Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Roles at http://pharmaceuticalintelligence.com

Co-Editor: e-Book on Nanotechnology in Drug Discovery and Drug Delivery

Mentor: Postdocs in Pharmaceuticals

Research Category OWNER

•             Health Economics and Outcomes Research
•             Pharmaceutical Analytics
•             Drug Delivery Platform Technology, Investigator Initiated Category
•             Advanced Drug MFG Technology, Investigator Initiated Category
•             Infectious Disease & New Antibiotic Targets
•             International Global Work in Pharmaceutical

Expert, Author, Writer for the following Research Categories:

•             BioSimilars
•             FDA Regulatory Affairs
•             Medical Devices
•                   Stents & Tools
•                   Valves & Tools
•             Health Law & Patient Safety
•             Interviews with Scientific Leaders
•             Medical Devices R&D Investment
•             Molecular Genetics & Pharmaceutical
•             Nanotechnology for Drug Delivery
•             Nutrition
•             Personalized Medicine & Genomic Research
•             Pharmaceutical Industry Competitive Intelligence
•             Pharmaceutical R&D Investment
•             Scientist: Career considerations
•             Technology Transfer: Biotech and Pharmaceutical

Deepak Thassu, PhD, MBA

Personal Bio

 

SENIOR R&D EXECUTIVE & NANOTECHNOLOGY EXPERT

Leveraging technical and business acumen to drive formulation development, analytical research and commercialization in stride with changing field and company demands.  Brings expertise in particle drug delivery technology, sterile and non sterile proprietary drug products, technology innovation, process development, and technology transfer in multinational ethical/consumer/generic pharmaceutical environments, whether startup or high-growth. Hand on experience on small molecule and biologics formulation development and product commercialization for Ophthalmic, Oral Nasal and Parenteral routes. Published books and scientific papers & Invited speaker  on Nanotechnology, Novel Formulations and Ocular Drug Delivery. Holds multiple US and European patents.

Key executive role for startup, building strategic portfolio group and specialty product portfolio, creating ground-breaking proprietary process for development of liposomes, targeted nanoparticles, and setting stage for commercialization & out licensing. Developed peak-performing teams to enhance value creation and expand capabilities.  Builds collaboration among scientific/executive groups. 

Areas of Excellence

• Expert in Nanotechnology in Drug Delivery

Solid Lipid Nanoparticles
Liposomes & Nanoparticles

• Product, Manufacturing and Process Development of nano-materials based drug products for Nasal, Parenteral and Ocular routes
• Expert in NDA & 505 b-2 filings
• Expert in IP Development
• Design & Development of product portfolio
• Strong Analytical and innovation skills
• Foster R&D alliance & ability to establish and maintain effective and cooperative working relationships
• Superior presentation and communication skills

Patents  and Patent Applications

• Ranitidine effervescent TABLETS (US Patent 5,728, 40100) 1998.
• Cefaclor / Cephalexin modified release solid dosage form using hydrophilic polymers (US Patent# 5,948,440) 1999.
• Multiplayer tablets. (US Patent #6,663,892) 2003.
• Acid labile drug compositions (us PATENT appl.publiShed 20070036851 ) world intellectual property organization WO/ 2004/060357) 2004.
• PHARMACEUTICALLY ACTIVE PARTICLES OF A MONOMODAL PARTICLE SIZE DISTRIBUTION AND METHOD 20040033266, 2004
• MULTIPLE ACTIVE DRUG RESIN CONJUGATES 20050142097, 2005
• Pharmaceutically Active Particles of a Monomodal Particle size Distribution (US Patent #7,445,796) 2008
• Multiple Active Drug Resin conjugate (20080260845) 2008
• Nanoparticle Pharmaceutical Formulations (US Patent aPPL. Pending) WO/2010/080754, 2010

Work Experience

Actavis, Inc., Owings Mills, MD 2011 – 2012

Managing Director, & Head of Semisolid and Liquid (SSL) R&D Actavis Inc [US]

Sterile & Non Sterile Generics & Specialty Pharmaceuticals

• Direct & Indirect reports 75 people including Directors and senior managers (Formulation Development, Process Chemistry, Analytical Development Portfolio and Project Management, Process Development & Pilot Plant)
• Site Head Owings Mills, MD Actavis location and SSL R&D global organization
• Expanded product & technology portfolio for both sterile and Non sterile generic SSL products.
• Developed Pilot Plant blue print and established the process group
• Established Life Cycle Management and Commercial Product Support groups
• Restructured R&D management team to support the US and global business goals
• In and Out licensing Novel Formulation ( Long acting parenteral, Vaginal Delivery & Analytical Technologies
• Developing & managing Product Portfolio  and providing CMC leadership to RA.

Pharmanova, Inc., Victor, NY            2008 – 2011

Chief Scientific Officer & VP of Pharmaceutical Development

Specialty Pharma,Oncology, Anti-Infectives, CNS

• Led Strategic product portfolio, product/technology development, innovation, and manufacturing process for startup’s proprietary nanotechnology product (NovaSperse) to provide commercial pharmaceutical dosage delivery platform for administration routes including Nasal, Ophthalmic, Pulmonary, Parenteral, and Oral. Development of nanomaterial for Drug Eluting stents.

• Lead new Dry Powder Inhalation products, portfolio selection and development of product pipeline (505-b-2s) for out licensing
• Partnered with business development team, identifies out-licensing opportunities, and drove technology planning; wrote books on nanaomedicines (Drug Delivery Nanoparticles Formulation & Characterization) in 2009.
• Transformed drug delivery technology, establishing client base of startup and mid-size companies. Generated $800K revenue stream within the first year vs. prior product development issues and submitted company’s first patent. and out license lyophilized nano-suspension to Altacor
• Invented NovaSperse, a proprietary technology.
• Developed Client Sponsored and New Product Program and brought clients: Pfizer, BMS . Eli Lilly Merck etc.
• Developed first nanoparticles based topical drug delivery system for Glaucoma( NDA 505-b-2).
• Developed surface modified nanoparticles for  targeted parentral delivery  of oncolytic compounds( NDA-505-b-2)
• Invented NovaSperse, a proprietary technology.

Holopack International Corp., Columbia, SC            2007

Chief Scientific Officer & Senior VP of Product Development

Generics & Specialty Pharma

• Direct & Indirect reports 55 people including Vice Presidents , Directors and Senior managers (Regulatory(CMC), Product Development,  Quality Process development Analytical Development Portfolio and Project Management)
• Headed 40-person team spanning process/product development, polymer research, compliance, quality, and intellectual property management for unit dose delivery technology of sterile/non-sterile liquid products and medical devices; controlled $2M budget.
• Member on commercial/business development teams and governance council to participate in growth initiatives.
• Established R&D for sterile inhalation solution & suspension and non sterile liquid products & devices.
• Implement QBD process & Quality Systems for sterile products.
• Established Packaging research group.
• Developed Innovative  BFS process to handle high viscosity  liquids  and Proteins/Biologics.
• Established IP strategy group

UCB Pharma, Inc., Rochester, NY 2002 – 2007

Associate Director of Global Pharmaceutical Technology Development

CNS, Biologics, Specialty Pharma. and Proprietary

• Revitalized R&D group to advance Specialty pharma business of $300M company, building leadership team, identifying cost-cutting initiatives, bridging quality systems and in-process control groups, and realigning project completion; enabled company to further commercialize portfolio, accommodate new clients, and develop pioneering devices within one year by expanding support network via research partnerships in the US and Europe.
• Established pharmaceutical development group for formulation of solid, liquid, and extended release suspensions using .polymer resin as a drug carrier (IEDS).
• Managed 14-person team as global project leader with direct reports in the UK, US, and Belgium for $3.2B Biopharmaceutical Corporation.
• Oversaw intellectual property activities, interfacing with patent counsels to devise strategies for patent applications in the US and Europe;
• Completed MBA degree, authored books on nanoparticulate drug delivery systems, Pharmaceutical suspensions and received patents.
• Drove IVIVC, biopharmaceutics, and pharmacokinetics projects, partnering with Boston Consulting Group to institute global program and consolidate project management functions.
• Developed IEDS based taste masked NDDS products
• Keppra ER tablets
• Developed IP strategy and filled/supported Technology patents
• Developed R&D title structure with BCS ( Boston Consulting Group)
• Developed M&A strategy to support non organic growth in  emerging market
• Implemented Project Management System: PRISM

Celltech Americas, Inc, Rochester, NY            2003 – 2004

Acquired by UCB Pharma

Senior Principal Investigator (2003 – 2004)

Principal Investigator, Product Development, (2002 – 2003)

• Led R&D of solid/oral liquid formulations for $100M biopharmaceutical company, handling budgeting, strategic planning, project execution, intellectual property, and financial management; member on global project management team.
• Administered development and life cycle management for Pennkinetic^® extended release technology for oral products.
• Oversaw preformulation and development of delivery systems for NCEs (poorly soluble CDP-323) as well as peptide delivery systems for immune/inflammatory disorder and cancer therapy.
• Facilitated R&D for solid/oral liquid formulations (IR&MR).
• Handled life cycle management of company’s Pennkinetic^® extended release technology for liquid suspensions.
• Recipient of Celltech Star Award, contributing critical research results and intellectual property including two patent submissions.
• Invented  new technology, IEDS (Ion Exchange Delivery System) for oral NDDS products
• Developed several NDA using  Drug Delivery Technologies : Metadate CD
• Development of Delivery System for Cimzia® /Certolizumab Pegol (Rheumatoid arthritis)
• Launched two commercial products based on the IDES technology: Tussionex ER suspension, NDA, and Delsym ER suspension, NDA

Periggo Company, Allegan, MI 2000 – 2002

Senior Research Scientist

• Directed development/conversion of new products and taste-masking technology as well as technology transfer and process development for commercial OTC company; customized controlled release dosage forms for externally-developed products.
• Secured two patents and received Outstanding Performance Bonus for introduction of Acetaminophen ER Tablets.
• Developed Bilayer tablet of acid labile APIs.
• Developed Multiparticulate Technology for Controlled Drug Release.
• Established Rx to OTC switch group.

P.T. Kalbe Pharma, Indonesia.            1996 – 1999

Research & Development Director

• Led startup of Controlled Release Oral Dosage Forms Development Center for one of Southeast Asia’s largest pharmaceutical companies, overseeing staff of 55 formulation, process, and analytical development scientists/managers.
• Managed process/product development, including technology transfer to production, CGMP implementations, and US FDA ANDA submissions, for release of value-added products and global generics; vital in international product launches.
• Established Process Innovation/Regulatory and Technology Transfer group.
• Established Product Development Group.
• Developed following commercial generic Oral Modified Release Tablets products:
• Nifedipine
• Theophylline and Pentoxifylline
• Diltiazem Oral Modified Release Capsules.

Ranbaxy Laboratories, LTD, New Delhi, India  [3 years]

Senior Research Scientist

• Created proprietary technologies for global launch.
• Developed First Modified Release Oral Dosage of Cefaclor.
• Developed Modified release dosage forms of Etodolac
• Developed technology for multiparticulate system for Ciprofloxacin.
• First NDDS patent.
• Established IP group and initiated US Patent filing process.
• Worked towards Establishment of NDDS group.

National Institute of Immunology New Delhi, India [2 Years]

Scientist In-Charge – Vaccine Delivery & Bio-organic Lab,

NATIONAL INSTITUTE OF IMMUNOLOGY [INDIA] 

Education

MBA, Cornell University-Johnson School of Management [US] –

New Venture Project: business plan for NanoT Antiaging Cosmeceutical.  International Project: Strategy development for non-organic growth of UCB in emerging markets.

Post-Doctoral Fellow, University of Cincinnati

US Department of Industrial Pharmacy, Biopharmaceutics, IVIVC, and Designing of Controlled Release Dosage Forms 

Ph.D. in Pharmaceutics, Sagar University [India] –

Thesis: Formulation & Evaluation of Transdermal Drug Delivery (TDD) Systems Using Prodrug Concept.

Masters Pharma in Pharmaceutics, Sagar University [India] –

Thesis: Formulation & Evaluation of TDD System of Anti-asthmatic Drug Using Prodrug Concept.

Bachelors Pharma in Pharmaceutical Sciences, Sagar University [India]

Invited Speaker

2009, 2010, 2011, 2012

Controlled Release Society and American Pharmaceutical Society Annual Meetings

Nanotechnology and its application in the area of Oral Parenteral and Ophthalmic drug delivery

Research papers published in peer reviewed Journals:

Controlled  Transdermal Mucolytic Delivery system. Drug Development  & Industrial Pharmacy, 17(4), 561-595, 1991.

Controlled  Transdermal Mucolytic Delivery  system:  In-Vivo   Performance. Drug Development & Industrial Pharmacy, 17 (16), 2185-2196, 1991.

Controlled   Transdermal  Occlusive  Delivery  Device  of  Primaquine.  Drug Development  & Industrial  Pharmacy, 19 (11), 1343-1356, 1993.  

Development in Drug Delivery Systems, Part I:  Oral Controlled-Release Drug Delivery System. Cermin Dunia Farmasi, 34, 25-27, Indonesia 1997.

Products: A Case Study. MEDIKA, Journal of Medical and Pharmaceutical Sciences, Indonesia, Comparative In-Vitro and In-Vivo evaluation of commercially available Pentoxifylline Sustained release February 1999