Maximizing the Value of Your Company's First Commercial Product

Launching a company’s first life sciences commercial product can be daunting, especially from a legal, regulatory and compliance perspective.

Many key elements are in play related to planning a new product launch, as well as building a cross-functional team and infrastructure. Effective legal, regulatory and compliance practices can help to maximize the success of a biotechnology or pharmaceutical product and the company.

At the outset, stakeholders must recognize the critical importance of cross-functional teams comprised of clinical, legal, regulatory, medical affairs, marketing and managed care. These teams must be involved early in the process, as well as throughout the clinical development, pre-launch and launch stages of a product.

Transparent communications across these functional areas early and often can often facilitate decision-making, speed review and avoid delays, both before and after product launch.

During the critical Phase III clinical trials, legal and regulatory team members review protocols, informed consents and HIPAA authorizations, and help negotiate clinical study agreements to initiate the study sites on a timely basis.

A legal review of pre-clinical data and any other known side effects of the experimental drug/biologic or other drugs in the same class can help to assess the adequacy of disclosure in the informed consents. It will also help to avoid later litigation regarding the clinical trial, a recent focus of the plaintiff’s bar.

The informed consent will be read by the plaintiff’s bar with 20/20 hindsight: What did the company know, or, even more difficult, what should the company have known? Did the informed consent provide disclosure and was all material information provided to investigators and study subjects?

Phase III clinical trials and the data generated also define the patient population through inclusion and exclusion criteria and affect the positioning of the drug/biologic as a therapeutic agent. For example, is it intended as first or second line therapy? What are the types of claims that marketing and sales would most likely want to make for the product upon launch?

The clinical trials should be geared not only to obtain regulatory approval, but also to look ahead to provide substantial evidence needed to support these claims.

During the pre-launch phase, the cross-functional teams should develop an in-depth understanding of the clinical trial results and a better defined understanding of the efficacy and safety claims which the commercial team would like to make.

Knowledge of the product, the clinical trial results and the business needs enable the legal and regulatory team members to provide valuable input into the discussions with the FDA regarding the product’s approved label and the review and clearance of launch materials.

Nearing Product Launch

As the company nears product approval and launch, it should develop, implement and train personnel on policies, such as educational grants, gifts to healthcare professionals, consultants and speakers, and other issues relating to compliance with the PhRMA Code on the Interactions with Healthcare Providers. It should also develop and implement standard operating procedures for review of sales training, journal reprints and promotional materials.

The company’s legal, regulatory and compliance team members help build the infrastructure for appropriate scientific discussions in the medial community, and, later, marketing and promotional practices. Review by the cross-functional team review team comprised of medical, legal, regulatory and marketing help ensure that no marketing or promotional activities take place prior to FDA approval, and, once approved, ensure that appropriate marketing and sales practices are followed.

The launch team should review anticipated direct-to-consumer (DTC) programs and activities, and whether the company will adopt PhRMA’s Guiding Principles on Direct to Consumer Advertising.

Consider the role of television advertising and any necessary physician education prior to the launch of DTC activities. As part of developing websites for the product, a company-wide privacy policy will need to be adopted.

Consider any patient education and support programs, such as call centers, and take into account privacy and HIPAA issues.

Finally, pricing, formulary issues for managed care reimbursement and managed care contracting must be an integral part of the planning and launch process.

Protecting IP

Throughout the process, protection of intellectual property and people assets forms the foundation of building value of a product to the company.

It is no longer enough to gain patent protection for products. IP counsel plays a strategic role in protecting the company’s market from competing products and establishing IP rights to enable the company to achieve its goals. People assets – research scientists, the clinical trial team and the commercial team – gain valuable knowledge and expertise about the product and the market during its development, approval and marketing.

Don’t overlook the roles of vendors, such as clinical research organizations, agencies, your outside counsel, as well as contractors or other temporary personnel.

Legal, HR and each functional area should consider and put in place invention agreements, confidentiality agreements and noncompete agreements with the appropriate individuals and vendors to secure and protect the value of the company’s assets.

There’s a lot of groundwork to be laid for a company’s first commercial product. Thereafter, much work must be completed for any new product launch.

The various contributions of the members of a high performance cross-functional team can make the launch smoother and help make the new product/biologic a success for patients and physicians by providing an innovative treatment option. And the contributions can contribute to the success of the company by helping the company meet its objectives in build its business and reputation as a leader in its field.

Ellen V. Chiniara is associate corporate counsel at Serono, Inc., a leading biotechnology company headquartered in Geneva, Switzerland. Its North American office is located in Rockland, Mass.