Summary
Overview
Work History
Education
PRECEPTOR/TEACHING EXPERIENCE
Timeline
Generic
MEGHAN COLASANTO, PHARMD

MEGHAN COLASANTO, PHARMD

Southbury,CT

Summary

Accomplished Medical Director specializing in Hematology/Oncology with a strong background in Clinical Development as a Clinical Scientist. Over 13 years of experience in clinical development and medical affairs within the pharmaceutical and biotech industries. Graduated with a Doctor of Pharmacy degree from the University of Connecticut, complemented by a Bachelor of Science in Pharmacy Studies and Physiology/Neurobiology. Expertise in providing medical strategy for early pipeline hematology asset and late-stage breast cancer asset, specifically in PROTAC protein degradation. Proven track record in driving clinical trial execution on complex global Phase 1/2 Oncology trials. Previous experience as a clinical pharmacist at Yale New Haven Hospital and mentor to pharmacy students, residents, and fellows.

Overview

20
20
years of professional experience

Work History

Medical Director, Medical Affairs

Arvinas, Inc.
03.2024 - Current
  • Develop and Implement medical affairs plans and strategies for early development hematology asset, BCL6 PROTAC degrader (ARV-393) and late-stage breast cancer asset, ER PROTAC Degrader (Vepdegestrant)
  • Lead strategy and KOL engagement at congresses for the hematology BCL6 degrader / ARV-393 program
  • Oversee creation, maintenance, and review of internal and external scientific content (scientific communication platform, medical training materials, external facing materials, etc)
  • Lead medical strategy support for patient advocacy initiatives for Vepdegestrant
  • Provide Medical strategy support and oversight of medical sponsorships and grants
  • Actively participate in the Global Asset Team core team for ARV-393
  • Lead joint medical affairs activities with alliance partners in medical information initiatives, including medical input and review of medical information standard response documents
  • Plan and execute medical affairs advisory boards for the hematology BCL6 degrader program
  • Initiate, expand, and maintain peer-to-peer KOL relationships aligned with therapeutic areas of interest.
  • Provide medical review as part of the Medical, Legal, & Regulatory (MLR) process and/or Medical Review Committee (MRC)

Director, Clinical Scientist, Clinical Development – Oncology

Arvinas, Inc.
09.2021 - 03.2024
  • Lead Clinical Scientist, driving the study data review and analysis, clinical document development, clinical study planning/training, and scientific literature review of the Androgen Receptor (AR) PROTAC asset.
  • Led the clinical data review and analysis in preparation for data readouts (internal safety and efficacy interim data readouts for leadership; monthly safety data review meetings) and external data readouts [quarterly (SRC) Safety Review Committee meetings]
  • Led and presented on protocol design, pre-clinical and background data for Study Initiation Visits (SIVs); Quarterly SRCs and internal monthly (SDR) Safety Data Review Meetings
  • Contributed in the development and review of clinical study reports (CSRs) and provided input on the development and review of the statistical analysis plans (SAPs) and tables, listings and figures (TLFs)
  • Drove the development of all protocol and protocol amendments including synopsis and researching historical data for specific high-risk mcSPC , mCRPC, and BCR populations
  • Led the development of study specific documents for the protocols and protocol amendments including feasibility questionnaires, informed consent forms (ICFs), electronic case report forms (eCRFs), training slides, medical monitoring plans, medical data review plans
  • Authored and reviewed clinical sections of the IB and DSUR and expedite timelines for early completion and prepare, synthesize and update the risk sections for the master ICFs
  • Led Medical Monitoring activities including review of eligibility packets, development of the clinical development plan and worked with the Study physician in ongoing clinical data review bringing forth new trends on safety and efficacy data
  • Researched, drafted, and finalized Health Authority (HA) responses for both the UK, France, and Health Canada CTAs and leads efficient updates and authoring to all impacted documents (IB, ICFs and protocol country specific amendments)
  • Supported execution of database migrations for updated eCRFs in supporting site and CRO training, to ensure data integrity and data updates are timely, through eCRF completion guidelines reviews/updates

Associate Director, Study Management and Conduct – Oncology

Boehringer Ingelheim Pharmaceuticals, Inc.
05.2019 - 06.2021
  • Drove the clinical trial execution for 3 global complex Phase 1 Oncology trials. Two included below and one in early trial set up platform trial with a large, external academic collaborator:
  • A Study in Patients with Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (MDM2-inhibitor) in Combination with BI 754091 (anti-PD-1) and 754111 (anti-LAG-3) https://clinicaltrials.gov/ct2/show/NCT03964233?term=BI+907828&draw=2&rank=2.
  • SOS:KRAS inhibitor monotherapy and in combination with trametinib in patients with different types of advanced cancer (Solid Tumors with KRAS mutation): https://clinicaltrials.gov/ct2/show/NCT04111458?term=B+1701963&draw=2&rank=1.
  • Led and oversaw large, global, cross-functional trial teams to ensure clinical study deliverables of complex Phase 1 clinical trials are within the planned budgets and agreed upon timelines, and adhering to operational procedures, quality standards, GCP, SOPs and business guidelines
  • Identified and pro-actively anticipated operational risks and mitigation plans and escalated issues and recommended contingency plans to Senior leadership during monthly TRMs (Trial Review Meetings)
  • Provide operational and scientific/clinical expertise into the development and implementation of all study specific documentation including synopses, protocols, clinical trial reports, informed consents, Investigator Site Files, Patient-facing documents, electronic case report forms, trial training plans, site monitoring plans
  • Maintained oversight of study-specifics systems, including CTMS (Impact), TMF (BIRDS-Wings), ClinSights, IRT (Almac/SupplyTraQ), RAVE
  • Led feasibility assessments and oversees sight evaluation and sight selection
  • Planned and implemented investigator Meeting initiatives and activities
  • Responsible for the oversight of data quality, including resolution of all queries and timely mitigation plans in preparation for Dose escalation Safety Monitoring Committee (SMC) meetings
  • Participated in departmental committees involved in Study Start up Process improvement initiatives, and developed and led Communication and Engagement initiatives

Associate Director, External Research – Oncology

Boehringer Ingelheim Pharmaceuticals, Inc.
11.2017 - 05.2019
  • Executed project management of External Research studies through the intake, evaluation, documentation, conduct and final close out activities, encompassing over 40 Oncology Investigator Initiated Studies (IIS) and External Collaborative Research (ECR) studies
  • Drove External Research review meetings to ensure efficient conduct in alignment with established processes. Accountable for timely and accurate documentation and prompt action following reviews and committee-directed actions, ensuring the accurate translation of scientific discussions into well-formulated communication to stakeholders.
  • Led and worked cross functionally with Global Pharmacovigilance, Medical, Regulatory Affairs, Legal and contracting, and data management and biostatistics to co-develop (ECRs) and (IIS) on the study proposal, protocol and associated documents, ensuring that appropriate safety monitoring, language and reporting, drug supply requirements, and protocol methods are included and clearly defined in the Sponsor-Investigator's protocol for all External research trials.
  • During conduct, managed study recruitment, drug supply and adverse event reporting requirements, ensuring applicable trial related information is tracked in CTMS and other systems/repositories and working with internal and external stakeholders (finance controller, Medical, Contracting, Legal, FBM, GPV, RA, BDS; Principal Investigator, Study coordinator) to ensure timely and efficient study updates are communicated
  • Led and facilitated teleconferences with Investigators and sites regarding study status updates including major US Oncology institutions, Southwest Oncology Group (SWOG), National Comprehensive Cancer Network (NCCN), National Cancer Institute (NCI), and other consortiums (ASCO, ITOG)
  • Provided a strong partnership with Oncology FBM, Oncology Therapeutic Area leads, and cross-functional teams to inform of IIS/ECR study progress and challenges, revisions to publicly posted research objectives, yearly Medical Tactical Plan (MTP) updates; update trackers to reflect the current status of each study which is used to facilitate discussions in the field and within management
  • Monitored and planned trial budgets and maintained accurate financial forecasts on a monthly basis to report to finance controller and TA leadership
  • Executed the SOP Simplification Project from development to finalization leading reviews with CDMA internal stakeholders and other BI colleagues that interface with BI processes in support of External Research. This entailed conducting multiple workshops, updated the Local Working Instruction and a comprehensive “How to Guide.”
  • Directed the External Research team in the design and development of the new global grants and external research funding system. This required step by step examination of the intake, review and processing, approval, and communications of an application and to work with the Global Process Owner, Gobal IT, vendor members to ensure a customer-centric system was built.
  • Steered the operational success in the study start up timelines between an Oncology basket study with ASCO and BI being a collaborator. Presented at a BI Medicine TownHall meeting in front of 5,000 colleagues, highlighting the operational best practices which led to key successes with the ASCO/BI collaboration.

Senior Manager, Global Medical Information – Complement Inhibitor (Eculizumab)

Alexion Pharmaceuticals, Inc.
04.2017 - 10.2017
  • Developed and maintained a written database of specialty-focused Standard Response Documents (SRDs) and FAQs based on requests received and/or new data available in disease specific areas of hematology, nephrology and neurology
  • Ensured timely and accurate documentation, tracking, triaging and fulfillment of responses to all unsolicited inquiries for global medical information related to the complement inhibitor (Eculizumab) franchise
  • Analyzed, customized, and presented on quarterly trend analyses from medical and scientific inquiries to key internal stakeholders
  • Initiated and implemented a rapid response team led by the Chief Medical Officer to ensure timely company-wide distribution of FAQs and presented on inquiries to date on company sensitive topics (received Alexion’s Appreciation Award)

Program Director, Medical Information Fellowship Program

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI)
01.2014 - 03.2017
  • Led a MI Fellowship team, coaching and developing the Fellows through formal, quarterly performance evaluations.
  • Facilitated career development opportunities and created development plans by providing on-the-job learning and rotational opportunities to help further strengthen and expand the Fellows’ diverse skill sets and competencies
  • Prepared for the yearly Fellowship recruitment by developing the Fellowship brochure and curriculum and interviewing at the ASHP Midyear Conference to identify and select the top candidates to further continue the success of the program and initiate early pipeline leadership succession.
  • Provided guidance and oversight on Fellow’s rotations, day -to- day activities, and longitudinal research project

Associate Director, Medical Information Therapeutics

Boehringer Ingelheim Pharmaceuticals, Inc.
05.2013 - 03.2017
  • Led all medical information therapeutic activities to fully support the launches of Spiriva Respimat in Asthma and COPD by providing medically-accurate, focused, fair- balanced, and most current scientific responses to health care providers, consumers, and internal stakeholders
  • Developed and maintained an extensive written database of HCP-focused Standard Response Documents (SRDs) and consumer- focused FAQs based on requests received and/or new data available with emphasis on customer-centricity
  • Created and updated the AMCP Managed Care Formulary Product Dossiers for Spiriva Respimat in Asthma and COPD used to obtain and maintain formulary approval of BIPI products
  • Facilitated, developed, and reviewed evidence submissions to external Drug Information Resources (i.e., PHARMACIST’S LETTER/PRESCRIBER’S LETTER) and Evidence-Based Practice Centers (e.g. Drug Effectiveness Review Project [DERP], Agency for Healthcare Research and Quality [AHRQ] on data regarding the Spiriva Respimat in Asthma program
  • Provided comprehensive call center oversight by conducting product and disease state training and performing weekly quality assessment of medical information cases; providing re-education to call center staff when specific trends were noted
  • Served as voting member of the Medical Education Grant Review Committee by reviewing COPD and asthma educational grant proposals and presenting recommendations from a Medical information perspective; providing feedback in the areas of content bias, balance of treatment options, and ensuring alignment of BIPIs educational objectives
  • Conducted continuous pre- and post-launch respiratory product trainings to various large-scale audiences by tailoring the training to the needs of diverse audiences (i.e., pharmacists, nurses, BIPI sales representatives, sales trainers, and Field Based Medicine)
  • Identified analyzed and customized monthly trend analyses on medical and scientific inquiries to key internal stakeholders
  • Conducted MLR review of promotional materials to support preparation of Spiriva Respimat in asthma launch by working with cross disciplines (Medical and Marketing) and ensuring call center launch readiness and alignment on post-launch communications
  • Participated in scientific and medical communications’ conferences, (i.e. ATS, DIA) by serving as a source of medical information at product-specific medical booths and supporting the Fellows’ poster exhibition at the DIA Medical and Scientific Communications’ Annual Forum

Clinical Pharmacist – Internal Medicine

Yale New Haven Hospital Pharmacy Department, Saint Raphael Campus
01.2010 - 05.2013
  • Rounded daily with medical teaching team, evaluating patient profiles and monitoring drug therapy
  • Collaborated with continuing care, social work, and other disciplines in daily discharge rounds to help facilitate discharge of patients and optimize transition of care
  • Participated in daily geriatric rounds, working with the geriatric consult team, nurses, and other disciplines, focusing on minimizing poly-pharmacy and inappropriate prescribing in the elderly
  • Reviewed medication orders for accuracy and appropriateness, using the hospital’s CPOE system in the areas of general medicine, adult and pediatric psychiatry, surgical step-down unit, labor and delivery, and the newborn intensive care unit

Clinical Pharmacist – Intensive Care Unit/ Operating Room

Yale New Haven Hospital Pharmacy Department, Saint Raphael Campus
01.2006 - 01.2010
  • Rounded daily with the surgical ICU team collaborating with nurses and physicians on topics of infectious disease, intubation and sedation, stress ulcer prophylaxis, TPN management, and helped facilitate medication reconciliation upon transfer from the unit to the floor
  • Reviewed medication orders for accuracy and appropriateness using the hospital’s CPOE system in the areas of surgical intensive care unit (SICU), cardio-thoracic intensive care unit (CTICU), medical intensive care unit (MICU), and the coronary intensive care unit (CICU)
  • Served as a liaison between pharmacy Sterile Products and the ICUs in addressing IV push protocols, solution compatibilities, titration audits, continuous renal replacement and TPN therapy
  • Launched new operating room pharmacy satellite, working on various quality improvement projects on cost savings by implementing proper medication distribution in the OR department
  • Checked IV admixtures prepared in the sterile products OR hood, entered and reviewed pre-op and post-op surgical orders using the CPOE system, checked all medications stocked daily in the anesthesia carts, and served as a clinical resource to the anesthesia and surgical staff

Community Pharmacist, Per Diem

CVS Pharmacy
01.2006 - 01.2010

Education

Doctor of Pharmacy - undefined

University of Connecticut
Storrs, CT
01.2006

Bachelor of Science - Pharmacy Studies

University of Connecticut
Storrs, CT
01.2004

Bachelor of Science - Physiology and Neurobiology

University of Connecticut
Storrs, CT
01.2002

PRECEPTOR/TEACHING EXPERIENCE

  • ASHP – accredited PGY-1 Internal Medicine Preceptor
  • Yale New Haven Hospital Pharmacy Department
  • New Haven, CT
  • 2010 - 2013
  • Provided didactic teaching to six pharmacy residents per year in general medicine by incorporating and applying evidence-based medicine into the patient care process
  • Assessed residents’ drug information skills and clinical knowledge by evaluating formal drug information write-ups, formal presentations, and in-services given to the medicine and pharmacy departments
  • Integrated the residents to their internal medicine teaching teams and multidisciplinary discharge teams, providing support and guidance in helping them build effective professional pharmacist-provider relationships in becoming an integral part of the healthcare team
  • Met with the residents daily for patient case work-ups and topic discussions to provide an ongoing daily assessment of their knowledge and clinical skills
  • Performed an initial, midpoint, and final evaluation of the residents’ progress via Resitrak system

Timeline

Medical Director, Medical Affairs

Arvinas, Inc.
03.2024 - Current

Director, Clinical Scientist, Clinical Development – Oncology

Arvinas, Inc.
09.2021 - 03.2024

Associate Director, Study Management and Conduct – Oncology

Boehringer Ingelheim Pharmaceuticals, Inc.
05.2019 - 06.2021

Associate Director, External Research – Oncology

Boehringer Ingelheim Pharmaceuticals, Inc.
11.2017 - 05.2019

Senior Manager, Global Medical Information – Complement Inhibitor (Eculizumab)

Alexion Pharmaceuticals, Inc.
04.2017 - 10.2017

Program Director, Medical Information Fellowship Program

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI)
01.2014 - 03.2017

Associate Director, Medical Information Therapeutics

Boehringer Ingelheim Pharmaceuticals, Inc.
05.2013 - 03.2017

Clinical Pharmacist – Internal Medicine

Yale New Haven Hospital Pharmacy Department, Saint Raphael Campus
01.2010 - 05.2013

Clinical Pharmacist – Intensive Care Unit/ Operating Room

Yale New Haven Hospital Pharmacy Department, Saint Raphael Campus
01.2006 - 01.2010

Community Pharmacist, Per Diem

CVS Pharmacy
01.2006 - 01.2010

Doctor of Pharmacy - undefined

University of Connecticut

Bachelor of Science - Pharmacy Studies

University of Connecticut

Bachelor of Science - Physiology and Neurobiology

University of Connecticut

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