East or West: A Multi-Partner Approach to Clinical Trials
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With several thousand clinical trials currently running in Scandinavia, Nordic biotech and pharma companies, CROs and research institutions are increasingly extending their reach into other geographic regions. Maria Ohlander, Head of Clinical Development at Karo Bio, shares valuable lessons learnt during the multi-partner approach Karo Bio took to develop compounds with an Indian partner and 3 other CROs.
Pharma IQ: What are the current challenges and opportunities around outsourcing clinical trials today?
M Ohlander: Well, from my perspective, the current challenges are actually defining the CRO that has the therapeutic area experience and knows the challenges that are within that area for conducting such studies.
Pharma IQ: Maria, could you define the difference between clinical outsourcing and clinical partnerships?
M Ohlander: In partnership an organisation selects the CRO to build a partnership with and they help in rolling out the program or developing compounds. When outsourcing, there is more flexibility to select different CROs.
Partnerships are about providing a full concept rather than bits and pieces where you can go to different vendors. And working in a small company like Karo Bio, we don't have partnerships; we either outsource bits and pieces or outsource the full program to one CRO, but we do it based on the therapeutic area, the knowledge from the CRO and so forth.
Pharma IQ: Can you tell us a little bit about the current work that you are outsourcing from Karo Bio?
M Ohlander: We have outsourced a phase III program from Karo Bio. We went through the normal proposal format with four or five different CROs and found a CRO that was really suitable for the phase III program we were conducting. The CRO we selected had the therapeutic experience and knew exactly what we needed. We did a similar thing with smaller phase I studies, where it was more about outsourcing rather than a partnership with one big CRO.
Pharma IQ: Where are the majority of the clinical trials being outsourced globally? Is it to the East or to the West?
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M Ohlander: I think a lot of programs these days are outsourced to Eastern countries, mainly because of cost sensitivity and the availability of patients. We have outsourced a Phase III program to be conducted both in Europe and Asia. From our perspective, it was a cost issue: It’s cheaper to conduct clinical studies in Asia, but we also have a partner called Alichem that is present in India and so we are conducting studies in India too.
Pharma IQ: At the Nordic Clinical Trials Forum, which takes place in Stockholm at the end of May, you will be speaking about your multi-partner approach. Could you explain the unique approach Karo Bio has taken?
M Ohlander: Karo Bio is a small biotech company and we were working on a Phase III project, which has unfortunately ended, with our partner, Alichem Pharmaceuticals, an Indian pharmaceutical company, which I mentioned earlier. The plan was to half the costs for the program. We were conducting the phase III study in Europe and in some other countries - 12 countries in total, while our Indian partner was taking the responsibility of the other half of the program, which was going to be conducted through three CROs in India.
The benefit for our partner, Alichem, promised to be access to the Indian market for this drug. But this program has failed due to toxicity results, so we ended it a couple of weeks ago.
Pharma IQ: I'm sorry to hear that, Maria. So what approach do you think you will take now?
M Ohlander: Well, the program has closed so we're not proceeding with this anymore but I do think that this is a really valuable approach for small pharmas wanting to develop their compounds all the way through to an approval. Having a partner on board meant we could use the data in both regions in the end.
Pharma IQ: How long did that partnership last?
M Ohlander: We started the partnership about a year ago, but we managed to achieve so much; we were just about to start including patients in the first Indian study. The partnership worked very well and everybody was really happy about it, so I must say it’s a shame that we had to close it down so early on before seeing the results of it.
Pharma IQ: It certainly is, Maria. What's next for Karo Bio?
M Ohlander: I can't really go into details but what we are mainly working on early discovery projects and collaborations; we don't have anything in clinical right now.
Pharma IQ: Are you outsourcing or intending to outsource other functions apart from clinical trials?
M Ohlander: We do outsource other pieces as well, since we are a small company. For instance, all toxicology studies and preclinical work that needs to be according to GLP is outsourced. All the CMC work, production of the API and the tablets, plus regulatory functions are also outsourced. So we do outsource the majority of our work, I would say.
Pharma IQ: Maria, what are you hoping to gain most from the Nordic Clinical Partnerships Forum?
M Ohlander: I always think it’s important to meet with other colleagues doing the same thing as we are doing and to share best practice and learn new ways of doing things, so I think that will be the major focus for my side.
Pharma IQ: Thank you, Maria
Interview by Niamh Madigan, Pharma IQ, www.pharma-iq.com
M Ohlander: Well, from my perspective, the current challenges are actually defining the CRO that has the therapeutic area experience and knows the challenges that are within that area for conducting such studies.
Pharma IQ: Maria, could you define the difference between clinical outsourcing and clinical partnerships?
M Ohlander: In partnership an organisation selects the CRO to build a partnership with and they help in rolling out the program or developing compounds. When outsourcing, there is more flexibility to select different CROs.
Partnerships are about providing a full concept rather than bits and pieces where you can go to different vendors. And working in a small company like Karo Bio, we don't have partnerships; we either outsource bits and pieces or outsource the full program to one CRO, but we do it based on the therapeutic area, the knowledge from the CRO and so forth.
Pharma IQ: Can you tell us a little bit about the current work that you are outsourcing from Karo Bio?
M Ohlander: We have outsourced a phase III program from Karo Bio. We went through the normal proposal format with four or five different CROs and found a CRO that was really suitable for the phase III program we were conducting. The CRO we selected had the therapeutic experience and knew exactly what we needed. We did a similar thing with smaller phase I studies, where it was more about outsourcing rather than a partnership with one big CRO.
Pharma IQ: Where are the majority of the clinical trials being outsourced globally? Is it to the East or to the West?
[inlinead]
M Ohlander: I think a lot of programs these days are outsourced to Eastern countries, mainly because of cost sensitivity and the availability of patients. We have outsourced a Phase III program to be conducted both in Europe and Asia. From our perspective, it was a cost issue: It’s cheaper to conduct clinical studies in Asia, but we also have a partner called Alichem that is present in India and so we are conducting studies in India too.
Pharma IQ: At the Nordic Clinical Trials Forum, which takes place in Stockholm at the end of May, you will be speaking about your multi-partner approach. Could you explain the unique approach Karo Bio has taken?
M Ohlander: Karo Bio is a small biotech company and we were working on a Phase III project, which has unfortunately ended, with our partner, Alichem Pharmaceuticals, an Indian pharmaceutical company, which I mentioned earlier. The plan was to half the costs for the program. We were conducting the phase III study in Europe and in some other countries - 12 countries in total, while our Indian partner was taking the responsibility of the other half of the program, which was going to be conducted through three CROs in India.
The benefit for our partner, Alichem, promised to be access to the Indian market for this drug. But this program has failed due to toxicity results, so we ended it a couple of weeks ago.
Pharma IQ: I'm sorry to hear that, Maria. So what approach do you think you will take now?
M Ohlander: Well, the program has closed so we're not proceeding with this anymore but I do think that this is a really valuable approach for small pharmas wanting to develop their compounds all the way through to an approval. Having a partner on board meant we could use the data in both regions in the end.
Pharma IQ: How long did that partnership last?
M Ohlander: We started the partnership about a year ago, but we managed to achieve so much; we were just about to start including patients in the first Indian study. The partnership worked very well and everybody was really happy about it, so I must say it’s a shame that we had to close it down so early on before seeing the results of it.
Pharma IQ: It certainly is, Maria. What's next for Karo Bio?
M Ohlander: I can't really go into details but what we are mainly working on early discovery projects and collaborations; we don't have anything in clinical right now.
Pharma IQ: Are you outsourcing or intending to outsource other functions apart from clinical trials?
M Ohlander: We do outsource other pieces as well, since we are a small company. For instance, all toxicology studies and preclinical work that needs to be according to GLP is outsourced. All the CMC work, production of the API and the tablets, plus regulatory functions are also outsourced. So we do outsource the majority of our work, I would say.
Pharma IQ: Maria, what are you hoping to gain most from the Nordic Clinical Partnerships Forum?
M Ohlander: I always think it’s important to meet with other colleagues doing the same thing as we are doing and to share best practice and learn new ways of doing things, so I think that will be the major focus for my side.
Pharma IQ: Thank you, Maria
Interview by Niamh Madigan, Pharma IQ, www.pharma-iq.com
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Please note that we do all we can to ensure accuracy within the translation to word of audio interviews but that errors may still understandably occur in some cases. If you believe that a serious inaccuracy has been made within the text, please contact +44 (0) 207 368 9425 or email niamh.madigan@iqpc.co.uk
