Syed Shahabuddin, Phd Email & Phone Number

Naperville, Il, Us

Responsible for biopharma drug development program and alliance management strategic and operational support for IND enabling studies through clinical trials and regulatory submission

San Diego, California, Us

Managed a small molecule discovery stage urology program through creating fully integrated program timelines from Pre-IND to NDA, key milestones, inflection points, and budget, and long range plan (LRP)• Developed an integrated project plan and timelines in Smartsheet and budget that facilitated C-Suite stage gate decision making process• Mapped 3, 5 and 10 years LRP for strategic decision• Facilitated program team meetings, including development of agendas and meeting minutes• Prepared presentations for program team meetings and portfolio Strategy leadership team

South San Francisco, Ca, Us

Responsible for strategic planning and monitoring of antibodies-based research and development activities in Oncology/Immuno-Oncology (I/O), Immuno-Inflammation, Metabolic & Ocular diseases. • Interim head of Program Management; facilitated efficient businesses and weekly meetings Development Review Committee (DRC) which consisted of EC and Board Chair• Successfully led multiple cross-functional drug development teams across oncology, metabolic, and ocular diseases through different stages including Pre-IND to Phase 1/Phase 2 • Efficiently led and managed strategic NGM-Merck alliance and executed deliverables on time• Created and drove integrated program timelines (Gantt charts) and milestones• Facilitated efficient cross-functional project team meetings leading to key decision making• Developed meeting agendas, meeting minutes and action Items• Provided presentations for governance meetings • Introduced new project management tools and processes for continuous improvement• Compiled and tracked program budget • Performed risk management and implemented mitigation plans to prevent project delays • Managed a senior project manager• Organized and maintained SharePoint, shared folders, and PM website

Brisbane, California, Us

Responsible for strategic planning and monitoring early and late-stage drug development CMC activities for Oncology, Neurodegenerative, Metabolic, and Rare diseases using gene and cell therapy • Successfully led CMC activities in multiple therapeutic areas, including autoimmune, oncology, Neurodegenerative and inherited diseases; Created IND enabling study plans, coordinated drug supply chain, and external manufacturing plans using MS Project• Led and supported cross-functional CMC teams from pre-clinical through clinical development including autologous and allogeneic CAR-T and CAR-Treg cell therapy • Created Phase III development plans with timelines, budget, resources, and scenarios for a rare disease; identified gaps in Phase II processes through a cross functional workshop• Drove scenario plans that led to strategic decision making on AAV serotype and manufacturing platform selection for Gene and Cell therapy• Mapped 5 years LRP for strategic decision making

Deerfield, Illinois, Us

Served as a Syngene (CRO, India) representative and a strategic partner in Baxter-Syngene collaboration; Syngene performed CMC activities; safety testing; and statistical & clinical data management services for Baxter products• Successfully led Baxter/Syngene partnership maximizing team system effectiveness across the drug development life cycle• Made significant improvement in alliance/collaboration by implementing metrics/KPIs and achieved operation excellence for over 1000 deliverables managing over 35 stakeholders• Organized and facilitated cross-functional team meetings, issued agendas, tracked meeting minutes and actions, communicated issues and decisions• Identified risks and applied mitigation that resulted improved process and performance

Served as a consultant for small/mid/larrge size biopharma companies and provided strategic and tactical support for preclinical IND studies, API procurement and manufacturing of generics, and clinical trials; established/coordinated R&D and drug development activities with CROs and CMOs in USA/Europe/India for global clients• Provided Project Mangement support at Baxter; Led global portfolio of commercialized products and manufacturing of DS and DP and clinical trial material supply for Phase 4; Participated in the development of the strategy and test methods for all solution based pharmaceutical products to comply with new metal impurity guidance from the US Pharmacopeia• Established business development & alliance management strategies, and identified clients • Designed and developed preclinical and clinical study plans in early phases, prepared study documents, including protocols, reports, and FDA presentations for clients• Designed/coordinated/monitored IND enabling preclinical studies including PK/PD/Tox studies • Developed 6 preclinical study protocols, 5 SOPs, and 3 study reports for regulatory submission

• Directed all external preclinical and clinical trial projects in oncology and infectious diseases therapeutic areas and served as the single point of contact; Effectively managed project timelines to ensure all deliverables were achieved in a timely fashion• Designed, coordinated, managed and monitored globally outsourced projects including bioavailability and bioequivalence (BA/BE), 505(b)(2), and Phase I-II clinical trials with CROs.• Planed and designed clinical studies incorporating use of pharmacodynamic biomarkers such as Ki-67, Her2, progesterone and estrogen receptors, estradiol, estrone sulfate, and insulin-like growth factor as surrogate markers in breast cancer patients on 2 drug candidates in Phase I trial. • Directed drug supply, CMC, regulatory, data management/biostatistics, and clinical pharmacology (PK/PD)• Developed 8 clinical trial protocols, 6 Investigator Brochures (IB), and several CRFs, consent forms, and regulatory documents such a IND, NDA/505(b)(2) for DCGI (India) and contributed in submissions for registration.

Us

• Directed process development and manufacturing/CMC of cancer therapeutics including a therapeutic protein in Phase III and several liposomal drugs (Phase I-II)• Oversaw drug supply, CMC, regulatory, quality and data management/biostatistics activities• Exercised leadership, matrix management role, monitoring progress, and reporting to management on project deliverables• Managed cross-functional project timelines• Developed project budgets and managed project expenses against approved budget• Developed and reviewed progress report including the CMC section for regulatory documentation such as CTD and BLA for FDA (USA), EMEA (EU), and MHRA (UK)

Phd, Immunology And Cell Biology

Postdoctoral Fellow, Immunology

Postdoctoral Fellow, Microbiology And Immunology

Certificate, Exercising Leadership: Foundational Principles