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SPARKs Fly When Stanford Profs Talk BD with Industry Leads

October 16, 2014
5:30 PM, October 8th, 2014. Li Ka Shing Learning & Knowledge Center, Stanford University.

Stanford’s SPARK Seminar Series provides a forum where BD leads can meet with aspiring academics to foster better collaboration and tech transfer. That said, much of the forum’s discussion has applicability outside of academia as well. Today Kanad Das (no relation), Associate Director of Partnering and Alliance Management at SPARK, has assembled a dream team of industry business development frontrunners to talk about HOW to go about getting an asset licensed or funded. Panelists:

  •  Sarah Bodary, Sr. Director, New Ventures, J &J Innovation

  •  Sylvaine Cases, Director, External Innovation, Sanofi

  •  Joseph Dal Porto, Director, Pfizer Center for Therapeutic Innovation (CTI)

  •  Roxanne Duan, Director, Collaborations & Partnering, MedImmune

  •  David Parry, Executive Director & Entrepreneur in Residence, Discovery Partnerships with Academia (DPAc), GlaxoSmithKline

  •  Rick Harkins, Principal Scientist, Global Drug Discovery, Bayer HealthCare

  •  Felix Karim, Director, Transactions, Amgen

  •  Go Saito, Research Strategy & BD, Venture Science Labs, Daiichi Sankyo

  •  Catherine Soldano, VP, R&D, Teva Pharmaceuticals

  •  Neil Smith, Sr. Advisor, External Innovation, Eli Lilly


Question: What do you consider a “validated target”? What’s the bar for funding?

Answers: Almost all panelists emphasize that a “validated target” is not necessary to obtain funding. Additionally the topic of portfolio alignment and therapeutic fit is discussed, with the conclusion being that it’s not always easy for outsiders to determine that therapeutic priorities of a company, since they shift often at the indication-level (e.g. patent cliffs can influence). That said, definitions of a “validated target” are offered:

  •  In vivo efficacy or PD or proof of activity in animal models or strong human genetic data

  •  Clear therapeutic hypothesis. Clear pathway, and insight into the mechanism. Assays or ideas for assays

  •  Genetic validation – 2 compounds that are externally put into the culture has the same effect

  •  Therapeutic rationale, human genetic data, not “just a hunch”


Question: What is the internal decision-making process on going forward with a project/deal?

Answers: Not all the respond with direct answers. Nonetheless, the replies are informative.

  •  When you interact with academics, programs look different. There is much more emphasis on the science. The process is to work with the PI to generate the slide deck and hypothesis, and then pitch it internally to peers. Afterwards the work plan needs to be built e.g. candidate selection

  •  Need to determine how much money needs to be put in, and how much money it will take. In a smaller company [“smaller company” referring to the in-licensor or funder] you can get to the terms of a deal without much internal collaboration. THEN you go to internal approval. A $300K animal deal can be easily approved. Bigger deals get more burdensome.


Question: [A familiar voice comes from the back of the room – it’s Stan Cohen] Would multiple competing companies work together to form consortia to provide more funding for pre-competitive assets? Do you ever work together?

Answers: The answer seems to be ‘no’ for consortia for funding of pre-competitive assets

  •  Pharma does that well for late stage because it has to

  •  Pfizer is involved in the consortium of structural genetics, which has, as one of its goals, to understand epi genetics. There is a joint steering committee that oversees that

  •  There is a European consortium for better understanding of cell biology


Question: What is the expected success rate?

Answers: Better than the NIH! [laughter]

Question: I have biology, a good patent and SAR, and the therapy area is a good fit. Why aren't you knocking on my door?

Answers:

  •  We will work collaboratively to determine if it’s a fit. If so, we can fund in exchange for 1st right

  •  If you don’t make your development plan/program public, how will we know?

  •  We need to do a better job at this


Question: What’s the best way to interact with academics?

Answers:

  •  We really enjoy getting the scientists talking

  •  Working with VCs

  •  Do you own it? The patent is important.

  •  Come with your story buttoned up: Here’s my evidence, here’s the pathway, here’s the market size, here’s why you should be interested. This is the next milestone, this is how much money is needed. That makes for faster due diligence


Question: What do academics do badly?

Answers:

  •  Something is good in vitro but bad pharmacodynamics – this happens a lot

  •  Timeline. Academics may prioritize making nice publications over business

  •  Focus. The asset might do 10 different things. Instead of talking about all of them, say this is my focus, this is the benefit

  •  Pharma sees glass half full – if they believe in something they do what it takes to try to make it work. Academia is more ‘science seeking’, pursuing multiple studies that are cool science but not relevant to a marketable drug

  •  Share common stage gates

  •  Not clearly define how they can provide value to the potential in-licensor


Question: What are the timelines for doing a deal?

Answers:

  •  4 – 12 months: Scout. Internal team meeting. Talk to BD and therapeutic teams with a non-con. CDA but not structures at first. Then talk to the R&D management team, then a larger diligence team. Deal terms go through two cycles of discussion. Then there’s deal review with sr. management. If it’s M&A, it goes to the CEO/Board

  •  6 months. Smaller companies [“smaller company” referring to the in-licensor or funder] have a certain budget per year. So deals end in March. The scout does a deal together with researchers. Then it goes to legal.

  •  Find out the fiscal year of each company you want to out-license your asset to!

  •  You need to find an internal champion within the pharma. One regulatory person in each region. One CMC person. The champion has to be your internal sales man – pharmas want alignment

  •  Lilly has an open innovation platform. If you submit to the platform and there’s a hit, then Lilly has first chance to talk to you. Lilly will try to replicate your cool science; a material transfer agreement starts things off


Question: How does a post doc get to be a BD leader?

Answers:

  •  Think like a business – what is the differentiator?

  •  Spend some time in pharma R&D

  •  Be multi-faceted – think about the future – think out of the box e.g. how will the cloud affect healthcare?

  •  Get cited and speak. Be vocal about your interests and leverage your network

  •  Be ready to fail – don’t be afraid to fail. THINK: How do you kill your compound?


And, in conclusion, if I may quote Catherine Soldano, VP R&D, Teva Pharmaceuticals:

'I don’t want to come to pharma too early' is the wrong strategy. DO come early. Don’t waste time on the wrong evidence!