Tuesday, April 1, 2014

#PCTUS: Growing Pains: Outsourcing for Mid-sized Pharma

Today at Partnerships, we have a post from guest blogger Paul Ivsin VP, Consulting Director at CAHG Clinical Trials. He specializes in study enrollment strategies and patient engagement. He writes on clinical trial issues at companion blogs Placebo Lead-In and Placebo Control.

The morning sessions for Partnerships “Strategies for Small to Midsized Pharma and Biotech” track covered three different areas: vendor ID and selection, full-service outsourcing, and site contracting. However, they had a clear unifying theme: standardization and alignment.

This makes sense for midsized companies (and those who aspire to be midsized). Small biotechs can live with a level of chaos is some processes – what they lose in efficiency, they usually more than make up for in nimbleness and flexibility. However, as they grow, the costs of continuously reinventing the wheel start to get prohibitive.

1. Mallinckrodt Pharmaceuticals’ Approach to Vendor ID & Selection: Choosing a Team Rather than a Company
The first presentation, by Bernadette Donohue and Varry Henderson from Mallinckrodt, was a veritable treasure trove of standardization best practices. Donohue started by focusing on the financial health of prospective vendors, and suggested a combination of very specific metrics to look for (book-to-bill ratio and operating income to expense ratio), both as stand-alone indicators of health and as signs of general trends (for example, a company with steady income but mysteriously declining expenses may be looking to make itself more attractive as an acquisition target). She also suggested a thorough review of accessible data from Dunn & Bradstreet reports and SEC filings.

Varry followed by stressing the importance of detailed, well-structured RFP – with the added recommendation of requiring a standardized response from all vendors. Varry also strongly urged sponsors to “not skimp on the bid defense”, allowing a full 3 hours to go through all aspects of the proposed scope of work.

2. Evaluation & Lessons Learned from Year One of Astellas’ Full Sourcing Outsourcing Model for Phase 1 Clinical Trials
The second presentation was jointly given by Astellas’s Edwina Wyatt-Knowles and Rachel Garrido from Parexel, and presented a recap of the first year of their companies’ strategic partnership. Wyatt-Knowles opened by noting that the partnership created its own individual brand (APPEX, short for “Astellas + Parexel Pursuing Excellence”). The intent of the name was to reduce distinctions between the two companies so that all employees felt equally vested in, and responsible for, delivery. She also spoke about the need for clearly defined roles and responsibilities within the team as a key to getting everyone aligned.

Garrido covered the key lessons learned during the first year, which seemed very emblematic of a growing collaboration:

  • ◊ Agree on norms
  • ◊ Create a clear governance structure
  • ◊ Invest in relationship management
  • ◊ Identify relationship inefficiencies
  • ◊ Measure performance

Garrido also emphasized that the metrics collected were not “vendor” metrics, but rather were selected to reflect on the performance of the entire aligned team

Transformation of a Fragmented Site Contract Process into Multi-Partner Collaboration

The third presentation, by UCB’s James Kime and Constance Hopkins, was perhaps the most archtypical of a successful transition from small and chaotic to mid-sized and efficient. Through mergers and growth, UCB found itself with 14 different CROs managing a thousand site contracts, with minimal standardization in how those contracts were written, reviewed, or managed.

The most interesting point of the morning came up when Kime noted that his team initially tried to use a Functional Service Provider (FSP) to handle all contracts on an outsourced basis. However, the team quickly realized that the existing processes were simply too chaotic: successful outsourcing would require a level of organization they hadn’t yet achieved (that’s a remarkable admission, I think, as most sponsors would likely push even harder to outsource a dysfunctional system, so kudos to the UCB team for realizing the only smart move was to build up their internal capabilities).

Hopkins did note that there are still ongoing challenges inherent in their process, including

  • ◊ Turnover at the CRO and sites
  • ◊ Implementation of a Fair Market Value system (especially training sites on how it worked)
  • ◊ Ongoing regulatory change (such as the Sunshine Act)
  • ◊ Increasingly complicated protocols that necessitate custom contracts

However, she noted that even with these challenges, key cycle time metrics had significantly improve (e.g., time to signature was reduced by 36%).

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