Thomas Sandal Email & Phone Number

København N, Dk

• Part of executive management, reporting to the CEO• Together with CEO build funding strategy and present investment case to VCs• Responsible for CMC strategy, plans and budget to support clinical trials• Responsible for the daily preclinical and CMC related activities

Support Engimmune Therapeutics AG (Soluble TCR immunotherapy)• Implementation of IND enabling activities and CMC plans and budget to support a series A funding• Establishment of developability assessment of clinical candidates

• Part of the site senior Leadership Team, responsible for development and implementation of CMC and supply chain plans• Front PokeAcell as part of leadership team towards investors, collaboration partners and other stakeholders• Project manage all aspects on the CMC project in close collaboration with the other product developmentand business development tracks

Bothell, Wa, Us

• Part of of the site senior Leadership Team, responsible for providing leadership and decision making to the Copenhagen site• Provide leadership and strategic direction to the Process Development organization, an area of 100+ scientists and technicians • The PD organization is responsible for Cell Line Development (CLD), Upstream Process Development (UPD), Downstream Process Development (DPD), Analytical Development (AD), and Process Transfer (PT). The area covers both Microbial and Mammalian Cell Culture, early and late stage development.• In addition, the PD organization is also responsible for process characterization, process validation and continuous validation post licensure.

Cambridge, Cambridgeshire, Gb

• Part of executive management, reporting to the CEO• Build Microbiotica’s vision and strategy for preclinical development and clinical material supply • Responsible for developability assessment and strain characterization of potential drug candidates• Responsible for analytical and process development• Responsible for all aspects of CMC both internally and externally• Identified and evaluated all the CDMO’s relevant in the field. Selected and established special relationship with CDMO of choice for both Drug Substance and Drug product development and manufacture.• Responsible for all CMC aspects of the C Difficile program

Cambridge, Gb

• Part of executive management and responsible for an R&D organization of up to 40 Scientists• Built and developed strong Cell assay, Protein Science, Expression, Purification and Analytical departments• Implemented high through put developability assessments very early into the discovery process • Main responsible for landing the $36m collaboration and equity investment from Takeda Pharma. • Alliance manager and project leader for multi target collaboration with Takeda • Responsible for all Humabody Drug Conjugate projects, internal as well as external. • Drove organisational changes towards more functionalised functions as the organisation grew in order to stay efficient.• Responsible for and facilitating implementation of a continuous Process Review system in order to identify process bottlenecks and ensure the R&D process is as optimal as possible reflecting the size of the company.• Responsible for all preclinical programme activities• Responsible for moving the lead candidate into clinic, involving all CMC, regulatory, toxicology and clinical activities plus interaction with regulatory bodies.• Actively involved in Series A funding round, presenting to investors.• Responsible for and defining the R&D budget pre- and post-series A funding.• Heavily involved in target identification in the first years.• Presented Crescendo for investors, potential collaborators and at international conference multiple times

Boston, Massachusetts, Us

Responsible for assessing the developability of new molecules, cell line development, analytical and formulation development, process development and manufacture of Drug Substance and Drug Product• Restructured the Bioprocess group to enable increased efficiency and throughput.• Selected CMO and negotiated contracts and Scope of Work for both Drug Substance and Drug product• Defined scope and initiated formulation development• Active member of management team

Brentford, Middlesex, Gb

• The remit was: 1) to evaluate the developability of many more lead molecules prior candidate selection 2) to construct, screen and manufacture pre-Master Cell Bank of commercial cell lines.• Defined a new strategy to cope with 3 times more lead molecules with only half the number of FTE’s.• The group was extended and high through put (HTP) cell line screening, downscaled upstream and downstream screening tools were implemented• The HTP strategy to evaluate the developablity of multiple leads was proven successful• Three programs have successfully passed through the group, and cell line and processes successfully transferred to process development in the US.

Brentford, Middlesex, Gb

• Established a very efficient, motivated and empowered team consisting of both cross functional GSK staff and CMO staff.• Navigated a very complex and issue rich project resulting in a very high yielding process, freeze dried formulation and a comprehensive analytical package. • Provided pre-clinical and clinical material on time and of appropriate quality • Successfully defined budget, managed and delivered the project on time and within budgets• Responsible for the CMC section in the IMPD which resulted in an HMRA approval of the IMPD without any CMC questions. • A second generation DSP process was developed resulting in a significant reduced HCP level.

Brentford, Middlesex, Gb

• Built/assembled/established a new process development well functioning group at Stevenage from scratch.• The group was responsible for vector construction and screening for final expression strain to be used in cGMP manufacture of clinical and potentially post launch material.• Defined URS and purchase of small to mid scale UPS and DSP equipment.• Finalized all the URS’s on key UPS and DSP equipment and negotiations with key equipment suppliers.

• Sole responsible for all CMC activities within Domantis and member of senior management team.• Successful transfer of domain antibody project to CMO. • Successful management of all aspects of process development including overcoming a number of technical and quality issues. • Successfully defined budget, managed and delivered the project on time and within budgets• Evaluated, selected and negotiated contracts with CMOs for both Drug Substance and Drug Product development and manufacture. These included tech transfer and scope of work documents, legal contracts and quality agreements. • Educated Domantis’ discovery groups by setting standards and expectations for moving products into development.• Set specifications for drug substance and drug product. • Wrote the CMC section of the IND briefing document. • Provided material to pre-clinical and clinical studies. • Acted as backup for Kevin Moulder, VP of Development, and was thus heavily involved in preparing toxicological and clinical studies.

• As the very first employee at CMC I was intensively involved in all aspects of taking the company from the start with only 7 people to where CMC had more than 100 employees and a brand new state of the art facility suitable for a commercial contract manufacturing organization handling multiproducts and serving a portfolio of clients. This was achieved in only 3½ years.• Successfully established the Department for Microbial Development responsible for fermentation process development in scales from 5 L to 100 L working volume fermenters and all molecular biology tasks including host strain development.• Successfully established class C facilities and procedures for cGMP cell banking.• Successful project management of a number of customer projects, from early development projects and projects covering production of material for phase III clinical trials.• Successfully defined and established a quality system suitable for development and production areas in a pharmaceutical cGMP facility.• Liaised closely with the Business Development team and customers, prepared quotations and project proposals and timelines.

Bagsvaerd, Dk

Management of the department and projects. Production and quality control of seed strains. Conduct small scale fermentations. Development of improved propagation methods. Design of new laboratory facilities. Consultant for production sites regarding propagation.

Bagsværd, Dk

Sreening bacteria for potential enzyme candidates. Cloning and expression of various bacterial enzyme genes. Managing research projects. Supervisor for M.Sc. and Ph.D. students.

Bagsværd, Dk

Screening of fungi for potential enzyme candidates. Cloning and expression of various fungal enzyme genes. Development of expression systems in various yeasts.

Bagsværd, Dk

Screening of fungi for potential enzyme candidates. Cloning and expression of various fungal enzyme genes. Development of expression systems in various yeasts.

Biochemistry And Molecular Biology

Eba, Engineering Business Administration

Education record