Sponsor Bid Defence Meetings: a few thoughts!
I have been privileged enough to have taken part in over 100 Sponsor Bid Defences as CRO Regulatory Lead in the last 3 and a half years and am proud to have achieved a >30% win rate. There definitely are a few lessons learnt that really helped me along the way:
1) Every BDM is different and needs to be treated as such with bespoke planning, slides preparation and delivery tailored specifically to this opportunity/study, sponsor and compound. The less stock info presented the better as the sponsor will likely have a good idea of your capabilities already.
2) Focus on delivering what the sponsors stated deliverables actually are: e.g. is there a required FPI date (may be related to future funding), RA/EC approval timelines (real-life observed), KOLs to be included, CTA submission responsibilities, document requirements/sourcing, recent site/country nuances, potential regulatory roadblocks, latest Reg intel data available etc.
3) Every sponsor will have different regulatory requirements. A small biotech may need a lot more hand holding and support than larger pharma with more established Regulatory departments. Hence flexible bespoke planning and delivery is a must.
4) Be prepared and do your research. What is the trial history of the IP (FIH, previous P1/2 studies completed etc)? Has Scientific Advice been received? Does the sponsor have previous experience in the proposed sites/countries on this or other programs? Has the sponsor used EU CTR before (e.g. discuss issues such as language requirements, doc redaction, full doc requirements etc)? Use your company's reg intel to have recent site and country experience/metrics to hand (processes, timelines, recent RFIs issued). Here’s where real-life recent experience really is worth its weight in gold. Check LinkedIn profiles of likely sponsor representatives and utilize previous experience and relationships as much as possible. Explore what might have happened at previous BDMs with this sponsor-any lessons learnt to bring forward?
5) Make sure your Reg slides content is relevant and concise-wordy slides do not always come across well. Concise bullets points work well-you can then expand on the bullets verbally as you present. Utilize ppt graphics for maximum visual impact.
6) Try to make the discussion as interactive as possible and invite participation and feedback.
7) Expect a curveball or two. Some BDMs start with a sponsor update where new previously unknown info/requirements may be tabled. This often means some of the info on the slides prepared may no longer be applicable-so maintain flexibility as much as possible. From a regulatory perspective, have at hand info on additional countries, sites or processes as discussions often lead down pathways where preferred sites, KOLs or countries are requested. Don't be afraid to say, "I will get back to you on this". The order of presentation often changes depending on sponsor queries, so be prepared.
8) Team harmony is essential. Get to know and interact with your BDM colleagues as team harmony shines through during BDM delivery and always comes across positively. Try not to compartmentalise your small part of the delivery-stay in tune to help out colleagues as much as possible during the BDM-good team dynamics. You will win or lose together as a team.
9) Read the room: the sponsor team may be sitting through their second or third long BDM of the day. Hence, be sharp and concise. Explain what is your USP? What makes you stand out from the other CROs? Keep the general stuff to a minimum.
10) Relax! Remember, you are the expert in the room and people are here to listen to you and your ideas. There is no short cut to being a successful presenter-just experience, practice, research and utilizing lessons learnt to improve. Seek constructive feedback.
11) Out of the box thinking: are there any additional trial or IP specific considerations worth mentioning e.g. paediatrics (informed consent/assent, max blood volumes, age appropriate patient docs), gene therapy/GMO (additional Biosafety Committee approvals needed, manufacturing process complexities, LT patient follow up requirements), IP (administration, storage, shelf-life, process for import to sites etc), comparators/background therapy (supply, license conditions, import), device considerations, language requirements, import/export issues, Legal Rep requirements etc.
12) Soft skills. As well as regulatory and scientific rigour, sponsors often really appreciate soft skills like friendliness, empathy, patience, Open-mindedness, humour-all positive assets for relationship building.
13) To paraphrase a football quote: "don't leave anything in the changing rooms"-ie give it your all, that is all that can really be asked of you. Don't be afraid to interrupt with your considerations.
14) Offer post BDM follow ups of Reg processes, systems, doc requirements, metrics etc.
15) As much as is possible-are the operational team going to be the ones presenting at the BDM? A very often heard sponsor complaint is that the BDM team is NOT the ones the sponsor ends up with to run the study.
16) Ensure the information you are presenting matches what has already been provided to the sponsor in a proposal or RFI.
17) 'Walk a mile in the sponsors shoes'. If you were them, what would you be looking for? Plan accordingly?
18) Some flexibility in pricing is often required ie award discounts etc. Ensure costs delivered are accurate based on previous experience and the project requirements. Another frequent sponsor moan is the sheer number of COFs. Try to pre-empt these with an accurate costing for the services provided which is easy to understand. This way, sponsors can easily compare apples with apples when reviewing bids.
GOOD LUCK AND TRY TO ENJOY!!
In the beginning….
It all begins with an idea.
October 2025
It all begins with an idea. Maybe with so much turmoil in the global pharmaceutical market, there is an increasing need for flexibility in the delivery of regulatory services and support where clients can choose the level and design of regulatory support to be provided to fit their own requirements, timelines and costs. Hence RegFlexSolutions was born as a service offering expert regulatory insight, but with the flexibility to suit all company sizes and requirements.
