Features

Newsmakers Q&A: Lilly’s Adrienne Takacs

Managing Alliances At Lilly Research

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

 

Lilly’s transition from FIPCo (Fully Integrated Pharma Company) FIPNet (Fully Integrated Pharmaceutical Network) constitutes an ambitious rethinking of the pharmaceutical business structure, requiring buy-in from both internal staff and outsourcing partners. 
 

Adrienne Takacs, Ph.D., senior director at Lilly Research Laboratories Operations, spoke with  Contract Pharma recently about her role in managing Lilly’s strategic alliance with Covance, lessons learned in implementing FIPNet, and how the company is transitioning R&D from “shots on goal” to “shots in goal.”
 

You can find Dr. Takacs’ full bio on page 118 of this issue, in our Conference Preview section. I hope you’ll join us on Sept. 22 for her presentation at Contracting & Outsourcing 2011: The Value of Strategic Alliances in Transforming Pharma R&D!

—GYR

 

Contract Pharma: What’s your role in managing partnerships at Lilly?

 

Adrienne Takacs: My role in Lilly is leading external partnerships, including alliance management of the Lilly-Covance strategic alliance. 


The partnership with Covance is quite broad, beyond its bioanalytical component. It covers discovery services, routine assays and in vivo pharmacology, toxicology and ADME, as well as GLP toxicology, clinical pharmacology, early stage clinical, late stage clinical and central lab services. So it supports work across the value chain, and that’s one of the reasons we get such value from the partnership.


We announced the Lilly-Covance partnership in 2008, so we’re concluding our third year. It built on existing relationships we had with Covance. We’d worked with them on GLP toxicology for more than a decade. Our central lab and clinical diagnostics work with them stretches back almost 20 years. This new phase adds areas, like discovery services. 

 

CP: How far back does your own involvement with the Covance partnership go?

 

AT: I was involved from the time we announced the partnership, but not in the development of the deal.

 

CP: Was it a problem, not being involved in the deal from the ground up?

 

AT: There’s good and bad to that. Not being involved early on meant that I came in fresh, ready to set up how we would design the governance and manage this very large partnership ($1.6 billion over the course of 10 years). The bad is that I sometimes have to take a step back in order to really grasp some of the intricacies of the deal.


All things considered, going forward, I would recommend that someone leading a partnership of this size be involved at the outset but not at the deal-making phase. That person should certainly share his or her insights, but I don’t think it would be productive for them to be involved in the negotiations.

 

CP: Are there mechanisms in place for you to share insights at Lilly that you’ve learned in the past three years? 

 

AT: Absolutely. I provide feedback for our business development group as well as our sourcing groups. I utilize our Lilly Research Laboratories (LRL) newsletter to share with the broader research organization. 

 

CP: What trends have you seen among providers? How has Lilly’s approach to them evolved?

 

AT: We announced the Fully-integrated Pharmaceutical Network (FIPNet) strategy around five years ago, but we’d been working with partners in a variety of areas long before that. It’s evolving in a number of ways. Our core is scientific innovation, and we have identified the activities that reliable third parties can provide for us. As we set up a number of these partnerships and strong strategic alliances, we then had to understand how to manage them effectively. This included setting up clear expectations for the partner, what we want them to deliver, having effective methods for monitoring escalating issues and making decisions as part of the good governance process.


I can’t say this enough: “communication is key.” You can’t just hand it over and step away. You need to be continually working with your partners to reliably deliver and in a quality manner. FIPNet enables us to focus on innovation, but it also enables us to drive speed of delivery and quality. We work with partners who are well established and with whom we have strong relationships.

 

CP: What interaction do you have among your peers at other major pharma companies?

 

AT: I spend time at meetings like the Contract Pharma conference, where I get to meet a number of my peers throughout the year. I really do believe that we’re a first mover among our peers and looked to as a model for how to implement a FIPNet strategy effectively. I get questions quite a bit about it.

 

CP: Are you looking at more alliances within the clinical area? We spoke with Lilly about the Advion Bioanalytical partnership in our previous issue.

 

AT: We continue to evaluate what is core for us and what capabilities from our partners can help advance our objectives of improved outcomes for individual patients. The Advion partnership is one that I think has a lot of potential for success. I’m really looking forward to seeing how that alliance progresses.

 

CP: How do you balance the metrics-oriented six sigma approach to improving R&D operations with the amount of serendipity that still permeates drug discovery/development? In past years, the drug discovery and development model at many big pharmas seemed to be geared toward “shots on goal,” and I was always suspicious that a numbers-oriented target could be gamed too easily by management, that is, by pushing forward compounds that superficially fit but had no real chance in development. I know this is far from your area, but can you talk about that notion, that reconcilability of heavy-duty metrics with something that requires a fair dose of serendipity and/or luck to succeed?

 

AT: I’m really glad you asked this question; it’s something I’m very interested in. Our R&D head, Dr. Jan Lundberg, has changed that approach. “Shots on goal” referred to what we had to do to refill our pipeline to potentially get x number of molecules approved. But he’s transitioned our organization to a new terminology of “shots in goal”. We have the substrate in terms of numbers of compounds in our pipeline, but shots in goal refers to the initiatives we’re employing to maximize the chances that we can get many of those approved.


I really feel strongly that both six sigma and scientific innovation can be very effective in driving innovative new medicines to our patients. We use six sigma to improve R&D as part of our business, to focus on productivity and cycle time, We have many successful examples in clinical and preclinical research We also use it in partnership with Covance to help them improve their effectiveness and efficiency.

 

CP: Can you give us some examples of that?

 

AT: I don’t want to give away too much before my presentation at Contracting & Outsourcing!

 

CP: Speaking of! You’ve attended our conference and exhibition in the past and this is your first time as a speaker. What brings you back each year?

 

AT: First, I really appreciate the opportunity to talk at the conference this year. I think Lilly has a great story to tell about how it’s working with third parties to implement FIPNet through strategic alliances. In the past, I’ve found your meeting very valuable in helping me to understand how other companies are working with outsourcing providers. We’re at an exciting place and time for the industry right now. Your sessions have been great in getting at the best practices for pharmaceutical and biopharmaceutical outsourcing.


But even more than the talks and the roundtables, I like the opportunity to have one-on-one conversations with my colleagues and peers. That’s the most valuable aspect of it for me; the critical mass of the attendees and speakers.

 

CP: Final piece of advice for your peers?

 

AT: When selecting a partner to work with, make sure your strategies are aligned with theirs, and ask yourself whether this is a partner whom you trust.
 



Gil Roth has been the editor of Contract Pharma since its debut in 1999. He can be reached at gil@rodpub.com.

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters