- Hello, my name is Girish Aakalu.
I'm Vice President of Scientific Affairs
North America for Ipsen.
I received my PhD in neurobiology from Caltech.
I'd like to talk to you today about
Academic-Biopharma Strategic Collaborations.
By the end of this class you should be able to define
what industry seeks to achieve
when partnering with an academic lab.
Describe common industry-academic partnering models.
Understand how partnering process works
and list key best practices
for industry-academic collaborations.
First let's discuss what makes a collaboration strategic?
Collaborations are strategic when it helps meet
an organization's goals through its stated strategy.
In industry this makes a collaboration strategic
if it helps deliver drugs patients
typically by enhancing the company's pipeline
and/or capabilities.
Academia often has broader goals.
So, for an academic institution,
collaboration may be strategic
if it helps further scientific knowledge
and/or human health typically by
enabling scientific publication
and/or delivering drugs to patients.
It is important to understand
that the strategy of an organization
guides the actions it takes to achieve its goals.
As discussed in the previous lecture
an organization strategy should be informed
by its value proposition and organizational context.
In turn, the strategy should inform
the type of collaboration that an organization pursues.
For a biopharma company,
the influence of strategy
on the type of collaborations pursued
can be broken down into two main categories,
science, in other words, what disease areas,
mechanisms of action or technologies
a company is interested in
based on the types of therapies
it intends to bring to market.
And relationships or how an organization
would prefer to work with partners.
Two important conventions of this aspect
of partnering approach are how flexible an organization is
with its partnering models,
and how collaborative as opposed
to transactional or inquisitive
an organization prefers to be.
We just talked at a high level
about how an organization strategy
should inform what it seeks in a collaboration
but it might be useful to walk through a few examples
of how translation of strategy
to partnering interests works in more detail
with the folks around the science category.
For example, a biopharma company
often specializes in specific areas
to be able to build deep expertise and capabilities.
Even more pharma companies have moved
to specialized and specific disease areas
and smaller biotech companies often specialize
in specific therapeutic modalities
such as antibodies, peptides or cell therapies.
And typically companies are primarily interested in
seeking partnerships to advanced therapies
in their areas of specialization or focus.
Appetite for risk in partnership
is also informed by strategy.
Some companies focus on more proven, lower risk approaches
while other companies seek novel breaking science
to support their high-risk, high reward strategies.
Thus some companies may be more interested
in partnering to advanced early stage science discoveries
while others may be more focused
on acquiring molecules that have more data
and impress validated molecular targets.
A company's business model also plays a critical factor
in defining the types of partnerships
that are of interest to it.
Some biopharma companies seek to develop
and commercialize products
for all aspects of disease management
and thus are interested in diagnostics,
supportive care, as well as therapeutics.
Other companies may only be interested
in commercializing therapeutics
so it would be less interested in science
that wouldn't form a supportive care option
even for a disease area that they specialize in.
Next, we'll discuss how partnerships are structured.
Previously in the series of lectures
we've covered the common deal types.
The deal structures most commonly used
in the context of academic collaborations
with biopharma companies
are research collaborations, licenses and license options.
As it's discussed in the business development lecture,
you can expect that many deals
would be a combination of the aforementioned deal types.
Whatever deal type pursued,
the partnership agreement should be built on
based on a clear understanding
of the goals of the partnership.
In other words, what you hope to achieve by working together
as well as each partner's capabilities,
resources and constraints
which will inform who may be best suited
to perform a given task.
At a slightly more granular level
the answers to the following questions
can help guide the structure of a partnership
and ultimately the agreement or contract
that will govern a relationship.
What we want to achieve and who will do what?
Who pays for what?
How is intellectual property handled?
How are publications handled?
And how are risk and reward shared?
Now let's take a closer look
at some interesting partnering models
employed across the biopharma industry
and some example deals.
The first example we'll look at
is Pfizer's Centers for Therapeutic Innovation or CTI.
The goal for CTI is to enable more seamless
and interactive collaboration of Pfizer
and academic scientists by physically collocating
Pfizer's scientists and capabilities
in or near academic centers.
The first CTI site in collaboration
was established with UCSF in 2010
and has since been expanded to cover
roughly 20 academic centers.
The CTI model folks is exclusively
on antibody and small molecule
drug discovery collaborations.
New opportunities are sourced
by a request for proposal process
that work similarly across all academic partners.
General deal structure which includes
milestones and royalties
and alliance management approach
also work similarly across projects and academic partners.
The next example we'll explore
is the Harvard-Ipsen research alliance.
This alliance was established in 2015.
The first goal of this alliance
was to increase the likelihood of Ipsen
identifying collaboration opportunities of interest
both through a formal RFP process
as well facilitating ad hoc discussions.
The second important goal of this alliance
is to shrink the time to launch collaboration
with a Harvard PI.
By streamlining the agreement development process
but still managing to maintain flexibility
to support a wide range of scientific efforts.
The last example we'll discuss
relates to the use of an accelerator model.
Accelerators typically provide
both funding and guidance
to help translate science
into concrete drug discovery programs
or even stand-alone businesses.
In this example, Harvard professor Matthew Shair
worked with a Harvard biomedical accelerator
to advance his kinase inhibitors
for the treatment of acute myeloid leukemia
to a more advanced stage of pre-clinical development
and typically possible, an academic setting.
With this more advanced program and dataset,
Harvard team was able to attract
the interest of Merck
who agreed to provide significant financial compensation
for licensing the program
including a $20 million payment
in the form of an upfront and royalties.
Now in Merck's hands, hopefully this program
will rapidly move towards the clinical testing
to enable benefit of patients.
Now let's talk about how the partnering process works.
It's first important to understand
who the players of the deal process are.
With regards to the scientist in the academic side,
the key scientific stakeholders
are the primary investigator,
and often they're postdocs, grad students and staff.
While the PI typically takes the lead role
at negotiating partnerships
and guiding the scientific strategy,
their lab members frequently play a key part
in drafting the research plans
and of course executing the collaborative research
once an agreement is in place.
On a company side, the type and role of scientist
participating in the partnering discussions
vary company by company
but they can typically be divided into two groups,
scientific scouts and internal R&D scientists.
The primary role of scientific scouts
is to identify breaking science
or drug discovery efforts
that their company could help advance
into marketed therapies.
These individuals will often be the first
to reach out to a PI
or who a tech transfer office will contact
to make company aware of an opportunity.
Internal R&D scientists are typically people
who actually run drug discovery efforts in a company
and they will often also be
part of the partnering discussions
once the scientific scout has done some initial assessment
of the academic team's proposal.
The internal R&D scientists
also play a key role in drafting the research plan
and executing parts of the collaborative research
once a partnership is in place.
With regards to the business aspects of negotiation,
on the academic side the tech transfer
development office professionals
or strategic alliance group typically will play a key role.
On the company side, the scientific scouts
or business development professionals
will lead business aspect of the partnering process.
Finally, both the company and academic institution
will have transactional and IP attorneys
involved to assess the post-partnership
from a legal perspective
and lead the development of partnership agreement.
Next, let's review the typical high level steps
in putting an academic industry partnership in place.
Typically, the genesis of the process
is the interest of a PI in seeking an industry partner
to help fund and/or advance
a therapeutically relevant finding
or drug discovery effort into a medicine.
Or a company's interest in the expertise
or capabilities of primary investigator
to help advance one their drug discovery efforts.
The next critical step is making contact
with potential academic or industry partner.
Historically this was a surprisingly
and unfortunately challenging step.
However, with the growing sophistication
of tech transfer offices
and the proliferation of scientific scouting teams,
this process is finding interested potential partners
has become less challenging
and is still far from efficient.
The next step in a company's partnering process
is for the scientific scout to evaluate
the academic group's proposal for strategic fit.
As we discussed previously,
this assessment will include if the proposal
fits with the company's area of focus,
therapeutic modality, et cetera,
as well as the company's risk tolerance
and business model and other elements company strategy.
If there is a good strategic fit
and the science seems to be sound at a high level
the next step would be for the academic
and company scientist
to have in depth scientific discussions.
Initially these would be non-confidential discussions,
in other words discussions and information exchange
not governed by confidentiality agreements.
If there is mutual interest in pursuing discussions
at a greater level of depth,
often confidentiality agreements
are put into place to ensure information exchange
by each of the groups are not shared by third parties
and is only used for the purposes
of advancing potential partnership.
The next key step is developing
a clear and thorough research plan
with the well-defined decision points
built on aligned and well-articulated project goals.
This is a critically important step
and one that is well-worth
investing time and effort doing well.
Once a research plan is in place,
the potential partners can start discussing business terms
in developing a contract to govern the collaboration.
Some of the business and legal discussions
can occur in parallel with the research plan development
but the research plan plays a critical role
in defining the business terms
and often even the structure of the contract.
It is important to note,
the contract should include
clear alliance management plan
describing the decision making bodies
and process for the collaboration.
Finally, once a contract is in place,
collaborative research can finally begin.
Note that the timing this process takes
can vary quite a bit
based on the complexity and the scope of the project
that often can take six months of more
between initial contact to having a contract in place.
The decision making process
for approving a collaboration on the company side
can vary quite a bit from company to company.
However, the complexity and process
and seniority of the approvers
typically increases as a function of the overall budget
financial terms to collaboration.
It is important that you ask
company team that you are working with
to describe their company's approval process
including key decision points and timelines early on.
They should be happy to provide this for you.
Next, let's review a few key
success factors for collaborations.
As I mentioned before, it's critical that before embarking
on a collaborative research effort
that there's a clear alignment on project goals,
a well-defined research plan,
a clearly articulated alliance management plan in place.
This may seem like a set of
cumbersome administrative tasks
as you are itching to get started in your project ASAP,
however, these elements will help ensure
that the years of work to come
will have the best chance of meeting both partner's goals
and ultimately impacting human health.
The other key success factor
is regular and clear communication
both during a process of establishing the partnership
and as research is being conducted.
The more regularly both parties are in touch,
the more likely you are to stay aligned
and can efficiently course correct as needed.
The consequences of not pursuing these key success factors
should be fairly clear.
A collaboration by its nature
is not an independent activity.
You are acting part of the team
and the team that involves two different organizations
typically in two or more places.
Thus misalignment is a natural outcome
without the appropriate tools in place
to ensure that you are working together
towards a common goal
and that you keep doing so
through the life of the collaboration.
Finally, I'd like to mention a few items
that may make garnering biopharma interest challenging.
The first is an unwillingness to discuss
a potential opportunity
on a non-confidential basis at a high level.
Confidentiality agreement represents
this very serious obligation
and a company needs to be sure
that there is at least a high level strategic fit
and no conflict with internal programs
before agreeing to put such an agreement in place.
The second is lack of enthusiasm
for collaborative dialog or approach.
A collaboration is different from a grant.
In the context of a collaboration,
the company is not interested
in just funding a PI's research and staying at arms length.
The company wants to work together with the academic team
to advance or support drug discovery efforts as a team.
Another frequent challenge
to go from initial discussion to partner and collaboration,
put a partner and collaboration in place
is the unwillingness to focus.
While a particular avenue of research
may have many possible directions to pursue,
companies need to define focused efforts
to efficiently evaluate the therapeutic approaches.
Again, there is always room for flexibility
to evolve research plans.
A few companies have the appetite
to pursue open-ended research without clear deliverables.
A few additional topics
that we didn't have an opportunity to cover in depth
include intellectual property,
contracts and alliance management.
Many of these topics may be highlighted
in the podcast strategy for scientists.
Please check it out.
Now that we've concluded this lesson,
hopefully you should now be able to define
industry seeks to achieve
when partnering with an academic lab.
Common industry-academic partnering approaches.
Understanding how the partnering process works
and highlighting a few best practices
for industry-academic collaborations.
Thank you for watching.