Incorporating Therapeutic Strategies
A commonality among most companies analyzed in this study
is that the business development and licensing strategy-setting
process is owned by each company’s respective therapeutic areas or
business units. While the BD&L strategy is usually approved by
senior management, business unit leaders know their own pipelines
and competition best. It makes sense that therapeutic area senior
management should identify pipeline gaps and assets to divest, set a
strategy for pursuing in- and out-licensing deals, and hand off that
strategy to the BD&L to develop and execute a plan that meets each
business unit’s pipeline needs.
Among larger organizations, therapeutic area strategies help to
determine licensing plans. This is the case with Company A, which
relies on therapeutic area strategies to build its licensing plans.
Each therapeutic area’s plans aim to establish dominance over
specific treatments and their markets. The company makes its
licensing decisions based on pipeline gaps around those therapeutic
categories.
Licensing figures into the company’s plan for therapeutic area
growth. As part of its strategy, Company A in-licenses and partners
for compounds anywhere from discovery to commercialization.
Executives from discovery, clinical research and marketing
ultimately decide how licensed products will fit into and benefit
the overall portfolio. All three determine with whom the company
should partner. The three groups form a committee that works in
concert with a separate group that identifies new opportunities. The
committee also ensures the business development group is activated
once the company approves a deal.
(Excerpted from Chapter 1, Section 2: Deal-Making Strategy) In
the full report, a discussion follows on how companies focus on business development’s role
in annual therapeutic area pipeline planning.
Business Development and Licensing Structure
Business development and licensing organizational
structures grow organically out of need and culture and evolve
rapidly as a company’s alliance and licensing activity increases. In
recent years alliances and licensing have become more prevalent
across the biotechnology and pharmaceutical sectors. During this
time, BD&L functions’ evolution has been influenced by corporate
culture, their own merger and acquisition activity, and leaders
championing change to improve operating efficiency and
effectiveness.
Industry research into pharmaceutical business development and
licensing organizations reveals interesting variations on similar
structures. The largest organizations, which also happen to be those
that have found a need to restructure in the past few years, have
the luxury of structuring by process to enable specialization and to
build expertise and knowledge. For example, Company B’s BD&L
function is divided into three sub-departments: search and
evaluation, negotiation, and alliance management. Several companies
have recently migrated to this structure or a similar one, and
several others are considering it.
Other companies divide their BD&L functions not by process but by
therapeutic area or geographic region, and licensing executives are
expected to handle a deal from beginning to end – search and
identification, deal evaluation, negotiation, and sometimes even
alliance management. These structures enable expertise to develop in
therapeutic areas and foster stronger relationships with companies
by region. Their drawback, however, is that they do not build
expertise in each stage of the BD&L process.
The ideal structure, according to a majority of BD&L executives
interviewed in this research, is a process-based specialization
combined with therapeutic area alignment. A couple of companies have
begun to move in this direction and have built specialized,
process-based competencies within one to three of their largest
business units. The trend in BD&L structure points to more companies
evolving toward this point in the near future; but such large-scale
structural change must be driven by increased demand and deal
volume, a merger, or an executive to champion the change.
(Excerpted from Chapter 2, Section 1: Business Development
and Licensing Structure) The full report contains detailed
discussion of different organizational structures for BD&L groups.