
Prior to that she was Head of In Silico Immunology at Johnson & Johnson for the Immunology Therapeutic Area. She has also worked at Oracle and Sun Microsystems where she had roles spanning pre-sales, product management and business development. Susie has a PhD in Physiology; post-doctoral experience in Molecular Biology; and is an alumnus of Harvard Business School.
Susie has over 20 peer reviewed papers and has presented at many industry conferences on data, advance analytics, precision medicine, and innovation. She is the founding Chair of the PRISME Forum.
Vice President, R&D IT CIO, Merck and Co.
Sandy Tremps, VP, Merck Research Labs Information Technology, has more than 25 years of IT experience in the pharmaceutical industry. Her experience spans many aspects of IT including delivery, strategic planning, portfolio management, and process management. Sandy has extensive experience in leadership roles of organizations that provide IT capabilities in support of emerging markets, sales and marketing, pharmaceutical manufacturing and R&D including clinical and laboratory information management, shop floor control and supply chain capabilities.
At Merck, Sandy currently is the R&D IT CIO. In this role, she has responsibility for all aspects of Information Technology from strategy development through implementation for the Merck R&D function. Sandy will focus on opportunities to enable key MRL priorities ensuring a focus on optimization in support of Discovery and Development with an emphasis on compliance. A key priority will be realization of the IT strategy by leveraging IT platforms to realize greater data integration and visibility for MRL.
Since joining Merck in 1988, Sandy has led IT organizations across multiple divisions and spanning critical programs in support of MRL Global Development, MRL Pre-Clinical, GHH Emerging Markets, MMD IT Automation and MMD Project 2000.
Sandy earned her Bachelors in Computer Information Systems from Purdue University, and her Masters in Technology Management from the University of Pennsylvania.
John CM Wise
PRISME Forum Program Coordinator
John CM Wise, MA, is the Program Coordinator for the PRISME Forum and is also a consultant at the Pistoia Alliance with responsibilities that include business development and member relations. He specializes in the coordination of pre-competitive collaborations in life science R&D IT and has had a long-time commitment to encouraging pharma to use expert, third-party, cost-effective, regulatory-compliant, secure, hosted information services.
Previously, Mr. Wise has held Informatics leadership roles in a variety of organizations including the University of London, Sandoz, the Imperial Cancer Research Fund (now CRUK), Roche, Ipsen and Daiichi Sankyo. He has also worked in the technology supply side of the industry. In these roles, he has gained direct hands-on experience writing analytical software, teaching computation, delivering IT services, and providing computer-based services to the discovery, non-clinical development, clinical development, and regulatory affairs domains of the life-science industry.
The PRISME Forum and Accenture Collaboration
In support of this mission, the PRISME Forum determined that it should better understand the burgeoning biopharmaceutical R&D pre-competitive collaboration (PCC) ecosystem and identify the characteristics and value of key pre-competitive collaborations (PCCs). The PCCs that provide significant impact on biopharmaceutical R&D IT activities in support of drug discovery, development, and approval will be of interest and primary focus.
In furtherance of this mission, the PRISME Forum has retained Accenture as the firm best qualified to provide the domain knowledge and logistical expertise. It is anticipated the results of this work will develop during 2017, in time for a full report to be available at the PRISME Forum Fall 2017 meeting in November.
An executive of the PRISME Forum, Dr. Errol Sandler said, “the PRISME Forum is delighted to be working with Accenture on this strategic project. The outputs will inform the global biopharma R&D IT leadership community of where they should be investing in the pre-competitive collaboration space.”
Nicole Cohen, Managing Director from Accenture Life Sciences, said, “Accenture is pleased to be selected by the PRISME Forum to address this important topic. We are eager to provide clarity on the evolving and complex biopharmaceutical R&D pre-competitive collaboration landscape and gain better understanding of the areas of focus and value that pre-competitive collaborations provide to the industry.”