Director of Business Science to help advance Immuneed

“I want Immuneed to be a voice for the use of New Approach Methodologies in life science, as our services and technology are in line with the 3Rs.”

Wing Cheng is the Director of Business Science at Immuneed. We sat down for a chat to listen to his thoughts on his position and how his regulatory background can help advance the company and promote the use of New Approach Methodologies (NAMs).

Can you give us a brief overview of your background and experience? 

I have worked for 20 years in Life Science Business, 10 years within regulatory and Health Technology Assessment (HTA) authorities, such as the MPA, the European Commission, the EMA and TLV. At the EMA I worked for 3 years with drug approvals and was a Swedish member of the Committee for Advanced Therapies (CAT) approving ATMPs (Advanced Therapy Medicinal Products, Editor’s note). In the life science industry, I have primarily worked with topics aimed to maximise the potential of drugs, medical devices and IVDs (in vitro diagnostics, Editor’s note) from proof of concept to commercialization. 

* MPA = The Swedish Medical Products Agency, EMA = The European Medicines Agency, TLV = The Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsverket)  

How will your Director of Business Science role help Immuneed advance forward? 

By engaging key opinion leaders and working with regulatory authorities (the FDA and EMA) to advance ID.Flow®, the technology behind Immuneed’s services. Now is the time to provide input to the discussion and have a chance to impact the future of drug development, as the European Commission has just published a proposal for a new Directive and Regulation1 (on the 26th of April 2023, Editor’s note).  

I also want us to publish more scientific articles. Together with my team, I want to work towards further strengthening the scientific evidence for using ID.Flow® as a part of non-clinical immunotoxicity studies. This will increase the trust in Immuneed, both by customers and authorities, which I believe is key to our success. I want us to add value for our customers and, in the end, help enable safer drugs for the patients.  

What are the current regulatory trends and developments that Immuneed should focus on? 

Above all, the initiatives from the FDA1 and EMA2 pushing the 3Rs (the replacement, reduction and refinement of animal studies, Editor’s note). I want Immuneed to be a voice for the use of New Approach Methodologies (NAMs) in life science, as our services and technology are in line with the 3Rs.  

Although not strictly regulatory, what is interesting for us is that we are also in line with recent changes and trends in the pharma industry, moving towards smaller and specialized companies focusing on certain niche areas.  

How do you keep up with regulation changes and provide the most up-to-date advice? 

I can list a couple of things:  

• I make sure to keep track of updates from the EMA and FDA. 
• I stay in touch with former colleagues within regulatory authorities. 
• I follow discussions on social media and visit conferences. 

Could you elaborate on what you do to follow updates from the authorities? 

Of course! Again, I can list a few things: 

• I follow the FDA and EMA newsletters.  
• I follow all publications of approved guidelines and recommendations by the committee for medicinal products for human use (CHMP).  
• I follow a number of communities for regulatory questions, for example, TOPRA (The Organization for Professionals in Regulatory Affairs) and RAPS (The Regulatory Affairs Professionals Society), and different regulatory interest groups on LinkedIn.  

How do you approach collaboration and communication with internal and external stakeholders? 

By actively participating in symposiums and congresses within our business areas. I want to be a panel member for the discussion and help steer the conversation between customers and regulatory authorities. I also believe it is important to be open-minded, to find a common solution for our customers and the business.  

To finish off – what do you do when you are not at work? 

I like to be with my family and spend time in our summer cottage in the Stockholm archipelago.  

Since I was a teenager, I have been very interested in business and national economy and I still like to spend time on activities relating to these topics. I am a bit of a geek – I prefer reading an annual report from a company to a book during my vacation.         

If you want to know more about the new regulation from FDA and the Proposal from the EU Commission, read our blog about the topic here.  

Are you curious to know more about how Immuneed’s services can help reduce animal testing? Contact us here.