Reflecting on the 2016 BIO International Convention

bio logoPark IP Translations recently exhibited at the 2016 BIO International Convention. Michael Chugranis, Strategic Director of Life Sciences at Park IP Translations, took part in the event and shares his key insights from the event.

The BIO International Convention covered a wide range of life sciences topics for both delegates and exhibitors. There were representatives from all areas including drug discovery, cell therapy, drug manufacturing, nanotechnology and biofuels. There was a lot of representation from young, start-up companies who were looking to get their drug discovered, funded and moved on to the next clinical phase and there were investors looking to put money into future pharmaceutical projects.

One thing that stood out was the sheer number of companies who are focused on discovering, creating and inventing pharmaceutical products. Some may be the next revolutionary drug, others we will never hear of again.

The life sciences industry is highly regulated and is always under the scrutiny of various government agencies. From intellectual property (IP) through to commercialization of a product, content and documentation is complex and has to meet requirements of local governments to be legally accepted. Anyone involved with the authoring, production, translation and handling of documentation must be a specialist and fully understand the process and regulatory implications.

The life cycle of a pharmaceutical product is long and expensive, from initially looking to register a chemical patent right through to full manufacture and distribution to global markets. It’s a rigorous process to go through with extensive research and development, regulatory submission and clinical phases to get a drug fully approval. Only a minute percentage of drugs succeed.

20160608_134228_resized bioThe main objective for Park IP’s participation in the event was to meet with BIO attendees and share how we provide language solutions to life sciences clients across a product’s life cycle. From the early patent filing and IP protection right through to the clinical trial phase, ensuring patient and drug information is understandable and compliant in all the appropriate languages.

There were many key conversations and takeaways from BIO. It was an excellent event with thousands of like-minded people sharing experiences. Here are my main observations reflecting on the conference and many discussions with professionals in the life sciences industry.

#1 – Protection of IP: With so many start-up organizations in attendance, many were keen to identify the right, successful path to get their patent filed and IP protected. The Park IP team was able to offer solid guidance on how to best protect life sciences patents in local markets.

#2 – High Volumes of Paperwork: There is a lot of paperwork involved at every stage of a product life cycle. From patent filing through to full FDA and EMA approval. There are essential documents required to conduct clinical trials and all documents must be in the right language, depending on where trials are to take place. Feedback from patients involved in trials could come in multiple languages and the information must be accurately translated and understood to be legally compliant as part of an official trial. Even when a drug is being fully marketed, information will continue to be gathered as part of the pharmacovigilance (PV) stage in every country the drug is being used.

#3 – Patient-Centricity: Many clinical trials are now patient-centric. Many companies are moving towards paperless methods of collecting data so they can communicate and obtain data from patients in an easier way. E-Clinical systems allow data to be easily collected and stored digitally. Use of smartphones and tablets are increasing. If trials take place in a rural area where the clinical center may be far away, patient participants can submit data electronically using a smartphone app. Text or SMS messages can be used to communicate and remind patients to take their drug. Use of social media to gather information and listen to patient feedback. There are a growing number of ways companies are looking to improve communications between patients and monitors.

#4 – Growth of International Pharmaceutical Companies: There are a growing number of companies entering the US market from key geographies, like Latin America, Mexico and parts of Europe. They have FDA or EMA approval to sell their product into the USA and were looking for guidance on globalization and localization. Language is a key enabler and any product content must be translated correctly and meet local regulatory standards.

Globalization of life sciences and biotech products requires a wide range of skills and discipline. Having a good, long-term language service provider on board will help any pharma company to successfully progress a product from initial conception through to full manufacture. If you have any questions about developing regulated multilingual content in the life sciences space, please email me at Michael.chugranis@parkip.com

Michael

Based in New York, Michael Chugranis is Strategic Director of Life Sciences at Park IP Translations.

 

 

 

 

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