Health (Pharmaceuticals - Oncology)

 

• Legal support for the oncology business unit (including issues such as account management, brand objectives, channel marketing, copay and other market access matters, discount arrangements, distribution agreements, market access initiatives, pharmaceutical pricing, product strategies and risk mitigation).

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• Legal support for the development of oncology products, such as the: changes in accounting practices – such as changing reimbursement methodology to the average selling price (ASP) model; expansion of the oncology pipeline through the clinical trial testing of new compounds; greater participation in the compliance review and marketing processes by the Federal and state governments, insurers, patient advocacy groups, and various payer entities (thus reducing decision-making opportunities for actual oncologists); increased risk of more oncology product liability litigations, due to the increases in oncology products and treatments; increased use of biomarkers to increase the efficacy of smaller clinical trial groups when seeking narrow results for specific cancer characteristics or types; increases in oncology products sales forces (thus requiring more personnel training for brand awareness, compliance, ethics, FDA guidelines, FTC advertising representations and the like); movement away from non-specific therapeutic agents, such as cytotoxics and broad cell-cycle inhibitors towards more-targeted solutions; testing of multiple agents on rare tumors; use of new alternative payment and payer models – such as Group Purchasing Organizations (GPOs) and Pharmacy Benefit Managers (PBMs) – to force reductions in pricing; use of multiple oncology therapies to target the same molecular pathways; use of the Center for Medicare and Medicaid Innovation (CMS) Oncology Care Model (OCM) to promote new payment strategies that would still allow for high-value and high-quality oncology care.

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• Provided enterprise-level risk assessments for new oncology products, involving significant financial and reputational risk to the enterprise. 

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• Close collaboration with a cross-functional team including subject matter experts (SMEs) in brands, compliance, distribution, intellectual property, legal, marketing, regulatory, research and development (R&D), and other business units, to ensure efficient rollout of oncology products. 

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• Legal support for domestic and international commercial and late-stage development oncology products. 

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• Consultation for commercial, development, distribution, market access, medical affairs, for late-stage clinical and marketed oncology products. 

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• Managed cross-functional legal initiatives related to oncology product advertising, branding, incentives, medical drug information, promotions, and various review committees.

 

• Reviewed business materials related to oncology products, such as advertising campaigns, brand plans, incentive plans, medical plans, promotional and training documentation for accuracy and claims, and provided advice regarding FDA regulatory submissions, label negotiations and privacy considerations.

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• Personal interaction with external relevant parties during the development of new oncological products, such as academic institutions, governmental agencies, healthcare professionals, patients, and payers.

 

• Developed and implemented oncology product-related training materials for management and sales personnel. 

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• Legal support for the development of oncological products targeted for rare hematological cancers. 

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• Legal support for oncology review committees (such as government affairs, investigator, medical affairs, trials). 

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• Legal support for R&D operations involving complex intellectual property issues for biologics, such as biologic platform activities (including antibody discovery, formats, reformatting and optimization), biological molecules (including antibodies, fusion proteins, nucleic acids and peptides), and biologics chemistry, manufacturing and controls (CMC) activities.

 

• Legal support for gastrointestinal, oncology and neuroscience R&D. 

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• Management of domestic and international oncology intellectual property rights (IPRs) portfolios. 

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• Legal support for oncological patent opposition proceedings.

 

• Legal support for various oncological business units, including clinical science, medical affairs, medical specialties, pharmacovigilance and regulatory. 

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• Legal support for oncological R&D operations involving cardiovascular disease, hematology, immunology, obesity and oncology. 

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• Negotiation and drafting of agreements to support oncological-related functions, such as business insights and analytics (BI&A), digital health (DH), real world evidence (RWE), research and development (R&D), including all types of business agreements, such as algorithm development and licensing, buy-side, clinical research, clinical trial, complex infrastructure, contract research organization (CRO), cooperative research, discovery, early asset, health economics, lab services, material transfer, outcomes research, patient-reported outcomes, patient-level data licensing, procurement, related routine, sell-side, technology development.

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• Negotiation and drafting of oncology collaboration agreements and oncology strategic alliance management agreements for oncological (R&D) projects. 

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• Understanding of the oncology drug discovery and development processes within the global bio-tech and pharmaceutical industries. 

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• Alliance management for oncological clinical programs. 

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• Ensured a successful working relationship with alliance partners through efficient contract management during early stage, exploratory oncology clinical collaborations. 

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• Ensured that alliance governance functioned consistently with the intent of the oncology alliance agreement, through joint decision-making relating to combination studies, including the eventual extension of such studies into registrational trials.

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• Legal support for activities related to the conduct, initiation, recruitment, quality data collection and timely completion of domestic Phase I-IV oncology and pharmaceutical clinical trials.

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• Managed background checks, feasibility studies, financial checks, requests for information (RFIs), requests for proposals (RFPs), requests for qualifications (RFQs) to evaluate the capabilities of potential Investigators and networks to conduct oncological clinical trials. 

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• Legal support and recommendations for oncology clinical trial site selection.

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• Training for relevant management and staff regarding the legal aspects of oncological clinical trials, such as agreements, amendments, document management, privacy and records retention.

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• Assisted in the development of oncological product strategy, in alignment with enterprise objectives (such as cost, manufacturing, production, time).

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• Legal support for applying standard budgeting and forecasting models to oncology projects involving compounding, to help identify alternative options to avoid technical risk and to possibly accelerate compound development.

 

Last updated 210509_1542