Ocera Therapeutics                                                

Dear Sir or Madam,

It is my pleasure to provide a reference for Kate Hanham, Ph.D. of Mentara, a drug development and clinical research consulting company.

Dr Hanham functioned as Clinical and Regulatory Team Leader for Ocera Therapeutics, a semi-virtual drug development company founded in 2005 by Dr. Eckard Weber and myself that licensed a clinical stage compound for the treatment of Crohn’s disease from Japan.  I have worked very closely with Dr. Hanham who played the role of a Chief Medical Officer and Head of Regulatory Affairs since September 2005.

Dr Hanham and her team established a sound clinical and regulatory strategy in a matter or weeks and built the infrastructure and clinical operations logistics required to initiate and support our first pivotal clinical trial in North America and Europe.

Dr Hanham worked tirelessly to achieve a number of critical milestones in record time for Ocera Therapeutics:

• Conducted a successful pre-IND meeting with the FDA
• Selected and managed our CRO
• Filed an IND (US) and CTA (Europe and Canada)
• Designed and developed pivotal clinical trial protocol
• Chaired two phase 3 investigator meetings (North America and Europe)
• Interacted with opinion leaders
• Initiated the first pivotal trial
• Led CMC, Manufacturing and related Regulatory strategy

I have worked - and traveled - extensively with Dr Hanham in the past months and am constantly impressed by her level of knowledge, industry experience, intelligence, professionalism and ability to grasp complex issues and resolve them in an effective and collaborative manner in multi-cultural environments.

Dr. Hanham is equally able to take charge and lead an entire project as she is able to participate on an ad hoc basis with both external partners and new team members, making her and Mentara an ideal partner to support a rapidly growing drug development company like Ocera Therapeutics. Working with Kate is truly a pleasure as she always delivers a high quality product, on time, with utmost professionalism.

I highly recommend Dr. Hanham and her team at Mentara and look forward to working with her on this, and many successful projects in the future.

Sincerely,

Laurent Fischer, MD

President and Chief Executive Officer,

Ocera Therapeutics, Inc

April 3, 2006

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Roche Pharmaceuticals

Dear Sir or Madam,

It is my pleasure to provide a reference for Kate Hanham, Ph.D. of Hanham Consulting, Inc.

I worked closely with Dr. Hanham from November 1999 to March 2001 on a gene therapy project. This project involved Roche and two external partners, a gene therapy start up company and a vector manufacturing company and, thus, was complex from both intellectual and practical aspects. I was the global team leader and Dr. Hanham was a consultant to the team for the two, separate, but related, areas of CMC and clinical operations. In those 18 months I saw Dr. Hanham in action leading and minuting regularly scheduled CMC meetings, co-chairing a successful Phase 2 investigator meeting and dealing on an ad hoc basis with both external partners to bring manufacturing in line with team timelines and FDA requirements. I learned from these specific examples, from numerous one-on-one discussions and many face-to-face meetings with all the involved parties that Dr. Hanham brings the following attributes and attitudes with her at all times:

• Intelligence
• Knowledge
• Energy
• A drive to seek, and ability to achieve, win-win solutions
• Fair play and
• Integrity

Best regards,
Ann L. Goldstein, Ph.D.
Global Deputy Head and Director of
Exploratory Pharma Development
Roche Pharmaceuticals

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AGY Therapeutics

Dear Sir or Madam,

It is my privilege to unequivocally recommend the services of Hanham Consulting. During the final three quarters of 1999 Dr. Hanham and her team were able to professionally manage the transition of an entire clinical development program between two major pharmaceutical companies. Their ability to work with very diverse groups while meeting deadlines was truly impressive. When Dr. Hanham and her team arrived on site they were given a directive that required them to work virtually non-stop for months so an important transaction could be closed on time. Not only did the Hanham team meet every deadline, they did so without compromise. In the final analysis the both companies realized an FDA compliant clinical package and excellent systems never before established in the company.

In my twenty plus years in the Biopharmaceutical industry I have seen many consultants who sell their services based on hype. Usually one ends up with a poorly constructed patch to a complex problem. Kate Hanham has the personal and professional integrity to market a broad range of expertise. Not only does Hanham Consulting deliver on their promise they provide in-depth and lasting solutions to complex problems. Working with Kate and her team was a highlight of my professional career.

Philip J. Young
President and COO
AGY Therapeutics

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Roche Products, Ltd.

Testimonial for Hanham Consulting

In my role as project manager at Roche I am responsible for the global development of a novel drug for the treatment and prophylactic therapy of influenza. During the planning phase of the development program, which was being fast tracked with many clinical trials and other scientific investigations being conducted in parallel, it became evident that we required an additional resource with expertise in laboratory logistics.

I became aware of Hanham Consulting through various Pharmaceutical contacts, and invited Kate Hanham to consult to, and become an integral part of our global project team in March 1998. Since that time, Kate and her consulting team have worked within our project team, providing an interface between the clinical study management teams, and the external global safety laboratory, as well as the individual commercial and academic laboratories providing virological and serological analyses and courier companies.

Kate Hanham and her team have provided strategic consulting services to the planning of the logistics of all laboratory specimens collected (from some 5000 patients), and their transport, analysis, tracking, storage and reporting onto the Roche database. This has included specimens for biochemistry, hematology, virology serology and resistance testing. Hanham Consulting was responsible for the management of the implementation of the agreed strategy. In addition, Hanham Consulting assisted each laboratory used, to develop specific SOPs, to ensure consistency of processes and data across the program.

Hanham Consulting has provided these services to Roche across the global development program, working on up to six multicentre studies with approximately 1000 investigator sites simultaneously, in both the Northern hemisphere (USA, Canada, and many European countries) as well as the Southern hemisphere (Argentina, Chile, Brazil, South Africa, Hong Kong, Australia and New Zealand).

Hanham Consulting have consistently managed the logistics of all laboratory specimens and facilitated the successful outcome of the clinical trials, completed within the planned timelines and to high quality standards. A particular characteristic of Hanham Consulting is their flexibility in meeting the challenges presented , and changes in priorities, under tight timelines, whilst maintaining their high quality of work.

I would have no hesitation in retaining the services of Hanham Consultancy on any future project that I am involved with, or recommending their services to any other project team.

Renata Crome
Project Account Leader
Roche Products Ltd.

July 28th 1999

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VRL: An ESOTERIX Company

In 1996, VRL was a small Infectious Disease testing laboratory serving the clinical diagnostic needs of hospitals located in the Southwestern United States. It became painfully obvious that we had been so narrowly focused on that single niche market that we were missing many chances to capitalize on valuable opportunities existing in the Biopharmaceutical industry. After a year of frustrating internal attempts to adapt our core operations toward becoming a GLP compliant structure, I found Hanham Consulting.

Kate Hanham and her staff quickly and efficiently assessed our progress, developed a fast track plan, structured workable a time tables, assisted in physical plant redesign, created tracking systems, wrote protocols, taught our staff how to write procedures and how to operate within GLP guidelines. Within six months, we passed three sponsor audits for GLP compliance and began three lucrative Biopharmaceutical studies. We continue to use Hanham Consulting to monitor and constantly improve our systems. Hanham Consulting has also become our first choice to meet our external audit requirements.

Many times in my business life, I have hired consultants with excellent skills and knowledge who fail to generate enough progress to justify their fees. I have discovered a difference using Hanham Consulting. Their vision helped create a revolutionary change at VRL. They raised our level of service while increasing our bottom line profitability. Hanham Consulting continues to be a major contributor to VRL's refocus, growth and success.

I sincerely recommend Hanham Consulting as an affordable and knowledgeable partner.

Sincerely,

J.Dean Barry
President & CEO
VRL, Inc. an Esoterix Company

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