It is my pleasure provide recommend Marc Andersen as a CMC consultant. CoLucid is a virtual company that relies on consultants to advise, provide plans, and solve problems at CROs so as to keep programs on track.  Over a 4 year period, Marc has represented the chemistry and manufacturing aspects of two programs, one advanced program with a Phase II compound and another preclinical discovery program. Since CoLucid has no in-house CMC capabilities, we are dependent on Marc’s expertise and leadership in this critical area. Having worked with a large number of consultants across different technical specialties, I can recommend Marc without hesitation as someone who is rigorous, thorough and passionate about the projects he represents. 

Phase II Support

Throughout a 4 year period Marc has managed the chemistry, manufacturing, analytical, and regulatory activities at CROs for CuLucid’s NCE.  Marc prepared the CMC data in CTD format to support proposed clinical studies in both the EU (IMPD format) and US (IND format).  He addressed CMC questions from several EU countries were addressed allowing progression of the clinical studies without any down time.  The project management and leadership Marc provided during this period were to define the regulatory and scientific scope of work with respect to pre-formulation solid form studies (polymorphism), analytical validation, setting of specifications, and overall CMC regulatory coordination for both US and EU activities.  

Preclinical Lead Development

CoLucid’s second program that Marc supported was a preclinical lead compound which was ‘on hold’ due to pre-formulation issues.  The compound presented itself as an oil and needed to be developed as a tablet formulation.  A well known multi-national CRO synthesized this molecule and developed a scalable process, but were unsuccessful in identifying a suitable solid (salt) form for development, despite considerable effort.  Marc was then brought in to review the project and work with the CRO. He suggested a list of solvents for crystallization that they had not yet investigated.  One of his suggested solvents led to a crystalline compound.  Subsequent pre-formulation work identified 3 potential salt candidates for development.  A composition of use and process patent for these salt forms is pending and lists Marc as an inventor.  The ‘magic solvent' was successfully used to manufacture kilo quantities of this compound to support early development studies. The result is that a previously undevelopable compound is now suitable for formulation into a solid dosage form.  The remarkable success of this project was completely attributable to Marc’s expertise in identifying the appropriate solvents where the efforts of others had failed.

In addition to the activities outlined above, Marc has also assisted with the construction of an extensive CMC data room and has addressed questions arising during due diligence by prospective acquirers. He has been a terrific resource, teacher and a valued colleague. We would welcome an opportunity to work with Marc again in the future.

Nadia Rupniak, Ph.D.
VP of Research & Development

As president of CellPoint, LLC I had the pleasure of working with Marc Andersen at a critical point in time for CellPoint.  Basically, CellPoint had completed Phase I of its oncology trial and asked permission from the FDA to proceed to Phase II/III. While Phase I showed satisfactory safety data the FDA queried the CMC data specifically related to the manufacturing process, purity and stability of the agent. Further, the issue of presenting the data in an acceptable format following FDA guidance documents was not a capability within the CellPoint structure Marc was assigned to CellPoint to serve as point-person/consultant to accomplish the above tasks. Marc provided leadership and professional know-how in directing the preclinical studies, including required toxicology, as well as the manufacturing process to create a product that exceeded the purity and stability requirements of the FDA but also the preparation of the CMC report on chemistry, manufacturing and control. Marc's leadership resulted in CellPoint having an expedited process for the FDA submission but equally important an approval from the FDA to begin Phase II,III without a single query My experience with Marc and my observation of his professional knowledge leads me to provide the highest level of support and endorsement of his skills in the development of CMC guidance for developing pharmaceuticals as well as support for the regulatory process I would be pleased to have further discussion with anyone regarding Marc Andersen and his staff.

David Rollo M.D., Ph.D., FACC, FACNP 
President CellPoint 

Marc and his staff worked with us as part team setting up a small scale cGMP synthesis lab and continues to be a point of contact for the project. His in depth technical knowledge of chemistry combined with his experience and regulatory certifications was a key asset for us. Being a smaller company with a wide variety of projects we needed to have someone who was able to craft solutions that both fit the business model and achieved compliance to applicable regulations. Marc brought this these solutions to the table in addition to a wealth of resources that we were able to put to use in our facility. His varied expertise and experience also allowed him to wear multiple hats and additionally to support us in business development areas.

Bhaskar Venepali, Ph.D.
CEO of CiVentiChem

Inhibitex is a Pharmaceutical company of approximately 30 employees developing drugs for the treatment of hepatitis C.  Marc and his group was brought on board to oversee all CMC activities with the primary objective of understanding scientific data of both API and drug product formulation in terms of regulatory requirements and alerting Inhibitex of potential risk areas and provide options on how to mitigate risks. Additionally marc was tasked with working as part of an overall "IND Team" being responsible for "gap analysis", assembling and writing the Module 3 (Drug Substance & Drug Product CMC) section to support an electronic filing in eCTD format. The program involved a challenging synthesis as well as formidable formulation challenges. The end result was the IND was filed on time with no CMC questions back from the agency.  Marc is a conscientious, knowledgeable, and easy to work with individual who has added a lot of value to our organization. Marc is detail oriented but understands our competitive goals. He has helped us work through some difficult problems with outstanding results.

Stan Chamberlain, Ph.D.
VP Chemistry at Inhibitex