The increasing complexity and globalization of clinical trials has changed the pre-market environment, with more companies outsourcing operations and investigating emerging markets. Pharma IQ hosted a roundtable session with three members of the Summit Advisory Board prior to the event. In Part I
, the panel considered questions around regulation and strict handling requirements for many biopharmaceutical products entering clinical development.
In Part 2, our industry experts discuss specifications around quality agreements, what to consider when conducting a due diligence and tips on achieving project manager success when outsourcing operations.
Pharma IQ: If an organisation is listening to this podcast and is considering outsourcing clinical trials, Rafik, could you perhaps take us through some considerations they should be going through before doing so?
R Bishara: The major concern I’d like to share with everybody to complement what Alisa and Steve have said is that the infrastructure in some of those new regions is not known and in some article I read last week, it became apparent without mentioning names that a major country that is now considered a producer of active pharmaceutical ingredients, of filled finished products and vaccines that are exported globally; thousands of their active material were not up to standard, according to the FDA, and as a result two companies received warning letters.
Therefore it is my recommendation quality systems/quality agreements must specify all the details of how you will purchase your material and who you’re going to purchase it from. Carry out a due diligence to make sure they meet the standards and, most importantly, when it comes to clinical trials, ensure that there are agreed specifications and they have been met.
We are dealing with lives; we are dealing with new innovative medicines to treat diseases that are not met as far as medication. It is very, very important to ensure there is no counterfeiting or tampering or diversion of material, but this is happening in the United States and in Europe, where, the elicit people are manoeuvring and pushing low standard material, low quality material into the supply chain.
In summary, know who you are dealing with, have everything in writing. A quality agreement or a business agreement document is important to protect the patients’ safety, efficacy as well as the business. It is very expensive to delay a clinical trial or repeat a clinical trial, so due diligence upfront is very important.
S Jacobs: Well, I think one thing I can say is that I’m seeing outsourcing increasing. It has certainly been increasing exponentially since the economic impact back in 2008 but I’m also seeing that the companies that are the most successful are typically the mid-size to the smaller companies, because they realise almost from the beginning that their success is based on the partnership that they establish with their vendors. I think some of the larger companies are still having problems and part of that is due, in fact, to their own internal silos, internal cultures and how well they interact with the vendors.
That doesn’t mean all of them are doing poorly, it just means that there are still challenges in the larger companies in how they actually partner and sometimes try and get out of that mind-set that says I’m paying you a lot of money, so therefore you’re my slave as a vendor, that’s something where I’m slowly seeing change - I am seeing a much higher success level with companies working with the vendors.
R Bishara: I will add my voice to Alisa’s and Steve’s. The majority of clinical partnerships are successful. If you invest in a quality system and quality agreement, you do the due diligence; you monitor and validate the source of your material.
If it’s not manufactured in your facility or whether it is the comparator; it’s very important, where you are getting your comparator and how you handle it? You do not have the data that the original company of the comparator has, so you have to do the proper handling, storing and distribution. It is, however, important for us because we’re going to new regions, new venues to make sure we earn the right data and the right trust with the people we are partnering with.
A Wright: I would echo what both Steve and Rafik said. I think it’s all about developing the right partnerships; if you’re the sponsor know what your culture is and what culture you work best with, the number of resources you have available and how tight-knit your team will be in working with whoever you choose as an outsourcing partner.
I think that makes a really big difference and that’s no different in our industry. Those are the winning partnerships, where you really can’t tell the difference between who’s the sponsor company and who’s the outsourcing partner, because they work so closely together.
Pharma IQ: Thank you, Alisa. Finally I’d like to ask you all individually what you’re looking forward to most at this year’s event and what you hope to gain from it. Can I start with you, Alisa?
A Wright: Well, I can’t wait to hear more from Rafik and Steve because this session in itself has been very good and I think that they’ll be able to share more with a forum that gives us a bit more time and a lot of dialogue. So, I’m looking forward to hearing more about what they’re seeing in the marketplace.
Pharma IQ: Alisa, you’re giving a session on achieving project management success when outsourcing operations, what’s your number one tip?
A Wright: That the project managers from both organisations really set the tone of what the partnership is going to be able to achieve. They’re effectively the lids on how successful you’ll be.
Pharma IQ: Steve, what are you looking forward to most at this year’s clinical trials conference?
S Jacobs: Well, interestingly enough, I’m looking forward to hearing how you can really conduct great project management to keep our clinical trials on track as well as what are some of the new and wonderful ways that we can actually go ahead and start with early development because that’s always a challenge, even in some companies that are still looking for investment from VPs and everything else as well as planning and forecasting. I’m always interested in planning and forecasting and how to create better partnerships with our vendors and the sponsor company.
Pharma IQ: Finally, Rafik, you will be chairing the Clinical Trials Supply and Logistics Summit. Can you perhaps tell me what you’re hoping to bring to the conference?
R Bishara: I want to ensure we have a meeting on a conference that will be a vehicle for all of us to exchange what have we learnt in clinical trials and some of the challenges with the handling, storage and distribution. I’m very excited about the concept of the roundtable discussion, the great networking and the location of this conference is very important to me in that we have moved it to the west coast since last year and that gives us a chance to interact with colleagues that do not come to the east coast or the Midwest of the United States.
Thank you so much for your participation today.
Roundtable hosted by Niamh Madigan
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