Daniel Lobo Guerrero

Daniel Lobo Guerrero

Work History

Work History
Jun 2007 - Present

Consultor

Gerson Lehrman Group

Virtual (vía Internet/pone) advising to Global Healthcare, Pharmaceutical (R&D, Clinical Trials Design) and Software R & D Companies.

Jun 1979 - Present

Home (domiciliary) Physician

Particular

Medical attention provided to private patients in their own home.Achievements: more than 30 years providing home medical services to patients and their families, attending right now the third generation of some of them.

Jul 2002 - Jul 2007

Medical Director

Laboratorios Metlen Pharma

Medical Director, half time (outsourcing), 5 years fixed term contract.

Achievements: in those five years, successfully recovered the image of the company and one of its products, Tiroxin (sodium levothyroxine), severely damaged by the previous administration and the poor quality of the product itself. The implemented strategies were able to position the product among the first places on the ethical market. Also implemented registration strategies for optimize and reduce time to include new products in the laboratory's portfolio.In addition, the demonstration of efficacy of Tiroxín (levothyroxine) through the design and implementation and supervision of a novel program of pharmacovigilance for more than 2 years, returning the product to the 3 first places on the ethical market, competing head to head with 2 products of multinationals.With the advice and orientation to the General Manager of the Company it achieved the increment of the product portfolio in various products of the endocrine and general therapeutic areas.

Nov 1996 - Aug 2000

Area Team Clinician for Latin America and Canada for eletriptan and New Products Development Physician for the CeLA countries in the Business Development Division

I was promoted due to the results obtained as Associate Medical Director.Tasks and Responsibilities (for Latin America / Canada and / or CeLA [Colombia, Equator and Venezuela region])

  • Contribute to the overall Phase IIIb/IV clinical program strategy and implementation for the region, including pharmacovigilance
  • Design and agree objectives and plans for the development of new products from the company’s pipeline, in coordination with the Global Development teams of each product, including the registration strategy
  • Manage relationships and actively work with key opinion leaders and also managing and participate in advisory meetings with opinion leaders
  • Lead the execution of medical projects: (epidemiological studies and clinical studies, phases IIIb–IV) directed to prepare medical community to the introduction of the above mentioned products
  • Plan and coordinate all different activities directed to develop physicians as opinion leaders according with global/regional strategies and also to provide up to date information regarding the new products to the medical community
  • Factibility assessment (medical point of view) for launching new products in the CeLA region, including plans of action and its application to optimally prepare the market to the introduction of the new substances before their launch.

Achievements: In support of the development and positioning of Eletriptan, product for the treatment of migraines, I achieved the execution of the first Latin-American epidemiological study of migraine, involving 6 countries with more than 8000 polled people, employing the same questionnaire and methodology in all the work.  This permitted the recognition of the market potential and also of the product and the active integration of the medical and marketing departments of the different countries involved, facilitating the execution of other pioneering clinical studies in Latin America.I also contributed to the launch of Celebrex that quickly obtained the first positions in the market of the region.  I contributed to the launch of Viagra, reaching the first position in the market in the first month.  For this product I also contributed with another epidemiological study related to Erectile Dysfunction; it was done in Colombia, Equator and Venezuela with more than 3000 polled patients and its sexual partners.

Feb 1981 - Oct 1996

Associate Medical Director

Tasks and Responsibilities

  • Similar to the above mentioned but limited to the Colombian territory

Achievements: I contributed to the launch of diverse products like Diflucan, Zitromax, Norvas, Zolof, all reaching the first positions in their respective markets and of Unasyn, that not only reached positions of utmost importance in his market but also became the product leader in its field.

Also I contributed to the Medical Department organization, sales force training and the organization and implementation of clinical studies and Key opinión Leaders that permitted the successful launch (between others) of Feldene, Quantrel and Cefobid (including the organization, follow up and audit of the compassionate use of Cefobid on more than 100 patients, survivors from a volcano’s eruption that destroyed and affected the city of Armero).

Education

Education

Working Knowledge

Pfizer In-house training

Laboratorios Metlen Pharma

  • Laboratorios Metlen Pharma Integral Control Panel, 2004 and 2005

PFIZER:

  • Training the trainer, Miami, March 1982
  • Kepner-Tregoe, Problem Solving Traninig, 1984
  • S–4, Training in Communication Styles and Sales’ Techniques, 1984, then yearly until 1996
  • Sales to Groups, 1985, 1988
  • Training in Personnel Administration, 1985
  • Steven Covey' s Training Seminar on 7 habits, 1986, 1988
  • Sales to Hospitals, 1986, 1987, 1988, 1990
  • English (as a second language, also business), at various institutes:
    • Meyer Language Center, 1984,
    • Centro Colombo Americano (1990, 1991, 1992),
    • First Class English, 1993,
    • Berlitz Institute (1995, 1996, 1997, 1999, 2000)
  • Training and Re-training in Clinical Studies Monitoring (a week, generally, with periodic exam):  1983, 1985, 1988, 1990, 1991, 1993, 1994, 1996, 1998, 2000
  • Training and Re-training in Clinical Studies Audit (a week, generally, with periodic exam):  1986, 1989, 1990, 1991, 1993, 1995, 1996, 1997, 1998, 1999, 2000
  • Training and Re-training in Good Clinical Practices for Investigation (a week, generally, with periodic exam):  1983, 1985, 1988, 1990, 1991, 1993, 1994, 1996, 1998, 2000
  • Product Manager and Product Physician (PMPP)Training, 1990, 1994
  • Medical Director’s Training, 1989, 1993, 1996
Dec 2006 - Jul 2007

Leader

Optimus Leadership Institute

Training in leadership

Jan 1970 - Jul 1977

MD

Universidad Nacional de Colombia

Medical studies

Skills

Skills

Medical Director's Skills

Honesty, integrity, loyalty Capable to oversee the development of clinical plans for strategic products' support Able to design the studies to achieve desired label, working with internal and external regulatory partners Working knowledge and understanding of clinical regulatory requirements Capable to bring innovation and creative thinking to optimize time to market as well as reduce/mitigate risk within and across the clinical development plan Lead the development and implementation of clinical research and education strategies in a therapeutic area Ability to drive the development of rational strategic plans for future clinical studies Acted as Medical Monitor for clinical research studies Solid ground abilities in clinical trial safety assessment Continuously developed and maintained "state of the art" level of knowledge as to developments and trends in medical sciences, in the therapeutic areas of interest for the laboratory Provided medical and scientific direction on clinical matters affecting the preparation and submission of timely and sound information to the Regulatory authorities as needed Contributed to the training, leadership and continuing education for all departmental staff, includying sales forces Continuously developed knowledge of regulatory, pharmacovigilance, and quality assurance requirements in alignment with Internal Business Practice Standards Developed and ensured compliance with all Business Policies and Guidelines for Good Clinical Practices and Good Pharmaceutical Practices Participated in the development/implementation of a global clinical development plan in order to first develop regulatory approval across the world and second, maximized trial efficiency and optimize timelines, by using different locations around the world for the same trial/study Having experience in conducting clinical trials in different part of the world such as Canada, and Latin American countries Solid knowledge of GCP and experience in analysis of clinical trial safety information Have leadership capabilities; are teamwork oriented; capable to work in a multicultural and cross-functional environment Have strong management skills: decisive, resourceful, intuitive Use permanently a well developed interpersonal skills Ability to provide education on complex scientific/clinical issues in a clear manner both to a peer and larger audience

Clinical Research Abilities/Pharmacovigilance

Honesty, loyalty, integrity Capable of independently manage various activities associated with multiple clinical studies in accordance with assignments Able to oversee clinical trial progress and to ensure compliance with SOPs and regulatory requirements (CRF/ICH GCP Capable to identify, evaluate, select, and manage CROs, contractors, and other suppliers (monitoring, clinical drug storage/distribution centers, central/specialty laboratories, etc). Have critical insight regarding supplier selection process Participated actively in the design and development of clinical protocols and case report forms. Capable to write clinical protocols, amendments; informed consent forms, monitoring plans, site study manuals, and related study documentation Prepare study budgets and timelines Manage site and supplier budget and contract negotiation Coordinated efforts in study start up through closeout activities, including: study feasibility, site selection, preparation and follow-up of site regulatory packages Coordinated and conducted CRA and site training of protocol and operational requirements Ensured consistency in instructions to investigators and their personnel for compliance with protocol and regulatory requirements Oversighted and reviewed of monitoring reports Managed key study parameters (study start-up activities, drug preparation, enrollment, data collection, etc) and proactively identified/proposed/implemented solutions within the study process when issues appear Created and implemented project tools, tracking tools, etc. to report study specific metrics Prepared progress updates Managed all study supply requirements (storage, distribution, site inventory, etc) Assisted with the projection and management of clinical supply inventory Performed independent monitoring of sites as required Assisted in the review of clinical study reports Ability to use problem-solving skills to address needs appeared throughout the study Addressed cross-departmental issues that affect clinical trial or marketing activities Support of departmental functions such as preparation for and attendance at departmental meetings, project team meetings, clinical operations training and developmental activities as required Actively managed supplier budget and payment reconciliation processes (e.g. reviews contracts, tracks payments in association with agreed-upon budget, etc.) Able to coordinates pharmacovigilance input into global development teams regarding ongoing risk assessment based upon the development of strategy for optimal characterization of product safety profile Capable to provide pharmacovigilance expertise in regulatory dossier activities (risk-benefit analyses, Pharmacovigilance Management Plan, Position Papers, etc…) For marketed products, capable to provide expert advice for internal/external customers regarding safety profiles Periodic Safety Update Reports, prepare/review all company internal and external safety documentation regarding signal detection/evaluation, communicate with Regulatory Authorities regarding product safety profile Able to review post-marketing products, providing clinical overview of cumulative adverse event reports, reviews of relevant literature for safety information pertinent to product safety, detection and evaluation of potential safety signals, also able to develop safety action plans, including epidemiology studies and preparedness for a product recall.

Analytical Skills

Able to strategic understanding of clinical regulatory requirements and needs Strong analytical and organizational skills and attention to detail

Communication, Training, Leadership

Lead through influence Excellent oral and written communication abilities Ability to make successful presentations and to lead meetings Ability to moderate a group Capable of build rapport with internal/external communities, i.e. medical/marketing Able to interact succesfully with a variety of within and outside of the company, to include clinical investigators, contract research organizations, medical providers and regulatory officials Capable of developing and maintain strong scientific and medical relationships with key opinion leaders and scientific community members Training capabilities at all levels of the organization and external personnel also Ability to work in cross-functional environments Capable to write/edit protocols, CRFs, etc. Lead medical portion of new product pitches and communication plans Able to, proactively, identify medical opportunities that contribute to strategic development Able to identify marketing opportunities and implications through critical analysis and creative interpretation of data Conceptualize innovative initiatives that communicate marketing strategy in a scientifically credible way Able to interact with healthcare professionals on programs to meet strategic objectives through: advocacy development; use of medical marketing rationale; identification/selection of appropriate healthcare professionals as Key Opinion Leaders        

Objective

My objective is to contribute the community's health and welfare improvement commnicating my experience and sharing/teaching organizational, administrative and interpersonal skills, with honesty, ethics and respect, always seeking the excellence in the performance of my work.

Summary

Physician with extensive experience in pharmaceutical R&D, project management and medical affairs. Led the development and authorship of clinical trials, marketing strategies, market research, and communication programs always following SOP’s, regulatory requirements and ICH/GCP guidelines.

Also administrated and optimized the institutional resources available for new products development achieving twenty successful launches in Colombia and other countries in Latin America. Creative and innovative thinking that optimizes the lead time to launch products according to the market needs and corporate strategies.

Capable to work in a cross-functional environment that requires high capacity for information procurement and analysis. Problem solving abilities generating creative and innovative plans of action based on the analysis and evaluation of the specific situations.

Results oriented by creating win – win inter-personal relations through dialogue and teamwork. Teaching and coaching skills that achieve changes in behavior with visible results in diverse audiences.

References

PEERSAna Maria Valderrama, M.D.Phone (day):+212 733 4502; Email: ana.valderrama@pfizer.comCo & Title: Area Director Clinical Research; Canada / Latin America / Africa / Middle East Region, Pfizer, Inc.Ana B Salgado, M.D. (Marketing)Phone (day):+1212 733 5868; Email: ana.b.salgado@pfizer.comCo & Title: Senior Director- Business Operations; Established Products Business Unit, Pfizer Inc.Marina Ruíz, Pharmaceutical ChemistPhone (day):57-1-6190077, ext 108.; Email: marirusa05@yahoo.comCo & Title: New Products Development, Metlen Pharma Laboratories, Bogotá, Colombia PEOPLE MANAGED

Francisco Lotero Q., M.D.Phone (day): 57-317 401 7172; Email:Co & Title: Internal Medicine, Clínica Medellín, Colombia (formerly, Pfizer’s Medical Delegate for Medellín)Angela Iriarte de Arteaga, RNPhone (day): 571 6250445. Bogota, Email: angelairiarte4@hotmail.comCo & Title: SIPLASRO Lead Monitor for COMPAS/GSK Project, Panama until July 15th, then in another project in Cali, Colombia (Former monitor at Pfizer)Henry Mauricio Arenas, MDPhone (day): +57-3114716994, Bogota; Email: hmarenasq@unal.edu.coCo & Title: Resident of Endocrinology, Faculty of Medicine, Universidad Nacional de Colombia (Former Medical Assistant at Metlen Pharma)SUPERVISORSHonorio Silva, M.D.Phone (day):+1917 434 8499; Email: honorio.silva@globecpd.orgCo & Title: Director, Project Globe Consortium for Continuing Professional Development708 Third Avenue 6th Floor, New York, NY 10017 (formerly, Vice President, Medical and Regulatory Affairs, Japan, Asia, Africa, Latin America, Pfizer Inc)OTHERS/FRIENDSEduardo Leiderman Watstein, M.D.Phone (day):+1919 5628687; Email: leidermanw@gmail.comCo & Title: (Retired) Chief, Infectious Diseases Section, Faculty of Medicine, Universidad de Antioquia, Medellín, ColombiaLeón Zapata, Pharmaceutical ChemistPhone (day): 52 1 55 54-12-63-93, Mexico; Email: leonzapata@guiamark.comCo & Title: Owner and General Manager, Guiamark (www.guiamark.com) Pharmacoeconomic studies in Mexico (Formerly, Training Manager, Pharmaceutical Division, Pfizer S.A., Colombia, Country Manager, Allergan Laboratories, Mexico)José Agustín Pulido OsunaPhone (day): 571-6460565; Email: JoseP@saludtotal.com.coCo & Title: Manager, Bogota Branch, SaludTotal (Health care institution) (Formerly, Training Manager, Sales Manager at the Pharmaceutical Division, Pfizer S.A., Colombia, Country Manager at Ecuador, Pfizer).Jairo A. ArboledaPhone (day): Tel (571) 3263600, Ext 232; Tie Line 5280 + 232; Email: Jarboleda@worldbank.org Co & Title: Consultant, World Bank, Bogotá, ColombiaVicky ColbertPhone (day): PBX + 571 2452712; Email: vcolbert@escuelanueva.orgCo & Title: Executive Director, Fundación Escuela Nueva Volvamos a la Gente, Bogotá, Colombia