Summary
Overview
Work History
Education
Skills
Affiliations
Awards
Publications
Training
Timeline
Generic

ATUL PATHAK

Lexington,MA

Summary

Program leader with global experience in driving a portfolio of high-value assets. Steering various programs, pipeline strategies and alliances, addressing business issues, and activities from discovery to registration and market entry. Experienced in leading cross-functional asset strategy with sound knowledge of drug development processes, regulatory requirements, and industry standards.

Overview

20
20
years of professional experience

Work History

Director, Program and Alliance Management

Keros Therapeutics
Lexington, MA, US
10.2022 - Current
  • Spearheaded cross-functional drug development teams throughout preclinical and clinical phases, guiding the advancement of groundbreaking therapeutics across diverse therapeutic areas and modalities to achieve global development and commercialization.
  • Steering strategic discussions and decision-making processes to effectively lead external collaborations and partnerships
  • Leading the development of project management tools, systems, processes, and standard methodologies for the smooth operation of the alliance management function.
  • Accountable for leading the cross-functional asset strategy team to gain endorsement from organizational leadership and drive the efficient execution of the approved strategy, on time and within budget.
  • Leading the design, implementation, and update of Strategic Development Plans which define the scope of project team deliverables and establishing development pathways with decision stage gates. Contributing to developing and constantly improving standard methodologies, tools, and processes.
  • Leading program teams, coordinating the development of data and information packages to support stage-gate decision points.
  • Sponsoring the creation of the target product profile (TPP) in collaboration with new product planning
  • Responsible for establishing realistic program goals, timelines, deliverables, and metrics, and providing support for budget-related activities and the execution of those plans.
  • Apply program management tools and techniques for issue and risk management: identification, mitigation, and escalation through the established governance model.
  • Stays pinnacle of internal and external developments, industry trends, and dynamics; identifies new, enhanced, or revised capabilities as relevant to the organization.
  • Identify, mitigate/resolve program-level issues and risks leveraging strong internal collaborations and ability to influence stakeholders/outcomes.
  • Maintain close cross-functional relationships to ensure that all critical parties are aware of project activities, issues, and contingencies.
  • Continue to build program management processes at Keros including governance engagement, decision structure and best practices to enable high-performing teams.
  • Expert in creating Gantt charts in Smartsheet, Think-Cell and Office Timeline Pro+ software, along with report generation

Director, Program Management

BioMedica Inc
Toronto, ON, Canada
06.2021 - 07.2022
  • Worked closely with R&D Scientific Team to ensure successful project and program delivery.
  • Successfully managed program execution through the creation and upkeep of detailed program management plans encompassing all aspects including scope, schedule, budget, communications, risks, staffing and change management.
  • Streamlined collaboration between cross-functional teams (CMC, Medical, Clinical, Regulatory) to enhance project efficiency and meet deadlines.
  • Ensured efficient project management by prioritizing tasks and optimizing market reach, achieving consistent delivery of business objectives.
  • Collaborated with team leaders to define program strategy and drive operational execution of clinical-stage programs.
  • Ensuring cross-functional alignment and accountability and proactively monitoring timelines, critical path activities and resources for assigned projects/programs.
  • Supported and facilitated resources, financial planning, and assessments for projects/programs.
  • Ensuring meaningful project communications, including dashboards, reports, and metrics, to enable timely information and analyses for senior management

Head, Program and Alliance Management

American Regents (A Daiichi Sankyo Company)
Brea, CA, USA
04.2020 - 04.2021
  • Enabled senior leadership and key stakeholders to endorse the team's data-driven recommendations through effective facilitation of the preparation process.
  • Played a key role in enhancing the program and alliance management function aligned with business requirements.
  • Developed and executed project plans and timelines, effectively tracking and managing milestones within given scope, time, and cost limitations. Fostered coordination and communication across teams to provide regular updates on project progress to senior leadership.
  • Created risk management registers, and scenario planning and developed contingency and/or risk mitigation plans for projects/programs.

Director, Program Management

BioVectra Inc (HIG Capital Company)
Charlottetown, PE, Canada
04.2017 - 03.2020
  • Served as a reliable source of strategic direction and oversight for program activities, ensuring alignment with corporate goals and regulatory requirements.
  • Led, managed, and directed the drug development programs; provided leadership to steer decisions, clarity, milestones, risks, and commercialization
  • Liaised with cross-functional teams to ensure timely regulatory submission and approval
  • Established and maintained functionally integrated project schedules to enable accurate project analyses, and identification of critical path activities and areas of resource constraint
  • Formed and upheld valuable partnerships with key internal departments as well as external stakeholders such as senior leaders, functional heads, collaborators, and partners.

Associate Director, CMC Project Management

Dr. Reddy’s Laboratories Ltd.
, India And Netherlands
11.2014 - 04.2017
  • Led the CMC Team to establish and maintain integrated CMC development plans from candidate identification through commercialization including risk and appropriate contingencies
  • Facilitated pertinent CMC scenario planning around key program inflection points, gathered stakeholder input, and evaluated, collated, managed, and communicated implications and adjustments to the overall plan.
  • Integrated, represented and drove cross-functional communication between CMC Team members, Program Teams and other impacted areas with timely and effective decision-making.
  • Increased efficiency by developing and managing an integrated CMC budget and long-range plan in collaboration with CMC Team members and Finance, effectively aligning with corporate goals.

Senior Scientist, Clinical Drug Development

Novartis Pharma AG
Hyderabad, India
09.2013 - 10.2013
  • Led, planned, supervised and delivered CMC and tech operations, including lipid-based drug delivery systems for pediatric drug development;
  • Accountable for CMC milestones, deliverables, and dependencies so the Team consistently meets program needs.
  • Developed and characterized pre-clinical pediatric formulations for efficacy and early-stage toxicity studies, and collaborated with multidisciplinary and international teams.
  • Represented the CMC team to communicate progress, risks, changes, and implications. Understand the interdependencies across functions.

Scientist, CMC

Viatris (A Pfizer Company)
Hyderabad, India
08.2011 - 08.2013
  • Initiated complex drug development program from CMC perspective,
  • Developed and characterized liposome and PLGA microspheres (Long-acting release); nano-formulations
  • Optimized, led technology transfer initiative to CMO.
  • Conducted training sessions on intellectual property rights and innovative drug delivery technologies.

Postdoctoral Research Fellow, Cellular and Molecular Medicine, Children’s Hospital

Harvard Medical School
Boston, USA, MA
03.2009 - 07.2011
  • Led a project to develop novel antibody-conjugated liposome and PLGA-based nanoparticles for targeted siRNA delivery to blood cancers, which included multiple myeloma in collaboration with the Dana Farber Cancer Institute;
  • Investigated the ability of drug carriers, which included liposomes and nanoparticles to silence genes and suppress proliferation of cancer cells, studied therapeutic efficacy of siRNA and drug delivery by nanoparticles
  • Presented findings of propriety Integrin targeted stabilized nanoparticles, which included I-TsNPs drug delivery technology in various conferences.

Graduate Student

CSIR Institute of Genomics and Integrative Biology
Delhi, India
09.2004 - 02.2009
  • Developed and characterized polysaccharides coated, which included hyaluronic acid and chondroitin sulphate and pegylated polymeric nanoparticles for efficient and site-specific nucleic acids delivery;
  • Examined the in vitro cell cytotoxicity and transfection efficiency in various mammalian cells, evaluated the in vivo ability of nanoparticles to target solid tumours in mice models
  • Presented research work at a conference organized by the Institute of Bioengineering and Nanotechnology, Singapore

Education

MBA -

University of Prince Edward Island
Charlottetown, Canada
05-2020

PhD, Pharmaceutical Sciences -

Institute of Genomics And Integrative Biology
New Delhi, India
02-2009

Master of Pharmacy -

Dr. Harisingh Gour University
Sagar, India
01.2003

Bachelor of Pharmacy -

Dr. Harisingh Gour University
Sagar, India
05-2000

Some College (No Degree) - Post Doctoral Research

Harvard Medical School
Boston, MA
07-2011

Skills

  • Program Leadership and Asset Strategy
  • Clinical Drug Development
  • Portfolio Management
  • CMC and Technical Operation
  • Stakeholder Management and Collaboration
  • Cross-Functional Leadership
  • BLA, IND, CTA
  • Immunology and Rare Diseases

Affiliations

  • Member, Canadian Society of Pharmaceutical Scientist
  • Member, Controlled Release Society

Awards

  • Indian Council for Medical Research Fellowship Honor, 2006-2009
  • Lady Tata Memorial Trust Fellowship Honor, 2004-2006

Publications

  • Crosslinked polyethylenimine-hexametaphosphate nanoparticles to deliver nucleic acids therapeutics, Nanomedicine: Nanotechnology Biology Medicine, 2010, Patnaik S., Arif M., Kurupati R.K., Pathak A., Kumar P., Gupta K.C., 6: 344-354
  • In vitro and in vivo evaluation of PEI-alginate nanocomposites, International Journal of Pharmaceutics, 2010, Patnaik S., Pathak A., Arif M., Singh N., Gupta K.C., 385: 194-202
  • Gene expression, biodistribution, and pharmacoscintigraphic evaluation of chondroitin sulfate-PEI nanoconstructs mediated tumor gene therapy, ACS Nano, 2009, Pathak A., Chutani K., Jain S., Mishra A., Vyas S.P., Kumar P., Gupta K.C., 3(6): 1493-1505
  • Polyethylenimine derived nanoparticles for efficient gene delivery, Nucleic Acids Symp Ser (Oxf), 2009, Pathak A., Patnaik S., Gupta K.C., 53:57-58
  • Efficient Tumor targeting by polysaccharides decked PEI based nanocomposites, Journal of Biomedical Nanotechnology, 2009, Pathak A., Patnaik S., Swami A., Choitani K., Jain S., Mishra A., Vyas S.P., Gupta K.C., 5: 264-277
  • N(Iodoacetyl)-N'-(anthraquinon-2-oyl)-ethylenediamine (IAED): A new heterobifunctional reagent for the preparation of biochips, Bioconjugate Chemistry, 2007, Patnaik S., Swami A., Sethi D., Pathak A., Garg B.S., Gupta K.C., Kumar P., 18(1):8-12
  • A unique and highly efficient non-viral DNA/ siRNA delivery System based on PEI- bisepoxide nanoparticles, Biochemical and Biophysical Research Communications, 2007, Swami A., Kurupati R.K., Pathak A., Singh Y., Kumar P., Gupta K.C., 62:835-841
  • Recent trends in non-viral mediated gene transfer technology, Biotechnology Journal, 2009, Pathak A., Gupta K.C., 4: 1- 15
  • Nano-vectors in liver-specific gene transfer, International Journal of Nanomedicine, 2008, Pathak A., Vyas S.P., Gupta K.C., 1:1-18
  • Cationic Polymers based Non-viral Gene Carriers: Pharmaceutical Applications of Nano-vectors in Transfection Technology, LAP LAMBERT Academic Publishing GmbH & Co. KG, Germany
  • Novel Cross-linked PEI nanoparticle-based transfection reagents for delivery of Biomolecules, KC Gupta, P Kumar, A Swami, A Pathak, US Patent App 12/1/81,798, 2008

Training

  • Advances in technology and business potential of new drug delivery systems, Controlled Release Society 2016
  • Antibody-functionalized polyethyleneimine based nanoparticles for efficient RNAi mediated gene silencing, Recent advances in drug delivery 2011
  • Immuno-nanoparticle for efficient siRNA delivery, Lymphoma and Leukemia Society Meeting 2010

Timeline

Director, Program and Alliance Management

Keros Therapeutics
10.2022 - Current

Director, Program Management

BioMedica Inc
06.2021 - 07.2022

Head, Program and Alliance Management

American Regents (A Daiichi Sankyo Company)
04.2020 - 04.2021

Director, Program Management

BioVectra Inc (HIG Capital Company)
04.2017 - 03.2020

Associate Director, CMC Project Management

Dr. Reddy’s Laboratories Ltd.
11.2014 - 04.2017

Senior Scientist, Clinical Drug Development

Novartis Pharma AG
09.2013 - 10.2013

Scientist, CMC

Viatris (A Pfizer Company)
08.2011 - 08.2013

Postdoctoral Research Fellow, Cellular and Molecular Medicine, Children’s Hospital

Harvard Medical School
03.2009 - 07.2011

Graduate Student

CSIR Institute of Genomics and Integrative Biology
09.2004 - 02.2009

MBA -

University of Prince Edward Island

PhD, Pharmaceutical Sciences -

Institute of Genomics And Integrative Biology

Master of Pharmacy -

Dr. Harisingh Gour University

Bachelor of Pharmacy -

Dr. Harisingh Gour University

Some College (No Degree) - Post Doctoral Research

Harvard Medical School

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