Archana Sah Email & Phone Number

Leverage my 30 years expertise and thought leadership to provide strategic consulting and advisory services to organizations/companies/Boards and investor VC firms on clinical research and development. Service areas include innovation and transformation in:- clinical development strategy and execution, trial designs, data driven insights, clinical evidence generation, driving efficiencies in time, cost and quality of clinical trials. Thought leadership in Oncology, and Rare diseases. Also experienced in Dermatology, Metabolic, Cardiovascular & Womens Health.- digital biomarkers & endpoints strategy and digital health tech solutions and integration- patient recruitment and retention, engagement and experience- patient diversity equity and inclusion Clients include pharma, emerging biotechs, digital health technology software companies, venture capital firms, industry consortiums, cancer advocacy organizations, cancer treatment and research institutions etc Contact: archana.sah@aspharmaadvisors.com

Judge and Mentor for the several cohorts of CancerX Moonshot Accelerator (co hosted by Digital Medicine Society (DiMe) and Moffit Cancer Center). Cohorts of startups dedicated to revolutionizing advancements in cancer care, clinical trials, patient support, biotech & pharma and drive integration of digital tools in oncology. Launched by the WhiteHouse Office of Science and Technology Policy Cancer Moonshot initiative, CancerX represents a powerful public-private partnership aimed at catalyzing digital innovation in the battle against cancer on a global scale decreasing the death rate by 50% over the next 25 years and to work towards reducing the burden on patients and their families. Judging for the CancerX Accelerator was led by Moffitt Cancer Center and MassChallenge MC

Hanover, Maryland, Us

Member of Oncology Board to lead cross industry collaboration in Oncology Clinical Research. Member of strategic initiatives in Site Education and the Annual Oncology Site Solutions Summit focused on delivering best practices and solutions for operational excellence in Oncology Clinical Trials.

Hanover, Maryland, Us

Appointment by invitation: Founding Chair of the Board to lead cross industry collaboration in Oncology Drug Development: set the vision, mission and oversee the strategy of the Oncology Program with SCRS. Board members are senior executives from Sponsors, CROs, Oncology Research Sites and Oncology Vendors.• Chair strategic initiatives in Site Engagement, Site Assessments and Site Education• Chair Annual Oncology Site Solutions Summit focused on delivering best practices and solutions for operational excellence in Oncology Clinical development and operations across the entire ecosystem. http://oncologysitesolutionssummit.com/

Atlanta, Georgia, Us

Palo Alto, Ca, Us

• Led the vision and go to market strategy and deployment of therapeutic aligned Oncology Solutions and product suites (eConsent, Televisit, eCOA Library of 30+ prebuilt, validated, pre-configured Oncology instruments to speed start up and improve data quality) as the market leader/best in class in the DCT space. Partnered with Marketing for product launch and campaign strategies.• Defined therapeutically effective workflows solutions for disease groups focusing on participant experience, site engagement and endpoint collection• Lead effective governance and relationship oversight with key partners• Supported Medable digital and decentralized solutions team with the assessment and evaluation of new ecosystem partners, engaging in their delivery and oversight. Identified and engaged with external SME’s, KOL’s and partners to effect a therapeutically aligned, best-in class solutions • Developed evidence base, in collaboration with partners, external bodies and agencies and Medable research team, to define therapeutic digital standards and endpoints globally to meet the requirements of different clinical and healthcare outcomes • Facilitated and oversaw effective product engagement and deployment at strategic and study levels, supporting the Customer Success and Project Management functions as needed to ensure therapeutically focused solutions are deployed and effective for high-quality data delivery • Provided operational oversight and leadership to ensure effective delivery of the proposed strategies to clients, with focus on quality, time, and cost as well as ICH GCP compliance

South San Francisco, Ca, Us

Reporting into CEO and key member of the company leadership management team. Accountable for the strategic leadership and operational design and delivery of all clinical stage global oncology programs in partnership with partners (Abbvie, Gilead). Present regular portfolio Clinical updates at Corporate Board and Joint development and governance committees. • Strategy and delivery of TTX-30, developed in collaboration with Abbvie, dose escalation and RP2D determined within record 6 months of IND approval before being spun-off into Trishula Therapeutics• Led the team to successful TTX-080 IND filing and approval and first patient dosed within 2 weeks of IND approval. Dose escalation and RP2D delivered within record 6 months of IND approval• Set up framework and oversight of strategy, prioritization, governance body reviews and decision making to achieve on time and within budget delivery of clinical portfolio• Implement and drive resource strategy for clinical operations (internal and external resources (CROs, vendors, consultants, contractors). Hire, develop and manage clin ops staff. • Establish, implement, and manage clinical trial processes, strategic outsourcing and performance indicators • Contribute to clinical CDP, tactical strategy and protocol designs • Member of the Corporate Management Team setting yearly corporate goals; set functional goals • Provide continuous assessment and alignment of the clinical operations functions to ensure efficiency, effectiveness, and quality-by-design in operational execution • Accountable for the implementation of PK-guided dose escalation, early combination strategies for all first-in-human clinical trials with input from preclinical, translational research, regulatory cross functional teams • Accountable for full compliance with GCPs and ICH guidelines and inspection readiness as well as development of SOPs and processes. Represent Clin dev operations at Corporate QA Leadership Team

Switzerland 🇨🇭 , Ch

Appointment by invitation on Rotation: Founding Chair of the Society for Clinical Research Sites Oncology Board: set the vision, mission and chair strategic initiatives in Site Engagement, Site Assessments and Site Education. Founded and chaired the Annual Oncology Site Solutions Summit focused on delivering best practices and solutions for operational excellence and collaborations between Sponsors, Sites, CROs, Vendors across the Oncology Clinical operations ecosystem. Led Site Partnership initiatives for Roche to be sponsor of choice.

South San Francisco, California, Us

• Accountable for oncology therapeutic area (TA) expertise, clinical strategy and delivery of Phase I-III oncology portfolio with 21 molecules in late phase in mono and combination oncology therapies and almost 25 molecules in early development (over 300 oncology studies) for numerous signaling pathway inhibitors, anti-angiogenics and immunotherapies against key metrics leading to 12 FDA/EMA oncology approvals with several FDA breakthrough and PRIME designations (Tecentriq® in multiple indications, Alecensa®, Polivy®, Hemlibra®, Gazyva®).• Senior member of Leadership team (LT), accountable for department vision and strategy, competency framework for staff, fostering functional excellence through governance metrics and performance improvements. Member of SSF Roche Site Leadership Team.• Provide insights based on competitive landscape, RWD based data analytics, patient insights and SOC trends. Ensure operational processes, systems and standards are adopted and implemented consistently.• Innovation and Clinical Capabilities: Formulate a vision for future state and lead the org to achieve them through process improvements and large scale change management. • Founding member of the Roche Advancing Inclusive Research Initiative to enroll representative trial participants • Hire and develop senior managers and lead Clinical Operations staff of up to 60 employees within my org and up to 300 staff across the entire department. • Contribute to sourcing strategy and oversee resourcing and vendor oversight including FSP staff of about 400. • Experienced in multiple indications- Lung- NSCLC and SCLC, Melanoma, Hem-Onc NHL/AML/FL/DLBCL/CLL, Multiple Myeloma, Breast, Head and Neck, GI/GU and GYN Cancers and Rare Diseases (Hemophilia, PNH).

Dublin, Ie

• Core Leadership Strategy Leader within the Oncology Center of Excellence advising key strategies for multiple oncology clients. Support business development and legal teams adding new clients/growing existing assets• Accountable for the clinical strategy and delivery of client's global oncology portfolio and management of global project teams, including regionally-based and in-house employees. Formal mentor for multiple Project Directors, Project Managers and Lead CRAs.• Led portfolio level Quarterly governance of partnerships with key clients ensuring alignments and delivery • Identified and implemented efficiencies, best practices and lessons learned across all programs resulting in 20% improvements in enrollment, data quality, timelines and budget. • Handpicked by CEO to lead a team to rescue a failing metabolic disease program in chronic kidney disease that was delivered 3 months ahead of target which was pivotal to corporate business with top 3 Pharma client.

Seattle, Wa, Us

Senior leader providing clinical portfolio strategy and delivery to multiple Phase 1-IV global (US, EU, APAC) programs within timelines, budget and resources. Accountable to CMO for portfolio governance and KPI delivery. Part of Core leadership team. Hired and managed clinical operations staff.• Contributed to the development of abstracts, presentations, and manuscripts, liaise with Medical Affairs and Commercial for ISTs, scientific exhibits at ASCO, ASH and IASLC meetings. • Hand-picked by Executive Team to lead pivotal Pixuvri® Phase III program for the company, start up milestones delivered 50% ahead of industry standard which was critical for fund raising. Product was approved in EMA for NHL.

Leverkusen, North Rhine-Westphalia, De

Global Program Operations Lead (OPL) for ZK-Epothilones® in Solid Tumor global programs accountable for leading cross functional teams and driving business goals.

New Brunswick, Nj, Us

• Accountable for the strategy planning and execution of clinical trials for assigned portfolio within budget, timelines and resources using combination of insourced and outsourced trials. Publications and awarded worldwide patents for innovations. • Conducted competitive analysis to identify therapeutic opportunities, support future product strategies • Partnered with medical affairs for scientific research and publication strategy, KOL engagements, strategies and tactics designed to emphasize product benefits and positioning at AAD conferences • Led global corporate initiatives: Invited by Global VP at J&J to scope, create and establish clinical trials capability in Asia Pacific and Latin America for J&J. Established strategic liaisons with KOL/TAEs and institutions, established clinical research capabilities in the regions, trained local staff and executed validation project. The learning’s from the validation project prompted a product launch in the Asian market fueling business growth in global markets.

Cincinnati, Ohio, Us

• Set up and managed the clinical operations group (10-15 staff) for assigned therapeutic areas •Developed and executed trials to competitively differentiate products/enhancements to maximize customer satisfaction and fuel global portfolio growth • Managed development plans and clinical roadmaps for key products aligning the evidence plans to the product goals and criteria for success • Led several key products through development process, gathering customer insights, creating related design requirements & specifications, prototype evaluation and product design • Monitored & communicated clinical trends and competitive activity affecting key products • Implemented innovative and strategic research projects involving cutting-edge technology in Doppler Imaging to measure clinical safety and efficacy profile • Partnered with marketing team for promotional strategies and tactics designed to emphasize product benefits and positioning at trade shows

Blackfriars, London, Gb

• Implemented innovative and strategic research projects involving cutting-edge technology in OCT and Fluorescence Imaging with key opinion leaders. Worldwide Patents issued. • Led the clinical trials to evaluate safety and efficacy of assigned projects. • Represent projects to management and work cross-functionally with stakeholders (R&D, clinical, engineering, regulatory, business development, legal, marketing). • Partnered with Marketing Communications team for promotional strategies and tactics designed to emphasize product benefits and positioning at trade shows

Cincinnati, Ohio, Us

Conducted development and validation of in vitro assays studying active absorption/permeation PK profiles into animal modelsCultivated expertise in topical dermal delivery technologies and assisted professor on research projects including grants submissions Managed protocol design and execution of clinical studies, led project management, data management, analysis, interpretation, dissemination, and study reporting for research projectsDeveloped strong expertise in bioengineering and digital technology; designed and developed techniques for measuring in vivo dermal efficacy and safety endpoints

Msc Pharmaceutical Sciences

Bachelors In Pharmacy, Pharmacy

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