Unlocking the Mystery of Drug Development & Drug Pricing

Are you interested in getting a high level overview of the therapeutic drug/device development process? Do you want to learn more about the strategic and data considerations and regulatory oversight process associated with drug/device approvals? Do you want to understand how companies secure reimbursement and enable access to medicines? Join us on National STEM/STEAM Day for this informative seminar and discussion as we learn from experienced panelists about how new prescription drugs are discovered, tested, approved, and sold. This panel discussion will be moderated by Meena Subramanyam, Vice President and Global Program Leader in Takeda Oncology.

Panelists include:
- Hani Houshyar, VP, Head of Pipeline Product Development and Commercialization at Biogen
- Elizabeth Mulkey, FDA/Life Sciences Associate at Goodwin
- Ipek Ozer Stillman, Head, Global Health Economics, Payer Value & Patient Access at Takeda
- Olivia Piccione, Principal at ClearView Healthcare Partners
- Cristiane Silva, Global GI Lead – Early Assets, Global Pricing and Access at Takeda Pharmaceuticals

Panelist Bios

Hani Houshyar is Vice President, Head of Pipeline Product Development and Commercialization (PDC) at Biogen. In this role, she oversees the pipeline PDC and commercial teams accountable for driving Biogen’s pipeline assets toward global launches across all of Biogen’s disease areas, inclusive of neuropsychiatry, neuromuscular, neurodegeneration, neurovascular, immunology, ophthalmology and pain. Hani is also the PDC lead for zuranolone, a partnered program with Sage Therapeutics in Phase III development for treatment of postpartum depression and major depressive disorder. Hani joined Biogen’s R&D organization in 2015 as the early stage program leader for the ALS portfolio. In that role, she managed Biogen’s alliance with Ionis and led cross-functional teams across R&D, PO&T, medical, and commercial to advance several programs from research through early clinical development. In 2017, Hani established the portfolio leadership team within R&D with her organization responsible for supporting establishment, communication and execution of the R&D strategy. In 2018, Hani joined the Global Product Strategy and Commercialization team as the the global PDC lead for tofersen, Biogen’s leading asset in Phase III development for the treatment of ALS patients with a mutation in the superoxide dismutase 1 gene. Previous to Biogen, Hani was at Merck for over ten years. Hani obtained her Ph.D. in pharmacology from the University of Michigan and conducted her post-doctoral studies in neuroscience at the University of California, San Francisco.

Elizabeth Mulkey is a senior associate in Goodwin’s Technology and Life Sciences groups and a member of the firm’s FDA regulatory practice. She counsels pharmaceutical, biologic, medical device, digital health, and consumer product companies on FDA regulatory compliance issues, including advertising, promotion and labeling review, drafting and review of standard operating procedures, drug and device development issues, interactions with FDA, internal corporate investigations, and responding to FDA inspection observations and enforcement actions. Ms. Mulkey advises clients as a member of promotional review committees and works with biopharmaceutical companies on communication activities from early-stage development through commercial launch.

Olivia Piccione is currently a Principal and a member of the leadership team at ClearView Healthcare Partners, a life sciences consulting company headquartered in Newton, MA. Olivia has developed expertise across a range of therapeutics areas over the course of 8+ years of experience in life sciences research and consulting, but she has a specific interest in rare diseases, immunology, and ophthalmology. She has a passion for supporting clients with highly innovative technology platforms in the development and commercialization of their therapies for patients with significant unmet need. During her time at ClearView, Olivia has assisted a wide array of clients, ranging from leading biopharmaceutical companies to early-stage biotechs, in addressing their highest-priority strategic issues. Olivia’s work focuses on commercialization strategy, including new product planning, portfolio prioritization, M&A and due diligence support, and strategic launch planning. Through this diversity of experience, Olivia has a demonstrated track record of ensuring commercial, clinical, and scientific factors are effectively considered to address her clients’ strategic questions.Prior to ClearView, Olivia received her B.A. in Economics and a Secondary Field in Chemistry from Harvard University.

Cris Silva is an experienced commercial and market access leader, with 20+ years of experience in the pharmaceutical industry, in the US and international markets. Collaborative team player and strategic thinker in global market access and pricing, global commercial development, marketing, sales and account management, clinical research, medical affairs and operations, Cris led several blockbuster product launches in oncology and specialty care. Strong commercial and market access team leader that successfully leads teams through often complex environments, from developing and communicating solid strategy to effective execution of projects, resources and product launches.

Date and Time:
November 8, 2021
6:15-7:45 PM EST

Location:
Zoom

Cost:
Free, subsidized by the WEST Board to bring this important information to everyone.

Given our mission is to promote women's development in STEM we would like to offer a free spot in our workshops to those in transition between jobs or who cannot afford the ticket price. Please contact [email protected] if you qualify.