Makarand Jawadekar was the first person I invited onto the Contract Pharma editorial advisory board in 1999, and he’s been of great value to the magazine all these years. Now that he’s a “free agent,” he’s writing our new outsourcing advice column, I, Mak. To start things off, I invited Mak to tell us his history in the industry. Starting next issue, he’ll be answering your pharma/biopharma outsourcing questions! You can ask this industry veteran your queries by e-mailing me at [email protected]. -GYR

Well, I had a successful 28-year tenure at Pfizer Inc., before opting for an early retirement this year! I started with Pfizer, directly out of Graduate School after obtaining my Ph.D. in Pharmaceutics at the University of Minnesota. The late Dr. Armando Aguiar (then Pfizer’s Pharmaceutical R&D director) had come to do campus interviews at the University in 1979; he followed my career through my graduation in 1982 and offered me an opportunity to be a part of his R&D Group at Groton, CT, which was growing. Pfizer R&D here in CT then only had around 800 employees, a number that ultimately grew 8- to 10-fold over the years. I got to be part of so much of that growth over the years.

I was given an opportunity to be a research scientist at the bench level, formulating new compounds into dosage forms, applying my pharmaceutics expertise. I really enjoyed working on some of these early development projects, including Sorbinil. An ARI (Aldose Reductase Inhibitor), Sorbinil was in development for a long time, but never made it to NDA or the marketplace due to safety issues such as skin rash in a handful of patients.

Following my formulation and drug delivery R&D experience, I gained the added responsibilities for solid dosage manufacturing, excipient subdivision function, and the research pharmacy – clinical supplies manufacturing / packaging and distribution – areas, which were considered logical extensions of my R&D role. I later took on the drug delivery assessment role when it came to licensing assessment and due diligence of external DDS technologies and their application to our compounds in the R&D and post-marketing stages.

I had the privilege to work hands-on with on many compounds, including trimazosin and sertraline tablets, as well as managing projects working with senior Pfizer colleagues, including Tim Hagen. I enjoyed collaborating with Pfizer Global Manufacturing on co-development projects, working with them on scale-up and technology transfers, and developing novel orally dispersible tablet (ODT) formulations and manufacturing processes. I enjoyed working with external partners.

Management, considering my interests and looking at the broad portfolio of our activities, management understood the need for outsourcing around 1997. I took on the challenge to form a new group called Strategic External Alliance Manage-ment (SEAM) group, which became a blueprint for Pfizer’s entry into contracting out R&D projects. We created preferred alliances with several companies; some were very successful and some were . . . not so successful. We learned from both sets of experiences, and captured our knowledge through a company-wide initiative in the late ’90’s, which was named Strategic Resourcing Initiative (SRI). Formed across all the disciplines and departments within R&D, SRI was quite a useful initiative, allowing the art of outsourcing to become more of a science. It ultimately became a key tool for assessment of in-sourcing vs. outsourcing decision making.

Post-2000, Pfizer and its organizational structure changed as it went through mergers with Warner Lambert, Pharmacia and finally Wyeth. I enjoyed being part of this constantly changing organization. I was quite interested in looking at the emergence of Asia (India and China) on the global scene, so I opted to change my role. I also raised my hand to be a part of the Portfolio Management & Performance Group, where I could see the bird’s eye-view of the entire company’s portfolio and compare it to those of other Pharma companies. I participated in various benchmarking exercises against external companies.

I also had an opportunity to be personally invited by President George W. Bush’s India delegation for a unique event. I accompanied our Global R&D president, John LaMattina, to India and had the opportunity to facilitate a meeting with the President of India, Mrs. Pratibha Patil. I also accompanied Martin Mackay, the current president of Pfizer Pharma Therapeutics, to India and enabled various potential partnership meetings with Indian companies. We attended the Bio-Asia Conference in Hyderabad, where Martin received India’s prestigious Genome Valley Award for 2009. Pfizer now has an ‘Asia Business Development’ function within R&D, and I’m glad to have been part of that building process.

Looking back, I feel that I was fortunate enough to witness the best of the best changes within the global pharma industry and see how one navigates through those changes. Certainly there have been some unfavorable headwinds , but there have also been times with favorable tailwinds! I, of course, always tend to look at the positives!

Makarand (Mak) Jawadekar most recently served as Director, Portfolio Management and Performance at Pfizer Global R&D, until February 2010, when he opted for an early retirement after 28 years at Pfizer Inc. He currently serves on several companies’ advisory boards and also consults with bio/pharmaceutical companies for global outreach in emerging market regions. He can be reached at [email protected].