What are the various internal organization structures for pharmaceutical / biotechnology companies in regards to companion diagnostics / precision medicine?

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What are the various internal organization structures for pharmaceutical / biotechnology companies in regards to companion diagnostics / precision medicine?

The organizational structures of the departments associated with companion diagnostics and precision medicine vary across the top pharmaceutical and biotech companies. However, most of them appear to fall within the research and development division of the company with further segmentation by business line (oncology, pharmacology, neuroscience, early stage development, etc.).


METHODOLOGY
I began by searching for existing data on the organizational structures of companion diagnostics or precision medicine departments within pharmaceutical or biotech industry.

Finding no such preexisting data, I searched for noted positions within the relevant departments at top pharmaceutical and biotech companies, using job posting sources such as Indeed and Glassdoor, as well as company job postings. I then looked for information on who these roles report to within the organization, in an attempt to build an organizational chart.

Within the scope of a single Wonder request, I was able to evaluate four specific companies to provide an overview of their organizational structures within relevant departments.


CELGENE
A job posting for a Director, Precision Medicine and Companion Diagnostics at Celgene suggests that this role functions within the Translational Development area of the Research and Early Development department.

Therefore, I visited the Celgene career website to search for job openings within this department. Then, I looked at each job opening to see if the job description mentioned who each role reports to, in order to build an organizational structure. Unfortunately, most postings do not list the reporting structure for the position.

I've also looked for press releases or news stories regarding leadership changes within the department. A 2016 article at BusinessWire looks at leadership changes within the Research and Early Development department, suggesting the following structure for top management:
• Tom Daniel, M.D., Chairman of Celgene Research
• Rupert Vessey, Executive VP of Research and Early Development
• Rob Hershberg, MD, PhD, Chief Scientific Officer (CSO)

Upon reviewing the job openings in Research and Early Development department, it would appear that the following areas fall within this department.

Translational Development
Translational Medicine
• Clinical Pharmacology
• Research Analytics
• Compound Management

Job titles:
Rupert Vessey is the Executive VP of Research and Early Development, having served as Senior VP, Translational Development. Before joining Celgene, he worked at Merck as Senior VP of Early Development and Discovery Sciences.

Director, Precision Medicine and Companion Diagnostics
- This job description states that the "Translational Development team is in the process of establishing a precision medicine and companion diagnostics group to support multiple disease areas of interest including Myeloma, Lymphoma, MDS/AML and other hematological malignancies."

Sr. Principal Scientist, Bioanalytical
- Relevant job responsibility: "Serve as an outsourcing liaison and technical expert for methods placed externally."
- No reporting structure is indicated.

Principal Scientist, Immune Oncology Translational Development
- Relevant job responsibility: "Work closely with corporate partners to support preclinical, translational and clinical development of cancer therapeutics."
- No reporting structure is indicated.

Senior Scientist, Downstream Process Development
- Relevant job responsibility: "Work collaboratively with external partners to manage downstream process development programs and outsourced activities."

- No reporting structure is indicated.

Manager, Clinical Pharmacology Trials
- Relevant job responsibility: "Review study budgets, contracts, and work orders."
- No reporting structure is indicated.


MERCK
Merck's organizational chart for companion diagnostics or precision medicine appears to be structured along business lines under the Early Development and Discovery Science (EDDS) and Translational Medicine departments. The Regulatory Affairs department also appears to have roles related to companion diagnostics

Rupert Vessey, who is now with Celgene as noted above, was previously the Senior Vice President of Early Development and Discovery Sciences (EDDS) at Merck. In a report on his department at Merck, there is a chart showing the business lines within which the EDDS department works, along with the names of the heads of those areas. They are:
• Mark Erion, Cardiometabolics
Darryle Schoepp, Neuroscience
• Deborah Law, Immunology, IMR, Oncology
Daria Hazuda, Infectious Diseases Vaccines
• Robert Plenge, Genetics & pharmacogenomics
• John Hunter, Pharmacology
• Chris Hill, Discovery Chemistry
• Gary Herman, Early Stage Development
Merck's Translational Medicine department was launched in 2015. An article about its launched lists job openings for scientists in cardiometabolics, neuroscience, infectious disease, and clinical pharmacology.

Searching for Merck job titles related to companion diagnostics or precision medicine, I found the following roles, by way of example:

Director, Regulatory Affairs Companion Diagnostics Lead
- also referred to as Principal Scientist/Director, this position reports to the Sr. Director, IVD/CDx.
- The role provides "regulatory leadership and input to internal teams involved with IVD/CDX development planning, including Diagnostic Development Teams, and to Joint Development Teams with diagnostic partners."

- Functions within the Oncology Business unit
- "responsible for leading and executing the Biomarker and Companion Diagnostics Medical Affairs strategy"


PFIZER
Precision medicine falls within the Research & Development area at Pfizer but crosses all business lines with a specific focus on oncology. Chris Boshoff, M.D., Ph.D., FRCP, FMedSci, serves as the Head and Senior Vice President for Immuno-Oncology, Early Development and Translational Oncology. However, a search for organizational structure or other job titles within this department proved fruitless.

In a brochure entitled, "Partnering with Pfizer Worldwide R&D," the precision medicine section notes that the company seeks to establish "alliances to develop and access":
• patient cohorts
• systems biology and pharmacology
• Breakthrough diagnostic technologies,
• In vivo imaging technologies
Biospecimen analysis
• Physiological biomarkers
iPS cell resources / technologies
Biospecimen collection and stabilization technologies
• Remote patient monitoring technologies
• Advanced computational biology platforms and approaches

It states that the "External Science & Innovation Contact" person for this area is Fan Zhang (fan.zhang8@pfizer.com).


BRISTOL-MYERS SQUIBB
At Bristol-Myers Squibb, companion diagnostics and precision medicine appear to fall within the Translational Medicine Division of Research and Development, according to several job descriptions. The Translational Medicine Organization, Biomarkers and Pharmacodiagnostics team and the Translational Sciences, Biomarkers and Precision Medicine team are noted, specifically.

Steven D. Averbuch is listed at his LinkedIn profile as the Head of Precision Medicine, R&D, but a recent conference bio lists him as "Vice President, Development, Oncology & Pharmacodiagnostics."

A sampling of job titles within the Translational Medicine division include:

- This role reports to the Head of Precision Medicine, in the Translational Medicine Division.

- While this is the same job title, this role reports to the "Head of Biomarker, Pharmacodiagnostics, and Oncology Translational Medicine."

Director, Clinical Genomics and Genetics Laboratory
- This role oversees scientists working in the Clinical Genomics and Genetics group within the Translational Medicine division.

- This role contributes to the Translational Medicine Organization, Biomarkers and Pharmacodiagnostics team.


CONCLUSION
In conclusion, while the organizational structures of companion diagnostics and precision medicine departments at the top pharmaceutical and biotech companies varies, most of them fall within the research and development division of the company and are further segmented according to business line.
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