Omar advises a range of clients on issues including supply chain, drug pricing, launch strategy, and oncology market analytics and planning.
He brings deep expertise working on strategy, operations, commercialization, and analytics across core client segments.
Omar previously led McKesson Specialty Health’s multisource products group. In this role, he held P&L responsibilities for specialty generics, biosimilars, and drugs launching into crowded spaces. Omar also managed the development and execution of their oncology and rheumatology biosimilar strategies. Additionally, he integrated advanced analytics into key functions of McKesson’s business, including pricing strategy, customer segmentation, product campaign design, and portfolio optimization. Prior to McKesson, Omar held roles at A.T. Kearney, Chicago Venture Partners, Omnicell, and HDC Corporation.
Omar has an MBA from Chicago Booth School of Business, an MS in mechanical engineering from Stanford University, and a BS in mechanical engineering from Columbia University.
Authored Content
Manufacturers have noted challenges arising from 505(b)(2) code descriptors, prompting CMS to consider proposed updates
Avalere experts provide insights on the dynamics and policy proposals surrounding recent drug shortages.
Ahead of Asembia 2024, Avalere experts discuss the evolution of biopharmaceutical value requirements and how organizations will need to evolve their business models accordingly.
Drug shortages have consequences for a broad range of stakeholders, and policy proposals vary in their ability to address negative impacts.
Analysis of Dispense as Written codes highlight that many factors influence stakeholder preferences for brand or generic drugs after loss of exclusivity.
The industry should expect and prepare for changes to regulatory oversight of drug supply chains and quality.
The revised guidance contains significant changes to the initial guidance released in March, but important outstanding questions remain.
Avalere’s expert presentations at the AXS23 Summit described IRA drug-pricing policies and the law’s impact on patient access and affordability.
Stakeholders in the drug supply chain should consider operational complexities that will result from variable arrangements for accessing the MFP.
Regulatory changes to the 505 (b)(2) pathway will impact the go-to-market strategy for follow-on products that are not currently deemed therapeutically equivalent to the reference product.
Understanding where federal agencies will make key determinations on details of the IRA’s policies will be crucial for stakeholders seeking to shape implementation and prepare for their impact.
CMS announces long-awaited successor to the Oncology Care Model (OCM), which is scheduled to conclude on June 30, 2022.
As manufacturers prepare for discarded drug rebates to begin in 2023, an Avalere analysis identified 39 drugs at risk for rebates totaling $151 million.
An Avalere analysis found differences in the performance of low- and high-intensity prostate cancer episodes in the Oncology Care Model (OCM). High-intensity prostate cancer episode expenditures were consistently below the benchmark price while low-intensity episode expenditures were similar to the benchmark price. This finding is likely driven by the Centers for Medicare & Medicaid Services (CMS) methodology used to calculate benchmark prices but may also indicate participant success in controlling costs for these episodes.
An Avalere analysis found that Oncology Care Model (OCM) lung cancer episode expenditures increased over 20% from performance periods 2 to 6 while the benchmark price increased about 10% during this period. During this same period, The Center for Medicare & Medicaid Innovation (CMMI) included 20 lung-cancer-specific changes to the OCM Novel Therapy Adjustment (NTA) list. This dynamic supports the inclusion of tumor-specific adjustments in the future Oncology Care First (OCF) model to further account for advancements in cancer management.
Manufacturers currently in the developmental phase for drug assets targeting rare or orphan diseases should assess the commercialization implications when bringing novel therapies to market and how they may differ from the standard pharmaceutical supply chain and economics.
Avalere experts examined the changing oncology landscape amid the COVID-19 pandemic.
Earlier today, the Trump Administration released long-anticipated drug pricing reforms, including rules related to a Most Favored Nation (MFN) approach for drugs administered by providers in Medicare and rebate reform for the Medicare Part D program. Both rules represent fundamental shifts in our current system and have significant implications for manufacturers, health plans, pharmacies, providers, and patients.
Liquid biopsies test blood samples for circulating tumor DNA (tumor derived cell-free DNA), circulating tumor cells, cell-free tumor DNA, proteins, metabolites, exosomes, messenger RNA, and microRNAs. The promise of liquid biopsies is a new modality that screens for cancer in ways that complement and, in some cases, improve existing tests, and allow testing for early detection, cancer diagnosis, and monitoring of minimum residual disease and recurrence, without the need for invasive biopsies.
Join Avalere experts for Part 1 of our Market Access Enablement Strategies webinar series to learn about how life sciences companies are pivoting with pre-/post-new product launch strategies, including differential investments to inform market access execution.
In response to the COVID-19 pandemic, FDA has announced actions that may have much broader implications for drug development, lifecycle management, and oversight.
Globally, the need to flatten the epidemic curve of COVID-19 cases has become the top public health priority to save lives and minimize the burden on the health care system. In the absence of treatments and prophylactics for the novel coronavirus, social distancing and quarantine strategies continue to be implemented in the US.
On Monday, March 23, over 90 products that had historically been regulated as drugs were deemed to be licensed as a biologic. This includes insulin products. During the past several years, the Food & Drug Administration (FDA) has released guidance about their interpretation of the provision to guide sponsors and provide information about what to expect for the transition.
Opportunities exist to accelerate potential vaccine development.
On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA approval. The FDA has not approved a single homeopathic product thus far. The agency is currently restructuring its enforcement and regulatory priorities in this space.
The Food and Drug Administration’s (FDA) efforts to modernize medical device oversight in the agency’s Center for Devices and Radiological Health (CDRH) have continued with the release of multiple draft and final guidances in 2019, as well as a plan for additional releases in 2020.
A new FDA resource is available to identify drug candidates for additional study and serve as a resource to shape medical decisions.
Patient access to high-quality, low-cost generic drugs continues to increase, due to a record number of generic approvals by the FDA in fiscal year 2019.
New call center also supports investigational requests.
On August 6, Avalere’s regulatory experts published an article in BioDrugs highlighting upcoming regulatory changes for insulin.
In its proposed changes to the Medicare Physician Fee Schedule (MPFS) for Calendar Year 2019 (CY2019), the Centers for Medicare & Medicaid Services (CMS) proposes a potentially sweeping change to the way it values physician office and outpatient visits, also known as Evaluation & Management (E/M) codes.
Earlier this week, the Food & Drug Administration (FDA) released a Part 15 public hearing announcement and request for comment on how the FDA can facilitate greater availability while balancing competition and innovation for all biologics.
Avalere evaluated payer policies for biologics when biosimilars are available.
In just two years, on March 23, 2020, biologics currently regulated as drugs will transition to being regulated as biologics. Many aspects of how FDA will implement this transition have yet to be established.
Most people are familiar with generic drugs as less costly alternatives to drugs whose patents have expired.