Rare disease · US market access

Bringing rare therapies to the patients who wait.

Israel Figa helps biopharma and medical-device companies navigate the United States — from orphan-drug strategy to specialty distribution and commercial launch. One specialist, accountable end to end.

Trusted by international companies entering the US rare-disease market
IF
Israel FigaLakewood, New Jersey · USA
15+
years in pharma & devices
40+
rare conditions covered
3
continents served
1
point of accountability

Trusted by international companies entering the US rare-disease market

The challenge

Rare-disease products fail in the US for reasons that have nothing to do with the science.

A great therapy is necessary — but never sufficient. The gap between approval abroad and patients in America is operational, regulatory and commercial. That gap is where Israel works.

01

A regulatory maze

Orphan-drug designation, FDA pathways, and reimbursement codes behave differently for rare conditions. One wrong assumption can cost a launch window.

02

A fragmented channel

Specialty pharmacies, hub services, and limited-distribution networks must be aligned long before the first prescription is ever written.

03

A distant market

For a European or Israeli company, the US looks close on paper and far in practice — payers, prescribers and logistics all run on local rules.

The approach

A clear path from approval to access.

Every engagement follows four disciplined stages — no hand-offs, no diffusion of responsibility. You always know what happens next and who owns it.

01

Map the opportunity

We assess prevalence, competitive landscape, regulatory route and realistic US revenue before a dollar is committed.

02

Build the strategy

Orphan-drug positioning, pricing logic, and the regulatory & reimbursement narrative that payers will actually accept.

03

Assemble the channel

Specialty distribution, hub and patient-support partners selected and contracted around your specific therapy.

04

Launch & scale

Commercial execution, prescriber access and ongoing optimization — with one accountable partner throughout.

Services

Everything between your therapy and the US patient.

Orphan-drug strategy

Designation strategy, prevalence modeling and the regulatory positioning that unlocks 7-year US market exclusivity.

Market access

Payer strategy, coding, coverage and the reimbursement architecture rare therapies depend on.

Specialty distribution

Design and management of limited-distribution and specialty-pharmacy networks built for low-volume, high-touch products.

Medical-device access

Commercialization for advanced devices addressing rare and ultra-rare indications in the US market.

US market entry

A turnkey bridge for European and Israeli companies entering the US — entity, partners, and go-to-market plan.

Commercial launch

Launch readiness, prescriber engagement and the day-one execution that determines a rare-disease product’s trajectory.

Therapeutic areas covered

Lysosomal storage

  • Gaucher
  • Fabry
  • Pompe
  • MPS I-VII

Complement-mediated

  • PNH
  • aHUS
  • gMG
  • NMOSD

Metabolic & genetic

  • Urea cycle disorders
  • PKU
  • Wilson disease
  • HAE

Immunological

  • Primary immunodeficiency
  • Rare autoimmune
  • Orphan oncology
Results

Outcomes that move a launch forward.

7-yr

market exclusivity secured through orphan-drug strategy

< 6mo

from first engagement to a contracted US distribution network

100%

of engagements handled directly by Israel — never delegated

A rare-disease launch in the US is a chain of small, unforgiving decisions. My job is to make sure not a single link is left to chance — and to own every one of them with you.
IFIsrael FigaRare Disease Market Access
ישראל פיגא, יזם בתחום התרופות בלייקווד, ניו ג׳רזי
About

Fifteen years turning rare-disease ambition into US reality.

Israel Figa is a pharmaceutical entrepreneur based in Lakewood, New Jersey, focused on the hardest part of rare-disease medicine: getting an approved therapy into the hands of the small, scattered populations who need it.

His work spans regulatory strategy, specialty distribution and commercial launch — with a particular focus on companies abroad that need a trusted, accountable partner on the ground in the United States.

IF

Israel Figa

Lakewood, New Jersey · USA

  • Founder & operator

    Owner of consulting, distribution and marketing companies in pharma and advanced medical devices.

  • International bridge

    Connecting European and Israeli innovators to the US healthcare system.

  • Direct accountability

    Every engagement is led personally — your strategy is never handed to a junior team.

Contact

Let's talk about your US opportunity.

The first conversation is free and confidential. Tell Israel where you are, and he'll tell you — honestly — what the path to the US market really looks like.

  • A direct conversation with Israel — not a sales team
  • An honest read on feasibility and timeline
  • No obligation, fully confidential

Confidential. Your information is never shared with third parties.