The Trials and Tribulations of Pharmaceutical Drug Development:

From Discovery to Commercialization

Pharmaceutical industry overview
Drug development in Canada what does it take?
Career considerations
Flumist: first intranasal flu vaccine
Shire: leader in ADHD
o Very little knowledge about binge-eating

What is Pharmaceutical Industry

Collection of companies that research, create, and market generic and brand-
name pharmaceuticals, medical devices, and OTC drug products
The global pharmaceuticals market is worth US$300 billion a year expected
to increase to US$400 billion with 3 years
Drug sales to pharmacies (89%)
11% sales in hospitals (buy drugs from manufacturers)
Drug spending:
o 42% by government
o remainder through private insurance companies and cashpayers
Most Canadians have insurance (public or private insurance company), for
those whose drugs are not covered, people paying out of pocket

Canadian Pharmaceutical Market

56 Pharma companies, 10th largest market sales in the world, 6.8% market
growth 2015, 26, 301 employees, 110, 849 prescribers
Shire recently acquired Vaxolta, as a result, company is moving to Toronto;
right now based outside Montreal
2015: 7% growth
Federal/National Responsibilities
o Health Canada market authorization
o Patented Medicines Pricing Review Board pricing regulator
o Common Drug Review HTA review (look at clinical data and
determine whether drug will be reimbursed for Canadians)
Probably number one challenge: difference between access and
no access; not everyone has private insurance; number of
individuals rely on provincial reimbursement outweigh those that
have private insurance
More difficult for CDR to provide a positive recommendation
Provincial
o Provinces independent review of drugs and determine reimbursement
o PCPA Pan-Canada Pricing Alliance
Independent but links with CDR; if CDR comes with negative
recommendation, individual provinces through PCPA have ability
and authority to reimburse and make decision to reimburse drug
for that province
 o Province delivers healthcare (budget) (doctors, hospitals, drugs)
Canadian pharmaceutical environment: universal healthcare for all free
access to physicians
98% of Canadians have drug coverage; drugs are funded through both
private insurers and public health systems
Improving IP System
A relatively predictable regulatory and reimbursement environment
Strong clinical science early clinical research through post-marketing
studies

Company Rankings in Canada (2015)

Johnson and Johnson massive entity with several companies that fall under
umbrella
o One company is Janson (has drug with most revenue)
o Remecade for arthritis
Novatris, Treva/Cobalt/Actavis, Apotex, Gilead, Pfizer/Hospira

Pharmaceutical Development is High Risk

High-risk research: more than $1 billion over 10-15 years

Market exclusivity following approval: 8-10 years
Takes around $1 billion for one molecule to reach market
Every 10,000 compounds they have to screen, only one might make it
Along the way, company is evaluating whether this is something that is going
to be worth our time
Controversial industry: business is for profit
o Research and Development only second to IT
Compliance and rigour around what we can and cannot do

Access to New Medicines in Canada

23% of new medicines receive public coverage/reimbursement across

Canada, 90% of new medicines listed by Canadian public drug plans have
limitations placed on their coverage e.g. only between ages 6 and 12, or
people over 25 would not get reimbursed for drug with ADHD in atlantic
provinces, Canadians wait an average 562 days from Health Canada approval
to public coverage (17th,14th,16th)
Have drugs come to market (time, money), but no access: Canadians dont
have access to latest developments

Pharma Sales and Marketing

Marketing Mix from Porter: Product (people), Price (positioned), Place,

Promotion (packaging)
Target market
Example of Brand Communication Overview
o Vision (what do we want the drug to represent), Strategy (overall plan
to establish the brand in the marketplace, reimbursement,
 doctor/patient, supply chain strategies), Positioning (the enduring
perception we wish to create), Messaging (promotional claims guide),
Campaign (local promotional materials
o Idea (unspoken expression of the positioning, including personality)
o Creative concept (e.g. advertisements), Guidelines
Complicated web: new and/or complex disease areas, health Canada,
impending generics, institutional selling, specialists, retail pharmacists,
common drug review, pricing, complex customer groups, PCP, hospital
listings, hospital pharmacists, protocols, pCPA, field force resourcing, payors
Career in pharma
o Pros: challenging, work with educated, caring, intelligent professionals,
good compensation, flexible environment, fast-paced and always
changing, no i=day ever same, get to travel world
o Cons: little job security constant change, external perceptions of the
industry, small fish in a big pond, can be political, tight regulations
limit creativity, performance pressures