Pharma Expansions, Mergers and Acquisitions - Clinical Operations - De-centralization vs. Centralization

Recently and due to expansions, mergers and acquisitions, I was approached by pharma to assess and develop and implement a more centralized clinical operations function. With a pipeline of promising new products and rapid growth, the pharma's clinical operations organization expanded considerably and rapidly, becoming fragmented. This fragmentation generated operational inefficiencies and lethargic performance due to several business models existing under the same roof, serious communication issues, a loss of focused leadership, a de-centralized team, duplication of resources, capacity, responsibilities and accountabilities. Certainly, in addition, lost timelines, target dates and quality were sacrificed in the expansion.

This is now a common issue throughout the pharma industry with current expansions, mergers and acquisitions. The assessment required the development and implementation of a new internal and external re-structure, plan and operational process moving forward. The new structure included a good deal of re-work pertaining to, but not limited to, internal and external functions, outsourced resources, leadership, management and strategic planning.

As the pharma company prepared for its first clinical and regulatory submission to FDA, EMEA, and product launch, there was a great need to identify, process and communication bottlenecks and determine which of its functions required the most improvement in a limited time. Short term, long term objectives. Gaps and stumbling blocks in the pharma company's processes were identified and worked through to improve the pharma company's clinical trials operations, performance and quality, good clinical practice. In-depth assessments, process and quality forensics, data and documentation audits focused on short and long term objectives, outlining the best practices. Opportunities for improvement were assessed and implemented. The implementation plan was agreed upon by all functions, all teams, all CROs, inhouse and outsourced, external. An implementation guide was developed for the pharma and was critical to the execution of the prioritized recommendations. Bridging the gap between corporate leaders and operational staff, team and functions was the main key to improvement. Re-build and revise, budgets, processes, standards of operations, plans, optimize alliances, internal and outsources and maximize efficiency and leadership. Key short term objectives.

• Optimize focus groups of operational staff, CRAs, CTMs to solve operational problems as they arise.
• Provide a no consequences feedback mechanism from operational staff to corporate leadership thereby opening communication.
• Perform a where, when, who and why responsibility trail and train to clarify roles and decision makers.

Phase 4 Clinical Research - Increasing Importance to "Buyers"

Phase 4 clinical research data provides key groups and decision makers with important information pertaining to the safety and efficacy of a drug once approved by FDA. Data and documentation must find its way to physicians, insurance providers, buyers, opinion leaders, pharma sales force and of course FDA, for purposes of review, promotion, education, prescribing, retail, regulatory rigor, patient safety.

Phase 4 clinical research has increasing importance for distributors when helping consumers understand product labels, PDR, package inserts, product brochures. With increasing consumer demand for drugs, natural products, and otherwise, there is more need for research and in-store nutrition knowledge within the retail sector. Sales, marketeers and retailers must be well informed about the products they distribute and sell. Retailers have an important role in explaining nutrition product labels to consumers. This presents opportunity for natural product suppliers to utilize clinical research, in conjunction with market and outcomes research to train and educate their distributors using their product's clinical trial data and documentation.

Opportunities such a advertising displays, promotional items, leaflets, brochures, manuals, pamphlets, videos, infomercials, and otherwise must be used by distributors so they can market to their consumers. Phase 4 clinical data and documentation must be quality controlled and collected with regulatory rigor and good clinical practice. All promotional information whatever form of media used to educate, disseminate and/or train, must also be quality-reviewed and quality-controlled. Phase 4 clinical research must be transcribed, translated, presented and summarized with quality control, consistency, version control, precision, clarity, consistency of claim, statement, storyline and accuracy. Engage experts in quality. Engage gate-keepers who ensure version control of didactic, Phase 4 clinical research, promotional materials, data and documentation worldwide.

The Importance of the Sales Team - The Importance of Quality and Communicated Phase 4 Clinical Research

Key target groups must be involved with drug safety and efficacy throughout the life cycle of the drug once approved by FDA. Key groups are physicians, providers, opinion leaders, sales, buyers and FDA. Sales Team - Although not a target group, the sales force must nonetheless be a priority for any pharma engaging in direct to physician sales. The sales team acts as the spokesperson between the pharma/product and the physicians. Pharma must proactively and continuously keep members of the sales force educated on the benefits (and risks) of the product. The degree of success of the pharma sales team directly influences the revenue, ROI, generated for the pharma and the longevity of the brand in the market.

Sales and marketing groups must be proactively informed with consistent, up to date, quality-controlled, clinical trial data and documentation. Global ongoing Phase 4 clinical trials generate global data and documentation. The data and documentation must be organized and managed by experts who serve as gate-keepers for data and documentation version control. Gate-keepers, who are quality control experts in compliance, quality and regulation, ensure quality review and presentation of accurate and adequate, safety and efficacy data and documentation and must interact with marketeers worldwide. Phase 4 clinical research is of course, worldwide.

Remember, every communication to the physician, the patient, the key groups...abstract, newsletter, data, database, clinical protocol, Phase 4 clinical submission, CSR, CTR, expedited safety report, periodic safety update report, annual report, safety narratives and otherwise must be in compliance with regulatory rigor and FDA, Code of Federal Register (CFR) and must be consistent in data, storyline, presentation, statement, claim, product label, previously submitted clinical submission dossiers and must demonstrate clinical, therapeutic application and statistical significance, worldwide. Monitor the clinical trials, monitor the monitors, monitor the quality of the data, review all source documents, follow good clinical practice. Engage experts.

Phase 4 Clinical Research - The Role of Key Opinion Leaders

Phase 4 Clinical research data provides current information pertaining to an FDA approved drug in the marketplace and in a real life setting. The drug, once approved by FDA, must be monitored with rigor for safety and efficacy by pharma throughout the life cycle of the drug product. Pharma especially, must closely monitor and adhere to safety surveillance and risk marketing plans agreed to with FDA before granting approval to market. In earlier posts, we spoke of the contribution of physicians and health care providers and their role in the dissemination of clinical research data and documentation to key target groups. Key Opinion Leaders, another target group, as well, have a unique position in the dissemination of clinical data and documentation to interested parties.

Effectively marketed clinical data to Key Opinion Leaders (KOLs) is a critical huge factor in gaining full product support in the marketing arena. KOLs are expert physicians who have influence over medical practice. KOLs are sought out groups of experts who set the pace for industry trends. KOLs will share a wealth of information and insight ranging from clinical science to advertising concepts and provide highly credible exposure for a product in the medical community through speaking engagements, published articles in medical journals and general practice. Engage KOLs in market research and medical symposiums. Engage KOLs with the latest clinical research early and throughout the product's life cycle. Engaging KOLs early in marketing practice and plans will ensure pharma with an invaluable feedback and insight throughout the life of the product and thus increased marketing exposure in clinical practice. KOLs are essential to quality. KOLs are essential to ROI.

Responsibility to Disseminate Clinical Research and Educate Key Target Groups

Clinical research data from Clinical Trial Phases 1, 2, 3 and 4 provides the most up to date scientific objectives and prescribing information for an approved drug. Pharma must educate all key groups who have a vested interest in the well being of the patient throughout the life cycle of the drug. Dissemination of information to at least the following primary constituents is a must.

• Health Care Physicians
• Health Care Provider's - A provider's responsibility is to provide health care that is effective, affordable and satisfactory to as many people/patients as possible. When new products have entered the market, health care providers are primarily concerned with clinical research that demonstrates information pertaining to patient tolerability, safety and effectiveness. Clinical trial research is paramount for adequate development of "friendly and patient focused" health plans. In today's medical culture where the paradigm has shifted from the physician to the patient, health care plan companies see the need to become more patient-oriented. This presents huge opportunities for pharma companies to work with in-house and external clinical researchers and spearhead additional types of clinical research.
• Buyers, Consumers, Distributors
• Key Opinion Leaders
• Sales and Marketing
• FDA.

Responsibility to Disseminate Clinical Research and Educate Key Target Groups

Questions often asked - Can clinical research be used to disseminate and educate key target groups? Who is responsible for the dissemination of product information once the drug is approved by FDA? The answers are yes and the responsibility of pharma primarily as per post-marketing commitment plans with FDA, respectively.

It is the responsibility of pharma to continue to investigate, elucidate and clarify safety and efficacy benefits and risks for the life cycle of the drug once approved by FDA. Clinical research provides the most up to date scientific intelligence pertaining to drug mechanism of action, safety, tolerability and effectiveness. Clinical research assists key target groups and decision-makers, physicians, health care agencies, health care providers, health care payers, patients, buyers, M&A, key and expert opinion leaders, shareholders, stockholders, sales and marketing, FDA and regulatory agencies worldwide and otherwise to make clinically and meaningful decisions.

It is essential for the pharma industry to educate and disseminate, well monitored, well audited, integrated, summarized quality data and documentation to relevant and appropriate communities and interested parties.

• Physicians - It is ideal, especially for pharma companies that health care professionals base their prescribing decisions on supporting evidence provided by quality clinical submission, regulatory approved data, statements and documentation. Prescribing code reinforces that professional exchanges with the medical community are designed to benefit patients and medical practice. The more robust the clinical evidence, data and documentation, the better the case for that drug to be prescribed. Now more than ever, during the post approval period and life cycle of the drug, there is, as well, a good opportunity to more define the product's ROI - return on investment, with continued clinical research.

More to come...

• Health Care
• Health Care Payers
• Key Opinion Leaders
• Sales and Marketing
• Buyers, Patients, Distributors, Consumers
• FDA.