Michael Deluca, Pharmd, Mba, Msra Email & Phone Number

Chicago, Il, Us

• Oversee EVESANA's Global Medical Affairs and Medical Information business unit, which includes our Global Medical Information Contact Center and Medical Affairs services (including medical content development, medical review of promotional and non-promotional materials, digital medical affairs solutions, including medical portals and medical chatbots with conversational AI, etc.). • Manage multi-million Profit and Loss (P&L) and budget. • Develop and deliver Value & Quality driven solutions that are deep-seated in EVERSANA's cultural beliefs of Client Delight and being Patient Minded. Optimally support our clients throughout their products' life-cycle by providing high-quality service and customer engagement to support our clients most important stakeholders - the patients and the healthcare professionals they serve. • Develop the vision and mission of Global Medical Affairs and Medical Information department and the strategic roadmap, including the technology roadmap which includes evaluating and implementing solutions with AI and automation. • Develop and execute thought leadership strategy and build strong industry relations within Medical Affairs / Medical Information communicating, including actively participating in DIA, MAPS, phactMI, MILE, etc.

Chicago, Il, Us

• Support the President Compliance Services Business Unit in 4 main areas of Business Strategy, Business Growth, Business Operations and Business Performance Management. Partner with President to understand current initiatives, create execution plans and monitor performance. Drive the entire P&L for Medical Affairs/Medical Information business globally.• Business Strategy: Actively participate in building and delivering the overall vision of EVERSANA’s Global Medical Affairs services. Proactively work internally and externally to uncover market unmet needs and building right solutions. Building the entire strategy for Medical Affairs line of services to create market differentiation and deliver enhanced value to our pharmaceutical/biotechnology/medical device/digital therapeutics customers. Examples include developing customer satisfaction survey solution, data analytics tool & dashboards, medical chatbot with conversational AI, and medical portal solutions. • Business Growth: Collaborate with commercial teams, understanding the commercial strategy and providing the required support through participating in overall solution development, responses to RFI/RFPs and building customer proposals. Support business development and oversee client relations, including developing capabilities decks, proposals, bid defense presentations, etc. • Business Operations: Collaborate with Medical Information and Medical Affairs Leadership and Business Managers globally to ensure seamless execution of day-to-day operations.• Business Performance Management: Drive overall monthly operational reporting & dashboards both for business growth as well as business operations.

Glen Mills, Pa, Us

Ann Arbor, Michigan, Us

In addition to responsibilities listed below under Head of Medical Information:• Oversee the development and execution of strategic publication plan and scientific platform.• Oversee the development, management and execution of medical communications tactical plans, including the development of congress presentations and manuscript development. • Oversee the strategic and tactical execution of Investigator Initiated Studies (IIS) program.• Oversee the strategic and tactical execution of Independent Medical Education (IME) program.• Oversee the development, implementation, and maintenance of medical information and medical communications policies and standards for operational excellence. • Ensure databases and systems are in place to support the tactical execution of medical information and medical communications strategic plan. • Oversee the medical information and medical communications operating budget.

Ann Arbor, Michigan, Us

• Establish and oversee the operations of Esperion’s medical information contact center, systems, and procedures. This included evaluating and selecting contact center and systems vendors; establishing the avenues by which medical inquiries are received (phone, email, web request form, Veeva CRM, etc.); working collaboratively with pharmacovigilance and quality around adverse event and product complaint procedures; etc. • Oversee the development and implementation of medical information policies and standards for operational excellence of medical information. • Oversee the development and maintenance of all content needed for responses to unsolicited requests for medical information (e.g., Frequently Asked Questions (FAQs), Standard Response Documents (SRDs), Slide Decks, Cover Letters, Email templates, etc.). This included establishing materials for use during pre-approval period and development of materials needed for post-approval and post-launch of Nexletol® (bempedoic acid) and Nexlizet® (bempedoic acid and ezetimibe). • Ensure timely, accurate, evidenced-based and scientifically balanced responses to unsolicited requests for information from internal and external customers consistent with regulatory guidelines and best practices• Provide guidance and training on all aspects of medical information to colleagues involved in responding to unsolicited medical inquiries. Train field teams on how to appropriately document and submit unsolicited requests for medical information. • Ensures that medical information inquiries are screened for potential or actual adverse events or product complaints and these are reported to pharmacovigilance or quality teams in a timely manner.• Develop medical information metrics and customer insights to ensure optimization of medical information inquiry response and escalation processes; to ensure service levels are met; and continuously improve customer satisfaction.• Etc.

Boston, Massachusetts, Us

In addition to the responsibilities listed below under Director:• Establish and oversee the Strategic Operations function of Global Medical Information (GMI) and Medical Review department.• Establish Technology and Digital Strategy Steering Committee for Global Medical Communications and lead the development of technology and digital strategy roadmap. • Evaluate and establish new operating model for the development and maintenance of GMI response documents. • Assist in establishing Medical Review Committee (MRC) process for the cross-functional (medical, legal, regulatory) review and approval of medical affairs materials for use by field medical teams. Provide oversight of MRC operations. • Lead, train, mentor team of medical reviewers for medical, legal, and regulatory review of promotional and medical materials for metabolic disorders franchise.

Boston, Massachusetts, Us

- Serve as a global source and therapeutic expert to ensure content is scientifically accurate and medically relevant to guide clinical decision-making and serve patients and healthcare professionals.- Disseminate accurate and medically relevant scientific content to improve clinical decision-making globally.- Provide strategic planning in alignment with internal stakeholders (Global Medical Affairs, US and Global Commercial, Clinical Development) to ensure product launch preparedness in the global dissemination of medical information for metabolic disorder products.- Oversee the development, review and approval of medically accurate, up-to-date, and timely intellectual capital (e.g., medical information response documents, frequently asked questions) addressing the global medical/scientific community’s knowledge gaps in metabolic disorders, product information and clinical data in order to ensure consistency in scientific exchange by local and world-wide Medical Affairs personnel in a compliant manner.- Build a high-functioning medical information team to support metabolic disorders and medical information operations.- Evaluate cost-benefit outcomes of implementing innovations in quality control mechanisms, supportive systems/databases, efficient inquiry handling work-streams, and overall global dissemination of and access to scientific information. - Ensure procedural consistency and regulatory compliance in the global exchange and dissemination of global medical information by developing and training personnel on global SOPs.- Provide timely, accurate, strategic and comprehensive medical review of promotional and medical materials submitted via the medical, legal, regulatory review process. Train and mentor junior staff on providing medical review of promotional materials.

Marlborough, Ma, Us

• Responsible for many of the same objectives as detailed in Associate Director position below, plus the following.• Oversee and manage the budget for the Medical Information department. • Oversee the medical review team for the Latuda (lurasidone HCl) Promotional Material Review Committee (PMRC) process.• Provide oversight in developing policies, procedures, infrastructure, and training to improve efficiency and scalability for both Medical Information and Medical Affair processes. • Manage and provide oversight of Medical Information pre-launch and post launch planning for Latuda’s new indication for bipolar depression and new drug approval of eslicarbazepine acetate.• Assist in providing Medical Affairs support, including assisting in speaker training for Speaker Bureau program; training of sales representative at National Sales Meeting, Launch Meeting, etc.; assisting in the development of Medical Affairs brand project plans. • Work cross-functionally with Health Economic and Outcome Research (HEOR) department; Area Medical Specialists (AMS) department; and Medical Directors to execute Medical Affairs brand project plans.• Oversee the recruitment, training, and development of Medical Information department staff.

Marlborough, Ma, Us

• Responsible for many of the same objectives as detailed in the Sr. Manager position below, plus the following.• Oversee and manage the pre-launch medical information initiatives for eslicarbazepine acetate, a product in late stage development for partial onset seizures. • Oversee and manage the pre- and post-launch medical information initiatives for Latuda (lurasidone HCl), a recently approved atypical antipsychotic. Initiatives include the creation of verbal scripts (Frequently Asked Questions – FAQs); creation of written response letters (Standard Response Letters – SRLs); training of call center; inclusion of Prescribing Information in Physicians’ Desk Reference Drug Information Service (www.PDR.net and mobilePDR); Epocrates Contact Manufacturer Tool; etc. • Participate and assist with a number of Medical Affairs initiatives for Latuda, including Speaker Training Program; Launch Meeting; Promotional Material Review Committee (PMRC – medical reviewer); Latuda Readiness to Launch Meetings, etc.• Oversee the creation of the Latuda AMCP Dossier, including the eDossier. Ensure that managed care organizations and state Medicaid programs receive the appropriate requested materials.• Oversee the training and development of newly hired medical information staff.

Marlborough, Ma, Us

• Responsible for managing the Respiratory & CNS divisions of the Medical Information Department [marketed products supported Xopenex (levalbuterol tartrate) Inhalation Solution, Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, Brovana (arformoterol tartrate) Inhalation Solution, Alvesco (ciclesonide) Inhalation Aerosol, Omnaris (ciclesonide) Nasal Spray, and Lunesta (eszopiclone) Tablets; products in development eslicarbazepine acetate, lurasidone, ciclesonide HFA nasal spray)• Ensure that department meets its goals in turnaround time of medical inquiries and achieving its goals in customer satisfaction • Oversee the development of monthly and annual Medical Information metric reports• Develop and create the monthly Medical Information Newsletter• Assist in the creation and review of standard response letters (SRLs) and frequently asked questions (FAQs)• Assist in the management of daily workflow; and updating and creation of working guidelines and standard operating procedures• Develop and oversee the creation and maintenance of the Medical Information web-portal (www.SepracorMedical.com) • Assist with managing the budget and expenses for the Medical Information Department• Develop and oversee the Medical Information project plans for products in development • Staff and oversee Medical Information staff at Scientific/Medical Meetings• Assist with the creation and updating of departmental standard operating procedures (SOPs)• Participate and represent Medical Information in cross-functional teams • Develop editorial and formatting guidelines for the drafting of standard response letters• Assist in the creation, review, and updating of AMCP Dossiers• Manage the staff of medical information specialists, coordinator(s), contract writers, and Medical Information vendors

Toronto, On, Ca

• Responsible for managing the newly created Clinical Services department.• Oversee all clinical content, both print and electronic, for all PDR products. Includes trade/copy sales publications and customized publications for pharmaceutical companies.• Work closely with product development and upper management on strategy for individual products and business as a whole.• Provide clinical insight to product development, solution managers (sales reps), and upper management.• Stay current with trends in the healthcare industry, pharmaceutical industry, medical publishing, and medical communications.• Spokesperson for PDRhealth.com.• Create bi-monthly Strategic Marketing Newsletters for PDR sales and product management groups.

Toronto, On, Ca

• Responsible for conducting competitive analysis of online, handheld, and print offerings of clinical/drug information providers. • Work closely with product management in the development of new products (e.g. PDR Drug Interactions Pocket Guide, PDR Brand/Generic Reference, PDRhealth.com). • Assist in the development of business cases for new products.• Identify opportunities, through partnerships, acquisitions, and internal development to give company competitive advantage for online, handheld, and print offerings.• Understand healthcare industry trends and the strengths and weaknesses of healthcare information providers.• Understand pharmaceutical industry trends and help sales identify potential opportunities. • Spokesperson for PDRhealth.com.• Create bi-monthly Strategic Marketing Newsletters for PDR sales and product management groups.

Toronto, On, Ca

• Responsible for managing the Drug Information Specialists (pharmacists). • Work closely with product management, sales, project management, and operations for meeting client (pharmaceutical companies and clinicians) needs. • Work closely with solution managers (sales) to develop strategies and provide clinical knowledge to help prep solution managers for meetings with clients. • Involved in developing and reviewing clinical content for all print and electronic products (www.PDR.net, www.PDRhealth.com, Thomson Clinical Xpert, PDR Electronic Library). • Set the overall objectives for the professional services group and create/maintain the standard operating procedures/working instructions for all clinical content. • Work closely with product management on the development of new products and restructuring of current products.

Toronto, On, Ca

• Write and edit content for Physicians’ Desk Reference (PDR) publications and products. • Draft PDR Addendum letters and PDR Clinical Update letters.• Create front-matter and content of PDR Monthly Prescribing Guides and PDR Concise Prescribing Guides. • Database management of PDR Concise and Pharmacopoeia databases.• Develop content for PDR Pharmacopoeia and Red Book. • Develop and create content for new products and assist in the restructuring of current products. Examples include Hopkins ABX Guide, Physicians’ Desk Reference for Non-Prescription Drugs, and PDR Guide to Terrorism Response.

Ingelheim Am Rhein, Rhineland-Palatinate, De

• Directly responsible for resolving day to day issues related to adverse event reports received from both marketed and investigational use.• Manage documentation, electronic storage, timely reporting and follow-up adverse event case reports at each step of the process.• Ensure the processing of adverse event reports in a timely fashion as specified by Federal Regulations and departmental SOPs. • Work with other departments to ensure consistent, accurate and timely reporting of adverse event information. • Participate in project team meetings and act as contact within Drug Surveillance regarding adverse event reporting procedures, coding issues, conventions and summary reports for therapeutic area.• Perform final review and resolves issues related to safety assurance review at clinical trial completion, including review of coding and reconciliation between clinical and safety databases for therapeutic area.

New York, New York, Us

• Contract Position• Document, data-base, and report adverse event cases.• Trained on ARISg, RSGT, WHO Drug, MedDRA.

• Fill new prescriptions and refill existing prescriptions via written and verbal prescriber orders.• Supervise technicians and interns.• Counsel patients on OTC and Rx drugs.

Bentonville, Arkansas, Us

• Fill new prescriptions and refill existing prescriptions via written and verbal prescriber orders.• Supervise technicians, interns, and the OTC manager.• Counsel patients on OTC and Rx drugs.

Pharmd, Pharmacy

Master Of Science In Regulatory Affairs, Regulatory Affairs

Mba, Mba Pharmaceutical Management And Operations

Pharmacy School Prerequisites