Peter Olagunju Email & Phone Number

Sevenoaks, Gb

Houston, Tx, Us

New York, Ny, Us

Operating Partner focused on new company formation.

Provide a full range of strategic and tactical support for cell and gene therapy and private equity companies as it relates to corporate strategy, search and evaluation, financing, technical operations/CMC considerations, execution in the clinical setting, and commercial planning.*Past clients: Beam Therapeutics, Indapta Tx, BioLine Rx, Sofinova Partners, Letter One Health, General Atlantic, TPG Life Sciences.

Sold to Adaptimmune (Nasdaq: ADAP) June 2023

Led the Global Technical Operations function for a TCR platform cell therapy company that is in late-stage clinical trials evaluating our lead product Gavo-cel in 4 solid tumor indications (Mesothelioma, Ovarian Cancer, Lung Cancer, and Cholangiocarcinoma). Global Technical Operations includes: Manufacturing, Supply Chain, Process and Analytical Development, Quality, Program and Alliance Management, and Information Technology

San Francisco, California, Us

• Served as an advisor related to new opportunities in the cell and gene therapy space• Performed due diligence on an opportunity as part of the search and evaluation process

New York, Ny, Us

• I advised the Blackstone Life Sciences team on new opportunities in the cell and gene therapy space.• I advised Blackstone Life Sciences funded biotech companies.

Cambridge, Ma, Us

Led the Technical Operations function at FerGene, which was a newly formed Blackstone backed startup, commercializing a gene therapy for bladder cancer patients.The Technical Operations function included: Manufacturing, Supply Chain, Process Sciences, Project Management, and Quality

New York, Ny, Us

• Supported the General Atlantic team on new opportunities in the cell and gene therapy space.• Performed due diligence on opportunities as part of a search & evaluation process.

Somerville, Massachusetts, Us

Led the Patient Operations function which includes the following departments:-Apheresis Operations -Drug Product manufacturing -Patient Scheduling/Client ServicesThe Patient Operations function is the primary point of contact within CMC at bluebird bio for Centers of Excellence (COE) interfaces including the collection of patient cells, manufacture of drug product, and operational execution of patient treatments. Creating an optimized point of care experience for patients, providers, and stakeholders related to the treatment process.

Somerville, Massachusetts, Us

Lentiglobin Program leader with responsibility for a cross-functional team spanning research, development and commercial. This team was focused on providing broad access for a transformational EMA approved therapy (ZYNTEGLO), for thalassemia patients and has been a catalyst for innovation in the following areas: - product development: by introducing process improvements, such as cryopreservation, to provide more flexibility in product delivery. - regulatory innovation: by developing creative and appropriate designs of clinical trial and data review protocols that are more acutely aligned with the goals and objectives of a one-time potentially curative therapy; and through negotiations with regulators to drive thinking/understanding in identifying new approval pathways for a novel product. -market access: by developing and advancing an innovative value-based reimbursement model that is tied to the clinical outcome of patients. At the heart of this model is a shared value— shared risk approach that is tied to the “real” value that is realized by patients and by the healthcare systems that serve them.Head of Patient OperationsPioneered the formation of a new organizational function (Patient Operations) specific to cell and gene therapies that focuses on optimizing the patient experience of providing a personalized therapy. Patient Operations combines the Apheresis (cell collection), Drug Product Manufacturing (made to order), and Client Services (operational execution of all activities in the patient pathway) functions, to ensure an exceptional experience for all involved at the point of care and helps to enable timely revenue recognition via avoiding unnecessary stalls in the treatment pathway.

Somerville, Massachusetts, Us

Manage Technical Operations function which is the primary interface with outsourced manufacturing entities, critical GMP service providers and analytical testing partners.

Bridgewater, Nj, Us

Technical Operations lead at Dendreon the Oncology business unit of Valeant Pharmaceuticals.• Developed a scheduling model to align with the dynamic commercial prostate oncology market (physicians, locations, and patients) which led to record profitability ($22 million net income) for the business unit in Q2 2015. • Provided strategic and operational direction for patient scheduling, process excellence, and operational services (training development and coordination) for commercial and clinical production. • Created policies and parameters specific to the development, implementation and maintenance of process methods for the Scheduling Department.• Ensured that the appropriate electronic systems exist to support patient scheduling and the apheresis network. • Guided and directed the Client Services Department; assessed the required skill sets and constructed the department to support all Dendreon production sites. • Managed the logistics function, including managing relationships with couriers and ensuring that appropriate infrastructure is in place to transport products with 18hr shelf life constraint.• Developed commercial forecasts and ensured alignment with headcount capacity at manufacturing facilities.• Participated on the Operations Leadership Team with the General Manager of the Oncology business unit, Head of Manufacturing site(s), the Head of Facilities and Engineering, and the Head of Supply Chain. • Represented the corporation during high-level discussions and investigations with external customers, vendors and FDA representatives.

Seal Beach , Ca, Us

Seal Beach , Ca, Us

• Managed the manufacturing operations and US/EU supply chain that included contract manufacturers, critical raw materials, couriers, and contract testing facilities. Effectively managed an annual departmental budget of $40 million dollars.• Managed Domestic and European network of 130+ apheresis sites that annually produced $15 million dollars of starting raw material.• Managed the Client Relations team that was responsible for providing real time global support for external and internal partners.• Managed logistics function that leveraged relationships with global couriers to ensure validated pack out for product was successful transported given highly specific requirements and expiry constraints.• Led technology transfer process that included transfer of assays, manufacturing process, equipment, documents, and stability studies to EU CMO. Tech transfer was completed on time and on budget.• Managed vendor selection process to identify shortlist candidates and subsequent preferred EU commercial contract manufacturer. Process included effectively communicating technical requirements, obtaining data (RFP), preparing cost models to assess benefits and weakness of each proposal, and performing site visits.• Identified, contracted, and on-boarded EU network of Apheresis (critical raw material) sites that included UK, Germany, Netherlands, Austria, France, Italy, and Spain.• Participated as operations lead in business development initiatives focused on making product available in Asia.• Participated in the authoring, review, and submission strategies of regulatory filings including CMC sections of EU Submissions (CTA-Clinical Trial Application and MAA-Manufacturing Authorization Application).• Developed financial models for various projects that were presented to senior management (technology evaluation, in-licensing, commercial partnerships, manufacturing economics).

Lawrence Township, Nj, Us

Responsible for Quality functions for one commercial and three development stage monoclonal antibody products:- RECOTHROM® for surgical hemostasis- PEG-Interferon lamda for hepatitis C- IL-21 for metastatic melanoma- IL-31 mAb for atopic dermatitis

Seattle, Washington, Us

• Senior level QA management representative responsible for: o Managing quality assurance organization responsible for GxP (GLP, GCP, & GMP) quality operations, and document control for both internal mfg operations & international CMOso Negotiating and executing Quality/Technical Agreements with domestic and international Contract Manufacturers (CMO), Contract Service providers (CSO) and Corporate Partners.o Managing the corporate GLP and GCP auditing/compliance programs.o Managing the clinical and commercial GMP product lot release programs.o Managing the corporate Medical Device 21 CFR 820 compliance program.o Performing external regulatory (US, EU, Canada, JP, Australia) and quality compliance audits of foreign and domestic vendors (CMOs and CSOs).o Generating and presenting key quality metrics to corporate senior management.

Seattle, Washington, Us

• QA management representative responsible for: o Managing internal and external cGMP/GLP/QSR/ISO 13485:2003 regulatory compliance auditing programs.o Performing external regulatory (US, EU, Canada, JP, Australia) and quality compliance audits of foreign and domestic vendors.o Negotiating and executing Quality/Technical Agreements with domestic and international Contract Manufacturers, Contract Service providers and Corporate Partners.o Performing regulatory and quality compliance audits of internal departments.o Managing and coordinating corporate FDA, EMEA, QP, and ISO Regulatory Inspection readiness program.o Managing and coordinating Corporate GxP Training Programo Managing the clinical and commercial product complaint programso Oversight of Biological Product Deviation Reports (BPDRs) and Product Recall systemso Executing Annual Product Review including collating/editing data from CMOs throughout the worldo Generating and presenting key quality metrics to senior management

Foster City, Ca, Us

Responsible for the performance of external vendor compliance audits, duties included:o Conducted qualification audits of contract manufacturing facilities, international API vendors, testing laboratories, software vendors, and distribution vendors.o Provided formal compliance reports and audit summaries for senior management.o Served as primary point of contact for the QA component of software validation activities.o Corporate GMP Trainer

•Led the implementation of a vendor qualification program. Activities included writing of SOPs, development of tracking/monitoring tools, and scheduling/execution of vendor audits. •Primary contact for all manufacturing related issues or items which included; performing facility startups and product change over inspections of manufacturing suites, providing QA oversight in final product line clearance fill inspections, and acted as QA contact for all cell bank and viral bank transfers. •Corporate GMP Trainer•Lead reviewer of all documentation associated with contract manufacturing lot release. •Played key role in the implementation of two core QA systems; Corrective Action/ Preventative Action system and a Change Control system.

Switzerland 🇨🇭 , Ch

•Main duties involved the validation and verification of company specific software programs, and spreadsheets that were integral in the manual specimen preparation process, and the COBAS Taqman HIV-1 kit release testing process. •Performed various IQ, and IOPQ (Installation Operation Performance Qualification) validations on internal spreadsheets and computer programs. Became extremely familiar and accustomed to dealing with compliance, regulatory, and 21 CFR part 11 issues regarding computer systems in the pharmaceutical industry. •Duties also included the verification and validation of visual basic codes. Created user requirement specifications, and functional requirement specifications in addition to developing in-house SOPs and process protocols. •Became extremely proficient in writing of summary reports and presentations

San Rafael, Ca, Us

•Worked in a team setting for the production of Aldurazyme (recombinant human alpha-L-iduronidase), a Phase III investigational enzyme replacement therapy treatment of MPS I. •Performed, with increasing proficiency, mammalian cell culture operations and enzyme purification operations required for the clinical manufacturing of pharmaceutical products. •Gained vital knowledge in the GMP laboratory practices, documentation, and manufacturing processes needed in the biotech industry. •Gained, thru training and experience, proficiency in the operation of numerous biotech-specific pieces of equipment used in all manufacturing steps from seed train operations to final product recovery. •Helped ensure that the manufacturing department achieved annual objectives with respect to production goals and minimization of cost of goods. At the same time helped to contribute in maintaining a safe, yet challenging work environment.

Alameda, California, Us

•Registered and maintained inventory of compounds purchased or synthesized by Exelixis. •Responsible for Entry and verification of compound information into Activity-base database. Utilized the latest automation technology to reformat compounds into plates so that scientist can more easily analyze them. •Created Protocols and developed Standard Operating Procedure documents for applicable portions of process.

•Contributed an integral role in all daily activities in outlet that generated over $750,000 dollars in revenue annually. •Responsibilities included the supervising, hiring, and training of employees. •Contributed in developing and analyzing a monthly budget and financial forecast for sales. •Reviewed profit and loss reports each month and made any necessary adjustments. •Performed the weekly making of employee schedules. •Worked with distributors to ensure that inventories were adequately stocked at all times.

Worked as a clinical research assistant on two Phase III cardiovascular drugs Xemiofiban and Orbofiban.

Mba, Business

Biology, Immunology