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Expertise

Siddharth Agrawal

 シニアプリンシパル

Expertise:

Commercialization, Consulting (Strategy Management & Regulatory), Forecasting Activities, Market Access, Market Research, Neurology/CNS, Pricing, Reimbursement & Market Access

Sid brings 20 years of experience in pharma sales, marketing and management consulting. He partners with pharmaceutical industry clients at various levels and functions (brand team, medical affairs, clinical development, regulatory, product development) to assess their business decision needs and design relevant research.

Over the last 15 years, Sid worked with IQVIA (formerly known as IMS Health) Consulting Services, most recently serving as Senior Principal, where he led the competitive intelligence practice as part of the leadership team. During this tenure, he led and delivered more than 500 consulting projects related to brand business insights, competitive intelligence, due diligence, organizational benchmarking, patient journey, analog analysis, brand planning, launch strategy, scenario planning and competitive simulation workshops.

Prior to IMS Health, Sid worked with Ranbaxy Labs as Product Manager, Africa. In this role, he conducted primary market research, market assessment of pharmaceutical products and competitive strategies of other products in the market to develop marketing plans and promotional collaterals, select new products, and optimize the product portfolio. Prior to Ranbaxy, he worked as Product Executive in the Critical Care Division of Dr. Reddy’s Labs in Hyderabad, India, playing a lead role in creating and implementing the launch plan for a new division to market anti-cancer drugs in India.

Sid holds an MBA from Case Western Reserve University in Cleveland; an M.Pharm from Birla Institute of Technology & Science, Pilani, India; and a B.Pharm from Birla Institute of Technology, Ranchi, India.

Articles by Siddharth Agrawal

Critical Success Factors for Launching Products with Orphan Drug Designation

The Orphan Drug Act (ODA) was passed in 1983 to financially incentivize pharmaceutical companies to develop drugs for rare diseases or conditions, defined as a disease or condition that affects less than 200,000 people in the US.1 The financial incentives offered by the ODA are substantial and include tax credits up to 50% of the qualified clinical testing expenses for the taxable year, waived Prescription Drug User Fee Act (PDUFA) user fees that may be upwards of $3 million in 2022, and an extended market exclusivity period of seven years after approval.2 A recent analysis found that receiving an orphan drug designation does, on average, positively impact companies’ value as […]

Against the Odds: Managing the Uncertainty of FDA Approval for Emerging Companies

47% of  FDA applications are delayed for resourceful larger pharma. The situation is even worse for emerging pharma, with 78% of FDA applications being delayed.   Pharmaceutical companies have seen a steady and daunting rise in FDA approval delays for their new products over the past decade. From 2010-2021 the percentage of approved drugs referred to an advisory committee decreased from 55% to just 6% per year. Approval barriers are faced even more by emerging companies with less resources and reputation with the FDA.    Issues such as inspection related delays and changes in FDA leadership paired with evolving industry challenges, especially since the start of the COVID-19 pandemic, continue to drag […]

Breaking through Barriers: Critical Success Factors for Launching Products with Breakthrough Therapy Designation

The FDA’s Breakthrough Therapy Designation (BTD) expedites patient access to innovative new treatments. While speeding up these processes can get new drugs to patients in need faster than they normally would through standard tracks, limited clinical evidence at launch and a compressed launch timeline can present stumbling blocks and uncertainties for commercialization teams tackling launch strategy, planning and execution. A differentiated product will contribute to broader adoption in the marketplace, but that is not the sole factor determining its success. Launch teams must understand that they can control and shape the product’s trajectory. Download the white paper to learn more about the implications of launching BTD products and some critical […]

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