Birgit Anderegg PhD
- 20+ years hands-on and strategic experience in EU and U.S. life science environment: managing positions in pharmaceutical companies, startup technology enterprises and academic research.
- Specializes in partnering therapeutics, biomarkers and companion diagnostics, e.g. in CNS, ENT and ophthalmology; provides strategic management consulting for pharmaceutical and biotech companies, including turn-around situations and situations that call for change management.
- Clients have included: academic labs on the verge of spinning out a service-providing or technological entity; tech transfer offices of academic research organizations; entrepreneurial start-ups; biotech companies at various R&D stages; pharma companies in temporary need of strategy assessment or with a gap in alliance management; chemical companies expanding their strategic portfolios to API for the therapeutic life science industry; patient adherence program specialists.
- Geography of clients: Germany, Spain, The Netherlands, Israel, USA, Australia, New Zealand.
- Expert Reviewer to the European Commission, reviewing grant applications in Life Science/SME-relevant fields.
- All 7 Best Practices
- Pre-Meeting Discovery Process
- One-on-One Call with Expert
- Meeting Summary Report
- Post-Meeting Engagement
Business Development and Out-Licensing for Life Sciences Companies
- Business development staffs are shrinking.
Under pressure to control costs in an industry that burns through cash at a fast clip, pharmaceutical companies of all sizes have been responding with headcount reductions in areas deemed non-essential or redundant. Ironically, an industry urgently looking for new drugs to replace those going off-patent has been putting those responsible for finding those new products and skilled in negotiating deals in the cost-cutting crosshairs.
The paring of business development departments translates to challenges for pharmaceutical companies scouting for partners and licensing deals and SMEs and biotechs alike. BD&L staff stand-ins, frequently scientist/technical types who take on these duties on a project-by-project basis, lack many of the unique BD&L skills, further complicating the already complex job of deal-making. Continued cutting of these staffers also jeopardizes the maintenance of consistency and continuity as extended deal negotiations are pursued.
- Pre-competitive consortia/collaborative partnerships take root.
Early-stage partnerships in which prospective licensors and licensees agree to work collaboratively on elements of product development are an emerging response to the high stakes that characterize modern drug development.
Pledging to share knowledge and combine resources, these consortia are designed to shorten the time and reduce the expenditures required to bring a promising and potentially lucrative product to market.
The structure generally enables multiple companies exploring similar or different facets of a development challenge to join forces to get quicker answers, share in intellectual property claims if something of potential value emerges and then split apart and resume a competitive track on the road to commercialization.
- The era of blockbuster drugs is ending.
The business model that built Big Pharma – a stable of high-volume, patent-protected drugs that constituted near monopolies for decades – is fast receding, putting pressure on drug marketers to fashion an entirely new approach to product development.
In place of these products with mass appeal, little or no competition and hefty price tags, drug marketers are turning their attention to niches that can be exploited for novelty in addressing unique indications, method of administration, side-effect suppression, etc. Examples might include a patch-delivery mechanism for a diabetes drug, and new classes of pediatric drugs that are safer and more tolerable. What they don’t want are costly “me-too” drugs that will almost certainly face higher approval hurdles.
In searching for these new opportunities, drug makers are of course on the hunt for promising collaborations and partnerships, a fact that should bode well for efforts by SMEs and biotechs looking for exactly the same thing.
- Industry sub-sectors are beginning to “grow together.”
Traditionally pursued on separate and very distinct tracks, prospective therapeutics, diagnostics and medical technology products are starting to converge developmentally as their crossover and complementary potential is better understood and increasingly seized.
More ventures pursuing products with that potential – diagnostics that can help therapeutics target better; therapeutics that can be delivered more optimally via medical devices – are finding that they not only can, but practically must lock arms as they move forward. And the earlier the better.
An example might be the pairing of an asset that has strong promise as a diagnostic, often a lower value proposition than a therapeutic, with a therapeutic one that could benefit from its marker qualities in clinical trial settings. In this scenario, the diagnostic asset owner would be able to tap into an upstream market where its value might be higher. The therapeutic asset owner would benefit by being able to better target and decrease risk.
Still in the early stages, this convergence offers intriguing opportunities to commercialize prospective products sooner and more broadly, but also poses very real regulatory and approval risks.
- “Framework” agreements become a relationship development model.
To get a foot in the door of a prospective licensee and firmly secure it, more SMEs with promising products are thinking big-picture and long-term. Recognizing the developmental value of a prospective partnership, they’re working to structure deals around the concept of deeper partnering and collaboration to fully explore how and where an asset might fit into a licensee’s current and future portfolio.
In framing a product or technology as a discovery platform, the parties establish the basis for a development commitment with the potential to extend well beyond what may be currently known or evident about an asset.
Such framework relationships, because they imply commitment and may preclude the opportunity to seek out other prospective partners, require and often foster a high degree of trust on both sides. When well-conceived and well-designed, they can establish a solid foundation for fully and efficiently leveraging a prospective asset’s value, to each party’s benefit.