Life Sciences Business Round Table

Track: Preconference | P01 |
One-and-a-half-day Program, Special Registration Requirement
Tuesday, October 13, 2015, 2:00pm – 6:00pm 
Wednesday, October 14, 2015, 9:00am – 12:30pm 
Wednesday, October 14, 2015, 1:30pm – 5:00pm
Held in: Cypress
Simon Andriesen - MediLingua 
Jeffrey Kiser - LanguageWire 
Anthony Lee - Knowtions Research, Inc. 
Alex Lik - A-CLID Ltd. 
Ann Rockley - The Rockley Group Inc.
Moderator: Clio Schils

In the world of translation and localization, the life sciences sector is different from any other industry because of the unique and specific nature of its requirements. With regulations changing on a continual basis, a premium is placed on quality above all else. For our Life Sciences Business Round Table in Silicon Valley, we are delighted to offer a stellar one-day program with a particular focus on the challenges of life sciences localization. In this discussion forum, subject matter professionals, clients and vendors will be presenting and sharing their thoughts and experiences on specific processes as well as discussing the market entrance requirements and challenges in the life sciences industry in general.

Clients, vendors and life science professionals from other disciplines are welcome to participate in this session. However, vendor participation is limited and subject to screening. If you would like to participate in this round table, please contact Clio Schils to obtain the admission code necessary for registration.

2015 Life Sciences Business Round Table Silicon Valley Agenda

Tuesday, October 13, 2015

 2:00pm2:30pm: Welcome and Introductions

 2:30pm3:30pm: Symbiotic Approach to Development of the Information Component of the Product

Presenter: Alex Lik, A-CLID

A symbiotic approach to the development of the information component of a product has proven itself beneficial for all parties. In this session we will present a summary of the information development and localization process evolution as experienced by a life sciences company over time and the course of various projects — an evolution from a painful and detached cost center to an integral part of product development. The process ultimately ensured compliance, boosted usability and drove down translation expenses. Bringing all involved parties to the table creates better products every step of the way. Attendees will gain an understanding of all of the permutations of life sciences content that must be managed for globalization; best practices for managing these complexities; and how to ensure proper communication of the content permutations to language service providers.

 3:30pm–4:00pm: Break

 4:00pm–5:00pm: How Crowdsourcing Advances Quality Assurance Systems

Presenter: Anthony Lee, Knowtions Research, Inc.

The ultimate challenge to crowdsourcing translation is quality. Is it possible to gather a crowd with varying aptitude, skills and experience to deliver the absolute quality required in life science translation? It turns out that designing for crowdsourcing-specialized translations led us to a broader and deeper understanding of the role of quality assurance (QA) systems in general. The variances and organizational difficulties associated with using the crowd accentuates all the limitations of a “normally good” QA system and presents the most rigorous stress test around. To pass it, our work focuses on pushing the frontiers of what a QA system can cover into the realms of culture, cloud collaboration, big data and motivating human expertise.

5:00pm–5:15pm: Wrap-up

 5:15pm–6:45pm: Break

 6:45pm–10:00pm: Life Sciences dinner at the Village California Bistro and Wine Bar, transportation provided.


 Wednesday, October 14, 2015

9:00am–9:30am: Welcome and Recap of Tuesday, October 13, 2015

9:30am–11:00am: Managing the Complexities of Global Life Sciences Content

Presenter: Ann Rockley, The Rockley Group

The globalization of life sciences content is very complex. There are numerous changes that must be tracked and used correctly, such as units of measure, severity of alerts (warning vs. precaution), use of symbols, regulated statements, brand marks (trademark vs. registered trademark), drug or device names, image changes, health authority specific requirements and so on. While the language may be the same, there can be multiple permutations based on health authority, region and country. Most life sciences companies track the variations with either a core data sheet or massive Excel spreadsheets. The language service provider may have another method of tracking these variants, and the publishing vendor responsible for the InDesign materials may have yet another! In this session, we will provide best practices for managing these complexities, identifying how the variants can best be controlled in content creation, content management, translation and production.

11:00am–11:30am: Break

11:30am–12:30pm: The Deployment of Global English in the Life Sciences Marketplace

Presenter: Jeff Kiser, Vistatec

In today’s day and age, there’s an increasing demand for source English content to be adjusted, revised, primed or seasoned for an international audience. Far too many companies still author in US English and try to adjust it for their international markets or have their language service providers (LSPs) do this for them during the translation cycle. This doesn’t always work, especially for the Japanese market. In this presentation, we take a closer look at what’s being done to craft the English source content correctly from the beginning. What are LSPs doing to help their clients? What are clients doing to minimize the feedback loop that typically points to the English content not being appropriate for their market? What are some best practices that can be used across the board? When is transcreation necessary to address this issue?

12:30pm–1:30pm: Lunch

1:30pm–2:30pm: A Well-developed Translation Infrastructure for Pharma, and No Such Luck for Devices

Presenter: Simon Andriesen, Medilingua

During this session, we will discuss why there seems to be a much more developed translation infrastructure for pharma than for devices. We will discuss the European Medicines Agency driven quality control of pharma documents, as well as the Medical Dictionary for Regulatory Activities (MedDRA) and the EDQM Standard terms for routes of administration. Should devices be jealous, or should they be happy? Would it be possible to build something similar for devices?

2:30pm–3:15pm: Group Discussions

Certifications and standardizations: A must or nice-to-have?

The inner workings of regulatory departments at life sciences companies: Do companies always just follow the regulations, their interpretations of them or a mix or both?

 3:15pm–3:30pm: Break

 3:30pm–4:45pm: Breakout Sessions

 4:45pm–5:00pm: Presentations and Wrap-up