Sarath Kanekal

Current

• President at WWW.TOX-CONSULTANT.COM

Past

• Executive Director, Preclinical Development at SuperGen
• Consultant, Nonclinical at Chemgenex Inc
• Toxicology PK consultant at SuperGen

• Associate Director, Drug Assesment & Development at Chiron (Novartis)
• Senior Director, Pharmacology & Toxicology at Salmedix Inc (Cephalon)
• Director Drug Safety at Corixa
• Assoc Director, Tox/PK at Matrix Pharmaceuticals

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Education

• American Board of Toxicology
• The University of Texas at Austin
• University of California, Davis

• Madras Veterinary College (TNAU)

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Recommended

1 person has recommended Sarath

Connections

311 connections

Industry

Pharmaceuticals

Sarath Kanekal’s Summary

Board certified Toxicologist (DABT).
17 years of Non-Clinical Pharma Leadership & Consultancy in Biotech/Pharma companies: Toxicology, Pharmacology, Pharmacokinetics, Metabolism and Translational Medicine.
Strategy, design and management of IND- and NDA/BLA-enabling studies.
IND/NDA strategy, authoring and troubleshooting.
Leadership & mentoring of Toxicology/Safety Pharmacology/TK/DMPK and Translational/Clinical Pharmacology groups.
16 INDs and 7 NDA/BLAs (Treanda, Bexxar, Accusite, Omacetaxine, IntraDose etc).
I can answer:
Is your drug worthy of Development?
Can I file an IND? Will it be safe & efficacious in humans (odds of)?
Odds of FDA approval?
How to get approval for 'unapproved' marketed prescription drugs?

Sarath Kanekal’s Specialties:

Preclinical strategy- animal POC to IND (cPOC)
NCEs, Biologics (Abs,Vaccines & Adjuvants): oncology & dermatology drugs
Approval for 'unapproved marketed' prescription drugs
ClinPharm strategy & PK data analysis.
Toxicology & DMPK issues, go/no-go decisions
Clinical holds- FDA responses & rebuttals.
IND/NDA/BLA strategy and authoring.
Memberships:
Round Table of Tox Consultants
Amer Board of Toxicology
Amer College of Toxicology
Soc of Toxicology
Reg Affairs Prof Society

Sarath Kanekal’s Experience

• President

  WWW.TOX-CONSULTANT.COM

  (Pharmaceuticals industry)

  January 2009 — Present (11 months)

  Drug Development consultancy for Pharma & Biotech companies.
  Toxicology, Pharmacology, Drug Metabolism and Pharmacokinetics.
  Authoring IND, NDA & BLA documents for US & EU.
  GLP toxicology protocols, study placement and monitoring.
  Clinical Pharmacology program development and protocol generation.
  Strategy for FDA clinical holds and authoring FDA rebuttal letters.

• Executive Director, Preclinical Development

  SuperGen

  (Public Company; SUPG; Pharmaceuticals industry)

  February 2007 — January 2009 (2 years )

  In charge of nonclinical Drug Development: Toxicology, Pharmacology, Drug Metabolism, Pharmacokinetics and Translational Medicine.
  Focus: oncology, inflammation and anti-infectives, targeted TKIs.
  Clinical Pharmacology support: ClinPharm strategy, BA assay transfer, validation, PK report review & interpretation.
  Designed and executed preclinical programs for:
  MP470 IND (cMet & Rad51 inhibitor)
  SGI-1776 (PIM Kinase).
  MP529 IND (Aurora kinase inhibitor)
  SGI-1252 (JAK Kinase).
  Biomarker PK/PD program development: cells, mouse models and human explants.
  Mentored DMPK, Toxicology, Bioanalytical Chemistry and Translational Pharmacology PhD scientists.
  Executed extramural IND-enabling GLP studies at CROs.
  Participated in FDA preIND and IND meetings and teleconferences.
  Provided Regulatory Strategy for drug development.
  Authored IND (CTD format), IB and other Regulatory documents.
  Global outsourcing to China & India CROs to save $$ and increase efficiency

• Consultant, Nonclinical

  Chemgenex Inc

  (Pharmaceuticals industry)

  September 2006 — February 2007 (6 months)

  Nonclinical (Tox DMPK) and clinical PK program development for Omacetaxine (HHT).
  Developed NDA-enabling strategy for both nonclinical (DMPKTOX) & clinical (PK)
  Troubleshoot tox issues holding drug development.
  IND strategy, authoring & support for both US & EU
  Attended FDA meetings- IND & EOPII
  Authored FDA rebuttal letters.
  Authored & reviewed omacetxaine NDA.

• Toxicology PK consultant

  SuperGen

  (Public Company; 1-10 employees; SUPG; Pharmaceuticals industry)

  July 2006 — February 2007 (8 months)

  Nonclinical (Tox DMPK) and clinical consultancy at Supergen.
  Troubleshoot tox issues holding drug development.
  GLP tox studies monitoring.
  IND strategy, authoring & support.
  Attended FDA meetings- IND.
  Authored FDA rebuttal letters.

• Associate Director, Drug Assesment & Development

  Chiron (Novartis)

  (Biotechnology industry)

  September 2005 — October 2006 (1 year 2 months)

  Toxicology support for Novartis' (Chiron) global operations: world-wide tox/drug safety support to all Divisions.
  Toxicology strategy & assessment for CHIR-265 IND, an oncology TKI product targeting RAF kinase.
  Toxicology representative on several project teams.
  Monitored extramural and intramural toxicology GLP & non-GLP studies.
  Development of toxicology programs for novel immunostimulants (SMIPS).
  Special Toxicology programs for immuno modulator drug leads (vaccines & adjuvants).
  Toxicology support for Chiron’s marketed drug products: PSURs, Annual Reports.
  Mentored junior DABT Toxicologists
  Toxicology Report writing/editing to support Regulatory filings (FDA & EU).
  Authoring sections of- and critical review of IND, IB and other Regulatory documents.
  Safety assessment/Toxicology support to commercial manufacturing operations (MSDS etc).

• Senior Director, Pharmacology & Toxicology

  Salmedix Inc (Cephalon)

  (Pharmaceuticals industry)

  October 2002 — September 2005 (3 years )

  Lead the non-clinical development of Bendamustine (Treanda), authored the nonclinical sections of NDA.
  Built the Tox/PK group and developed budgets for capital expenditures and labor.
  Developed several cancer models (prostate, colon, lymphoma etc) in nude/SCID mice for efficacy screening.
  Developed academic research collaborations in US and Europe.
  Evaluated in-licensing drugs for efficacy, safety and toxicity to assess probability of clinical success (Fujisawa, Aventis, Vertex, Collgard, Asahi Kasei, Chemgenex, Fortress, ImaRx, Neopharma, SLIL, Heidelberg Pharma etc.)
  Prepared out-licensing packages of preclinical stage drug candidates (Aventis, BMS etc.).
  Clinical Pharmacology:
  Reviewed European clinical PK studies on SDX-105 for the US IND.
  Drafted an NDA-enabling clinical PK study plan for FDA EOP2 meeting.
  Analyzed clinical PK data using WINNONLIN to support clinical PII trials.
  Provided clinical PK expertise and strategic plans at project team meetings.

• Director Drug Safety

  Corixa

  (Pharmaceuticals industry)

  September 2001 — October 2002 (1 year 2 months)

  Designed and monitored intra- extra-mural non-GLP/GLP toxicology and PK animal studies on novel immunostimulatory biologics including toll-like receptors, antibodies, antigens, vaccines and adjuvants for a variety of indications to support INDs or Phase-I/II clinical trials. (Lung cancer, Tb, Leishmania vaccine products, Ab+NCE targeted combos such as Super LuDox).
  Cancer vaccine development, IND support: NSCLC & Melanoma
  In charge of building a Drug Safety Group to conduct Toxicology/Safety studies; developed budgets for capital expenditures and labor.
  Lead the nonclinical Drug Safety group spread across two states (CA and MT).
  Active participation in project teams, regulatory and clinical groups and interactions with partners (such as Japan Tobacco and Xambone Pharma Italy).
  Participation in pre-IND meetings with the FDA and in animal house management meetings ( IACUC).
  Retained as Executive Consultant by Corixa Corp.

• Assoc Director, Tox/PK

  Matrix Pharmaceuticals

  (Pharmaceuticals industry)

  May 1993 — August 2001 (8 years 4 months)

  Toxicology:
  Designed and monitored intra- extra-mural non-GLP/GLP toxicology animal studies on oncology and dermal drug products.
  Designed and monitored PK/ADME via storage-phosphor autoradiography.
  Lead the Tox/PK R&D group.
  Developed budgets for capital expenditures and labor.
  Generated study reports for Tox/PK studies to support IND, NDA and European regulatory filings (MAA) per ICH guidelines (AccuSiteTM and IntraDoseTM NDAs).
  Addressed Tox/Safety/PK issues raised by Regulatory Agencies in US and Europe.
  Supervision of Lab Animal facility, establish policies to ensure compliance with State and USDA regulations.
  Clinical Pharmacology:
  Designed clinical PK phase I/II and NDA-enabling studies of slow release products, (AccuSite and IntraDose NDAs, interferon, and FMdC PII PK trials).
  Analyzed and interpreted clinical PK data using WINNONLIN/PCNONLIN.
  Authored Regulatory PK reports, documents, and clinical PK manuscripts.
  Authored ODAC briefing documents.

Sarath Kanekal’s Education

• American Board of Toxicology

  DABT , Toxicology , 1995 — 1995

  Activities and Societies:

  Board Certification in Toxicology

• The University of Texas at Austin

  Postdoc , Toxicology , 1990 — 1993

  Mechanisms of cancer drug toxicity.
  American Pharmaceutical Manufacturer Association Scholar, PhRMA

• University of California, Davis

  PhD , Pharmacology & Toxicology , 1984 — 1990

  UC Regents Fellow
  Thesis Advisors: Dr. Alan Buckpitt, Dr. Charles Plopper and Dr. Hanspeter Witschi, Dr Bruce Hammock

  Activities and Societies:

  Member:
  ASPET: Pharmacology
  SOT: Toxicology
  ISSX: Metabolism/Pharmacokinetics

• Madras Veterinary College (TNAU)

  BVSC (DVM) , Vetrinary Medicine & Surgery , 1979 — 1984

  Small animal & large animal medicine & surgery, pets & domestic animals.

Additional Information

Sarath Kanekal’s Interests:

Pharmaceutical Toxicology Drug metabolism & disposition Regulatory Affairs Philosophy Photo/videography

Sarath Kanekal’s Groups:

Roundtable of Toxicology Consultants (RTC)
American Board of Toxicology (ABT)
Society of Toxicology (SOT)
Pharmacology & Experimental Therapeutics (ASPET)
Regulatory Affairs Professionals (RAPS)
American Association of Cancer Research (AACR)
American Association of Pharmaceutical Scientists (AAPS)

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•    The Toxicology Forum
•    Regulatory Affairs Professionals Society (RAPS)
•    Pharmaceutical & Biotech Licensing & Business Network
•    Early Stage Clinical Trials
•    RADSP - Regulatory Affairs & Drug Safety Professionals
•    Cell Therapy Industry group
•    Biotech Investment Group
•    Pre-Clinical Forum
•    Drug Discovery & Development Professionals
•    The Science Advisory Board
•    San Diego Biotechnology Network (SDBN)
•    Oncology Drug Development (1400+ Members)
•    China Pharma Biotech Professional Network
•    The Association of Asian American Professionals in Biotechnology and Pharmaceuticals
•    BioTech Leaders
•    Contract Research Organizations in Asia-Pacific
•    Biotech and Pharma Consultants
•    BEXXAR Alumni

Sarath Kanekal’s Honors:

Pharmaceutical Manufacturers' Association Fellow (PhRMA Fellow).
UC Regents Fellow, University of California, Davis
UC Regents Distinguished Scholar, University of California, Davis

Sarath Kanekal’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• new ventures
• expertise requests
• reference requests
• getting back in touch