Nearly a decade on from when he first founded the CRO Orphan Reach, CEO Thomas Ogorka, recognised the opportunities in orphan product development and made this his company’s mission from then on. He talks to RARE Revolution about the challenges faced in developing new products and how supporting rare disease patients is a huge motivator for him and his team

​CEO Series: meeting the beating hearts behind the RARE brands

1.

What made you want to move into the wide world of rare disease, and then specifically go on to found Orphan Reach and what did that journey look like?

I set up QED Clinical Services back in 2002 as a functional CRO before it was later rebranded to Orphan Reach. From 2011 we noticed that clinical trials were coming in that had not been taken care of very well. When more of these so-called rescue projects came our way, we thought this is not a comfortable situation neither the sponsor nor the patient should find themselves in. Taking over a clinical study in mid-swing from another CRO service provider usually means delays to the study with a cost impact for the company, and other potential downsides, particularly for patients who just don’t have the time to wait. All these rescue projects involved rare disease indications where conventional CROs found it difficult to cope.

We then carefully analysed the gaps, looked at the market and concluded that there was an opportunity for us to make orphan product development our mission from then on. At that point already, around 90% of our trials took place in orphan indications, so it was not too much of a stretch for us to go all the way. However, with no additional investment on board and having to finance our growth using our own means, our journey to where we are today took longer than anticipated. 

2.

What do you anticipate will be the biggest challenges and opportunities for your organisation in the next two years?

We need to be making sure that we adapt to the ever-increasing demands, regulations, data protection rules, etc. for clinical trials which can potentially all have a negative impact on the speed of which new products can be developed and then made available to patients in need.

​On the other hand, we are learning on a daily basis and can implement changes, answering with adequate solutions quickly as long as we are staying as dynamic as we are now. There is a great source of talent out there who want to join companies with more than just business in mind. Being able to support unmet medical needs, to visualize the affected patients and how we can help our clients to bring new therapies to them is a great motivator.

3.

What is your proudest moment in your career thus far?

​When we had our Christmas event with the team at the end of last year, giving a presentation, I realised how much we had grown and what wonderful people we have on board. Maybe this moment now comes more to mind as we have not met each other for some time due to the restrictions currently in place. I do really miss the face to face contact.

4.

What and who are your personal and professional inspirations and why?

5.

What advice would you give someone considering working in the rare disease space?

Expect the unexpected! We know that clinical trials can be extremely complex involving a lot of different stakeholders who are all working towards one goal: to provide effective therapies to patients with rare diseases. So, if you enter the world of rare diseases, be open to surprises and prepare for a lot of lessons to be learned. As long as you are prepared to learn and adapt, you will feel at home.

6.

Do you think the government does enough for the rare disease community at a local and central level, and what gaps do you see currently or emerging?

There should be earlier and more frequent interactions between regulatory agencies and drug developers including scientific and ethical considerations of clinicians and the patient community. This could help to accelerate the design of non-clinical and clinical programs.

​We have seen conditional marketing approvals in the past, but this route should be made broader, so that more drugs with an established safety profile can be conditionally approved to reach patients with rare and rapidly progressing conditions. Patients could benefit from new drugs sooner while post-approval safety and efficacy monitoring will continue to provide the required data.

7.

What would you say are some of the biggest motivators for your employees? 

​Our employees find their biggest motivation in team collaboration, achieving deadlines and celebrating their achievement together. This all happens on the understanding that patients with rare diseases are much more visible and everyone working at Orphan Reach knows what sometimes is easy to forget: behind the data that we collect to test new therapies are personal destinies, very often children, with little or no hope. If we all work a bit harder, we may help save lives or make life easier for patients and their families.

8.

What are the toughest parts of being a CEO, and conversely what are the most rewarding? 

Orphan Reach is a service provider, and as a team we are only as good as our weakest link. It is sometimes tough to say goodbye to someone who we get on with very well, but who may not be the right fit for us.
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On the other side it’s great to see team members thriving in their roles and to see them reaching their full potential is a very rewarding feeling.

9.

What would be your one wish for Orphan Reach for the year ahead?

​I am sure that I am not the only one wishing that we will hopefully find effective treatments and vaccines for COVID-19, and soon. We have done amazingly well during this crisis but naturally also needed to find workarounds to make things happen in this different world. Once we can manage COVID-19 properly, I can see us working with more innovative biotech companies and serving more patients with devastating diseases and their families, supporting them.

10.

​If you weren’t CEO of Orphan Reach, what was Plan B?  What did your 10-year-old-self want to do as a job?

I would probably have become a music producer, as firstly I like music and secondly, I like to create something out of nothing. For me seeing the parts coming together one by one, arriving at something which sounds beautiful, fills me with joy and happiness.