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.
PRISME will maintain a standing Steering Committee as follows:
- The Steering Committee will be chaired by the PRISME Chair. Members for the Steering Committee 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 Steering Committee will be communicated to the Membership, and if approval is needed, voting as describe below will be conducted.
PRISME Forum Chair
Olivier Gien, PhD, was elected as PRISME’s Chairman at the Forum’s business meeting of November 2014 and re-elected in November 2016.
Dr. Gien is the VP, 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 the role of Global Head of Clinical IT role in Paris area in 2010.
Matteo di Tommaso
OUR MEMBERS INCLUDE:
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).
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.
Head of Informatics, Pharma Research and Early Development, Roche Innovation Center
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.
M. Hall Gregg
Vice President, Business Technology, R&D, Pfizer
Hall Gregg, PhD, is Vice President of Business Technology, Research & Development at Pfizer. She works closely with the head of R&D and the CIO to provide information technology strategic and operational leadership in support of Pfizer’s worldwide initiatives in drug discovery and development. Before joining Pfizer, Dr. Gregg served as the Vice President Information Systems, Research and Development Informatics at Amgen where she was responsible for providing all information technology solutions and services to Amgen’s R&D functions. She sponsored and led initiatives across R&D that delivered information search, data discovery and analytics, and integrated, cloud-based platform capabilities for research and clinical development.
Prior to Amgen, Dr. Hall held a variety of roles in information technology and business functions at Quest Diagnostics, including CIO and VP for global central laboratory services and South American laboratory operations. While at Quest Diagnostics, Dr. Hall was appointed by the Governor of New Jersey to serve on the New Jersey Healthcare IT Commission. She also served as the Vice President of Business Information Systems and Deputy CIO at the American Red Cross. Dr. Hall received her PhD in biostatistics from Virginia Commonwealth University and her bachelor’s degree in mathematics from Vanderbilt University.
VP, R&D Information Technology, 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.
PRISME Forum Board Secretary/Treasurer
Errol Sandler, PhD, worked in the information technology industry for 30 years. His career focused on research and development computing problems in the life sciences.
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.
John CM Wise
PRISME Forum Program Coordinator
John CM Wise is the Program Coordinator for PRISME Forum as well as Executive Director of Pistoia Alliance, serving as the primary liaison between the project teams and the operational team and board. He is committed to encouraging pharma to use expert, third-party, cost-effective, regulatory-compliant, hosted information services.
Previously, Mr. Wise has held Informatics leadership roles in a variety of organizations including the University of London, Sandoz, ICRF, Roche, Ipsen, and Daiichi-Sankyo. In these roles, Mr. Wise 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.”