Summary
Overview
Work History
Education
Skills
Other Experience
Certification
Phone
Critical Skills
Languages
Timeline
Generic

Andrew J. Weis

Pittsburgh,PA

Summary

Experienced in medical affairs, I have a versatile and quickly adaptable skill set as a field scientist, HEOR specialist, and strategist. Throughout my career, I consistently deliver demonstrable results on-time and on-budget. With a strong track record of success, I am well-equipped to contribute to any organization in need of a dedicated and accomplished professional in the medical field.

Overview

21
21
years of professional experience
1
1
Certification

Work History

Independent Medical Affairs Consultant

Self-employed
04.2018 - Current
  • Providing complete Medical Affairs Strategy consulting to corporate customers in pharmaceuticals, biopharma, biotechnology and device
  • Services include: MSL team building, education and training; AMCP Dossier construction/design and execution; building of headquarters and vending resources balancing; lifecycle management; and HEOR planning
  • Extensive work across multiple functional areas with special emphasis on demonstration of value and scientific/clinical benefits to patient outcomes
  • Successful launch experience for Antibody:drug and Antibody:Radioligand Conjugates in malignant hematology (leukemias, multiple myeloma) and Solid Tumor (Prostate, Hepatic, Ovarian)
  • Over 37 successful new product/indication launches in career
  • Extensive work with biosimilars in oncology (rituximabs, filgrastims, epoietins), and CAR-T cell therapy (multiple agents)

HEOR/Strategy Consultant (contract)

ALKU Holdings
10.2023 - 01.2025
  • Serve as HEOR consultant for AMCP Dossier on specific existing product new indication in rare autoimmune neurological disease state
  • Advise on construction on BIM, integrative PRO instrumentation for RWE models of patient experience with specific disease state and advise on market access strategy for deployment of new targeted studies for US and ex-US markets
  • Also wrote AMCP SOP for company

Sr. Medical Science Liaison (contract)

Servier Pharmaceuticals
04.2022 - 07.2023
  • Serve as senior field medical scientist/acting Associate Medical Director for solid tumor team focused on cytostatic-targeted mutated Isocitrate Dehydrogenase I (mIDH1) inhibitor (ivosidenib) and mIDH 1/2 inhibitor (Vorasidenib) for Cholangiocarcinoma (intrahepatic biliary tract cancer) and low-grade glioma respectively
  • Served as acting/interim Associate Medical Director for Vorasidenib and Low-Grade Glioma for rollout of INDIGO study Plenary Session presentation at ASCO '23
  • Expanded RWE/HEOR inclusion into ongoing Phase 3 trial data mining project to add to Scientific Platform for additional Value Messaging
  • Rewrote major sections of value messaging section of Scientific Platform for Vorasidenib to reflect INDIGO scope of IIT plans and potential launch positioning of NCCN guidelines on brain tumor guideline
  • Rewrote major section of field engagement section of Scientific Platform for Vorasidenib to enhance insight gathering and utilization measurement section commensurate with new MAPA guidelines
  • Served as the primary point of contact, fostering strong relationships between internal teams and external partners.

Adjunct Professor of Pharmacotherapy

University of North Texas System College of Pharmacy
07.2012 - 08.2022
  • Founding faculty member, founding curriculum committee member
  • Teach in multiple rare disease states in oncology and hematology (benign/malignant), addiction medicine and rare neuromuscular/neuroimmunology (e.g
  • Myasthenia Gravis, Niemann-Pick)
  • Taught first lectures in gene therapy in Sickle Cell Disease and Hematologic Malignancies
  • Successfully implemented teaching of novel oncology clinical trial methodology to students
  • First consulting contract for College of Pharmacy was for phototherapy medication for dermatological oncology application
  • Lecture on transition to Oncology Care Model and precepts of precision medicine and targeted patient journey, and HEOR functions within industry during development process
  • Executed external contracts on medical affairs strategy between UNTSCoP and multiple manufacturer clients to introduce young faculty to industry
  • Developed in-house capacity to deliver ACPE-accredited continuing professional education for pharmacists and technicians from accreditation to successful delivery into crowded marketplace

Director of Real-World Evidence and Medical Information

AVEO Oncology
08.2020 - 04.2022
  • Leader of RWE & HEOR generation, distribution and awareness function (including AMCP dossier generation, medical information, clinical outcomes information database generation) for small bio pharma with three major molecules (Tivozanib for mRCC, Hepatocellular carcinoma (clinical development)), Ficlatuzumab (H&NSCC), and AV-380 (anti-GDF15 mAb for cancer-related cachexia)
  • Team led delivery of company's lead product (Tivozanib) from previous negative clinical trial results through to new positive trials results and FDA approval to launch
  • Successfully rebuilt awareness and launch infrastructure to ultimately obtain NCCN 1b recommendation
  • Successfully brought med info functionality back in-house and improved response timelines
  • Successfully rewrote and restructured AMCP Dossier for Tivozanib

Senior Manager/Medical Affairs

Cumberland Pharmaceuticals
08.2012 - 04.2018
  • All medical affair strategy, medical information, field medicine and medical review functions
  • Successfully rebuilt all medical affairs activities in field, including HEOR, medical inquiries, publication/strategy and development products, including BD&L medical reviews with team of two MSLs and four CNEs
  • Successfully expanded department from single person in 2012 to staff of six after prior team left due to prior leader left
  • Successfully lead medical affairs portion of product development for Duchenne muscular dystrophy cardiomyopathy with ifetroban candidate
  • BD & L reviews for three in-licensing candidates in neuroscience
  • Rebuilt MSL/field medical functionality, including re-designing field medical orientation, training, certification, and deployment across target high-growth products and corporate partnerships
  • Conducted 12 successful Consultant/Advisory Boards for GI, pain management/anesthesia, and oncology support with 9.6/10 mean rating from participants per independent consultant post-survey
  • Successfully lead development of oncology medical affairs team components for solid tumor (breast, head/neck, prostate, hepatic)
  • Built successful clinical trial support program with CRO that resulted in President's Club award in 2017
  • Built and developed fully integrated Medical Education, Grant and IIT capacities through SOP development, formal reporting structures, program evaluation and reconciliation procedures and successful delivery of six IITs
  • Major HEOR accomplishments: RWE study of post-surgical opioid complications using extended NSAID/Acetaminophen and non-drug pain management techniques presented at 2015 meeting of American Society for Anesthesia
  • Recipient of President's Club Award, 2017

Principal Medical Science Liaison (contract)

The Medical Affairs Company (for Alkermes, Inc.)
04.2011 - 08.2012
  • Contracted Medical Science Liaison for Alkermes, Inc
  • (Vivitrol)
  • (TX, OK, LA, KS, NE, NM, CO, WY, MT, IA, MN)
  • Coordinated medical affairs team on AMCP Dossier re-write to current standard
  • Developed and delivered training curriculum for MSLs on HEOR/managed care and led certification and key performance indicator development for team that continued past contract
  • Presented four posters on alcohol and opioid dependence pharmacoeconomics at national venues
  • Achieved bonus for vendor contract based on health economics re-assessment of addiction treatment landscape

Interim Director (System) of Pharmacy

Vibra Specialty Health System
01.2011 - 04.2011
  • Interim Director of Pharmacy for multi-campus (three facilities / 160 beds total) long-term acute care hospital system

Clinical Program Manager (contract)

Prime Therapeutics LLC
01.2010 - 01.2011
  • Clinical pharmacy program manager (contract) for Health Care Services Corporation (BCBS authorized for Texas, New Mexico & Oklahoma) Southwest region
  • Clinical program management including formulary development and execution strategy, utilization administration and benefit design consulting
  • Led team that reduced duplication across four major spend categories while improving patient satisfaction per survey
  • Re-aligned specialty delivery channel to speed delivery of oral oncology agents (e.g
  • Gleevec, etc.) to patients by streamlining hub/communication processes and introducing partial fill program

Director-Outcomes Research/Specialty Medicines

Pfizer, Inc.
05.2008 - 01.2010
  • Outcomes research/health economics team member for infectious diseases, oncology and pain/CNS development pipeline and LAUNCH strategies with marketing, market access, clinical development and tech ops
  • Proactively built health care/pharmacy benefit management interface using voice of provider model
  • Designed and implemented PROs and HEOR endpoints in oncology clinical trials in solid organ and hematologic tumors across oncology portfolio
  • Tore down barriers to PRO instrument completion in clinical trials by reworking patient visit flow in 2 critical Phase 3 trials
  • Produced three internal HEOR assessments for oncology/immunology development projects leading to inclusion of endpoints in clinical trials, unable to disclose due to CDA
  • Developed four external HEOR/RWE SOPs that are now standard in all Pfizer Phase 2/3 studies successfully and won commendation from Vice President/Division Head

Senior Manager - Medical Affairs

Dey L. P.
11.2007 - 05.2008
  • Field-based medical scientist for specialty pharmaceutical/branded division of large generics manufacturer (Dey LP division of Mylan)
  • Led key opinion leader development and deployment, investigator-initiated trials, placement/coordination of corporate-initiated research protocols and coverage of assigned professional meetings
  • Products: DuoNeb, Perforomist, Cyanokit, Curosurf

Sr. Medical Science Liaison

Actelion, Inc.
05.2006 - 08.2007
  • Field-based medical scientist for specialty biopharmaceutical company specializing in pulmonary arterial hypertension and lipid storage disorders
  • Duties include: key opinion leader (KOL) management/development, placement/coordination and management of corporate and investigator-initiated research protocols, coverage of assigned medical and professional meetings and special projects as assigned
  • Products: Ventavis, Tracleer, Zavesca

Regional Account Scientific Associate Director

Novartis
04.2004 - 05.2006
  • Field-based health outcomes/managed care liaison supporting entire portfolio
  • Specialty internal input teams on Gleevec (PC+ Leukemias, GIST) and developmental oncology portfolio
  • Led national medical affairs market access team for successful Gleevec GIST launch
  • Led national medical affairs market access team for oncology pipeline

Education

Doctor of Pharmacy - Pharmacy

University of Iowa
Iowa City, IA

Bachelor of Science - Business/Managerial Economics

Allegheny College
Meadville, PA

Skills

  • HEOR/RWE
  • Field medical
  • Clinical trials/operations
  • Medical strategy
  • Launch to life cycle management
  • New product launch strategy
  • Vendor/project management
  • Effective communication
  • Adaptability
  • Quick learning
  • Technology awareness
  • Clinical experience in oncology
  • Clinical experience in autoimmune
  • Clinical experience in neurological
  • Clinical experience in rare genetic

Other Experience

  • Eight years of progressively increasing responsibility in the pharmaceutical industry in medical affairs.
  • Nine years of progressively increasing responsibility in banking industry culminating in Vice President/Chief Operating Officer of Bank of Old York Road, Willow Grove, PA overseeing 90 employees and 15 branches.
  • Licensed in State of Texas for 25 years with clear license and no actions on license.

Certification

  • Certificate in Institutional Epidemiology, Harvard School of Public Health, 2008
  • Certificate in Public Health Research, Harvard TS Chan School of Public Health, 2010
  • Certificate in Industry Medical Affairs, University of Texas/Austin College of Pharmacy, 2009

Phone

cell, 206.992.0700

Critical Skills

  • Experienced medical scientist in HEOR/RWE
  • Field medical
  • Clinical trials/operations
  • Medical strategy and launch to life cycle management
  • New product launch strategy
  • Outstanding vendor/project record - on time and on or below budget
  • Effective communicator across diverse audiences, venues, and levels
  • Adaptable to rapidly changing situations
  • Quick learner and early adopter
  • Current with latest technologies and apps (AI engines, software, hardware)
  • Clinically experienced in multiple therapeutic and functional areas (oncology, autoimmune neurological, rare genetic)

Languages

Dutch
Professional Working

Timeline

HEOR/Strategy Consultant (contract)

ALKU Holdings
10.2023 - 01.2025

Sr. Medical Science Liaison (contract)

Servier Pharmaceuticals
04.2022 - 07.2023

Director of Real-World Evidence and Medical Information

AVEO Oncology
08.2020 - 04.2022

Independent Medical Affairs Consultant

Self-employed
04.2018 - Current

Senior Manager/Medical Affairs

Cumberland Pharmaceuticals
08.2012 - 04.2018

Adjunct Professor of Pharmacotherapy

University of North Texas System College of Pharmacy
07.2012 - 08.2022

Principal Medical Science Liaison (contract)

The Medical Affairs Company (for Alkermes, Inc.)
04.2011 - 08.2012

Interim Director (System) of Pharmacy

Vibra Specialty Health System
01.2011 - 04.2011

Clinical Program Manager (contract)

Prime Therapeutics LLC
01.2010 - 01.2011

Director-Outcomes Research/Specialty Medicines

Pfizer, Inc.
05.2008 - 01.2010

Senior Manager - Medical Affairs

Dey L. P.
11.2007 - 05.2008

Sr. Medical Science Liaison

Actelion, Inc.
05.2006 - 08.2007

Regional Account Scientific Associate Director

Novartis
04.2004 - 05.2006

Doctor of Pharmacy - Pharmacy

University of Iowa

Bachelor of Science - Business/Managerial Economics

Allegheny College
Andrew J. Weis