Carolyn Hustad, PhD, Merck & Co., Inc., Kenilworth, NJ
In the last five years, an increasing number of pharmaceutical and biotech companies have joined forces to develop and commercialize new compounds or drug combinations rather than go it alone. This trend is especially apparent in oncology and often involves a smaller biotech company partnering with a large pharma company to co-develop novel product combinations. These collaboration agreements allow both companies to pool resources and potentially get new drugs to market more quickly, which is a good outcome for patients.
These collaborations can be challenging on many levels. Since the processes, structures, and even the cultures of the two entities may differ in significant ways, many decisions need to be made along the drug development continuum about whose processes to follow or if a new process will be established specifically for the partnership. Some of these are decided during the initial negotiations between the two partners and specified in the partnership agreement, including those related to the publication of data resulting from the collaboration. The more detailed, area-level processes (eg, medical publications) are usually discussed by workstreams of subject-matter experts for that area, which are set up after the licensing agreement is finalized. The recommended processes to be followed typically are approved by a partnership executive committee.
Managing publications under a licensing agreement can be challenging for the publication professional. Decisions have to be made about which roles from each company will be on the joint publication team, as well as who needs to review joint publications and what the review timelines will be. Publication development processes need to be compared and harmonized if they are different. Who controls the publication budget and who needs to approve how the budget is spent need to be determined. All of these decisions then need to be documented, usually in a publication charter. Here are some best practices from company experience that can minimize potential misunderstandings that lead to delays and “churn.” Advanced planning is the key to success.
Collaboration Publication Best Practices:
- Try to get involved before the licensing agreement is signed to be sure the included publication language makes sense and follows good publication practices. This means finding out who on the clinical team is involved in the contract negotiation process or determining who the business development lead or alliance management lead is so you can ask to see the publication language and suggest changes if needed. The agreement may include how costs are to be shared for the partnership (eg, 50:50, 60:40), which will impact the publication budget.
- If the partner is an Academic Research Organization (ARO), the contract should also stipulate that a publication manager be assigned or hired to manage publications developed by the academic partner; failure to include this will result in many, many delays and missed timelines! Determine whether or how the budget for an academic publication manager will be shared between the sponsor and the ARO.
- For AROs, define the role of the company-sponsor publication manager on the executive committee and the subsequent publication committee. The best case is for the sponsor publication manager to be an ad hoc member of the executive committee and co-lead the publication committee with the academic publication manager.
- Review data ownership and data transparency rules in the contract. Larger companies will likely have policies and processes in place for data sharing, but smaller companies may not. Even if both companies have policies, they may differ significantly, so a decision needs to be made about what process to follow for the partnership.
- Meet with the publication manager/point of contact at the partner to discuss publication development processes for each company and identify differences that need to be addressed. If the processes differ, a suggestion is to pick the simplest that is compliant with authorship and good publication practice guidelines. This can be more difficult if one partner or both partners is under a corporate integrity agreement (CIA); in that case, the process will likely need to follow that defined by the CIA or by the most stringent CIA if each company has one. Although it is challenging to try to anticipate every issue that may come up during publication development under the partnership, the more time you spend upfront discussing potential problems and documenting an agreed-upon resolution or determining an escalation process to resolve future disagreements, the less time you will lose later when there is clinical trial data to be communicated.
- Form a joint publication team and develop a publication charter. A typical charter should contain the elements shown in Table 1 below. It should also document any other decisions made during the comparison of the publication development processes of both partners. This charter should then be discussed with the joint publication team, so all are aware of the practices and processes to be followed.
Table 1: Suggested Elements in a Partnership Publication Charter
- Scope of the joint publication team
- Functional roles from each company represented on the joint publication team
- How often the joint publication team will meet for status updates/discussions
- Process for joint publication planning
- What publication development process to follow
- Authorship guidelines for joint publications
- Review process and approval for joint publications
- How data will be shared between the partners
- Decisions about data transparency and data sharing for joint clinical trials
- Define how to work with medical communication agency partners for joint publications. Determine if both companies will use the same agency for publications or if each will use their own. If working with different agencies, predefine roles and responsibilities for each. If using one agency, determine how the budget will be shared/divided between the partners.
- Develop a joint publication plan. This includes determining which publications will be led by each partner. For example, if one partner ran the Phase 1 and Phase 2 trials before the collaboration agreement was finalized, and the second partner will run the Phase 3 trials, the first partner will likely take the lead on publishing the results from the early trials, and the second partner will lead those from the Phase 3 program. All publications will be part of the joint publication plan, which should include target dates and venues for the data release. The plan should be revisited at the regular status meetings, as defined in the publication charter.
- Determine publication development timelines and a harmonized publication review standard process. Define who from each partner company will review publications and when the review will occur in the development process. Determine who from each company needs to approve the publication before release, including which company patent attorney. Review timelines should be shorter for abstracts and congress presentations, but sometimes the partnership agreement stipulates the same timelines for all publications, which is why you should be involved before the final contract is signed (see number 1 above).
- Determine if the partner has permission to share congress presentations developed by the other partner after the congress and if partner congress presentation information can be included in any congress compendium. Sometimes partners want all requests for joint publications developed by them to be routed through their own medical information group. Some partners do not want joint publications included in a congress compendium that also lists congress presentations that are out of scope for the partnership, but they may agree to a separate compendium of joint publications.
- Define rules for use of partner-led publications by medical information when creating standard responses and other documents. Determine who needs to obtain the appropriate permissions for use.
These best practices can be used for any type of collaboration, be it two large pharma companies, pharma-biotech, pharma-ARO, or any combination thereof. The most important element for a successful collaboration is communication. Regular status meetings between the publication managers of each partner will help prevent surprises during joint publication team meetings and hopefully forge a good working relationship. Incorporation of these best practices into the planning and execution of publication plans in your next collaboration should help to make the experience go more smoothly.