PIA Insider, Third Edition (April 2014)
PIA Insider 2014 3rd Edition
Pharmaceutical Industry Association
Of Puerto Rico
June 19, 2014
October 29, 30 & 31, 2014
12th PIA-FDA Regulatory Conference
The Ritz-Carlton, San Juan
25th PIA Annual Meeting
Rio Mar Beach Resort and Spa
For more information visit www.piapr.org
PIA’S PATIENT OUTCOMES
COMMITTEE INTEGRATES ASES
March 27, 2014
Under the stewardship of Camilo
Gómez, the former “Market
Access” committee evolved to
become the “Patient Outcomes,”
a PIA strategic priority with the
objective to establish Puerto
Rico as leader in best patient
The Committee defined its mission, its
three pillars (prevention, access to
quality care and adherence), and
redefined its purpose to focus in a
more holistic approach to patients
“When we met with Ricardo Rivera
Cardona, executive director of the
Administration (ASES by its Spanish
acronym), we realized it was essential
that he had to be a member of our
Steering Committee,” she explains.
“We invited him to join, he immediately
accepted to become a member of the
Steering Committee and invited PIA
members to share the industry’s
knowledge with ASES.”
Rivera Cardona, Executive Director of ASES
“Previously, we had agreed that for
thepatient outcomes approach to be
successful we needed to focus in one
healthcare area. We determined that,
in this early stage of the Patient
Outcomes strategic priority, our focus
should be on ASES,” Saavedra
Since Rivera Cardona is so eager to
receive PIA members’ feedback, he shared
a Memorandum of Understanding (MOU)
agreement with the Committee.
Committee is in the process of reviewing
the MOU and urges all Committee
members to share it within their own
companies. The next step will be to sign
the MOU by both parties (ASES and
PIA) to comply with HIPPA and keep the
confidentiality of the data that ASES will
share with PIA.
“Rivera Cardona shared that there are
12,000 ‘superutilizers,” patients within
“Mi Salud” health plan, including up to
1,500 patients per region who, for various
reasons, are not receiving the health care
they should and end up in an ER and
hospitalized,” Saavedra said.
“We have experts within our own
companies who can analyze, break down
and offer alternative care/ solutions and
outcome recommendations based on the
data ASES will provide for us to give
them our feedback,” said Saavedra, who
works as Commercial Business Director
with AstraZeneca. Quite an achievement!
“We are excited with this
collaboration and the impact
we will have in the health and
lives of many patients in
Puerto Rico,” said Saavedra.
MEMBERS OF THE PATIENT OUTCOMES COMMITTEE
• Elsa Saavedra, Committee leader.
• The leader of the prevention pillar is Darren Washington working with Iván Figueroa,
Lysette Dávila, Juan Orengo, Amarilys Sylva and Maribel Torres.
• The leader of access to quality care pillar is Jennifer Herron working with Néstor Ortiz,
Samuel Alvarado, Olga Lebrón, Javier Moria, José Torres, Alina González, Sheila Freytes,
Michelle Bustello, Cristina Coll, Leonardo Cintrón and Antonio García from ASES,
appointed by Rivera Cardona.
• The leader of adherence pillar is Yvonne McBurney with Marina Vital, Dr. José
Ramírez, Mariseli Caraballo, William Prieto, Reinaldo Hernández, Homero Monsanto,
Raúl Porrata, Vanessa Delgado Blanca Cortés, Sylvia Flores, Zuna Maza, and
Kermarenid Rivas from ASES, appointed by Rivera Cardona.
Noel Torres joined GSK Puerto Rico
Team as new Business Improvement Lead,
effective March 24, 2014.
As part of the GSK Puerto Rico, Noel will be responsible for
continuing and refining the Business Improvement Strategy for the
Puerto Rico operation to develop Business Improvement
capabilities within the organization, as well as training and
coaching leaders in the use of management systems within their
Noel has 20 years of pharmaceutical industry experience in a
variety of areas such as Marketing and Sales, Information
Technology, Operations and Supply Chain Management. Previously,
he worked as Associate Director of Business Consulting and
Operation Excellence at Merck, where he led different initiatives for
restructuring and simplifying business processes.
He holds a Bachelor of Science in Industrial Engineering from the
University of Puerto Rico in Mayaguez. Noel also has several
certifications and trainings in change management, facilitation
techniques and conflict resolution, among others.
PIA BOARD OF DIRECTORS:
President: Camilo Gómez, VP & GM Abbvie
Vice President: Carlos Ceinos, GM Novartis
Secretary: Yvonne McBurney, VP & GM GSK
Treasurer: Robert Maroney, VP & GM Amgen
- Lourdes Colón, VP & GM Lilly Manufacturing Operations
- Jennifer Herron, VP & GM BMS Commercial Operations
- John O’Hara, VP & GM J&J Manufacturing
- Barry Regan, VP & GM Abbvie Manufacturing
- César Simich, VP & GM Merck Commercial Operations
- Rafael Castro, Operations VP PIA
- Iván Román, Advisor to the Board
- Eduardo Negrón, Legal Counsel, FGR
Science, Technology and Research Trust acting director, Iván Ríos
Mena, announced early April that construction work began in “Oso
Blanco,” the former Río Piedras State Penitentiary grounds, expected
to be developed and turned into a Science City to promote R&D
projects in Puerto Rico.
“With the development that is being planned for the area we now
have a new opportunity to promote R&D projects that will help
transform Puerto Rico’s economy,” said Ríos Mena.
The Science City will be an essential component of a Knowledge
Corridor to include UPR, the Rio Piedras Medical Center and the
Comprehensive Cancer Center of Puerto Rico’s main building and the
new hospital that recently began construction in a lot across Oso
Blanco and Highway 18 in Rio Piedras.
Former “Oso Blanco” state penitentiary. These grounds
will be redeveloped to turn them into the Science City.
Artist rendering of a future Science City in San Juan.
Samuel Astacio wins Amgen
Excellence in Volunteering Award
Samuel Astacio, Manufacturing manager and
Amgen Manfacturing Limited staff member, was
the recipient of Amgen’s Excellence in
Volunteering Award in Puerto Rico.
The Amgen Foundation awarded $5,000 in his
name to Cuerpo de Bomberos de Puerto Rico,
which is the organization Samuel selected in the
application for the award.
A panel of internal and external reviewers selected
Samuel based on the impact of his efforts as a
volunteer, the frequency of his activities and the
length of time he has committed to helping others
while displaying the values that distinguish Amgen.
Amgen Volunteers is an Amgen Foundation
program that connects staff members with local
volunteer opportunities they are passionate about,
and provides $500 Volunteer Service Grants to
eligible nonprofit organizations for every 15
hours volunteered by Amgen staff. The Amgen
Foundation also matches staff contributions
to eligible nonprofit organizations.
As a part of the Amgen Volunteers program,
the Amgen Excellence in Volunteering
volunteers from Amgen’s U.S. and Puerto
Rico sites and field-based staff by providing a
$5,000 award to each nonprofit organization
featured in the winning staff members’
To be considered, Amgen staff were asked to
complete an application with information about
their volunteers efforts and provide a letter of
recommendation from the nonprofit organization.
Congratulations to Samuel and thank you for setting an example
to the community of the values that drive our work at Amgen!
GSK expands its Oncology
and Respiratory portfolios
GSK received FDA approval for combination use of Mekinist®
(trametinib) and Tafinlar® (dabrafenib) for unresectable melanoma or
metastatic melanoma and Anoro Ellipta to treat chronic obstructive
First approved combination of oral targeted therapies for unresectable or
metastatic melanoma with BRAF V600E or V600K mutations
Mekinist® (trametinib) was approved for use in combination with Tafinlar®
(dabrafenib) for the treatment of patients with unresectable melanoma (melanoma
that cannot be removed by surgery) or metastatic melanoma (melanoma which has
spread to other parts of the body) with BRAF V600E or V600K mutations. These
mutations must be detected by an FDA-approved test.
The approval of the combination is based on the demonstration of response rate
and median duration of response in a Phase I/II study. The combination was
approved through FDA’s Accelerated Approval program and reviewed under a
Priority Review designation.
First approved as once-daily dual bronchodilator for the treatment of COPD in
Anoro Ellipta (umeclidinium and vilanterol inhalation powder) was approved for
the once-daily, long-term maintenance treatment of airflow obstruction in patients
Anoro Ellipta is a combination of umeclidinium, an inhaled anticholinergic that
affects the muscles around the large airways and stops the muscles from
tightening, and vilanterol, a long-acting beta2-adrenergic agonist (LABA) that
improves breathing by relaxing the muscles of the airways to allow more air to flow
into and out of the lungs. The safety and efficacy of Anoro Ellipta were evaluated
in over 2,400 patients with a diagnosis of COPD. Those treated showed improved
lung function compared to placebo.
Passion for Science
To discover and develop innovative medicines to improve global
health, we need people with curiosity and a strong passion for
science. For more than 135 years, science has been the
cornerstone of our operations as we draw on our scientif ic and
technical exper tise to serve our patient’s needs. Fur thermore, our
longstanding relationship with the academia has been key as we
embarked in the journey of contributing to the development of
new generations of professionals in Puer to Rico.
Three years ago, we instituted the Dr. Frank M. Deane Passion for Science Award to inspire
talented students that exude passion for science to pursue a higher education career in the science
and engineering f ields. This award, which recognizes students for their overall academic
accomplishments and resiliency to achieve excellence, provides f inancial suppor t, oppor tunities for
internships and work experience. In addition, the research laboratory that hosted the student’s
undergraduate investigation experience receives a one-time grant. Our f irst two recipients are
exceptional students egressed from the University of Puer to Rico and pursuing doctorate degrees
with a thirst for learning and rediscovering science.
AT LILLY, WE REMAIN CONFIDENT THAT OUR RELENTLESS EFFORTS
WITH THE ACADEMIA WILL HAVE A LIMITLESS EXPRESSION IN THE
COMPETITIVENESS OF THE BIOPHARMACEUTICAL INDUSTRY
AND PUERTO RICO.
Premio a la
EN MERCK FOMENTAMOS
LA INNOVACIÓN PARA MEJORAR LA SALUD
DE PUERTO RICO
Los Premios Merck a la Innovación en Salud reconocen a grupos cuyos
proyectos innovadores resultan en mejor salud para Puerto Rico.
Proyectos realizados por un grupo de estudiantes
de escuela superior que a través de prácticas o
para su escuela o una comunidad.
Comunicación en Salud
Propuestas diseñadas por un grupo de estudiantes
universitarios que a través del uso innovador de
múltiples medios proponen comunicar temas de
salud para educar la población universitaria o
público en general.
Proyectos de investigación que con una idea
Proyectos realizados por un grupo comunitario
que a través de prácticas o temas innovadores
Actívate y comparte con Puerto Rico tu innovación en salud.
Para más detalles visita merckpr.com.
EXCiPACT™ is a voluntary international scheme to provide
independent 3rd party certification of manufacturers, suppliers
and distributors of pharmaceutical excipients.
By ensuring the competency of the 3rd party auditors, and the frameworks in which
they operate, the Scheme will ensure patient safety through supplier quality, whilst
minimizing the audit burden and overall costs for assessing the excipient supply chain
without sacrificing quality.
EXCiPACT™ certification enables manufacturers, suppliers and distributors to
demonstrate that their operations meet the minimum Good Manufacturing Practice
(GMP) and/or Good Distribution Practice (GDP) requirements for excipients. It also
enables them to verify the compliance of other actors in the supply chain, reducing
the need for duplicate audits saving both time and money. Accepted by all major
stakeholders, including relevant authorities globally - European Union (EU), US Food
and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory
Authority (MHRA) - it is not however a substitute for regulatory inspection, where
With a global network of experienced EXCiPACT approved 3rd party auditors, client
operations can be assessed against the EXCiPACT™ Standard and successful
organizations will be awarded an EXCiPACT™ Certificate, giving access to:
• A safer, more reliable and transparent pharmaceutical supply chain
• Cost savings by reducing the audit burden for both customer and supplier without
For more information visit http://www.excipact.org
During the past year we have been involved in rigorous training
and certification efforts within the automation control
platforms/systems we support. Technical Competency is one
of PACIV’s three (3) main strategic objectives – Commitment
Culture and Trusted Brand are the other two – as such, our
single most significant investment is in Trainings/Certifications.
Technical competency is a core strength required to be able to
carry our work with the highest quality possible, thus we gladly
invest in our most valuable asset: Our Associates.
In the past year alone, a total of (32) associates and over
$100,000 have been invested through all offices PACIV-PR,
PACIV-USA & PACIV-Europe for the required training and
certification in the automation platforms we serve (DeltaV,
Rockwell, Foxboro, Wonderware, iFix, OSI-Pi and others).
Among the trainings and certificates were : Factory Talk
Vantage Point Rockwell, Rockwell PlantPAX, RSLogix 5000
Level 3, Power Flex 525 Ac Drives, RS Logix50002 Control
Logics System, DeltaV 7009,7016, 7070, 7071, Foxboro I/A and
PACIV recognizes the building blocks of a learning technical
organization and the factors which are essential for
organizational learning and adaptability: a supportive learning
environment, concrete learning processes and practices, and
leadership behavior that provides reinforcement.
Pharma Serv Academy will offer the course “Statistical
Applications in the Life Sciences Industry” on June 27, 2014.
This training is designed to present the basic concepts of
data analysis using statistical tools. The statistical concepts
discussed during this training are required to understand
advanced statistical applications in the manufacturing
industry. Such advanced applications include statistical
process control (SPC) and sample size calculations.
The training will be delivered as a mix of theory, practice exercise,
and group discussion of case studies. The facilitator Marie-Jose
Musso Cardot, Ph.D. is a Subject Matter Expert in Statistics and has
over 25 years of experience in the Life Sciences Industry. Don’t
miss this opportunity! For more information on this training or to
register, please access www.academycalendar.com
Benefiber got a chance to inspire
participants of the World’s Best 10k.
The community showed joyful during
exercise and stretching routines
before the race sponsored by the
brand. Conversations were held
between the brand’s representatives
and consumers, many interested to
try and check that Benefiber had no
taste, and can be added into just
about any drink, food and even
Benefiber® © 2014 Novartis Consumer Health, Inc.
For more information, recipes and
discounts you can access: