PIA INSIDER - Pharmaceutical Industry Association of Puerto Rico

PIA INSIDER
SEPTEMBER 2013
YOUR INSIDE GUIDE TO
THE PUERTO RICO PHARMACEUTICAL INDUSTRY
UPCOMING
EVENT S
October 30 - November 1:
PIA 24th Annual Meeting at the Wyndham Rio Mar
Beach Resort in Rio Grande
PIA Board of Directors:
President: Camilo Gómez, General Manager, AbbVie
Vice President: Carlos Ceinos, General Manager, Novartis
Secretary: Frank Rodríguez, VP & General Manager Pharma Operations,
Warner Chilcott
Treasurer: Robert Maroney, VP & General Manager, Amgen
Directors:
- Jennifer Herron, VP & General Manager, Bristol-Myers Squibb
- Barry Regan, Site Director, AbbVie
- Lourdes Colón, VP & General Manager, Lilly del Caribe
- Elsa Saavedra-Garay, Commercial Business Director, AstraZeneca
- Yvonne McBurney, VP & General Manager, GlaxoSmithKline
Ex-Officio:
- Rafael Castro, Operations VP, PIA
- Iván Román, Advisor to the Board, StraTech LLC
- Eduardo M. Negrón-Navas, Legal Counsel, Fiddler Gonzalez & Rodríguez
PIA Committeeʼs:
Communications: Rafael Castro, Operations VP, PIA
Competitiveness: Lourdes Colón, Vice President & General Manager, Lilly
del Caribe
Government Affairs: Néstor Ortiz, Commercial & Government Affairs
Director, AbbVie
Market Access: Marina Vital, Strategic Customer Group Director, Johnson
& Johnson
Medical Affairs: Dr. Carlos Rivera Vázquez, Medical & Scientific Aff.
Director, AbbVie
Quality Assurance: Gloria Martínez, Director Quality Sciences, Amgen
A Message from the President,
Camilo Gómez
About 35 years ago, the Pharmaceutical Industry Association of PR
started its journey to serve the people of PR. Today, the industry is
facing significant new challenges in many facets of the business;
nevertheless, PIA continues its mission to “foster an environment that
strengthens Puerto Rico’s pharmaceutical and biotechnology
industry’s global competitiveness and improves access to innovative
medicines for its citizens.”
Our efforts have been focused on four strategic priorities:
1) Improve competitiveness to retain and attract operations to PR.
2) Ensure market access.
3) Build strong links with key stakeholders.
4) Strengthen PIA’s position and capabilities.
As part of our objective of having an inclusive Association that shares
this strategic map and promote participation of all its members, we
start today a new initiative: PIA Insider. This electronic newsletter will
convey information about our industry and individual companies to
learn about the value the Pharmaceutical Industry adds to Puerto Rico
and the puertorricans.
PIA Insider will be published quarterly and will be distributed to all
manufacturing and commercial sites management to be cascaded to
our entire industry employees. We urge you to share the information
you believe should be of public knowledge though this mean of
communications.
www.piapr.org
PIA Members:
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Abbott
AbbVie
Allergan
Amgen
AstraZeneca
Bristol-Myers Squibb
GlaxoSmithKline
Johnson & Johnson
Lilly del Caribe
Merck
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Novartis
Pfizer
Procter & Gamble
Sanofi
Warner Chilcott
PIA Supporting Members:
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Business Excellence Consulting
Caribbean Industrial Construction, S.E.
CRB Caribe, LLP
Fiddler, Gonzalez & Rodriguez, P.S.C.
IMS Health, Inc.
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MC-21
PACIV
PharmaBioServ, Inc.
PharMaCon
VWR Advanced Instruments, LLC
Novartis shines with
President’s Award at PRMA
Recently, Novartis was recognized by the
Puerto Rico Manufacturing Association
(PRMA) with their President’s Award for their
excellent achievement in the Occupational
Safety and Health records during 2012 as a
result of management and associates’ joint
efforts to reduce work injuries in our industrial
operations.
The Novartis Humacao site has received this
award for more than five consecutive years
demonstrating to have sustainable results due
to adequate HSE management systems and
the commitment of our associates and
management toward the safety of our people.
“This award is a reflection of the individual
contribution of all our associates to jointly
achieve the Novartis Corporate Goal of Zero
Harm to our People”, said Ángel Ortiz, HSE
Manager, Novartis.
In the picture from left to right: Tania Álvarez, President of PRMA
Safety Group; Martín Del Río, Occupational Health Nurse from
Novartis; Ángel Ortiz, HSE Manager; and Waleska Rivera, PRMA
President.
Lilly: Leading
the Development
of Future Generations
Our employees are highly engaged
with our outreach efforts and proudly
devote time to participate in the Bio
For more than 135 years, Lilly has
remained dedicated to discovering
and developing innovative medicines
to improve the health of millions of
people around the globe. Since 1965,
with the establishment of our operations
in Puerto Rico, Lilly del Caribe has been
committed to being a leader in corporate
citizenship and maintains a proven record
of community involvement that extends far
beyond the medicines we make.
Week activities, AIDIS Science Fair, and
seminars at K-12 and higher education
institutions to share their knowledge
and experiences.
Our commitment is to develop future generations of
professionals in Puerto Rico by proudly advocating
opportunities and experiences as avenues to further the biopharmaceutical industry and shape the
communities we serve. As part of our concerted efforts, we have a variety of pioneering programs in
place including “The Lilly Academy”. This comprehensive program provides talented students with
industrial internships and post-doctorate fellowship opportunities as well as enriching seminar series
and technical forums provided by first class speakers. Such technical forums become an exciting
center of academic exchange for a select group of industry and academia scientists, engineers, and
students with interests in protein biochemistry, large scale protein purification, bacterial fermentation,
and bio-analytics. It encourages an open dialog and provides students with the opportunity to
demonstrate their courage and curiosity to pursue the unknown.
The Lilly Academy is complemented with the hosting each year of more than 100 students from
different research-based institutions through a Cooperative Learning Program, where they receive
mentorship and a real hands-on experience in the industry. Furthermore, we instituted the “Dr. Frank
M. Deane Passion for Science Award” for outstanding graduating baccalaureate students interested
in pursuing post-graduate degrees in the science and engineering fields to supplement the “Beca
Lilly” for graduate students in applied sciences. Our employees are highly engaged with our outreach
efforts and proudly devote time to participate in the Bio Week activities, AIDIS Science Fair, and
seminars at K-12 and higher education institutions to share their knowledge and experiences and
significantly impact younger populations.
As an innovation-driven company, we know science underlies all aspects of our operations and
people’s technical capabilities are of upmost importance for the growth and competitiveness of
Puerto Rico. To that end, we will continue playing an active role in the development of future
generations through innovative efforts that pose limitless possibilities for the success of our
operations, the biopharmaceutical industry, and Puerto Rico.
GlaxoSmithKline Puerto Rico
appoints Miguel Vázquez Padua
as their Commercial Director
Yvonne McBurney, Vicepresident and General Manager for GlaxoSmithKiline Puerto Rico
recently announced the appointment of Miguel Vázquez Padua as Commercial Director –
General Pharma.
Miguel initiated his career path through academia, initially joining Universidad Central del
Caribe School of Medicine as an Assistant Professor and Researcher in Pharmacology, and
later becoming Associate Professor and Chairman of the Department of Anatomy and Cell
Biology.
He transitioned to the pharmaceutical industry in 1996 by way of SmithKline Beecham, later
to be followed by GSK, Pharmacia and Pfizer through the following years. During that time
Miguel held various well regarded industry positions including Senior Regional Medical
Associate, Clinical Research Manager, Senior Regional Medical and Research Specialist and
Clinical Director. Later, he accepted a position to lead local commercial operations in
Primary Care as State Director for the Pfizer Puerto Rico Primary Care Unit.
Miguel has additionally participated in pharma trade activities as member of the Puerto Rico
Pharmaceutical Industry Association’s Board of Directors as well as Chair of its Medical
Committee. He was also elected president the Puerto Rico HealthCare Council.
Miguel completed his PhD degree in Human Cancer Biology (Biochemistry minor) at
University of Wisconsin –Madison Comprehensive Cancer Center. He joined as a
Post-doctoral Associate at the Department of Pharmacology at the University of North
Carolina-Chapel Hill School of Medicine, where Miguel pursued research activities under the
mentorship of Dr. Yung-chi Cheng, giving him the opportunity to conduct studies in Cancer,
HIV and Herpes viruses. He later became the recipient of the Leslie H. Warner Foundation
Fellowship during his post-doctoral tenure in the Department of Pharmacology at the Yale
University School of Medicine.
Pfizer Oncology
educates on personalized medicine
Pfizer Oncology announced today the launching of a new educational campaign on
personalized medicine and how new targeted therapies can help identify specific treatments for
certain types of cancer.
“Personalized medicine is a top-notch field of science that is changing the way in which many
people manage cancer treatment,” said Nelson Morales, Specialty Care Director, of Pfizer Puerto
Rico. “By identifying specific genetic mutations with disease-causing potential, new treatments
are being developed that are strengthening the battle against a great number of various types of
cancer,” explained Morales.
“Now we understand that cancer tumors have unique molecular characteristics called
biomarkers, which can help determine the most appropriate treatment strategy. In some cases,
cancer treatment is taking a more bio-specific approach, that is, tumors may be tested for
biomarkers and it can be determined if a specific treatment works or not,” said Morales.
According to the National Cancer Institute, personalized medicine is a medicine model that uses
information about an individual’s genes, proteins, and the environment to prevent, diagnose,
and treat diseases.
The “Cancer: It’s Personal” campaign
is presented by Pfizer and it has the
endorsement of the Department of
Health of Puerto Rico, Comprehensive
Cancer Center of the University of
Puerto
Rico,
Association
of
Hematologists and Oncologists of
Puerto Rico, the Academy of Pathology
and Laboratory Medicine of Puerto
Rico, and the American Cancer Society
of Puerto Rico.
The initiative involves advertisement
and a website for patients, caregivers,
and healthcare professionals, and will
be active all year long.
From left to right: Rocío González, Senior Marketing Manager of
Pfizer PR’s Oncology Division; Nelson Morales, Specialty Care
Director of Pfizer PR; Dr. Marcia Cruz-Correa, Scientific Director of
the Comprehensive Cancer Center; Dr. Francisco Joglar Pesquera,
Former Secretary of the Department of Health; Dr. Lourdes
Feliciano, President of the Puerto Rican Society of Hematology and
Medical Oncology; Dr. Juan Pérez Berenguer, President of the
Pathology and Laboratory Medicine of PR and Dr. Keyla Rivera
Román, Sub-specialist in Molecular Pathology.
PACIV’s contribution
to the Bio-Pharma Industry
PACIV was founded in Puerto Rico
in 1997. When “Process Automation,
Controls, Instruments and Validations”
was founded, the Bio-Pharma industry did
not have any single supplier in Puerto Rico
with the capability to supply, under one
roof, three interdependent fields; control
systems (automation), instrumentation
and computerized system validation
(CSV).
An industry competitiveness driver is the implementation
of process efficiencies and higher yields in where
automated systems play a significant role. PACIV is proud
to being a local “Critical Industry Supplier” with such
competences as it permits the industry to be more
competitive. Moreover, PACIV value creation in the past
15 years has taken it to establish offices in USA, UK and
Ireland with total revenues exceeding $140 Million.
PACIV business success has been the source of the first
ever Harvard Business School case study of a Puerto Rico
base company.
FDA
Approvals
GlaxoSmithKline Receives
U.S. Food and Drug Administration
Approval for Four products
GlaxoSmithKline plc [LSE/NYSE: GSK] announced during May - August 2013 that the U.S. Food
and Drug Administration (FDA) has approved the following four products for the US market:
FLULAVAL® QUADRIVALENT (Influenza Virus Vaccine), Breo Ellipta for COPD, Tafinlar and
Mekinist monotherapies for metastatic melanoma.
GSK has seen significant progress delivering against strategy receiving approvals for four of the
six key assets recently filed with regulators.
FLULAVAL® QUADRIVALENT (Influenza Virus Vaccine) for the active immunization of persons three
years of age and older to help prevent disease caused by seasonal influenza (flu) virus subtypes
A and B contained in the vaccine. This is the second GSK intramuscular quadrivalent influenza
vaccine approved by the FDA. GSK's Fluarix Quadrivalent was the first-ever intramuscular flu
vaccine approved by the FDA in December 2012, and is now shipping to customers.
BRAF-inhibitor Tafinlar® (dabrafenib) capsules and the first MEK-inhibitor Mekinist™ (trametinib)®
approved by FDA as single-agent therapies. Both approved for unresectable or metastatic
melanoma with BRAF V600E mutation; Mekinist also aproved for BRAF V600K mutation
Tafinlar is indicated as a single-agent oral treatment for unresectable melanoma (melanoma
that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to
other parts of the body) in adult patients with BRAF V600E mutation. Tafinlar is not indicated for
the treatment of patients with wild-type BRAF melanoma. Mekinist is indicated as a single-agent
oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600E or
V600K mutations. Mekinist is not indicated for the treatment of patients who have received a
prior BRAF inhibitor therapy. These mutations must be detected by an FDA-approved test, such
as the companion diagnostic assay from bioMérieux S.A., THxID™-BRAF.
BREO™ ELLIPTA™- GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX)
announced that the US Food and Drug Administration (FDA) has approved BREO™ ELLIPTA™
as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients
with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or
emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of
exacerbations. BREO ELLIPTA is a combination of the inhaled corticosteroid (ICS), fluticasone
furoate “FF”, and the long-acting beta2 agonist (LABA), vilanterol “VI” (FF/VI 100/25 mcg).
Acknowledgements
Congrats!
PIA would like to congratulate PharmaBioServ and their founder,
Elizabeth Plaza and staff, on their celebration of their 20th
Anniversary of their foundation, and their subsidiary Scienza Labs fifth
year anniversary. Ranked as the No. 1 compliance & validation company in
PR for the past 10 years, PharmaBioServ has over 100 employees working
in PR and over 200 abroad.
Scienza Labs is an industrial laboratory designed and built to comply with
good manufacturing practices. Scienza Labs is properly registered and
audited by the Foof and Drug Administration (FDA) and is ISO 9001 certified.
PIA acknowledges MC-21 in their
15 year anniversary!
Established in 1998, MC-21 was the first Puerto Rican PMB to receive in 2009 the
full Pharmacy Benefit Management accreditation from URAC, an independent,
nonprofit organization.
MC-21 manages over 1,000 pharmacy benefit designs and its pharmacy network
includes over 65,000 independent and major chain pharmacies throughtout
Puerto Rico and the US, and expanding their services to other Latin American
countries like Colombia.
Group of volunteers of Amgen associates and
family members along with staff of the “RESERVA
NATURAL LAS CABEZAS” of San Juan in Fajardo at the
culmination of the event.
Amgen brings together more than 100 volunteers for the cleanup of the
Las Cabezas de San Juan Nature Reserve coastline
Juncos, Puerto Rico- The associates of Amgen and their families visited Las Cabezas de San Juan
Nature Reserve in Fajardo to participate in a coastline cleanup day.
Once they got to the beach, Amgen associates were divided in groups headed by guides of the
Conservation Trust of Puerto Rico. The guides took them through the trails of the Reserve and to
Canalejo Beach to pick-up waste and other objects foreign to nature, that wash-up on the shores of
Puerto Rico’s Eastern area.
The volunteers collected more than 1,300 pounds of recyclable material (plastic, glass and
aluminum), household waste, and other objects such as: a wooden boat, buoys, foam coolers, fishing
nets, disposable diapers and truck tires.
“Activities like these symbolize the importance of forming teams and together tending to the needs of
our Island to collaborate on solutions” said Annette Rodríguez.
Look forward
to our
corporate identity
...coming soon!