consulting services

 
 
 
 
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CLinical trial design & execution

Sheng Consulting provides end-to-end management of the clinical development process, beginning with careful design of individual trials and overarching clinical programs up to and including trial conduct.

Dr. Sloan has designed, implemented, and managed more than 50 early- and late-stage clinical trials and worked on more than 10 full development programs. Among his successes:

  • Dr. Sloan conceived of and designed the initial trial of apremilast (Otezla®) in oral ulcers associated with Behçet disease for Celgene, which led in 2019 to the first approval of any product for this indication in the US.

  • Dr. Sloan was instrumental in guiding certolizumab pegol (Cimzia®) to the first US approval for any product for non-radiographic axial spondyloarthritis (nr-axSpA).

  • As Vice President for Inflammation and Immunology at Celgene, Dr. Sloan led a team that designed and implemented 7 Phase 2 and 3 trials in psoriatic arthritis, psoriasis, and rheumatoid arthritis in only 6 months.

  • Dr. Sloan championed and directed the proactive withdrawal of the pediatric indication for Tussionex®, resulting in an invited presentation at an FDA Advisory Committee, which he gave on behalf of UCB.

  • Sheng Consulting is working with a global Top 10 pharmaceutical company to develop Phase 3b/4 trial designs in inflammation.

 
 
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regulatory filings

Sheng Consulting provides strategic guidance and active management to prepare filings for submission to regulatory authorities, including the US FDA, the EMA, Health Canada, and the NMPA in China.

Dr. Sloan has been deeply involved with several successful filings including:

  • Lumiracoxib (Prexige®) for osteoarthritis and rheumatoid arthritis.

  • Certolizumab pegol (Cimzia®) for rheumatoid arthritis.

  • Certolizumab pegol (Cimzia®) for non-radiographic axial spondyloarthritis (nr-axSpA).

  • In addition, Sheng Consulting is working with a major biotech to complete a post-marketing requirement. Dr. Sloan proposed a significant change in regulatory strategy that was approved by FDA and will lead to significant shortening of timelines and millions in cost savings.

 
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Advisory committee preparation & Execution

Sheng Consulting provides comprehensive strategy to prepare for a strong representation of the clinical profile and datasets for compounds under FDA review. In addition to in-depth involvement in the preparation of the strategy, including selection of mock advisors and external speakers, Dr. Sloan served as the lead spokesperson for UCB’s groundbreaking 2013 advisory committee for Cimzia in nr-axSpA.

 
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ALLIANCE MANAGEMENT

With Dr. Sloan’s significant experience in joint ventures as a member of several joint development teams, Sheng Consulting can help establish productive relationships between stakeholders and partners.

 
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benefit-risk evaluation / safety management

Sheng Consulting provides guidance on both clinical and strategic assessments on products across the portfolio.

At UCB, Dr. Sloan was the immunology expert on the Benefit-Risk Board, which evaluated the benefit:risk ratio of every UCB product on a regular basis. Examples of his leadership include:

  • Withdrawal of the rheumatoid arthritis indication for D-penicillamine due to the advent of newer treatments with more favorable benefit:risk ratios.

  • Championing and leading UCB’s proactive withdrawal of the pediatric cough indication for Tussionex®, resulting in an invited presentation on behalf of UCB by Dr. Sloan at an FDA advisory committee.   

For more than 10 years, Dr. Sloan has been involved in OMERACT. His accomplishments include:

  • Developing and co-leading a training program for new OMERACT attendees.

  • Co-authoring Rheumatology Common Toxicity Criteria (RCTC), used by multiple sponsors to assess safety in rheumatology clinical trials.

  • In 2019, Dr. Sloan led an effort to update the RCTC to better reflect recent science and trial results.

 
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ADDITIONAL SERVICES

  • Sheng Consulting is working with a preclinical stage biotech on strategy for pivoting lead asset to potential clinical trials for coronavirus.

  • Dr. Sloan worked with a global CRO to prepare bid defense for an inflammatory arthritis program.