Pistoia Alliance Debates Webinar Series

Next Webinar


April 2017

 Details TBC.

Watch Again

Ontologies Mapping for more effective data integration and knowledge management

February 2017

The Life Sciences face increasing volumes, variety and sources of data. In addition, there is a pressing need for better integration of data. Despite these needs data standards remain poorly defined and even when present, can often be overlooked or ignored. Ontologies are an important solution because they serve as the “smart glue” for data integration to semantically enable management of knowledge. This is hampered by multiple standards and many varying ontologies which overlap in the same data domain such as disease and phenotype. In response to these challenges we set up the Ontologies Mapping project in 2015 to support better tools, services and best practices for ontology management and mapping in the Life Sciences.

This webinar will bring together a panel of experts in the ontologies engineering field from Industry and Academia. It will be chaired by Ian Harrow (Consultant and Manager for the Pistoia OM project) and includes two more members of the OM project team:- Martin Romacker (Roche) and Yasmin Alam-Faruque (Eagle Genomics). Further panel members will be Simon Jupp (EMBL-EBI) and Lee Harland (SciBite).

IDMP: It’s all about the patient: enhancing patient safety through improved R&D information exchange

January 2017

IDMP will increase Patient safety by closing the information loop from early Drug Research, through Market Authorization to Patient Surveillance and Monitoring. Touching on all areas and making the information available in a structured and electronic format needs a lot of coordination, standardisation and process changes.


Andrew Marr (Marr Consultancy) will provide us an overview of the IDMP process and give us an update on the current timelines from a regulatory perspective. He will describe the 5 ISO standards that build the framework for IDMP and describe the work happening in the different international organisations to come up with one harmonized approach for IDMP.

Frits Stulp (Iperion) and Edsel David (Astellas) will illustrate in a case study what it means to implement IDMP compliant processes in a Pharmaceutical company. They will describe the challenges a company is facing moving from what was very much a paper based process to the electronic age.

Martin Romacker (Roche) will talk about the role of Ontology Mapping and Sergio Rotstein (Pfizer) will describe HELM, a standard for the representation of Macromolecules. These two presentations will provide examples how the pharmaceutical industry will contribute to ensure a high level of IDMP data quality. A consortium like Pistoia Alliance can ensure that this support happens in a well-coordinated fashion.

CRISPR: what it is, and why it is having a profound impact on human health

November 2016 (no webinar in October)

Scientific articles, science news, and even popular press stories have exploded on the topic of CRISPR and so it seems an appropriate time for us to delve in and get a better understanding of the technique itself, the applications and the implications.

  • We will commence with an elementary description of CRISPR, providing a general understanding of what it is and how it is carried out and, in particular, how certain proteins can cut DNA in precise, targeted locations
  • With that background, we will then move to the of the radical scientific implications, not least the acceleration of understanding of basic molecular biology that can be achieved by exploiting this technology
  • We will then explore contemporary bioinformatics principles and techniques and how they can evolve to support and indeed enhance the exploitation of CRISPR in science and Medicine
  • Next we will touch on the clinical potential of CRISPR, with special reference to the possibilities in the treatment of Cystic Fibrosis
  • And finally we will explore the ethics of CRISPR, and the importance of engaging and informing the public about this profound, revolutionary, scientific, technical and medical development.


  • Panel Chairman - Alvis Brazma - Senior Team Leader, Functional Genomics, EMBL-EBI
  • Biopharma Scientist perspective - Mike Ollman - Principal Scientist at Amgen
  • Clinical Perspective - Patrick Harrison, University College Cork

Sequence Analysis in the Regulated Domain of the Biopharmaceutical Industry

September 2016 (no webinar in August)

Sequence analysis is of strategic importance to R&D in the biopharmaceutical industry. Key issues include analysis reproducibility and the quality of the different steps along the NGS processing workflow in the context of massively-parallel, computer-based methodologies.

Regulatory expectations increase as this work becomes increasingly implicated in the pharmaceutical industry GxPs and in particular GCP i.e. “Good Clinical Practice”. As such various regulations come into scope e.g. the ICH’s “INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE” (and in particular section 1.60.1 “Validation of computerized systems”) and also its “GUIDELINE ON GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA”.

Furthermore, two draft guidances that contribute to this regulatory framework have recently been published by the FDA; one is on the use of Next Generation Sequencing (NGS)-based in-vitro Diagnostics for use in diagnosing germline diseases and the other for the use of public human genetic variant databases in support of clinical interpretation.

This webinar, moderated by Etzard Stolte, Global Head Knowledge Management at Roche, will address some of the opportunities for, as well as some of the challenges of Sequence Analysis in the Regulated Domain of the Biopharmaceutical Industry. Panelists include:

  • George Asimenos, Vice President and Director of Strategic Projects at DNAnexus
  • Les Mara, Founder and Director at Databiology
  • Martijn Brugman,Manager Vector Integration and Genome Analysis at GSK

The PhUSE Framework for the Adoption of Cloud Technology in the Regulated Life Sciences Industry

July 2016 (no webinar in June)

Within the PhUSE Computational Science Collaboration (a collaborative initiative including PhUSE, pharma, SDOs and regulatory agencies), the Emerging Trends and Technologies Working Group has formulated a framework to enable life sciences organisations to address and overcome real or perceived barriers to the adoption of cloud-based technology solutions in the GxP-regulated spaces.

Our framework outlines approaches for our industry that leverage existing ISO and NIST standards and, above all, illustrates the multiple operational models that are a) possible, b) practical, c) beneficial, and d) compliant with appropriate regulatory predicate rules and security standards. Our discussions will provide a brief outline of the framework and an opportunity to get the panelists’ views on particular thoughts and challenges for yourselves and/or within your organisations.

Our framework outlines approaches for our industry that leverage existing ISO and NIST standards and, above all, illustrates the multiple operational models that are a) possible, b) practical, c) beneficial, and d) compliant with appropriate regulatory predicate rules and security standards. Our discussions will provide a brief outline of the framework and an opportunity to get the panelists’ views on particular thoughts and challenges for yourselves and/or within your organisations.

Panelists include:

  • Tony Hewer, Senior Quality & Regulatory Affairs Director, Medidata Solutions Inc
  • Chris Whalley, Global Security Assurance Leas, Healthcare and Life Sciences, Amazon Web Services
  • Anders Vidstrup,Senior IT Quality SME, Quality & Security, NNIT A/S
  • Daniel Dziadiw, Director, IT Compliance and Risk Management, IT Supplier Compliance, Merck & Co.
  • Bill Telford, Director, ITS Security, R&D, Sanofi
  • Suzanne Studinger, Lead Auditor Quality Consultant, Quality Assurance Studinger

Moving Research Informatics to the Cloud

May 2016 (no webinar in April)

 While there is increasing consensus that R&D informatics must move to the cloud, how and when is still an open issue. Do we simultaneously migrate the 1000's of internally hosted, R&D life science applications as is? Or is there a different, more agile and cost-effective approach that can drive innovation, transformation and efficiency to create a very different future state for research at scale? Our panel - from varied backgrounds and organizations - will discuss the short, mid and long term benefits, the key challenges to implementation, the new opportunities afforded by this change, as well as the varied roles that different organizations can play in this partner ecosystem.

SEND, the CDISC Standard for Exchange of Nonclinical Data

March 2016

The FDA issued its final Guidance for “Providing Regulatory Submissions In Electronic Format — Standardized Study Data” in December of 2014. This guidance specifically identified SEND as the FDA-accepted way of transmitting non-clinical development study data to the agency.

This webinar, in the series of “Pistoia Alliance Debates”, will introduce its audience to the key principles of SEND. Using web-based presentations and discussion, the webinar panel members will guide webinar delegates to understand how efficient management, exchange and submission of non-clinical development study data can be implemented using SEND. SEND empowers sponsors, CROs and regulators to share, visualize and analyze study data more efficiently.

Furthermore, the webinar will identify some of the key, due-diligence, questions that need to be addressed before considering exchanging information with other companies in the information ecosystem including CROs.

Smart glasses, Smart scientists

February 2016

Google recently cancelled its beta Glass Explorer project, but that was by no means the end of the smart glass story. Companies such as Vuzix are creating a number of practical solutions that enable efficient and compliant applications in all kinds of settings, and work has already started to bring this technology into the world of life science R&D.

This Pistoia Alliance Debates webinar will be chaired by Lance Anderson of Vuzix who will provide an overview of the current state of the technology and clarify the distinction between virtual reality, augmented reality, and heads-up displays. This will be followed by some recent use-case illustrations that will assess the outcomes of early applications in the pharmaceutical industry. The closing audience Q&A will allow delegates to ask questions and debate the place of this technology in the future of their own labs and the corresponding regulatory environment.

Clinical trials and wearables

January 2016

Wearables are making a big impact on the consumer scene, with the Apple Watch setting the trend for general-purpose devices and FitBit well-established in wellness and fitness related applications. There is great potential for deploying such devices in the context of clinical trials in order to gain better metrics on patient behaviour and their response to the medication. With general-purpose consumer devices available widely and at relatively low cost, is it worth continuing to develop the existing ranges of specialist medical grade devices for this market, or could we make better use of the technology that already exists by re-purposing it with custom apps? How will such technology drive future clinical trial strategies in the pharma industry?

Join Richard Lingard (Dotmatics), Matt Jones (Tessella), Marie McCarthy (ICON), and Christian Gossens (Roche) for this Pistoia Alliance Debates webinar.

Sharing Data with my Co-opetition

December 2015 (rescheduled from October)

Pharmaceutical discovery and development has always been a collaborative endeavor but in recent years there has been a dramatic increase in the number and type of external collaboration projects throughout drug discovery, development and clinical trials. These range from fee-for-service CRO/CMO engagements to large multi-pharma/biotech and research institute collaborations. A critical success factor in these engagements is the ability to share all of the data necessary for the multi-organization team to operate efficiently and effectively, while protecting the intellectual property of the partners and adhering to any regulatory requirements associated with that data.

Analytics in Pharma R&D

September 2015

Analytics has seen an explosion of interest over the last 5 years with the advanced and predictive analytics market projected to grow from $2.2B from 2013 to £3.4B by 2018 (IDC).

R&D groups in pharma are making significant investments in order to increase their 'analytics' capability; structured and unstructured data, big-data management, static and live data analytics, predictive analytics, Business Intelligence and analytics modelling.

We are only now starting to understand how data analytics will change the life science industry; from new target discovery through to novel application for existing drugs and therapies. We'd like to explore a number of topics with our Pistoia friends about their analytics experiences, share some use cases and examples.

What is the role of analytics in Lifescience and R&D? How is Pharma R&D making use of analytics? What are the key challenges R&D is wanting analytics to solve? What are the blockers; in-house skills? Investment? C-Suite awareness? What are the best practices and real-world application of an R&D analytics investment and solution? How is R&D working with suppliers and partners on their analytics endeavours?

This webinar will be chaired by Matthew Jones of Tessella.

Sustaining translational data for secondary use

July 2015

The growing amount of data generated in large scale translational medicine collaborations (e.g: IMI U-BIOPRED, etc.) creates a new challenge for the research community since there are no established publicly funded repositories as in contrast to for example biological sequences or molecular structures. To enable secondary use of the wealth of such data sustainable repositories are needed. In this debate we will discuss the basic premise, what are the potential funding models, what are the technical challenges, and ethical, legal and privacy considerations of such repositories.

This webinar will be chaired by Sandor Szalma, Head, Translational Informatics & External Innovation at Janssen Research & Development LLC.

Printing therapeutic nanobots: Nanoscale 3D-printing in pharmaceutical R&D

June 2015

Nanoscale 3D-printing technology has evolved to the point where it is possible to create devices that can operate on the cellular level in biological systems. The implications for the use of these devices in patient therapies are extremely interesting and it would be useful to explore the potential of applying this technology to pharmaceutical and therapeutic development.

During this webinar, Jim McGurk, ‎Global Head of Data Architecture R&D Informatics at Daiichi-Sankyo, will chair a discussion with a panel of experts and ask them to lay out their vision on the potential uses for these devices in the initial- and longer-term.

Panellists include:

  • Dr. Ahmed A. Busnaina, the William Lincoln Smith Chair Professor and Director of the National Science Foundation’s Nanoscale Science and Engineering Center (NSEC) for High-rate Nanomanufacturing and the NSF Center for Nano and Microcontamination Control at Northeastern University
  • Dr. Utkan Demirci, Associate Professor at Stanford University School of Medicine, Canary Center Early Cancer Detection

Ethics Considerations for Big Data Initiatives

May 2015

When we think of Big Data we often focus on the technology and potential for advancements in treatment of chronic, rare or unmet medical need. But there is a growing recognition that these new capabilities create new ethical concerns. We have assembled a panel of experts to highlight some of the emerging concerns and some potential mitigations:

  • Implications for informed consent, and how to ensure data usage is compliant with it
  • Growing risks of re-identification of de-identified patient data
  • Challenges of cloud based platforms for ensuring privacy across country jurisdictions
  • Permanence, transience, and the right to be forgotten in an increasingly interconnected world

The webinar will be chaired by David Fritsche of Sanofi. Panellists include Jennifer E. Miller, Assistant Professor, NYU Langone Medical School, and Fellow, E.J. Safra Center for Ethics, Harvard University, Pete Mills of the Nuffield Council on Bioethics, and Brent Mittelstadt of the Oxford Internet Institute.

The impact of consumerisation in IT on the R&D environment

April 2015

The typical user in a modern organisation has an expectation of corporate IT that has changed dramatically in the last 5-10 years based on the applications available in the ‘outside world’ of daily life. How are organisations responding to those changes and understanding how they work? How are IT professionals delivering these kinds of service-oriented capabilities in a modern setting, moving away from big enterprise technology platforms and towards an ecosystem of smaller specialist solutions? This webinar will look at the impact these changes have had and ask what needs to be done to enable IT organisations to adapt as the technology they have to work with becomes increasingly consumerised.

Text-mining for pharma R&D in a social world

March 2015

Text-mining of journal articles and other publications has long been a subject of interest. It already has applications across R&D and beyond into health care, for instance by analysing electronic health records. The technology has value but also has its limits. With new sources of text to mine becoming mainstream, such as Twitter feeds or Facebook posts that might reference a company’s brand or a drug’s efficacy or adverse events, existing technology needs to be adapted to keep pace. Not only that, but whole new compliance questions arise: does a fleeting mention on Twitter require the same response as a formal notification of an adverse event?

This webinar, chaired by Veit Ulshöfer, Director and Global Head of Research Informatics at Merck KGaA, aims to stimulate discussion and raise interest in this topic, illustrating some interesting case studies along the way. Panellists will include:

  • Jane Reed, Head of Life Science Strategy, Linguamatics
  • Luca Toldo, Associate Director Information Services, Merck KGaA
  • Gordon Baxter, CSO, Instem

Big Data: Solution or Pollution?

February 2015

We are inundated with more and more data. The proliferation of duplicative and un-curated personal health data could confound and complicate any kind of big data efforts. For example, I like to use my Withings fitness tracker to track daily and weekly steps and progress. Now my healthcare company will give me a discount on my premium if I use a Fitbit. So I put that on my other wrist. Suppose I enroll in a clinical trial, and it requires tracking via an iPhone app, which I put in my pocket. I could soon purchase Internet of Things sneakers which would track even more. Every time I walk around, I’m spewing 4x as much biometric data as needed! Which version is correct? Which persists over time? Where does it all end? Does it all have to be generated, stored independently? Can standards and interoperability enable a more rational approach?

Have you encountered or considered these kinds of challenges? Are there solutions already envisioned? Any reason not to worry about the potential impact on medical R&D?

The debate will be chaired by David Fritsche of Sanofi. Panellists will include:

  • Anthony Rowe, Director, Translational Informatics and External Innovation, Johnson & Johnson
  • Ashley George, Global Head of IT Lite, GSK

Ontologies as the glue for knowledge management

January 2015

Ontological resources, such as curated vocabularies and hierarchical ontologies, are used as the glue which is vital for knowledge management on the semantically enabled worldwide web. This webinar will explore selected use cases and challenges for ontological engineering which is critical for a successful life science sector.

Ontology expert Ian Harrow will invite panel members to investigate the current challenges and opportunities in ontology design and management through lively informal debate. The floor will then be opened to webinar participants to ask the panel their own questions and give their opinions.

Panellists include:

  • Martin Romacker, Roche
  • Philippe Rocca-Serra, University of Oxford e-Research Centre
  • Gordon Baxter, Instem

Genomics, Pharmaceutical R&D & Healthcare

Are we there yet?

December 2014

As various genomics initiatives have promised to revolutionize healthcare for over 20 years, it is important to ask whether these have had the impact they were expected to make, and how we might take greater advantage of the technology available.

The Pistoia Alliance, a global, not-for-profit alliance of life science companies, vendors, publishers, and academic groups that work together to lower barriers to innovation in R&D, is hosting a ‘Pistoia Alliance Debates’ webinar which will look at whether the economic, technical and regulatory barriers have been addressed, and how to overcome any that may remain.

The webinar will see Gordon Baxter, CSO at Instem, chair a panel comprised of experts in the field including Abel Ureta-Vidal, CEO at Eagle Genomics, Fiona Nielsen, CEO at DNA Digest, Dan Housman, Director at ConvergeHealth by Deloitte, and Etzard Stolte, former CIO of the Jackson Laboratory.

As well as exploring the remaining obstacles to greater adoption of genomics technology in healthcare, the panel will look at the success of recent genomics initiatives, the impact they have had, and will consider what future genomic innovation may bring to the industry. Following the discussion, webinar attendees will be able to ask questions of the panel.

Cloud Security for Life Science R&D

October 2014

Heartbleed, Russian hackers, Target, HomeDepot, and iCloud breaches - Have the recent high visibility cases of intrusions and data theft altered your plans to move to the cloud?

The webinar will feature introductory remarks by industry experts William Telford (Director, R&D IS Security at Sanofi), and Chris Dagdigian (Founding Partner and Director of Technology at Bioteam). The opening presentations will set the stage for a lively and informative panel debate.

With almost 100 people signed up already, the original round-table format is no longer practical and so we have introduced a panel discussion instead. There will still be an open Q&A with all attendees at the end of the session. Please bring your opinions as well as your questions!