SMi proudly presents this half-day workshop before the 3rd annual Biosimilars USA  conference on 'Optimizing Price and Access'!

Workshop will address, in a deliberative and interactive manner, factors to consider when:
1. A biosimilar is entering an original biologic’s space
2. Evaluation process for biosimilars
3. Legal aspects around biosimilars and competitive pricing
4. Evaluating price-points for biosimilars
5. Defensive considerations and when to start
6. Hedging outcomes between biologics and biosimilars

The workshop will help participants understand drivers of access and pricing within the legal environment and prevailing competitive landscape:

a) Leading areas where biologics’ market share and access are facing incoming biosimilars

b) Biotechnology heads leading development of biosimilars and preparing such products for launch and/or price-setting
Will find this workshop invaluable in understanding the competitive dynamics associated with biosimilars in this new but evolving market

VPs, Directors, Heads, Managers of:

  • Pricing & Reimbursement
  • Market Access
  • Commercial Strategy
  • Health & Economics Outcome Research
  • Evidence

of pharmaceuticals and biotechs companies

Workshop LEADER


Mkaya Mwamburi

Vice President of Health Economics & Outcomes Research, Market Access Solutions

Mkaya Mwamburi MD, PhD, MA (Econ), is Vice President of Health Economics & Outcomes Research and heads the HEOR practice area. Mkaya is an HEOR specialist and evidence strategist with extensive experience in consulting for pharmaceutical industry leading health economic modeling, systematic reviews, and value determination and communication projects among others. He also has experience in the clinical trial analysis of oncology and immunology products and has published extensively in this space.

Market Access Solutions

MKTXS Market Access Solutions, LLC is a boutique consultancy that helps pharmaceutical and biotechnology companies with integrated evidence generation and market access and price optimization strategies. MKTXS helps clients identify and align product value with unmet needs to optimize access and price through robust evidence generation and values demonstration and communication.


Workshop programme

13:30 Registration & Coffee

14:00 Workshop Leader Introduction

Mkaya Mwamburi

Mkaya Mwamburi, Vice President of Health Economics & Outcomes Research, Market Access Solutions
View Bio

14:10 How Much Should We Charge?

15:15 Afternoon Tea

15:45 Case Study & Exercise: Developing a Sustainable Business Model

16:30 Round Up Q&A

16:45 Workshop Leader Closing Remarks and End of Workshop


Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830

Renaissance Woodbridge Hotel

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.



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CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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